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Clinical Trial
. 2017 Sep;14(9):1302-1308.
doi: 10.1016/j.hrthm.2017.05.038. Epub 2017 May 31.

Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial

Lucas V Boersma  1 , Hueseyin Ince  2 , Stephan Kische  3 , Evgeny Pokushalov  4 , Thomas Schmitz  5 , Boris Schmidt  6 , Tommaso Gori  7 , Felix Meincke  8 , Alexey Vladimir Protopopov  9 , Timothy Betts  10 , David Foley  11 , Horst Sievert  12 , Patrizio Mazzone  13 , Tom De Potter  14 , Elisa Vireca  15 , Kenneth Stein  16 , Martin W Bergmann  17 ; EWOLUTION Investigators
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Free article
Clinical Trial

Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial

Lucas V Boersma et al. Heart Rhythm. 2017 Sep.
Free article

Abstract

Background: Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials.

Objective: EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry.

Methods: A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice.

Results: The baseline CHA2DS2-VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related.

Conclusion: LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation.

Keywords: Atrial fibrillation; Bleeding; LAA closure; Left atrial appendage; Stroke.

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