Helmsley Electrophysiology Center, Mount Sinai School of Medicine, New York, New York 10029, USA.
J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.
The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy.
The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation.
A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS₂ (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death.
The mean CHADS₂ score and CHA₂DS₂-VASc (CHADS₂ score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS₂ scores of the patient cohort.
LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ASAP]; NCT00851578).
本研究旨在评估在不适合华法林治疗的非瓣膜性心房颤动（AF）患者中，经皮左心耳（LAA）封堵术的安全性和有效性。
PROTECT AF（Watchman 左心耳封堵系统用于房颤患者的栓塞预防）试验表明，使用 Watchman 装置（波士顿科学公司，马萨诸塞州纳提克）进行 LAA 封堵不劣于华法林治疗。然而，PROTECT AF 试验仅纳入了适合华法林治疗的患者，甚至随机分配至 LAA 封堵组的患者在 Watchman 植入后也需要接受 6 周的华法林联合治疗。
一项多中心、前瞻性、非随机研究纳入了 150 例非瓣膜性 AF 且 CHADS₂（充血性心力衰竭、高血压、年龄≥75 岁、糖尿病和既往卒中或短暂性脑缺血发作）评分≥1 的患者，这些患者被认为不适合华法林治疗，采用 Watchman 装置进行 LAA 封堵。主要疗效终点为缺血性卒、出血性卒、全身性栓塞以及心血管/不明原因死亡的联合事件。
平均 CHADS₂评分和 CHA₂DS₂-VASc（CHADS₂评分加年龄≥75 岁者 2 分和血管疾病、65 岁至 74 岁或女性者 1 分）评分为 2.8±1.2 和 4.4±1.7。华法林不适用的最常见原因是出血/出血倾向史（93%）。平均随访时间为 14.4±8.6 个月。8.7%（150 例患者中的 13 例）的患者发生严重的与手术或器械相关的安全性事件。4 例患者发生全因卒或全身性栓塞（2.3%/年）：3 例患者发生缺血性卒（1.7%/年），1 例患者发生出血性卒（0.6%/年）。根据患者队列的 CHADS₂评分，该缺血性卒发生率低于预期（7.3%/年）。
在不进行华法林过渡的情况下，使用 Watchman 装置进行 LAA 封堵是安全的，对于有卒中高风险但存在全身口服抗凝禁忌的患者，这是一种合理的替代治疗方法。（ASA Plavix 可行性研究与 Watchman 左心耳封堵技术[ASAP]；NCT00851578）。
