Cited by 727Atrial Fibrillation Management and OutcomesCardiovascular and Diving-Related ComplicationsAcute Ischemic Stroke Management

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Left Atrial Appendage Closure With the Watchman Device in Patients With a Contraindication for Oral Anticoagulation

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Reddy, Vivek Y., Möbius-Winkler, Sven, Miller, Marc A., Neuzil, Petr, Schuler, Gerhard, Wiebe, Jens, Sick, Peter, Sievert, Horst·2013·Journal of the American College of Cardiology

DOI 10.1016/j.jacc.2013.03.035

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Abstract

Objectives The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy.Background The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation.Methods A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS₂ (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death.Results The mean CHADS₂ score and CHA₂DS₂-VASc (CHADS₂ score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS₂ scores of the patient cohort.Conclusions LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ASAP]; NCT00851578).

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Method
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Authors: Reddy, V. Y., Möbius-Winkler, S., Miller, M. A., Neuzil, P., Schuler, G., Wiebe, J., Sick, P., & Sievert, H.
Affiliations: Icahn School of Medicine at Mount Sinai (US)
Leipzig Heart Institute (DE)
Cardiovascular Center Frankfurt (DE)
Krankenhaus Barmherzige Brüder (DE)
Corresponding author: Reddy, Vivek Y.
ORCID: Reddy, Vivek Y.
Miller, Marc A.
Schuler, Gerhard
Wiebe, Jens
Venue: Journal of the American College of Cardiology
Publisher: Elsevier BV
Published: 2013-06
Volume: 61
Issue: 25
Pages: 2551-2556
ISSN: 0735-1097 (ISSN-L)
DOI: 10.1016/j.jacc.2013.03.035
OpenAlex: W2115996784
Cited by: 727
References: 31
Citations by year: 2026: 25 · 2025: 28 · 2024: 46 · 2023: 51 · 2022: 43 · 2021: 57 · 2020: 48 · 2019: 59 · 2018: 61 · 2017: 72 · 2016: 83 · 2015: 75 · 2014: 59 · 2013: 17
FWCI: 52.98
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 389 d)
Locations: Journal of the American College of Cardiology (publishedVersion)
PubMed (publishedVersion)
Funders: Boston Scientific
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cardiovascular and Diving-Related Complications
Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
Keywords: left atrial appendage closure, Watchman device, non-valvular atrial fibrillation, stroke prevention, systemic embolism, CHADS2 score, CHA2DS2-VASc score, bleeding risk, procedural safety, ischemic stroke, hemorrhagic stroke, anticoagulation alternatives
MeSH terms: Contraindications, Clopidogrel, Administration, Oral, Aged, Aged, 80 and over, Anticoagulants, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Platelet Aggregation Inhibitors, Prospective Studies, Ticlopidine, Treatment Outcome, Atrial Appendage

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Left Atrial Appendage Closure With the Watchman Device in Patients With a Contraindication for Oral Anticoagulation

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