房颤患者左心耳夹闭术后3月停用口服抗凝药物

心房颤动是一种快速、不规则的房性心律，与多种严重并发症相关的多系统疾病，卒中作为其并发症之一，是目前卫生系统面临的重大挑战。左心耳由于其独特的结构与功能，具有较大的个体差异性，成为非瓣膜性房颤患者血栓形成主要部位。近年来随着左心耳检查技术的发展，对于规律使用抗凝药物仍发生血栓事件患者，左心耳封堵术是一种新方向，所以研究左心耳结构与功能对血栓防治具有重要意义。

缺血性脑卒中在中国的发病率逐年增加，其中大约20%的缺血性脑卒中是心源性卒中(CES)。心源性卒中的发生是多因素的，近年来随着诊断手段的丰富，为心源性卒中的防治提供了重要帮助。溶栓治疗是急性心源性卒中的治疗基础，另外临床常规口服传统抗凝药物预防血栓形成，新型抗凝药的出现为患者提供了新的抗凝选择，对于不能耐受抗凝药物或伴随心脏手术的患者通过房颤消融术或左心耳闭合术来预防卒中的发现也是当前的研究热点。本文重点对心源性卒中的诊断、防治进行了综述。

目的：研究肾功能正常或轻度损害[估算肾小球内生肌酐清除率(eGFR) ≥ 60 ml/(min•1.73 m2)]的心房颤动(房颤)患者行冷冻消融一站式手术后对比剂肾病(CIN)的发生率，并进一步分析CIN发生的相关危险因素。方法：选取2019年6月至2022年6月在上海市松江区中心医院心内科行房颤冷冻导管消融一站式手术(房颤冷冻消融及左心耳封堵一站式手术) eGFR ≥ 60 ml/(min•1.73 m2)的患者64例，计算手术前后eGFR值；并依据对比剂肾病定义[血清肌酐值较基线期水平升高 ≥ 0.3 mg/dl (26.5 μmol/L)或达到基线期水平的1.5倍以上]将64例术后患者分为对比剂肾病组(n = 6)和非对比剂肾病组(n = 58)，记录所有患者的基线资料包括实验室指标、手术指标及估算的eGFR值。结果：房颤冷冻消融一站式术后eGFR水平较术前有显著降低(P < 0.05)。64例房颤患者冷冻导管消融一站式术后6例发生对比剂肾病，发生率为9.4%。二元Logistic回归分析显示，术前N末端前体脑利钠肽(NT-proBNP)水平(OR = 15.205, 95% CI: 1.082~213.646)是对比剂肾病发生的独立危险因素。结论：肾功能正常或轻度损害的房颤患者冷冻导管消融一站式术后可能出现急性肾功能损伤；房颤冷冻消融一站式术前高水平NT-ProBNP可能是患者术后发生对比剂肾病的独立危险因素。

目的：分析射频消融联合左心耳封堵术对房颤患者左心功能及结构的影响，为一站式的临床应用提供更客观的依据。方法：连续纳入2022年3月至2023年4月期间在青岛大学附属医院心血管内科病房住院行一站式手术(LAAO + CA)的心房颤动患者50人，另取单纯行射频消融术(CA)患者50人为对照组，收集两组患者的临床资料，左心结构及功能指标，术后随访6个月，探索一站式手术患者对左心功能及结构的影响。结果：1) CA组与CA + LAAC组年龄、性别、体重指数(BMI)均无统计学差异(P > 0.05)，HAS-BLED、CHA2DS2-VASc评分有统计学差异(P值 0.05)，在左心房内径(LAD)、左心室舒张末期容积(LVDs)、二尖瓣环组织多普勒速度(e')、二尖瓣舒张末期速度E和二尖瓣环速度比值(E/e')方面的差异具有统计学意义(P 0.05)。结论：1) 单纯射频消融术后患者，LAD较前缩小，LVEF上升，LVFP减小，可逆转心脏结构重构，改善心功能，与一站式手术相比，LAD缩小程度不如单纯射频消融术，左心收缩功能未受影响，提示左心耳封堵术可能减低射频消融术对左房重构的改善程度。2) 一站式手术e'减小，差异具有统计学意义，E/e'增加，差异具有统计学意义，说明左心耳封堵器内皮化后可能会引起舒张早期流入左心室的血量减少，左心室充盈压升高。

目的：分析心房颤动患者射频消融联合左心耳封堵术(一站式手术)术后房颤晚期复发的危险因素，为房颤患者开展临床及介入的诊疗方案决策提供参考意见及依据。方法：连续纳入2019年3月至2022年4月期间在青岛大学附属医院心血管内科病房住院行一站式手术的心房颤动患者共80人，根据术后半年内房颤是否复发分为复发组与非复发组，收集并比较两组患者术前的临床指标、心脏结构与功能学指标和血清学指标，进行回顾性研究，分析一站式术后房颤复发的相关危险因素。结果：共24例(30%)研究对象术后房颤复发，单因素分析表明，复发组房颤病程(t = 2.682, P = 0.012)、房颤性质(χ2 = 17.654, P 2 = 38.355, P 2 = 12.444, P < 0.001)、CHA2DS2-VASc评分(t = −2.806, P = 0.008)、左心室射血分数(LVEF) (t = −2.093, P = 0.040)、血清脂蛋白a (t = −3.245, P = 0.002)水平低于非复发组，上述结果均具有统计学意义(P < 0.05)；Logistic回归分析提示，术前LAD (OR = 1.225, P = 0.013)是影响房颤患者一站式术后房颤复发的独立危险因素。结论：术前左心房前后径可在一定程度上评估行一站式手术的房颤患者术后房颤晚期复发风险。

目的：探讨老年非瓣膜性心房颤动(NVAF)合并慢性心力衰竭(CHF)患者行射频消融联合左心耳封堵术的安全性和有效性。方法：回顾性收集自2019年1月1日至2023年12月30日就诊于青岛大学附属医院行射频消融联合左心耳封堵术的年龄 ≥ 60岁的非瓣膜性房颤患者88例，根据是否合并CHF分为CHF组45例与非CHF组44例，另选取同期接受口服药物治疗年龄 ≥ 60岁的NVAF合并CHF患者(药物组) 49例作为对照组。收集三组临床基本资料，记录心衰组与非心衰组患者围术期不良事件，电话随访结合门诊随访方式随访，记录1年内三组主要不良心血管事件(MACE)发生率及再入院率情况并分析。结果：CHF组与非CHF组比较，手术并发症及围术期不良事件等发生率，差异无统计学意义(P > 0.05)。随访1年发现CHF组与非CHF组比较，MACE、再入院发生率差异无统计学意义(P > 0.05)。药物组MACE、心力衰竭、再入院发生率高于CHF组与非CHF组，差异有统计学差异(P < 0.05)。结论：射频消融联合左心耳封堵术对于老年非瓣膜性房颤合并慢性心力衰竭患者是一种安全有效的治疗方法，可有效降低主要心血管不良事件和再入院发生率。

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. To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT. 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. Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group). The primary outcome was time to first ischemic stroke. 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. 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.

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. 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. 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 CHA 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. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534.

Left atrial appendage occlusion (LAAO) serves as an alternative to oral anticoagulation (OAC) for atrial fibrillation (AF) patients at high risk of bleeding. The aim of this study was to compare the peri-procedural safety, complete or incomplete occlusion, the incidence of the peri-device leak (PDL), and device-related thrombosis (DRT) among LAAO, cryoballoon ablation (CBA) combined with LAAO, and radiofrequency catheter ablation (RFCA) combined with LAAO and to explore the risk factors of PDL and incomplete occlusion. 382 patients with non-valvular AF who underwent either LAAO alone ( Peri-procedural complication rates were low among all groups, with 2.9% in the RFCA combined with the LAAO group. In contrast, the LAAO alone and CBA combined with LAAO groups reported no major complications ( Peri-procedural complications, complete occlusion, PDL, and DRT rates were similar across the three treatment strategies. Persistent AF and SCr were significant risk factors for incomplete occlusion and PDL. These findings highlight the importance of individualized treatment strategies based on patient-specific risk factors for optimizing outcomes.

Among patients with atrial fibrillation (AF), a nonpharmacologic option (e.g., percutaneous left atrial appendage occlusion [LAAO]) is needed for patients with oral anticoagulant (OAC) contraindications. Among beneficiaries in the Medicare fee-for-service coverage 20% sample databases (2015-18) who had AF and an elevated CHA Patients undergoing percutaneous LAAO were matched to up to five OAC users by sex, age, date of enrollment, index date, CHA Median follow-up was 10.3 months. After multivariable adjustments, no significant difference for risk of stroke or death was noted when patients with percutaneous LAAO were compared with OAC users (HRs [95% CIs]: 1.14 [0.86-1.52], 0.98 [0.86-1.10]). There was a 2.94-fold (95% CI: 2.50-3.45) increased risk for hospitalized bleeding for percutaneous LAAO compared with OAC use. Among patients 65 to <78 years old, those undergoing percutaneous LAAO had higher risk of stroke compared with OAC users. No association was present in those ≥78 years. In this analysis of real-world AF patients, percutaneous LAAO versus OAC use was associated with similar risk of death, nonsignificantly elevated risk of stroke, and an elevated risk of bleeding in the post-procedural period. Overall, these results support results of randomized trials that percutaneous LAAO may be an alternative to OAC use for patients with contraindications.

In Europe left atrial appendage occluders (LAAO) are most frequently used in patients with contraindications for oral anticoagulation (OAC); therefore, the classical therapeutic OAC scheme from the PROTECT-AF trial (vitamin K antagonist plus acetylsalicylic acid) is usually changed to dual anti-platelet therapy (DAPT) after implantation of a Watchman® or Amulet® LAAO (St. Jude Medical/Abbott, Eschborn, Germany). For many years, patients with an LAAO received DAPT for 1-6 months. The current standard comprises DAPT for 3 months, followed by permanent acetylsalicylic acid monotherapy if the transesophageal echocardiogram excludes a thrombus at the site of the LAAO. In patients with high risk of bleeding, anti-platelet therapy can be stopped at 3 months after an individual risk-benefit calculation. There are no randomized studies on the risk of bleeding and stroke/embolism in patients with an LAA occluder under DAPT versus OAC. Experience from the EWOLUTION registry shows that NOACs may be used as an alternative with low bleeding and thrombus risks. In patients with a suboptimal implantation result, thrombus on the LAAO or specific risk factors, variations of the standard scheme have to be applied and if necessary lifelong DAPT or NOAC therapy has to be used. Thrombi on the LAAO occur in approximately 4-6% of patients and are associated with a very low short-term stroke risk.

Atrial fibrillation (AF) is associated with all-cause mortality, heart failure and non-fatal stroke, and thromboprophylaxis is traditionally provided with oral anticoagulants (OACs). Percutaneous left atrial appendage occlusion (LAAO) with a dedicated device is an alternative approach to thromboprophylaxis in patients with AF who are: (i) intolerant to OACs (e.g. life-threatening haemorrhage); (ii) non-adherent to OACs; or (iii) at a high bleeding risk with OACs. Non-inferiority of LAAO compared with OACs was demonstrated in e.g. the WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) trial. Only very limited data are available on percutaneous LAAO in South Africa (SA), and no local outcome data have been reported. To compare the safety and efficacy outcomes of an SA percutaneous LAAO programme with larger international series. All patients undergoing percutaneous LAAO from 2013 to 2020 at a single centre (SAEndovascular, Kuils River Netcare Hospital, SA) were included from an ongoing registry. Survival analysis was performed with the Kaplan-Meier method. Of 101 LAAO recipients (mean (standard deviation) age 77 (10) years, 64% male) analysed, 90 (90%) had permanent AF, 1 (1%) persistent AF and 9 (9%) paroxysmal AF. The most common indication for LAAO was previous severe bleeding (n=23; 23%). The mean device size was 23 (3) mm and the procedural success rate was 98%. After a median (interquartile range) follow-up of 21 (5 - 41) months, 6 patients (6%) experienced stroke or all-cause mortality. Four patients (4%) had a life-threatening procedural complication (tamponade n=2 (2%) and device embolisation n=2 (2%)). These outcomes are comparable to large international series, e.g. PROTECT AF. The safety and efficacy outcomes of an SA percutaneous LAAO programme were comparable to large international series. A successful percutaneous LAAO programme is feasible in a southern African context.

The aim of this study was to investigate the outcomes of left atrial appendage occlusion (LAAO) in high bleeding risk patients suffering atrial fibrillation (AF) and to analyze the different antithrombotic therapies following the intervention. This monocentric study included 68 patients with nonvalvular AF with an absolute contraindication to OAT or at high bleeding risk. Follow-up was done with a clinical visit at 3-6-12 months. Successful LAAO was achieved in 67/68 patients. At discharge, 32/68 patients were on dual antiplatelet therapy (APT), 34/68 were without any antithrombotic therapy or with a single antiplatelet drug, and 2/68 were on anticoagulant therapy. At three-month follow-up visit, 73.6% of the patients did not receive dual APT, of whom 14.7% had no thrombotic therapy and 58.9% were on single antiplatelet therapy. During a follow-up of 1.4 ± 0.9 years, 3/62 patients had late adverse effects (2 device-related thrombus without clinical consequences and 1 extracranial bleeding). The device-related thrombosis was not related to the antithrombotic therapy. LAAO is feasible and safe and prevents stroke in patients with AF with contraindication to oral anticoagulant therapy. After LAAO, single antiplatelet therapy seems to be a safe alternative to dual antiplatelet therapy, especially in patients at high bleeding risk. No benefit has been observed with dual APT.

The coexistence of atrial fibrillation (AF) and chronic kidney disease (CKD) increases the risk of thromboembolic complications, as well as hemorrhagic incidents - percutaneous left atrial appendage occlusion (LAAO) is an alternative. To evaluate the long-term outcomes of LAAO performed in patients with CKD and non-valvular AF. Two hundred and seventy-two patients with AF who underwent LAAO between 2009 and 2019 were prospectively analyzed. Patients were divided into two groups: CKD (105 patients) and non-CKD (167 patients) (cut-off point: eGFR 60 ml/min/1.73 m The LAAO was successful in 269 (98.9%) patients. Seven (2.6%) patients suffered an ischemic stroke, including 2 (1.9%) with CKD and 5 (3.0%) in the non-CKD ( Considering the significant reduction in thromboembolic events, with a simultaneous reduction of major bleeding complications, LAAO is a safe and effective alternative for AF patients with CKD.

We previously pioneered a negatively ionized polyethylene terephthalate membrane method (the SMART technique) with the LAMax (test) occluder to reduce platelet adhesion and promote endothelialization. This study aimed to compare the safety and efficacy of the test occluder with the Watchman 2.5 device (control) in patients with nonvalvular atrial fibrillation to reduce stroke risk. Overall, 236 patients were randomly assigned (1:1) (open-label) to the test or control device for left atrial appendage occlusion (LAAO). The effectiveness endpoints included 12-month successful left atrial appendage (LAA) sealing with residual flow ≤5 mm and clinical success (composite of ischemic stroke, transient ischemic attack, and systemic embolism). Safety endpoints were also studied. A noninferiority margin of -7% was set between the devices. The test device was noninferior to the control device for the effectiveness endpoints of successful LAA sealing (test 93.2% vs control 89.8%; P < 0.05) and clinical success (test 93.2% vs control 89.8%; P < 0.05). The 12-month safety endpoints were similar between the 2 devices. The device-related thrombus rates for the control device at the 3- and 12-month visits were 5.7% and 4.6%, respectively; no cases of device-related thrombus occurred with the test device. This study suggests that transcatheter LAAO using the SMART technique may effectively and safely prevent stroke in patients with nonvalvular atrial fibrillation. Although further studies with larger sample sizes are needed, this novel technique may prevent device-related thrombus formation and has high potential for application in interventional therapies. (LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke; NCT04429646).

Anticoagulants (AC) are associated with epistaxis in atrial fibrillation (AF) patients. Left atrial appendage occlusion (LAAO) is a treatment that allows AF patients to stop AC. The aim of this study is to evaluate the risk of developing epistaxis following LAAO versus direct oral anticoagulants (DOAC) and warfarin. This study uses the TriNetX database as well as institutional records. The TriNetX database was searched for AF patients on a DOAC, warfarin, or treated with LAAO. Epistaxis odds ratios were compared 1 day-6 months and 6 months-3 years following initiation of DOAC, warfarin, or LAAO. Records of LAAO patients at our institution were also reviewed. The TriNetX query returned 1,185,862 patients. On TriNetX, LAAO patients had significantly higher odds of epistaxis likely due to antiplatelet therapy from 1 day-6 months compared to warfarin patients with DOAC patients (p < 0.0001). From 6 months-3 years after treatment initiation, LAAO patients experience reduced odds of epistaxis and epistaxis requiring nasal packing compared to warfarin patients (OR: 0.69 p = 0.0003; OR: 0.58 p = 0.0043). Institutionally, epistaxis resolved in 66% (8/12) LAAO patients with a history of epistaxis with an average follow-up of 1.5 years. LAAO decreased the frequency of epistaxis and epistaxis requiring nasal packing in AF patients on warfarin after 6 months. Our institutional experience demonstrates long-term improvement in epistaxis after LAAO for DOAC and warfarin patients. Additional studies need to be performed to account for dual antiplatelet following LAAO on epistaxis risk. 3 Laryngoscope, 135:1636-1641, 2025.

Direct current cardioversion (DCCV) is a common rhythm control strategy in patients with symptomatic atrial fibrillation or flutter. There is no long-term data regarding the safety of DCCV in patients with endocardial left atrial appendage occlusion (LAAO) devices. The purpose of this study was to assess the feasibility and safety of DCCV in patients with an LAAO device. This multicenter retrospective study included 148 patients with an LAAO device who underwent DCCV for symptomatic atrial fibrillation or atrial flutter. The average age of the included patients was 72 ± 7 years and 59% were men. All patients (100%) had a transesophageal echocardiogram prior to DCCV. Device-related thrombus was seen in 2.7%. They were all successfully treated with oral anticoagulation (OAC) and were able to undergo DCCV after 6 to 8 weeks. DCCV restored sinus rhythm in all patients. None of the patients had DCCV-related thromboembolic complications. A total of 22% of patients were newly started on OAC after DCCV. There was no difference in DCCV-related complications between patients treated with or without OAC post-DCCV. Patients receiving OAC post-DCCV were found to undergo cardioversion at an earlier time after implantation (3.6 months [interquartile range (IQR): 0.7 to 8.6 months] vs. 8.6 months [IQR: 2.5 to 13.3 months]; p = 0.003). Three transient ischemic attacks, unrelated to DCCV, were found during follow-up. During a median follow-up of 12.8 months (IQR: 11.8 to 14.2 months), no device or left atrial thrombosis, device dislodgement, or a new device leak were observed. One patient died during follow-up due to noncardiac cause. DCCV is feasible in high-risk AF patients with an LAAO device without the need for oral anticoagulation if pre-procedural transesophageal echocardiography shows good device position, absence of device-related thrombus, and peridevice leak of ≤5 mm. The preliminary results are encouraging, but further large studies are warranted to establish safety.

Non-valvular atrial fibrillation (AF) greatly increases the risk of ischaemic stroke. For people with contraindications to oral anticoagulation, left atrial appendage occlusion (LAAO) provides a non-pharmacological management alternative. The aim of this study was to measure the procedural safety and longer-term effectiveness of LAAO for AF in a UK setting. This was a prospective, single-armed registry of patients with AF for whom anticoagulation was unsuitable. Registry data were collected between October 2014 and April 2018 and linked to routine data sources for follow-up. Data from 583 LAAO procedures were entered into the registry, of which 537 (from 525 patients) were eligible for inclusion (median CHA2DS2-VASc score 4). A closure device was successfully implanted in 93.4% of cases, with a procedural success rate (device implanted without major complication) of 88.9%. Five patients (1.0%) died in hospital. During follow-up [median 729 (Q1:Q3, 523:913) days] 45 patients experienced neurological events; 33 of which were ischaemic. The ischaemic neurological event rate was 3.3 (1.6-5.0)% at 1 year (n = 387) and 7.0 (4.3-9.6)% at 2 years (n = 196). There were significant improvements in overall patient health (via Visual Analogue Scale) measured at 6 weeks and 6 months, but no significant improvements observed in patient utility over time. The findings of our study suggest that LAAO is not without procedural risk, but that this risk may be justified in high-risk patients with AF who cannot take an anticoagulant. Moreover, the data do not provide support for more widespread use of LAAO as the complication rate was relatively high and would be difficult to justify in many patients with AF who tolerate anticoagulation.

Patients with atrial fibrillation or flutter (AF) on anticoagulation (AC) for stroke prevention are at an increased risk of bleeding. A common clinical dilemma is deciding when to safely restart AC following a bleed. Although studies have shown better outcomes with re-initiation of AC after hemostasis, there are clinical barriers to restarting AC. Left atrial appendage occlusion (LAAO) is a safe and efficacious alternative for patients who are unable to tolerate AC following major bleeding. We aimed to evaluate the rate of stroke prevention strategies instituted at time of discharge in patients with AF on AC who had been hospitalized for a bleeding event. We retrospectively identified patients with AF on AC admitted for bleeding between January 2016 and August 2019. The type of AC, form of bleeding, and CHA One hundred seventy-four patients with AF on AC were hospitalized with a bleeding event, of which 10.9% died. Among patients who survived, AC was restarted in 45.2% of patients, 9.7% were referred for LAAO, and 45.1% were discharged without stroke prevention strategy. At 3 months, 32.6% of patients still had no documented stroke prophylaxis. Those referred for LAAO had, on average, higher CHA A significant number of patients with AF hospitalized for bleeding were discharged with no plan for stroke prophylaxis. Despite its safety and efficacy, LAAO appears to be an underutilized alternative in AF patients with high bleeding risk.

Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO). A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively. Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups.

To demonstrate the feasibility of combining left atrial appendage electrical isolation (LAAEI) with left atrial appendage occlusion (LAAO) to increase efficacy of persistent/longstanding atrial fibrillation (PLAF) catheter ablation (CA) while mitigating risk of left atrial appendage (LAA) thrombus. CA for atrial fibrillation (AF) plus LAAO is safe and feasible. LAAEI may improve freedom from recurrence in PLAF but may increase LAA thrombus. We performed 42 concomitant procedures in patients with PLAF. After standard lesions, LAAEI was performed. LAAO immediately followed ablation. If 3-month transesophageal echocardiogram (TEE) was benign, oral anticoagulation (OAC) was transitioned to dual antiplatelet therapy for 3 more months. Patients were 71.1 ± 8.5 years old, with CHADS2-VASc of 3.3 ± 1.1 and HAS-BLED of 2.5 ± 1.4. Twenty-eight of 42 patients (66.7%) were completely AF free over an average follow-up of 18.6 ± 8.6 months. The AF-free survival estimate was 94.5% at 1 year. There was no thromboembolism (TE) during the follow-up. There were six non-significant leaks acutely and six non-significant leaks at 6 months. There were three device-related thrombi, although 2/3 stopped OAC prematurely. A combined procedure is feasible and effective in treating arrhythmia and stroke risk associated with PLAF. The risk of TE despite OAC after LAAEI supports simultaneous LAAO.

Atrial fibrillation (AF) is highly prevalent in patients with mitral stenosis (MS), but the efficacy of left atrial appendage occlusion (LAAO) in these patients remains unclear.The aim of this study was to evaluate the efficacy and safety of LAAO in patients with MS complicated by AF at high risk of bleeding.We recruited patients from September 2015 to September 2018. We compared the 3-year outcomes of LAAO in 21 patients with AF complicated by MS and 42 sex- and age-matched patients with AF without MS.The MS group had more cases of peripheral arterial embolism (28.6% versus 2.4%, P = 0.004), more spontaneous echo contrast (47.6% versus 9.5%, P = 0.001), a larger LAA orifice diameter (P < 0.01), and a slower LAA flow (P < 0.05) than the Non-MS group. The mean size of the selected occluder device was bigger for patients with MS than for patients with Non-MS (29.2 ± 3.7 versus 26.9 ± 3.1 mm, P = 0.014). In the first 45 follow-up days, 2 (9.5%) patients with MS had device-related thrombi (DRT); one of them had transient ischemic attack 24 hours postoperatively. From 45 days to 6 months, one patient in each group had DRT. After 6 months, two patients in the Non-MS group still had residual leaks; one of them had a stroke, with a small DRT. The proportion of dual antiplatelet therapy was higher in the Non-MS group than in the MS group (33.3% versus 4.8%, P = 0.012), but this population had an increased bleeding risk.LAAO is relatively effective and safe for preventing embolic events in patients with MS complicated by AF, at high risk of bleeding.

The aim of this study is to present a dedicated left atrial appendage closure protocol, which could be of great interest in the approach of frail patients. Left atrial appendage (LAA) occlusion emerged as a promising therapeutic tool for stroke prevention, as most of the atrial fibrillation (AF) related strokes result from LAA thromboembolism, with an important residual risk even for anticoagulated patients. As an internationally recognized and scientifically-based protocol for the patients with higher comorbidities has not yet been defined for this procedure in terms of anaesthesia use or post procedural antithrombotic therapy and follow-up, we developed a dedicated protocol that could be applied in frail patients. In this study we describe the mid-term outcome of our strategy. We enrolled 32 patients that underwent percutaneous LAA occlusion under transesophageal echocardiogram guidance, using only superficial sedation. A dedicated anti-thrombotic regimen was chosen for all patients, taking into consideration their bleeding and thrombotic risk profile. All patients routinely performed echocardiography after 3 months follow-up. Procedural success was achieved in all cases, except for one, due to extreme angulation of the LAA neck, while one patient required general anaesthesia. Only 9.4% of the patients, having previous stroke and still at high risk for cardio-embolic events, continued anticoagulation, while 31.2% discontinued any anti-thombotic drug. While no in-hospital complication was encountered, we found one asymptomatic device-thrombosis, managed by 30 days anticoagulation. No deaths, strokes or major bleedings occurred during an average 10.3 months of follow-up. A tailored post-implantation anti-thrombotic regimen and the avoidance of general anaesthesia can be a safe and effective strategy for the usually frail patients requiring percutaneous LAAO.

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.

This study aimed to evaluate the performance of non-vitamin K antagonist oral anticoagulation (NOAC) in patients with previous stroke and non-valvular atrial fibrillation (AF) compared with left atrial appendage occlusion (LAAO) in primary and secondary stroke prevention settings. This was a prospective, single-center, non-randomized cohort study of 302 consecutive patients with non-valvular AF and at high risk for stroke. Two treatment strategies were compared: LAAO (n=91) and long-term treatment with NOAC (n=149). The primary outcome was the composite endpoint of death, stroke and major bleeding. Propensity score and cause-of-death analyses were performed to compare outcomes. In a mean follow-up of 13 months, there were 30 deaths (LAAO 8.8% vs. NOAC 14.8%), five strokes (LAAO 1.1% vs. NOAC 2.7%) and six major bleeds (LAAO 1.1% vs. NOAC 3.4%). There was a non-significant trend for a lower incidence of the primary endpoint in the LAAO group (11.0% vs. 20.9%; HR 0.42, 95% CI 0.17-1.05, p=0.064). Considering only secondary prevention LAAO patients (34.1% of the LAAO group), there was also a non-significant lower incidence of the primary endpoint (LAAO 6.5% vs. 20.9%; HR 0.30, 95% CI 0.07-1.39, p=0.12). While about a fifth of LAAO patients stopped antiplatelet treatment six months after device implantation due to recurrent minor bleeding, no adverse cardiovascular event or major bleeding occurred in this subset of patients. In this registry-based study, LAAO was a reasonable alternative to NOAC for the prevention of a composite endpoint of all-cause mortality, stroke and major bleeding in patients at high risk for stroke.

In patients with atrial fibrillation (AF) and end-stage renal disease (ESRD), oral anticoagulants are contraindicated, and left atrial appendage occlusion (LAAO) is an alternative treatment. However, the efficacy of thromboembolic prevention using LAAO in these patients has rarely been reported in Asian populations. To our knowledge, this is the first long-term LAAO study in patients with AF undergoing dialysis in Asia. In this study, 310 patients (179 men) with a mean age of 71.3 ± 9.6 years and mean CHA2DS2-VASc 4.2 ± 1.8 were consecutively enrolled at multiple centers in Taiwan. The outcomes of 29 patients with AF and ESRD undergoing dialysis who underwent LAAO were compared to those without ESRD. The primary composite outcomes were stroke, systemic embolization, or death. No difference in mean CHADS-VASc score was noted between patients with versus without ESRD (4.1 ± 1.8 vs. 4.6 ± 1.9, p = 0.453). After a mean follow-up of 38 ± 16 months, the composite endpoint was significantly higher in patients with ESRD (hazard ratio, 5.12 [1.4-18.6]; p = 0.013) than in those without ESRD after LAAO therapy. Mortality was also higher in patients with ESRD (hazard ratio, 6.6 [1.1-39.7]; p = 0.038). The stroke rate was numerically higher in patients with versus without ESRD, but the difference was not statistically significant (hazard ratio, 3.2 [0.6-17.7]; p = 0.183). Additionally, ESRD was associated with device-related thrombosis (odds ratio, 6.15; p = 0.047). Long-term outcomes of LAAO therapy may be less favorable in patients with AF undergoing dialysis, possibly because of the poor condition of patients with ESRD.

Both percutaneous left atrial appendage occlusion (LAAO) and nonvitamin K antagonist oral anticoagulants (NOACs) are noninferior to warfarin for stroke prevention in high-risk patients with atrial fibrillation (AF). However, there is limited data comparing LAAO with NOACs. The CATALYST trial compares a dual-seal LAAO device (Amplatzer™ Amulet™) to NOACs in AF patients indicated for thromboprophylaxis. CATALYST is a prospective, multicenter, randomized controlled, open-label trial with an adaptive statistical design. Up to 2,650 AF patients with CHA CATALYST is evaluating the safety and effectiveness of a dual seal LAAO device compared to NOACs in patients with AF at increased risk of stroke. URL https://clinicaltrials.gov; Unique Identifier NCT04226547.

Patients with atrial fibrillation (AF) have an increased risk of stroke and systemic embolism. Catheter ablation (CA) is increasingly applied for the treatment for drug-refractory AF; however, its long-term success rate is <50%. It has been proved that percutaneous left atrial appendage occlusion (LAAO) exerts the same efficacy as novel oral anti-coagulants [(N)OACs] in reducing thromboembolic events. The present study investigated whether a combined procedure of AF ablation and LAAO may be feasible and efficacious. CA was performed for patients with AF and a high risk of stroke according to their CHADS

Left atrial appendage closure (LAAC), a device-based therapy for stroke prevention in patients with atrial fibrillation, is considered an alternative to oral anticoagulation therapy, particularly for patients at high risk of bleeding. Proof of concept has been demonstrated by the PROTECT AF and PREVAIL trials which evaluated the WATCHMAN device (Boston Scientific, Marlborough, MA, USA) versus warfarin, showing favourable outcome for the device group. The most commonly used devices for LAAC are the WATCHMAN and its successor, the WATCHMAN FLX (Boston Scientific) and the AMPLATZER Cardiac Plug and more recently the AMPLATZER Amulet device (both St. Jude Medical, St. Paul, MN, USA). The procedure is typically performed via a transseptal puncture under fluoroscopic and echocardiographic guidance. Technically, it is considered quite demanding due to the anatomic variability and fragility of the appendage. Careful material manipulation, adequate operator training, and good cardiac imaging and device sizing allow a safe, uneventful procedure. Post-procedure antithrombotic drug selection is based on the patient's history, indication and quality of LAAC.

Antithrombotic therapy is required after left atrial appendage occlusion (LAAO) whilst endothelialization of the device occurs. LAAO patients are usually at high bleeding risk and the optimal antithrombotic regimen post-implantation remains debated. We aimed to study the efficacy of using maximum of 6-month antithrombotic treatment post-LAAO in high bleeding risk patients with atrial fibrillation. Data from patients who had LAAO at our center between 2015 and 2024 were examined. Those who were discharged on a plan of 6 months antithrombotic therapy were included. Incidence of stroke, transient ischaemic attack (TIA), major bleeding or death during follow-up was measured. A total of 128 patients met the analysis criteria. One hundred and six (82.8%) patients had a previous major bleeding event with or without oral anticoagulation. Seventy-eight (60.9%) patients had a previous stroke. The median CHA Complete cessation of antithrombotic treatment 6 months after LAAO was associated with a low incidence of subsequent stroke or TIA in patients at high bleeding risk.

Left atrial appendage occlusion is an increasingly proposed treatment for patients with atrial fibrillation and poor tolerance to anticoagulants. All endovascular devices require antithrombotic therapy. Anatomical and clinical variables predisposing to device-related thrombosis, as well as post-procedural peri-device leaks, could mandate the continuation or reintroduction of aggressive antithrombotic treatment. Because of the absence of foreign material inside the heart, epicardial appendage closure possibly does not necessitate antithrombotic therapy, but data of large series are missing. Multidisciplinary team evaluation for standalone totally thoracoscopic epicardial appendage closure was done in 180 consecutive patients with atrial fibrillation and poor tolerance to antithrombotic therapy. One hundred and fifty-two patients consented (male 66.1%, mean age 76.1 ± 7.4, CHA Procedural success was 98.7%. At a mean follow up of 38.2 ± 18.8 months, cardioembolic and bleeding events were 1.3% and 0.6%, respectively. Among patients with a history of blood transfusions (41.1%), none needed further transfusions or treatment post procedure. Epicardial appendage occlusion without any antithrombotic therapy appears to be safe and effective. This strategy could be advised when minimization of bleeding risk concomitant to stroke prevention is needed.

Left atrial appendage closure (LAAC) has emerged as a viable option for stroke prevention, especially in those intolerant of or not suitable for long-term oral anticoagulation therapy. This article describes the clinical characteristics, indications, and a proposed referral system for potential LAAC patients. Patient selection remains a challenge because of the paradox between the available randomized data on this intervention and the actual patient population who may gain maximum benefit. Further investigations comparing different LAAC devices with each other and with novel oral anticoagulants are needed. Also, the optimal antithrombotic regimen post-procedure has yet to be determined.

To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.

This study sought to assess long-term clinical outcomes in adults with nonvalvular atrial fibrillation (AF) who are ineligible for oral anticoagulation therapy and underwent left atrial appendage (LAA) ligation with the Lariat device. LAA exclusion has been used to prevent thrombus formation within the LAA in AF patients and is believed to decrease the risk of cardioembolic events. LAA ligation with the Lariat device was performed in 139 patients with nonvalvular AF. LAA closure was verified during the procedure by LA angiography and transesophageal echocardiography. A follow-up transesophageal echocardiography was performed at 30 to 45 days post-procedure. After the procedure, patients received aspirin only, clopidogrel only, aspirin plus clopidogrel, or no antithrombotic drugs. Patients did not receive transition oral anticoagulation therapy post-LAA ligation. Patients were followed for LAA closure and adverse events, including stroke, systemic events, and death. Acute closure was accomplished in 138 of 139 treated patients (99%). In 1 patient, a posterior lobe was partially closed. At the day-30 to day-45 transesophageal echocardiography (n = 127), 114 (90%) had complete LAA closure, and 13 (10%) had a 2- to 4-mm leak. There were no leaks ≥5 mm. The periprocedural adverse event rate was 11.5%, including 2 cardiac perforations and 1 death due to pulmonary embolus. Over a mean follow-up of 2.9 ± 1.1 years, the event rate for the composite endpoint of stroke and systemic embolism was 1.0% per year (n = 4). The combined stroke, embolism, and death of any cause event rate was 2.8% (n = 11) per year. The findings from this analysis of post-procedure event rates suggest that LAA ligation with the Lariat device effectively closes the LAA and may be a beneficial approach to reduce the risk of embolic events in AF patients ineligible to oral anticoagulation therapy. However, future randomized clinical trials are needed to verify these results and to determine device and procedural safety.

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. A 72-year-old woman with paroxysmal AF (CHA 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. 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.