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Percutaneous Left Atrial Appendage Closure for Stroke Prevention in Patients With Atrial Fibrillation: An Assessment of Net Clinical Benefit
Study Questions:
What is the net clinical benefit (NCB) of percutaneous left atrial appendage (LAA) closure?
Methods:
This was a post-hoc analysis of outcomes among 707 adults with AF in the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) trial, and 566 in the Continued Access (CAP) registry undergoing LAA closure with the Watchman device, compared with sustained anticoagulation. Outcomes were ischemic stroke, intracranial hemorrhage, major bleeding, pericardial effusion, and death, weighted to reflect the relative impact in terms of death and disability. Net clinical benefit was calculated as the sum of annualized rates of these outcomes after intervention minus rates on warfarin.
Results:
The NCB of LAA closure during 1,623 person-years of follow-up in the trial was 1.73%/year (95% confidence interval [CI], −0.54 to 4.39%/year), and during 741 patient-years in the registry, was 4.97%/year (95% CI, 3.07-7.15%/year). Among patients with a history of ischemic stroke, the NCB was greater in the registry (8.68%/year, CI, 2.82-14.92%/year) than the trial (4.30%/year, CI −2.07 to 11.25%/year). In the registry, the NCB of LAA closure increased from 2.22%/year (CI, 0.27-6.01%/year) in patients with CHADS2 scores = 1 to 6.12%/year (CI, 3.19-8.92%/year) in those with scores ≥2.
Conclusions:
The authors concluded that the NCB of LAA closure is greatest for patients at a higher risk of stroke.
Perspective:
This analysis reports that the net clinical benefit of percutaneous LAA closure in patients with nonvalvular atrial fibrillation is greatest for those at highest risk of stroke, and suggests that combining rates of thromboembolism, intracranial hemorrhage, major adverse events, and death allows objective comparison of the benefit and risk of device therapy versus anticoagulation in patients with atrial fibrillation. An assessment that considers the combined risk of thromboembolism, intracranial hemorrhage, death, and other clinically important adverse events is indicated to more appropriately select patients for device-based therapy over long-term anticoagulation and improve clinical outcomes.
Keywords: Thromboembolism, Stroke, Intracranial Hemorrhages, Follow-Up Studies, Atrial Appendage, Cardiology, Warfarin, Atrial Function, Risk Assessment, Pericardial Effusion
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