First multicenter experience of pulmonary vein and posterior wall isolation via a novel focal 9mm lattice tip catheter in a real-world scenario

Abstract

Abstract Background Pulsed field ablation (PFA) is an innovative technology recently adopted for the treatment of atrial fibrillation (AF). Preclinical and clinical studies have reported a remarkable safety profile, as a result of its tissue specific effect targeting cardiomyocytes and sparing adjacent tissues. The AfferaTM system is a focal 9-mm lattice tip catheter that has recently received regulatory approval. No data currently exist on the feasibility of this technology for first-time pulmonary vein isolation (PVI) and posterior wall isolation (PWI) in a real-world scenario. Objective To evaluate the safety and efficacy of the focal 9-mm lattice tip catheter Sphere-9 (Affera Inc) in a real-world population undergoing PVI and PWI. Methods Consecutive AF patients undergoing first-time PVI plus PWI with the AfferaTM system in two different centres between August and November 2023 were prospectively included. PFA was always used to ablate the posterior left atrium, whereas anterior applications were performed using either radiofrequency energy (RF/PF strategy) or PFA (PF/PF strategy) based on operator's discretion. Primary efficacy endpoint was acute procedural success (successful PVI with evidence of bidirectional block at the end of the procedure). Primary safety endpoint included major technology-related complications occurring within 7 days post-ablation. Secondary endpoints were first pass isolation, acute reconnection, overall complications, procedural, dwelling, and fluoroscopy time. Results Thirty consecutive patients [mean age: 68±6.8 years; 61.7% males; CHA2DS2-VASc Score 2.0 (1.5 – 3.5)] were included. Among them, 66.7% (n=20) had non-paroxysmal AF. PVI was performed with an RF/PF strategy or PF/PF one in 10 (33.3%) and 20 (66.7%) patients, respectively. Posterior wall isolation (PWI) was performed in 30 (100%) cases. The primary endpoint was achieved in 100% of patients for both PVI and PWI with average procedural time of 95 min (77-120 min), dwelling time of 78 min (55-92 min) and fluoroscopy time of 6 min (5-10.5 min) (Figure 1). No technology-related complications were observed. First-pass isolation occurred in 100% of PVI and PWI, with no acute reconnection for PW and 1 case of right PV reconnection in the RF/PF strategy group. Conclusions AF ablation with the focal 9-mm lattice tip catheter Sphere-9 confirmed high efficacy and safety in PVI + PW in a real-world population.Figure 1