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

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan and Meier, Bernhard

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1522-1946

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

10 Feb 2020 13:01

Last Modified:

18 Sep 2020 01:31

Publisher DOI:

10.1002/ccd.28530

PubMed ID:

31631493

Uncontrolled Keywords:

Amplatzer cardiac plug Amulet atrial fibrillation bleeding left atrial appendage closure stroke

BORIS DOI:

10.7892/boris.139060

URI:

https://boris.unibe.ch/id/eprint/139060

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