Abstract 19389: The Net Clinical Benefit of Left Atrial Appendage Closure in the Continued Access Protocol (CAP) Registry
Introduction: PROTECT AF revealed LA appendage closure (LAAC) to be an effective alternative to warfarin in nonvalvular AF patients. The non-randomized CAP registry demonstrated that with increased operator experience, there were fewer procedure-related complications with LAAC. Our objective was to estimate the net clinical benefit (NCB) of percutaneous LAAC in the CAP registry.
Methods: Post hoc analysis of outcomes in both the randomized PROTECT AF trial (n=707) and the non-randomized CAP registry (n=566). Based on the relative clinical impact, outcomes were weighted using death as the index parameter (ie, =1): ischemic stroke = 0.2, intracranial hemorrhage = 0.6, major bleeding = 0.1, tamponade =0.1. NCB was calculated as the sum of annualized rates of these outcomes after LAAC in the CAP registry minus rates on warfarin in the PROTECT AF control group.
Results: The NCB of LAAC during 962 person-years of follow-up in the CAP registry was 3.87%/year (95% CI 1.90-6.11%/year), compared with 1.62%/year (95% CI -0.25-3.72%/year) in PROTECT-AF trial. Among patients with a history of ischemic stroke, NCB was greater in CAP (7.34%/year, CI 1.97-14.85%/year) than PROTECT AF (3.62%/year, CI -1.50-9.23%/year). In the registry, the NCB of LAAC increased from 1.64 %/year (95% CI -0.3-5.16%/year) in patients with CHADS2 scores=1 to 4.99%/year (95% CI 1.3-9.07%/year) in those with scores >2.
Conclusion: With increased operator experience, the net clinical benefit of LAA closure exceeds Warfarin therapy.
- © 2012 by American Heart Association, Inc.