Cardiac Electrophysiology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.
Department of Cardiology, Ospedale Generale Regionale F. Muilli, Acquaviva delle Fonti, Italy.
JACC Clin Electrophysiol. 2019 Jul;5(7):778-786. doi: 10.1016/j.jacep.2019.04.009. Epub 2019 May 8.
This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation.
The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions.
QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation.
A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits.
This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).
本研究旨在评估一种新型导管在治疗阵发性心房颤动中的超高功率-短时间（vHPSD）消融的安全性和短期疗效。
vHPSD 导管是一种新型接触力感应导管，经过优化可与微电极和 6 个热电偶一起用于温度控制射频消融，以实现实时温度监测；相关的 vHPSD 算法可调节功率以在 90 W、4 s 病变期间维持目标温度。
QDOT-FAST（使用 THERMOCOOL SMARTTOUCH SF-5D 系统的快速消融模式治疗阵发性心房颤动患者的安全性和急性性能评估的临床研究）是一项前瞻性、多中心、单臂研究，招募了有症状的阵发性心房颤动患者，这些患者需要导管法肺静脉隔离。主要终点是短期疗效（腺苷/异丙肾上腺素激发后所有靶向肺静脉均出现入口阻滞）和短期安全性（主要不良事件）。参与者通过磁共振成像筛查无症状性脑病变。患者在消融后随访 3 个月。
共有 52 例患者接受消融并完成随访。所有患者均单独使用研究导管实现肺静脉隔离，总手术和透视时间分别为 105.2±24.7 min 和 6.6±8.2 min。大多数患者（n=49；94.2%）在 3 个月时处于窦性心律。报告了 2 例主要不良事件：1 例假性动脉瘤；1 例无症状性血栓栓塞。无死亡、中风、房-食管瘘、肺静脉狭窄或意外不良器械相关事件。6 例患者发现有无症状性脑病变——均归类为无症状性病变，无临床或神经学缺陷。
这项新型导管优化温度控制的首次人体研究证明了 vHPSD 消融的临床可行性和安全性。手术和透视时间明显低于使用点到点导管的传统标准消融。（使用 THERMOCOOL SMARTTOUCH SF-5D 系统的快速消融模式治疗阵发性心房颤动患者的安全性和急性性能评估的临床研究[QDOT-FAST]；NCT03459196）。
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