WASHINGTON — New data from the WATCHMAN US POST-APPROVAL STUDY showed a high rate of procedural success and a low rate of complications in patients with nonvalvular atrial fibrillation.
“The ‘real-world’ data collected from this study indicate high procedural success, even with the large number of new implanting physicians performing one-half of the procedures,” Vivek Y. Reddy, MD, director of electrophysiology at Mount Sinai Medical Center in New York, said in a press release. “More importantly, we confirmed the safety of this therapy as evidenced by the low rate of complications.”
Vivek Y. Reddy
From March 2015 to May 2016, 3,822 consecutive patients received Watchman Left Atrial Appendage Closure Device (Boston Scientific). Implantations were performed by 382 physicians at 169 centers across the United States. Procedural data were collected in advance of a formal national clinical registry becoming available, according to the release.
The rate of implant success was 95.6%. Median procedure time was 50 minutes.
Newly trained “novice” physicians who underwent FDA-approved training made up 71% of the implanting physicians and performed 50% of implantation procedures included in the data set.
There were, however, some major complications reported in the study, according to the researchers, including pericardial effusion (n = 11; 0.29%), need for urgent cardiac surgery, procedural-related stroke (n = 3; 0.078%), device embolization (n = 9; 0.24%) and death (n = 3; 0.078%).
“It’s important to recognize that even though 71% of the operators were ‘novice’ operators, these are operators [who] were probably chosen because of their skill in transseptal procedures, left atrial procedures or heart procedures,” Reddy said during a press conference at TCT 2016.
David R. Holmes
The overall complication rate was relatively low (1.63%) and was favorable compared with other clinical data amassed before device approval, according to the researchers.
“The benefit that [Dr. Reddy] has written about and the investigators have shown is an 80% reduction in hemorrhagic stroke,” David R. Holmes, MD, professor of medicine at Mayo Clinic College of Medicine and consultant in the division of cardiovascular diseases and the department of internal medicine at Mayo Clinic in Rochester, Minnesota, said during a panel discussion following the press conference. Holmes was also an investigator for this trial. “No. 2, there is sustained improvement in terms of all-cause mortality that is bigger than anything that has been seen in a patient sample this size and that has been well documented.” – by Dave Quaile
Reddy VY, et al. Late-Breaking Clinical Trials 4. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington, D.C.
Reddy VY, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.10.010.
The researchers report receiving grant support and/or consultant fees from Boston Scientific, Coherex and St. Jude Medical.
Editor’s Note: This article was updated on Nov. 4, 2016, to correct data on complication rates. The editors regret the error.