Unilateral versus Bilateral Groin Puncture for Atrial Fibrillation Ablation: Multi-Center Prospective Randomized Study

Abstract

Purpose: Catheter ablation for atrial fibrillation (AF) requires heavy anticoagulation and uncomfortable post-procedural hemostasis. We compared patient satisfaction with and the safety of unilateral groin (UG) puncture-single trans-septal (ST) ablation with conventional bilateral groin (BG) puncture-double trans-septal (DT) ablation in paroxysmal AF patients. Materials and Methods: We enrolled 222 patients with paroxysmal AF (59.4 +/- 10.7 years old) who were randomized in a 2: 1 manner into UG-ST ablation (n=148) and BG-DT ablation (n=74) groups. If circumferential pulmonary vein isolation could not be achieved after three attempts of touch-up ablation in the UG-ST group, the patient was crossed over to BG-DT by performing a left groin puncture. Results: Ten patients in the UG-ST group (6.8%) required crossover to the BG-DT approach. There were no significant differences in procedure time (p=0.144) and major complications rate (p>0.999) between the UG-ST and BG-DT groups. Access site pain (p=0.014), back pain (p=0.023), and total pain (p=0.015) scores were significantly lower for the UG-ST than BG-DT group as assessed by the Visual Analog Scale. Over 20.2 +/- 8.7 months of follow up, there was no difference in AF recurrence free-survival rates between the two groups (Log rank, p=0.984). Conclusion: UG-ST AF ablation is feasible and safe, and was found to significantly reduce post-procedural hemostasis-related discomfort, compared to the conventional DT approach, in patients with paroxysmal AF.