Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke Center for Atrial Fibrillation and Clinical Cardiac Electrophysiology Section, Duke University Medical Center, Durham, NC, United States of America.
Duke Center for Atrial Fibrillation and Clinical Cardiac Electrophysiology Section, Duke University Medical Center, Durham, NC, United States of America.
Prog Cardiovasc Dis. 2021 May-Jun;66:92-100. doi: 10.1016/j.pcad.2021.06.006.
Stroke is a major driver of increased morbidity and mortality in patients with non-valvular atrial fibrillation (NVAF). While systemic oral anticoagulation (OAC) continues to be the mainstay for stroke reduction therapy in patients with NVAF, several barriers prevent the sustained long-term use of OAC, including increased risk of bleeding, non-compliance, cost, drug-drug interactions, and the need for ongoing laboratory testing. Given the need for continued stroke reduction therapies in patients who are intolerant of or non-compliant with OAC, percutaneous left atrial appendage (LAA) occlusion (LAAO) has emerged as a nonpharmacologic alternative to OAC. The development of percutaneous LAAO techniques is based on data suggesting that more than 90% of thrombi in patients with NVAF originate in the LAA. Two percutaneous LAAO devices are currently in widespread clinical use: Watchman (United States and Europe) and the Amplatzer type of devices (Europe); randomized trial data exist only for the Watchman device. Multiple randomized and nonrandomized trials and registries have demonstrated the safety and effectiveness of LAAO in patients who are suitable for short-term anticoagulation using a variety of post-procedural antithrombotic strategies. Ongoing randomized clinical trials on LAAO are focused on OAC-ineligible patients to compare efficacy of LAAO devices against a multitude of antithrombotic options. This review aims to discuss the rationale and evidence for LAAO and post procedural antithrombotic strategies and opportunities for research examination. In addition, we discuss the need for continued investigation of LAAO in populations not well represented in clinical trials or registries, including women, older patients, and underrepresented racial and ethnic groups.
中风是非瓣膜性心房颤动(NVAF)患者发病率和死亡率增加的主要原因。虽然系统口服抗凝(OAC)仍然是 NVAF 患者减少中风治疗的主要方法,但有几个障碍阻止了 OAC 的持续长期使用,包括出血风险增加、不遵医嘱、成本、药物相互作用以及需要持续实验室检测。鉴于不能耐受 OAC 或不遵医嘱的患者需要持续减少中风的治疗,经皮左心耳(LAA)闭塞(LAAO)已成为 OAC 的非药物替代方法。经皮 LAAO 技术的发展基于以下数据:NVAF 患者中超过 90%的血栓起源于 LAA。目前有两种经皮 LAAO 设备广泛应用于临床:Watchman(美国和欧洲)和 Amplatzer 型设备(欧洲);只有 Watchman 设备有随机临床试验数据。多项随机和非随机试验和登记研究表明,在适合短期抗凝治疗的患者中,使用各种术后抗血栓策略,LAAO 是安全有效的。正在进行的关于 LAAO 的随机临床试验侧重于 OAC 不适用的患者,以比较 LAAO 设备与多种抗血栓选择的疗效。本综述旨在讨论 LAAO 和术后抗血栓策略的原理和证据,并探讨研究检查的机会。此外,我们还讨论了需要继续在临床试验或登记中代表性不足的人群中研究 LAAO 的必要性,包括女性、老年患者和代表性不足的种族和族裔群体。