Key result
Focal lattice tip matches HPSD with 100% success, reducing PVI time and improving first-pass isolation.
Why the study?
A novel focal lattice tip catheter allowing delivery of pulsed field or radiofrequency energy received regulatory approval, but its acute procedural outcomes compared with high-power short-duration radiofrequency ablation were unproven.
Does a focal lattice tip catheter toggling between pulsed field energy and radiofrequency improve procedural outcomes compared to high-power short-duration radiofrequency for first-time pulmonary vein isolation in AF patients?
Cohort (n=358)
Yes
Does a focal lattice tip catheter toggling between pulsed field energy and radiofrequency improve procedural outcomes compared to high-power short-duration radiofrequency for first-time pulmonary vein isolation in AF patients?
Absolute Event Rate: 100% vs 100%
The novel focal lattice tip catheter significantly reduced PVI and procedural times and improved first-pass isolation rates compared to HPSD radiofrequency, with comparable safety and 1-year efficacy.
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
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Vetta et al. (2026) conducted a cohort in Atrial fibrillation (n=358). Focal 9-mm lattice tip catheter (Sphere-9) vs. High-Power Short-Duration radiofrequency ablation (HPSD) was evaluated on Acute procedural success. The focal lattice tip catheter achieved 100% acute procedural success, matching HPSD, while significantly reducing PVI time (25 vs 31 min, p=0.003) and improving first-pass isolation (p<0.0001).
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