Reddy Vivek Y, Peichl Petr, Kautzner Josef, Anter Elad, Metzner Andreas, Koruth Jacob, Jais Pierre, Rackauskas Gediminas, Petru Jan, Funasako Moritoshi, Marinskis Germanas, Turagam Mohit, Aidietis Audrius, Selma Jada M, Nejedlo Vojtech, Kueffer Fred, Tarakji Khaldoun G, Natale Andrea, Neuzil Petr
Department of Cardiology, Helmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, New York; Department of Cardiology, Na Homolce Hospital, Prague, Czechia.
Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czechia.
Heart Rhythm. 2025 Apr 26. doi: 10.1016/j.hrthm.2025.04.031.
Most single-shot pulsed-field ablation (PFA) catheters require extensive repositioning for pulmonary vein isolation (PVI), posing a challenge for obtaining contiguous, durable lesions.
To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating paroxysmal atrial fibrillation (PAF).
After PVI with the large-lattice catheter with expandable tip (Sphere-360), follow-up included Holter monitoring at 180 and 365 days and scheduled/symptomatic trans-telephonic monitoring (TTM) or modeled insertable loop recorder (ILR) data. Efficacy outcomes were acute PVI and 12-month freedom from atrial arrhythmias (AA), after 90-day blanking. Optional invasive remapping at 75 days facilitated waveform refinement from PULSE1, PULSE2, to the optimized PULSE3.
At 3 centers, 100 PAF patients underwent PFA with PULSE1 (n = 30), PULSE2 (n = 20), or PULSE3 (n = 50). Procedure, left atrial dwell, and fluoroscopy times were 57.9 ± 20.6, 22.2 ± 11.8 and 6.8 ± 5.7 minutes, respectively. All 395 targeted PVs were acutely isolated, with a transpired PVI time of 11.5 ± 6.0 minutes, using 4.0 ± 1.3 lesions/PV. There were no primary safety events (serious device-related events within 7 days post-PFA). PVI durability with PULSE3 (n = 40) was 98% (per-vein) and 93% (per-patient). One-year freedom from AA recurrence was 82.0% (95% CI:73.0%-88.3%) overall, and 88.0% (95%CI, 75.2%-94.4%) for PULSE3 patients. Of the ILR sub-cohort (n = 15 PULSE3 patients), 3 patients (20%) had recurrences, with an AA burden reduction from 26% (baseline) to 1.6% (post-ablation).
The large lattice PFA catheter was efficient, safe, and effective in treating PAF. The observed high PVI durability translated to clinical effectiveness, even in continuously monitored patients.
大多数单次脉冲场消融（PFA）导管在进行肺静脉隔离（PVI）时需要频繁重新定位，这给获得连续、持久的损伤带来了挑战。
确定用于治疗阵发性心房颤动（PAF）的单次、一体化标测与消融PFA导管的1年治疗效果。
使用带可扩张尖端的大网格导管（Sphere-360）进行PVI后，随访包括在180天和365天时进行动态心电图监测，以及定期/有症状时的经电话远程监测（TTM）或模拟植入式环路记录器（ILR）数据。疗效指标为急性PVI以及在90天空白期后的12个月无房性心律失常（AA）。75天时的可选侵入性重新标测有助于将波形从PULSE1、PULSE2优化至PULSE3。
在3个中心，100例PAF患者接受了PULSE1（n = 30）、PULSE2（n = 20）或PULSE3（n = 50）的PFA治疗。手术时间、左心房停留时间和透视时间分别为57.9±20.6分钟、22.2±11.8分钟和6.8±5.7分钟。所有395个目标肺静脉均实现急性隔离，使用每个肺静脉4.0±1.3个损伤，PVI总时间为11.5±6.0分钟。无原发性安全事件（PFA术后7天内的严重器械相关事件）。PULSE3组（n = 40）的PVI持久性为98%（每个肺静脉）和93%（每个患者）。总体1年无AA复发率为82.0%（95%CI：73.0%-88.3%），PULSE3组患者为88.0%（95%CI，75.2%-94.4%）。在ILR亚组（n = 15例PULSE3患者）中，3例患者（20%）复发，AA负担从26%（基线）降至1.6%（消融后）。
大网格PFA导管在治疗PAF方面高效、安全且有效。即使在持续监测的患者中，观察到的高PVI持久性也转化为了临床疗效。
