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亚洲患者使用WATCHMAN封堵器进行左心耳封堵:来自WASP注册研究的2年结果

Left atrial appendage closure with WATCHMAN in Asian patients: 2 year outcomes from the WASP registry.

作者信息

Phillips Karen P, Santoso Teguh, Sanders Prashanthan, Alison Jeffrey, Chan Jason Leung Kwai, Pak Hui-Nam, Chandavimol Mann, Stein Kenneth M, Gordon Nicole, Razali Omar Bin

机构信息

HeartCare Partners, GenesisCare, Brisbane, Australia.

Medistra Hospital, Jakarta, Indonesia.

出版信息

Int J Cardiol Heart Vasc. 2019 Apr 9;23:100358. doi: 10.1016/j.ijcha.2019.100358. eCollection 2019 Jun.

Abstract

BACKGROUND

Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk non-valvular atrial fibrillation patients, but has not been widely studied in Asian patients. The prospective WASP registry assessed real-world outcomes for patients undergoing WATCHMAN implant in the Asia-Pacific region.

METHODS

Data were collected from consecutive patients across 9 centres. Major endpoints included procedural success, safety and long-term outcomes including occurrence of bleeding, stroke/transient ischaemic attack/systemic embolism and all-cause mortality.

RESULTS

Subjects ( = 201) had a mean age of 70.8 ± 9.4 years, high stroke risk (CHADS-VASc: 3.9 ± 1.7), elevated bleeding risk (HAS-BLED: 2.1 ± 1.2) with 53% patients from Asian countries. Successful implantation occurred in 98.5% of patients; 7-day device/procedure-related SAE rate was 3.0%. After 2 years of follow-up, the rates of ischaemic stroke/TIA/SE and major bleeding were 1.9 and 2.2 per 100-PY, respectively, representing relative reductions of 77% and 49% versus expected rates per risk scores. The relative risk reductions versus expected rates were more pronounced in Asians vs. Non-Asians (89% vs 62%; 77% vs 14%). Other significant findings included larger mean LAA ostium diameter for Asians vs. Non-Asians (23.4 ± 4.1 mm vs. 21.2 ± 3.2 mm,  < 0.001) and hence requirement for larger median device size (27 mm for Asians, 24 mm for non-Asians [ < 0.0001]).

CONCLUSION

Real-world experience of left atrial appendage closure with WATCHMAN has demonstrated low peri-procedural risk, and long-term efficacy for stroke and bleeding prevention in a primarily Asian cohort.

摘要

背景

左心耳封堵术是高危非瓣膜性心房颤动患者预防卒中的一种非药物替代方法,但在亚洲患者中尚未得到广泛研究。前瞻性WASP注册研究评估了亚太地区接受WATCHMAN植入术患者的真实世界结局。

方法

收集了9个中心连续患者的数据。主要终点包括手术成功率、安全性和长期结局,包括出血、卒中/短暂性脑缺血发作/全身性栓塞的发生以及全因死亡率。

结果

受试者(n = 201)的平均年龄为70.8±9.4岁,卒中风险高(CHADS-VASc:3.9±1.7),出血风险升高(HAS-BLED:2.1±1.2),其中53%的患者来自亚洲国家。98.5%的患者成功植入;7天器械/手术相关严重不良事件发生率为3.0%。经过2年随访,缺血性卒中/TIA/SE和大出血发生率分别为每100人年1.9例和2.2例,相对于风险评分预期发生率分别降低了77%和49%。与预期发生率相比,亚洲人与非亚洲人的相对风险降低更为明显(89%对62%;77%对14%)。其他重要发现包括,亚洲人的平均左心耳开口直径大于非亚洲人(23.4±4.1mm对21.2±3.2mm,P<0.001),因此亚洲人所需的器械中位数尺寸更大(亚洲人为27mm,非亚洲人为24mm[P<0.0001])。

结论

WATCHMAN左心耳封堵术的真实世界经验表明,在以亚洲人为主的队列中,围手术期风险较低,且在预防卒中和出血方面具有长期疗效。

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