Department of Cardiology and Angiology, Klinikum Merheim, University Witten/Herdecke/Germany, Cologne, Germany.
Int J Med Sci. 2013;10(1):24-33. doi: 10.7150/ijms.4771. Epub 2012 Dec 7.
Pulmonary Vein Isolation (PVI) is evolving as an established treatment option in atrial fibrillation (AF). Different fluoroscopy-guided ablation devices exist either on the basis of expandable circumferential and mesh designs with mapping and ablation of pulmonary vein potentials, or of a balloon technology, a "single shot" device with a purely anatomical approach. Systematic comparisons between procedure duration (PD), fluoroscopy time (FT) and clinical outcome in using different ablation tools are lacking in the literature.
In a single center retrospective analysis, 119 PVI procedures were performed between August 2008 and March 2011 in paroxysmal AF (PAF, 59.7%) and persistent AF (persAF, 40.3%) patients with mean age of 59.4±10.3 years and history of AF since 8.1±9.7 months. The PVI procedures were evaluated by comparing PD and FT using I) the High Density Mesh Mapper (HDMM), II) the High Density Mesh Ablator (HDMA), and III) the Arctic Front® Cryoballoon. The primary endpoints were FT and PD, the secondary endpoint was procedural safety and efficacy in short- and longterm follow-up.
The procedures performed for 119 patients (63.0 % male) included 42 PVIs with the HDMM (35.3 %), 47 with the HDMA (39.5 %) and 30 with the cryoballoon (25.2 %). Comparing the 30 first procedures in groups of 10 in the HDMM and HDMA group, PD and FT fell in the HDMM group (PD from 257.5 to 220.9 min and FT from 80.5 to 67.3 min, both p < 0.05) as well as in the HDMA group (PD from 182.9 to 147.2 min and FT from 41.02 to 29.1 min, both p < 0.05). In the cryoballoon group, there was a steep learning curve with a steady state after the first 10 procedures (PD and FT decreased significantly from 189.5 to 138.1 min and 36.9 to 27.3 min, p values 0.005 and 0.05 respectively). With respect to recurrence of AF in a 24 months follow up, the HDMM and cryoballoon group showed comparable results with ~72% of patients free of arrhythmias. None of the patients died due to severe complications, or suffered a hemodynamic relevant pericardial effusion and/or stroke. Impairment of the phrenic nerve was observed in three patients.
Use of the cryoballoon technology was associated with a steep learning curve and a reduced PD and FT; the long-term outcome was similar compared with the HDMM group. The efficacy and safety of the devices but also PD and FT should be respected as the strongest indicators of the quality of ablation. Further studies with long time follow-ups will show if the time for correct mapping of the PV potentials is a price we should be willing to pay or if we should adopt a "wait-and-see" attitude referring the AF recurrence.
肺静脉隔离(PVI)作为心房颤动(AF)的一种既定治疗选择正在不断发展。现有的不同的透视引导消融设备基于可扩展的环形和网孔设计,具有肺静脉电位的映射和消融功能,或者基于球囊技术,即具有纯粹解剖学方法的“单次”设备。在文献中缺乏关于不同消融工具的程序持续时间(PD)、透视时间(FT)和临床结果的系统比较。
在单中心回顾性分析中,2008 年 8 月至 2011 年 3 月期间,对 119 例阵发性 AF(PAF,59.7%)和持续性 AF(persAF,40.3%)患者进行了 PVI 手术,患者平均年龄为 59.4±10.3 岁,AF 病史为 8.1±9.7 个月。通过比较 I)高密度网孔映射仪(HDMM)、II)高密度网孔消融仪(HDMA)和 III)北极 Front®冷冻球囊,评估了 PVI 程序的 PD 和 FT。主要终点是 FT 和 PD,次要终点是短期和长期随访中的程序安全性和疗效。
对 119 例患者(63.0%为男性)进行了 42 例采用 HDMM(35.3%)、47 例采用 HDMA(39.5%)和 30 例采用冷冻球囊(25.2%)的 PVI 手术。在 HDMM 和 HDMA 组中,每组比较前 10 例的 PD 和 FT 降低(HDMM 组的 PD 从 257.5 降至 220.9 分钟,FT 从 80.5 降至 67.3 分钟,均 p<0.05;HDMA 组的 PD 从 182.9 降至 147.2 分钟,FT 从 41.02 降至 29.1 分钟,均 p<0.05)。在冷冻球囊组中,存在一个陡峭的学习曲线,在前 10 例之后达到稳定状态(PD 和 FT 分别显著从 189.5 降至 138.1 分钟和 36.9 降至 27.3 分钟,p 值分别为 0.005 和 0.05)。在 24 个月的随访中,HDMM 和冷冻球囊组的 AF 复发率相似,约 72%的患者无心律失常。没有患者因严重并发症、血流动力学相关的心包积液和/或中风而死亡。有 3 例患者出现膈神经损伤。
使用冷冻球囊技术与 PD 和 FT 的减少相关,且存在陡峭的学习曲线;与 HDMM 组相比,长期结果相似。设备的疗效和安全性以及 PD 和 FT 应被视为消融质量的最强指标。进一步的长期随访研究将表明,是否正确映射肺静脉电位的时间是我们应该愿意付出的代价,或者我们是否应该采取“观望”的态度,等待 AF 复发。