英国伦敦大学学院Rajdip Dulai团队比较了肺静脉隔离和假手术干预对房颤患者预后的影响。2024年9月2日，《美国医学会杂志》发表了这一成果。

有人担心，肺静脉隔离治疗心房颤动可能具有深远的安慰剂效应，但尚未进行双盲随机临床试验。为了确定肺静脉隔离是否比假手术更有效地改善房颤患者的预后，2020年1月至2024年3月，研究组在英国2个三级中心对有症状的阵发性或持续性房颤患者进行了一项双盲随机临床试验。主要排除标准包括长期持续性房颤、既往左心房消融、其他需要消融治疗的心律失常、左心房5.5厘米或更大以及射血分数低于35%。

将参与者随机分配接受冷冻消融肺静脉隔离（n=64）或膈神经起搏假手术（n=62）。主要终点是6个月时的房颤负荷，不包括3个月的空白期。次要结局包括生活质量指标、事件发生时间和安全性。心房颤动负荷由植入式环路记录仪测量。

共有126名参与者被随机分配（平均年龄66.8岁；89名男性[70.63%]；20.63%患有阵发性房颤）。消融组和假手术组从基线到6个月的房颤负荷绝对平均变化分别为60.31%和35.0%（几何平均差，0.25；95%CI，0.15-0.42；P<0.001）。6个月时，支持导管消融术的房颤对生活质量的总体影响评分估计差异为18.39分（95%CI，11.48-25.30分）。消融后，简表36的通用健康评分也有了显著改善，6个月时估计差异为9.27分（95%CI，3.78-14.76分）。

研究结果表明，与假手术相比，肺静脉隔离导致6个月时房颤负担在统计学上显著降低，具有临床意义，症状和生活质量显著改善。

附：英文原文

Title: Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial

Author: Rajdip Dulai, Neil Sulke, Nick Freemantle, Pier D. Lambiase, David Farwell, Neil T. Srinivasan, Stuart Tan, Nikhil Patel, Adam Graham, Rick A. Veasey

Issue&Volume: 2024-09-02

Abstract:

Importance  There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted.

Objective  To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation.

Design, Setting, and Participants  Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%.

Intervention  Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n=64) or a sham procedure with phrenic nerve pacing (n=62).

Main Outcomes and Measures  The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder.

Results  A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P<.001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points).

Conclusions and Relevance  Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.

DOI: 10.1001/jama.2024.17921

Source: https://jamanetwork.com/journals/jama/fullarticle/2823283