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Updated: Jan 17, 2026
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Vascular Closure Device Following Pulsed Field Ablation for Atrial Fibrillation: A Randomized Controlled Trial
Alexander Dashwood1, Francis J Ha1,2, Stewart Healy1
1Victorian Heart Hospital, Melbourne, Australia.
Insights
Vascular closure devices (VCDs) with Prostyle significantly reduced ambulation time and minor bleeding after pulsed field ablation (PFA) for atrial fibrillation (AF). This improves patient recovery and safety following the procedure.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Surgery
Background:
- Atrial fibrillation (AF) ablation frequently uses large-diameter catheters, complicating post-procedure hemostasis and patient discharge.
- The efficacy of Perclose Prostyle vascular closure device (VCD) for improving ambulation time and reducing vascular access complications in patients undergoing pulsed field ablation (PFA) remains unclear.
Purpose of the Study:
- To evaluate the impact of the Perclose Prostyle VCD compared to figure-of-eight sutures (FO8) on time to ambulation.
- To assess vascular access complications, including bleeding, in patients undergoing PFA for AF.
Main Methods:
- A single-center, open-label, randomized controlled trial comparing Prostyle VCD to FO8 closure in patients undergoing PFA for AF with 16.8F sheaths.
- The primary endpoint was time to ambulation; secondary endpoints included peri-procedural adverse events. Ultrasound guidance was used for all procedures.
- Sixty patients were randomized (30 per group), with follow-up up to two weeks.
Main Results:
- Time to ambulation was significantly shorter in the VCD group (215 ± 113 min) versus the FO8 group (338 ± 71 min; p < 0.001).
- No major peri-procedural adverse events occurred in either group. Minor bleeding was significantly reduced with VCD (0%) compared to FO8 (27%; p = 0.005).
- Manual compression rates were numerically lower in the VCD group (10%) compared to FO8 (33%; p = 0.057).
Conclusions:
- Perclose Prostyle VCD significantly reduces time to ambulation post-PFA for AF.
- VCD use also leads to a significant reduction in minor bleeding complications compared to standard figure-of-eight suture closure.
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.
