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After atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to clinical outcomes at 36 months.

Percutaneous left atrial appendage (LAA) closure is a viable alternative to chronic oral anticoagulation for reducing thromboembolic risk in non-valvular atrial fibrillation (AF) patients. To date, no clinical data have been published on the novel nonpacifier LAA closure device evaluated herein. We therefore conducted a prospective, non-randomized, multi-center registry across 6 Chinese hospitals to provide the first clinical evidence of its safety and effectiveness among AF patients with an increased risk of stroke, using performance goals to assess 6-month effective LAA closure and 12-month ischemic stroke incidence. Among 187 enrolled patients (mean age 67.7 ± 7.5 years; mean CHA 2 DS 2 -VASc 4.0 ± 1.6; mean HAS-BLED 2.5 ± 1.1), device implantation succeeded in 184 (98.4%), with 4 (2.1%) major peri-procedural complications. Effective LAA closure was achieved in all (100%) patients at 6 months with a 1-sided 95% lower confidence interval (CI) of 98.0%. During the 12-month follow-up period, 1 of 176 patients (0.6%, 1-sided 95% upper CI 2.9%) experienced ischemic stroke, thus meeting both prespecified performance goals. The cumulative incidence of major clinical events was 11 of 176 patients (6.5%, 95% CI 2.9–10.1%). This novel LAA closure device is effective for stroke prevention in non-valvular AF, with high procedural success and low adverse events.

Background Approximately 90% of intracardial thrombi originate from the left atrial appendage in non-valvular atrial fibrillation patients. Even with anticoagulant therapy, left atrial appendage thrombus (LAAT) still occurs in 8% of patients. While left atrial appendage closure (LAAC) could be a promising alternative, the current consensus considers LAAT a contraindication to LAAC. However, the feasibility and safety of LAAC in patients with LAAT have yet to be determined. Methods This systematic review synthesizes published data to explore the feasibility and safety of LAAC for patients with LAAT. Results This study included a total of 136 patients with LAATs who underwent successful LAAC. The Amulet Amplatzer device was the most frequently utilized device (48.5%). Among these patients, 77 (56.6%) had absolute contraindications to anticoagulation therapy. Cerebral protection devices were utilized by 47 patients (34.6%). Transesophageal echocardiography (TEE) is the primary imaging technique used during the procedure. Warfarin and novel oral anticoagulants were the main anticoagulant medications used prior to the procedure, while dual antiplatelet therapy was primarily used post-procedure. During a mean follow-up period of 13.2 ± 11.5 months, there was 1 case of fatality, 1 case of stroke, 3 major bleeding events, 3 instances of device-related thrombus, and 8 cases of peri-device leakage. Conclusions This review highlights the preliminary effectiveness and safety of the LAAC procedure in patients with persistent LAAT. Future large-scale RCTs with varied LAAT characteristics and LAAC device types are essential for evidence-based decision-making in clinical practice.

This study was designed to first evaluate the histological compatibility of the split occluder in preclinical animal models, followed by clinical validation of its procedural feasibility and occlusion effectiveness in a first-in-human trial cohort. Eight healthy labrador retrievers were selected for this study. A split-type occluder was introduced to occlude their left atrial appendage. The experimental animals were euthanized at 1, 3, and 6 months, respectively. Prior to being euthanized, transesophageal echocardiogram (TEE) and pulmonary vein computed tomography venography (CTV) were conducted on the subjects. A gross anatomical examination was then conducted on each animal post euthanasia. Additionally, data from 12 patients who underwent LAAO procedures using this device were included in the study. Each patient was monitored over a 3-month follow-up period. The operations to insert split left atrial appendage occluders into each of the eight test dogs were successful. Subsequent TEE and pulmonary vein CTV revealed that occluder surfaces exhibited no thrombus formation and that the occluders exhibited no significant residual flow. The gross anatomical examination indicated satisfactory endothelialization. The occluders were successfully implanted in all 12 patients, with no complications reported in the occlusions during the subsequent 3-month follow-up period. In both animal and human studies, the split occluder demonstrated a significantly high immediate success rate in the occlusion of the left atrial appendage. This was accompanied by a low occurrence of residual shunts and device-related complications, indicating its reliability and efficacy.

Background We sought to investigate the safety of using left atrial appendage (LAA) closure with clip devices in patients who underwent off-pump coronary artery bypass grafting and who experienced atrial fibrillation. Methods We applied LAA clips in 25 patients between November 2018 and May 2025. The mean age was 74 years, and 5 patients were female. All patients underwent off-pump CABG via a heart positioner and stabilizer and an LAA clip (21 with AtriClip and 4 Penditure). The mean number of coronary anastomoses was 4.0. The mean follow-up period was 28.6 ± 17.5 months. Results There were no complications related to the LAA clips. During the operations, we used a fluorescence imaging system in 13 patients to confirm the closure of the LAA. Moreover, in all 25 patients, postoperative enhanced computed tomography confirmed the occlusion of the LAA. No patient experienced stroke or thromboembolic events during the follow-up period. Conclusions Left atrial appendage closure with a clip was safely performed in patients undergoing off-pump CABG without harmful effects on the heart or grafts. This surgical option may be effective for stroke prevention in patients undergoing off-pump CABG.

Background 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. Methods 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. Results After PSM, 184 patients were included in each group. The mean CHA 2 DS 2 -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). Conclusion The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.

Background Atrial fibrillation (AF) significantly increases stroke risk, particularly through left atrial appendage (LAA) involvement. This trial evaluated the safety and efficacy of the Perclip system for LAA exclusion in Chinese AF patients. Methods This prospective study recruited patients with AF and CHA 2 DS 2 -VASc scores  ≥  2 who required conventional concomitant open-heart surgery or AF surgery through thoracoscopy at nine centers in China. The Perclip LAA occlusion system was implanted during surgery and follow-ups were scheduled at 30 days and 3, 6, and 12 months after surgery. The primary efficacy endpoint was the complete LAA closure rate at 3 months after surgery. The primary safety endpoint was the incidence of device-related serious adverse events within 30 days after surgery. Results Perclip implantation was performed on 76 participants (concomitantly with open-heart surgery in 65 participants). The device was successfully implanted in all subjects. The complete LAA closure rate was 98.7% (75/76) at 30 days and 100% (75/75) at 3 months post-surgery. The incidence of device-related serious adverse events within 30 days after surgery was 1.3% (1/76). One participant, who underwent left atrial plication and LAA occlusion, developed an atrial thrombus. Additionally, there were no cases of cardiovascular death, cardiac structural damage, myocardial infarction, major bleeding, stroke, or non-central nervous system embolism within 12 months post-surgery. Conclusions This 1-year multicenter trial supports the efficacy and safety of the Perclip system for LAA exclusion in Chinese AF patients. Long-term follow-up will provide additional insights into the outcomes of the Perclip system. Trial registration This trial was retrospectively registered on the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) on January 31, 2024. Registration number: ChiCTR2400080521.

Background Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA 2 DS 2 -VASc score and preoperative atrial fibrillation or flutter (AF) status—the current trial attempts to provide such evidence. Methods The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA 2 DS 2 -VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years. Discussion The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases. Trial registration Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 . Protocol version https://doi.org/10.1016/j.ahj.2023.06.003 .

Abstract A significant proportion of patients with atrial fibrillation (AF) who need thromboembolic protection are not treated with or discontinue oral anticoagulation after its initiation. Undertreatment in clinical practice has not improved sufficiently despite the availability of direct oral anticoagulants, which are associated with less intracranial bleeding than vitamin K antagonists. Multiple reasons account for this phenomenon, including bleeding events or ischemic strokes while on anticoagulation, poor treatment adherence despite best educational attempts, or aversion to drug therapy. Percutaneous left atrial appendage (LAA) closure was introduced as an alternative to pharmacological therapy in AF patients in the early 2000s. Due to significant improvements in procedural safety over the years, left atrial appendage closure (LAAC), predominantly achieved through a percutaneous catheter-based device implantation approach, is increasingly favoured for preventing thromboembolic events in patients who cannot achieve effective anticoagulation or have a high hemorrhagic risk. This focused summary and update of a recently published practical guide, developed within guideline/guidance boundaries, provides a perspective of current evidence of potential indications, benefits, complications and limitations of LAAC for neurologists and stroke physicians who may consider this increasingly utilised therapy. Graphical Abstract Graphical abstract

Atrial fibrillation (AF) is one the most prevalent arrhythmias globally and is associated with a significantly higher risk of morbidity and mortality, including an up to five-fold increase in risk of stroke. While oral anticoagulation therapy remains the standard approach for stroke prevention in nonvalvular AF, left atrial appendage occlusion (LAAO) has emerged as a viable alternative for patients who are intolerant to long-term oral anticoagulation therapy. However, selecting appropriate candidates for LAAO requires a comprehensive evaluation that considers various clinical factors, although this presents a challenge in clinical practice. This review aims to provide an overview of the current recommendations for patient selection in LAAO procedures and the key factors that need to be considered both before and after the procedure, as well as the ongoing advancements in this field that may facilitate the selection of patients for LAAO.