Matsumoto Kazuo, van Bragt Kelly A, Kueffer Fred J, Mburu Waruiru, Tarakji Khaldoun G
Higashi Matsuyama Medical Associate Hospital, Saitama, Japan.
Cardiac Ablation Solutions, Medtronic GmbH, Meerbusch, Germany.
J Interv Card Electrophysiol. 2025 Sep 10. doi: 10.1007/s10840-025-02124-6.
Catheter ablation is beneficial in patients with symptomatic persistent atrial fibrillation (PerAF), and pulsed field ablation (PFA) is a promising energy source to safely and durably create ablation lesions. However, catheter-specific "PFA waveforms and designs" result in effectiveness and safety profiles that are not transferable to other PFA technologies. A head-to-head comparison between the dual-energy, wide-footprint lattice-tip (Sphere-9, Medtronic) and pentaspline PFA catheter (Farawave, Boston Scientific) is not yet available. Consequently, this study aims to perform an indirect treatment comparison (ITC).
Outcomes (efficacy, safety, and procedure times) between the SPHERE Per-AF trial (N = 212; NCT05120193) and ADVANTAGE AF trial (N = 260; NCT05443594) studies were compared using matched-adjusted indirect comparison (MAIC) methods. Matching was performed based on subjects' baseline characteristics.
After matching, SPHERE Per-AF showed a higher probability (OR 0.51 (95% CI:0.32 - 0.80), p = 0.003) of 12-month freedom from arrhythmias (77.4%) compared to ADVANTAGE AF (63.5%). There was no evidence of adjusted probability of a primary safety difference (OR 0.76 (95% CI:0.17 - 3.42), p = 0.72) between trials (1.8% vs. 2.3%, respectively). Adjusted procedure and pulmonary vein isolation time were comparable, but fluoroscopy time was significantly shorter in SPHERE Per-AF compared to ADVANTAGE AF (-14.4 min (95% CI:-16.2, -12.5); p < 0.01).
PFA is generally safe and efficient; however, in this ITC, SPHERE Per-AF showed a higher probability of treatment success in PerAF patients compared to ADVANTAGE AF. Overall, these results underline possible differences even amongst PFA systems, which must be validated in randomized trials. Until then, MAIC methods fill the current evidence gap. Registry and the Registration No. SPHERE Per-AF: NCT05120193 and ADVANTAGE AF: NCT05443594.
导管消融术对有症状的持续性心房颤动（PerAF）患者有益，脉冲场消融（PFA）是一种有前景的能量源，可安全、持久地形成消融灶。然而，特定导管的“PFA波形和设计”所产生的有效性和安全性特征无法转移至其他PFA技术。双能量、宽足迹点阵尖端（Sphere-9，美敦力公司）和五样条PFA导管（Farawave，波士顿科学公司）之间尚未进行直接对比。因此，本研究旨在进行间接治疗对比（ITC）。
使用匹配调整间接对比（MAIC）方法比较SPHERE Per-AF试验（N = 212；NCT05120193）和ADVANTAGE AF试验（N = 260；NCT05443594）的结果（有效性、安全性和手术时间）。根据受试者的基线特征进行匹配。
匹配后，与ADVANTAGE AF（63.5%）相比，SPHERE Per-AF在12个月无心律失常方面显示出更高的概率（OR 0.51（95%CI：0.32 - 0.80），p = 0.003）（77.4%）。试验之间没有证据表明主要安全性差异的调整概率（OR 0.76（95%CI：0.17 - 3.42），p = 0.72）（分别为1.8%和2.3%）。调整后的手术和肺静脉隔离时间相当，但与ADVANTAGE AF相比，SPHERE Per-AF的透视时间显著更短（-14.4分钟（95%CI：-16.2，-12.5）；p < 0.01）。
PFA总体上安全且有效；然而，在本ITC中，与ADVANTAGE AF相比，SPHERE Per-AF在PerAF患者中显示出更高的治疗成功概率。总体而言，这些结果强调了即使在PFA系统之间也可能存在差异，这必须在随机试验中得到验证。在此之前，MAIC方法填补了当前的证据空白。注册信息及注册号：SPHERE Per-AF：NCT05120193和ADVANTAGE AF：NCT05443594。
