Key result
Larger LAA device sizing shows no benefit over smaller sizing for cardiovascular mortality and stroke.
Why the study?
In left atrial appendage closure using newer-generation WATCHMAN FLX/FLX Pro devices, managing borderline-sized LAA within overlapping zones is common, but optimal device sizing strategies remain unknown.
Does a larger device sizing strategy improve clinical outcomes and reduce device-related complications compared to a smaller sizing strategy in patients undergoing LAAC for borderline-sized LAA?
Cohort (n=91)
No
Does a larger device sizing strategy improve clinical outcomes and reduce device-related complications compared to a smaller sizing strategy in patients undergoing LAAC for borderline-sized LAA?
Hazard Ratio: 0.372 (95% CI 0.074–2.65)
Absolute Event Rate: 3.6% vs 8.3%
p-value: p=0.334
In patients with borderline-sized LAA undergoing closure, a larger device sizing strategy yields similar clinical outcomes but significantly reduces the risk of significant peridevice leak and device-related thrombus compared to a smaller sizing strategy.
Optimal sizing for borderline LAA remains unclear; leaves open whether smaller or larger WATCHMAN FLX devices improve outcomes.
BACKGROUND: In left atrial appendage closure (LAAC) using newer-generation WATCHMAN FLX/FLX Pro devices, managing borderline-sized LAA within overlapping zones is common, but optimal device sizing strategies remain unknown. AIMS: To compare clinical outcomes and device-related complications between smaller and larger device sizing strategies for borderline-sized LAA. METHODS: This single-center retrospective study evaluated 91 patients undergoing newer-generation WATCHMAN implantation for borderline-sized LAA between September 2021 and June 2024. Follow-up imaging (transesophageal echocardiography and/or cardiac computed tomography angiography) was performed 45-120 days post-LAAC, and one-year clinical outcomes were assessed. RESULTS: Patients were divided into smaller (n = 36) and larger (n = 55) device groups. The composite primary endpoint (cardiovascular mortality and ischemic stroke) was similar between groups (8.3% vs. 3.6%; hazard ratio [HR], 0.372; 95% CI: 0.074-2.650, p = 0.334). However, the secondary efficacy endpoint-peridevice leak (PDL) 〉3 mm and/or device-related thrombus (DRT)-was significantly higher in the smaller device group at initial follow-up, even after covariate adjustment (13.9% vs. 1.8%; HR, 0.091; 95% CI: 0.009-0.887, p = 0.039). Similar findings were observed at one year. CONCLUSION: For borderline-sized LAA treated with newer-generation WATCHMAN devices, smaller and larger sizing strategies yielded similar one-year clinical outcomes. However, the larger device strategy showed a lower incidence of PDL >3 mm and/or DRT.
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Fukutomi et al. (2026) conducted a cohort in Borderline-sized left atrial appendage (n=91). Larger device sizing strategy vs. Smaller device sizing strategy was evaluated on Composite of cardiovascular mortality and ischemic stroke (HR 0.372, 95% CI 0.074-2.650, p=0.334). A larger device sizing strategy for borderline-sized left atrial appendages yielded similar one-year cardiovascular mortality and ischemic stroke compared to a smaller strategy (3.6% vs 8.3%; P=0.334).
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