背景:经皮左心耳封堵术(LAAC)是预防房颤患者中风的既定方法,提供口服抗凝药物的替代方案。已经开发了各种封堵器装置以满足个体解剖学需要并确保安全和有效的程序。在这次回顾中,单中心队列研究,我们比较了不同的LAAO装置的临床结果,左心耳密封性能,和设备相关的并发症。
方法:我们对2009年至2023年在我们中心接受经皮LAA封堵术的270例患者进行了回顾性分析。从病历中提取患者数据,包括性别,植入时的年龄,指示,设备类型和尺寸,实验室值,左心耳解剖学,围手术期并发症,心电图参数,经胸和经食管超声心动图参数(TTE和TEE),以及出院时的药物治疗。此外,透视时间和植入时间,以及植入后长达1年的临床事件,被收集。终点为出血事件,复发性中风,装置上的血栓,和死亡。
结果:植入的设备是Watchman2.5,WatchmanFLX,Amplatzer心脏封堵器(ACP),还有护身符.手术成功率为95.7%(n=265),仙人掌的解剖构成了所有设备的最大挑战。患者平均年龄为75.5±7.7岁,64.5%是男性。CHA2DS2-VASc评分中位数为4.8±1.5,HAS-BLED评分中位数为3.8±1.0。LAA封堵的适应症包括既往出血事件和出血风险升高。围手术期并发症最常见的是穿刺部位出血,特别是ACP植入后(p=0.014)。在21.4%的简单密封机构设备中观察到明显的周围装置泄漏(PDL),而在双密封机构设备中观察到0%(p=0.004)。在6名患者的设备上检测到血栓,随后无缺血性卒中或血栓栓塞事件。比较分析显示中风的发生没有显着差异,短暂性脑缺血发作(TIA),血栓栓塞事件,装置相关血栓,或不同设备类型之间的死亡率。在568.2患者年中,可以观察到血栓栓塞事件的相对风险降低62.3%,重大出血的相对风险降低38.6%。
结论:总之,我们的研究强调了使用各种封堵器封堵LAA的有效性和安全性,尽管存在解剖学挑战.我们的长期随访结果支持左心耳封堵术是在选定的患者队列中预防中风的有希望的选择。需要进一步的研究来完善患者选择标准并优化左心耳封堵手术的结果。
BACKGROUND: Percutaneous left-atrial appendage closure (LAAC) is an established method for preventing strokes in patients with atrial fibrillation, offering an alternative to oral anticoagulation. Various occluder devices have been developed to cater to individual anatomical needs and ensure a safe and effective procedure. In this retrospective, monocentric cohort
study, we compare different LAAO devices with respect to clinical outcomes, LAA sealing properties, and device-related complications.
METHODS: We conducted a retrospective analysis of 270 patients who underwent percutaneous LAA closure in our center between 2009 and 2023. Patient data were extracted from medical records, including gender, age at implantation, indication, device type and size, laboratory values, LAA anatomy, periprocedural complications, ECG parameters, transthoracic and transesophageal echocardiography parameters (TTE and TEE), as well as medication at discharge. Moreover, fluoroscopy time and implantation duration, as well as post-implantation clinical events up to 1 year, were collected. Endpoints were bleeding events, recurrent stroke, thrombi on devices, and death.
RESULTS: The implanted devices were the Watchman 2.5, Watchman FLX, Amplatzer Cardiac Plug (ACP), and Amulet. The procedural success rate was 95.7% (n = 265), with cactus anatomy posing the most challenges across all devices. The mean patient age was 75.5 ± 7.7 years, with 64.5% being male. The median CHA2DS2-VASc score was 4.8 ± 1.5 and the median HAS-BLED score was 3.8 ± 1.0. Indications for LAA closure included past bleeding events and elevated bleeding risk. Periprocedural complications were most commonly bleeding at the puncture site, particularly after ACP implantation (p = 0.014). Significant peridevice leaks (PDL) were observed in 21.4% of simple sealing mechanism devices versus 0% in double sealing mechanism devices (p = 0.004). Thrombi were detected on devices in six patients, with no subsequent ischemic stroke or thromboembolic event. Comparative analysis revealed no significant differences in the occurrence of stroke, transient ischemic attack (TIA), thromboembolic events, device-related thrombi, or mortality among different device types. A 62.3% relative risk reduction in thromboembolic events and 38.6% in major bleedings could be observed over 568.2 patient years.
CONCLUSIONS: In summary, our
study highlights the efficacy and safety of LAA closure using various occluder devices despite anatomical challenges. Our long-term follow-up findings support LAA closure as a promising option for stroke prevention in selected patient cohorts. Further research is needed to refine patient selection criteria and optimize outcomes in LAA closure procedures.