Helmsley Electrophysiology Center, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1030, New York, NY 10029, USA.
Circulation. 2011 Feb 1;123(4):417-24. doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.
The Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) randomized trial compared left atrial appendage closure against warfarin in atrial fibrillation (AF) patients with CHADS₂ ≥1. Although the study met the primary efficacy end point of being noninferior to warfarin therapy for the prevention of stroke/systemic embolism/cardiovascular death, there was a significantly higher risk of complications, predominantly pericardial effusion and procedural stroke related to air embolism. Here, we report the influence of experience on the safety of percutaneous left atrial appendage closure.
The study cohort for this analysis included patients in the PROTECT AF trial who underwent attempted device left atrial appendage closure (n=542 patients) and those from a subsequent nonrandomized registry of patients undergoing Watchman implantation (Continued Access Protocol [CAP] Registry; n=460 patients). The safety end point included bleeding- and procedure-related events (pericardial effusion, stroke, device embolization). There was a significant decline in the rate of procedure- or device-related safety events within 7 days of the procedure across the 2 studies, with 7.7% and 3.7% of patients, respectively, experiencing events (P=0.007), and between the first and second halves of PROTECT AF and CAP, with 10.0%, 5.5%, and 3.7% of patients, respectively, experiencing events (P=0.006). The rate of serious pericardial effusion within 7 days of implantation, which had made up >50% of the safety events in PROTECT AF, was lower in the CAP Registry (5.0% versus 2.2%, respectively; P=0.019). There was a similar experience-related improvement in procedure-related stroke (0.9% versus 0%, respectively; P=0.039). Finally, the functional impact of these safety events, as defined by significant disability or death, was statistically superior in the Watchman group compared with the warfarin group in PROTECT AF. This remained true whether significance was defined as a change in the modified Rankin score of ≥1, ≥2, or ≥3 (1.8 versus 4.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.24 to 0.82; 1.5 versus 3.7 events per 100 patient-years; relative risk, 0.41; 95% confidence interval, 0.22 to 0.82; and 1.4 versus 3.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.22 to 0.88, respectively).
As with all interventional procedures, there is a significant improvement in the safety of Watchman left atrial appendage closure with increased operator experience. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00129545.
在心房颤动（AF）患者中，使用 Watchman 左心耳封堵系统进行栓塞保护的 PROTECT AF 随机试验将左心耳封堵与华法林进行了比较，这些患者的 CHADS₂ 评分≥1。尽管该研究达到了预防中风/全身性栓塞/心血管死亡的非劣效性主要疗效终点，但与华法林治疗相比，并发症风险显著增加，主要是心包积液和与空气栓塞相关的程序性中风。在这里，我们报告了经验对经皮左心耳封堵安全性的影响。
本分析的研究队列包括 PROTECT AF 试验中接受尝试设备左心耳封堵的患者（n=542 例）和随后接受 Watchman 植入的非随机登记患者（持续访问协议[CAP]登记；n=460 例）。安全性终点包括出血和程序相关事件（心包积液、中风、设备栓塞）。在两项研究中，术后 7 天内程序或设备相关安全性事件的发生率显著下降，分别有 7.7%和 3.7%的患者发生事件（P=0.007），在 PROTECT AF 和 CAP 的前半部分和后半部分之间，分别有 10.0%、5.5%和 3.7%的患者发生事件（P=0.006）。在植入后 7 天内发生严重心包积液的发生率，在 PROTECT AF 中占安全性事件的 50%以上，在 CAP 登记中较低（分别为 5.0%和 2.2%；P=0.019）。程序相关中风的经验相关改善也类似（分别为 0.9%和 0%；P=0.039）。最后，PROTECT AF 中 Watchman 组与华法林组相比，这些安全性事件的功能影响（定义为显著残疾或死亡）具有统计学优势。无论意义定义为改良 Rankin 评分的变化≥1、≥2 还是≥3，这一结果均成立（每 100 患者年发生 1.8 与 4.3 个事件；相对风险，0.43；95%置信区间，0.24 至 0.82；每 100 患者年发生 1.5 与 3.7 个事件；相对风险，0.41；95%置信区间，0.22 至 0.82；以及每 100 患者年发生 1.4 与 3.3 个事件；相对风险，0.43；95%置信区间，0.22 至 0.88）。
与所有介入性操作一样，随着操作人员经验的增加，Watchman 左心耳封堵的安全性显著提高。
