Pezzulich B, Taralli S, Villata G, Sori P
Maria Pia Hospital, GVM Care & Research, Turin, Italy -
Minerva Cardioangiol. 2015 Apr;63(2):99-103. Epub 2014 Jul 7.
This paper aimed at assessing clinical efficacy and safety of a new fully irrigated and flexible tip catheter (Therapy™ Cool Flex™, St Jude Medical, St. Paul, MN, USA) in ablation of atrial fibrillation (AF).
The study enrolled 117 consecutive patients with symptomatic AF who underwent for the first time a circumferential pulmonary vein isolation with a new irrigated and flexible tip catheter.
All patients underwent successful pulmonary vein circumferential ablation. The mean procedure duration was 100 ± 27 min, total fluoroscopy time was 7.4 ± 5 min. The mean number of RF lesion was 139 ± 43 and the mean total RF time was 22.45 ± 3.9 min. Median follow-up was 665 ± 241 days. Through Kaplan-Meier analysis, overall event-free survival was 79.7%. In details, arrhythmia free survival was 85.4% in patients with persistent AF, 76% in paroxysmal AF and 75% in chronic AF. Three patients (2.5%) suffered from minor vascular complication (groin hematoma). Two patients (1.7%) suffered from pericardial effusion, treated with pericardiocentesis and with no sequelae. We did not observe any atrioesophageal fistula or pulmonary vein stenosis.
The present study represents the largest cohort of patients receiving AF ablation with this new tip-flexible catheter. It demonstrated comparable efficacy to that previously reported, with a very low complication rate and procedural time. A head-to-head clinical trial would be necessary to address the relative efficacy of catheter type.
本文旨在评估一种新型全灌注、可弯曲尖端导管(Therapy™ Cool Flex™,美国明尼苏达州圣保罗市圣裘德医疗公司)在房颤(AF)消融中的临床疗效和安全性。
该研究纳入了117例有症状房颤的连续患者,这些患者首次使用新型灌注可弯曲尖端导管进行肺静脉环形隔离术。
所有患者均成功进行了肺静脉环形消融。平均手术时间为100±27分钟,总透视时间为7.4±5分钟。射频消融灶的平均数量为139±43个,平均总射频时间为22.45±3.9分钟。中位随访时间为665±241天。通过Kaplan-Meier分析,总体无事件生存率为79.7%。具体而言,持续性房颤患者的无心律失常生存率为85.4%,阵发性房颤患者为76%,慢性房颤患者为75%。3例患者(2.5%)出现轻微血管并发症(腹股沟血肿)。2例患者(1.7%)出现心包积液,经心包穿刺治疗,无后遗症。我们未观察到任何心房食管瘘或肺静脉狭窄。
本研究是接受这种新型可弯曲尖端导管进行房颤消融的患者的最大队列研究。它显示出与先前报道相当的疗效,并发症发生率和手术时间非常低。有必要进行一项直接对比的临床试验来探讨导管类型的相对疗效。