Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstraße 20, 04317, Leipzig, Germany.
Abteilung für Rhythmologie, Herzzentrum Leipzig, Leipzig, Germany.
Clin Res Cardiol. 2022 Jan;111(1):114-123. doi: 10.1007/s00392-021-01959-z. Epub 2021 Oct 28.
The interpretation of recent trials on pulmonary vein ablation (PVI) for the treatment of atrial fibrillation (AF) is hampered by the lack of blinding and sham controls. The feasibility of a sham-controlled trial has been questioned. We aimed to assess the attitude of potential participants regarding a sham-controlled trial in a common AF-patient population planned for PVI.
Patients in two tertiary care centres planned for PVI were asked for their current AF symptoms using the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire 1 day before catheter ablation. Subsequently, the study design of a hypothetical sham-controlled PVI-study was introduced, and patients were asked for their agreement in participation. Telephone follow-up of the AFEQT questionnaire was conducted 3 months after PVI.
One hundred and ninety-six patients (mean age 64 ± 11 years, 63% male) were included. Seventy-nine (40%) patients expressed their agreement to participate in the hypothetical sham-controlled trial. An additional 7% agreed to participate if a cross-over option after three months was offered. Agreement rate was similar in patients with first and Redo-PVI and minimal, moderate or severe symptoms. Mean overall AFEQT at baseline was 55 ± 19 and improved by 25 ± 20 points after 3 months (p < 0.001 versus baseline).
With a participation rate of 40% in potential study participants, a sham-controlled trial for pulmonary vein isolation seems feasible. Patient-reported symptom relief after pulmonary vein isolation is in accordance with previous randomized open studies. The benefit of PVI should be rigorously evaluated in a sham-controlled trial.
由于缺乏盲法和假手术对照，最近关于肺静脉消融（PVI）治疗心房颤动（AF）的试验的解释受到了阻碍。假手术对照试验的可行性受到了质疑。我们旨在评估潜在参与者对计划用于 PVI 的常见 AF 患者人群中假手术对照试验的态度。
在两个三级护理中心计划进行 PVI 的患者，在导管消融前一天使用心房颤动对生活质量的影响（AFEQT）问卷评估其当前的 AF 症状。随后，介绍了一个假设的假手术对照 PVI 研究的研究设计，并询问患者是否同意参与。在 PVI 后 3 个月进行了 AFEQT 问卷的电话随访。
共纳入 196 例患者（平均年龄 64±11 岁，63%为男性）。79 例（40%）患者表示同意参加假设的假手术对照试验。如果提供三个月后的交叉选项，另外 7%的患者表示同意参加。首次和再次 PVI 以及症状轻微、中度或严重的患者的同意率相似。基线时的平均整体 AFEQT 为 55±19，3 个月后改善了 25±20 分（p<0.001 与基线相比）。
在潜在的研究参与者中，有 40%的人表示愿意参加，假手术对照试验进行肺静脉隔离似乎是可行的。肺静脉隔离后患者报告的症状缓解与之前的随机开放研究一致。应该在假手术对照试验中严格评估 PVI 的益处。
