Left atrial appendage closure: A therapy uniquely suited for specific populations of patients with atrial fibrillation

Atrial fibrillation (AF) is the most common clinically relevant arrhythmia and confers a fivefold increased risk for stroke. Cardioembolic stroke secondary to AF is a devastating event, but is largely preventable with appropriate oral anticoagulation (OAC). The PROTECT and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage closure (LAAC) device in combination with short‐term warfarin therapy is noninferior to long‐term warfarin with respect to a composite endpoint of stroke, cardiovascular death, and systemic embolism. Importantly, the WATCHMAN confers a significant reduction in life‐threatening bleeding compared to OAC. Although direct‐acting oral anticoagulant (DOAC) are superior to warfarin in eligible patients, several important AF populations exist in whom left atrial appendage (LAA) closure may be preferable to DOAC. Populations warranting strong consideration of LAAC include patients with contraindications to DOAC, end‐stage renal disease, prior intracranial hemorrhage, recurrent gastrointestinal bleeding, and patients undergoing transcatheter aortic valve replacement or left atrial electrical isolation. Device‐related thrombosis is an important complication of LAAC, and DOAC may be preferential to warfarin for prevention and treatment of this complication remains unexplored. Prospective clinical trials comparing DOAC to LAAC in these unique populations are either ongoing or needed.     

Direct current cardioversion practices following percutaneous left atrial appendage closure

Introduction

Among patients with non-valvular atrial fibrillation (AF) and percutaneous left atrial appendage closure (LAAC) undergoing direct current cardioversion (DCCV), the need for and use of LAA imaging and oral anticoagulation (OAC) is unclear.

Objective

The purpose of this study is to evaluate the real-world use of transesophageal echocardiography (TEE) or cardiac computed tomography angiography (CCTA) before DCCV and use of OAC pre- and post-DCCV in patients with AF status post percutaneous LAAC.

Methods

This retrospective single center study included all patients who underwent DCCV after percutaneous LAAC from 2016 to 2022. Key measures were completion of TEE or CCTA pre-DCCV, OAC use pre- and post-DCCV, incidence of left atrial thrombus (LAT) or device-related thrombus (DRT), incidence of peri-device leak (PDL), and DCCV-related complications (stroke, systemic embolism, device embolization, major bleeding, or death) within 30 days.

Results

A total of 76 patients with AF and LAAC underwent 122 cases of DCCV. LAAC consisted of 47 (62%), 28 (37%), and 1 (1%) case of Watchman 2.5, Watchman FLX, and Lariat, respectively. Among the 122 DCCV cases, 31 (25%) cases were identified as “non-guideline based” due to: (1) no OAC for 3 weeks and no LAA imaging within 48 h before DCCV in 12 (10%) cases, (2) no OAC for 4 weeks following DCCV in 16 (13%) cases, or (3) both in 3 (2%) cases. Among the 70 (57%) cases that underwent TEE or CCTA before DCCV, 16 (23%) cases had a PDL with a mean size of 3.0 ± 1.1 mm, and 4 (6%) cases had a LAT/DRT on TEE resulting in cancellation. There were no DCCV-related complications within 30 days.

Discussion

There is a widely varied practice pattern of TEE, CCTA, and OAC use with DCCV after LAAC, with a 6% rate of LAT/DRT. LAA imaging before DCCV appears prudent in all cases, especially within 1 year of LAAC, to assess for device position, PDL, and LAT/DRT.     

经皮左心耳封堵术后器械相关血栓的研究进展

心房颤动（简称“房颤”）是临床上最常见的心律失常,房颤患者脑卒中的风险显著增加。作为口服抗凝药的替代治疗,经皮左心耳封堵术已成为预防房颤脑卒中的重要手段。器械相关血栓是左心耳封堵术后常见的并发症之一,也是目前临床关注的热点问题。本文拟对器械相关血栓的发生率、危险因素、预后及治疗等方面的研究进展作一综述。     

Left atrial appendage closure for thromboembolism prevention in patients with atrial fibrillation: advances and perspectives

Atrial fibrillation (AF) is a frequent cause of stroke. More than 90% of thrombi were found in the left atrial appendage (LAA) in non-valvular AF. Transcatheter LAA closure has been developed as a novel approach to reduce the risk of stroke in patients with AF over the last decade. In this article, we review the recent advances and propose the possible challenges regarding the LAA closure for thromboembolism prevention in patients with AF.     

Short‐term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia

1 Introduction

Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width < 17 mm has not been evaluated. The goal of this study was to determine the acute and short‐term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width < 17 mm.

2 Methods and results

Thirty‐two consecutive patients with a maximal LAA ostial width < 17 mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA₂DS₂‐VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5 kg/m², and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6 mm (range 14–16) and 23.2 ± 4.5 mm (range 13–31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak > 5 mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure.

3 Conclusions

LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width < 17 mm.     

Evaluation of left atrial remodelling following percutaneous left atrial appendage closure

Objectives The left atrial appendage (LAA) is known to play a reservoir role in left atrial (LA) hemodynamics. The physiologic consequences of its percutaneous occlusion have not been evaluated. We sought to evaluate the effect of percutaneous LA appendage closure (LAAC) on LA remodelling and cardiac hemodynamics. Methods: All patients referred for LAAC in our institution were enrolled. Cardiac computed tomography for LA volume measurement and transthoracic echocardiography (TTE) for left ventricular diastolic function and filling pressure assessment were performed at baseline and 3 months after closure. Results: Sixty-three patients (mean age 73 ? 9 years) underwent successful LAAC and remain clinically stable at 3 months without change in medical treatment except the introduction of an antiplatelet therapy. Mean LA volume, excluding the LAA did not change between baseline and follow-up (145 55 mL and 144 50 mL, p=0.30). Among diastolic function echographic parameters, the E/E’ ratio increased (7.9?2.1 vs 9.1?3.6; p=0,038), suggesting a trend toward an elevation of LV filling pressure. Conclusions: In this preliminary study, we showed no early significant LA remodelling after LAA occlusion in terms of volume change, but a trend toward an increase of LV filling pressure. Our results suggest potential changes in cardiac hemodynamics after LAA closure, suggesting to be cautious when performing this procedure in patients with heart failure. Additional studies with longer follow-up and invasive evaluations should be performed to better investigate this potential issue.     

左心耳封堵术在心房颤动患者中的应用价值

心房颤动是临床最常见的快速性心律失常。而血栓栓塞是心房颤动的主要危害之一,长期口服抗凝药物是预防栓塞的主要方法。但由于其存在较大的局限性,严重限制了其临床应用。     

Comparison of the effects of left atrial appendage closure and oral anticoagulants in preventing stroke in patients with non-valvular atrial fibrillation: A protocol for systematic review and meta-analysis

Background:This study aims to analyze and evaluate the difference in efficacy between left atrial appendage closure (LAAC) and oral anticoagulants (OA) in preventing stroke in patients with non-valvular atrial fibrillation (NVAF) through the method of meta-analysis. The purpose is to provide for the prevention of stroke in patients with NVAF valuable treatment guidance.Methods:This study is a comprehensive collection of randomized controlled studies of LAAC and OA in the prevention of stroke in patients with NVAF, and searches PubMed, Embase, the Cochrane Library, Web of Science, CNKI, SinoMed, VIP Database, WANFANG Database, and other Chinese and English databases by combining subject words with free words, and the retrieval time is from the establishment of each database to June 1, 2021. At the same time, searching the included literature and literature of related reviews by manual. Two researchers independently conduct literature screening and quality evaluation. Statistical software RevMan 5.3 and Stata 12.0 were used for meta-analysis.Results:This study evaluating the difference in efficacy between LAAC and OA in preventing stroke in patients with NVAF will be published in high-quality medical academic journals.Conclusion:This study will give the best treatment strategy to prevent stroke in patients with NVAF, and provide some reference for clinical medical staff.OSF registration number: DOI 10.17605/OSF.IO/2UXPA (https://osf.io/2uxpa).     

Long‐term safety and efficacy of left atrial appendage closure in patients with small appendage orifices measured with transesophageal echocardiography

BackgroundThe Watchman device is the most widely used occluder but is indicated in atrial fibrillation (AF) patients with a maximal left atrial appendage (LAA) orifice diameter between 17 and 31 mm. We aimed to compare the long‐term safety and efficacy of left atrial appendage closure (LAAC) between patients with a small LAA (<17 mm) and those with an indicated LAA (17–31 mm) measured by transesophageal echocardiography (TEE).MethodsA total of 369 AF patients treated with LAAC between March 2015 and February 2019 were included and divided into two groups based on the maximal LAA orifice diameter measured by TEE: small LAA group (n = 22) and indicated LAA group (n = 347). Periprocedural complications and long‐term clinical outcomes were compared.ResultsThe Watchman device was successfully implanted in all patients. Mean device compression was higher in the small LAA group. Four patients (1.2%) in the indicated LAA group experienced pericardial effusion, and none experienced pericardial effusion in the small LAA group. Device‐related thrombus was detected in one (4.5%) patient in the small LAA group and five (1.4%) in the indicated LAA group (p = .310). After a mean follow‐up period of 4.1 ± 1.6 years, one patient in the small LAA group (4.5%; 1.1/100 person‐years) and four in the indicated LAA group (1.2%; 0.3/100 person‐years) suffered an ischemic stroke (p = .266).ConclusionsThe safety and efficacy of LAAC with the Watchman device were comparable between patients with small and indicated LAA orifice diameters measured by TEE.     

Non-surgical left atrial appendage closure for stroke prevention in atrial fibrillation

Non-Surgical Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation. The most feared complication associated with atrial fibrillation (AF) is stroke, the risk of which increases with advanced age. Because of its complex anatomy and diminished blood flow during AF, the left atrial appendage (LAA) has been a common site of left atrial thrombi and presumed source of thromboembolism. Systemic anticoagulation to treat what may be largely a localized phenomenon is associated with significant complications. Newer anticoagulation agents hold great promise in facilitating dosing and eliminating drug and food interactions, but do not eliminate bleeding risk. These challenges have led to interest in mechanical exclusion of the LAA as a means of preventing thromboembolism in AF. Although surgery permits greater visualization and management of complications, the potential morbidity has limited adoption in often-frail elderly patients. In this paper, we review the current state of percutaneous left atrial exclusion for stroke prevention in AF, and the strengths and limitations of each of these strategies. The nonsurgical approaches to excluding the LAA from the central circulation can be divided into 3 broad categories: transseptally placed devices, percutaneous epicardial approach, and hybrid approaches. The availability of several approaches will allow physician selection of the optimal approach for a given patient based on clinical, physiological, and anatomical considerations. LAA exclusion stands to become an increasingly attractive option for patients with nonvalvular AF because it can be offered to elderly AF patients, and eliminates the long-term cumulative bleeding risks and adherence challenge of anticoagulants.     

咽喉部表面麻醉在老年心房颤动患者左心耳封堵术中的应用

目的观察咽喉部表面麻醉对老年患者全身麻醉下行左心耳封堵术(LAAC)的效果。方法 2016年9月一2019年6月上海交通大学医学院附属第九人民医院拟全身麻醉下行LAAC的老年阵发性/持续性非瓣膜性房颤(NVAF)患者56例,随机分为对照组(全身麻醉)和观察组(全身麻醉复合咽喉部利多卡因喷雾表面麻醉),每组28例。观察麻醉诱导前(T0)、气管插管即刻(T1)、置入经食管超声心动图(TEE)即刻(T2)、封堵器放置即刻(T3)和拔除气管导管即刻(T4) 5个时间点的收缩压(SBP)、舒张压(DBP)、心率(HR);记录心血管不良事件的发生情况。结果与T0时比较,对照组 T1、T2 时 HR 均增快(F=7.108,P<0.05);T2 时 SBP 降低(F=19.600,P<0.05);T1时 DBP 升高,T2时DBP降低(F=10.450,P<0.05)。与T0时比较,观察组T2时SBP降低(F=5.857,P<0.05)。T1时观察组HR较对照组减慢(P<0.01),SBP和DBP均较对照组降低(均P<0.01);T2时HR较对照组减慢(P<0.05)、SBP和DBP均较对照组升高(P<0.05)。与对照组比较,观察组高血压、低血压、快房颤伴低血压发生比例降低,差异均有统计学意义(均P<0.05)。结论全身麻醉下,老年房颤患者行LAAC是安全可行的,咽喉部表面麻醉可能有利于维持循环稳定,减少快房颤等心血管不良事件的发生。