Author + information
- 1Cedars-Sinai Medical Center, Los Angeles, California, United States
- 2Mount Sinai Medical Center, New York, New York, United States
- 3Pacific Heart Institute, Santa Monica, California, United States
- 4Boston Scientific, Maple Grove, Minnesota, United States
- 5Mayo Clinic, Rochester, Minnesota, United States
Long-term follow up of NVAF patients (pts) undergoing left atrial appendage occlusion (LAAO) for stroke prevention remains of significant interest. For LAAO with the Watchman™ (St. Paul, MN) device, the Continued Access to PROTECT AF Registry (CAP) is the largest U.S. registry with the longest follow-up.
Pts were enrolled from August 2008-June 2010 and included 566 patients implanted with a WATCHMAN device and was designed to collect additional safety and efficacy data after the randomized trial completed enrollment. The primary efficacy endpoint was a composite of CV mortality, all stroke, or systemic embolism.
Mean age was 74.0±8.3 years, 35% were female, 96% had a CHA2DS2VASc score ≥2 (mean 3.9±1.5; CHADS2 mean 2.5±1.2). Average follow-up was 50.1 months and 2293 patient-years (pt-yrs). Primary efficacy endpoint events occurred in 70 subjects (12.4%), yielding a rate of 3.1/100 pt-yrs (95% CI 2.4-3.9). Notably, the ischemic stroke rate was 1.16/100 pt yrs (95% CI 0.78-1.71), indicating a 78% and 75% relative risk reduction when compared to expected rates of similar risk patients with no treatment or aspirin only, respectively. At 60 months, ∼95% of patients remained off warfarin. Primary long-term safety events were mainly GI bleeding and occurred in 66 patients at a rate of 3.1/100 pt-years.
In a high stroke risk population, the 5-year outcome of the CAP registry is notable for a low rate of stroke, particularly hemorrhagic stroke, and mortality, documenting excellent continued WATCHMAN device performance.
STRUCTURAL: Left Atrial Appendage Exclusion