Vascular Closure Device Following Pulsed Field Ablation for Atrial Fibrillation: A Randomized Controlled Trial.

Abstract

Introduction: Atrial fibrillation (AF) ablation often involves large-diameter catheters, posing challenges for post-procedure hemostasis and discharge. The impact of Perclose Prostyle vascular closure device (VCD) on time to ambulation and vascular access complications in patients undergoing pulsed field ablation (PFA) is uncertain.

Methods: Patients undergoing PFA for AF with 16.8 French (F) sheaths were randomly assigned in a 1:1 ratio to Prostyle (Abbott Vascular, USA) or standard closure with a figure-of-eight suture (FO8) at a single center in an open-label design. A maximum of three VCDs were allowed. Pre-closure was achieved with deployment at 2 and 10 o'clock positions and a final Prostyle secured the second 6F short sheath. Ultrasound guidance was used in all patients. The primary end point was time to ambulation post-procedure. Secondary end points included major and minor periprocedural adverse events. Follow-up occurred up to 2 weeks post-procedure.

Results: Sixty patients were randomized to undergo VCD (30 patients) or F08 suture (30 patients). There were no significant differences in baseline characteristics between groups. Time to ambulation was significantly reduced (215 ± 113 min) in the VCD group compared with the FO8 group (338 ± 71 min; p < 0.001). There were no major peri-procedural adverse events in either group. Rate of minor bleeding was significantly increased in the FO8 group (27%; 8/30) compared with none in the VCD group ((0%; 0/30; p = 0.005)). Rate of manual compression was numerically higher in the FO8 group (33%; 10/30) compared with the VCD group (10%; 3/30; p = 0.057). There were no differences in acute pain score, confidence in walking, overall patient satisfaction, or overall nurse satisfaction between groups.

Conclusion: In this randomized controlled trial, VCD with Prostyle reduced time to ambulation and reduced minor bleeding in patients undergoing PFA for AF.