Watchman Device Linked to Low Complications, Successful Procedures

Use of the Watchman left atrial appendage closure (LAAC) device has been linked to high rates of success among cardiac patients with atrial non-valvular atrial fibrillation (AF), according to research¹ presented at the 2016 Transcatheter Cardiovascluar Theraputics (TCT) scientific symposium in Washington, DC.

Data were simultaneously published online in the Journal of the American College of Cardiology.

Between March 2015 and May 2016, 3822 consecutive patients had the Watchman device implanted at 169 centers across the US. Twenty-nine percent of surgeons had previously performed LAAC procedures as a part of clinical trials; 71% were “naïve operators” who had not performed a Watchman procedure prior to device approval by the FDA. The “naïve operator” group performed 50% of all procedures during the study period.

Successful device implantation (median procedure time: 50 minutes) was performed in 95.5% of all patients, with 1.38 devices used, on average, per case. A partial recapture of the final device was needed in 23% of cases, with 1.49 average recaptures per procedure.

Among all implantations, the most common complication was pericardial effusion in 1.02% of patients (n=39). In 24 of these cases, effusions were successfully drained percutaneously. The other 12 required surgery, and 3 patients did not survive. Eleven patients developed pericardial effusions that only required conservative management.

Additional adverse events included 3 strokes and 3 deaths attributed to device implantation, as well as 1 unrelated pulmonary embolism. Nine patients required device embolization, and two-thirds required surgical device removal; the remaining third were removed percutaneously.

“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 Reddy, MD, co-principal investigator and director of Cardiac Arrhythmia Services at Mount Sinai Hospital in New York City, said in a press release.² “More importantly, we confirmed the safety of this therapy as evidence by the low rate of complications.”

Disclosures: Drs Reddy, Gibson, Kar, Doshi, Horton, and Buchbinder have received various fees from Boston Scientific. Additionally, Dr Kar is the national principal investigator of the Continuous Access Registries (CAP and CAP2) and has served as a proctor for Boston Scientific. Dr Gordon is an employee of Boston Scientific. Dr Holmes and the Mayo Clinic have financial interests in technology related to this research, which has been licensed to Boston Scientific.

References

1. Reddy VY, Gibson DN, Kar S, et al. Post-FDA approval US experience with left atrial appendage closure for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2016. doi: 10.1016/j.jacc.2016.10.010
2. Boston Scientific announces initial US commercial performance of the WATCHMAN^TM left atrial appendage closure device [news release]. Marlborough, MA: Boston Scientific; November 2, 2016. http://news.bostonscientific.com/2016-11-02-Boston-Scientific-Announces-Initial-U-S-Commercial-Performance-Of-The-WATCHMAN-Left-Atrial-Appendage-Closure-Device. Accessed November 7, 2016.