Rovaris Giovanni, De Filippo Paolo, Laurenzi Francesco, Zanotto Gabriele, Bottoni Nicola, Pozzi Mattia, Giofrè Fabrizio, De Girolamo Piergiuseppe, Visentin Emanuela, Piazzi Elena, Ferrari Paola
Ospedale San Gerardo, Azienda Socio Sanitaria Territoriale, Monza, Italy.
Ospedale Papa Giovanni XXIII, Bergamo, Italy.
J Interv Card Electrophysiol. 2017 Dec;50(3):245-251. doi: 10.1007/s10840-017-0278-y. Epub 2017 Sep 5.
Complete pulmonary vein isolation (PVI) is the best documented target for catheter ablation, and different technologies have shown comparable outcomes. The multielectrode phased-RF/duty cycled (PhRF/DC) pulmonary vein ablation catheter (PVAC) and its second generation (PVAC-GOLD) have shown promising clinical results in single and multicenter experiences. Our aim is to assess and compare the safety and efficacy in the real clinical practice among two generations of circular PhRF/DC catheters by performing PVI in patients suffering from recurrent atrial fibrillation (AF).
Eighty-four AF patients treated with PVAC and 64 with PVAC-GOLD were prospectively followed in five Italian cardiology centers in the mainframe of the 1STOP-ClinicalService project.
Fluoroscopic and total procedure time were significantly different in the two groups. In particular, in the PVAC-GOLD group, the mean fluoroscopic time was 22.8 ± 12.7 min vs 31.6 ± 18.9 in the PVAC group (p = 0.002), and the mean total procedure duration was 117.6 ± 36.0 vs 147.4 ± 40.6, in the PVAC-GOLD group and the PVAC group, respectively (p = 0.001). Only two out of 148 patients reported a peri-procedural complication. Over 20.9 ± 12.0 months of follow-up, AF recurrence occurred in 58 patients. Kaplan-Meier freedom from AF recurrence did not differ between the two groups (64.1 ± 10% in the PVAC group vs 68.2 ± 9% in the PVAC-GOLD group at 1 year, p = ns).
In our multicenter analysis, AF ablation using two generations of circular PhRF/DC catheters is safe and effective. No difference was observed in terms of safety and efficacy of the AF ablation between the two catheters, with the mean procedural time being shorter in the PVAC-GOLD group.
完全肺静脉隔离（PVI）是导管消融最有充分文献记载的靶点，不同技术已显示出相当的疗效。多电极相控射频/占空比控制（PhRF/DC）肺静脉消融导管（PVAC）及其第二代产品（PVAC-GOLD）在单中心和多中心研究中已显示出有前景的临床结果。我们的目的是通过对复发性心房颤动（AF）患者进行PVI，评估和比较两代环形PhRF/DC导管在实际临床实践中的安全性和有效性。
在1STOP-ClinicalService项目框架下，五个意大利心脏病中心对84例接受PVAC治疗的AF患者和64例接受PVAC-GOLD治疗的患者进行了前瞻性随访。
两组的透视时间和总手术时间有显著差异。特别是，在PVAC-GOLD组，平均透视时间为22.8±12.7分钟，而PVAC组为31.6±18.9分钟（p = 0.002），平均总手术时长在PVAC-GOLD组和PVAC组分别为117.6±36.0分钟和147.4±40.6分钟（p = 0.001）。148例患者中只有2例报告了围手术期并发症。在超过20.9±12.0个月的随访中，58例患者出现AF复发。两组的Kaplan-Meier无AF复发率无差异（PVAC组1年时为64.1±10%，PVAC-GOLD组为68.2±9%，p = 无显著差异）。
在我们的多中心分析中，使用两代环形PhRF/DC导管进行AF消融是安全有效的。两组之间在AF消融的安全性和有效性方面未观察到差异，PVAC-GOLD组的平均手术时间较短。
