Ke Jin-Yan, Jin Lu-Shen, Lin Yuan-Nan, Xu Jing, Liu Wei-Ke, Fu Jia-Yang, Li Ling, Chen Yi-Lian, Qiu Yi-Xuan, Li Yue-Chun
Department of Cardiology, Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.
Front Cardiovasc Med. 2022 Nov 2;9:1011037. doi: 10.3389/fcvm.2022.1011037. eCollection 2022.
Left atrial appendage closure (LAAC) combined with radiofrequency catheter ablation is an emerging one-stop hybrid procedure for non-valvular atrial fibrillation (AF). This study was performed to compare the efficacy and safety of the Watchman device vs. the LAmbre device for this combined procedure.
Two hundred and thirty two patients with AF who underwent the combined procedure were enrolled and divided into two subgroups depending on the device choice: the Watchman-combined group ( = 118) and the LAmbre-combined group ( = 114). The periprocedural and follow-up adverse events in both groups were documented.
The mean CHADS-VASc score and HAS-BLED score in the Watchman-combined group and LAmbre-combined group were 3.7 ± 1.5 vs. 3.8 ± 1.5 and 2.5 ± 1.1 vs. 2.3 ± 1.1, respectively (all > 0.05). Successful LAAC was achieved in all patients. The rate of major periprocedural complications and AF recurrence at 6 months post-procedure were similar between the Watchman-combined group and LAmbre-combined group (0.8 vs. 0.9%, = 1.00; 22.0 vs. 15.8%, = 0.23). During 2.6 ±0 .7 vs.1.6 ± 1.6 years follow-up, the rate of major clinical adverse events, including stroke and major bleeding, were comparable between the Watchman-combined group and the LAmbre-combined group (2.6 vs. 1.1% per 100 patient-years, = 0.33). The intraprocedural peri-device leakage (PDL) rate was similar between the Watchman-combined group and the LAmbre-combined group (5.1 vs. 6.1%, = 0.73), but the PDL rate was significantly higher at 3-6 months transesophageal echocardiography (TEE) follow-up than the intraprocedural PDL rate in both groups (21.6 vs. 5.1%; 36.6 vs. 6.1%, respectively), with a more obvious increase in minimal PDL rate in the LAmbre-combined group than the Watchman-combined group (36.6 vs. 21.6%, < 0.05).
The Watchman and LAmbre devices were comparable in efficacy and safety for the combined procedure. The minimal PDL rate at short-term TEE follow-up was higher in the LAmbre-combined group than the Watchman-combined group.
左心耳封堵术(LAAC)联合射频导管消融术是一种新兴的用于非瓣膜性心房颤动(AF)的一站式杂交手术。本研究旨在比较Watchman装置与LAmbre装置用于该联合手术的疗效和安全性。
纳入232例行联合手术的AF患者,并根据装置选择分为两个亚组:Watchman联合组(n = 118)和LAmbre联合组(n = 114)。记录两组围手术期及随访期间的不良事件。
Watchman联合组和LAmbre联合组的平均CHADS-VASc评分分别为3.7±1.5和3.8±1.5,HAS-BLED评分分别为2.5±1.1和2.3±1.1(均P>0.05)。所有患者均成功完成LAAC。Watchman联合组和LAmbre联合组围手术期主要并发症发生率及术后6个月房颤复发率相似(0.8% vs. 0.9%,P = 1.00;22.0% vs. 15.8%,P = 0.23)。在2.6±0.7年 vs. 1.6±1.6年的随访期间,Watchman联合组和LAmbre联合组主要临床不良事件(包括卒中及大出血)发生率相当(每100患者年分别为2.6%和1.1%,P = 0.33)。Watchman联合组和LAmbre联合组术中装置周围渗漏(PDL)率相似(5.1% vs. 6.1%,P = 0.73),但两组术后3 - 6个月经食管超声心动图(TEE)随访时的PDL率均显著高于术中PDL率(分别为21.6% vs. 5.1%;36.6% vs. 6.1%),LAmbre联合组最小PDL率的升高比Watchman联合组更明显(36.6% vs. 21.6%,P<0.05)。
Watchman装置和LAmbre装置用于联合手术的疗效和安全性相当。LAmbre联合组短期TEE随访时的最小PDL率高于Watchman联合组。