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Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the Watchman Left Atrial Appendage Closure Technology

Tuesday, April 9, 2019

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Source Name: Circulation: Electrophysiology and Arrhythmia


Lucas V. Boersma, Hueseyin Ince, Stephan Kische, Evgeny Pokushalov, Thomas Schmitz, Boris Schmidt, Tommaso Gori, Felix Meincke, Alexey Vladimir Protopopov, Timothy Betts, Patrizio Mazzone, David Foley, Marek Grygier, Horst Sievert, Tom De Potter, Elisa Vireca, Kenneth Stein, Martin W. Bergmann, for the EWOLUTION Investigators

Boersma and associates reported the outcomes of left atrial appendage (LAA) closure with the Watchman device in international registry (EWOLUTION), which recruited 1,020 patients from 47 different centers. Mean age was 73.4 years and 49% had a CHA2DS2-VASc score of 5 or higher—indicating a high risk of stroke.

After a median follow-up of two years, the following outcomes were observed:

  1. Twenty-two strokes, or 1.3 per every 100 patient-years, which correlates to an 83% reduction in strokes compared to historic data of the population’s risk profile.
  2. Forty-seven nonprocedural bleeding events, translating to 2.7 per 100 patient-years—a 46% reduction versus historic data.
  3. Stroke and bleeding rates were 76% and 41% lower, respectively, compared to historic data among the 311 study participants with prior ischemic stroke. For the 153 participants with prior hemorrhagic stroke, stroke and bleeding rates were 81% and 67% lower, respectively.
  4. Device thrombus occurred in 34 patients (4.1%).

The authors conclude that LAA closure with the Watchman device was associated with low rates of stroke and bleeding events in high-risk atrial fibrillation patients over a two-year follow-up period.

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