Safety and efficiency of direct transseptal puncture using an RF needle and large-bore sheath during PFA-PVI with a penta-spline catheter

Background Transseptal puncture (TSP) is a critical step in pulmonary vein isolation (PVI) performed with pulsed field ablation (PFA) using a penta-spline catheter. A standardized workflow employing direct TSP with a radiofrequency (RF) needle through a large-bore sheath may enhance procedural safety and efficiency. This study evaluated the feasibility, safety, and performance of this approach in a real- world clinical setting. Methods A total of 108 consecutive patients undergoing PFA-PVI were prospectively analyzed. All patients underwent first-time PVI with no prior ablation procedures. Direct TSP was performed using an RF needle via a large-bore sheath. Procedural parameters, time to TSP, left atrial dwell time, the need for RF energy delivery through the needle, and procedure-related complications were recorded. PFA applications were delivered in both flower and basket configurations. The median total number of PFA applications per procedure was 48 (range 32–64), distributed across both configurations. Results The mean patient age was 64 ± 12 years, and 41.7% were female. Paroxysmal AF was present in 64.8% of patients, persistent AF in 29.6%, and long-standing persistent AF in 5.6%. The mean procedure duration was 46 ± 12 min, with a TSP time of 15 ± 5 min and a left atrial dwell time of 30.4 ± 10.2 min. Mean fluoroscopy time was 13 ± 5 min, corresponding to a radiation dose of 637 ± 450 Gy·cm². RF energy was applied in 48.1% of procedures. Subgroup analysis (RF applied vs. not applied) revealed no significant differences in TSP time (p = 0.77) or fluoroscopy time (p = 0.14), but a significantly lower radiation dose when RF energy was used (p = 0.005). The overall complication rate was 1.9% (one pericardial tamponade, one stroke). No deaths, atrioesophageal fistulas, or permanent phrenic nerve palsies occurred. Conclusion A standardized direct TSP workflow using an RF needle and a large-bore sheath during PFA-PVI was safe and efficient, allowing short procedure times, reduced radiation exposure, and a very low complication rate. Larger multicenter studies are needed to confirm these findings and evaluate their generalizability across operators and centers.