Postapproval Community Hospital Experience in the United States with Left Atrial Appendage Closure Device (Watchman).

BACKGROUND

To review the procedural safety and postimplantation complications of Watchman device implanted at 2 community hospitals for primary prevention of systemic embolization in patients with nonvalvular atrial fibrillation (NVAF) who were not candidates for long-term oral anticoagulation (OAC).

METHODS

This was a retrospective case series of 48 patients carried out in 2 community hospitals in the United States. Patients with NVAF who had a CHADS2 higher than 2 or CHADS2VASc2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack [TIA] or thromboembolism, vascular disease, age 65-74 years, and female gender) score of 3 or higher and were not candidates for long-term OAC. These patients were selected for implantation of Watchman device. They were followed up at 45 days, 6 months, 9 months, and 12 months after implantation of Watchman device to assess for complications involving the device and to determine if anticoagulation could be discontinued at the 45 days follow-up. They were monitored for any systemic thromboembolism while off anticoagulation.

RESULTS

The success rate of device implantation was 98% (48 of 49). Only a single patient could not get Watchman implantation because of unfavorable left atrial appendage anatomy. Access-related and device implantation-related complications were zero (0%). At 45 days follow-up and end of follow-up duration, the rate of thrombus formation on the Watchman device was 4% (2 of 48). One patient had TIA after warfarin discontinuation.

CONCLUSION

With improved procedural technique and well-trained operators, Watchman implantation is feasible in a community hospital also.