Department of Clinical and Experimental Medicine, A.O.U. Policlinic "G. Martino", University of Messina, Messina, Italy.
Division of Cardiology, CAST "G. Rodolico", A.O.U. Policlinic "Vittorio Emanuele-San Marco", Catania, Italy.
Catheter Cardiovasc Interv. 2022 Jul;100(1):154-160. doi: 10.1002/ccd.30237. Epub 2022 May 20.
The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise.
We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included.
According to mean CHAD DS -VASc (5 ± 1.40) and HAS-BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient's procedure was unsuccessful (0.5%), due to left atrial appendage (LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in-hospital death (0.5%) rarely occurred. After a follow-up of 272 ± 173 days, 2.3% of cases experienced a non-device-related stroke and 0.6% fatal bleeding.
Our registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period.
Watchman-FLX 左心耳封堵（LAAC）装置具有创新性的特点：更高的顺应性、更短的长度、在展开过程中关闭远端的“柔性球”以及更平坦的表面。我们报告了在两个具有 LAAC 专业知识的中心使用 Watchman-FLX 装置的真实经验。
我们在一个非随机的双中心注册研究中纳入了 200 例连续的 Watchman-FLX 患者（2019-2021 年）；收集了手术数据和中期临床结果随访。纳入了 100 例接受第一代 Watchman（2.5）治疗的患者作为对照组。
根据平均 CHAD DS-VASc（5±1.40）和 HAS-BLED（3.8±1.01）评分，本研究人群具有高风险：29%有既往卒中史，56.5%有出血事件。LAAC 的主要适应证为症状性出血（39.5%）、需要三联抗栓治疗（39%）、胃肠道出血（32%）和口服抗凝剂不耐受（18%）。93%的病例采用经食管超声心动图引导（48%全身麻醉，45%清醒镇静）。20%的病例需要重新定位 FLX 装置，无并发症发生。96%的患者成功植入了首选装置，而 4%的患者需要在首选装置后更换装置尺寸（7%改用 Watchman 2.5）。植入后发现 2 例（1%）存在＜5mm 的器械周围漏。总体而言，手术成功率为 99.5%。1 例患者（0.5%）因左心耳解剖结构导致手术不成功；而 Watchman 2.5 的平均失败率为 2%。未报告器械栓塞。并发症（8.5%）主要与入路部位相关（3%）；大出血（1%）和院内死亡（0.5%）罕见发生。随访 272±173 天后，2.3%的病例发生非器械相关卒中，0.6%的病例发生致命性出血。
我们的注册研究显示，在高危人群中，Watchman-FLX 的手术成功率较高。根据我们的经验，其主要优点包括易于植入和重新定位、无栓塞、良好的左心耳封堵和随访期间并发症发生率低。
