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

doi:10.1016/j.hrthm.2017.05.038

Heart Rhythm

Volume 14, Issue 9, September 2017, Pages 1302-1308

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https://doi.org/10.1016/j.hrthm.2017.05.038 Get rights and content

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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

Stroke

Left atrial appendage

Atrial fibrillation

LAA closure

Bleeding

Cited by (0)

: Boston Scientific Corporation provided funding for the study.

: Dr Boersma has received personal fees from Boston Scientific and Medtronic (outside the submitted work). Dr Ince is a proctor for Boston Scientific Corporation and has received personal fees from Boston Scientific (outside the submitted work). Dr Schmidt has received personal fees from Boston Scientific and St. Jude Medical (outside the submitted work). Dr Betts has received personal fees from Boston Scientific (outside the submitted work). Dr Sievert has received personal fees from Abbott, Aptus, Atrium, Biosense Webster, Boston Scientific, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Comed B.V., Contego, Covidien, CSI, CVRx, ev3, FlowCardia, Gardia, Gore, GTIMD Medical, Guided Delivery Systems, Hemoteq, InSeal Medical, InspireMD, Kona Medical, Lumen Biomedical, Lifetech, Lutonix, Maya Medical, Medtronic, Occlutech, Pfm Medical, Recor, Trireme, Trivascular, Valtech, Vascular Dynamics, Venus Medical, Veryan, and Vessix (outside the submitted work). Dr Sievert also reports stock options in Cardiokinetix, Access Closure, Coherex, and SMT (outside the submitted work). Dr Mazzone is a proctor for Boston Scientific and a consultant for St. Jude Medical. Ms Vireca is an employee at BSC. Dr Stein is an employee and shareholder at BSC. Dr Bergmann has received personal fees from Boston Scientific, St. Jude Medical, Biosense Webster, and Johnson & Johnson (outside the submitted work).