線維性心房細動におけるデュアルエネルギー・ワイドフットプリントカテーテルを用いた線状アブレーションの影響 - SPHERE Per-AF無作為化試験からの解析

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.

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.

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.

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.

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.

NCT05120193- Treatment of Persistent Atrial Fibrillation with Sphere-9 and Affera Mapping and Ablation System (SPHERE Per-AF).