Prominent cardiologist calls for a halt to Watchman implants

A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite. Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose. “Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “I’ve avoided calling for a halt to LAA closure for as long as possible, but 2 recent events have changed my mind.” Mandrola said that the 1st motivation to strike out against LAA comes from him “feeling pressure” from colleagues to organize a left atrial appendage closure program at his hospital, due to other hospitals in his area developing similar programs. His 2nd motivation comes from other physicians “irrational exuberance” for the procedure. Mandrola referenced a recent study from the Transcatheter Cardiovascular Therapeutics meeting this year, which he called “deeply flawed.” “This nonrandomized, nonadjudicated series of nearly 4000 US patients implanted with the Watchman device, included as its primary end point safety data reported by device representatives present on the day of the procedure,” Mandrola w...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Boston Scientific Source Type: news