Focal lattice tip catheter toggling between pulsed field energy and radiofrequency vs. high power short duration for pulmonary vein isolation: a multicentre study
G Vetta, A Almorad, J Lyne, J Rodriguez, V Maslova, I Doundoulakis, R Scacciavillani, G Pelargonio, L Evgeny, M Efremidis, S Boveda, A Sarkozy, C De Asmundis, G B Chierchia, D G Della RoccaAbstract
Introduction
A novel focal lattice tip catheter allowing the delivery of either pulsed field (PF) or radiofrequency (RF) energy has recently received regulatory approval. The technology features a proprietary 3D electroanatomical mapping system. Our aim was to compare the acute procedural outcomes between focal 9-mm lattice tip catheter (LT) and High-Power Short-Duration radiofrequency ablation (HPSD).
Methods
Consecutive AF patients undergoing first-time pulmonary vein isolation (PVI) with the LT or HPSD in six different centres between August and June 2024 were prospectively included. In the Sphere-9 arm PVI was performed with PFA on the posterior wall and anteriorly with radiofrequency or PFA at the operator's discretion. In the HPSD arm PVI was performed anteriorly with 50W /550 ablation index and posteriorly with 40W or 50W/ 400 ablation index. Primary endpoints were acute procedural success, PVI time and first pass isolation. Primary safety endpoint included major complications occurring within 7 days post-ablation.
Results
358 patients (mean age: 64.9 ± 9.5 years; 66.7% males) were enrolled (142 Affera, 216 HPSD). The primary efficacy endpoint was achieved in 100% of patients in both groups. Sphere-9 significantly reduced PVI time compared to HPSD ( 25 min vs 31 min; p=0.003). First-pass PV isolation was higher in the Sphere-9 group on patient basis (97.2% vs 82.9%; p<0.0001) and per PV (99.3% vs 93.6%; p<0.0001) compared to HPSD. No differences were reported for major complications (0% vs 0.5%; p=0.42) and overall complications (1.4% vs 0.9%; p=0.67) between LT and HPSD. Sphere-9 significantly reduced procedural time (60 min vs 88 min; p<0.001), dwelling time (41 min vs 66 min; p<0.001) and fluoroscopy time ( 4 min vs 6 min; p=0.04) compared to HPSD (Figure 1). No significant differences were observed at the 1-year follow-up between LT and HPSD in terms of survival for atrial tachyarrhythmia (86.2% vs. 85.5%; p = 0.82) and AF (90.7% vs. 88%; p = 0.49) (Figure 2).
Conclusions
LT proved to significantly reduce PVI, procedure, dwelling and fluoroscopy time compared to HPSD ensuring a higher rate of first pass isolation. No significant differences were observed at the 1-year follow-up between LT and HPSD in terms of survival for atrial tachyarrhythmia and AF.Figure 1Figure 2