Experience with various occluder types for endovascular hemodynamic isolation of the left atrium appendage in patients with non-valvular atrial fibrillation

Abstract

The aim of our study was to evaluate implantation efficacy and safety across various occluder types and to identify factors determining device selection.Methods. This single-site prospective observational study included patients above the age of 40 years with non-valvular atrial fibrillation (AF) and high thromboembolic risk, undergoing endovascular isolation of the left atrium appendage (LAA) with Watchman or Amplatzer Cardiac Plug/Amulet devices. Occluders were implanted to patients without either had contraindications to anticoagulant therapy (ACT) or refused ACT. We evaluated technical aspects of device implantation, short- and long-term outcomes of the intervention over 3 years of follow-up.Results. 90 patients were enrolled in the study (62 into the Watchman arm and 28 into the Amplatzer arm). Interventions were technically successful in 89 cases. In 1 patient (1/90, 1.1%) technical success was not achieved due to device migration (Amplatzer Amulet). The incidence of early (occurring within˂ 24 hours) implantation complications was 0% in the Watchman arm, and 3.6% in the Amplatzer arm (1/28) (р=0.135) (device migration). The cumulative incidence of all in-hospital complications was 11.3% and 14.3%, respectively (р=0.734). No significant differences between arms were found in the incidence of device thrombosis within 90 days post-implantation (3.3% in the Watchman’s arm and 8.3% in the Amplatzer arm, р=0.316). During the observation period, there were no significant differences in comparison groups in the incidence of net clinical efficacy endpoint events (р=0.58). The bleeding rate was 17.7% and 14.3%, respectively, р=0.769. No factors influencing the choice of the device could be identified reliably; however, there was a trend towards Watchman preference for appendage anatomic variants such as broccoli and cactus. Amplatzer was preferred in patients with contraindications to ACT.Conclusion. Implantation of Watchman and Amplatzer Amulet occluders is equally effective and safe in preventing thromboembolism in patients with AF not receiving ACT for various reasons. The individual choice of a device may be influenced by appendage anatomy and indications to occluder implantation.

Efficacy and safety of left atrial appendage closure in patients with atrial fibrillation and high thromboembolic and bleeding risk

“…В нашей работе были применены два вида окклюзирующих устройств -Watchman (Boston Scientific, Natwick, США) и Amplatzer Cardiac Plug в модификации Amulet (St Jude Medical, Plymouth, США). Технические аспекты и особенности вмешательства, периоперационного обследования подробно изложены в ранее опубликованной нами работе [10].…”