Comparative Clinical and Procedural Outcomes Among Three Pulsed Field Ablation Systems for Atrial Fibrillation: A Prospective Real-World Study

T. Chiba (Berlin)¹, R. Wakili (Frankfurt am Main)², L. Rottner (Frankfurt am Main)², D. Leistner (Frankfurt am Main)², E. Roth (Frankfurt am Main)², C. Baldauf (Berlin)³, C. Benachi (Berlin)⁴, P. Formum (Berlin)⁵, P. Wienke (Berlin)⁶, P. Nagel (Berlin)⁷, J. Lucas (Berlin)⁶, M. Huemer (Berlin)⁷, U. Landmesser (Berlin)⁸, N. Dagres (Berlin)⁹, F. Hohendanner (Berlin)¹⁰, G. Hindricks (Berlin)¹¹, R. Hättasch (Berlin)⁶, P. Attanasio (Berlin)⁷, V. Tscholl (Berlin)^10
1Deutsches Herzzentrum der Charité Berlin, Deutschland; ²Universitätsklinikum Frankfurt Med. Klinik III - Kardiologie, Angiologie Frankfurt am Main, Deutschland; ³Charité - Universitätsmedizin Berlin Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland; ⁴Deutsches Herzzentrum der Charité Rhythmologie Berlin, Deutschland; ⁵Charité Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland; ⁶Berlin, Deutschland; ⁷Charité - Universitätsmedizin Berlin CC 11: Med. Klinik für Kardiologie Berlin, Deutschland; ⁸Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland; ⁹Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin, Campus Charité Mitte Berlin, Deutschland; ¹⁰Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin | CBF Berlin, Deutschland; ¹¹Charité - Universitätsmedizin Berlin CC11: Med. Klinik m. S. Kardiologie und Angiologie Berlin, Deutschland

Background
Pulsed field ablation (PFA) is an innovative for the treatment of atrial fibrillation (AF). Although several PFA technologies are now available, real-world and comparative data on their safety and efficacy remain limited. This study aimed to compare outcomes between 3 PFA systems in a real-world cohort.

Methods
Consecutive patients undergoing their first pulmonary vein isolation (PVI) using the circular multielectrode array catheter (CMAC)(PulseSelect), the variable-loop circular catheter (VLCC)(Varipulse) or the lattice-tip catheter (LTC)(Affera) were included. CMAC and VLCC procedures were performed at Deutsches Herzzentrum der Charité, whereas LTC procedures included patients treated at both Deutsches Herzzentrum der Charité and Frankfurt University Hospital. Freedom from any atrial arrhythmia (AA) was evaluated using 12-lead electrocardiography and 24-hour Holter at 3, 6 and 12 months.

Results
A total of 198 patients (CMAC:91, VLCC:50, LTC: 57) were included. Acute PVI was achieved in all patients (median age, 68 years; 64.1% male; paroxysmal AF, 49.0%). Procedure duration was significantly longest in the LTC group (CMAC; 67.0 [56, 79], VLCC; 53.5 [40, 59.5], LTC; 78 [69.0, 88.0] minutes, p< 0.01). Fluoroscopy time was significantly longest in the CMAC group. During a mean follow-up of 352.4±207.2 days, the estimated 12-month freedom from atrial arrhythmia recurrence beyond the 8-week blanking period was comparable among the CMAC, VLCC, and LTC groups (76.9%, 71.6%, and 78.8%, respectively; log-rank p = 0.46). In multivariable Cox proportional hazards regression analysis, the PFA system was not independently associated with AA recurrence. Within each group, no significant difference was observed between paroxysmal and persistent AF. One major complication (0.51%, one ischemic stroke (CMAC)) occurred with no difference among groups (P=1.00).

Conclusion
In this prospective real-world study, PVI using the CMAC, VLCC, and LTC systems showed comparable clinical outcomes in patients with paroxysmal or persistent AF. No significant differences were observed among the three PFA systems in AA recurrence or major complication rates.