Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.
Electrophysiology Section, Duke University Hospital, Durham, North Carolina, USA.
JACC Cardiovasc Interv. 2022 Nov 14;15(21):2115-2123. doi: 10.1016/j.jcin.2022.09.002.
Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described.
The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device.
The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX.
The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001).
Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.
经导管左心耳封堵术（LAAO）的程序并发症限制了其临床获益。新一代设备采用了旨在提高程序安全性的设计改进，但尚未描述其临床影响。
本研究旨在比较 Watchman FLX 与前一代 Watchman 2.5 装置的住院期间结局。
使用全国心血管数据注册 LAAO 登记处，在每个地点的首个 Watchman FLX 病例之前，确定接受 Watchman FLX 和相同数量的在相同地点接受 Watchman 2.5 的患者。主要终点为住院期间的主要不良事件（MAE），定义为死亡、心脏骤停、卒 中、短暂性脑缺血发作、颅内出血、体循环动脉栓塞、大出血、大血管并发症、心肌梗死、需要干预（经皮或手术）的心包积血以及设备栓塞的复合事件。对接受 Watchman 2.5 或 Watchman FLX 的患者进行了 2:1 的倾向评分匹配的二次分析。
研究队列包括 27013 例接受每种设备的患者。与 Watchman 2.5 相比，Watchman FLX 的住院期间 MAE 发生率显著降低（1.35% vs. 2.40%；调整后的 OR：0.57；95%CI：0.50-0.65；P<0.0001），这主要是由于心包积血需要干预的发生率较低（0.42% vs. 1.23%；调整后的 OR：0.34；95%CI：0.28-0.42；P<0.0001）。Watchman FLX 也与较低的住院期间死亡率（0.12% vs. 0.24%；P<0.0001）、大出血（1.08% vs. 2.05%；P<0.0001）、心脏骤停（0.13% vs. 0.24%；P=0.006）和设备栓塞（0.02% vs. 0.06%；P=0.028）的发生率较低相关，而心肌梗死、卒中和大血管并发症在两组之间无差异。倾向评分匹配分析也得到了类似的结果，Watchman FLX 的 MAE 发生率较低（1.34% vs. 2.58%；OR：0.51；95%CI：0.46-0.58；P<0.0001）。
与前一代 Watchman 装置相比，经导管左心耳封堵术（LAAO）联合 Watchman FLX 可降低住院期间 MAE 的发生率，包括死亡率、心包积血、大出血、心脏骤停和设备栓塞。这可能有利于影响经导管左心耳封堵术（LAAO）在预防心房颤动患者卒中方面的风险-获益平衡。
