A dual-energy lattice-tip ablation system reduced ablation times vs conventional RF (p<0.0001), with a trend toward higher 12-month effectiveness for PVI plus linear lesions vs PVI alone (p=0.07).
RCT (n=360)
Does a dual-energy lattice-tip mapping and ablation system improve linear lesion characteristics and effectiveness compared to conventional RF ablation in patients with persistent atrial fibrillation?
A novel dual-energy lattice-tip catheter significantly reduced ablation times for linear lesions in persistent AF, with exploratory data suggesting potential efficacy benefits of adding linear lesions to PVI.
p-value: p=0.07
BACKGROUND Among patients with persistent atrial fibrillation (PerAF), linear ablation lesions beyond pulmonary vein isolation (PVI) are often performed with variable efficacy and inconsistent added value. New catheter designs and energy sources have the potential to improve outcomes. OBJECTIVE To examine: 1) the performance of a novel dual-energy (pulsed field PF /radiofrequency RF) lattice-tip mapping and ablation system for linear ablation, and 2) the impact of the ablation strategy on outcomes in the randomized SPHERE Per-AF trial. METHODS Linear lesion characteristics, safety, and effectiveness were assessed for a conventional RF ablation system in the control arm vs. the dual-energy lattice-tip system in the investigational arm. RESULTS In the investigational arm, 203 (95.8%) received left atrial roof and/or posterior wall isolation (LAPWI), 117 (55.2%) cavotricuspid isthmus (CTI) line, and 76 (35.8%) mitral line. In the control arm, 102 (68.9%) patients received LAPWI, 76 (51.4%) CTI, and 19 (12.8%) mitral line ablation. Transpired ablation and energy application times were shorter for each lesion type using the investigational vs. control catheter (all p<0.0001). Overall, there was a trend towards numerically higher 12-month effectiveness of a "PVI + all linear lesions combined" (n=25) approach compared to a PVI-only (n=56) ablation strategy (p=0.07), and the effect was more pronounced in the investigational arm, but sub-groups were small. CONCLUSION There was a trend towards numerically higher effectiveness with linear lesions vs. PVI-alone. These findings are exploratory and hypothesis-generating and should prompt future randomized controlled trials of additional lesion sets vs. PVI with this new technology. CLINICAL TRIAL REGISTRATION NCT05120193- Treatment of Persistent Atrial Fibrillation with Sphere-9 and Affera Mapping and Ablation System (SPHERE Per-AF).
Mansour et al. (Sun,) conducted a rct in Persistent atrial fibrillation (PerAF) (n=360). Dual-energy (pulsed field/radiofrequency) lattice-tip mapping and ablation system vs. Conventional radiofrequency (RF) ablation system was evaluated on 12-month effectiveness of PVI + all linear lesions combined vs PVI-only (p=0.07). A dual-energy lattice-tip ablation system reduced ablation times vs conventional RF (p<0.0001), with a trend toward higher 12-month effectiveness for PVI plus linear lesions vs PVI alone (p=0.07).