Efficacy and safety of Proglide use and early discharge after atrial fibrillation ablation compared to standard approach. PROFA trial.

Background And Objectives: The common practice after atrial fibrillation ablation is to admit patients for an overnight stay. The aim of this study was to compare a strategy of vascular suture mediated closure system utilization and early discharge (strategy A) compared to traditional closure and overnight hospitalization (strategy B) regarding feasibility, safety, quality of life and health care cost effectiveness.

Methods And Results: Hundred patients were randomized to compare both strategies. No clinical differences were reported except diabetes mellitus. Six patients (6%) had and emergency visit or were admitted in the first 30 days after procedure. Three occurred in strategy A versus three in strategy B (p = 1) (p < .005 for non-inferiority). Forty out of 50 patients (80%) were safely discharged in a time frame of 3 h and 42 patients (84%) were discharged in the same day of the procedure in strategy A. Time to discharge was shorter in strategy A compared to strategy B. (5.89 ± 7.47 h vs. 27.09 ± 2.29 p < .005). No differences were obtained in quality-of-life outcomes. Mean (95% CI) euros cost saving per patient in strategy A was 379.16 ± 93.55 p < .001. Ten acute complications (10% patients CI 95% 4.02%-15.98%) were reported during the trial. Seven (14% CI 95% 4.04%-23.96%) occurred in strategy A patients versus 3 (6% CI 95% 0.8%-12.8%) in strategy B. (p = .182) CONCLUSION: A strategy of vascular suture mediated closure system utilization and early discharge was feasible, reduced time to discharge, saved costs and was not associated with more complications or admissions/emergency visits in a 30-day time frame after procedure compared to a strategy of regular admission and discharge after overnight stay. There were no differences regarding quality-of-life parameters between both strategies.