left atrial appendage closure

左心耳封堵术
  • 文章类型: Case Reports
    WATCHMAN™心房附件封堵装置旨在降低不适合长期口服抗凝治疗的非瓣膜性心房颤动患者的卒中风险。然而,该设备还具有很小的风险,包括手术并发症,如设备迁移,栓塞,或者心包积液.我们描述了WATCHMAN设备迁移需要手术取回的情况。
    The WATCHMAN™ atrial appendage closure device is designed to reduce the risk of stroke in patients with nonvalvular atrial fibrillation who are not suitable candidates for long-term oral anticoagulation therapy. However, the device also carries small risks, including procedural complications such as device migration, embolization, or pericardial effusion. We describe a case of WATCHMAN device migration requiring surgical retrieval.
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  • 文章类型: Journal Article
    经皮左心耳封堵术(LAAC)是预防房颤患者缺血性卒中的有效替代口服抗凝治疗方法。欧洲和美国批准的经皮LAAC装置含有金属,强烈建议在植入后进行临时抗血栓治疗,以防止心房装置表面形成血栓。由于多种原因,器械植入后最佳抗血栓药物方案仍存在不确定性。因此,本综述旨在总结现有的证据以及与LAAC手术中抗血栓治疗管理相关的剩余挑战.
    Percutaneous left atrial appendage closure (LAAC) is a valid alternative to oral anticoagulation to prevent ischemic stroke in patients with atrial fibrillation.The devices approved in Europe and United States for percutaneous LAAC contain metal and temporary antithrombotic therapy is strongly recommended following implantation to prevent thrombus formation on the atrial device surface. There is still uncertainty regarding to the optimal antithrombotic drug regimen after device implantation for several reasons. Thus, this review aims at summarizing the available evidence and the remaining challenges related to the management of antithrombotic therapy in the context of LAAC procedure.
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  • 文章类型: Journal Article
    左心耳(LAA)的解剖结构不均匀,因此必须进行术前成像,以规划经皮LAA闭塞(LAAO)手术。虽然经食管超声心动图(TOE)仍然是金标准,心脏计算机断层扫描(CT)正变得越来越流行。为了解决在最佳成像模式上缺乏共识的问题,我们比较了LAAO手术计划的术前TOE和CT结果.进行了所有LAAO手术的回顾性单中心队列研究,以比较接受术前TOE的患者与接受CT的患者的预后。主要结果是手术成功率和主要不良事件发生率。次要结果是总手术时间,设备尺寸变化率,和最大着陆区直径。共纳入64例患者。其中,25例(39.1%)行TOE,39例(60.9%)行CT。手术成功率无显著差异(96.0%vs.100%,P=0.39)或主要不良事件发生率(4.0%vs.5.1%,TOE和CT患者之间的P>0.99)。与TOE相比,CT与中位手术时间明显缩短相关(103分钟vs.124分钟,P=0.02)和较低的设备尺寸变化率(7.7%与28.0%,P=0.04)。与CT相比,TOE与显著较小的平均最大着陆区直径(20.8mm与25.8mm,P<0.01)和更高的设备升级率(24.0%vs.2.6%,P=0.01)。在TOE和CT之间没有发现检测到的残余泄漏率的显着差异(50.0%vs.52.2%,P>0.99)。使用CT规划LAAO程序与较短的总程序时间和较低的设备尺寸变化率相关,并且不太可能低估最大着陆区直径。
    The heterogeneous anatomy of the left atrial appendage (LAA) necessitates preprocedural imaging essential for planning of percutaneous LAA occlusion (LAAO) procedures. While transoesophageal echocardiography (TOE) remains the gold standard, cardiac computed tomography (CT) is becoming increasingly popular. To address the lack of consensus on the optimal imaging modality, we compared the outcomes of preprocedural TOE versus CT for LAAO procedure planning. A retrospective single-center cohort study of all LAAO procedures was performed to compare the outcomes of patients receiving preprocedural TOE versus those receiving CT. The primary outcome was procedural success and rate of major adverse events. The secondary outcomes were total procedure time, rate of device size change, and maximum landing zone diameter. A total of 64 patients was included. Of these, 25 (39.1%) underwent TOE and 39 (60.9%) underwent CT. There was no significant difference in the procedural success rate (96.0% vs. 100%, P = 0.39) or major adverse event rate (4.0% vs. 5.1%, P > 0.99) between TOE and CT patients. Compared with TOE, CT was associated with significantly shorter median procedure time (103 min vs. 124 min, P = 0.02) and a lower rate of device size change (7.7% vs. 28.0%, P = 0.04). Compared to CT, TOE was associated with a significantly smaller mean maximum landing zone diameter (20.8 mm vs. 25.8 mm, P < 0.01) and a higher rate of device upsizing (24.0% vs. 2.6%, P = 0.01). No significant difference in detected residual leak rates was found between TOE and CT (50.0% vs. 52.2%, P > 0.99). Planning of LAAO procedures with CT is associated with a shorter total procedure time and a lower rate of device size change and is less likely to underestimate the maximum landing zone diameter.
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  • 文章类型: Journal Article
    背景:联合导管消融(CA)和经皮左心耳封堵(LAAC)可以为心房颤动(AF)提供综合治疗,从而在不需要长期口服抗凝治疗的情况下实现心律控制并降低卒中风险。然而,该策略的有效性和安全性仍存在争议.
    方法:本荟萃分析根据系统评价和荟萃分析指南的首选报告项目进行报告。Medline,Scopus,系统检索了Cochrane中央对照试验登记册,以确定相关研究。使用改良的纽卡斯尔-渥太华量表和Cochrane偏差风险工具评估偏差风险。符合条件的研究报告了接受联合CA和LAAC与单独CA的房颤患者的结局。不进行肺静脉隔离的CA研究被排除。
    结果:纳入了8项研究,包括1878例患者(2例RCT,6观察)。当比较联合CA和LAAC与单独CA时,汇总结果显示心律失常复发无差异(风险比(RR)1.04;95%置信区间(CI)0.82-1.33),卒中或全身性栓塞(RR0.78;95%CI0.27-2.22),或主要的围手术期并发症(RR1.28;95%CI0.28-5.89)。单独使用CA的总手术时间较短(平均差异48.45分钟;95%CI23.06-74.62)。
    结论:CA联合LAAC治疗房颤与无心律失常生存率相似,中风,和主要的围手术期并发症相比,单独CA。对于中度至高度出血事件风险的患者,联合策略可能是安全有效的,以消除对慢性口服抗凝药物的需求。
    BACKGROUND: Combined catheter ablation (CA) with percutaneous left atrial appendage closure (LAAC) may produce comprehensive treatment for atrial fibrillation (AF) whereby rhythm control is achieved and stroke risk is reduced without the need for chronic oral anticoagulation. However, the efficacy and safety of this strategy is still controversial.
    METHODS: This meta-analysis was reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Medline, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched to identify relevant studies. The risk of bias was assessed using the Modified Newcastle-Ottawa scale and Cochrane risk of bias tool. Eligible studies reported outcomes in patients with AF who underwent combined CA and LAAC vs CA alone. Studies performing CA without pulmonary vein isolation were excluded.
    RESULTS: Eight studies comprising 1878 patients were included (2 RCT, 6 observational). When comparing combined CA and LAAC vs CA alone, pooled results showed no difference in arrhythmia recurrence (risk ratio (RR) 1.04; 95% confidence interval (CI) 0.82-1.33), stroke or systemic embolism (RR 0.78; 95% CI 0.27-2.22), or major periprocedural complications (RR 1.28; 95% CI 0.28-5.89). Total procedure time was shorter with CA alone (mean difference 48.45 min; 95% CI 23.06-74.62).
    CONCLUSIONS: Combined CA with LAAC for AF is associated with similar rates of arrhythmia-free survival, stroke, and major periprocedural complications when compared to CA alone. A combined strategy may be as safe and efficacious for patients at moderate to high risk for bleeding events to negate the need for chronic oral anticoagulation.
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  • 文章类型: Journal Article
    目的:评估WatchmanFLX左心耳封堵(LAAC)后使用心脏计算机断层扫描(CT)成像解释低衰减增厚(HAT)和周围渗漏(PDL)的可重复性。
    结果:在这项多中心回顾性可重复性研究中,100个匿名后LAAC心脏CT扫描在同一心脏相位内由经验丰富的评估者和对先前评估不知情的新手评估者进行评估。每个评分者对所有扫描进行两次评估,评估总体HAT和PDL类别,以及基于LAAC后解释的建议算法的具体相关发现。使用绝对协议评估者之间和内部协议和可靠性,科恩的kappa和肯德尔的tau用于分类变量,和平均差异,Bland-Altman阴谋,连续变量的一致性极限和组内相关系数(ICC)。在HAT和PDL的总体类别中,观察到基本一致(kappa>0.61)和可靠性(Kendall的tau-b>0.75)。具体来说,鉴定高级别HAT(κ>0.78)和远端通畅(κ>0.85)在HAT和PDL解释中显示出最高的一致性。同时,在评估者之间和评估者内部比较(ICC<0.75)中,测量近端螺纹毂的高度代表了最不可靠的HAT评估,而可疑的泄漏机制代表了最不可重复的PDL措施。
    结论:尽管只对一名评估者进行了很少的培训,在WatchmanFLXLAAC后HAT和PDL解释的所选算法中观察到总体高水平的评分者之间和评分者之间的一致性和可靠性.纳入变量的预后影响将在未来的试验和注册中进行探讨。
    OBJECTIVE: To assess the reproducibility of interpreting hypoattenuated thickening (HAT) and peridevice leak (PDL) using cardiac computed tomography (CT) imaging following Watchman FLX left atrial appendage closure (LAAC).
    RESULTS: In this multicenter retrospective reproducibility study, 100 anonymized post-LAAC cardiac CT scans were evaluated within the same cardiac phase by an experienced and a novice rater blinded to prior evaluations. All scans were evaluated twice by each rater, assessing overall HAT and PDL categories as well as specific associated findings based on suggested algorithms for post-LAAC interpretation. Inter- and intra-rater agreement and reliability were evaluated using absolute agreement, Cohen\'s kappa and Kendall\'s tau for categorical variables, and mean difference, Bland-Altman plots, limits of agreement and intraclass correlation coefficients (ICC) for continuous variables.Within overall categories of both HAT and PDL, substantial agreement (kappa >0.61) and reliability (Kendall\'s tau-b  > 0.75) were observed. Specifically, identifying high-grade HAT (kappa >0.78) and distal patency (kappa >0.85) displayed the highest agreement within HAT and PDL interpretation. Meanwhile, measuring the height of the proximal screw hub cove represented the least reliable HAT assessment among both inter- and intra-rater comparisons (ICC<0.75), while suspected leak mechanism represented the least reproducible PDL measure.
    CONCLUSIONS: Despite only minimal training of one rater, overall high levels of inter- and intra-rater agreement and reliability were observed across the chosen algorithms for interpretation of HAT and PDL following Watchman FLX LAAC. Prognostic implications of the included variables are to be explored in future trials and registries.
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  • 文章类型: Journal Article
    为了降低非瓣膜性心房颤动(NVAF)患者发生脑血管意外(CVA)的风险,左心耳封堵(LAAO)装置正在成为口服抗凝剂的替代品。
    分析LAAO手术在NVAF患者和口服抗凝药禁忌症和/或失效患者中的疗效和安全性。
    在电子数据库Medline和Embase中进行了证据搜索,直到2024年1月。在GoogleScholar上进行了其他搜索。还查阅了临床试验注册数据库。两名失明的调查人员进行了搜查,研究选择,和数据收集,并使用Cochrane工具评估随机临床试验的质量和偏倚风险。采用RevMan5.4.1软件对符合条件的试验进行Meta分析。随机效应模型用于所有分析。
    选择了五篇文章,其中3项为非劣效性随机临床试验,与使用维生素K拮抗剂(AVK)或新型口服抗凝药(NOAC)相比,分析了LAAO器械的性能和安全性.没有发现对口服抗凝剂绝对禁忌症人群进行分析的随机临床试验。以主要结局分析卒中(缺血性或出血性)的发生,心血管或无法解释的死亡和全身性栓塞,与使用口服抗凝药相比,LAAO程序具有非劣效性.
    对于有抗凝绝对禁忌证和/或不能使用口服抗凝药的患者,使用LAAO设备的证据很少。
    With the aim of reducing the risk of Cerebrovascular Accident (CVA) in patients with Non-Valvular Atrial Fibrillation (NVAF), Left Atrial Appendage Occlusion (LAAO) devices are emerging as an alternative to oral anticoagulants.
    To analyze the efficacy and safety of the LAAO procedure in patients with NVAF and contraindications and/or failure for oral anticoagulants.
    The search for evidence was carried out in the electronic databases Medline and Embase till January 2024. Additional searches were conducted on Google Scholar. The clinical trials registry database was also consulted. Two blinded investigators performed the search, study selection, and data collection, and assessed quality and risk of bias using the Cochrane tool for randomized clinical trials. Meta-analyses of eligible trials were performed using RevMan 5.4.1 software. The random effects model was used for all analyses.
    Five articles were selected, among which three were non-inferiority randomized clinical trials that analyzed the performance and safety of LAAO devices compared to the use of Vitamin K Antagonists (AVKs) or Novel Oral Anticoagulants (NOACs). No randomized clinical trials were found that analyzed populations with absolute contraindications to oral anticoagulants. Having as primary outcomes analyzed the occurrence of stroke (ischemic or hemorrhagic), cardiovascular or unexplained death and systemic embolism, the non-inferiority of the LAAO procedure compared to the use of oral anticoagulants was verified.
    For patients with an absolute contraindication to anticoagulation and/or failure to use oral anticoagulants, evidence for the use of LAAO devices is scarce.
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  • 文章类型: Journal Article
    左心耳封堵术(LAAC)是不适合长期抗凝治疗的非瓣膜性心房颤动患者预防中风的关键干预措施。Amulet和Watchman是世界上用于执行LAAC的植入最多的设备,这篇综述的目的是提供一个全面的比较,重点是它们的功效,安全,以及短期和长期结果。守望者装置,第一个获得FDA批准的人,已被广泛研究,并证明中风和全身性栓塞的发生率显着降低。护身符装置,一个新的选择,承诺更有效的附件密封增强的设计特点。目前的数据表明,这两种设备对LAAC具有相似的疗效和安全性。虽然两种装置在术中并发症发生率方面不同,它们在器械周围泄漏方面提供了类似的短期到长期结果,装置相关血栓形成,和死亡率。两种设备均适用于无法耐受OAC的患者,考虑到他们相似的风险和安全性。较新的临床研究旨在确定两种设备的功效,作为预防房颤中风的主要方法,作为OAC的替代方法。
    Left atrial appendage closure (LAAC) is a crucial intervention for stroke prevention in patients with non-valvular atrial fibrillation who are unsuitable for long-term anticoagulation. Amulet and Watchman are the most implanted devices worldwide for performing LAAC, and the aim of this review is to provide a comprehensive comparison focusing on their efficacy, safety, and short- and long-term outcomes. The Watchman device, the first to gain FDA approval, has been extensively studied and demonstrates significant reductions in stroke and systemic embolism rates. The Amulet device, a newer alternative, promises enhanced design features for more efficient appendage sealing. Current data highlight 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 terms of peri-device leaks, device-related thrombosis, and mortality. Both devices are indicated for patients who are unable to tolerate OAC, given their similar risk and safety profiles. Newer clinical studies are directed at establishing the efficacy of both devices as the primary method for stroke prevention in AF as an alternative to OAC.
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  • 文章类型: Journal Article
    背景:本研究的目的是调查发病率,潜在风险因素,在接受Watchman左心耳封堵术(LAAC)的房颤(AF)患者中,器械内皮化(IDE)不全的临床结果。
    方法:在本研究中,68例房颤患者在随访期间成功植入Watchman装置而无装置周围渗漏(PDL)。在植入后6周和6个月,使用经食管超声心动图(TEE)和LAA计算机断层扫描血管造影(CTA)评估内皮化状态。在一年的随访中记录了不良的脑心事件。基线特征,包括年龄,设备尺寸,和临床指标,被分析为IDE的潜在预测因子。
    结果:在植入后6周和6个月,在70.6%和67.6%的患者中观察到IDE,分别。较高水平的高密度脂蛋白胆固醇(HDL-C)[比值比(OR):15.109,95%置信区间(CI):1.637-139.478,p=0.017和OR:11.015,95%CI:1.365-88.896,p=0.024]和较低的天冬氨酸氨基转移酶(AST)(OR0.924,95CI:0.865:0.886)在基线时间为0.017-0.93%分别,尽管在1年随访期间,不完全和完全DE组之间的不良脑心事件没有显著差异。结论:发现IDE在LAAC后的人类中普遍存在.HDL-C水平升高和AST水平降低显示与LAAC后IDE风险增加有关。
    BACKGROUND: The objective of this study is to investigate the incidence, potential risk factors, and clinical outcomes of incomplete device endothelialization (IDE) in atrial fibrillation (AF) patients undergoing Watchman left atrial appendage closure (LAAC).
    METHODS: In this study, 68 AF patients who underwent successful implantation of the Watchman device without peri-device leak (PDL) during follow-up were included. The endothelialization status was assessed using Transesophageal echocardiography (TEE) and LAA computed tomography angiography (CTA) at 6 weeks and 6 months post-implantation. Adverse cerebro-cardiac events were documented at one-year follow-up. Baseline characteristics, including age, device sizes, and clinical indicators, were analyzed as potential predictors for IDE.
    RESULTS: IDE was observed in 70.6% and 67.6% of patients at 6 weeks and 6 months after implantation, respectively. Higher levels of high-density lipoprotein cholesterol (HDL-C) [odds ratio (OR): 15.109, 95% confidence interval (CI): 1.637-139.478, p = 0.017 and OR: 11.015, 95% CI: 1.365-88.896, p = 0.024] and lower aspartate aminotransferase (AST) (OR 0.924, 95% CI: 0.865-0.986, p = 0.017 and OR: 0.930, 95% CI: 0.874-0.990, p = 0.023) at baseline were found to be significantly associated with IDE at 6 weeks and 6 months, respectively, although no significant difference in adverse cerebro-cardiac events was noted between incomplete and complete DE groups during 1-year follow-up CONCLUSIONS: IDE is found to be a prevalent occurrence in humans following LAAC. Elevated HDL-C and reduced AST levels are shown to be linked to an increased risk of IDE after LAAC.
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  • 文章类型: Case Reports
    左心耳封堵装置可降低非瓣膜性心房颤动患者卒中风险,同时避免治疗性抗凝相关风险。这个显著的价值伴随着与装置植入或手术闭合相关的额外的独特风险。我们讨论了Watchman装置(波士顿科学公司)植入的一种罕见并发症,其中在左心耳和左旋支动脉之间形成了无症状的瘘管连接。此外,我们回顾了其他记录在案的左心耳瘘病例,以及目前与手术左心耳封堵术相关的医源性瘘连接的处理方法.
    Left atrial appendage closure devices reduce the risk of stroke in patients with nonvalvular atrial fibrillation while avoiding the risks associated with therapeutic anticoagulation. This significant value comes with additional unique risks associated with device implantation or surgical closure. We discuss an uncommon complication of Watchman device (Boston Scientific) implantation wherein an asymptomatic fistulous connection developed between the left atrial appendage and the left circumflex artery. Additionally, we review other documented cases of left atrial appendage fistulas and current management approaches for iatrogenic fistulous connections associated with procedural left atrial appendage closure.
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  • 文章类型: Journal Article
    关闭左心耳(LAA)是房颤消融手术的常规部分,可显着降低中风率。在心脏手术中使用了不同的LAA闭合技术,并报告了不同的结果。因此,我们评估了4种不同的LAA闭合技术在接受心脏手术的患者中的疗效。
    总共,2015年至2019年期间在心脏手术期间同时进行LAA封堵的149例患者被纳入这项回顾性经食管超声心动图研究。评估了四种不同的左心耳闭合技术:左心耳夹闭(n=62),缝合结扎(n=28),吻合器切除术(n=30),和手术左心耳切除术(n=29)。成功的LAA闭合被定义为没有LAA灌注和没有大于10mm的残端。
    患者平均年龄为68.7±9.4岁;61.7%为男性。未观察到与左心耳闭合相关的并发症。平均随访36.5±8个月。经食管超声心动图随访显示LAA封堵成功率为98.4%,手术切除93.1%,吻合器切除率76.6%,缝合结扎39.2%。缝合结扎导致较高的再通率(50%)和残端(10.8%),而吻合器切除术导致较高的残端率(23.4%)。总的来说,4例(2.7%)患者在随访期间出现卒中。详细来说,27例(7.4%)左心耳封堵不成功患者中有2例中风,而122例成功封堵LAA的患者中有2例(1.6%)出现卒中.
    在我们的研究中,LAA夹闭和手术LAA切除被证明都是成功的LAA闭合方法。外部LAA结扎和吻合器切除导致LAA闭合成功率低,应避免。
    UNASSIGNED: Closure of the left atrial appendage (LAA) is a routine part of atrial fibrillation ablation surgery and significantly reduces stroke rates. Different LAA-closure techniques are used in cardiac surgery with variable results reported. We therefore evaluated the efficacy of 4 different LAA-closure techniques in patients undergoing cardiac surgery.
    UNASSIGNED: In total, 149 patients who underwent concomitant LAA closure during cardiac surgery between 2015 and 2019 were included in this retrospective transesophageal echocardiography study. Four different LAA-closure techniques were evaluated: LAA clipping (n = 62), suture ligation (n = 28), stapler resection (n = 30), and surgical LAA excision (n = 29). Successful LAA closure was defined as absence of LAA perfusion and absence of a stump greater than 10 mm.
    UNASSIGNED: The mean patients age was 68.7 ± 9.4 years; 61.7% were male. No complications related to LAA closure were observed. Mean follow-up was 36.5 ± 8 months. Transesophageal echocardiography follow-up showed the following LAA closure success rates: LAA clip 98.4%, surgical excision 93.1%, stapler resection 76.6%, and suture ligation 39.2%. Suture ligation resulted in a high rate of recanalization (50%) and residual stumps (10.8%), whereas stapler resection resulted in a high rate of residual stumps (23.4%). Overall, 4 patients (2.7%) had a stroke during follow-up. In detail, 2 of 27 (7.4%) patients with unsuccessful LAA closure had a stroke, whereas 2 of the 122 (1.6%) patients with successful LAA closure had a stroke.
    UNASSIGNED: In our study, LAA clipping and surgical LAA excision proved to be both successful LAA-closure methods. External LAA ligation and stapler resection resulted in low rates of successful LAA closure and should be avoided.
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