Utilization and Clinical Outcomes of Left Atrial Appendage Occlusion in Older Adults with Atrial Fibrillation and Frailty

PROJECT SUMMARY One in every 3 persons develops atrial fibrillation (AF) in their lifetime, and AF affects at least 10% of adults aged ≥65 years. Stroke prophylaxis with oral anticoagulants (OAC) is recommended, but half of older adults who are eligible for OAC are not treated because of concerns for major bleeding. Treatment with OAC is even less frequent in adults with frailty, who have excess risk for major bleeding but also for ischemic stroke. To reduce AF risks in vulnerable populations, left atrial appendage occlusion (LAAO) was approved by Centers for Medicare & Medicaid Services (CMS) and is recommended by practice guidelines to provide AF stroke prevention for individuals deemed unsafe for long-term OAC. However, given its short-term procedural complications and life- long requirement for antiplatelet therapy, the overall benefit of LAAO among adults with frailty is unknown. In fact, because LAAO’s efficacy and safety were established against OAC in randomized controlled trials (RCT) of OAC-eligible patients, LAAO’s effectiveness and safety remain uncertain for the population most likely to benefit—patients with frailty or OAC ineligibility—resulting in a critical evidence-practice gap. The long-term goal of our AF Outcomes Research program is to improve evidence-based, patient-centered care for older adults with AF. To this end, our current objective is to evaluate utilization and outcomes of LAAO compared to therapeutic alternatives in older adults with frailty. We will utilize multiple real-world data sources and apply advanced causal inference methods to enhance generalizability and the validity of inference. In Aim 1 we will determine characteristics of older adults who received LAAO and characterize concordance of LAAO use with CMS approved and guideline recommended indication. In Aims 2 and 3 we will determine effectiveness, safety, and net benefit (home time) of LAAO compared to OAC and no OAC, respectively. In absence of RCTs, the proposed research will be the main source of evidence for guiding rational use of LAAO in vulnerable populations.