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      Clinical outcomes of Watchman vs. Amplatzer occluders for left atrial appendage closure (WATCH at LAAC)

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          Abstract

          Aims

          This study compares clinical outcomes of Watchman vs. Amplatzer devices for left atrial appendage closure (LAAC).

          Methods and results

          Of two real-world registries, the Watchman registry Lichtenfels, Germany, and the Amplatzer registry Bern-Zurich, Switzerland, 303 and 333 consecutive patients, respectively, were included. After a 1:1 propensity score matching, 266 vs. 266 patients were compared by use of the predefined primary efficacy endpoint of stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major peri-procedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. Mean age was 75.3 ± 7.8 (Watchman) vs. 75.1 ± 9.9 (Amplatzer) years, CHA2DS2-VASc score 4.5 ± 1.7 vs. 4.5 ± 1.5, and HAS-BLED score 3.2 ± 1.0 vs. 3.2 ± 1.0. At a mean follow-up of 2.4 ± 1.3 vs. 2.5 ± 1.5 years and 1.322 patient-years, the primary endpoints of efficacy [40/646, 6.2% [Watchman] vs. 43/676, 6.4% [Amplatzer]; hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.66–1.58; P = 0.92] and safety (33/646, 5.1% vs. 30/676, 4.4%; HR, 0.57; 95% CI, 0.29–1.11; P = 0.10), as well as the combined hazard endpoint (69/646, 10.7% vs. 66/676, 9.8%; HR, 0.80; 95% CI, 0.55–1.12; P = 0.26) were similar for both groups.

          Conclusion

          This study suggests comparable efficacy and safety of the Watchman and Amplatzer devices.

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          Most cited references17

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          2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS.

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            Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

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              5-Year Outcomes After Left Atrial Appendage Closure

              The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time.
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                Author and article information

                Contributors
                (View ORCID Profile)
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                Journal
                EP Europace
                Oxford University Press (OUP)
                1099-5129
                1532-2092
                June 2020
                June 01 2020
                January 31 2020
                June 2020
                June 01 2020
                January 31 2020
                : 22
                : 6
                : 916-923
                Affiliations
                [1 ]Department of Cardiology, REGIOMED Klinikum Lichtenfels, Lichtenfels, Germany
                [2 ]Department of Cardiology, Schwarzwald-Baar Klinikum, Klinikstraße 11, 78052 Villingen-Schwenningen, Germany
                [3 ]Faculty of Medicine, University of Bern, Bern, Switzerland
                [4 ]Cardiology, Cardiovascular Department, University Hospital of Bern, Bern, Switzerland
                [5 ]Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland
                [6 ]Cardiovascular Center Zurich, Hirslanden Klinik Im Park, Zurich, Switzerland
                Article
                10.1093/europace/euaa001
                32003774
                fcca9a95-b2ad-418f-87ac-9c7b8d0291b9
                © 2020

                https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model

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