Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States.

OBJECTIVES: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States. BACKGROUND: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported. METHODS: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates. RESULTS: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA2DS2-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure. CONCLUSIONS: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.

Atrial fibrillation ablation leads to long-term improvement of quality of life and reduced utilization of healthcare resources.

In some patients, rapid activation from one or several foci can lead to atrial fibrillation. This study evaluated long-term changes in quality of life and healthcare resource utilization in patients with atrial fibrillation treated by ablation of focal triggers. Thirty-three patients underwent ablation for paroxysmal atrial fibrillation. Health surveys (SF-36) were obtained at baseline, and after 1 year and 3 years of follow-up. Health care costs were measured for the 3 years before and after ablation. Ablation was successful in 82%, partially successful in 12% (no sustained episodes but on antiarrhythmic drug therapy), and unsuccessful in 6% of patients. The average number of ablation procedures was 1.6 +/- 0.6 per patient. After ablation, patients reported significantly improved quality of life in all SF-36 categories except bodily pain. Healthcare resource utilization was significantly reduced after ablation (Clinic visits: 7.4 +/- 2.5 per year vs. 1.1 +/- 0.6 per year, p < 0.05; Emergency room visits: 1.7 +/- 0.90 per year vs. 0.03 +/- 0.17 per year, p < 0.05; Hospitalization: 1.6 +/- 0.81 vs. 0, p < 0.05). Cost of healthcare (not including procedural costs) was significantly reduced after ablation (Pre-ablation: 1,920 +/- 889 dollars/year vs. post-ablation: 87 +/- 68 dollars/year; p < 0.01). Procedural cost of ablation was 17,173 +/- 2,466 dollars/patient. Ablation of focal triggers of atrial fibrillation is associated with a sustained improvement in quality of life. Although the initial cost of ablation is high, after ablation, utilization of healthcare resources is significantly reduced.