Kayvanpour Elham, Kothe Max, Kaya Ziya, Pleger Sven, Frey Norbert, Meder Benjamin, Sedaghat-Hamedani Farbod
Department of Internal Medicine III, Heidelberg University, 69120 Heidelberg, Germany.
DZHK (German Centre for Cardiovascular Research), 69120 Heidelberg, Germany.
J Cardiovasc Dev Dis. 2024 May 21;11(6):158. doi: 10.3390/jcdd11060158.
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.
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.
The implanted devices were the Watchman 2.5, Watchman FLX, Amplatzer Cardiac Plug (ACP), and Amulet. The procedural success rate was 95.7% ( = 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 ( = 0.014). Significant peridevice leaks (PDL) were observed in 21.4% of simple sealing mechanism devices versus 0% in double sealing mechanism devices ( = 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.
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.
经皮左心耳封堵术(LAAC)是预防心房颤动患者中风的一种既定方法,为口服抗凝治疗提供了一种替代方案。已经开发了各种封堵器装置,以满足个体解剖学需求,并确保手术安全有效。在这项回顾性单中心队列研究中,我们比较了不同左心耳封堵(LAAO)装置在临床结局、左心耳封堵特性和与装置相关的并发症方面的差异。
我们对2009年至2023年期间在本中心接受经皮左心耳封堵术的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、植入时年龄、适应症、装置类型和尺寸、实验室值、左心耳解剖结构、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)以及出院时的用药情况。此外,还收集了透视时间和植入持续时间,以及植入后长达1年的临床事件。终点指标为出血事件、复发性中风、装置上的血栓和死亡。
植入的装置有Watchman 2.5、Watchman FLX、Amplatzer心脏封堵器(ACP)和Amulet。手术成功率为95.7%(n = 265),仙人掌型解剖结构对所有装置都构成了最大挑战。患者平均年龄为75.5±7.7岁,男性占64.5%。CHA2DS2-VASc评分中位数为4.8±1.5,HAS-BLED评分中位数为3.8±1.0。左心耳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,尤其是在植入ACP后(P = 0.014)。在21.4%的简单密封机制装置中观察到明显的装置周围渗漏(PDL),而在双密封机制装置中为0%(P = 0.004)。在6例患者的装置上检测到血栓,随后未发生缺血性中风或血栓栓塞事件。比较分析显示,不同装置类型在中风、短暂性脑缺血发作(TIA)、血栓栓塞事件、与装置相关的血栓或死亡率的发生方面没有显著差异。在568.2患者年中,可观察到血栓栓塞事件相对风险降低62.3%,大出血相对风险降低38.6%。
总之,我们的研究强调了尽管存在解剖学挑战,但使用各种封堵器装置进行左心耳封堵的有效性和安全性。我们的长期随访结果支持左心耳封堵作为选定患者群体中预防中风的一种有前景的选择。需要进一步研究以完善患者选择标准并优化左心耳封堵手术的结局。