To assess the safety and efficacy of left atrial appendage closure (LAA) in non-valvular atrial fibrillation (AF) patients ineligible for warfarin therapy.
The PROTECT AF trial demonstrated that LAA closure with the Watchman device was non-inferior to warfarin therapy. However, PROTECT AF only included patients that were candidates for warfarin, and even patients randomized to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation.
Multi-center, prospective, non-randomized study of LAA closure with the Watchman device in 150 patients with non-valvular AF and CHADS2 ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death.
The mean CHADS2 and CHA2DS2-VASc scores were 2.8 ± 1.2 and 4.4±1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13/150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year); ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS2 scores of the patient cohort.
LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation.