Real-world data from a post-market study of Boston Scientific’s Watchman anti-stroke device
Boston Scientific (NYSE:BSX) revealed the initial real-world data from a post-market study of its Watchman left atrial appendage closure device, saying the results showed high procedural success rates and low complication rates.
The results, also published in the Journal of the American College of Cardiology, covered more than 3,800 Watchman implantations between March 2015 and May of this year. The implant success rate was 95.6% with a median procedure time of 50 minutes, the Marlborough, Mass.-based company said.
Although half of the Watchman implantations were performed by doctors using the device for the 1st time, the overall complication rate was just 1.63%, which “compared favorably” to the rate observed in trials run before the device was approved.
Pericardial tamponade requiring intervention was the most frequent major procedural complication at 1.02%; hemodynamically insignificant pericardial effusion that did not require intervention occurred in 0.29% of patients. Device embolization, procedure-related stroke and mortality were 0.24%, 0.08% and 0.08%, respectively.
“The ‘real-world’ data collected from this study indicate high procedural success, even with the large number of new implanting physicians performing ½ of the procedures,” co-principal investigator Dr. Vivek Reddy, of New York CIty’s Mount Sinai Hospital, said in prepared remarks. “More importantly, we confirmed the safety of this therapy as evidenced by the low rate of complications.”
“This evaluation includes the largest Watchman device patient population studied to date and demonstrated low and consistent complication rates compared to those seen in previous clinical trials,” added co-principal investigator Dr. David Holmes of the Mayo Clinic in Rochester, Minn. “This provides important procedural insights in the absence of an official Centers for Medicare & Medicaid Services registry being available to collect data immediately following device approval by the FDA in March 2015.”