Clinical frailty scale and clinical outcomes after left atrial appendage closure: Insights from the OCEAN-LAAC registry

Background Anticoagulants are prescribed less frequently in older patients with atrial fibrillation (AF) because of concerns regarding bleeding risk, despite their high thromboembolism risk. Frailty assessed using the Clinical Frailty Scale (CFS) provides incremental risk stratification for mortality and bleeding after left atrial appendage closure (LAAC); however, its clinical implications remain unclear. Objective To evaluate the impact of frailty, assessed using the CFS, on clinical outcomes and postprocedural antithrombotic management following LAAC. Methods The OCEAN-LAAC registry included 1,409 patients who underwent LAAC. Patients were stratified by CFS into groups 1–3 and 4–8. The primary outcome was all-cause mortality at 1 year. Secondary outcomes included non-procedural major bleeding, ischemic stroke, device-related thrombi, and peri-procedural complications. Results Frailty (CFS 4–8) was present in 32.9% of patients. At 1 year, frail patients had higher mortality rates than nonfrail patients (10.3% vs 3.0%). After multivariable adjustment, frailty was independently associated with mortality (hazard ratio [HR] 3.23, 95% confidence interval [CI], 1.92–5.46). Frailty was also associated with non-procedural major bleeding in the competing risk analysis (subdistribution HR 2.13, 95% CI 1.14–3.96). Despite more frequent de-escalation of antithrombotic therapy in frail patients, rates of ischemic stroke and device-related thrombosis did not differ significantly across frailty groups. Conclusion Frailty assessed using the CFS identifies patients at increased risk of mortality and bleeding after LAAC and may provide incremental risk stratification to guide individualized postprocedural management. Clinical trial registration number OCEAN-LAAC registry (UMIN ID: UMIN000038498)