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Continued Access Left Atrial Appendage Closure Registries
Study Questions:
What is the 4.5- to 5-year data on the safety and efficacy of left atrial appendage closure (LAAC) for stroke prevention in two US Food and Drug Association LAAC-mandated registries?
Methods:
The investigators combined data from two registries (CAP [Continued Access to PROTECT-AF] and CAP2 [Continued Access to PREVAIL]) of patients implanted with LAAC devices, which provide the largest source of follow-up data. Both accompanied their respective randomized clinical trials, PROTECT-AF (Watchman Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device In Patients with Atrial Fibrillation versus Long Term Warfarin Therapy), which used the same endpoints (primary efficacy of composite of stroke, systemic embolism, cardiovascular/unexplained death, and safety). Mortality was identified from multiple sources including death records, and correspondence with the families. Due to the multiple sources, the exact cause of death frequently could not be determined even after review of the information available. Multivariate analysis was used to evaluate relationships between baseline factors and subsequent mortality using a Cox regression model and a p value cutoff of 0.05.
Results:
CAP included 566 patients with an average follow-up of 50.1 months (2,293 patient-years), and CAP2 included 578 patients with an average follow-up of 50.3 months (2,227 patient-years). CAP2 patients were significantly older and had higher CHA2DS2-VASc scores (4.51 vs. 3.88; p < 0.001). Procedural success was similar in both (94%). The primary composite endpoint occurred at a rate of 3.05 per 100 patient-years in CAP and 4.80 per 100 patient-years in CAP2; events contributing to this endpoint were most commonly cardiovascular/unexplained death (1.69 per 100 patient-years for CAP and 2.92 per 100 patient-years for CAP2). Hemorrhagic stroke was significantly less than ischemic stroke (0.17 per 100 patient-years in CAP and 0.09 per 100 patient-years in CAP2), and total stroke rates were significantly less than predicted by CHA2DS2-VASc score (78% reduction with CAP, 69% reduction with CAP2).
Conclusions:
The authors concluded that these registries, which contain the longest and largest follow-up data of patients with the Watchman device, support LAAC as a safe and effective alternative therapy for long-term anticoagulation in patients with nonvalvular atrial fibrillation (NVAF).
Perspective:
These final 5- and 4-year registry data presented from the CAP and CAP2 registries suggest that LAAC is an effective and safe alternative to long-term anticoagulation in patients with NVAF who are at increased risk for stroke. Furthermore, the current data report the lowest rate of hemorrhagic stroke in this patient population. Given lack of precisely matched control arms and the lack of cause of death information in these registries, additional prospective studies are indicated to define optimum post-procedural antithrombotic strategies and compare the outcomes of LAA occlusion against target-specific oral anticoagulant therapy in patients with NVAF.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiovascular Care Team, Prevention, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Anticoagulants, Atrial Appendage, Atrial Fibrillation, Brain Ischemia, Embolism, Myocardial Infarction, Secondary Prevention, Stroke, Warfarin, Vascular Diseases
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