JAMA:心房颤动导管消融与药物治疗和心理困扰的随机临床试验

2023-09-15 来源:

本文由小咖机器人翻译整理

期刊来源:JAMA

文献发表时间:2023-09-12

原文链接https://jamanetwork.com/journals/jama/article-abstract/2809419

关键点内容如下:

问题

房颤导管消融对心理健康有影响吗?

调查结果

在这项纳入100名症状性房颤患者的随机临床试验中,与单纯药物治疗相比,减少心律失常负担和使用抗心律失常药物的导管消融术与心理困扰指标的改善相关。

意义

严重心理压力的改善可能是房颤导管消融治疗的额外益处。

摘要内容如下:

重要性

心房颤动(AF)导管消融术对心理健康结果的影响尚不清楚。

目的

确定与单纯药物治疗相比,房颤导管消融术是否与心理痛苦指标的更大改善相关。

研究设计和参与者

导管消融术对房颤患者心理压力影响的随机评估(补救)研究是2018年6月至2021年3月在澳大利亚2个房颤中心对有症状的参与者进行的一项随机试验。

干预

受试者随机接受房颤导管消融术(n=52)或药物治疗(n=48)。

主要结果和措施

主要结果是12个月时的医院焦虑和抑郁量表(HADS)评分。次要结果包括随访评估严重心理困扰的患病率(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。同时分析心律失常复发和房颤负荷数据。

次要结果

共有100名参与者(平均年龄59[12]岁进行随机分组。31名[32%]妇女;54%伴有阵发性房颤)。消融组的所有参与者均成功进行了肺静脉隔离。6个月时,消融组的综合HADS评分低于药物组,(分别为8.2[5.4]和11.9[7.2];P=.006)和12个月时(7.6[5.3]vs 11.8[8.6];组间差异,−4.17[95%CI,−7.04至−1.31];P=.005)。同样,在6个月(时,消融组的严重心理痛苦发生率低于药物治疗组,分别为14.2%和34%;P=.02)和12个月时(10.2%vs 31.9%;P=.01),6个月时的焦虑HADS评分也是如此(4.7[3.2]vs 6.4[3.9];P=.02)和12个月(4.5[3.3]vs 6.6[4.8];P=.02);(3个月时抑郁HADS评分分别为3.7[2.6]和5.2[4.0];P=.047),6个月(3.4[2.7]vs 5.5[3.9];P=.004)和12个月(3.1[2.6]vs 5.2[3.9];P=.004);6个月时的BDI-II评分(7.2[6.1]vs 11.5[9.0];P=0.01)和12个月(6.6[7.2]vs 10.9[8.2];P=.01)。

结论和相关性

导管消融术的中位(IQR)房颤负荷低于药物治疗组(0%[0%-3.22%]vs 15.5%[1.0%-45.9%];P<.001)。结论和相关性在这项针对症状性房颤参与者的试验中,观察到导管消融术改善了焦虑和抑郁的心理症状,但药物治疗没有改善。

英文原文如下:

Key Points

Question  Does atrial fibrillation catheter ablation have an impact on mental health?

Findings  In this randomized clinical trial of 100 patients with symptomatic atrial fibrillation, catheter ablation with reduction in arrhythmia burden and antiarrhythmic drug use was associated with improvement in markers of psychological distress compared with medical therapy alone.

Meaning  Improvement of severe psychological distress may be an additional benefit of catheter ablation treatment for atrial fibrillation.

Abstract

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.

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