Watchman Left Atrial Appendage Closure (LAAC) Device procedural data shows a 95.6% implant success rate with a median procedure time of 50 minutes.- Boston Scientific

Boston Scientific announced initial U.S. commercial performance results of the Watchman Left Atrial Appendage Closure (LAAC) Device during a late-breaking clinical trial session at the 28th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Washington, D.C. Data demonstrated a high rate of procedural success and low rate of complications for the device which offers stroke risk reduction for patients with non-valvular atrial fibrillation (AF) who are seeking an alternative to long-term warfarin therapy. The study was also published online today in the Journal of the American College of Cardiology. In advance of a formal national clinical registry becoming available, procedural data were collected via Watchman clinical specialists during 3,822 consecutive LAAC procedures performed between March 2015 and May 2016 by 382 operating physicians at 169 U.S. medical centers. In this case series, there was a 95.6% implant success rate with a median procedure time of 50 minutes. Half of the procedures were performed by new implanting physicians without previous experience with the device.

The overall rate of complications evaluated within these data was low at 1.63%, and compared favorably to the clinical trial data leading to device approval, validating the rigorous process for selecting and training new operators. Pericardial tamponade requiring intervention was the most frequent major procedural complication, which was seen in 1.02% of patients. In an additional 0.29% of patients, a hemodynamically insignificant pericardial effusion was observed that did not require intervention. Device embolization, procedure-related stroke and mortality rates also remained low at 0.24%, 0.08% and 0.08%, respectively.

See-: Reddy VY, Gibson DN, Kar S, O�Neill W, Doshi SK, Horton RP, Buchbinder M, Gordon NT, Holmes DR, "Post-FDA Approval, Initial US Clinical Experience with Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation", Journal of the American College of Cardiology (2016), doi: 10.1016/j.jacc.2016.10.010.