Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry.

Karapet Davtyan,Arpi Topchyan,Oksana Drapkina,Pavel Mozgovoy,Sergey Boytsov,Vitaliy Shabanov,Yulia Miller,Andrey Kalemberg,Evgeniy Merkulov,Dmitry Pevzner,Vladimir Ufimtsev,Sergey Gureev,Georgiy Simonyan,Dmitriy Lebedev,Alexander Romanov,Gelin Xu

doi:10.1155/2020/2352648

Abstract

Purpose This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. Methods The study included data from 200 consecutive NVAF patients (66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD (n = 108) or ACP (n = 92) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. Results Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD (p = 0.053). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group (n = 9) and 1.1% of patients in the ACP group (n = 1) (p = 0.016). Conclusions In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

Highlights

It is well known that ischemic stroke is the leading cause of mortality and disability in patients with atrial fibrillation (AF) [1]
Several studies demonstrated that transcatheter Left atrial appendage (LAA) occlusion (LAAO) could be an alternative to oral anticoagulant therapy (OAC) in nonvalvular AF (NVAF) patients at high risk of thromboembolic (TEO) and hemorrhagic events [4]
At 12 months, primary safety endpoint occurred in 6.5% of patients in the Amplatzer Cardiac Plug (ACP) group with no events in the Watchman device (WD) group (6.5% vs. 0%, p = 0:008) (Figure 1)

Summary

Introduction

It is well known that ischemic stroke is the leading cause of mortality and disability in patients with atrial fibrillation (AF) [1]. Several studies demonstrated that transcatheter LAA occlusion (LAAO) could be an alternative to oral anticoagulant therapy (OAC) in NVAF patients at high risk of thromboembolic (TEO) and hemorrhagic events [4]. Present devices for endovascular LAAO are divided into three categories according to the LAA closure principle: “plug,” “pacifier,” and “ligation” [4]. The plug principle is to obstruct the neck of LAA by the LAAO device lobe or BioMed Research International umbrella, e.g., the Watchman device (WD) [5]. The pacifier devices have an additional disk to close LAA ostium from the left atrial site in addition to the device lobe/umbrella (Amplatzer Cardiac Plug (ACP), Amplatzer Amulet [6]). Complete ligation of the neck of the LAA is the mechanism of closure with ligation devices (LARIAT) [7]

Methods

Results

Conclusion