Post-Approval U.S. Experience with a Device for Left Atrial Appendage Closure

Procedural complications were low and reasonably reassuring.

Left atrial appendage closure (LAAC) with the Watchman device was approved by the FDA in 2015 for patients with nonvalvular atrial fibrillation (NVAF). The Centers for Medicare & Medicaid Services required enrollment in a national, prospective, post-approval registry as a condition for reimbursement. Now, researchers, several with ties to the manufacturer, report on the manufacturer's early procedural data on 3822 patients treated by 382 physicians at 169 centers in the U.S.

Procedural success was 96%; partial device recapture was needed in 23% of cases. Median time for the procedure was 50 minutes, and 71% of the proceduralists had no experience with the device before FDA approval. Complications included stroke (0.08%), pericardial effusion…

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)