May 1, 2026Journal of the American College of Cardiology132 citations
View Full PaperImpact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure
Structured PICO
Does the presence of a peridevice leak ≤5 mm increase the risk of thromboembolism and mortality at 5 years in patients who underwent LAA closure with the Watchman device?
P
Population
1,054 patients with atrial fibrillation who underwent successful left atrial appendage (LAA) closure with the Watchman device, mean age 74, 65% male.
I
Intervention
Presence of peridevice leak ≤5 mm (PDL≤5) assessed by transesophageal echocardiogram at 1 year post-implantation
C
Comparator
Absence of peridevice leak
O
Outcome
5-year clinical outcomes including thromboembolism, stroke, and mortalityhard clinical
A peridevice leak of ≤5 mm at 1 year after Watchman LAA closure is associated with an increased risk of thromboembolism, challenging the prior assumption that such leaks are clinically insignificant.
Abstract
BACKGROUND: In the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA "closure." However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized. OBJECTIVES: We sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device. METHODS: Using combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5. RESULTS: The cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA CONCLUSIONS: PDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality. (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation PROTECT-AF; NCT00129545; Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy PREVAIL; NCT01182441; Continued Access to PREVAIL CAP2; NCT01760291).