Abstract Body (Do not enter title and authors here): Introduction: Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA₂DS₂-VASc score ≥ 2 for stroke prevention. Left atrial appendage occlusion (LAAO) devices serve as alternatives to reduce stroke risk in select AF patients that are unable to tolerate long-term oral anticoagulation. However, Centers for Medicare & Medicaid Services reimburses left atrial appendage occlusion (LAAO) for patients with CHA₂DS₂-VASc score ≥ 3.
Objective: To evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA₂DS₂-VASc score of ≥ 3 versus < 3.
Methods: National Inpatient Sample and International Classification of Diseases, 10th Revision codes were used to identify AF patients who underwent LAAO device implantation in the U.S. from 2016−2020. The study population was stratified by stroke risk into two groups, CHA₂DS₂-VASc ≥ 3 and < 3. Study endpoints assessed included procedural complications, inpatient outcomes and resource utilization. A multivariable logistic regression model was used to assess the independent association of CHA₂DS₂-VASc score with study outcomes.
Results: A total of 73,795 and 15,500 LAAO devices were implanted in patients with CHA₂DS₂-VASc ≥ 3 and < 3, respectively. Compared to patients with CHA₂DS₂-VASc score of ≥ 3, patients with CHA₂DS₂-VASc < 3 had lower overall (6.9% vs 9.9%, P< 0.01) and major (4.5% vs 6.2%, P< 0.01) complications in the crude analysis. After multivariable adjustment for potential confounders, CHA₂DS₂-VASc < 3 was associated with lower overall complications (aOR 0.84, 95% CI 0.78 – 0.91), major complications (aOR 0.90, 95% CI 0.81-0.99) and cost of hospitalization (aOR 0.95, 95% CI 0.91-0.99).
Conclusions: Patients with CHA₂DS₂-VASc < 3 had lower complications and hospitalization costs after LAAO device implantation than patients with CHA₂DS₂-VASc ≥ 3 . These data, if redemonstrated in a large randomized trial can have important clinical implications for stroke prevention in AF patients.