Refereed journal article or data article (A1)

Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study




List of Authors: Freixa Xavier, Schmidt Boris, Mazzone Patrizio, Berti Sergio, Fischer Sven, Lund Juha, Montorfano Matteo, Della Bella Paolo, Lam Simon Cheung Chi, Cruz-Gonzalez Ignacio, Gage Ryan, Omran Heyder, Tarantini Giuseppe, Aminian Adel, Nielsen-Kudsk Jens Erik

Publisher: Oxford University Press

Publication year: 2021

Journal: EP-Europace

Journal name in source: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology

Journal acronym: Europace

Volume number: 23

Issue number: 2

ISSN: 1099-5129

eISSN: 1532-2092

DOI: http://dx.doi.org/10.1093/europace/euaa262

URL: https://academic.oup.com/europace/article/23/2/238/6024794


Abstract

Aims

Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up.

Methods and results

We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age.

Conclusions

Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.


Last updated on 2022-30-09 at 13:51