Frailty in Patients Undergoing Percutaneous Left Atrial Appendage Closure. The Frail-LAAC Study.

BACKGROUND The prevalence and impact of frailty in patients undergoing left atrial appendage closure (LAAC) remains unknow. OBJECTIVE To evaluate the prevalence and prognostic implications of frailty in patients undergoing LAAC. METHODS The Frail-LAAC trial was an international, multicenter, prospective study that included consecutive patients undergoing LAAC in four University centers (2022-2024). Frailty was assessed pre-procedurally using the Essential Frailty Toolset (EFT) and defined as an EFT score ≥ 3 (and pre-frail as an EFT=1-2). Clinical outcomes were evaluated at follow-up. RESULTS A total of 452 consecutive patients were included (mean age: 76±8 years; 34% of women), and frailty was identified in 101 (22.4%) of them. Frail patients were older, more commonly female, and had a higher comorbidity burden. Device success (99.6%) and procedural success (97.3%) were high across all groups, without differences in procedural-related complications. After a median follow-up of 12 (4-22) months, frail patients had a higher risk of all-cause mortality or ischemic events compared to non-frail patients 36.6% vs. 9.4%; adjusted HR = 4.85 (95% CI: 2.85-8.24); p<0.001, primarily driven by an increased mortality risk (33.7% vs. 7.7%; adjusted HR = 5.28 95% CI: 2.94-9.46; p<0.001). In contrast, pre-frailty was not associated with mortality compared to robust patients adjusted HR = 2.87 (95% CI: 0.83-9.98), p = 0.115. The inclusion of frailty in predictive models significantly improved mortality risk stratification. CONCLUSIONS Frailty is common in patients undergoing LAAC and is associated with a five-fold increased mortality risk. Incorporating frailty assessment into pre-procedural evaluations enhance risk stratification, highlighting the need for careful patient selection, particularly in those with advanced frailty, to optimize outcomes and avoid futile interventions.