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

Kleinecke, Caroline; Cheikh-Ibrahim, Mohammad; Schnupp, Steffen; Fankhauser, Mate; Nietlispach, Fabian; Park, Jai-Wun; Brachmann, Johannes; Windecker, Stephan; Meier, Bernhard; Gloekler, Steffen (2020). Long-term clinical outcomes of Amplatzer cardiac plug versus Amulet occluders for left atrial appendage closure. Catheterization and cardiovascular interventions, 96(3), E324-E331. Wiley-Blackwell 10.1002/ccd.28530

Text Long term clinical outcomes of Amplatzer cardiac plug versus Amulet occulders for left atrial appendage closure.pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (1MB)

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 (CHA2 DS2 -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.

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