Key result
Tissue proximity-guided pulsed field ablation achieves 93% first-pass PVI with rare vascular complications.
Why the study?
The VARIPULSE catheter was recently introduced in Japan for pulsed field ablation in AF, but multicenter real-world data remained scarce.
Does tissue proximity indication-guided pulsed field ablation provide procedural safety and efficacy in patients with atrial fibrillation undergoing initial pulmonary vein isolation?
Cohort (n=387)
Yes
Does tissue proximity indication-guided pulsed field ablation provide procedural safety and efficacy in patients with atrial fibrillation undergoing initial pulmonary vein isolation?
Tissue proximity indication-guided pulsed field ablation using the VARIPULSE catheter is safe and highly effective for initial pulmonary vein isolation in a real-world multicenter setting.
Answers are grounded in this paper and cite their sources.
Supports real-world use of proximity-guided PFA for initial PVI; hypothesis-generating and requires randomized confirmation.
BACKGROUND Pulsed field ablation (PFA) is a novel therapy for atrial fibrillation (AF) with myocardial selectivity and safety.The VARIPULSE catheter (variable-loop circular catheter [VLCC]; Biosense Webster, Inc.) was recently introduced in Japan, but multicenter real-world data remain scarce. OBJECTIVEThis study aimed to evaluate procedural features, acute safety, and early outcomes of tissue proximity indication (TPI)guided PFA under structured training and standardized protocols. METHODSWe retrospectively analyzed 387 consecutive patients with AF (66.4 6 10.9 years, 69% male, 87.1% paroxysmal) undergoing initial pulmonary vein isolation (PVI) with the VLCC at 10 Japanese centers (April 2024-May 2025).TPI-guided first-pass PVI targeted 12 applications per vein in 4 sets (proximal/distal), with additional ablation at TPI-negative sites.Operators received training and followed a harmonized workflow emphasizing TPI guidance and sheath management. RESULTSFirst-pass PVI was achieved in 360 patients (93.0%).After limited touch-up (6.9 6 3.6 applications), complete PVI was obtained in all.Mean PVI time was 32.1 minutes, procedure duration 89.7 minutes, and median fluoroscopy time 3.0 minutes.Three patients (0.8%) had vascular complications; no tamponade, stroke, transient ischemic attack, or renal injury occurred.Predictors of first-pass failure were higher body mass index and lack of pre-mapping, mainly in early cases, declining from 11.4% to 3.0% (P , .001).At median follow-up of 182 days, arrhythmiafree survival was 94.1% at 3 months and 88.5% at 6 months.CONCLUSION In this first multicenter real-world study, TPIguided PFA with the VLCC demonstrated high acute efficacy, no clinical strokes or TIAs, low complication rates, and favorable mid-term outcomes with structured training and standardized protocols.
No takes yet. Share an insight, caveat, or question.
Sawada et al. (2025) conducted a cohort in Atrial fibrillation (n=387). Tissue proximity indication (TPI)-guided pulsed field ablation (PFA) with VARIPULSE catheter was evaluated on First-pass pulmonary vein isolation (PVI). Tissue proximity indication-guided pulsed field ablation achieved first-pass pulmonary vein isolation in 93.0% of patients, with a 0.8% vascular complication rate and no strokes.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: