More Data on Left Atrial Appendage Occlusion

Longer-term follow-up of the PROTECT-AF trial provides evidence of efficacy with the Watchman device relative to warfarin.

Many patients and physicians are interested in finding a safe, effective alternative to oral anticoagulation for nonvalvular atrial fibrillation (NVAF). The Watchman device was initially evaluated in the PROTECT-AF trial (NEJM JW Gen Med Aug 27 2009) and subsequently in the PREVAIL trial (NEJM JW Cardiol Aug 7 2014) and has been the subject of three FDA panels. Most recently, the panel was split on efficacy, while confirming safety. Investigators now report for peer review the longer-term results of the original PROTECT-AF trial.

In this manufacturer-funded, unblinded trial, 707 patients were randomized 2:1 to device therapy at 59 sites. The mean CHADS₂ score was about 2.2, and the mean follow-up for this analysis was 3.8 years. Implant succ…

Reviewing Author

Howard C. Herrmann, MD

Disclosures

Consultant/Advisory BoardAffluent Medical; Artedrone; Caranx; Johnson & Johnson; Medtronic; Prolifagen; Wells Fargo

EquityMicrointerventional Devices, Inc.

RoyaltiesUniversity of Pennsylvania

Grant/Research SupportAbbott Vascular; Edwards Lifesciences; Johnson & Johnson; Medtronic

Editorial BoardsCatheterization and Cardiovascular Interventions; Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; JACC Cardiovascular Interventions; JACC Case Reports; JSCAI

Leadership Positions in Professional SocietiesHeart Valve Collaboratory (Scientific Committee Member, Chair of the Publications Committee)