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

Boersma, Lucas V.A.; Ince, Hueseyin; Kische, Stephan; Pokushalov, Evgeny; Schmitz, Thomas; Schmidt, Boris; Gori, Tommaso; Meincke, Felix; Protopopov, A. V.; Betts, Timothy R.; Foley, David P.; Sievert, Horst; Mazzone, Patrizio; Potter, Tom De; Vireca, Elisa; Steín, Kenneth M.; Bergmann, Martin

doi:10.1016/j.hrthm.2017.05.038

Cited by 377 publications

(332 citation statements)

References 21 publications

(16 reference statements)

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“…Considering the higher CHA 2 DS 2 ‐VASc score of 4.7 ± 1.6, which corresponds to an annual stroke risk of 5.7 ± 2.5%, as well as a higher prevalence of previous cerebrovascular events (50.0%) in this study, the rates of cerebrovascular events from the two LAA occlusion registries were low and acceptable for purposes of considering LAA occlusion as an alternative to oral anticoagulation. These results are consistent with the cerebrovascular event rates reported in the available randomized trials, PROTECT‐AF (1.3 per 100 patient‐years), Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients With Atrial Fibrillation vs Long Term Warfarin Therapy (PREVAIL) (1.9%), and Registry to Evaluate Real‐World Clinical Outcomes in Patients With AF and High Stroke Risk—Treated With the WATCHMAN Left Atrial Appendage Closure Technology (EWOLUTION) registry (1.1%) despite higher CHADS 2 and CHA 2 DS 2 ‐VASc scores …”

Section: Discussionsupporting

confidence: 82%

Favorable neurological outcome after ischemic cerebrovascular events in patients treated with percutaneous left atrial appendage occlusion compared with warfarin

Lee

Kim

Pak

et al. 2018

Cathet Cardio Intervent

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Objectives This study sought to investigate neurological disability after ischemic cerebrovascular events in patients treated with left atrial appendage (LAA) occlusion compared with those on warfarin. Background Prior studies demonstrated that cerebrovascular events after LAA occlusion in patients with nonvalvular atrial fibrillation (NVAF) is largely nondisabling. Methods From the 1,189 patients in the Korean LAA Occlusion and European Amplatzer Cardiac Plug Multi‐Center Registry, 24 patients who experienced ischemic cerebrovascular events after LAA occlusion were enrolled. The neurological outcomes were compared with those in 68 patients who experienced an ischemic cerebrovascular event while on warfarin (Yonsei Stroke Registry). A modified Rankin scale (mRS) score of 3–6 categorized the cerebrovascular event as disabling. The mRS at discharge and at 3 and 12 months postcerebrovascular event in the two groups was compared. Results The percentages of disabling cerebrovascular events were 37.5% and 58.8% at discharge (P = 0.07), 20.8% and 42.6% at 3 months (P = 0.08), and 12.5% and 39.7% at 12 months (P = 0.02) in the LAA occlusion and warfarin groups, respectively. The mRS was significantly lower in the LAA occlusion group at discharge and at 3 months (P < 0.01) and 12 months (P < 0.01) postcerebrovascular event despite no significant difference in mRS before cerebrovascular events (P = 0.98). Patients in the LAA occlusion group demonstrated a significant reduction in mRS between discharge and 12 months (P < 0.01), unlike patients in the warfarin group (P = 0.10). Conclusions Ischemic cerebrovascular events in patients who previously underwent percutaneous LAA occlusion for NVAF were more favorable than in patients on warfarin.

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Section: Discussionsupporting

confidence: 82%

Favorable neurological outcome after ischemic cerebrovascular events in patients treated with percutaneous left atrial appendage occlusion compared with warfarin

Lee

Kim

Pak

et al. 2018

Cathet Cardio Intervent

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“…As such, many of these patients were not represented in clinical trials and in fact may have been excluded. Within a “real world” high‐risk population, LAAC followed by short‐term OAC (with warfarin) or dual antiplatelet therapy (DAPT) has been shown to be well‐tolerated . The role of the novel oral anticoagulants (NOAC) in such high‐risk populations is not well‐studied.…”

Section: Introductionmentioning

confidence: 99%

A comparison of postprocedural anticoagulation in high‐risk patients undergoing WATCHMAN device implantation

Cohen

Heist

Galvin

et al. 2019

Pacing Clinical Electrophis

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Background Left atrial appendage closure (LAAC) is an alternative to long‐term anticoagulation for thromboembolic protection in patients with atrial fibrillation (AF) and high bleeding risk. Short‐term Warfarin use following LAAC is well‐studied, while data pertaining to novel oral anticoagulant (NOAC) use in this setting is less robust. Specifically, data regarding the safety and efficacy of postprocedural NOAC use in high‐risk patients is lacking. Objective To compare the safety and efficacy of Warfarin and NOAC use in a high‐risk patient population undergoing LAAC with the WATCHMAN device. Methods From November 2015 to October 2017, 97 patients underwent LAAC with the WATCHMAN device. All patients were discussed at a multidisciplinary meeting prior to device implantation. Longitudinal data were collected and analyzed for a composite endpoint of stroke and death at 8 months, and major bleeding at 3 and 6 months. Results Among the 90 patients included in the safety and efficacy analysis, 43 were prescribed Warfarin and 47 were prescribed NOACs. Baseline characteristics were comparable between study groups. There were no procedural complications and no significant differences in the incidence of death and stroke at 8 months or major bleeding at 3 and 6 months. Conclusion For patients with AF at high risk of both thromboembolic and hemorrhagic events, NOACs as compared to Warfarin, seem to be safe and effective for short‐term anticoagulation following LAAC with the WATCHMAN device. Further validation in large randomized controlled trials is required.

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“…The long‐term outcomes of prospective randomized trials demonstrated that left atrial appendage (LAA) closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, MN, USA) was protective in nonvalvular AF in a manner comparable to warfarin with additional reductions in major bleeding, hemorrhagic stroke, and mortality . Patients with contraindications for chronic oral anticoagulation (OAC) could also benefit from LAAC . Recently, the efficacy and safety of the concomitant therapy of CA for AF symptom relief and LAAC for stroke prevention in a single procedure have been assessed .…”

Section: Introductionmentioning

confidence: 99%

Optimal combination strategy of left atrial appendage closure plus catheter ablation in a single procedure in patients with nonvalvular atrial fibrillation

Wang

et al. 2018

Cardiovasc electrophysiol

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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

Abstract: 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.

Cited by 377 publications

References 21 publications

Favorable neurological outcome after ischemic cerebrovascular events in patients treated with percutaneous left atrial appendage occlusion compared with warfarin

Favorable neurological outcome after ischemic cerebrovascular events in patients treated with percutaneous left atrial appendage occlusion compared with warfarin

A comparison of postprocedural anticoagulation in high‐risk patients undergoing WATCHMAN device implantation

Optimal combination strategy of left atrial appendage closure plus catheter ablation in a single procedure in patients with nonvalvular atrial fibrillation

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