Long‐term clinical outcomes of Amplatzer cardiac plug versus Amulet occluders for left atrial appendage closure

Abstract

Objectives To compare long‐term clinical outcomes after left atrial appendage closure with the Amplatzer Cardiac Plug (ACP) and Amulet. Background The Amulet was designed to improve clinical outcomes of first‐generation ACP. Methods Three Amplatzer registries (Bern, Coburg, Zurich), with enrollment of patients from 2009 to 2018, were retrospectively analyzed. The primary safety endpoint was a composite of major peri‐procedural complications and major bleedings, the primary efficacy endpoint included stroke, systemic embolism, and cardiovascular/unexplained death. The net clinical benefit was a combination of all above‐mentioned hazards. Results A total of consecutive 563 patients (344 ACP vs. 219 Amulet) with a mean follow‐up of 2.9 ± 1.6 and 1.9 ± 0.9 years were included. Mean age (74.4 ± 9.9 [ACP] vs. 74.4 ± 9.1 [Amulet] years), stroke (CHA2DS2‐VASc score 4.4 ± 1.6 vs. 4.6 ± 1.7), and bleeding risk (HAS‐BLED score 3.2 ± 1.1 vs. 3.2 ± 0.9) were comparable. The primary endpoints of efficacy (72/998, 7.2% [ACP] vs. 43/417, 10.3% [Amulet]; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.44–1.02, p = .062), safety (40/998, 4.0% vs. 18/417, 4.3%; HR, 1.15; 95% CI, 0.53–2.51, p = .72), and the net clinical benefit (101/998, 10.1% vs. 55/417, 13.4%; HR, 0.73; 95% CI, 0.49–1.07, p = .11) were similar. Conclusion In the long term, left atrial appendage closure with first and second‐generation Amplatzer devices provided similar efficacy, safety, and net clinical benefit. Clinical outcomes may be rather determined by implantation technique and hemodynamics, but not by the design modifications of the Amulet.

Comparative Profiles of the WATCHMAN™ and Amplatzer™ Cardiac Plug/Amplatzer™ Amulet™ Devices for Left Atrial Appendage Closure in Non-valvular Atrial Fibrillation: A Comprehensive Systematic Review and Meta-analysis

“…Unlike standard anticoagulant therapies for non-valvular AF, these studies suggest that the WATCHMAN™ device may reduce bleeding duration and, in most cases, carry a stroke risk that is either equivalent to or lower than that of conventional anticoagulants. 36 , 37 …”

Percutaneous Treatment Approaches in Atrial Fibrillation: Current Landscape and Future Perspectives

“…When comparing the two Amplatzer LAAC devices, no major differences in the primary efficacy and safety endpoints were identified [ 183 ]. Interestingly, LAAC with Amplatzer devices led to a net clinical benefit compared with medical therapy in a propensity score-matched cohort study, by reducing the risk of stroke, systemic embolism, and cardiovascular/unexplained death (HR 0.70, 95% CI 0.53–0.95, p = 0.026) [ 184 ].…”

A comparison of intracardiac echocardiography and transesophageal echocardiography for guiding device closure of ostium secundum atrial septal defect: A 15‐year experience

“…1,2 Since the 1970s, when the first attempts at transcatheter closure of a OS-ASD were made, various devices have been used with improvement of successful deployment and closure of the defects over time. [3][4][5][6] Transcatheter device closure of OS-ASD is widely accepted as a treatment of choice in most patients with secundum OS-ASD, showing excellent efficacy and lower complication rate as compared to invasive surgery. 7 Similar to other cardiovascular fields, echocardiographic techniques assume a central role in patient selection, guidance and in follow up.…”