心房颤动导管消融与药物治疗和心理困扰的对比：一项随机临床试验。
Atrial Fibrillation Catheter Ablation vs Medical Therapy and Psychological Distress: A Randomized Clinical Trial.
机构信息
Department of Cardiology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
出版信息
JAMA. 2023 Sep 12;330(10):925-933. doi: 10.1001/jama.2023.14685.
IMPORTANCE
The impact of atrial fibrillation (AF) catheter ablation on mental health outcomes is not well understood.
OBJECTIVE
To determine whether AF catheter ablation is associated with greater improvements in markers of psychological distress compared with medical therapy alone.
DESIGN, SETTING, AND PARTICIPANTS: The Randomized Evaluation of the Impact of Catheter Ablation on Psychological Distress in Atrial Fibrillation (REMEDIAL) study was a randomized trial of symptomatic participants conducted in 2 AF centers in Australia between June 2018 and March 2021.
INTERVENTIONS
Participants were randomized to receive AF catheter ablation (n = 52) or medical therapy (n = 48).
MAIN OUTCOMES AND MEASURES
The primary outcome was Hospital Anxiety and Depression Scale (HADS) score at 12 months. Secondary outcomes included follow-up assessments of prevalence of severe psychological distress (HADS score >15), anxiety HADS score, depression HADS score, and Beck Depression Inventory-II (BDI-II) score. Arrhythmia recurrence and AF burden data were also analyzed.
RESULTS
A total of 100 participants were randomized (mean age, 59 [12] years; 31 [32%] women; 54% with paroxysmal AF). Successful pulmonary vein isolation was achieved in all participants in the ablation group. The combined HADS score was lower in the ablation group vs the medical group at 6 months (8.2 [5.4] vs 11.9 [7.2]; P = .006) and at 12 months (7.6 [5.3] vs 11.8 [8.6]; between-group difference, -4.17 [95% CI, -7.04 to -1.31]; P = .005). Similarly, the prevalence of severe psychological distress was lower in the ablation group vs the medical therapy group at 6 months (14.2% vs 34%; P = .02) and at 12 months (10.2% vs 31.9%; P = .01), as was the anxiety HADS score at 6 months (4.7 [3.2] vs 6.4 [3.9]; P = .02) and 12 months (4.5 [3.3] vs 6.6 [4.8]; P = .02); the depression HADS score at 3 months (3.7 [2.6] vs 5.2 [4.0]; P = .047), 6 months (3.4 [2.7] vs 5.5 [3.9]; P = .004), and 12 months (3.1 [2.6] vs 5.2 [3.9]; P = .004); and the BDI-II score at 6 months (7.2 [6.1] vs 11.5 [9.0]; P = .01) and 12 months (6.6 [7.2] vs 10.9 [8.2]; P = .01). The median (IQR) AF burden in the ablation group was lower than in the medical therapy group (0% [0%-3.22%] vs 15.5% [1.0%-45.9%]; P < .001).
CONCLUSION AND RELEVANCE
In this trial of participants with symptomatic AF, improvement in psychological symptoms of anxiety and depression was observed with catheter ablation, but not medical therapy.
TRIAL REGISTRATION
ANZCTR Identifier: ACTRN12618000062224.
重要性：心房颤动（AF）导管消融对心理健康结果的影响尚不清楚。
目的：确定与单独药物治疗相比，AF 导管消融是否与心理困扰标志物的更大改善相关。
设计、地点和参与者：随机评估导管消融对心房颤动患者心理困扰影响的研究（REMEDIAL）是一项在澳大利亚的 2 个 AF 中心进行的症状性参与者的随机试验，于 2018 年 6 月至 2021 年 3 月期间进行。
干预措施：参与者被随机分配接受 AF 导管消融（n=52）或药物治疗（n=48）。
主要结局和测量：主要结局是 12 个月时的医院焦虑和抑郁量表（HADS）评分。次要结局包括严重心理困扰（HADS 评分>15）、焦虑 HADS 评分、抑郁 HADS 评分和贝克抑郁量表-II（BDI-II）评分的随访评估。心律失常复发和 AF 负荷数据也进行了分析。
结果：共有 100 名参与者被随机分配（平均年龄，59[12]岁；31[32%]名女性；54%为阵发性 AF）。消融组所有参与者均成功实现了肺静脉隔离。与药物治疗组相比，消融组的 HADS 评分在 6 个月（8.2[5.4]与 11.9[7.2]；P=0.006）和 12 个月（7.6[5.3]与 11.8[8.6]；组间差异，-4.17[95%CI，-7.04 至-1.31]；P=0.005）时更低。同样，在 6 个月（14.2%比 34%；P=0.02）和 12 个月（10.2%比 31.9%；P=0.01）时，消融组严重心理困扰的患病率也低于药物治疗组，6 个月时的焦虑 HADS 评分（4.7[3.2]与 6.4[3.9]；P=0.02）和 12 个月时（4.5[3.3]与 6.6[4.8]；P=0.02）；3 个月时的抑郁 HADS 评分（3.7[2.6]与 5.2[4.0]；P=0.047）、6 个月（3.4[2.7]与 5.5[3.9]；P=0.004）和 12 个月（3.1[2.6]与 5.2[3.9]；P=0.004）；以及 6 个月时的 BDI-II 评分（7.2[6.1]与 11.5[9.0]；P=0.01）和 12 个月时（6.6[7.2]与 10.9[8.2]；P=0.01）。消融组的中位（IQR）AF 负荷低于药物治疗组（0%[0%-3.22%]与 15.5%[1.0%-45.9%]；P<0.001）。
结论和相关性：在这项有症状的 AF 参与者试验中，导管消融可改善焦虑和抑郁的心理症状，但药物治疗不能。
试验注册：ANZCTR 标识符：ACTRN12618000062224。
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