Safety and efficacy of PathBuilderTM transseptal puncture system for atrial fibrillation therapy: a multicenter prospective controlled clinical trial

Objective To evaluate the safety and efficacy of the PathBuilder™ transseptal puncture system for catheter ablation of patients with atrial fibrillation. Methods From August 2015 to March 2016, 70 patients(46 in male, 24 in female)with AF in 3 centers (Shenyang Northern Hospital, The First Affiliated Hospital of Dalian Medical University, Shanghai General Hospital) were enrolled in this multicenter prospective controlled trial. Both PathBuilder™ system and imported standard system were applied in each patient for transseptal puncture and catheter ablation. Procedure time, puncture time, transseptal puncture success rate, experimental product evaluation and postoperative adverse events after 2 days to discharge were recorded. Results The average procedure time, puncture time and fluoroscopy time of 70 cases with catheter ablation therapy were (171.9±1.4) min, (4.3±0.7) min, and (23.5±1.3) min, respectively.Seventy cases of AF ablation were successfully completed using PathBuilder™ transseptal puncture system and the imported standard transseptal system. The success rate of transseptal puncture was 100%. Circular pulmonary vein diagnostic catheter and radiofrequency ablation catheter passed through the PathBuilder™ introducer and reached the expected positions with a success rate of 100%. Patients before discharge had no incidence of adverse events related to the transseptal puncture system. Physicians were satisfied with the performances of introducer, dilator, guiding wire and needle. Conclusion PathBuilder™ transseptal puncture system is safe and effective for catheter ablation of atrial fibrillation. Key words: Atrial fibrillation; Atrial septum; Catheter ablation