Long‐term clinical outcomes of Amplatzer cardiac plug versus Amulet occluders for left atrial appendage closure
| Autor: | Mate Fankhauser, Mohammad Cheikh-Ibrahim, Bernhard Meier, Fabian Nietlispach, Stephan Windecker, Steffen Gloekler, Steffen Schnupp, Johannes Brachmann, Caroline Kleinecke, Jai-Wun Park |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Cardiac Catheterization medicine.medical_specialty Time Factors Septal Occluder Device Hemodynamics 030204 cardiovascular system & hematology Prosthesis Design 03 medical and health sciences 0302 clinical medicine Heart Rate Left atrial Germany Internal medicine Atrial Fibrillation Humans Medicine Atrial Appendage Radiology Nuclear Medicine and imaging Registries 030212 general & internal medicine Stroke Aged Retrospective Studies Aged 80 and over business.industry Hazard ratio Atrial fibrillation Systemic embolism Amplatzer cardiac plug General Medicine medicine.disease Confidence interval Treatment Outcome Cardiology Atrial Function Left Female Cardiology and Cardiovascular Medicine business Switzerland |
| Zdroj: | Catheterization and Cardiovascular Interventions. 96 |
| ISSN: | 1522-726X 1522-1946 |
| DOI: | 10.1002/ccd.28530 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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