左心耳夹闭术

BACKGROUND Combining pulsed field ablation (PFA) and left atrial appendage occlusion (LAAO) to one procedure is appealing for atrial fibrillation treatment. OBJECTIVE To compare the outcome of combined and standalone procedures METHODS: This is a retrospective cohort study of consecutive patients undergoing combined PFA and LAAO procedures in 3 centers in 2023. They underwent PFA pulmonary vein isolation (PVI) with Farapulse, followed by LAAO with Watchman FLX guided by transesophageal echocardiogram (TEE). Pulmonary ridge thickness was measured at 45 degrees, 5mm from tip of the ridge, before and after PFA. At 3-month, TEE or computed tomography was performed for LAAO patients to assess occlusion result. Peri-device leak (PDL) of more than 3mm was defined as significant. Consecutive PFA or LAAO standalone procedures served as control. RESULTS This cohort included 36 combined, 48 standalone LAAO and 52 standalone PFA cases. Acute PVI was achieved in all combined and PFA standalone procedures. Successful LAAO implantation with Watchman FLX was achieved in 97.2% combined procedures, and all standalone LAAO procedures. In the combined cohort, pulmonary ridge thickness increased after ablation by 2.72±1.19mm (p<0.001) or 69.4%±51.4%. At 3-month, the rate of PDL did not differ between combined and standalone LAAO cohorts (26.7 vs 15.2%, p=0.22). However, significant PDL (>3mm) occurred more commonly in the combined cohort compared to standalone LAAO cohort (20% vs 2.2%, P=0.013). CONCLUSION Combined PFA and LAAO was feasible. However, we observed a mean 69.4% increase in pulmonary ridge thickness immediately following PFA. Significant PDL was more prevalent in combined procedure.

BACKGROUND Left atrial appendage occlusion (LAAO) devices reduce the risk of atrial fibrillation-associated stroke relative to no oral anticoagulation. However, uncertainty and practice variation persist in the areas of patient selection, periprocedural imaging, adjunctive antithrombotic therapy, and management of peridevice leak (PDL) and device-related thrombus. The Society for Cardiovascular Angiography & Interventions and Heart Rhythm Society developed these evidence-based guidelines to support clinicians, patients, and other stakeholders in management decisions regarding LAAO. METHODS The Society for Cardiovascular Angiography & Interventions and Heart Rhythm Society convened a balanced, multidisciplinary guideline panel with <50% of members reporting significant conflicts of interest with the industry. Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for guideline development. The guideline panel formulated and prioritized clinical questions following the Grading of Recommendations Assessment, Development, and Evaluation approach in a population, intervention, comparison, outcome format. A technical review team of clinical and methodological experts conducted systematic reviews of the published evidence, synthesized data, and graded the certainty of evidence across outcomes. The guideline panel then developed recommendations and supporting statements informed by the technical review and using the Grading of Recommendations Assessment, Development, and Evaluation evidence-to-decision framework. RESULTS The guideline panel developed 8 evidence-based recommendations to address variations in care related to LAAO. The panel also identified 2 knowledge gaps. CONCLUSIONS Key recommendations address patient selection for LAAO, periprocedural imaging, adjunctive antithrombotic therapy, and management of PDL and device-related thrombus. The panel also recommended necessary future research regarding the use of single antiplatelet therapy following LAAO and regarding the management of PDL.

Background Intracardiac echocardiography (ICE) is an alternative to transesophageal echocardiography to guide left atrial appendage occlusion (LAAO). However, 2-dimensional ICE has important limitations that hinder its adoption in routine practice. Objectives This prospective multicenter study (NCT04569734) investigated the feasibility and safety of ICE-guided LAAO with Watchman FLX using a novel 3-dimensional ICE catheter (VeriSight Pro, Philips). Methods A total of 100 patients undergoing LAAO with the Watchman FLX device were recruited. All cases were performed under moderate sedation. A simplified 2 orthogonal view ICE imaging protocol was adopted to assess PASS (position, anchoring, sizing, and sealing) criteria. The feasibility endpoint was successful implantation of the FLX device and adequate seal (peri-device leak <5 mm) at 45 days. The safety endpoint was the incidence of major complications at 7 and 45 days. Physician experience and imaging quality scores were collected (1 = lowest, 5 = highest). Results The mean age was 77.0 ± 8.1 years, and 39 (39%) were women. CHA2DS2-VASc score was 4.8 ± 1.5 and HAS-BLED score was 3.2 ± 1.1. Total procedural time was 54 ± 25 minutes. Mean contrast volume was 41 ± 46 ml, with no contrast used in 16 patients. The feasibility endpoint was achieved in 95 patients (95%); 4 patients were not implanted due to unsuitable anatomy, and 1 patient had a leak >5 mm at 45 days. There was 1 periprocedural stroke and 2 gastrointestinal bleeds requiring transfusion at 7 days with no other major complications. Physicians’ rating of overall ICE imaging quality was 4.6 ± 0.6. Conclusions The novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.

Background Up to 50% of patients undergoing mitral transcatheter edge-to-edge repair (MTEER) have an indication for left atrial appendage occlusion (LAAO). However, prospective evaluation of this strategy is lacking. Objectives The aim of the study was to prospectively evaluate the outcomes of combined LAAO and MTEER. Methods The WATCH-TEER study is a prospective multicenter registry that aims to assess the feasibility and safety of concomitant MTEER with MitraClip and LAAO with WATCHMAN-FLX in patients with an approved clinical indication for both procedures. The primary endpoint was a composite of all-cause mortality, stroke, life-threatening, or major bleeding at 45 days. Results A total of 24 patients were included between October 2020 and March 2024. Mean age was 79.5 ± 6.3 years, and 83% were males. The Society of Thoracic Surgeons operative risk score was 11.8% ± 5.3%, the CHA2DS2-VASc score was 4.5 ± 1.1, and the HAS-BLED score was 3.3 ± 1.5. Total procedure time was 103.6 ± 33.7 minutes. At 45 days, the primary endpoint occurred in 21% (95% CI: 5%-37%, n = 5/24) of patients, all of which occurred after discharge including 1 cardiac death, 1 ischemic stroke, 1 trauma-related intracranial hemorrhage, and 2 nonprocedural major bleeds. At 45 days, most patients (68%) had ≤2+ mitral regurgitation, and 72% of patients were in NYHA functional class I-II symptoms. Additionally, 71% of patients were not on anticoagulation, compared with only 20% at baseline. Conclusions Combining LAAO with MTEER is feasible in patients who have a clinical indication for both procedures.

Left atrial appendage occlusion (LAAO) has emerged as an alternative to long-term anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation deemed high risk for bleeding. LAAO is performed via a transseptal approach with the placement of an occlusion device in the left atrial appendage (LAA) to seal it. Intraoperative imaging with echocardiography is needed to guide and complete the procedure. Historically, Transesophageal echocardiography (TEE) has been the most frequently used modality for intraprocedural guidance. Recently, there has been a growing interest in the use of intracardiac echocardiography (ICE) as an adjunct to, or even an alternative to, transesophageal echocardiography (TEE), with several unique advantages and potential challenges. Several publications have highlighted the safety and feasibility of ICE in LAAO (Hemam et al., 2019; Morcos et al., 2022; Zhang et al., 2023 [2, 5, 7]). The most recent SCAI/HRS consensus statement recommends using TEE or ICE in procedural guidance (Saw et al., 2023 [8]). To date, no prospective randomized controlled trials have addressed the safety and feasibility of ICE-guided LAAO, compared to TEE guidance. The ICE TEE trial is a single-center, prospective, randomized, parallel-controlled, open-label clinical trial that will assess the efficacy and safety of ICE-guided LAAO compared to traditional TEE-guided LAAO. Patients are randomized in a 1:1 fashion. The primary endpoint of the study is the procedural success of LAAO device implantation, defined as the appropriate device implantation as per the IFU, without device-related complications, and no peri-device leaks >5 mm on color Doppler, according to the Munich consensus. Secondary endpoints include periprocedural complications, procedural characteristics, and cost of hospitalization. Patients will be assessed at 45 days with a TEE to evaluate for any peri-device leak (PDL). The trial aims to assess the efficacy and potential complications of using ICE to guide the implantation of percutaneous left atrial appendage occlusion (LAAO) devices compared to the traditional transesophageal echocardiography (TEE)- guided LAAO.

BACKGROUND Transcatheter left atrial appendage occlusion (LAAO) is an alternative to lifelong anticoagulation, but optimal patient selection remains challenging. OBJECTIVES This study sought to apply a novel causal machine learning framework to identify patients who would benefit from LAAO vs a direct oral anticoagulant (DOAC). METHODS We identified 744,190 adult patients with atrial fibrillation treated with either LAAO or DOAC between March 13, 2015, and December 31, 2019, using data from OptumLabs Data Warehouse. One-to-one propensity score matching was used to create a cohort where patients were similar in 107 baseline characteristics. A causal forest model was used to estimate the heterogeneous treatment effect for a composite outcome of ischemic stroke, systemic embolism, major bleeding, and all-cause mortality. RESULTS In the matched cohort of 28,930 patients, the mean age was 76.8 ± 6.3 years; 5,818 patients (40%) were female, and the mean CHA2DS2-VASc score was 5.8. LAAO was associated with no difference with the primary composite outcome in comparison to NOAC early on (average treatment effect of -0.68% [-1.4%, 0.06%] at 1 year), but a lower risk at the end of 2 years (average treatment effect of -2.9% [-3.7%, -2.0%]). At the end of 2 years, 30.1% of the overall cohort were classified as potentially benefiting from LAAO, 69.7% were classified as neutral, and 1.4% were potentially harmed by LAAO. CONCLUSIONS Novel machine learning algorithms were developed to identify patients who are more likely to benefit from LAAO vs DOACs. This information can support clinical decision-making to determine which patients should be referred to subspecialists for further examination and discussion of LAAO.

Key Points Question Does percutaneous left atrial appendage occlusion compared with an oral anticoagulant offer reduced risk of bleeding, death, and stroke in patients with kidney failure and nonvalvular atrial fibrillation who are undergoing dialysis? Findings In this cohort study, 293 patients with kidney failure and atrial fibrillation who received left atrial appendage occlusion were propensity matched to 2051 patients receiving oral anticoagulants. The study found evidence that left atrial appendage occlusion was associated with a lower risk of recurrent bleeding events and death. Meaning The findings of this study suggest that in patients with kidney failure and atrial fibrillation, left atrial appendage occlusion may offer safer thromboembolic risk reduction compared with oral anticoagulants.

Watchman FLX (W‐FLX) is the most widely used left atrial appendage occlusion (LAAO) device to prevent atrial fibrillation (AF) related strokes in the United States. However, successful LAAO with W‐FLX can be challenging in patients with complex left atrial appendage (LAA) anatomies. This analysis aimed to assess the procedural success rates of LAA occlusion (immediate and short‐term outcomes) using the Amulet device, in patients with prior failed LAAO with W‐FLX device.

Importance Optimal antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is not well established as no randomized evaluation has been performed to date. Objective To compare the efficacy and safety of low-dose direct oral anticoagulation (low-dose DOAC) vs dual antiplatelet therapy (DAPT) for 3 months after LAAO. Design, Setting, and Participants The ADALA (Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion) study was an investigator-initiated, multicenter, prospective, open-label, randomized clinical trial enrolling participants from June 12, 2019, to August 28, 2022 from 3 European sites. Patients who underwent successful LAAO were randomly assigned 1:1 to low-dose DOAC vs DAPT for 3 months after LAAO. The study was prematurely terminated when only 60% of the estimated sample size had been included due to lower recruitment rate than anticipated due to the COVID-19 pandemic. Interventions The low-dose DOAC group received apixaban, 2.5 mg every 12 hours, and the DAPT group received aspirin, 100 mg per day, plus clopidogrel, 75 mg per day, for the first 3 months after LAAO. Main Outcomes and Measures The primary end point was a composite of safety (major bleeding) and efficacy (thromboembolic events including stroke, systemic embolism, and device-related thrombosis [DRT]) within the first 3 months after successful LAAO. Secondary end points included individual components of the primary outcome and all-bleeding events. Results A total of 90 patients (mean [SD] age, 76.6 [8.1] years; 60 male [66.7%]; mean [SD] CHADS-VASc score, 4.0 [1.5]) were included in the analysis (44 and 46 patients in the low-dose DOAC and DAPT groups, respectively). A total of 53 patients (58.8%) presented with previous major bleeding events (60 gastrointestinal [66.7%] and 16 intracranial [17.8%]). At 3 months, low-dose DOAC was associated with a reduction of the primary end point compared with DAPT (2 [4.5%] vs 10 [21.7%]; hazard ratio, 0.19; 95% CI, 0.04-0.88; P = .02). Patients in the low-dose DOAC group exhibited a lower rate of DRT (0% vs 6 [8.7%]; P = .04) and tended to have a lower incidence of major bleeding events (2 [4.6%] vs 6 [13.0%]; P = .17), with no differences in thromboembolic events such as stroke and systemic embolism between groups (none in the overall population). Conclusions and Relevance This was a small, randomized clinical trial comparing different antithrombotic strategies after LAAO. Results show that use of low-dose DOAC for 3 months after LAAO was associated with a better balance between efficacy and safety compared with DAPT. However, the results of the study should be interpreted with caution due to the limited sample size and will need to be confirmed in future larger randomized trials. Trial Registration ClinicalTrials.gov Identifier: NCT05632445.

BACKGROUND: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry’s Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States. METHODS: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year. RESULTS: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients. CONCLUSIONS: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.

Left atrial appendage occlusion (LAAO) is rapidly growing as valid stroke prevention therapy in atrial fibrillation. Cardiac imaging plays an instrumental role in preprocedural planning, procedural execution, and postprocedural follow-up. Recently, cardiac computed tomography (CCT) has made significant advancements, resulting in increasing use both preprocedurally and in outpatient follow-up. It provides a noninvasive, high-resolution alternative to the current standard, transesophageal echocardiography, and may display advantages in both the detection and characterization of device-specific complications, such as peridevice leak and device-related thrombosis. The implementation of CCT in the follow-up after LAAO has identified new findings such as hypoattenuated thickening on the atrial device surface and left atrial appendage contrast patency, which are not readily assessable on transesophageal echocardiography. Currently, there is a lack of standardization for acquisition and interpretation of images and consensus on definitions of essential findings on CCT in the postprocedural phase. This paper intends to provide a practical and standardized approach to both acquisition and interpretation of CCT after LAAO based on a comprehensive review of the literature and expert consensus among European and North American interventional and imaging specialists.

Importance Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT. Objective To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT. Design, Setting, and Participants This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score. Exposure Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group). Main Outcomes and Measures The primary outcome was time to first ischemic stroke. Results Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy. Conclusions and Relevance In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

BACKGROUND Data on the impact of residual peri-device leak after left atrial appendage occlusion (LAAO) are limited. OBJECTIVES The goal of this study was to explore the association of peri-device leak with adverse clinical events. METHODS The National Cardiovascular Data Registry LAAO Registry was queried to identify patients undergoing LAAO between January 1, 2016, and December 31, 2019. Patients were classified according to leak size on echocardiography at 45 ± 14 days (0 mm, no leak; >0-5 mm, small leak; and >5 mm, large leak). RESULTS A total of 51,333 patients were included, of whom 37,696 (73.4%) had no leak, 13,258 (25.8%) had small leaks, and 379 (0.7%) had large leaks. The proportion of patients on warfarin at 45 days was higher in the large vs small or no leak cohorts (44.9% vs 34.4% and 32.4%, respectively; P < 0.001). At 6 and 12 months, anticoagulant utilization decreased but remained more frequent in patients with large leaks. Thromboembolic and bleeding events were uncommon in all groups. However, compared with patients with no leak, those with small leaks had slightly higher odds of stroke/transient ischemic attack/systemic embolization (adjusted HR: 1.152; 95% CI: 1.025-1.294), major bleeding (HR: 1.11; 95% CI: 1.029-1.120), and any major adverse events (HR: 1.102; 95% CI: 1.048-1.160). There were no significant differences in adverse events between patients with large leaks and patients with small or no leaks. CONCLUSIONS Small (>0-5 mm) leaks after LAAO were associated with a modestly higher incidence of thromboembolic and bleeding events; large leaks (>5 mm) were not associated with adverse events, although higher proportions of these patients were maintained on anticoagulation. Newer devices with improved seal might mitigate the events associated with residual leaks.

BACKGROUND Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited. OBJECTIVES The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years. METHODS The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates. RESULTS A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 4 to 56) and for physicians was 12 (interquartile range: 0 to 14). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare. CONCLUSIONS The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.

BACKGROUND Multiple studies continue to evaluate the use of intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) for guiding left atrial appendage occlusion (LAAO). OBJECTIVE To conduct an updated meta-analysis comparing the effectiveness and safety outcomes of both imaging modalities. METHODS PubMed, Cochrane, and Embase were searched for studies comparing ICE vs TEE to guide LAAO. Odds ratios (OR) with 95% confidence intervals (CI) were pooled using a random-effects model. The primary effectiveness endpoint was procedural success. The primary safety endpoint included the overall complications rate. Additional safety outcomes were assessed as secondary endpoints. Subgroup analysis of primary endpoints was conducted according to device type (Amulet, LAmbre, Watchman, Watchman FLX) and study region (American, Asia, Europe). We used R version 4.3.1 for all statistical analyses. RESULTS Our meta-analysis included 19 observational studies encompassing 42,474 patients, of whom 4,415 (10.4%) underwent ICE-guided LAAO. Compared with TEE, ICE was associated with a marginally higher procedural success (OR 1.33; 95% CI: 1.01-1.76; p=0.04; I2=0%). There was no significant difference in the overall complications rate (OR 1.02; 95% CI: 0.77-1.36; p=0.89; I2=5%). However, ICE showed higher rates of pericardial effusion (OR 2.11; 95% CI: 1.47-3.03; p<0.001; I2=0%) and residual iatrogenic atrial septal defect (iASD) (OR 1.52; 95% CI: 1.15-2.03; p<0.004; I2=0%). Subgroup analysis revealed variations in procedural success within the ICE group across study regions (p=0.02). CONCLUSION In this updated meta-analysis, the increasing adoption of ICE-guided LAAO demonstrated higher procedural success rates compared to TEE, although with limited statistical significance. Overall complication rates were similar; however, ICE showed higher rates of pericardial effusion and residual iASD.

BACKGROUND The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described. OBJECTIVES This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens. METHODS The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression. RESULTS Among 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus. CONCLUSIONS In real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin.

BACKGROUND Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols. OBJECTIVES This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies. METHODS We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression. RESULTS Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up. CONCLUSIONS In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.

BACKGROUND Clinical outcomes of left atrial appendage occlusion (LAAO) combined with other cardiac procedures have not been previously examined. OBJECTIVES This study sought to evaluate the safety and efficacy of combining LAAO with other cardiac procedures vs isolated LAAO. METHODS We conducted a retrospective cohort study using the 2016 to 2020 National Inpatient Sample database to compare patients undergoing LAAO combined with another cardiac procedure vs isolated LAAO. Outcomes included risk-adjusted major adverse cardiovascular events (MACEs), in-hospital mortality, major complications, length of stay (LOS), and total costs. RESULTS The total cohort included 88,910 weighted encounters, of which 1,225 (1.4%) involved concomitant cardiac procedures. After risk adjustment, patients in the concomitant procedure group had similar odds of MACEs (adjusted OR: 1.82; 95% CI: 0.94-2.74); in-hospital mortality; and complications including stroke, acute kidney injury, major bleeding, blood transfusion, and vascular injury. They also had similar LOS (1 day vs 1 day; P = 0.32) and higher costs ($44,723 vs $32,364; P < 0.01) compared with isolated LAAO but shorter LOS (1 day vs 2 days; P < 0.01) and lower costs ($51,552 vs $63,170; P = 0.04) compared with LAAO with sequential procedures. In subgroup analyses, concomitant atrial fibrillation/atrial flutter ablation had higher adjusted odds of heart block (P < 0.01), and concomitant transcatheter aortic valve replacement had higher adjusted odds of stroke (P = 0.02) and vascular injury (P < 0.01). CONCLUSIONS In this retrospective observational study, combining LAAO with another cardiac intervention appeared to be associated with similar MACEs and LOS. However, certain complications appeared to be more frequent, and the cost was higher with combined procedures.

Abstract Aims Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. Methods and results The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan–Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0–18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03–1.08, per year increase], heart failure (HR 1.73, CI: 1.24–2.41), vascular disease (HR 1.47, CI: 1.05–2.05), valvular disease (HR 1.63, CI: 1.15–2.33), abnormal liver function (HR 1.80, CI: 1.02–3.17), and abnormal renal function (HR 1.58, CI: 1.10–2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. Conclusion One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. Clinical trial registration The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282.

BACKGROUND Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

BACKGROUND Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. OBJECTIVES This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. METHODS Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. RESULTS A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. CONCLUSIONS DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

BACKGROUND Long-term oral anticoagulation is the mainstay therapy for thromboembolic (TE) prevention in patients with atrial fibrillation (AF). However, left atrial appendage occlusion (LAAO) could be a safe alternative to direct oral anticoagulants (DOACs) in patients with a very high thromboembolic risk profile. OBJECTIVE to compare the safety and efficacy of LAAO versus DOACs among AF patients at very high stroke risk (CHA2DS2-VASc score ≥ 5). METHODS Data from patients with a CHA2DS2-VASc score ≥ 5 were extracted from a prospective multicenter database. To attenuate the imbalance in covariates between groups, propensity score matching was used (co-variates: CHA2DS2-VASc and HAS-BLED scores), which resulted in a matched population of 277 patients per group. The primary endpoint was a composite of cardiovascular death, TE events, and clinically-relevant bleeding during follow-up. RESULTS Among 2381 patients, 554 very high-risk patients were included in the study (79 ± 7 years; CHA2DS2-VASc: 5.8 ± 0.9; HAS-BLED: 3.0 ± 0.9). The mean follow-up duration was 25±11 months. A higher incidence of the composite endpoint was documented with DOACs compared to LAAO [14.9/100 patient-years (py) in DOAC vs 9.4/100py in LAAO group; p=0.03). The annualized clinically-relevant bleeding risk was higher with DOACs (6.3% vs 3.2%; p = 0.04), while the risk of TE events was not different between groups (4.1 % vs 3.2%; p = 0.63). CONCLUSIONS Among high-risk patients, LAAO had similar stroke prevention efficacy but a significantly lower risk of clinically-relevant bleeding when compared with DOACs. LAAO clinical benefit became significant after 18 months of follow-up.

No abstract available

BACKGROUND The safety and efficacy of a combined approach of catheter ablation (CA) and left atrial appendage occlusion (LAAO) compared to LAAO alone remain unknown. METHODS Patients with atrial fibrillation (AF) at increased stroke risk who underwent LAAO were divided into either combined (CA and LAAO) procedure or LAAO alone group. Propensity score matching was utilized to balance baseline characteristics. The primary endpoint of the study was a composite of death, thromboembolic events, major bleeding, heart failure (HF) rehospitalization and major periprocedural complications. RESULTS A total of 707 AF patients who underwent LAAO were included. After 1:1 propensity score matching, 166 patients who underwent LAAO alone (n=83) or the combined procedure (n=83) were analyzed. Successful LAAO was achieved in all (100%) patients, with a low incidence of periprocedural complications in both groups (2.4% vs. 4.8%, LAAO vs. combined, p=0.68). The incidence of peri-device leak post-LAAO was significantly higher in the combined group (25.3% vs. 43.4%, p=0.01). After a median follow-up of 2 years, there were no significant differences in the rates of the primary composite endpoint between the two strategies (22.2% vs. 14.3%, HR: 1.24 [95% CI: 0.51-2.97], p=0.63). However, the rate of HF rehospitalization was significantly lower in the combined group (19.6% vs. 3.6%, HR: 4.89 [95% CI: 1.50-15.97], p=0.024). CONCLUSIONS Combining CA and LAAO in a "one-stop" approach is safe and brings additional benefit in relieving symptoms of heart failure, although peri-device leak was more common compared to LAAO alone.

Left atrial appendage occlusion (LAAO) with WATCHMAN currently requires preprocedural imaging, general anesthesia, and inpatient overnight admission. We sought to facilitate simplification of LAAO.

Left atrial appendage occlusion (LAAO) is a suitable alternative to oral anticoagulant therapy to prevent stroke in patients with AF. Most procedures are performed under transoesophageal echocardiography (TOE) guidance, which facilitates transseptal puncture, reduces the risk of procedurerelated complications and provides an additional method for device selection and real-time monitoring during device deployment. However, TOE has significant shortcomings, including the need for general anaesthesia/deep sedation as well as a significant risk of procedure-related adverse events. More recently, intracardiac echocardiography has been proposed as an alternative to TOE guidance during LAAO procedures. In this review, we summarise the available evidence as well as providing a step-by-step approach for intracardiac echocardiography-guided LAAO.

Background Device-related thrombosis (DRT) occurs in up to 4% of patients undergoing left atrial appendage occlusion (LAAO) and is associated with substantial morbidity and mortality. However, its pathophysiology, predictors, and optimal management remain unclear. Objectives This study aims to assess flow dynamic factors correlating to DRT. Methods A multicenter registry of patients who underwent LAAO and had pre- and post-computed tomography imaging was used. Patient-specific 3-dimensional digital models of the left atrium were created, and finite element simulations were performed to implant an LAAO device into each model in a position that matched the clinical deployment. Computational fluid dynamic simulations were performed to quantify the following flow dynamic parameters: time averaged wall shear stress, oscillatory shear index, and endothelial cell activation potential. Results A total of 38 patients (19 with DRT and 19 without DRT) were included. Left atrium volumes and mitral valve areas were larger in the DRT cohort compared with controls. Patients with DRT had a significantly lower time averaged wall shear stress (1.76 ± 1.24 Pa vs 2.90 ± 2.70 Pa), a higher oscillatory shear index (0.19 ± 0.11 vs 0.17 ± 0.11), and a higher endothelial cell activation potential (0.23 ± 0.58 Pa–1 vs 0.17 ± 0.30 Pa−1) than the controls (P < 0.001 for all). Thrombus locations identified from in-vivo images correlated well with the flow dynamic parameters tested. Conclusions Flow dynamic parameters may be able to predict the risk of DRT after LAAO. Further investigation with a larger patient cohort and long-term follow-up is needed to assess the role of computational fluid dynamics in the risk stratification of patients considered for LAAO.

BACKGROUND The hemodynamic effects of transcatheter left atrial appendage occlusion (LAAO) remain unclear. OBJECTIVE We sought to assess the effect of LAAO on invasive hemodynamics and their correlation with clinical outcomes. METHODS We recorded mean left atrial pressure (mLAP) before and after device deployment. We assessed: (a) the prevalence and predictors of mLAP increase post-deployment; (b) the association between significant mLAP increase post-deployment and 45-day peridevice leak (PDL); (c) the association between mLAP increase and heart failure (HF) hospitalization. Significant mLAP increase was defined as one equal to or greater than the mean percentage increase in mLAP post-deployment (≥28%). RESULTS We included 302 patients (36.4% female; mean age, 75.8±9.5 years). Post-deployment, mLAP increased in 48.0% of patients, 38.0% of whom experienced significant mLAP increase. Independent predictors of mLAP increase were baseline mLAP ≤14 mmHg, non-paroxysmal atrial fibrillation, and age (odds ratios: 3.66; 95%CI 2.21-6.05, 1.81; 95%CI 1.08-3.02, and 0.85 (per 5 years); 95%CI 0.73-0.99, respectively). Significant mLAP increase was an independent predictor of 45-day PDL (OR: 2.55; 95%CI 1.04-6.26). There was no association between mLAP increase and HF hospitalization. CONCLUSION MLAP acutely rises in 48% of patients post-deployment, although this is not associated with increased HF hospitalizations. Patients with significant increase in mLAP post-deployment are more likely to develop PDL at 45 days, albeit most leaks were small (<5 mm). These findings suggest that mLAP increase post-deployment is not associated with major safety concerns. Additional studies are warranted to explore the long-term hemodynamic effects of LAAO.

Left atrial appendage occlusion (LAAO) is an established alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Antithrombotic therapy is used in the post-procedural period to prevent device-related thrombosis (DRT). The risk of DRT is considered highest in the first 45–90 days after device implantation, based on animal studies of the device healing process. Clinically applied antithrombotic regimens vary greatly across studies, continents, and centers. This article gives an overview of the evidence behind current antithrombotic regimens, ongoing randomized trials, and future post-procedural management.

BACKGROUND The optimal antithrombotic therapy following left atrial appendage occlusion (LAAO) remains debated. Ideally, this therapy should effectively prevent device-related thrombosis (DRT) while minimising the associated bleeding risk. AIMS We aimed to evaluate the long-term safety and efficacy of a postprocedural single antiplatelet therapy (SAPT) strategy following Amplatzer LAAO in a large consecutive cohort. METHODS This retrospective, single-centre, observational study included all patients discharged on SAPT after LAAO with the Amplatzer Cardiac Plug (ACP) or Amplatzer Amulet between March 2010 and December 2021 at Aarhus University Hospital, Denmark. Baseline, procedural, and imaging data were obtained locally, while clinical outcomes and medication data were extracted from the Danish national health registries. RESULTS A total of 553 patients underwent Amplatzer LAAO during the specified time frame. Of these, 431 (77.9%) high bleeding risk patients were discharged on SAPT with either acetylsalicylic acid (n=403, 72.9%) or clopidogrel (n=28, 5.1%). At 6 months, 173 (41.7%) patients were not on any antithrombotic therapy. The mean CHA2DS2-VASc and HAS-BLED scores were 3.9±1.5 and 3.4±1.1, respectively. DRT was detected in 6 (1.5%) patients on 8-week follow-up imaging using cardiac computed tomography (n=386, 89.6%) or transoesophageal echocardiography (n=27, 6.3%). The 1-year ischaemic stroke rate was 2.2% (95% confidence interval [CI]: 1.1-4.2). One-year rates for major bleeding and cardiovascular death were 5.9% (95% CI: 4.0-8.9) and 2.9% (95% CI: 1.6-5.1), respectively. CONCLUSIONS SAPT following Amplatzer LAAO displayed rates of DRT and stroke comparable to those reported with more intensive antithrombotic regimens. Meanwhile, we observed low rates of major bleeding.

No abstract available

BACKGROUND Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking. METHODS We conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated score (≥2 in men and ≥3 in women) on the CHA2DS2-VASc scale (range, 0 to 9, with higher scores indicating a greater risk of stroke) and who underwent catheter ablation. Patients were randomly assigned in a 1:1 ratio to undergo left atrial appendage closure or receive oral anticoagulation. The primary safety end point, tested for superiority, was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The primary efficacy end point, tested for noninferiority, was a composite of death from any cause, stroke, or systemic embolism at 36 months. The secondary end point, tested for noninferiority, was major bleeding, including procedure-related bleeding, through 36 months. RESULTS A total of 803 patients were assigned to undergo left atrial appendage closure, and 797 to receive anticoagulant therapy. The mean (±SD) age of the patients was 69.6±7.7 years, 34.1% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 36 months, a primary safety end-point event had occurred in 65 patients (8.5%) in the left atrial appendage closure group (device group) and in 137 patients (18.1%) in the anticoagulation group (P<0.001 for superiority); a primary efficacy end-point event had occurred in 41 patients (5.3%) and 44 patients (5.8%), respectively (P<0.001 for noninferiority); and a secondary end-point event had occurred in 3.9% and 5.0% (P<0.001 for noninferiority). Complications related to the appendage closure device or procedure occurred in 23 patients. CONCLUSIONS Among patients who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.).

No abstract available

BACKGROUND No study thus far has compared Amulet with Watchman FLX for clinical outcomes beyond 1 year after percutaneous left atrial appendage closure (LAAC). OBJECTIVES The goal of this study was to compare Amulet and Watchman FLX in terms of 3-year clinical outcomes. METHODS In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients with atrial fibrillation and high bleeding risk undergoing LAAC were randomly assigned (1:1) to receive Amulet or Watchman/FLX across 8 centers. Study endpoint included the composite of cardiovascular death, stroke, transient ischemic attack, or systemic embolism at 3 years. Analyses were repeated in the as-treated (AT) and per-protocol (PP) populations. RESULTS Of the 221 patients randomized to treatment, 220 completed LAAC and 3 patients randomized to receive the Amulet device received the Watchman FLX device. The follow-up rate at 3 years was 96.4% in the Amulet group and 97.3% in the Watchman group. The composite ischemic endpoint occurred numerically less frequently in the Amulet group compared with the Watchman group (18.2% vs 31.0%; HR: 0.58; 95% CI: 0.33-1.03; P = 0.06). In both the AT (17.0% vs 31.1%; HR: 0.53; 95% CI: 0.30-0.96; P = 0.035) and PP (16.2% vs 29.2%; HR: 0.54; 95% CI: 0.29-1.00; P = 0.049) populations, the composite ischemic endpoint was significantly lower in the Amulet group compared with the Watchman group. CONCLUSIONS At 3 years after LAAC, there was no significant difference in the ischemic risk between the Amulet and the Watchman FLX groups. The lower occurrence of the ischemic composite endpoint observed in the Amulet group in both the AT and PP analyses is hypothesis generating and emphasizes the need for further studies. (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure [SWISS-APERO]; NCT03399851).

BACKGROUND The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time. OBJECTIVES The final results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, are reported with patients in both trials followed for 5 years. METHODS PREVAIL and PROTECT AF are prospective randomized clinical trials with patients randomized 2:1 to LAAC or warfarin; together, they enrolled 1,114 patients for 4,343 patient-years. Analyses are by intention-to-treat, and rates are events per 100 patient-years. RESULTS For the PREVAIL trial, the first composite coprimary endpoint of stroke, systemic embolism (SE), or cardiovascular/unexplained death did not achieve noninferiority (posterior probability for noninferiority = 88.4%), whereas the second coprimary endpoint of post-procedure ischemic stroke/SE did achieve noninferiority (posterior probability for noninferiority = 97.5%); the warfarin arm maintained an unusually low ischemic stroke rate (0.73%). In the meta-analysis, the composite endpoint was similar between groups (hazard ratio [HR]: 0.820; p = 0.27), as were all-stroke/SE (HR: 0.961; p = 0.87). The ischemic stroke/SE rate was numerically higher with LAAC, but this difference did not reach statistical significance (HR: 1.71; p = 0.080). However, differences in hemorrhagic stroke, disabling/fatal stroke, cardiovascular/unexplained death, all-cause death, and post-procedure bleeding favored LAAC (HR: 0.20; p = 0.0022; HR: 0.45; p = 0.03; HR: 0.59; p = 0.027; HR: 0.73; p = 0.035; HR: 0.48; p = 0.0003, respectively). CONCLUSIONS These 5-year outcomes of the PREVAIL trial, combined with the 5-year outcomes of the PROTECT AF trial, demonstrate that LAAC with Watchman provides stroke prevention in nonvalvular atrial fibrillation comparable to warfarin, with additional reductions in major bleeding, particularly hemorrhagic stroke, and mortality. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation; NCT00129545; and Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy; NCT01182441).

Background Left atrial appendage closure (LAAC) has demonstrated favorable outcomes as an alternative to permanent anticoagulation in patients with nonvalvular atrial fibrillation (NVAF). In hemodialysis (HD) patients with NVAF, anticoagulation increases bleeding complications, with inconsistent benefits in stroke prevention. Objectives This study aimed to clarify the benefit of LAAC for HD patients. Methods Consecutive patients who underwent LAAC, as extracted from the Japanese multicenter registry, were eligible. When comparing HD and non-HD patients, perioperative events, including LAAC procedure success rates and the incidence of death, bleeding events, and ischemic stroke events, were analyzed. Results Among 1,464 patients (mean age 77.1 ± 7.6 years, mean CHA2DS2-VASc score 4.9 ± 1.5, mean HAS-BLED score 3.1 ± 1.0), 172 were HD patients. The HD group had higher HAS-BLED scores, whereas more patients in the non-HD group had a history of Bleeding Academic Research Consortium type 3 bleeding. Device implantation success was 97.3% (95% CI: 96.3%-98.0%) (HD group; 97.1% [167 of 172], non-HD group; 97.3% [1,257 of 1,292]; P = 0.88). There were no in-hospital deaths, and perioperative complications were rare and did not differ between the 2 groups. The median follow-up period was 367 days (Q1-Q3: 242-422 days). The ischemic stroke rate following LAAC in the HD group was 1.1% (95% CI: 0.3%-1.9%) per 100 patient-years, comparable to the non-HD group. Conclusions LAAC is feasible for HD patients and achieves results comparable to those in non-HD patients. Further research is necessary to determine the effectiveness of LAAC in preventing stroke in HD patients.

BACKGROUND Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).

Importance It is well appreciated that a small yet high-risk subset of patients with atrial fibrillation (AF) develops persistent left atrial appendage (LAA) thrombus despite optimal oral anticoagulation (OAC). In patients with either a heightened risk of bleeding precluding enhanced doses of OAC to dissolve the thrombus, or thromboembolism despite optimal OAC, there are limited nonsurgical options. Objectives To introduce a novel management strategy for resistant LAA thrombus: percutaneous mechanical thrombus aspiration with cerebral protection, followed by LAA closure (LAAC). Design, Setting, and Participants This descriptive, prospective case series of 9 consecutive patients with persistent LAA thrombus was conducted between August 2023 and July 2024 at Mount Sinai Hospital. After placing a cerebral protection device (CPD) when anatomically feasible, balloon atrial septostomy was performed as needed to enhance transeptal access. A 20F mechanical aspiration device with a 15-mm funneled ostium was advanced to the LAA ostium, and manual vacuum aspiration of thrombus was performed. After ultrasonic confirmation of thrombectomy, an LAAC device was implanted. Main Outcomes and Measures Patient demographic, clinical, and intervention data were collected. Results Nine patients (mean [SD] age, 74.7 [13.6] years; median [IQR] CHA2DS2-VASc [congestive heart failure, hypertension, age 75 years or older, diabetes, stroke, vascular disease, age 65-74 years, and female sex] score, 5 [2-8] points) presented with LAA thrombus in the context of contraindications to OAC. CPD was placed in 8 patients; one had prohibitive aortic arch anatomy. Given the patient's high thrombotic burden and limited alternatives, the decision was to proceed without CPD, based on a risk-benefit assessment. Balloon atrial septostomy was performed in 8 patients. In 8 patients, complete thrombus removal was achieved, followed by successful LAAC device placement. One patient had a small residual distal thrombus, presumably organized, which was strongly adherent to the LAA myocardium; this was compressed against the wall with the LAAC device. One patient had a small thrombus fragment recovered from the CPD postprocedure. During both the index procedure and during follow-up (range, 4-15 months), there were no complications. Conclusions and Relevance This cases series found that temporary cerebral protection, percutaneous mechanical vacuum thrombectomy, and mechanical LAA closure was feasible in patients with persistent LAA thrombus despite optimal OAC. Larger studies will be needed to fully assess the efficacy and safety of this approach.

This manuscript proposes a novel implanter classification system for left atrial appendage (LAA) closure, aimed at overcoming the limitations of current anatomical classifications. By integrating essential anatomical and functional details, this new classification system strives to provide a comprehensive framework that is both user-friendly and effective in distinguishing between complex and standard LAA anatomies, facilitating a common language among implanters and imagers, and predicting procedural risks.

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices. Endorsement: This statement was endorsed by the American College of Cardiology and the Society of Cardiovascular Computed Tomography.

BACKGROUND The PRAGUE-17 trial demonstrated that left atrial appendage closure (LAAC) was non-inferior to non-warfarin oral anticoagulants (NOAC) for preventing major neurological, cardiovascular or bleeding events in high-risk patients with atrial fibrillation (AF). OBJECTIVE To assess the pre-specified long-term (4-year) outcomes in PRAGUE-17. METHODS PRAGUE-17 was a randomized non-inferiority trial comparing percutaneous LAAC (Watchman or Amulet) with NOACs (95% apixaban) in non-valvular AF patients with a history of cardioembolism, clinically-relevant bleeding, or both CHA2DS2-VASc > 3 and HASBLED > 2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically-relevant bleeding, or procedure/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat (mITT). RESULTS We randomized 402 AF patients (201 per group, age 73.3±7.0 years, 65.7% male, CHA2DS2-VASc 4.7+1.5, HASBLED 3.1+0.9). After 3.5 years median follow-up (1,354 patients-years), LAAC was non-inferior to NOAC for the primary endpoint by mITT (subdistribution hazard ratio[sHR] 0.81, 95% CI 0.56-1.18; p=0.27; p for non-inferiority=0.006). For the components of the composite endpoint, the corresponding sHRs (and 95% CIs) were 0.68 (0.39-1.20; p=0.19) for cardiovascular death, 1.14 (0.56-2.30; p=0.72) for all-stroke/TIA, 0.75 (0.44-1.27; p=0.28) for clinically-relevant bleeding, and 0.55 (0.31-0.97; p=0.039) for non-procedural clinically-relevant bleeding. The primary endpoint outcomes were similar in the per-protocol [sHR 0.80 (95% CI 0.54-1.18), p=0.25] and on-treatment [sHR 0.82 (95% CI 0.56-1.20), p=0.30] analyses. CONCLUSION In long-term follow-up of PRAGUE-17, LAAC remains non-inferior to NOACs for preventing major cardiovascular, neurological or bleeding events. Furthermore, non-procedural bleeding was significantly reduced with LAAC.

BACKGROUND Pericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood. OBJECTIVES This study sought to assess the frequency, timing, predictors and clinical impact of PE after LAAC. METHODS Data on consecutive patients undergoing percutaneous LAAC between 2009 and 2022 were prospectively collected including the 1-year follow-up. Both single (Watchman 2.5/FLX, Boston Scientific) and double (Amplatzer Cardiac Plug or Amulet, St. Jude Medical/Abbott) LAAC devices were used. An imaging core laboratory adjudicated the PEs and categorized them as early (≤7 days) and late (8-365 days). Logistic regression analysis was used to identify predictors of early and overall PE. RESULTS Of 1,023 attempted LAAC procedures, PE was observed in 44 (4.3%) patients; PE was categorized as early in 34 (3.3%) and late in 10 (0.9%) patients. The majority of PEs occurred within 6 hours after LAAC (n = 25, 56.8%) and were clinically relevant (n = 28, 63.6%). Independent predictors of early PE were double-closure left atrial appendage devices (adjusted OR: 8.20; 95% CI: 1.09-61.69), female sex (adjusted OR: 3.41; 95% CI: 1.50-7.73), the use of oral anticoagulation (OAC) at baseline (adjusted OR: 2.60; 95% CI: 1.11-6.09), and advanced age (adjusted OR: 1.07; 95% CI: 1.01-1.23), whereas female sex and OAC at baseline remained independent predictors of overall PE. CONCLUSIONS In this large LAAC registry, PE was observed in less than 1 in 20 patients and usually occurred within 6 hours after procedure. The majority of early PEs were clinically relevant and occurred in the Amplatzer Cardiac Plug/Amulet procedures. Independent predictors included the use of double-closure devices, female sex, OAC at baseline, and advanced age. (LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure; NCT04628078).

BACKGROUND In the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA "closure." However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized. OBJECTIVES We sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device. METHODS Using combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5. RESULTS The cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA2DS2-VASc 4.1 ± 1.4. TEE imaging at 45 days revealed 634 patients (60.2%) without and 404 (38.3%) with PDL≤5, and 1-year TEE revealed 704 patients (71.6%) without and 272 (27.7%) with PDL≤5. The presence of PDL≤5 at 1 year, but not at 45 days, was associated with an increased 5-year risk of ischemic stroke or systemic embolism (adjusted HR: 1.94; 95% CI: 1.15-3.29; P = 0.014), largely driven by an increase in nondisabling stroke (HR: 1.97; 95% CI: 1.03-3.78; P = 0.04), while disabling or fatal stroke rates were similar (HR: 0.69; 95% CI: 0.19-2.46; P = 0.56). PDL≤5 was not associated with an increased risk of cardiovascular or unexplained death (HR: 1.20; P = 0.45) or all-cause death (HR: 0.87; P = 0.42). CONCLUSIONS PDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality. (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [PROTECT-AF; NCT00129545]; Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy [PREVAIL; NCT01182441]; Continued Access to PREVAIL [CAP2; NCT01760291]).

Supplemental Digital Content is available in the text. Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative. Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up. Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA2DS2-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (P<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271.

Patients with nonvalvular atrial fibrillation (AF) not suitable for long‐term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC) using the WATCHMAN device. The safety and efficacy of WATCHMAN‐FLX (WM‐FLX) compared with WATCHMAN‐2.5 (WM‐2.5), particularly in Asian populations, is unknown.

BACKGROUND Patient-specific 3-dimensional (3D) computational modelling offers a tailored approach with promising results, but experience using digital-twin fusion on real-time fluoroscopy to guide left atrial appendage closure (LAAC) is unreported. OBJECTIVES To assess whether LAAC guided by fusion of a 3D computational model on real-time fluoroscopy is safe and effective. METHODS We included retrospectively through a multicenter registry all consecutive patients with non-valvular atrial fibrillation (AF) who underwent LAAC guided by artificial intelligence (AI)-enabled computer simulations (FEops, Gent, Belgium) fusion with real-time fluoroscopy. Operators selected the appropriate device size and position in relation to the LAA using FEops HEARTguide™, and a digital twin was provided for image fusion. The primary efficacy endpoint was successful LAAC with the use of a single device, without moderate or greater peri-device leak and/or device related thrombus (DRT) on follow-up imaging. The primary safety endpoint was a composite of major procedural complications including tamponade, stroke, systemic embolism, major bleeding, and device embolization. RESULTS A total of 106 patients underwent LAAC with an Amulet™ or Watchman FLX™ device using CT-model-fluoroscopy fusion imaging. Device implantation was successful in 100 % of cases. The primary efficacy endpoint was met in 82 patients (89 %). A single-device deployment LAAC procedure was observed in 49 cases (46 %). The primary safety endpoint occurred in 2 patients (1.9 %). After a median follow-up of 405 days, two patients suffered an ischemic stroke and four expired. CONCLUSIONS Fusion of a CT-based 3D computational model on real-time fluoroscopy is a safe and effective approach that may optimize transcatheter LAAC outcomes.

Background and objectives Although left atrial appendage closure (LAAC) is performed in patients with non-valvular atrial fibrillation (NVAF) at increased risk of intracranial haemorrhage (ICH), outcome data are scarce. We assessed the detailed neurological indications for LAAC and outcomes after LAAC in high ICH risk patients. Methods Study population included consecutive patients with NVAF who underwent LAAC in a single hospital network between January 2015 and October 2021 because of prior ICH or the presence of high ICH risk imaging markers on brain MRI (cerebral microbleeds (CMBs)). Primary safety and efficacy outcome measures were the occurrence of ICH and thromboembolic events, respectively, after LAAC. Results Among 146 patients with NVAF who underwent LAAC for high ICH risk, 122 had a history of ICH, while 24 presented with high ICH risk imaging markers only. Mean age was 75.7±7.61, 42 (28.8%) were women. Mean CHA2DS2-VASc score was 5.23±1.52. Of 122 patients with ICH history, 58 (47.5%) had intraparenchymal haemorrhage (IPH), 40 (32.8%) had traumatic ICH (T-ICH) and 18 (14.7%) had non-traumatic subdural haemorrhage. Of 85 patients with brain MRIs including necessary sequences, 43 (50.6%) were related to cerebral amyloid angiopathy and 37 (43.5%) to hypertensive microangiopathy. While 70% of patients were discharged on oral anticoagulants (OAC), 92% were not taking OAC at 1 year. Over 2.12 years mean follow-up, one patient had recurrent non-traumatic IPH (incidence rate (IR) 0.32 per 100 patient-years), five had T-ICH (IR 1.61 per 100 patient-years) and six had an ischaemic stroke (IR 1.94 per 100 patient-years). Conclusions Among patients with NVAF at high ICH risk, LAAC demonstrated a low risk of recurrent ICH or ischaemic stroke compared with previously published data. LAAC in high ICH risk populations should be considered in clinical practice per FDA approval and recent guidelines.

BACKGROUND Percutaneous left atrial appendage closure (LAAC) is an effective alternative strategy for stroke prevention in atrial fibrillation (AF) patients at high risk for bleeding with anticoagulation (AC). Efficacy of this strategy in hypertrophic cardiomyopathy (HCM) remains uncertain. OBJECTIVE Compare risk of stroke in HCM-AF patients treated with LAAC to those treated with AC. METHODS Using TriNetX Global Research Network, HCM-AF patients from 2015 to 2024 were categorized into those treated with LAAC vs. solely with AC, and followed for 3-years for ischemic stroke, systemic embolism, and all-cause mortality. Propensity-score matching was used to limit confounders. RESULTS 14,867 HCM-AF patients were identified; 364 (2.5%) treated with LAAC vs. 14,503 (97.5%) treated with AC. HCM-LAAC patients were older (72 vs. 67, p<0.001), had more comorbidities, and more prior bleeding events, including higher rate of prior gastrointestinal bleeding (68% vs. 18%, p<0.001), compared to HCM patients treated solely with AC. After propensity matching, there was no baseline difference between groups including prior bleeding events (p>0.05). During follow-up, HCM patients treated with LAAC had higher rates of ischemic stroke (13% vs. 8%, HR 1.9, p=0.006) and systemic embolism (14% vs. 9%, HR 1.8, p=0.006), but no difference in mortality compared to matched HCM patients on AC. CONCLUSION This real-world data does not support percutaneous LAAC in HCM-AF patients as the primary treatment strategy over long term AC to reduce stroke risk. However, LAAC may remain a reasonable option for HCM-AF patients who are unable to tolerate AC due to prohibitive bleeding risk.

Abstract Background Device-related thrombosis (DRT) is a known complication to left atrial appendage closure (LAAC). The surface of a LAAC device should ideally have antithrombotic properties. The novel WATCHMAN FLX Pro (WFP) incorporates a fluoropolymer-coated fabric membrane designed to increase thromboresistance and facilitate endothelialization. Such features could potentially allow for a minimal post-procedural antithrombotic regimen. Radiopaque platinum markers at the device shoulders and a large 40 mm device are other novel features of the WFP. Case summary A 75-year-old man with atrial fibrillation was referred for LAAC due to prior subdural haemorrhage during direct-acting anticoagulation treatment. He underwent the first-in-human WFP implantation as part of the WATCHMAN FLX Pro CT study (NCT05567172). Computed tomography (CT) was used for pre-planning, and the procedure was performed under local analgesia guided by intracardiac echocardiography from the left atrium (LA) without any complications. Post-procedural antithrombotic treatment consisted of acetylsalicylic acid 75 mg/day only, and 45-day CT, transoesophageal echocardiography (TEE), and magnetic resonance imaging demonstrated optimal device position with complete LAAC. Hypoattenuated thickening (6 mm) appeared on the device as a smooth surface in continuity with the left atrial wall on CT and TEE. A specific magnetic resonance T1-weighted scan, used for visualization of fresh thrombus, suggested this to represent tissue ingrowth rather than thrombus. Discussion The advanced follow-up imaging protocol suggested a good WFP implantation result with signs of tissue ingrowth at 45 days. The added radiopaque markers facilitated optimal deployment, evaluation of device stability during tug test, and assessment of device protrusion into the LA.

Transesophageal echocardiography (TEE) has been the preferred imaging modality to help guide left atrial appendage closure. Newer technologies such as the Nuvision 4D Intracardiac echocardiography (ICE) catheter allow for real-time 3D imaging of cardiac anatomy. There are no direct comparison studies for procedural imaging between TEE and 4D ICE. To evaluate the performance and safety of left atrial appendage (LAA) closure procedures with the Watchman FLX and Amulet, guided by the Nuvision 4D ICE Catheter. This retrospective observational analysis was conducted on institutional LAAO National Cardiovascular Data Registry from January 2022 to March 2023. Patients had undergone LAA closure procedures with the Watchman FLX or Amulet device guided by TEE or a 4D ICE Catheter. The primary outcome evaluated was successful LAAO device placement. A total of 121 patients underwent LAAO device placement with 46 (38.0%) patients guided by 4D ICE during LAAO implantation. The 4D ICE group had a shorter procedural time compared with TEE guidance. Post procedural 45-day TEE post implant was also comparable for both groups with no patients in either group having incomplete closure of the left atrial appendage and peri-device leak > 5 mm. No device related complications (device related access, stroke, or pericardial effusion) occurred in either group at follow-up. There was no significant difference in device implant success or post procedural outcomes at 45 days in either the TEE or 4D ICE group. However, there was a noticeable improvement in procedural time with the 4D ICE catheter.

BACKGROUND Data regarding left atrial appendage closure (LAAC) in patients with left atrial appendage (LAA) thrombus are limited. Recently published cases have mostly been guided by transesophageal echocardiography (TEE). Intracardiac echocardiography (ICE) is now widely used during LAAC procedures. OBJECTIVE This is the first study to report the feasibility of LAAC in patients with LAA thrombus guided by ICE. METHODS Patients with persistent LAA thrombus despite anticoagulation or contraindications to anticoagulation who underwent a modified ICE-guided LAAC procedure between June 2021 and April 2023 were included. Periprocedural events and clinical outcomes during follow-up were recorded. RESULTS A total of 12 patients (aged 65 ± 7 years; 92% male) were included: 10 with persistent LAA thrombus and 2 with contraindications to anticoagulation. Most of the thrombus was at the apex (n = 6), followed by the body (n = 3) and the ostium (n = 3). LAmbre device was used and successfully implanted into all patients with the guidance of ICE. No thrombotic material was retrieved from patients with the protection of cerebral protection device (n = 11). No patient experienced severe periprocedural complications. All patients completed TEE follow-up, and no device-related thrombus or peridevice leakage > 3 mm was detected. None of the patients experienced stroke/TIA, systemic embolism, or major bleeding events during a median follow-up of 147 (80-306) days. CONCLUSION LAAC using the LAmbre device guided by ICE may be feasible in patients with LAA thrombus when performed by experienced operators.

Patients with atrial fibrillation (AF) who are not suitable for long‐term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC). The safety and feasibility of left atrial catheter ablation (CA) procedures after LAAC remain unclear. This study aimed to clarify the feasibility and safety of CA after LAAC, including in the early phase within 180 days.

Background: There are limited data about left atrial appendage closure (LAAC) in patients with cancer. We therefore sought to compare the outcome after LAAC in patients with vs. without cancer in a multicentre registry. Methods: In this sub-analysis of the prospective Austrian LAAC Registry, we analysed consecutive patients undergoing LAAC to assess the relationship between baseline characteristics and outcome in patients with vs. without cancer. Inverse probability weighting was performed to adjust for differences in baseline characteristics. Results: A total of 486 consecutive patients from 9 centres with a median age of 75 years (IQR 70–79 years; 35.8% female) were included. Fifty-seven patients (11.7%) had a history of cancer. The median CHA2DS2-VASc and HAS-BLED scores were similar in both groups (median [IQR], 4 [4–6] vs. 5 [3–5], p = 0.415; 4 [3–4] vs. 3 [3–4], p = 0.428 in cancer vs. other patients). Cancer patients were significantly older, and anaemia and gastrointestinal bleeding were significantly more common. Major procedural complications occurred in 5.3% vs. 7.0% (p = 0.276) of patients. The cumulative five-year survival rates were 80.7% and 84.8% in cancer vs. other patients (adjusted hazard ratio for death 1.29 [95% CI 0.67–2.48], p = 0.443). There were also no differences in one-year survival (96.1% vs. 94.0%, p = 0.582) and five-year event-free survival (64.9% vs. 74.4%, p = 0.124). Conclusions: In daily clinical practice, LAAC has already been accepted as a treatment option in patients with cancer. This retrospective analysis shows that short-term and adjusted long-term complications are similar in patients with vs. without cancer undergoing LAAC.

The Centers for Medicare & Medicaid Services (CMS) required a shared decision‐making (SDM) interaction, with an “independent” physician, before left atrial appendage closure (LAAC). The purpose of this study is to better understand how this requirement is implemented in clinical practice.

BACKGROUND Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed endothelialization play a role in the development of DRT. Fluorinated polymers are known to have thromboresistant properties that may favorably modulate the healing response to an LAAC device. OBJECTIVES The goal of this study was to compare the thrombogenicity and endothelial coverage (EC) after LAAC between the conventional uncoated WATCHMAN FLX (WM) and a novel fluoropolymer-coated WATCHMAN FLX (FP-WM). METHODS Canines were randomized for implantation with WM or FP-WM devices and given no postimplant antithrombotic/antiplatelet agents. The presence of DRT was monitored by using transesophageal echocardiography and verified histologically. The biochemical mechanisms associated with coating were assessed by using flow loop experiments to quantify albumin adsorption, platelet adhesion, and porcine implants to quantify EC and the expression of markers of endothelial maturation (ie, vascular endothelial-cadherin/p120-catenin). RESULTS Canines implanted with FP-WM exhibited significantly less DRT at 45 days than those implanted with WM (0% vs 50%; P < 0.05). In vitro experiments showed significantly greater albumin adsorption (52.8 [41.0-58.3] mm2 vs 20.6 [17.2-26.6] mm2; P = 0.03) and significantly less platelet adhesion (44.7% [27.2%-60.2%] vs 60.9% [39.9%-70.1%]; P < 0.01) on FP-WM. Porcine implants showed significantly greater EC by scanning electron microscopy (87.7% [83.4%-92.3%] vs 68.2% [47.6%-72.8%]; P = 0.03), and higher vascular endothelial-cadherin/p120-catenin expression after 3 months on FP-WM compared with WM. CONCLUSIONS The FP-WM device showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies indicated that the fluoropolymer-coated device binds more albumin, leading to reduced platelet binding, less inflammation, and greater EC.

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Background: In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation. Methods: We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA2DS2-VASC and HAS-BLED scores. Results: Of 1739 patients who received an implant (7159 patient-years follow-up; CHA2DS2-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18–5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90–5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as follows: history of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26–4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19–4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08–3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01–1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94–0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT. Conclusions: After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism.

Supplemental Digital Content is available in the text. Background: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure. Methods: In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days. Results: Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80–1.16]; P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%; P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%, P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups. Conclusions: Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03399851.

BACKGROUND The benefit related to the use of preprocedural computed tomography angiography (CCTA) on top of periprocedural echocardiography to plan percutaneous left atrial appendage closure (LAAC) procedures is still unclear. OBJECTIVES The authors sought to evaluate the impact of preprocedural CCTA on LAAC procedural success. METHODS In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients undergoing echocardiography-guided LAAC were randomly assigned to receive the Amulet (Abbott) or Watchman 2.5/FLX (Boston Scientific) device across 8 European centers. According to the study protocol ongoing at the time of the procedure, the first operators had (CCTA unblinded group) or did not have (CCTA blinded group) access to preprocedural CCTA images. In this post hoc analysis, we compared blinded vs unblinded procedures in terms of procedural success defined as complete left atrial appendage occlusion as evaluated at the end of LAAC (short-term) or at the 45-day follow-up (long-term) without procedural-related complications. RESULTS Among 219 LAACs preceded by CCTA, 92 (42.1%) and 127 (57.9%) were assigned to the CCTA unblinded and blinded group, respectively. After adjusting for confounders, operator unblinding to preprocedural CCTA remained associated with a higher rate of short-term procedural success (93.5% vs 81.1%; P = 0.009; adjusted OR: 2.76; 95% CI: 1.05-7.29; P = 0.040) and long-term procedural success (83.7% vs 72.4%; P = 0.050; adjusted OR: 2.12; 95% CI: 1.03-4.35; P = 0.041). CONCLUSIONS In a prospective multicenter cohort of clinically indicated echocardiography-guided LAACs, unblinding of the first operators to preprocedural CCTA images was independently associated with a higher rate of both short- and long-term procedural success. Further studies are needed to better evaluate the impact of preprocedural CCTA on clinical outcomes.

Background: Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice. Methods: One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years. Results: Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHA2DS2-VASc score ≥5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ≥3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (−76% and −41%) or hemorrhagic (−81% and 67%) stroke and prior bleeding (−85% and −30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up (P=0.28). Conclusions: During the complete 2-year follow-up of Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing. Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT01972282.

Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild‐to‐moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end‐stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials.

BACKGROUND When performing transcatheter left atrial appendage (LAA) closure, peridevice leaks and device-related thrombus (DRT) have been associated with worse clinical outcomes-hence, their risk should be mitigated. OBJECTIVES The authors sought to assess whether use of preprocedural computational modeling impacts procedural efficiency and outcomes of transcatheter LAA closure. METHODS The PREDICT-LAA trial (NCT04180605) is a prospective, multicenter, randomized trial in which 200 patients were 1:1 randomized to standard planning vs cardiac computed tomography (CT) simulation-based planning of LAA closure with Amplatzer Amulet. The artificial intelligence-enabled CT-based anatomical analyses and computer simulations were provided by FEops (Belgium). RESULTS All patients had a preprocedural cardiac CT, 197 patients underwent LAA closure, and 181 of these patients had a postprocedural CT scan (standard, n = 91; CT + simulation, n = 90). The composite primary endpoint, defined as contrast leakage distal of the Amulet lobe and/or presence of DRT, was observed in 41.8% in the standard group vs 28.9% in the CT + simulation group (relative risk [RR]: 0.69; 95% CI: 0.46-1.04; P = 0.08). Complete LAA closure with no residual leak and no disc retraction into the LAA was observed in 44.0% vs 61.1%, respectively (RR: 1.44; 95% CI: 1.05-1.98; P = 0.03). In addition, use of computer simulations resulted in improved procedural efficiency with use of fewer Amulet devices (103 vs 118; P < 0.001) and fewer device repositionings (104 vs 195; P < 0.001) in the CT + simulation group. CONCLUSIONS The PREDICT-LAA trial demonstrates the possible added value of artificial intelligence-enabled, CT-based computational modeling when planning for transcatheter LAA closure, leading to improved procedural efficiency and a trend toward better procedural outcomes.

Background Limited data are available describing left atrial appendage closure (LAAC) and age-related outcomes in Asians. Objectives This study summarizes the initial experience with LAAC in Japan and determines age-related clinical outcomes in patients with nonvalvular atrial fibrillation undergoing percutaneous LAAC. Methods In an ongoing, prospective, investigator-initiated, multicenter, observational registry of patients undergoing LAAC in Japan, we analyzed short-term clinical outcomes in patients with nonvalvular atrial fibrillation who underwent LAAC. Patients were classified into younger, middle-aged, and elderly groups (≤70, 70 to 80, and >80 years of age, respectively) to determine age-related outcomes. Results Patients (n = 548; mean age, 76.4 ± 8.1 years; male, 70.3%) who underwent LAAC at 19 Japanese centers between September 2019 and June 2021 were enrolled in the study, including 104, 271, and 173 patients in the younger, middle-aged, and elderly groups, respectively. Participants had a high-risk of bleeding and thromboembolism with a mean CHADS2 score of 3.1 ± 1.3, a mean CHA2DS2-VASc score of 4.7 ± 1.5, and a mean HAS-BLED score of 3.2 ± 1.0. Device success rates were 96.5% and anticoagulants discontinuation at the 45-day follow-up was achieved in 89.9%. In-hospital outcomes were not significantly different, but major bleeding events during the 45-day follow-up were significantly higher in the elderly group compared to the other groups (younger vs middle-aged vs elderly, 1.0% vs 3.7% vs 6.9%, respectively; P = 0.047) despite the same postoperative drug regimens. Conclusions The initial Japanese experience with LAAC demonstrated safety and efficacy; however, perioperative bleeding events were more common in the elderly and postoperative drug regimens must be tailored (OCEAN-LAAC [Optimized Catheter Valvular Intervention–Left Atrial Appendage Closure] registry; UMIN000038498)

Background Patients with severe aortic stenosis and atrial fibrillation (AF) undergoing transcatheter aortic valve intervention (TAVI) are at increased risk of bleeding and cerebrovascular events. This investigator-initiated, randomized, multicenter, open-label pilot study assessed left atrial appendage occlusion (LAAO) in patients with AF undergoing TAVI. Methods Patients were randomly assigned to LAAO (TAVI + LAAO) or standard medical therapy (SMT) (TAVI + SMT). The primary endpoint was a composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year. A sensitivity analysis was performed in the per-protocol population. Results Eighty-one patients (Society of Thoracic Surgeons score: 9.0% ± 5.4%) were enrolled. The primary endpoint occurred in 13 patients (33%) in the TAVI + LAAO group and in 15 patients (37%) in the TAVI + SMT group (adjusted odds ratio [OR], 0.87; 95% CI: 0.32-2.29, p = 0.77). Bleeding rates were comparable between TAVI + LAAO (13%) and TAVI + SMT (17%), with absent nonprocedural bleeding in the TAVI + LAAO group and 5 gastrointestinal bleedings in TAVI + SMT, and cerebrovascular events did not significantly differ between groups (10% in TAVI + LAAO vs. 2.4% in TAVI + SMT). In the per-protocol analysis, occurrence of the primary endpoint was comparable between groups (adjusted OR, 0.55; 95% CI: 0.18-1.56, p = 0.27) with cerebrovascular events in 5.6% and 2.4%, and bleeding events in 8.3% and 17% for TAVI + LAAO and TAVI + SMT, respectively. Conclusions This pilot study suggests that among high-risk patients with AF undergoing TAVI, a strategy of a combined procedure with LAAO and early cessation of oral anticoagulation overall showed similar rates of the primary end point as compared to a single TAVI procedure (NCT03088098).

Background/Objectives: Patients with atrial fibrillation and mitral regurgitation (MR) undergoing transcatheter edge-to-edge mitral valve repair (M-TEER) often have concomitant indications for left atrial appendage occlusion (LAAO), mandating a more personalized treatment approach. This study aimed to examine the effectiveness and safety of combining M-TEER/LAAO in one procedure. Methods: MEDLINE (PubMed), Scopus, and Cochrane were searched through 21 March 2025 for studies examining M-TEER/LAAO with or without control (M-TEER only). Double-independent study selection, extraction, and quality assessments were performed. Frequentist random-effects models were used to calculate mean differences (MDs) and risk ratios (RRs) with 95% confidence intervals (CIs). Results: Seven studies (223 participants) were included. For M-TEER/LAAO, the mean procedural time was 101.6 min (95% CI = [85.06, 118.13]), the mean radiation time was 29.97 min (95% CI = [23.85, 36.09]), the mean length of stay was 5.21 days (95% CI = [3.31, 7.12]), procedural success was achieved in 89.5% of cases (95% CI = [73.4, 96.3], and post-procedure MR > 2+ occurred in 14.8% of cases (95% CI = [3.6, 44.5]). Compared to M-TEER only, patients with M-TEER/LAAO had similar procedural (RR = 0.91, 95% CI = [0.71, 1.17]) and technical success (RR = 1, 95% CI = [0.94, 1.06]) with a similar risk of acute kidney injury (RR = 1, 95% CI = [0.07, 15.12]), bleeding (RR = 0.40, 95% CI = [0.01, 18.06]), and all-cause death (RR = 0.59, 95% CI = [0.22, 1.54]). M-TEER/LAAO was non-significantly associated with in-hospital death (RR = 3, 95% CI = [0.13, 70.23]), stroke (RR = 3, 95% CI = [0.13, 70.23]), and vascular complications (RR = 1.55, 95% CI = [0.43, 5.59]) compared to M-TEER only. Most patients (34.2%, 95% CI = [2.8, 90.4]) received dual antiplatelet therapy at discharge, followed by anticoagulation only (20.2%, 95% CI = [7.5, 44.3]). Conclusions: M-TEER/LAAO can be combined into a single procedure with good peri-procedural outcomes. Safety was also satisfactory; however, some concerns may arise regarding in-hospital death, stroke, and vascular complications. Further research is needed to explore the effectiveness and safety of this combined strategy and elucidate the risk–benefit profile of this personalized treatment approach.

BACKGROUND: Transcatheter left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulants (OACs) for stroke prevention in patients with atrial fibrillation, but the predictors of LAAO use in routine care are unclear. We aimed to assess the utilization trends of LAAO and compare the change in characteristics of LAAO users versus OACs since its marketing. METHODS: Using the US Medicare claims database (March 15, 2015, to December 31, 2020), we identified patients with atrial fibrillation, ≥65 years, and CHA2DS2-VASc score ≥2 (men) or ≥3 (women), with either first implantation of an LAAO device or initiation of OACs, including apixaban, dabigatran, rivaroxaban, edoxaban, or warfarin. Patient characteristics, measured 365 days before the first LAAO or OAC use date, were compared using logistic regression. RESULTS: There were 30 058 LAAO recipients (mean age, 77.74 years; female, 42.1%) and 792 600 OAC initiators (mean age, 78.48; female, 53.3%). In 2020, patients had higher odds of initiating LAAO use than in 2015 (0.52 versus 9.32%; adjusted odds ratio [aOR], 13.64 [95% CI, 12.56–14.81]). Old age (ie, >85 versus 65–75 years; aOR, 0.84 [95% CI, 0.80–0.88]), female sex (aOR, 0.74 [95% CI, 0.71–0.76]), Black race (aOR, 0.63 [95% CI, 0.58–0.68]) versus White race, and Medicaid eligibility (aOR, 0.61 [95% CI, 0.58–0.64]) were associated with lower odds of receiving LAAO. Among clinical characteristics, frailty, cancer, fractures, and venous thromboembolism were associated with lower odds of LAAO use, while history of intracranial and extracranial bleeding, coagulopathy, and falls were associated with higher odds of receiving LAAO. CONCLUSIONS: Among patients with atrial fibrillation receiving stroke-preventive therapy, LAAO use increased rapidly from 2015 to 2020 and was positively associated with the risk factors for OAC complications but negatively associated with old age, advanced frailty, and cancer. Black race and female sex were associated with a lower likelihood of receiving LAAO.

Atrial fibrillation (AF) is a prevalent arrhythmia in patients undergoing transcatheter aortic valve replacement (TAVR). Left atrial appendage occlusion (LAAO) has emerged as a viable strategy to prevent stroke in selected patients with AF. While both devices can be implanted simultaneously during a single procedure, the safety and efficacy of this approach remain uncertain. This study aims to evaluate the efficacy and safety of concomitant LAAO in patients with AF and aortic valve disease undergoing TAVR. We conducted a systematic review and meta-analysis of randomized controlled trials and observational studies that compared concomitant TAVR and LAAO with isolated TAVR. The study's primary outcomes were all-cause mortality, stroke or transient ischemic attack (TIA), and major bleeding. We established a minimum follow-up time of six months. Three studies met our eligibility criteria, including one randomized controlled trial and two observational studies. The meta-analysis included 570 patients, 249 (44%) who underwent LAAO and TAVR, with a mean follow-up of 16.3 months. In the overall population, there was no significant difference between the groups in all-cause mortality (relative risk [RR] 0.95; 95% confidence interval [CI] 0.67-1.35; p = 0.78; figure 1A), major bleeding (RR 1.15; 95% CI 0.75-1.77; p = 0.51; 1B), and stroke or TIA (RR 0.70; 95% CI 0.33-1.45; p = 0.33; figure 1C). In conclusion, concomitant LAAO and TAVR did not demonstrate discernible clinical differences compared to isolated TAVR in patients with AF and aortic valve disease. We recommend that this therapeutic approach be individualized until more robust data become available.

BACKGROUND: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied. METHODS: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies. RESULTS: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA2DS2-VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60–1.22]; Pnoninferiority<0.001). CONCLUSIONS: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534.

Background: Pericardial effusion (PE) is a potential complication of transcatheter left atrial appendage occlusion. The objective of this study was to investigate the incidence, associated characteristics, and outcomes of PE following left atrial appendage occlusion. Methods: Patients in the NCDR LAAO Registry who underwent a Watchman procedure between January 1, 2016 and December 31, 2019 were included. The primary outcome was in-hospital PE requiring intervention (percutaneous drainage or surgery). Odds ratios (ORs) were calculated for adverse event rates associated with PE. Results: The study population consisted of 65 355 patients. The mean patient age was 76.2±8.1 years, and the mean CHA2DS2-VASc score was 4.6±1.5. PE occurred in 881 patients (1.35%). Clinical variables independently associated with PE included older age, female sex, left ventricular function, paroxysmal atrial fibrillation, prior bleeding, lower serum albumin, and preprocedural dual antiplatelet therapy; procedural variables included number of delivery sheaths used, sinus rhythm during the procedure, and moderate sedation rather than general anesthesia. PE was associated with increased risk of in-hospital stroke (OR, 6.58 [95% CI, 3.32–13.06]; P<0.0001), death (OR, 56.88 [95% CI, 39.79–81.32]; P<0.0001), and the composite of death, stroke, or systemic embolism (OR, 28.64 [95% CI, 21.24–38.61]; P<0.0001). PE during the index hospitalization was associated with increased risk of death (OR, 3.52 [95% CI, 2.23–5.54]; P<0.0001) and the composite of death, stroke, or systemic embolism (OR, 3.42 [95% CI, 2.31–5.07]; P<0.0001) between discharge and 45-day follow-up. Conclusions: In-hospital PE during transcatheter left atrial appendage occlusion is infrequent but associated with a substantially higher risk of adverse events, including in-hospital and early postdischarge mortality. Strategies to minimize PE are critical to improve the risk-benefit ratio for this therapy.

ABSTRACT Introduction and objectives: The prevalence of atrial fibrillation and the number of patients experiencing ischemic strokes despite oral anticoagulation (OAC) are both on the rise, which presents a significant challenge due to the absence of clear and uniform treatment recommendations for these patients. To date, there is no formal combination merging into a high anticoagulant efficacy profile while keeping a low bleeding risk. Transcatheter left atrial appendage occlusion (LAAO) in combination with OAC might provide a balance between safety and efficacy. The objective of this study is to evaluate whether, in ischemic stroke patients, despite anticoagulation, the combination of LAAO plus long-term anticoagulation—direct oral anticoagulants or vitamin K antagonist when indicated—is associated with a lower rate of recurrent cardioembolic events at 12 months vs the optimal medical therapy recommended by the neurologist. Methods: A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized on a 1:1 ratio to receive the optimal medical therapy (control) or the combination of LAAO plus OAC or OAC. The primary endpoint of the study will be the occurrence of a cardioembolic event—ischemic stroke or arterial peripheral embolism—within the first 12 months after inclusion. Conclusions: This study is one of the first randomized clinical trials to compare the LAAO plus OAC combination and optimal medical therapy in patients who have experienced ischemic strokes despite being on OAC. If results confirm the superiority of LAAO plus OAC, it could lead to a paradigm shift in treatment guidelines for these patients.

The WATCHMAN device (Boston Scientific Corporation, Marlborough, USA), a left atrial appendage occlusion (LAAO) device, represents a significant advancement in stroke prevention for patients with non-valvular atrial fibrillation (AFib) who are contraindicated for long-term anticoagulation therapy. By sealing the left atrial appendage (LAA), the device reduces the risk of thromboembolic events, offering an alternative to traditional anticoagulants like warfarin and direct oral anticoagulants (DOACs). Despite its proven efficacy in clinical trials, such as perforation-reducing outcomes for transcatheter endocardial closing technology (PROTECT-AF) and proactive risk evaluation validation and integrated lifecycle (PREVAIL), the adoption of the WATCHMAN device in South and Southeast Asia faces significant challenges. High procedural costs, limited healthcare infrastructure, inadequate insurance coverage, and a lack of specialized training for interventional cardiologists hinder its widespread use. Additionally, the prevalence of AFib in these regions, though lower than in Western populations, is rising, necessitating innovative solutions for stroke prevention. This article explores the barriers to WATCHMAN Device adoption in South and Southeast Asia, including cost, accessibility, and awareness, while proposing future directions such as local manufacturing, government subsidies, and enhanced training programs. Multicenter studies, public awareness campaigns, and collaboration between healthcare stakeholders are essential to improve access and outcomes. By addressing these challenges, the WATCHMAN device can play a pivotal role in reducing stroke risk and improving the quality of life for AFib patients in these regions.

An 80–year–old male with multiple comorbidities (Charlson Comorbidity Index: 14), including paroxysmal atrial fibrillation, HFmrEF (NYHA III), cardiac amyloidosis due to multiple myeloma, transvenous ICD for primary prevention, COPD, multifactorial anemia, thrombocytopenia, advanced chronic liver disease with recurrent esophagogastric variceal hemorrhage (F3 varices), and CKD (KDIGO G3b), presented with low–flow, low–gradient severe aortic stenosis (Gmax/mean 42/22 mmHg; LVOTd 23 mm; AVA–VTI 0.9 cm²). The patient’s surgical risk was high (EUROSCORE II of 17.72%). Due to recurrent bleeding, anticoagulation was contraindicated, necessitating both left atrial appendage occlusion (LAAO) and transcatheter aortic valve implantation (TAVI). LAAO was performed using a 36 mm LAmbre device under conscious sedation. Intracardiac echocardiography (ICE) was used instead of TEE to eliminate the need for intubation and reduce the risk of variceal bleeding. An 8F transseptal introducer was inserted into the superior vena cava, followed by transseptal puncture. An Amplatzer Superstiff guidewire was advanced into the left superior pulmonary vein, and a 10F delivery sheath was advanced over the guide. The sheath was advanced into the LAA using a 6F pigtail catheter, followed by sizing of the landing zone. The LAAC device was implanted with good results (Fig. 2). The patient then underwent TAVI with a self–expanding 34 mm Evolut FX bioprosthesis. The anesthesiological protocol included induction with midazolam (2 mg) and fentanyl (50 mcg), followed by maintenance with dexmedetomidine. The procedure included crossing the aortic valve with a straight–tip guide supported by an AL 1.0 catheter and swapping with a Safari Extra Small wire. Aortic valvuloplasty was performed, followed by valve implantation. Postoperative imaging confirmed appropriate results (Fig. 3). The patient remained stable throughout hospitalization and was discharged on SAPT with aspirin 100 mg daily. Echocardiographic evaluation of the bioprosthetic valve showed a Gmax/mean of 4/1 mmHg and DVI of 0.75. At the 45–day follow–up CT scan, there were no significant leaks or device–related thrombosis in either device (Fig. 1). In conclusion, this case underscores the importance of tailored procedural and anesthesiologic planning to optimize transcatheter cardiovascular interventions outcomes in frail patients. Intracardiac ultrasound has a pivotal role for LAAO in patients with esophageal varices or high anesthesiologic risk.Fig. 1 Fig. 2 Fig. 3

Background Device embolization is a recognized complication of left atrial appendage occlusion (LAAO) procedures, with outcomes depending on the location of the embolized device and patient management. Case Summary A 70-year-old male with atrial fibrillation underwent LAAO due to high bleeding risk. Postoperative surveillance revealed an Amplatzer Amulet device embolized in the transverse arch of the aorta. The patient remained asymptomatic, and transcatheter retrieval was planned. A percutaneous approach was used with the ONOCOR system and snare devices with successful retrieval. The patient recovered without complications and remained stable at follow-up. Discussion Device embolization often presents challenges, with clinical outcomes varying by location and timing of diagnosis. Minimally invasive transcatheter retrieval has proven effective in most cases. We discuss a successful application of the ONOCOR retrieval system for an Amulet device embolization. Take-Home Message Transcatheter retrieval is a safe and effective option in most cases of LAAO device embolization.

Background/Objectives: Atrial fibrillation is a frequent comorbidity amongst patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation. Left atrial appendage occlusion (LAAO) can be performed to reduce the risk of stroke in patients with atrial fibrillation. Both procedures require large-bore venous access, transseptal puncture, and real-time imaging of the left atrium. However, limited data exist evaluating the safety and feasibility of concomitant M-TEER and LAAO. Methods: We performed a retrospective review of all concomitant M-TEER and LAAO procedures at our institution between May 2019 and September 2024 to evaluate the safety and feasibility of this approach. Results: Concomitant left atrial appendage occlusion was successful in all 15 patients, requiring an additional 15 min (IQR 11–29) of procedural time. No patients died or had a major vascular complication. Routine transesophageal echocardiography performed within 90 days showed no device related thrombus, and no significant peri-device leak in any patients. Conclusions: Concomitant M-TEER and LAAO are feasible but additional prospective studies or randomized trials are needed to evaluate the potential clinical benefit.

Background/Objectives: Percutaneous left atrial appendage occlusion (LAAO) has become an alternative to oral anticoagulation in selected patients with atrial fibrillation. The results of transcatheter LAAO were evaluated by conventional cardiac angiography (CCA), fluoroscopy, and 2D and 3D transesophageal echocardiography (TEE). Methods: In 47 consecutive patients (76 ± 8 years), LAAO was performed with the AmplatzerTM device. CCA and 2D and 3D TEE were performed for LAA measurements. The eccentricity of the device landing zone was assessed by 3D TEE as the ratio of the maximal and minimal diameters. The device size was selected depending on the CCA maximal diameter. The postprocedural device lobe morphology was classified by fluoroscopy as “square” type (sign of undersizing), “tire” type (optimal deformation), and “strawberry” type (sign of oversizing). After 6 months, TEE was repeated to evaluate peri-device leaks (PDLs). Results: The postprocedural device morphology was “square” type in 9 (19%), “tire” type in 28 (60%), and “strawberry” type in 10 patients (21%). After 6 months, peri-device leaks were observed in 11 patients (23%), with the lowest incidence in the “tire”-type group (11%) compared with “square” type (56%) and “strawberry” type (30%) (p = 0.019). The 3D TEE eccentricity index with a cut-off value of ≤1.29 (indicating a more circular morphology) was a very specific predictor for excluding postprocedural device deformation of the “strawberry” type (AUC = 0.689; sensitivity 48.7%, specificity 100%). Conclusions: Undersizing as well as oversizing of the LAA occluder, as characterized by deformation type by fluoroscopy, was associated with postprocedural PDLs. The eccentricity of the LAA landing zone by 3D TEE may indicate inadequate size selection of the AmplatzerTM device leading to oversizing in patients with a more eccentric LAA.

Transcatheter left atrial appendage occlusion (LAAO) is a valuable therapeutic option for stroke prevention in patients with non-valvular atrial fibrillation at high bleeding risk. Worldwide acceptance of LAAO therapy as an alternative to oral anticoagulation is growing. The most recent 2025 SCAI/HRS Clinical Practice Guidelines on Transcatheter Left Atrial Appendage Occlusion suggests Oral anticoagulation (OAC) or LAAO as treatment options for stroke prevention. While most patients are offered stroke prevention with OAC, those with elevated bleeding risk, prior bleeding complications, or strong preferences to avoid long-term anticoagulation would reasonably choose LAAO over OAC. In this case report we describe the first successful transcatheter LAAO in Nepal in a 75 years old male with CHA2DS2-VASc of 3 and HAS-BLED score of 3. Though he was treated with oral anticoagulation to prevent stroke but due to hemoptysis he could not continue it.TO prevent stroke patient party opted for the LAAO procedure. Under general anesthesia with Transesophageal echocardiogram guidance, patient underwent successful transcatheter LAAO with 31 mm Amulet device. He was discharged the next day of the procedure in stable condition without any complication.

Background Transcatheter left atrial appendage occlusion (LAAO) has become a suitable alternative to anticoagulation in patients with atrial fibrillation (AF). However, outcomes among patients age > 75 years undergoing LAAO are lacking. Methods We included 723 consecutive patients with AF undergoing LAAO from August 2015 to March 2020. Patient data including clinical, laboratory, procedural characteristics, medications and outcomes were collected. The primary composite outcome was major adverse cardiac events (MACE) including mortality, stroke, bleeding and readmissions at 60-days. Results Mean age was 75 ± 8 years and 434 (60%) were males. Median CHA2DS2-VASc score was 4 (IQR: 4, 5) points and median HASBLED score was 4 (IQR: 3, 4) points. Composite MACE outcome was significantly higher among patients age > 75 years in both unadjusted (17.1% vs. 11.5%, P = 0.03) and adjusted (Odds Ratio = 1.59, 95% CI: 1.02 - 2.46, P = 0.04) analysis. Composite MACE was primarily driven by higher all-cause mortality (1.3% vs. 0, P = 0.04) among patients age > 75 years. The secondary outcome of procedural success was also lower among patients age > 75 years (92.2% vs. 96.2%, P = 0.02). The occurrence of stroke (P = 0.38), major bleeding (P = 0.29) and readmissions (P = 0.15) did not differ between patients age > 75 years and less than 75 years. Conclusion Patients age >75 years undergoing LAAO have worse outcomes primarily driven by higher all-cause mortality and are less likely to achieve procedural success. Future prospective studies evaluating these findings are warranted.

Thrombosis‐induced stroke represents one of the most serious complications of atrial fibrillation (AF), and the presence of spontaneous echo contrast (SEC) is a well‐established echocardiographic predictor of pre‐thrombotic states. An 82‐year‐old woman with AF presented with recurrent ischemic strokes despite oral anticoagulation therapy and was referred to our center for left atrial appendage closure (LAAO). Transesophageal echocardiography (TEE) demonstrated slow flow within the left atrial appendage along with a large atrial septal aneurysm (ASA) exhibiting prominent SEC. Following multidisciplinary evaluation, simultaneous percutaneous closure of both the LAA and the ASA/PFO was successfully performed. Postprocedural follow‐up demonstrated no device‐related thrombosis, peri‐device leak, or further stroke events. This case underscores the potential benefit of combined LAA and ASA/PFO closure in high‐risk AF patients with recurrent embolic events despite anticoagulation.

No abstract available

BACKGROUND: The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. METHODS: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. RESULTS: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%–2.84%; interquartile range, 1.42%–1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65–0.70] and validation C-index, 0.66 [95% CI, 0.62–0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. CONCLUSIONS: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making.

A 67-year-old man with a history of heart failure (HF) secondary to ischemic cardiomyopathy, atrial fibrillation, and left atrial appendage occlusion (LAAO) developed worsening HF secondary to severe functional mitral regurgitation. Consequently, transcatheter edge-to-edge repair (TEER) was performed. Despite successful TEER, a large thrombus in the left atrium (LA) was unexpectedly discovered on postoperative day 3. Thrombus formation may be related to changes in the blood stream in the LA, endothelial injury by septal puncture, and an insufficient anti-thrombotic regimen. This case highlights the potential for the development of subacute LA thrombosis following TEER, even in patients with prior LAAO.

No abstract available

BACKGROUND There has been an increasing uptake of transcatheter left atrial appendage occlusion (LAAO) for stroke reduction in atrial fibrillation. OBJECTIVES To investigate the perceptions and approaches among a nationally representative sample of physicians METHODS: Using the American Medical Association Physician Masterfile, we selected a random sample of 500 physicians from each of the specialties: general cardiologists, interventional cardiologists, electrophysiologists, and vascular neurologists. The participants received the survey by mail up to three times from 11/9/2021-1/14/2022. In addition to the questions about experiences, perceptions, and approaches, physicians were randomly assigned to one of the four versions of a patient vignette: white man, white woman, black man, and black woman, to investigate potential bias in decision-making. RESULTS The top three reasons for considering LAAO were a history of intracranial bleeding (94.3%), a history of major extracranial bleeding (91.8%), and gastrointestinal lesions (59.0%), whereas the top three reasons for withholding LAAO were: other indications for long-term oral anticoagulation (87.7%), a low bleeding risk (77.0%), and a low stroke risk (65.6%). For the reasons limiting recommendations for LAAO, 59.8% mentioned procedural risks, 42.6% mentioned "limiting efficacy data comparing LAAO to NOAC" and 32.8% mentioned "limited safety data comparing LAAO to NOAC." There was no difference in physicians' decision-making by patients' race, gender, or the concordance between patients' and physicians' race or gender. CONCLUSIONS In the first U.S. national physician survey of LAAO, individual physicians' perspectives varied greatly, which provided information that will help customize future educational activities for different audiences. CONDENSED ABSTRACT Although diverse practice patterns of LAAO have been documented, little is known about the reasoning or perceptions that drive these variations. Unlike prior surveys that were directed to Centers that performed LAAO, the current survey obtained insights from individual physicians, not only those who perform the procedures (interventional cardiologists and electrophysiologists) but also those who are closely involved in the decision-making and referral process (general cardiologists and vascular neurologists). The findings identify key evidence gaps and help prioritize future studies to establish a consistent and evidence-based best practice for AF stroke prevention.

Abstract Background Patients with atrial fibrillation (AF) have a five-fold increase in stroke events, and ∼90% of the thrombi develop in the left atrial appendage (LAA). Left atrial appendage occlusion (LAAO) has emerged as a safe and feasible alternative to oral anticoagulation (OAC) for stroke prevention in selected patients with non-valvular AF and contraindications to OAC. Atrial fibrillation is closely associated with mitral disease, and there is a growing interest in combined procedures. More than half of patients undergoing a mitral transcatheter edge-to-edge repair (M-TEER) suffer of AF and many have high or unacceptable bleeding risk. Case summary We present a case of an 80-year-old woman suffering from paroxysmal AF, right carotid siphon aneurysm, and primary mitral regurgitation, with a high bleeding risk, who underwent a combined intervention of M-TEER and LAAO. Discussion The combination of these two procedures is a logical step once the access to the left atrium is obtained with a transseptal puncture (TSP) and a transesophageal echocardiography (TEE) is in place to guide both procedures. The turning point in LAAO procedure is a correct TSP allowing coaxial alignment of the sheath with the LAA neck. Steerable delivery sheaths are promising dedicated tools, particularly in challenging anatomy or during combined procedures requiring different TSP positions.

BACKGROUND Transcatheter left atrial appendage occlusion (LAAO) has emerged as an effective procedure for the prevention of thromboembolic events in non-valvular atrial fibrillation (AF) patients with contraindications to oral anticoagulation. After the procedure, different antithrombotic regimens have been used, in order to prevent device-related thrombus and trying to minimize bleedings. The search for the optimal antithrombotic strategy is still ongoing. We sought to assess efficacy and safety of different antiplatelet therapy (APT) regimens. METHODS We enrolled non-randomized consecutive patients who underwent LAAO at the University Hospital of Parma between 2010 and 2021. Three study groups were identified according to post-procedural APT: long (>1, ≤12 months)-dual APT (DAPT), short (≤ 1 month)-DAPT, lifelong single APT (SAPT). The choice of the APT was left to multidisciplinary team evaluation. The incidence of the primary outcome, a composite of any ischemic or hemorrhagic event, was assessed at follow-up. RESULTS We enrolled a total of 130 patients. Technical success was achieved in 123 (94.6%) patients. After LAAO, 39 [31.7%] patients were discharged on short-DAPT, 35 [28.5%] on long-DAPT and 49 [39.8%] on SAPT. After a median follow-up of 32 months, short-DAPT group had a significantly lower occurrence of the primary outcome (3 [7.7%] vs. 7 [20.0%] in long-DAPT vs. 14 [28.6%] in SAPT, p = 0.049], mainly driven by a lower occurrence of the bleeding endpoint (0 vs. 4 [11.4%] in long-DAPT vs. 9 [18.4%] in SAPT, p = 0.020). Finally, comparison of the Kaplan-Meier curves showed that short-DAPT group had a higher primary endpoint-free survival [p= 0.015] compared to the other groups. CONCLUSION Post-procedural short-DAPT strategy was associated with better outcomes, mainly driven by reduction of major bleedings.

Transcatheter left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Intraprocedural imaging is a crucial for a successful intervention, with transesophageal echocardiography (TEE) as the current gold standard. Since some important limitations may affect TEE use, intracardiac echocardiography (ICE) is increasingly used as an alternative to TEE for guiding LAAO. The lack of a standardized imaging protocol has slowed the adoption of ICE into clinical practice. On the basis of current research and expert consensus, this paper provides a protocol for ICE support of left atrial appendage occlusion.

Background Percutaneous left atrial appendage occlusion (LAAO) represents an alternative stroke prevention method in patients with atrial fibrillation and an increased bleeding risk, chronic kidney disease or contraindications to oral anticoagulants. Aim of our study was to evaluate the feasibility and safety of percutaneous LAAO in high-risk, frail patients having undergone transcatheter aortic valve implantation (TAVI). Methods Thirty-one patients having undergone TAVI and scheduled for LAAO were prospectively included in our study. Results Implantation was successful in 29 of 31 cases (93.5%).There were no patients that developed a major acute cardiovascular event, stroke, or device dislocation/embolization. There was a single case of major bleeding (3.2%) and 3 cases of acute kidney injury (9.7%). At 3 months, no patients experienced a stroke, one patient had a device-related thrombus (3.4%), one patient showed a significant peri-device leak, and one patient had a persistent iatrogenic atrial septal defect. Conclusions Our study shows that percutaneous LAAO may represent a feasible alternative strategy for stroke prevention, that can be safely performed in high-risk, multimorbid patients with high bleeding risk or contraindications to oral anticoagulation.

(1) Background: left atrial appendage occlusion (LAAO) is considered an effective and relatively safe treatment for the prevention of thromboembolic events in patients with atrial fibrillation and a contra-indication for anticoagulation. We present a large multicenter real-world experience of transcatheter LAAO implementation in patients with atrial fibrillation who cannot be treated with chronic anti-coagulation; (2) Methods: included were atrial fibrillation patients who underwent transcatheter LAAO between 1 January 2016 and 30 June 2021. The study was conducted using the electronic health record database of Clalit Health Services (CHS). The primary outcomes included hemorrhagic and ischemic stroke following LAAO; (3) Results: included were 389 atrial fibrillation patients. During a median follow-up of 2.1 years, 13% patients had ischemic cerebrovascular accident (CVA), and 4.4% patients had hemorrhagic CVA. While the risk of ischemic stroke increased gradually over time, the risk of hemorrhagic CVA was highest during the first 3 months following the procedure. Moreover, previous ischemic stroke was the only significant predictor for both hemorrhagic and ischemic stroke following LAAO; (4) Conclusions: while the annual performance rate of transcatheter LAAO has increased significantly over the past years, post procedural long-term prognosis remains poor with a substantial risk of both thrombotic and bleeding events.

Transcatheter left atrial appendage occlusion (LAAO) is non-inferior to vitamin K antagonists (VKAs) in preventing thromboembolic events in atrial fibrillation (AF). Non-vitamin K antagonists (NOACs) have an improved safety profile over VKAs; however, evidence regarding their effect on cardiovascular and neurological outcomes relative to LAAO is limited. Up-to-date randomized trials or propensity-score-matched data comparing LAAO vs. NOACs in high-risk patients with AF were pooled in our study. A total of 2849 AF patients (LAAO: 1368, NOACs: 1481, mean age: 75 ± 7.5 yrs, 63.5% male) were enrolled. The mean CHA2DS2-VASc score was 4.3 ± 1.7, and the mean HAS-BLED score was 3.4 ± 1.2. The baseline characteristics were comparable between the two groups. In the LAAO group, the success rate of device implantation was 98.8%. During a mean follow-up of 2 years, as compared with NOACs, LAAO was associated with a significant reduction of ISTH major bleeding (p = 0.0002). There were no significant differences in terms of ischemic stroke (p = 0.61), ischemic stroke/thromboembolism (p = 0.63), ISTH major and clinically relevant minor bleeding (p = 0.73), cardiovascular death (p = 0.63), and all-cause mortality (p = 0.71). There was a trend toward reduction of combined major cardiovascular and neurological endpoints in the LAAO group (OR: 0.84, 95% CI: 0.64–1.11, p = 0.12). In conclusion, for high-risk AF patients, LAAO is associated with a significant reduction of ISTH major bleeding without increased ischemic events, as compared to “contemporary NOACs”. The present data show the superior role of LAAO over NOACs among high-risk AF patients in terms of reduction of major bleeding; however, more randomized controlled trials are warranted.

BACKGROUND Transcatheter left atrial appendage occlusion (LAAO) has become a suitable alternative to anticoagulation in patients with atrial fibrillation (AF). However, volume-outcome relationships at the individual operator level have not been studied. METHODS Study population included 425 consecutive patients with AF undergoing LAAO from August 2015 to November 2018 by seven operators at BUMC-Phoenix. Operator volume was divided in tertiles by those with <40 cases/year (2 operators), 41-80 cases/year (3 operators) and >80 cases/year (2 operators). Patient data including comorbidities, labs, medications, procedural characteristics and outcomes were collected. The primary composite outcome was major adverse cardiac events (MACE) including mortality, stroke, bleeding and vascular complications. RESULTS Mean age was 75 ± 8 years and 251 (59%) were males. Mean CHA2DS2-VASc score was 4.5 ± 1.3 points and mean HASBLED score was 3.9 ± 1.0 points. MACE outcome was similar in the three operator groups in both unadjusted (p = 0.83) and adjusted (OR = 0.59: 95% Confidence Interval [CI]: 0.15-2.29, p = 0.45) analysis. The occurrence MACE was also similar between Interventional Cardiologist (IC) and Electrophysiologist (EP) operators in an unadjusted (p = 0.24) and adjusted (OR = 0.60: 95% CI: 0.21-1.68, p = 0.33) analysis. The secondary outcome of technical success did not differ among the three tertiles (p = 0.37) and among IC & EP operators respectively (p = 0.24) as well. CONCLUSION Operator experience does not affect MACE and technical success even after adjusting for comorbidities. These results suggest a lower learning curve for LAAO with high technical success achievable even by low volume operators.

Abstract Background  The left atrial appendage (LAA) is the main source of thromboembolism in atrial fibrillation (AF). Transcatheter closure is non-inferior to warfarin therapy in preventing stroke. Case summary  A patient with two consecutive strokes associated with AF was referred for transcatheter LAA occlusion (LAAO). Preprocedural cardiac CT and transoesophageal echocardiography demonstrated a spontaneously occluded LAA with a smooth left atrial surface, with stationary results at 6- and 12-month imaging follow-up. Warfarin was discontinued, and life-long aspirin instigated. Discussion  Left atrial appendage occlusion has shown non-inferiority to warfarin for prevention of stroke, cardiovascular death, and all-cause mortality. No benefits from anticoagulation have been demonstrated in patients with embolic stroke of undetermined source. In the present case, we observed that the LAA was occluded and, therefore, treated with aspirin monotherapy assuming similar efficacy as transcatheter LAAO.

No abstract available

Aims We aimed to compare long-term "real-world" outcomes of three left atrial appendage occlusion (LAAO) devices for stroke prevention in a Chinese population with non-valvular atrial fibrillation (NVAF). Methods and results Consecutive patients who underwent LAAO from June 2009 to October 2016 at a university-affiliated hospital were retrospectively analysed. In-hospital and major adverse events (MAE) including mortality, stroke and major bleeding rates were compared by LAAO device. One hundred and sixty-one (161) patients (mean age 71.4±8.2 years; 67.7% male) with mean CHA2DS2-VASc score of 4.1±1.6 and HAS-BLED score of 2.9±1.1 underwent 162 LAAO procedures, of which 47.5% (n=77), 41.4% (n=67) and 11.1% (n=18) were AMPLATZER Cardiac Plug (ACP)/Amulet, WATCHMAN and LAmbre, respectively. The procedural success rate was 97.5% (158/162). The in-hospital adverse event rate was 7.4% (12/162) and comparable among devices (p=NS). Mean follow-up duration was 28.3±24.4 months (373 patient-years). There were no significant differences in long-term MAE rates among devices (p=NS). Observed annual ischaemic stroke (1.1% vs. 5.1%, p<0.001) and major bleeding rates (2.7% vs. 4.5%, p=NS) were lower compared with the predicted rates, respectively. Conclusions The WATCHMAN, ACP/Amulet and LAmbre LAAO devices demonstrated similar long-term safety and efficacy in prevention of ischaemic stroke and major bleeding in patients with NVAF.

In patients with persistent atrial fibrillation (AF) with a high risk of bleeding, left atrial appendage closure (LAAC) has gradually become the best alternative to long-term oral anticoagulant therapy in preventing stroke.1 However, in some patients, the occlusion device falls off because of various reasons, such as improper selection or unstable preinstallation, and constitutes one of the most serious complications of LAAC.2 Here, we report a case of an elderly patient with AF. On the second day after the surgery, her Watchman device fell off. The detached device was retrieved using the double transseptal sheaths technique, and the LAmbre device was installed.

The advances in the left atrial appendage closure as a stroke prevention method in patients with atrial fibrillation and contraindications to oral anticoagulants made a huge revolution offering a great alternative for patients with a high risk of bleeding. The nitinol-based, self-expanding LAmbre closure system shows promising initial results in terms of efficacy and safety in worldwide different clinical trials offering an alternative to the known Amulet and Watchman closure systems. Lifetech received CE Mark approval for the LAmbre closure system on 15 June 2016. Different studies have shown encouraging results in terms of feasibility and efficacy of the novel occluder. The favorable device design gives a big advantage in the occlusion of difficult left atrial appendage anatomy.

No abstract available

Aims Stroke due to atrial fibrillation has been associated with a high risk of disability and mortality. Percutaneous left atrial appendage (LAA) closure has been established as an alternative strategy for stroke prevention in patients not eligible for oral anticoagulation. The LAmbre is a novel occluder, specifically designed for LAA closure adaptive to various LAA anatomies. The aim of this study was to demonstrate feasibility and initial experience in a nonprescreened patient cohort for LAA occlusion using the novel LAmbre occluder. Methods The device was implanted in 11 patients with nonvalvular atrial fibrillation. Follow-up included transesophageal echocardiography and an outpatient visit at 6 weeks and 6 months after implantation. Results All devices were implanted successfully. Device sizes ranged from 16/22 to 22/34 mm. Patients’ mean CHA2DS2-VASc and HAS-BLED scores were 3.3 ± 1.0 and 3.2 ± 1.0, respectively. Two out of 11 patients had previously been rejected for Watchman occluder implantation by reasons of too small LAA. At 6 weeks and 6 months, there were no deaths, strokes, systemic thromboembolism or severe bleeding complications. There was no device-related thrombus or pericardial effusion seen with transesophageal echocardiography. In one out of 11 patients, a minimal peridevice flow (less than 5 mm) was present at 6-week follow-up. Conclusion The LAmbre occluder is a novel LAA-closure device with features that provide many options for LAA-closure to physicians, particularly in patients with challenging anatomies. From our initial experience, implantation is associated with a good success rate and clinical outcome.

Closure of the left atrial appendage using percutaneous transcatheter occlusion devices is used for stroke prevention as an alternative for patients with a high risk or contraindications for long-term oral anticoagulation use. Herein, we will discuss the practical aspects of five among the available devices used for interventional left atrial appendage occlusion: Watchman, Amulet, WaveCrest, LAmbre, and Lariat.

Background: The goal of this study was to compare the procedural safety and long-term outcome associated with a combined catheter ablation and left atrial appendage occlusion (LAAO) procedure utilizing intracardiac echocardiography (ICE) guidance versus transesophageal echocardiography (TEE) guidance. The study focuses on implementing LAmbre and Watchman devices in patients diagnosed with nonvalvular atrial fibrillation (AF). Methods: A total of 363 patients diagnosed with nonvalvular AF and who underwent a combined procedure were prospectively enrolled between November 2017 and May 2022. Following 1:1 propensity score matching, the TEE group (n = 132) and ICE group (n = 132) were systematically compared in terms of the combined procedure, imaging parameters, events related to the procedure, and subsequent outcomes during follow-up, including mortality, stroke, bleeding, device-related thrombus (DRT), and peri-device leaks (PDLs). Results: The ICE group exhibited a significant reduction in total procedural duration (153.71 ± 31.71 vs. 174.74 ± 18.79 min), fluoroscopy radiation dosage (207.24 ± 108.39 vs. 268.61 ± 122.88 mGy), left atrial appendage occlusion procedure time (34.69 ± 10.91 vs. 51.46 ± 15.84 min), and contrast agent exposure (108.71 ± 37.59 vs. 158.41 ± 45.00 mL) compared to the TEE group. Angiography and ICE demonstrated a substantial correlation between the left atrial appendage (LAA) orifice and landing zone/LAA ostium (Pearson’s correlation coefficient r = 0.808 and 0.536/0.697, two-tailed p < 0.001). No occurrences of device-related embolism, thromboembolism, significant bleeding, or unexpected fatalities were observed in either group. Comparable rates of all-cause death (0.76% vs. 0.76%), stroke or transient ischemic attack (2.27% vs. 1.52%), severe bleeding (1.52% vs. 0.76%), PDL (23.81% vs. 24.62%), and DRT (1.52% vs. 1.52%) were noted after an average follow-up of 18.46 ± 7.70 months in both groups, with no discernible differences. Multivariate logistic regression analysis identified a correlation between LAA velocity and the risk of PDL. Conclusions: The effectiveness and safety of ICE-guided combined treatment were demonstrated to be comparable to TEE guidance, accompanied by the additional advantages of decreased procedure time and fluoroscopy radiation exposure. Clinical Trial Registration: NCT04391504, https://register.clinicaltrials.gov.

Background Percutaneous interventional left atrial appendage occlusion (LAAO) is a reliable, safe, and effective alternative for stroke prevention in selected patients with atrial fibrillation (AF). Methods In a retrospective observational study, 149 patients underwent LAAO between 2016 and 2022 at the Department of Cardiology of the Charité—Universitätsmedizin Berlin, Campus Virchow, with AF for prevention of thromboembolic complications. We compared patient characteristics, intraoperative details and postoperative outcomes between single-occlusive plug-type (SOPT) and dual-occlusive disc-type (DODT) devices. Results In all patients, the device implantation was successful. 60 patients received a SOPT occluder, including Watchman (35%) and Watchman FLX Occluders (65%), while 89 patients received a DODT occluder, including Amplatzer Cardiac Plug (37.1%), the Amplatzer Amulet (25.8%), and the LAmbre occluder (37.1%) systems. Procedure duration was significantly longer for DODT occluder implantation (49 ± 33 vs. 41 ± 25 min, p = 0.018). There were no in-hospital deaths or thromboembolic events reported after LAAO in both groups. Beyond that, a low rate of bleeding or access-side-related complications and pericardial tamponades were observed. Anticoagulation at discharge varied. About 60.8% of patients received dual antiplatelet therapy at hospital discharge, and 33.1% received direct oral anticoagulants. A 6-month follow-up was obtained in 85% of the patients. All implanted devices were in the desired position. However, in 5.7% of the patients, a device-related thrombus formation was detected in the SOPT group, while no thrombus was seen in the DODT group (p = 0.11). Thromboembolic events were noticed in 3.1%, without any difference between the device types. There was a statistically non-significant trend for less residual device leaks after SOPT vs. DODT implantation (no leak in 71.7% vs. 62.2%, p = 0.07; minor leaks <5 mm, 9.4% vs. 20.3%, p = 0.1). In the SOPT group, less bleeding complications were reported after LAAO (11.3% vs. 17.6%, p = 0.1). Conclusion Our data suggest the safety and efficiency of LAAO with a very high procedural implantation success rate irrespective of the used LAA device. Furthermore, no relevant procedural or device-related complication occurred during the 6-month follow-up in all patients.

Closure of the left atrial appendage (LAA) using percutaneous transcatheter occlusion devices is used for stroke prevention as an alternative for patients with a high risk and contraindications for long‐term oral anticoagulation use. In this manuscript, we will discuss the practical aspects of four among the available devices that provide percutaneous intravascular closure of the LAA: Watchman, Amulet, WaveCrest, and LAmbre.

Background: A Left atrial appendage occlusion (LAAO) or closure device is used in patients with atrial fibrillation who are poor candidates for anticoagulation and require cardioembolic stroke prophylaxis. Despite the widespread appeal, ischemic stroke may still occur, either due to a device-related thrombus (DRT) or a Peri-device leak (PDL). Hence, our study aims to examine clinical challenges when stroke occurs after LAAO and compare the outcomes between the Amulet and Watchman devices. Methods: We reviewed the Amulet Investigational Device Exempt (IDE) trial, along with seven meta-analyses and 12 multicenter registries (totalling 20 peer-reviewed articles) that reported stroke, PDL, DRT, and long-term anticoagulation after LAAO placement. We also used AI for assistance in helping us frame our thoughts more coherently. Results: In the Amulet IDE trial, for stroke and systemic embolization within 18 months, we found that the Amulet device (2.8%) was comparable to the Watchman device (2.8%) (HR 1.00, 95% CI {0.60–1.68}, p=0.99). Complete closure at the 45-day mark was higher with the Amulet device (98.9%) compared to the Watchman device (96.8%), with p=0.02. However, procedure-related complications, namely pericardial effusion, were higher with the Amulet device (4.5% vs 2.5%, p=0.04). DRT occurred in 3.4% of Amulet and 4.8% of Watchman patients; interestingly, however, it appeared earlier in the Amulet group and later in the Watchman cohort (p=0.03). In various meta-analyses, PDL occurred in approximately 26% of patients (about 1 in 4) when examined with transesophageal echocardiography. Additionally, these patients had twice the risk of suffering a thromboembolic event (RR 2.1, 95% CI {1.6–2.8}, p<0.001). Even small peri-device leaks (0–5 mm) carried a significant risk of thromboembolic events (HR 1.8, 95% CI {1.3–2.5}). At 5 years, patients who received the Amulet device had higher rates of anticoagulation discontinuation (94%) compared to those who received the Watchman device (90.9%), with OR 1.45 (95% CI {1.10–1.91}, p=0.01). Conclusion: Patients receiving the Amulet device had several benefits, including lower rates of DRT and higher rates of discontinuation of long-term anticoagulation therapy. Despite increased procedural complications, the preferred device in patients with a high risk of recurrent cerebrovascular events was the Amulet.

BACKGROUND The WATCHMAN device (Boston Scientific; Marlborough, MA, USA) is noninferior to warfarin in preventing ischemic strokes while reducing bleeding risks associated with long term anticoagulation in nonvalvular atrial fibrillation (AFib). The device's performance compared to direct oral anticoagulants (DOAC) is less well known. OBJECTIVE To compare 5-year major bleeding and ischemic stroke rates in patients with nonvalvular AFib who received a WATCHMAN device or DOAC therapy after a major bleeding event. METHODS This retrospective, multicenter, 1:1 matched cohort study was derived from the PearlDiver Mariner database from 2010 to 2020. Patients with nonvalvular AFib on oral anticoagulation who had a major bleeding event were identified. Those who received either WATCHMAN or DOAC after resolution of the bleeding event were selected. The two groups were exactly matched 1:1 based on various comorbidities. Rates of ischemic stroke, transient ischemic attack (TIA), major bleeding, and hemorrhagic stroke were compared over 5 years. RESULTS Each cohort consisted of 2248 patients after 1:1 matching. The mean CHADS2-VASC score was 4.81 ± 1.25. At 5 years, the WATCHMAN cohort had significantly lower rates of major bleeding events [OR 0.24 (0.21, 0.27)], TIAs [OR 0.75 (0.58, 0.95)], and ischemic strokes [OR 0.72 (0.61, 0.86)]. There was no significant difference in hemorrhagic strokes [OR 1.14 (0.83, 1.58)]. CONCLUSION Even in a high-risk population, the WATCHMAN is comparable to DOAC therapy in the primary prevention of hemorrhagic strokes and may provide benefit in the rates of bleeding events, TIAs, and ischemic strokes.

Abstract Introduction The Watchman device is approved in the US, but little is known about Watchman’s ischemic stroke reduction compared to the newer direct oral anticoagulants (DOACs). This study explored the differences in ischemic stroke reduction between the Watchman device, warfarin, and DOAC medication. Methods Three patient cohorts, each containing 10,969 patients, were created using TriNetX. The primary and secondary endpoints were the ischemic stroke risk and all-cause mortality risk at 1 and 5 years. Results At 1 year, the Watchman device’s relative risk of ischemic stroke was 0.86 against warfarin but 1.27 against DOACs (P < 0.0001). The relative risk of ischemic stroke between the Watchman and DOACs was higher at 1 and 5 years (1.27 and 1.30, P < 0.0001). The relative risk of all-cause mortality at 1 and 5 years was 0.49 and 0.72 for the Watchman device compared to warfarin (P < 0.0001) and 0.66 and 0.92 between the Watchman and DOACs (P < 0.0001 and 0.01). Conclusion While DOACs were associated with lower ischemic stroke rates, treatment with the Watchman device was associated with lower all-cause mortality. Patients placed on the Watchman device due to DOAC contraindications may benefit from its lower all-cause mortality risk.

Patients with non‐valvular atrial fibrillation (NVAF) and previous stroke have a significantly higher risk of stroke recurrence. This study aimed to examine the safety and efficacy of the LAmbre left atrial appendage occlusion device in NVAF patients with a history of stroke.

Supplemental Digital Content is available in the text. Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device. Methods: Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points. Results: A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=–0.14 [95% CI, –3.42 to 3.13]; P<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, –1.55 to 1.55]; P<0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=–2.12 [95% CI, –4.45 to 0.21]; P<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=–0.71 [95% CI, –3.72 to 2.31]; P=0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41–3.66]; P<0.001 for noninferiority; P=0.003 for superiority). Conclusions: The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.

Background Left atrial appendage closure (LAAC) combined with radiofrequency catheter ablation is an emerging one-stop hybrid procedure for non-valvular atrial fibrillation (AF). This study was performed to compare the efficacy and safety of the Watchman device vs. the LAmbre device for this combined procedure. Methods Two hundred and thirty two patients with AF who underwent the combined procedure were enrolled and divided into two subgroups depending on the device choice: the Watchman-combined group (n = 118) and the LAmbre-combined group (n = 114). The periprocedural and follow-up adverse events in both groups were documented. Results The mean CHA2DS2-VASc score and HAS-BLED score in the Watchman-combined group and LAmbre-combined group were 3.7 ± 1.5 vs. 3.8 ± 1.5 and 2.5 ± 1.1 vs. 2.3 ± 1.1, respectively (all P > 0.05). Successful LAAC was achieved in all patients. The rate of major periprocedural complications and AF recurrence at 6 months post-procedure were similar between the Watchman-combined group and LAmbre-combined group (0.8 vs. 0.9%, P = 1.00; 22.0 vs. 15.8%, P = 0.23). During 2.6 ±0 .7 vs.1.6 ± 1.6 years follow-up, the rate of major clinical adverse events, including stroke and major bleeding, were comparable between the Watchman-combined group and the LAmbre-combined group (2.6 vs. 1.1% per 100 patient-years, P = 0.33). The intraprocedural peri-device leakage (PDL) rate was similar between the Watchman-combined group and the LAmbre-combined group (5.1 vs. 6.1%, P = 0.73), but the PDL rate was significantly higher at 3–6 months transesophageal echocardiography (TEE) follow-up than the intraprocedural PDL rate in both groups (21.6 vs. 5.1%; 36.6 vs. 6.1%, respectively), with a more obvious increase in minimal PDL rate in the LAmbre-combined group than the Watchman-combined group (36.6 vs. 21.6%, P < 0.05). Conclusion The Watchman and LAmbre devices were comparable in efficacy and safety for the combined procedure. The minimal PDL rate at short-term TEE follow-up was higher in the LAmbre-combined group than the Watchman-combined group.

ABSTRACT Atrial fibrillation (AF) is one of the most common sustained dysrhythmias that increases in prevalence with age, and is associated with strokes that can lead to significant patient morbidity and mortality. AF prevalence is projected to double over the next 25 years, demonstrating the need for innovative and effective stroke prevention modalities. Two options are direct oral anticoagulants and left atrial appendage occlusion. This article discusses the Watchman device, a left atrial appendage occlusion device that provides an option for patients with contraindications for anticoagulation.

BACKGROUND Left atrial appendage closure (LAAC) has been suggested as an alternative to anticoagulation in non-valvular atrial fibrillation (AF). The present study aimed to compare a LAmbre LAA occluder system [Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen, China] with the most investigated Amulet (St. Jude Medical Inc., St. Paul, MN, USA) and Watchman (Boston Scientific, Plymouth, MN, USA) devices in terms of peri-procedural and short-term outcomes. METHODS This is a prospective observational study. RESULTS Overall, 140 patients (50 female, mean age 76.2±8.4 years) were consecutively enrolled. Mean CHA2DS2-VASc score was 3.8±1.5, and mean HAS-BLED score was 3.9±1.1. Baseline clinical characteristics were comparable between the three groups (LAmbre, n=30; Amulet, n=74; Watchman, n=36); the LAmbre group had significantly more patients with complicated LAA morphology (p=0.006). The implant success rate was 100% in LAmbre, 99% in Amulet, and 100% in Watchman group (p=0.638). The number of device repositions was not significantly different between groups (0.7±1.1 in LAmbre, 1.0±2.0 in Amulet, and 1.4±1.8 in Watchman group, p=0.345). Fluoroscopic and procedural times were similar between groups. Major peri-procedural adverse events did not differ between groups (0% vs. 0% vs. 2.8%, p=0.233). Six months' follow-up showed good device stability and patients' clinical condition in all groups. CONCLUSION LAmbre, Amulet, and Watchman exhibit remarkable implant success rate, low risk of peri-procedural adverse events, and good clinical outcomes.

Atrial fibrillation is the leading cause of cardioembolic stroke, with emboli most commonly originating from the left atrial appendage. We report the case of a 71-year-old male with left atrial appendage closure via implantation of the WATCHMAN device, due to possible anticoagulation therapy failure and increased bleeding risk, following a stroke. Following a new stroke over a year later, a 1.8-mm peri-device leak was observed. Surgical records noted a minimal (<5 mm jet flow) peri-device leak after the installation, which was considered successful WATCHMAN implantation per protocol. This case highlights the persistent risk of cardioembolic stroke in patients with nonvalvular atrial fibrillation despite device implantation and questions the significance of peri-device leak and further management with anticoagulation for recurrent stroke.

Although reported failure rates of the Watchman device are low, the ballshaped device is not suitable for shallow and multilobed left atrial appendages (LAAs). The LAmbre device is available in two configurations - standard (cover 4-6 mm larger in diameter than the umbrella) and special (cover 12- 14 mm larger than the umbrella) - which allows the closure of a wide range of LAA anatomies. This case illustrates that the LAmbre device can be used for complex LAA anatomies that are not suitable for the Watchman device.

Left atrial appendage closure (LAAC) is a well‐established alternative for stroke prevention in patients with atrial fibrillation (AF) who are not suitable for long‐term anticoagulation. The WATCHMAN FLX Pro 40 mm device is a novel advancement featuring a fluoropolymer coating to enhance thromboresistance and a size expansion to accommodate larger left atrial appendages (LAA). However, clinical data on this new device remains limited.

BACKGROUND Procedural complications, device-related thrombus, and peridevice leak may limit the benefit of transcatheter left atrial appendage occlusion (LAAO). Although next-generation devices incorporate design modifications meant to address these phenomena, the longer term impact of these modifications on outcomes has not been described. OBJECTIVES The aim of this study was to compare 1-year safety and clinical effectiveness of the Watchman FLX with the predicate Watchman 2.5 device. METHODS The National Cardiovascular Data Registry LAAO Registry was used to identify: 1) patients who received the Watchman FLX; and 2) an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was ischemic stroke. A secondary analysis was performed using 2:1 propensity score matching. RESULTS The study cohort consisted of 27,141 patients receiving each device. Among patients undergoing transesophageal echocardiography at 45 days, the rate of device-related thrombus was not different for Watchman FLX compared with Watchman 2.5 (0.4% vs 0.5%; P = 0.27) while the rate of any peridevice leak was significantly lower (14.7% vs 23.5%; P < 0.001). At 1 year, Watchman FLX was associated with a significantly lower risk for major adverse events (adjusted HR: 0.84; 95% CI: 0.80-0.88; P < 0.0001), ischemic stroke (adjusted HR: 0.82; 95% CI: 0.68-0.98; P = 0.02), and ischemic stroke or systemic embolism (adjusted HR: 0.74; 95% CI: 0.62-0.87; P = 0.0003). The findings of the propensity score matching analysis were similar. CONCLUSIONS Transcatheter LAAO with the Watchman FLX is associated with significantly lower risks for major adverse events and ischemic stroke at 1 year compared with the predicate Watchman device. These findings suggest that enhanced procedural safety and completeness of anatomical closure translate into better longer term safety and clinical effectiveness after transcatheter LAAO.

BACKGROUND & OBJECTIVES Incomplete endothelialization of the left atrial appendage(LAA) occluder potentially affects the long-term efficacy of stroke prevention in atrial fibrillation(AF) patients. This study aims to explore the value of routine preoperative transthoracic echocardiography(TTE) in predicting the endothelialization of Watchman LAA occluder. METHODS This single-center retrospective study included 437 AF patients who underwent the LAA closure with Watchman 2.5 occluder from January 2017 to December 2022. Cardiac CTA was performed 3-6 months after the procedure. Based on contrast infiltration into the LAA cavity, two groups were defined as follows: completely and incompletely endothelialized. The baseline and pre-procedural TTE parameters were analyzed. RESULTS The average age was 70.2 years old, with 208 females(47.6 %). The incompletely endothelialized group had an older age (71.4 ± 7.5 vs 69.8 ± 7.6,p = 0.053), a larger left atrial(LA) diameter (44.0 ± 5.9 vs 42.7 ± 6.1 mm,p = 0.045) and a lower left ventricular ejection fraction(LVEF%)(62.5 ± 7.5 vs 63.0 ± 5.4 %,p = 0.016) than the completely endothelialized group. Univariate analysis revealed that incomplete endothelialization was associated with persistent AF(OR:1.68;95 % CI:1.08-2.10;p = 0.021), a higher LA diameter(OR:1.04;95 % CI:1.00-1.07;p = 0.046), a higher left ventricular diastolic diameter(LVDD)(OR:1.05;95 % CI:1.00-1.10;p = 0.032),and the presence of mild mitral stenosis (mean pressure gradient <5 mmHg and mitral valve area > 1.5 cm2,OR:11.29;95 % CI:1.25-102.10;p = 0.031), while it was negatively correlated with mild left ventricular diastolic dysfunction (OR:0.49;95 % CI:0.26-0.94;p = 0.033). Multivariate analysis demonstrated that mild mitral stenosis(OR: 13.79;95 % CI:1.37-139.13;p = 0.026) was an independent predictor for incomplete endothelialization. CONCLUSION Preoperative TTE may predict the outcomes of endothelialization after left atrial appendage occlusion. Mild or severe mitral stenosis is an independent predictive factor for poor endothelial coverage.

Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC. Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed. After PSM, 184 patients were included in each group. The mean CHA2DS2-VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18–0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11–0.33). The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.

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BACKGROUND Percutaneous left atrial appendage occlusion (LAAO) is conventionally performed under fluoroscopic guidance. OBJECTIVES The aim of the study was to evaluate the feasibility and safety of performing LAAO with the Watchman FLX device without the use of fluoroscopy. METHODS Since June 15, 2023, we started performing LAAO procedures with the Watchman FLX device without the use of fluoroscopy. The procedures were performed under general anesthesia with transesophageal echocardiographic (TEE) imaging. The key safety endpoint was the occurrence of death, ischemic stroke, systemic embolism, open heart surgery or major endovascular intervention up to discharge or 7 days post-procedure, whichever came later. The key effectiveness outcome was assessed by the presence of peri-device leak, categorized as leaks < 3mm, 3-5mm and >5mm. RESULTS From June 15, 2023, until September 30, 2025, zero-fluoroscopy LAAO procedure with the Watchman FLX device was attempted in 239 consecutive patients (mean age 79 years, 31% female, median CHADS-VASc score 4), of whom 205 (85.7%) patients underwent successful zero-fluoroscopy LAAO procedure, and 34 (14.3%) required bailout fluoroscopy. The key safety endpoint occurred in 1 patient (in-hospital death at 165 days after the index LAAO procedure secondary to recurrent aspiration). No patient had a peri-device leak > 3mm. At 45 days, a peri-device leak < 3mm was noted in 16/218 (7.3%) patients, and device-related thrombus in 1 (0.4%) patients. CONCLUSIONS In this proof-of-concept study, a routine approach of TEE-guided, zero-fluoroscopy LAAO with the Watchman FLX device was safe and feasible.

Background Left atrial appendage closure (LAAC) effectively lowers stroke risk in atrial-fibrillation (AF) patients who cannot tolerate long-term anticoagulation. Device-related thrombosis (DRT), although infrequent, carries a threefold increase in subsequent embolic events and remains a therapeutic challenge, even with the newer Watchman FLX occluder. Case summary A 72-year-old woman with paroxysmal AF (CHA2DS2-VASc = 5; HAS-BLED = 2) underwent LAAC with a 30 mm Watchman FLX after bleeding-limited warfarin use. She was prescribed dual antiplatelet therapy (DAPT) post-procedure. Eight weeks later, cardiac CT detected a device-surface thrombus; warfarin (INR 2.5–3.0) achieved complete resolution by 7 months. Despite continued anticoagulation, repeat CT at 22 months revealed a larger thrombus. Transesophageal echocardiography confirmed recurrent DRT. Discussion This case underscores multifactorial DRT pathogenesis: patient-specific hypercoagulability (age, persistent AF, PAI-1 variant), anatomic factors (large LAA, 30 mm device), and premature INR reduction. Current evidence indicates that early hypoattenuation thickening on cardiac CT, peri-device leak, and suboptimal antithrombotic regimens are associated with DRT. Emerging data support CT-based surveillance, individualized anticoagulation—potentially favoring direct oral anticoagulants (DOACs)—and next-generation, endothelialization-oriented device designs. Conclusion Recurrent, large-burden DRT can occur late after Watchman FLX implantation despite initial thrombus resolution and guideline-directed therapy. Optimal management requires (1) vigilant, multimodality imaging follow-up; (2) stringent, patient-tailored anticoagulation with real-time INR or DOAC level assessment; (3) consideration of genetic or laboratory markers of thrombophilia; and (4) advances in device bioengineering to accelerate endothelial healing. Further studies should refine risk-stratified antithrombotic strategies and validate imaging biomarkers to pre-empt DRT in high-risk LAAC recipients.

BACKGROUND Evidence supporting the clinical superiority of the Watchman FLX with respect to its previous iteration, the Watchman 2.5, is still sparse. AIMS We aimed to compare the Watchman FLX and Watchman 2.5 in terms of device-related complications and clinical outcomes. METHODS All consecutive left atrial appendage closures (LAACs) completed with implantation of a Watchman device at two high-volume centres between July 2018 and January 2023 were considered. Based on the type of implanted device, patients were assigned to either the Watchman FLX or Watchman 2.5 group. The study endpoints included device-related thrombus (DRT) and peridevice leak (PDL), as evaluated by transoesophageal echocardiography (TOE), and stroke rate at the longest available follow-up. Propensity score matching (PSM) analysis was used to minimise baseline differences between groups. RESULTS After performing PSM, 1,128 patients were included in each group. In the TOE follow-up, performed at a mean of 2.3 months, both DRT (0.2% vs 3.1%; hazard ratio [HR] 0.35, 95% confidence interval [CI]: 0.21-0.38; p=0.017) and PDL (21.0% vs 30.6%; HR 0.68, 95% CI: 0.59-0.77; p=0.031) were significantly lower in the Watchman FLX group compared with the Watchman 2.5 group. At a mean of 1.6 years of follow-up, the stroke rate was numerically lower in the Watchman FLX group compared with the Watchman 2.5 group (3.4% vs 5.1%; HR 0.56, 95% CI: 0.15-1.69; p=0.078). CONCLUSIONS In a large dual-centre cohort of consecutive, successful LAAC procedures using two iterations of the Watchman device, the Watchman FLX was associated with significantly lower rates of both DRT and PDL compared to the Watchman 2.5.

Abstract Background Left atrial appendage occlusion is a treatment for patients with atrial fibrillation who have a high risk of bleeding and are unable to take oral anticoagulants. The Watchman device is an option and has been shown to be safe and effective in reducing embolic stroke risk. Rare but serious and potentially life-threatening complications, such as dislodgment, can occur. Though there is a designated apparatus available for delivery and implantation of these devices, there are no predefined instructions or required equipment available for extraction of dislodged device. Purpose This multicenter study aimed to describe the Watchman extraction procedure and to assess the success rates and potential complications associated with the procedure. Methods In this observational study, we analyzed prospectively collected data from 9 patients that underwent percutaneous Watchman extraction with an endoscopic gasping tool (Raptor) at two high volume centers for Watchman implant in United States between 2019 and 2023. Procedural success was described as complete extraction of Watchman without procedural complication. Results The Watchman was removed due to dislodgement, a potential risk factor for device embolization. The maximum and the minimum size of the extracted Watchman were 24 and 31 respectively. Mean dwell time was 34±8 days. In all the first attempt of retrieval the watchman was done with only one transeptal access with one bioptome (Raptor) to stabilize the watchman and trying to pull inside a 16 mm sheath. In 7 case a second transeptal was required to use another bioptome to allow entry into the sheath. Thus, in these cases sheath bigger than 16 mm was required to extract the Watchman (Fig.1-2). The device was replaced with a bigger watchman in 6 cases, with an amulet in 1 case and in 2 cases, it was not replaced but oral anticoagulation therapy was continued. Procedural success was obtained in 8 (73%) patients. In one case, the use of a single bioptome during extraction led to the embolization of the Watchman device into the ascending aorta, causing a dissection and the patient's subsequent death within the initial week. Conclusion Watchman extraction is a valuable option when complication, such as dislodgment, occur and should be done using two transeptal access with two bioptomes to improve safety and effectiveness.

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Atrial fibrillation (AF) increases the risk of thromboembolic events due to impaired function of the left atrial appendage (LAA). Left atrial appendage closure (LAAC) is a minimally invasive intervention designed to reduce stroke risk by sealing the LAA with an expandable occluder device. Current deployment relies on manual catheter control and imaging modalities like fluoroscopy and transesophageal echocardiography, which carry limitations including radiation exposure and limited positioning precision. In this study, we leverage a previously developed force-sensing delivery sheath integrating fiber Bragg gratings (FBGs) at the interface between the catheter and the occluder. Combined with electromagnetic (EM) tracking, this setup enables real-time measurement of interaction forces and catheter tip position during robot-assisted LAAC deployment in an anatomical phantom. We present a novel force-displacement profiling method that characterizes occluder deployment dynamics and identifies key procedural steps without relying on ionizing radiation. The force profiles reveal low-magnitude interaction forces, suggesting minimal mechanical stress on the surrounding anatomy. This approach shows promise in providing clinicians with enhanced intraoperative feedback, improving deployment outcome. Future work will focus on automating deployment steps classification and validating the sensing strategy in dynamic, realistic environments.

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting over 1% of the population. It is usually triggered by irregular electrical impulses that cause the atria to contract irregularly and ineffectively. It increases blood stasis and the risk of thrombus formation within the left atrial appendage (LAA) and aggravates adverse atrial remodeling. Despite recent efforts, LAA flow patterns representative of AF conditions and their association with LAA stasis remain poorly characterized. Aim: To develop reduced-order data-driven models of LAA flow patterns during atrial remodeling in order to uncover flow disturbances concurrent with LAA stasis that could add granularity to clinical decision criteria. Methods: We combined a geometric data augmentation process with projection of results from 180 CFD atrial simulations on a universal LAA coordinate (ULAAC) system. The projection approach enhances data visualization and facilitates direct comparison between different anatomical and functional states. ULAAC projections were used as input for a proper orthogonal decomposition (POD) algorithm to build reduced-order models of hemodynamic metrics, extracting flow characteristics associated with AF and non-AF anatomies. Results: We verified that the ULAAC system provides an adequate representation to visualize data distributions on the LAA surface and to build POD-based reduced-order models. These models revealed significant differences in LAA flow patterns for atrial geometries that underwent adverse atrial remodeling and experienced elevated blood stasis. Together with anatomical morphing-based patient-specific data augmentation, this approach could facilitate data-driven analyses to identify flow features associated with thrombosis risk due to atrial remodeling.

Morphological variations in the left atrial appendage (LAA) are associated with different levels of ischemic stroke risk for patients with atrial fibrillation (AF). Studying LAA morphology can elucidate mechanisms behind this association and lead to the development of advanced stroke risk stratification tools. However, current categorical descriptions of LAA morphologies are qualitative and inconsistent across studies, which impedes advancements in our understanding of stroke pathogenesis in AF. To mitigate these issues, we introduce a quantitative pipeline that combines elastic shape analysis with unsupervised learning for the categorization of LAA morphology in AF patients. As part of our pipeline, we compute pairwise elastic distances between LAA meshes from a cohort of 20 AF patients, and leverage these distances to cluster our shape data. We demonstrate that our method clusters LAA morphologies based on distinctive shape features, overcoming the innate inconsistencies of current LAA categorization systems, and paving the way for improved stroke risk metrics using objective LAA shape groups.

Despite the success of advanced segmentation frameworks such as TotalSegmentator (TS), accurate segmentations of the left atrial appendage (LAA), coronary arteries (CAs), and pulmonary veins (PVs) remain a significant challenge in medical imaging. In this work, we present the first open-source, anatomically coherent dataset of curated, high-resolution segmentations for these structures, supplemented with whole-heart labels produced by TS on the publicly available ImageCAS dataset consisting of 1000 cardiac computed tomography angiography (CCTA) scans. One purpose of the data set is to foster novel approaches to the analysis of LAA morphology. LAA segmentations on ImageCAS were generated using a state-of-the-art segmentation framework developed specifically for high resolution LAA segmentation. We trained the network on a large private dataset with manual annotations provided by medical readers guided by a trained cardiologist and transferred the model to ImageCAS data. CA labels were improved from the original ImageCAS annotations, while PV segmentations were refined from TS outputs. In addition, we provide a list of scans from ImageCAS that contains common data flaws such as step artefacts, LAAs extending beyond the scanner's field of view, and other types of data defects.

Left atrial appendage (LAA) closure (LAAC) is a minimally invasive implant-based method to prevent cardiovascular stroke in patients with non-valvular atrial fibrillation. Assessing the LAA orifice in preoperative CT angiography plays a crucial role in choosing an appropriate LAAC implant size and a proper C-arm angulation. However, accurate orifice localization is hard because of the high anatomic variation of LAA, and unclear position and orientation of the orifice in available CT views. Deep localization models also yield high error in localizing the orifice in CT image because of the tiny structure of orifice compared to the vastness of CT image. In this paper, we propose a centerline depth-based reinforcement learning (RL) world for effective orifice localization in a small search space. In our scheme, an RL agent observes the centerline-to-surface distance and navigates through the LAA centerline to localize the orifice. Thus, the search space is significantly reduced facilitating improved localization. The proposed formulation could result in high localization accuracy comparing to the expert-annotations in 98 CT images. Moreover, the localization process takes about 8 seconds which is 18 times more efficient than the existing method. Therefore, this can be a useful aid to physicians during the preprocedural planning of LAAC.

The assessment of left atrial appendage (LAA) thrombogenesis has experienced major advances with the adoption of patient-specific computational fluid dynamics (CFD) simulations. Nonetheless, due to the vast computational resources and long execution times required by fluid dynamics solvers, there is an ever-growing body of work aiming to develop surrogate models of fluid flow simulations based on neural networks. The present study builds on this foundation by developing a deep learning (DL) framework capable of predicting the endothelial cell activation potential (ECAP), linked to the risk of thrombosis, solely from the patient-specific LAA geometry. To this end, we leveraged recent advancements in Geometric DL, which seamlessly extend the unparalleled potential of convolutional neural networks (CNN), to non-Euclidean data such as meshes. The model was trained with a dataset combining 202 synthetic and 54 real LAA, predicting the ECAP distributions instantaneously, with an average mean absolute error of 0.563. Moreover, the resulting framework manages to predict the anatomical features related to higher ECAP values even when trained exclusively on synthetic cases.

Cardiac CT is often used clinically in electrophysiology to evaluate cardiac morphology. One such case is to evaluate patients with Atrial Fibrillation (AF). AF can cause regions of slow blood flow and blood stasis through the left atrial appendage (LAA), and therefore, it may be preferable to evaluate blood flow through the LAA in addition to morphology. Although CT cannot measure flow directly, CT data has been used to estimate flow using modeling approaches such as Computational Fluid Dynamics, which take into account the cardiac geometry to simulate flow. Advances in CT technology now enable high-resolution imaging of the whole heart with low radiation doses. With multi-heartbeat imaging during a contrast injection, we can obtain 4-dimentional CT (4DCT) images to measure dynamic contrast enhancement directly. In this study, we use high-resolution 4DCT to acquire images of contrast enhancement across the LAA over multiple heartbeats. The CT contrast signal at each voxel over time is used to create dynamic contrast enhancement maps of parameters derived from a gamma-variate fit. These contrast enhancement maps enable quantification and visualization of spatial-temporal characteristics of flow parameters across the LAA.

Patients with atrial fibrillation have a 5-7 fold increased risk of having an ischemic stroke. In these cases, the most common site of thrombus localization is inside the left atrial appendage (LAA) and studies have shown a correlation between the LAA shape and the risk of ischemic stroke. These studies make use of manual measurement and qualitative assessment of shape and are therefore prone to large inter-observer discrepancies, which may explain the contradictions between the conclusions in different studies. We argue that quantitative shape descriptors are necessary to robustly characterize LAA morphology and relate to other functional parameters and stroke risk. Deep Learning methods are becoming standardly available for segmenting cardiovascular structures from high resolution images such as computed tomography (CT), but only few have been tested for LAA segmentation. Furthermore, the majority of segmentation algorithms produces non-smooth 3D models that are not ideal for further processing, such as statistical shape analysis or computational fluid modelling. In this paper we present a fully automatic pipeline for image segmentation, mesh model creation and statistical shape modelling of the LAA. The LAA anatomy is implicitly represented as a signed distance field (SDF), which is directly regressed from the CT image using Deep Learning. The SDF is further used for registering the LAA shapes to a common template and build a statistical shape model (SSM). Based on 106 automatically segmented LAAs, the built SSM reveals that the LAA shape can be quantified using approximately 5 PCA modes and allows the identification of two distinct shape clusters corresponding to the so-called chicken-wing and non-chicken-wing morphologies.

Transesophageal echocardiography (TEE) is widely used to detect left atrium (LA)/left atrial appendage (LAA) thrombi. In this paper, the local binary pattern variance (LBPV) features are extracted from region of interest (ROI). And the dynamic features are formed by using the information of its neighbor frames in the sequence. The sequence is viewed as a bag, and the images in the sequence are considered as the instances. Multiple-instance learning (MIL) method is employed to solve the LAA thrombi detection. The experimental results show that the proposed method can achieve better performance than that by using other methods.

Computational fluid dynamics (CFD) studies of left atrial flows have reached a sophisticated level, e.g., revealing plausible relationships between hemodynamics and stresses with atrial fibrillation. However, little focus has been on fundamental fluid modelling of LA flows. The purpose of this study was to investigate the spatiotemporal convergence, along with the differences between high- (HR) versus normal-resolution/accuracy (NR) solution strategies, respectively. CFD simulations on 12 patient-specific left atrial geometries, obtained from computed tomography scans, were performed by using a second-order accurate and space/time centered solver. The convergence studies showed an average variability of around 30\% and 55\% for time averaged wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RRT), and endothelial cell activation potential (ECAP), even between intermediate spatial and temporal resolutions, in the left atrium (LA) and left atrial appendage (LAA), respectively. The comparison between HR and NR simulations showed good correlation in the LA for WSS, RRT, and ECAP (R^2 > 0.9), but not for OSI (R^2 = 0.63). However, there were poor correlations in the LAA especially for OSI, RRT, and ECAP (R^2 = 0.55, 0.63, and 0.61, respectively), except for WSS (R^2 = 0.81). The errors are comparable to differences previously reported with disease correlations. To robustly predict atrial hemodynamics and stresses, numerical resolutions of 10M elements and 10k time-steps per cycle seem necessary (i.e., one order of magnitude higher than normally used in both space and time). In conclusion, attention to fundamental numerical aspects is essential towards establishing a plausible, robust, and reliable model of LA flows.

Atrial fibrillation (AF) is considered the most common human arrhythmia. Around 99\% of thrombi in non-valvular AF are formed in the left atrial appendage (LAA). Studies suggest that abnormal LAA haemodynamics and the subsequently stagnated flow are the factors triggering clot formation. However, the relation between LAA morphology, the blood pattern and the triggering is not fully understood. Moreover, the impact of structures such as the pulmonary veins (PVs) on LA haemodynamics has not been thoroughly studied due to the difficulties of acquiring appropriate data. On the other hand, in-silico studies and flow simulations allow a thorough analysis of haemodynamics, analysing the 4D nature of blood flow patterns under different boundary conditions. However, the reduced number of cases reported on the literature of these studies has been a limitation. The main goal of this work was to study the influence of PVs on left atrium (LA) and LAA haemodynamics. Computational fluid dynamics simulations were run on 52 patients, the largest cohort so far in the literature, where different parameters were individually studied: pulmonary veins orientation and configuration; LAA and LA volumes and its ratio; and flow velocities. Our computational analysis showed how the right pulmonary vein height and angulation have a great influence on LA haemodynamics. Additionally, we found that LAA with great bending with its tip pointing towards the mitral valve could contribute to favour flow stagnation.

We analyze left atrium haemodynamics, highlighting differences among healthy individuals and patients affected by atrial fibrillation. The computational study is based on patient-specific geometries of the left atria to simulate blood flow dynamics. We devise a novel procedure aimed at recovering the boundary conditions for the 3D haemodynamics simulations, particularly useful in absence of specific ones provided by clinical measurements. With this aim, we introduce a parametric definition of the atria displacement, and we employ a closed-loop lumped parameter model of the whole cardiocirculatory system conveniently tuned on the basis of the patient characteristics. We evaluate a number of fluid dynamics indicators for the atrial haemodynamics, validating our numerical results in terms of several clinical measurements; we investigate the impact of geometrical and clinical features on the risk of thrombosis. To analyse the correlation of thrombus formation with atrial fibrillation, coherently with the medical evidence, we propose a novel indicator, which we call age stasis and that arises from the combination of Eulerian and Lagrangian quantities. This indicator identifies regions where the slow flow cannot rinse the chamber properly, accumulating stale blood particles and creating optimal conditions for clot formation.

Segmentation of the left atrial chamber and assessing its morphology, are essential for improving our understanding of atrial fibrillation, the most common type of cardiac arrhythmia. Automation of this process in 3D gadolinium enhanced-MRI (GE-MRI) data is desirable, as manual delineation is time-consuming, challenging and observer-dependent. Recently, deep convolutional neural networks (CNNs) have gained tremendous traction and achieved state-of-the-art results in medical image segmentation. However, it is difficult to incorporate local and global information without using contracting (pooling) layers, which in turn reduces segmentation accuracy for smaller structures. In this paper, we propose a 3D CNN for volumetric segmentation of the left atrial chamber in LGE-MRI. Our network is based on the well known U-Net architecture. We employ a 3D fully convolutional network, with dilated convolutions in the lowest level of the network, and residual connections between encoder blocks to incorporate local and global knowledge. The results show that including global context through the use of dilated convolutions, helps in domain adaptation, and the overall segmentation accuracy is improved in comparison to a 3D U-Net.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, characterised by a rapid and irregular electrical activation of the atria. Treatments for AF are often ineffective and few atrial biomarkers exist to automatically characterise atrial function and aid in treatment selection for AF. Clinical metrics of left atrial (LA) function, such as ejection fraction (EF) and active atrial contraction ejection fraction (aEF), are promising, but have until now typically relied on volume estimations extrapolated from single-slice images. In this work, we study volumetric functional biomarkers of the LA using a fully automatic SEGmentation of the left Atrium based on a convolutional neural Network (SEGANet). SEGANet was trained using a dedicated data augmentation scheme to segment the LA, across all cardiac phases, in short axis dynamic (CINE) Magnetic Resonance Images (MRI) acquired with full cardiac coverage. Using the automatic segmentations, we plotted volumetric time curves for the LA and estimated LA EF and aEF automatically. The proposed method yields high quality segmentations that compare well with manual segmentations (Dice scores [$0.93 \pm 0.04$], median contour [$0.75 \pm 0.31$] mm and Hausdorff distances [$4.59 \pm 2.06$] mm). LA EF and aEF are also in agreement with literature values and are significantly higher in AF patients than in healthy volunteers. Our work opens up the possibility of automatically estimating LA volumes and functional biomarkers from multi-slice CINE MRI, bypassing the limitations of current single-slice methods and improving the characterisation of atrial function in AF patients.

The deformation of the left atrium (LA), or its biomechanical function, is closely linked to the health of this cardiac chamber. In atrial fibrillation (AF), atrial biomechanics are significantly altered but the underlying cause of this change is not always clear. Patient-specific models of the LA that replicate patient atrial motion can allow us to understand how factors such as atrial anatomy, myocardial stiffness and physiological constraints are linked to atrial biomechanics. We created patient-specific LA models from CT images. We fitted regional model stiffness to peak CT-derived deformation during the LA reservoir phase ($\pm0.90$ mm) and used the CT deformation transients through the reservoir and conduit phase for model validation (deformation transients fell within $\pm0.38$ mm per unit time of targets). We found that myocardial stiffness varies regionally across the LA. The regional stiffness values were significant factors contributing to regional physiological LA deformation ($p=0.023$) while features of LA anatomy, including regional wall thickness and adipose volume, were less important. These findings provide insight into the underlying causes of altered LA biomechanics in AF.

Late Gadolinium Enhanced Cardiac MRI (LGE-CMRI) for detecting atrial scars in atrial fibrillation (AF) patients has recently emerged as a promising technique to stratify patients, guide ablation therapy and predict treatment success. Visualisation and quantification of scar tissues require a segmentation of both the left atrium (LA) and the high intensity scar regions from LGE-CMRI images. These two segmentation tasks are challenging due to the cancelling of healthy tissue signal, low signal-to-noise ratio and often limited image quality in these patients. Most approaches require manual supervision and/or a second bright-blood MRI acquisition for anatomical segmentation. Segmenting both the LA anatomy and the scar tissues automatically from a single LGE-CMRI acquisition is highly in demand. In this study, we proposed a novel fully automated multiview two-task (MVTT) recursive attention model working directly on LGE-CMRI images that combines a sequential learning and a dilated residual learning to segment the LA (including attached pulmonary veins) and delineate the atrial scars simultaneously via an innovative attention model. Compared to other state-of-the-art methods, the proposed MVTT achieves compelling improvement, enabling to generate a patient-specific anatomical and atrial scar assessment model.

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Prophylactic left atrial appendage occlusion has been suggested as a means of reducing cardioembolism risk in patients with atrial fibrillation. Its clinical benefits have been discussed together with potential endocrine or hemodynamic adverse effects, with conflicting conclusions. We aimed to provide a thorough overview of the current literature and a recommendation for daily clinical decision-making. A comprehensive Medline search through PubMed was conducted to search for relevant articles, which were further filtered using the title and abstract. Sixty-five articles were selected as relevant to the topic. Concomitant left atrial appendage occlusion during cardiac surgery for other reasons is effective in terms of thromboembolism risk reduction in patients with a history of atrial fibrillation and higher CHA2DS2-VASc scores. Surgical occlusion is safe, and epicardial closure techniques are preferred. Thoracoscopic and transcatheter techniques are also feasible, and the individual treatment choice must be tailored to the patient. The concerns about endocrine imbalance or risk of heart failure after occlusion are not supported by evidence. Current evidence is conflicting with regard to hemodynamic consequences of appendage occlusion.

Left atrial appendage (LAA) occlusion is emerging as a viable alternative to oral anticoagulation in high-risk patients with atrial fibrillation. However, there remains limited evidence for this approach, especially in certain subgroups, and therefore patient selection is an important aspect of treatment. Here, the authors present arguments for LAA occlusion as either a last resort versus patient choice by evaluating contemporary studies on this topic and discuss practical steps in the approach of patients who may be suitable for LAA occlusion. Overall, an individualized and multidisciplinary team approach should be adopted in patients who are being considered for LAA occlusion.

Calcific uremic arteriolopathy (CUA), often referred to as calciphylaxis, is a rare condition potentially life-threatening seen in 1-4% of patients with kidney failure on chronic dialysis. Pathogenesis is not clear, but several risk factors have been identified, one of the most known among them is coumarin anticoagulants therapy (tAC). When CUA occurs, tAC is contraindicated: the left atrial appendage occlusion, in dialysed patients affected by non-valvular atrial fibrillation, could be contemplated in replacement of tAC, that should be considered by nephrologist and discussed by a multidisciplinary team including cardiologists.

Resection of the left atrial appendage (LAA) to prevent recurrent arterial emboli in patients with atrial fibrillation was first suggested more than 60 years ago. Longer-term follow-up from randomized studies of the safety and efficacy of transcatheter LAA occlusion has recently been completed; data from large, observational cohorts are being reported. These recent data provide further insights into procedural safety with current techniques and the ability of LAA closure to reduce thromboembolic stroke compared with warfarin anticoagulation. This review summarizes the latest data regarding transcatheter LAA occlusion, focusing on larger prospective studies and further analyses of seminal clinical trials.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, significantly increasing the risk of thromboembolic events, particularly ischemic stroke. The left atrial appendage (LAA) is the predominant site of thrombus formation in patients with AF, making it a crucial target for stroke prevention strategies. Left atrial appendage occlusion (LAAO) has emerged as an important therapeutic alternative to oral anticoagulation, particularly in patients with contraindications to long-term anticoagulant therapy. This review examines the role of LAAO in AF management, discussing current indications, patient selection, procedural techniques, and clinical outcomes. We also explore the latest evidence from major clinical trials and real-world studies, highlighting the efficacy and safety of LAAO compared to standard anticoagulation. Additionally, we consider the unresolved questions and the potential future directions for this intervention, including emerging technologies and the integration of LAAO into broader AF management protocols. Our review underscores the growing importance of LAAO in reducing thromboembolic risk in AF patients, particularly those unable to tolerate traditional anticoagulation, and offers insights into the ongoing evolution of this treatment modality in clinical practice. Atrial fibrillation (AF) is a common heart rhythm disorder that increases the risk of stroke. In many cases, blood clots form in a small area of the heart called the left atrial appendage (LAA), which can travel to the brain and cause a stroke. Oral anticoagulants (OACs) – commonly referred to as blood thinners – are the standard treatment to prevent strokes in patients with AF. However, some patients cannot take these medications due to a high risk of bleeding or other medical reasons.Left atrial appendage occlusion (LAAO) is a minimally invasive procedure that seals off the LAA to prevent clot formation, offering an alternative for patients who cannot take OACs long-term. Several studies have shown that LAAOcan be just as effective as anticoagulation in preventing strokes, while reducing the risk of major bleeding. Different types of LAAO devices are available, and research continues to improve their design and effectiveness.This article provides an overview of how LAAOworks, who might benefit from the procedure, its safety and effectiveness compared to anticoagulation, and ongoing research into future advancements. As LAAO becomes more widely used, it may become a first-line treatment option for stroke prevention in patients with AF, especially those who are at high risk of bleeding from traditional blood thinners.

Atrial fibrillation (AF) is a devastating disease with a large global prevalence. The left atrial appendage (LAA) is a major source of thrombi in patients with AF. Echocardiography plays an important role in identifying LAA thrombi and has become an invaluable imaging tool in planning for LAA occlusion (LAAO) in patients intolerant to anticoagulation. This review article will discuss the role of echocardiography in selecting patients for LAAO, intraprocedural monitoring, and identifying procedure-related complications.

To allow readers to fully appreciate the uncertainties with this novel yet invasive approach to stroke prevention. Percutaneous left atrial (LA) appendage occlusion has emerged as potential nonpharmacologic means to prevent stroke and systemic embolism in patients with atrial fibrillation. Yet the evidence underpinning this new technology is not definitive. In this review, we consider the internal and external validity of the regulatory trials, pathophysiologic basis for LA appendage occlusion and clinical tradeoffs of the procedure.

Atrial fibrillation is the most common arrhythmia worldwide and is a major risk factor for embolic stroke. In this article, the authors describe the crucial role of two- and three-dimensional transesophageal echocardiography in the pre- and postprocedural assessment and intraprocedural guidance of percutaneous left atrial appendage (LAA) occlusion procedures. Although recent advances have been made in the field of systemic anticoagulation with the novel oral anticoagulants, these medications come with a significant risk for bleeding and are contraindicated in many patients. Because thromboembolism in atrial fibrillation typically arises from thrombi originating in the LAA, surgical and percutaneous LAA exclusion/occlusion techniques have been devised as alternatives to systemic anticoagulation. Currently, surgical LAA exclusion is typically performed as an adjunct to other cardiac surgical procedures, which limits the number of eligible patients. Recently, several percutaneously delivered devices for LAA exclusion from the systemic circulation have been developed, some of which have been shown in clinical trials to reduce the risk for thromboembolism. These devices use an either purely endocardial LAA occlusion approach, such as the Watchman and Amulet procedures, or both an endocardial and a pericardial (epicardial) approach, such as the Lariat procedure. In the Watchman and Amulet procedures, a transseptally delivered structure composed of nitinol is placed in the LAA orifice, thereby excluding the LAA from the systemic circulation. In the Lariat procedure, a magnet link is created between a transseptally delivered endocardial wire and epicardially delivered pericardial wire, followed by epicardial suture ligation of the LAA.

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Left atrial appendage closure aims to eliminate the stasis component of Virchow triad by eliminating a cul-de-sac that favors thrombosis, particularly when atrial contractility becomes inefficient, such as in atrial fibrillation. Left atrial appendage closure devices have a common objective of sealing the appendage completely, with device stability and avoidance of device thrombosis. Two main device designs have been used to perform left atrial appendage closure: those that use a pacifier design (lobe + disk) and those that use a plug (single lobe) design. This review highlights the potential features and benefits of the single-lobe devices.

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Left atrial appendage occlusion (LAAO) is an alternative option to oral anticoagulation therapy in patients with non-valvular atrial fibrillation. According to French regulations, this procedure is currently reserved for patients with formal contraindications to VKA and direct thrombin inhibitors. LAAO procedures reduce ischemic and stroke risks compared to no treatment and also reduce bleeding events compared to VKA therapy in eligible patients. The peri-procedural complications risk has been reported to be limited in the different series published so far. Although elderly patients (>75 years) have either higher ischemic and bleeding risk than younger subjects, they hardly benefit from optimal anticoagulation. Thus, these subjects might greatly benefit from LAAO. Published studies reported excellent feasibility and efficiency of LAAO procedure in elderly patients. Yet there is a trend towards a higher incidence of peri-procedural complications (including tamponade), long-term safety is excellent and comparable to what is observed in patients<75 years. Therefore, interventional percutaneous LAAO is an attractive strategy in elderly patients with atrial fibrillation that should be incorporated in a multidisciplinary management.

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Routine postprocedural imaging with transesophageal echocardiography or cardiac computed tomography angiography is the most commonly used imaging modality for follow-up surveillance usually performed 1 to 6 months after the procedure. Imaging enables recognition of well-suited and sealed devices in the left atrial appendage as well as of potential harmful complications such as peri-device leaks, device-related thrombus, and device embolization, which may lead to further surveillance observation with recurrent imaging, reinitiation of oral anticoagulants, or additional interventional procedures.

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Atrial fibrillation (AF) has been a source of fascination for more than 100 years. Most early investigations centered on the mechanisms of the arrhythmia (reentry versus automaticity; site of origin; approaches to treatment or prevention; and the clinical consequences), specifically tachycardia-induced cardiomyopathy and the potential for lethal events in special circumstances (eg, preexcitation syndromes). The current increased interest in AF has been heightened by increasing information on the clinical volume and number of patients affected. Recent data identify a current prevalence rate of 6 million patients in the United States, which is predicted to become 12 million by 2030.

Prevention of thromboembolism in atrial fibrillation has been investigated in light of the high numbers of patients unable to be treated with effective anticoagulation. Therefore, endovascular mechanical occlusion of the left atrial appendage (LAA) has been developed as a substitute for thromboprophylaxis. Initial clinical trials demonstrated high rates of procedural complications. Using computed tomography (CT), one can ascertain accurate left atrial appendage dimensions, appendage morphology; predict radiograph gantry angles; and produce physical models for ex vivo device and catheter fitting. This is an overview of available evidence for using CT and the clinical impact of CT on endovascular LAA occlusion.

Since the first percutaneous left atrial appendage occlusion (LAAO), many studies have shown the safety and efficacy of this technique to prevent embolic strokes in nonvavular atrial fibrillation. The design, characteristics, and clinical data of the most frequently used devices for LAAO are reviewed, including the Amplatzer cardiac plug and Amulet (Abbott Vascular), the Watchman (Boston Scientific), and the LARIAT device (SentreHEART). Similarly, newer closer devices, such as Ultraseal (Cardia), LAmbre (Lifetech), and Coherex WaveCrest (Johnson & Johnson), are also discussed. Finally, new technologies still in the stage of preclinical study or in the initial clinical experience are also reviewed.

Atrial fibrillation (AF) is the most common cardiac arrhythmia and the cause of thromboembolic events in elderly patients worldwide. AF is associated with a significantly increased risk of morbidity and mortality due to cardiac emboli, primarily from left atrial appendage (LAA) thrombus. Oral anticoagulation therapy is the standard treatment to effectively reduce the risk of thromboembolic events in patients with AF. However, anticoagulation treatment increases bleeding risk. LAA closure (LAAC) has recently been introduced as a feasible mechanical preventive intervention for thromboembolic events while minimizing the risk of bleeding. Transcatheter LAAC devices have evolved in the past decade, and several ongoing trials have demonstrated the improvements of safety and outcomes in newer generation devices. This review summarizes the current perspectives and outcomes regarding LAAC as an alternative to pharmacologic therapy.

The left atrial appendage (LAA) has gained increasing attention in the field of cardiology as a potential site for intervention in patients with atrial fibrillation (AF) and an elevated risk of thromboembolic events. Left atrial appendage occlusion (LAAO) has emerged as a promising therapeutic strategy to mitigate the risk of stroke and systemic embolism, especially in individuals who are unsuitable candidates for long-term anticoagulation therapy. This review aims to provide a comprehensive analysis of the current state of LAAO, encompassing its anatomic considerations, procedural techniques, clinical outcomes, and future directions.

Catheter-based left atrial appendage closure (LAAC) is currently a potential treatment option for stroke prevention in patients with atrial fibrillation and high risk for stroke/embolism as well as high bleeding risk. Due to improvements in LAAC devices, advances in implantation techniques and growing experience of the interventional teams, the safety profile of LAAC has significantly improved in recent years. These developments have led to a currently comprehensive exploration of novel indications for LAAC, such as patients with atrial fibrillation and a low risk of hemorrhage, patients with atrial fibrillation after pulmonary vein ablation or patients after electrical isolation of the left atrial appendage. The treatment principle of closure of the left atrial appendage is supported by new data, which show the effectiveness of surgical closure of the left atrial appendage with respect to a reduction of the risk of stroke, at least partly in conjunction with oral anticoagulation during cardiological surgical interventions. Currently, the application in the clinical practice is reflected by a high degree of active studies. These randomized studies are testing the use of LAAC in new fields of application and together with the new developments in implantation techniques should define the optimal future use of the methods for the clinical practice. The current potential indications for the LAAC procedure, ongoing randomized clinical trials and advances in device development, implantation planning and technique as well as future developments in the field of LAAC treatment are summarized and discussed in this review article. Der katheterbasierte Verschluss des linken Vorhofohrs („left atrial appendage closure“, LAAC) stellt bei Patienten mit Vorhofflimmern und hohem Schlaganfall- sowie hohem Blutungsrisiko eine potenzielle Therapieoption zur Reduktion des Schlaganfallrisikos dar. Aufgrund der Weiterentwicklung der Implantationstechnik sowie der Einführung neuer bzw. optimierter Devices hat sich das Sicherheitsprofil der perkutanen LAAC in den letzten Jahren verbessert. Diese Beobachtungen sind auch der Ausgangspunkt für eine aktuell umfangreiche weitere Prüfung der Behandlungsmethode für neue Einsatzgebiete, wie beispielsweise bei Vorhofflimmerpatienten mit niedrigem Blutungsrisiko bzw. nach Pulmonalvenenisolation (PVI) oder bei Patienten nach elektrischer Isolation des linken Vorhofohrs. Das Therapieprinzip des Herzohrverschlusses wird durch neuere Daten unterstützt, die die Wirksamkeit des operativen Verschlusses des linken Vorhofohrs bezüglich einer Reduktion des Schlaganfallrisikos z. T. auch zusätzlich zur Antikoagulation im Rahmen von kardiochirurgischen Eingriffen zeigen. Aktuell wird die Anwendung in der klinischen Praxis durch eine hohe Studienaktivität begleitet. Diese randomisierten Studien werden den Einsatz des LAAC in neuen Indikationsfeldern prüfen und sollen zusammen mit neuen Entwicklungen bei der Implantationstechnik den optimalen zukünftigen Einsatz der Methode für die klinische Praxis weiter definieren. Die aktuell möglichen Indikationen zum LAAC, laufende randomisierte Studien sowie Fortschritte bei der Device-Entwicklung, der Implantationsplanung- und -technik sowie zukünftige Entwicklungen auf dem Gebiet der LAA-Verschluss-Therapie sollen in der vorliegenden Übersichtsarbeit zusammengefasst und diskutiert werden.

Several studies in literature have shown that 90% of emboli related to non-valvular atrial fibrillation originate from left atrial appendage. Percutaneous closure or surgical exclusion of left atrial appendage in patients with high bleeding and high cardioembolic risk is currently a well established procedure in literature, clinical practice and guidelines. Knowledge of different techniques of left atrial appendage closure is necessary to individualize the procedure according to the patient anatomy and pre-procedural imaging evaluations. In this review the authors will evaluate different left atrial appendage closure systems and the different pre and intra procedural imaging methods.

This review summarizes the evidence for left atrial appendage closure (LAAC) as an alternative to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation. LAAC reduces hemorrhagic stroke and mortality versus warfarin, but is inferior for ischemic stroke reduction based on randomized data. Whilst a feasible treatment in OAC-ineligible patients, questions remain over procedural safety, and the improvement in complications observed in nonrandomized registries is uncorroborated by contemporary randomized trials. Management of device-related thrombus and peridevice leak remain unclear, and robust randomized data versus direct OACs are required before recommendations can be made for widespread adoption in OAC-eligible populations.

Atrial fibrillation is the most frequent cardiac arrhythmia worldwide, causing approximately 20% of all ischemic strokes. Therefore, oral anticoagulation is recommended in patients with atrial fibrillation with at least a moderate risk of stroke; however, there is a significant proportion of patients who cannot undergo long-term oral anticoagulation. As the left atrial appendage is of major relevance for atrial fibrillation-induced thrombus formation, catheter-based or surgical closure of the left atrial appendage appears to be a promising therapeutic option. Large registry studies including patients with catheter-based left atrial appendage closure have proven its effectiveness and a decreasing procedure-related complication rate. This review article summarizes the current knowledge and introduces major ongoing randomized studies, which will investigate the impact of left atrial appendage closure on stroke prevention. The authors hope that the results of the randomized CLOSURE AF trial, which is funded by the German Center for Cardiovascular Research e. V. and is now recruiting patients in Germany, will help to solve many of the currently prevalent clinical questions.

Left atrial appendage closure (LAAC) has shown to be non-inferior to oral anticoagulation (OAC) for non-valvular atrial fibrillation (AF). LAAC is now becoming a leading method for stroke prophylaxis in patients who have atrial fibrillation and are unable to tolerate OAC. There are currently two FDA-approved endocardial closure devices, namely, the Watchman FLX and Amplatzer Amulet. Current data highlights that both devices offer similar efficacy and safety for LAAC. While the two devices differ in terms of intraprocedural complication rates, they offer similar short- to long-term outcomes in regard to peri-device leaks, device-related thrombosis, and mortality. With similar risk and safety profiles, both devices are indicated for patients who are unable to tolerate OAC. Newer clinical studies are directed to establish the efficacy of both devices as the primary method for stroke prevention in AF as an alternate to OAC.

Left atrial appendage (LAA) closure has recently been approved as an alternative management for stroke prevention in patients with chronic atrial fibrillation who have difficulties with long-term oral anticoagulation. The various shapes and sizes of LAA and orientation of the atrial ostium may contribute to the incomplete LAA closure from circular design devices and orientation of the non-steerable delivery catheter. Incomplete closure of LAA leads to a high-velocity blood flow through the peri-device gap, resulting in peri-device leak (PDL). Residual leaks are frequently diagnosed after LAA closure procedures, regardless of closure methods. There is a controversy in the clinical significance of the leaks, particularly about its association with thromboembolic events. PDL <5 mm was not associated with any increase of risk for thromboembolism. Current literatures with small study population have not been sufficient to clarify the role of the leaks after LAA closure. Nevertheless, management of severe leaks has been a challenging concern for cardiologists. Leaks after epicardial LAA closures are at the neck of the incompletely closed LAA and have shown to increase the risk of thromboembolism. Percutaneous closure of the leaks after LAA closure has been attempted with good safety and success, but long-term safety and efficacy remains unclear. Further large long-term studies which aim to assess the role of leaks or PDLs in predicting thromboembolic events and management strategies are warranted.

Atrial fibrillation (AF) is the most common arrhythmia in the United States and the most common cause of embolic cerebrovascular events, with the majority of these thrombi originating in the left atrial appendage. The left atrial appendage (LAA) has separate developmental, ultrastructural, and physiological characteristics from the left atrium. Although LAA anatomy is highly variable, it can be categorized into 4 types: cactus, cauliflower, chicken wing, and windsock. The cauliflower type is associated with higher stroke risk in patients with nonvalvular AF. Although the cornerstone of therapy to prevent embolic strokes from AF has been anticoagulation with thrombin inhibitors, a large group of patients are unable to tolerate anticoagulation due to bleeding. This has led to the development and advancement of multiple surgical and percutaneous LAA closure devices to prevent embolic cerebrovascular accidents without the need for anticoagulation. In this article, we discuss the outcomes of major studies that utilized surgical LAA occlusion and its effectiveness. Furthermore, we summarize nonsurgical methods of LAA closure and future directions regarding LAA closure.

Left atrial appendage closure (LAAC) is a safe and effective therapy for the prevention of stroke in patients with nonvalvular atrial fibrillation and high bleeding risk with oral anticoagulants. Multimodality imaging with transesophageal echocardiography and computed tomography angiography to define the anatomy and its implications on endocardial exclusion is becoming increasingly important. The only LAAC device currently approved for clinical use in the United States is the WATCHMAN device. Systematic assessment of the transseptal crossing site, left atrial appendage anatomy, adequate device size selection, and device postdeployment evaluation is essential for the safety and efficacy of the procedure.

Left atrial appendage closure (LAAC) is noninferior to oral vitamin K antagonist therapy for the reduction of nonvalvular atrial fibrillation-related stroke risk. Currently, the procedure is most widely accepted in patients who cannot tolerate oral anticoagulants. This patient population is generally comorbid, making any reduction in procedural complications paramount. LAAC has important complications described in the periprocedural and postprocedural periods. The prevention and management of complications regarding vascular access, transseptal puncture, pericardial effusion, device embolization, stroke, air embolusperidevice leak, device-related thrombus and device erosion/ late pericardial effusion are discussed.

Percutaneous left atrial appendage closure (LAAC) has proven to be an effective alternative to oral anticoagulation (OAC) for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). International guidelines traditionally recommend LAAC for NVAF patients at high thromboembolic risk and contraindication to or at high risk for OAC. However, there are many other clinical situations in which this procedure may also be beneficial. This paper discusses the potential role of LAAC in specific haemorrhagic diseases (cerebral amyloid angiopathy, age-related macular degeneration, hereditary haemorrhagic telangiectasia, and Moyamoya disease), after left atrial appendage (LAA) electrical isolation, in cases of persistent thrombus inside the LAA, in end-stage renal disease and in special groups of patients for whom low compliance and persistence to OAC may be anticipated.

Whereas the left atrial appendage plays a rather minor role under physiological circumstances, it gains an importance in patients with atrial fibrillation. Compelling evidence has revealed that the left atrial appendage is implicated as the source of thrombus in the vast majority of strokes in atrial fibrillation. Oral anticoagulation remains the standard of care for stroke prevention in atrial fibrillation; nevertheless, this treatment has several limitations and is often contraindicated, particularly in the elderly population in whom the risk of stroke is high. Therefore, occluding the left atrial appendage is a logical approach to prevent thrombus formation and subsequent cardioembolic events in these patients. We present a review of clinical outcomes of patients with atrial fibrillation undergoing left atrial appendage closure and the challenges faced in this field.

Transcatheter left atrial appendage closure has emerged as a non-pharmacological alternative to long-term anticoagulation for stroke prevention in appropriately selected patients with AF. In this concise review, the Food and Drug Administration-approved and some other left atrial appendage closure devices that are under investigation are discussed. Currently, Watchman Flx and Amplatzer Amulet are the only two devices that have been approved for commercial use by the Food and Drug Administration. A brief overview of device designs, clinical data on efficacy and safety, major limitations of left atrial appendage closure devices, and perspectives on future direction are provided. The current generation of devices is effective; however, efforts should continue on innovations and refinement of device technology.

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To date, left atrial appendage closure (LAAC) devices continue to be assessed as an intuitive alternative to oral anticoagulant therapy to prevent embolic complications in patients with atrial fibrillation. Concerns remain about the up-front risks associated with device implantation as well as device efficacy in preventing embolic events as compared with anticoagulation. Currently, LAAC devices serve as a potential alternative to long-term anticoagulation with the benefit of decreased bleeding risk but with less protection against ischemic events. An individualized risk-benefit analysis with regard to stroke possibility, bleeding likelihood with long-term anticoagulation, the risks of an invasive procedure, and the risks associated with having a lifelong intracardiac device should be performed to guide careful patient selection for this operation.

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and its prevalence increases with age. AF causes palpitations, heart failure, and cardiogenic embolism. Of them, the most critical and fatal complication is a cardio-embolic event. Oral anticoagulation plays a central role in reducing stroke risk in AF patients. Recently, when oral anticoagulation is considered in patients with non-valvular AF who are eligible for direct oral coagulations, they are preferred to vitamin K antagonist based on accumulating evidence. Although many patients can tolerate oral anticoagulation, there is a subset of patients who cannot tolerate long-term oral anticoagulation. Such a subset has a higher bleeding risk as indicated by the HAS-BLED score under oral anticoagulation. This subset of patients requires effective and safe non-pharmacological alternative therapies for stroke prevention. One of the promising non-pharmacological therapies is left atrial appendage closure. Three randomized controlled trials demonstrated non-inferiority of percutaneous left atrial appendage closure using WATCHMAN family to oral anticoagulation (Boston Scientific, Marlborough, MA, USA). WATCHMAN FLX, which was innovated following WATCHMAN 2.5, was associated with fewer safety events and a higher success rate of effective appendage closure. Nevertheless, several unsolved issues remain, including device-related thrombosis, post-treatment antithrombotic therapy, and peri-device leakage. Left atrial appendage closure for patients with non-valvular AF may be an alternative therapy to avoid cardiac embolism for high bleeding risk patients with contraindications to long-term oral anticoagulation therapy.

Percutaneous left atrial appendage closure (LAAC) has been reported many therapeutic effects with regard to its safety and efficacy, and the number of patients with non-valvular atrial fibrillation undergoing LAAC is increasing worldwide. Although it is a highly safe procedure, further improvements are expected and preoperative planning is extremely important. For this purpose, transesophageal echocardiography has been mainly performed so far, however, nowadays, it is recommended to determine a more optimal treatment strategy combined with computed tomography. Preoperative CT predicts not only the risk of the intervention based on anatomical features of the left atrial appendage (LAA) but also the device type and size, sheath type, optimal location for septal puncture and pre-procedurally clarifies the left atrium and LAA dimensions. Furthermore, postoperative CT can evaluate device-related thrombus and peri-device leak, making it possible to observe the postoperative course using less invasive methods. This study reviews the practical utility of CT in pre- and post-LAAC.

Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described. The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device. The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX. The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001). Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.

LAAO is an emerging option for thromboembolic event prevention in patients with NVAF. We previously reported data on comparison between LAAO and DOAC at two-year follow-up in NVAF patients at HBR (HAS-BLED ≥3). Limited data are available on long term follow-up. We aimed to evaluate the efficacy and safety of DOACs versus LAAO indication after 5 years. We enrolled 193 HBR treated with LAAO and 189 HBR patients with DOACs. At baseline, LAAO group had higher HAS-BLED (4.2 vs 3.3, p < 0.001) and lower CHADS-VASc (4.3 vs. 4.7, p = 0.005). After 1:1 PSM, 192 patients were included (LAAO n = 96; DOACs n = 96). At 5-year follow-up the rate of the combined safety and effectiveness endpoint (ISTH major bleeding and thromboembolic events) was significantly higher in LAAO group (p = 0.042), driven by a higher number of thromboembolic events (p = 0.047). The rate of ISTH-major bleeding events was similar (p = 0.221). After PSM no significant difference in the primary effectiveness (LAAO 13.3% vs DOACs 9.5%, p = 0.357) and safety endpoint (LAAO 7.5% vs DOACs 7.5%; p = 0.918) were evident. Overall bleeding rate was significantly higher in DOACs group (25.0% vs 13.7%, p = 0.048), while a non-significant higher number of TIA was reported in LAAO group (5.4% vs 1.1%, p = 0.098). All-cause and cardiovascular mortality were higher in LAAO group at both unmatched and matched analysis. We confirmed safety and effectiveness of both DOAC and LAAO in NVAF patients at HBR, with no significant differences in thromboembolic events or major bleeding were at 5-year follow-up. The observed increased mortality after LAAO warrants further investigations in RCTs.

Left atrial appendage occlusion (LAAO) is recommended in patients with non-valvular atrial fibrillation (AF) who have contraindications to or are intolerant of long-term oral anticoagulants (OAC), but its impact on hospitalization rates has not been well described. The objective of our study is to describe the incidence of all-cause, bleeding-related, and thrombosis-related hospitalizations before and after LAAO. We used the Nationwide Readmission Database to include patients aged ≥ 18 years with a diagnosis of AF who underwent transcatheter LAAO during the months of February-November in each year between 2016 and 2018. Patients who died during the index procedure or had missing length of hospital stay or mortality information were excluded. A total of 27,633 patients were included (median age: 77 years, 41% female) with an average pre- and post-LAAO monitoring period of 6.5 and 5.5 months respectively. Of these, 10,808 (39.1%) patients had one or more admissions prior to the procedure compared to 7,196 (26.0%) after the procedure. There was a 26% reduction in incidence of all-cause admissions (rate ratio (RR) = 0.74, 95% confidence interval (CI): 0.71-0.76; In a contemporary, nationally representative dataset, we found that LAAO is associated with a significant decrease in all-cause, bleeding-related, and thrombosis-related admissions. These findings lend support to the current use of transcatheter LAAO in clinical practice for patients with contraindications to OAC and/or at high risk of bleeding.

The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States. The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported. Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates. The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.

In this article, most of the present or available in the near future left atrial appendage (LAA) occlusion devices are discussed in terms of structure of the devices and principle technique for implantation. Thus, the Watchman™ device from Boston, the Amulet™ device from Abbot, the Lambre™ device from Lifetech, the Occlutech® device from Occlutech®, and the WaveCrest® device from Biosense Webster (former Coherex) are discussed. The systems differ in terms of the concept of occlusion. Several devices consist of only one part (Watchman™ and Occlutech®) that is implanted in the body, ending up in the orifice of the LAA. Others like the Amulet™ or Lambre™ device have an additional disc covering the orifice of the LAA from the left atrial side. The distal anchoring system is implanted first in the body of the LAA; thereafter, the disc is placed upon the orifice. With the WaveCrest® device, covering of the orifice is performed as the first step followed by rolling in the anchoring system to fix the device to the body of the LAA.

Atrial fibrillation is the most common arrythmia and it is linked to an increased risk of stroke. Even if anticoagulation therapy reduces the rate of stroke the benefits of this therapy have to be balanced with the increased risk of hemorrhagic event. Left atrial appendage closure is a valid alternative to long-term anticoagulation in patients with atrial fibrillation and high hemorrhagic risk. Actually new devices with different features have been tested and introduced progressively in the clinical practice. Improvements in preprocedural imaging evaluation and the learning curve of the operators led to percutaneous left atrial appendage closure a safe and effective procedure. A good knowledge of different devices and the technique of implant is necessary for optimization percutaneous left atrial appendage closure and the reduction of complications during the acute phase and follow up.

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Left atrial appendage occlusion (LAAO) is usually performed via the guidance of procedural transesophageal echocardiography (TEE) companied by general anesthesia (GA). To investigate the feasibility and safety of LAAO guided by procedural fluoroscopy only. The patients eligible for LAAO were enrolled into the current study and received implantation of either Watchman device or LAmbre device. The procedure was carried out with procedural fluoroscopy only and no companied GA; the position, shape, and leakage of the device were assessed by contrast angiography. TEE was performed after 3-month follow-up to evaluate the thrombosis, and leakage of device. Ninety-seven patients with atrial fibrillation (AF) with either Watchman device (n = 49) or LAmbre device (n = 48) were consecutively enrolled. Watchman device group was of lower CHA LAAO with the procedural imaging of fluoroscopy only exhibited the promising results of efficacy and safety. A prospective randomized multicenter study would be required to verify the observations in this study.

Pericardial effusion or pericardial tamponade (PE/PT) is a relatively common complication of left atrial appendage closure (LAAC). However, delayed PE/PT is rare with limited data. The aim of the study was to analyze the incidence and clinical consequences of delayed PE/PT following LAAC. Patients with nonvalvular AF who were successfully implanted with LAAC devices from October 2014 to April 2021 were consecutively screened. Subjects experiencing delayed PE/PT after LAAC were included. All treatment sessions of the subjects were recorded in detail. After discharge, the patients were followed up for clinical outcomes. A total of 748 patients with successful LAAC [nitinol cage device (475 Watchman 2.5), nitinol plug device (131 ACP and 142 LAmbre)] were screened. Six patients experienced delayed PE/PT (1 Watchman, 2 ACP, 3 LAmbre). The incidence of delayed PE/PT was higher in patients with a nitinol plug device (1.8% vs. 0.2%, P = 0.027). Bloody PE only occurred in patients with a nitinol plug device (5/273, 1.8%). All the patients accepted pericardiocentesis and discontinuing antithrombotic medication, and none of the patients died or needed cardiac surgery. All patients were followed up for 810 (598, 1174) days after discharge. None of them developed constrictive pericarditis or thromboembolic or major bleeding events. Delayed PE/PT is rare but can occur, and the incidence of delayed bloody PE/PT for the nitinol plug device was higher than that for the nitinol cage device. The strategy of emergency pericardiocentesis combined with discontinuing antithrombotic medication may be effective for delayed bloody PE/PT.

To evaluate the influence of congestive heart failure (CHF) on safety and efficacy of left atrial appendage closure (LAAC) in non-valvular atrial fibrillation (NVAF) patients. A total of 401 patients who consecutively underwent LAAC with Watchman and LAmbre devices were divided into CHF (85 cases) and non-CHF (316 cases) groups. Comparisons between groups were performed against data. No significant differences were found in implantation success and periprocedural complication rates between the two groups. During a mean 2.2 years of follow-up, the incidence rate of thromboembolism, major bleeding, device-related thrombus, and non-cardiovascular death was comparable. However, patients with CHF had significantly increased risk of all-cause death ( Implantation of atrial appendage occluder is effective and safe in NVAF patients with CHF. The increased risk of mortality and combined efficacy endpoints in patients with CHF versus non-CHF after LAAC may be associated with the high risk of CHF itself.

Left atrial appendage occlusion (LAAO) in non-valvar atrial fibrillation (AF) reduces cardioembolic strokes. Despite increased risk, trials exclude valvar AF in structural heart diseases where clots extend beyond appendage. Patients with AF and relative risks for oral anticoagulation (OAC) needing structural interventions underwent concomitant LAAO. After six months of OAC, aspirin was continued. Transesophageal echocardiogram was done three monthly till one year and yearly thereafter. The patient demographics, procedural details, post-procedural follow-up were analyzed. Nine patients aged 51.5 ± 6.3 years with AF underwent LAAO concomitantly with balloon mitral valvotomy in four patients, atrial septal defect device closure in four and periprosthetic mitral leak closure in one patient. Six patients had heart failure, four had prior embolic events, and two had documented LAA thrombus. The mean CHADS On a detailed literature search, this largest LAAO experience in structural heart diseases indicates its utility. OAC for six months followed by aspirin seems to prevent thrombus formation in these patients. The only incidence of early thrombus formation indicates immunity from clot formation after device endothelialisation. Larger multicenter trials combining LAAO with structural interventions in valvular AF are warranted in developing nations.