低リスク心房細動患者における左心耳閉鎖デバイス留置術の比較転帰

Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA₂DS₂-VASc score ≥2 for stroke prevention. However, Centers for Medicare & Medicaid Services (CMS) reimburses left atrial appendage occlusion (LAAO) for patients with CHA₂DS₂-VASc score ≥3. This study aimed to evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA₂DS₂-VASc score of ≥ 3 versus < 3.

National Inpatient Sample (NIS) and International Classification of Diseases, Tenth Revision codes were used to identify LAAO device implantation in the U.S. from years 2016 to 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 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).

Patients with CHA₂DS₂-VASc < 3 had lower complications and hospitalization costs after LAAO device implantation. These data, if redemonstrated in a large randomized trial, can have important clinical implications for stroke prevention in AF patients.