Department of Cardiology, AZ Sint-Jan Hospital, Bruges, Belgium.
Division of Electrophysiology, Hasselt Heart Center, Jessa Hospital, Hasselt, Belgium.
Europace. 2020 Nov 1;22(11):1645-1652. doi: 10.1093/europace/euaa157.
To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions.
This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4-86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8-82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8-87.0%). Freedom fromrepeat ablations by the Kaplan-Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9-6.3%).
The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres.Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.
评估使用标准化工作流程进行阵发性心房颤动（PAF）肺静脉隔离的安全性和有效性，该流程旨在通过连续且优化的射频消融来封闭静脉。
这项多中心、前瞻性、非随机研究在欧洲的 17 个地点进行。肺静脉隔离由 VISITAG SURPOINT（前壁 VS 目标≥550；后壁≥400）和相间距离（≤6mm）指导。在标准护理监测（24 小时动态心电图和 12 导联心电图在 3、6 和 12 个月随访时）的基础上，每周和症状驱动的远程电话监测严格监测心房心律失常复发。纳入了 340 例药物难治性 PAF 患者。急性有效性（首次通过隔离证明在 30 分钟等待期和腺苷挑战）为 82.4%（95%置信区间[CI] 77.4-86.7%）。在 12 个月随访时，任何有记录的心房心律失常无复发率为 78.3%（95%CI 73.8-82.8%），而标准护理监测的无心律失常率为 89.4%（95%CI 78.8-87.0%）。根据 Kaplan-Meier 分析，在 12 个月的随访中，重复消融的无复发率为 90.4%。在 34 例重复消融的患者中，14 例（41.2%）显示所有肺静脉环的完全隔离。主要不良事件（PAE）发生率为 3.6%（95%CI 1.9-6.3%）。
VISTAX 试验表明，针对连续病变的标准化 PAF 消融工作流程可导致 PAE 发生率低、急性首次通过隔离率高，并且 12 个月的心律失常无复发率接近 80%。需要进一步研究以提高更广泛中心的结果的可重复性。临床试验注册：ClinicalTrials.gov，编号 NCT03062046，https://clinicaltrials.gov/ct2/show/NCT03062046。
