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Five years of keeping a watch on the left atrial appendage-how has the WATCHMAN fared?

ABSTRACT: Left atrial appendage closure (LAAC) is a promising site-directed therapy for stroke prevention in patients with non-valvular atrial fibrillation (AF) who are ineligible or contraindicated for long-term oral anticoagulation. A variety of LAAC modalities are available, including percutaneous endocardial occluder devices such as WATCHMAN^TM (Boston Scientific Corp., Marlborough, MA, USA), and an ever-increasing body of evidence is helping to define the optimal use of each technique. Similarly increased experience with LAAC has revealed challenges such as device-related thrombi and peri-device leaks for which the long-term significance and appropriate management are areas of active investigation. We review the evolution and long-term outcomes with the WATCHMAN^TM device with particular emphasis on the nuances of its use and its role in the broader landscape of appendageology.

SUBMITTER: Jazayeri MA

PROVIDER: S-EPMC5227183 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Five years of keeping a watch on the left atrial appendage-how has the WATCHMAN fared?

Jazayeri Mohammad-Ali MA Vuddanda Venkat V Parikh Valay V Lavu Madhav M Atkins Donita D Reddy Y Madhu YM Nath Jayant J Lakkireddy Dhanunjaya R DR

Journal of thoracic disease 20161201 12

Left atrial appendage closure (LAAC) is a promising site-directed therapy for stroke prevention in patients with non-valvular atrial fibrillation (AF) who are ineligible or contraindicated for long-term oral anticoagulation. A variety of LAAC modalities are available, including percutaneous endocardial occluder devices such as WATCHMAN<sup>TM</sup> (Boston Scientific Corp., Marlborough, MA, USA), and an ever-increasing body of evidence is helping to define the optimal use of each technique. Simi ...[more]

PMID: 28149625

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Project description:ObjectivesThe aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data.BackgroundPatients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.MethodsPropensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.ResultsA total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients.ConclusionIn clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441).

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Five years of keeping a watch on the left atrial appendage-how has the WATCHMAN fared?

Publications

Five years of keeping a watch on the left atrial appendage-how has the WATCHMAN fared?

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