Key points 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 arrhythmia burden reduction and use of antiarrhythmic drugs was associated with improvement in markers of psychological distress compared with medical treatment alone. Meaning Improvement of severe psychological distress may be an additional benefit of catheter ablation treatment for atrial fibrillation. |
Importance
The impact of atrial fibrillation (AF) catheter ablation on mental health outcomes is not well understood.
Aim
To determine whether catheter ablation of AF is associated with greater improvements in markers of psychological distress compared to medical treatment alone.
Design, environment 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 at 2 AF centers in Australia between June 2018 and March 2021.
Interventions
Participants were randomly assigned to receive AF catheter ablation (n = 52) or medical treatment (n = 48).
Main results and measures
The primary outcome was the Hospital Anxiety and Depression Scale (HADS) score at 12 months. Secondary outcomes included follow-up assessments of the prevalence of severe psychological distress (HADS score >15), HADS anxiety score, HADS depression score, and Beck Depression Inventory-II (BDI-II) score. Data on arrhythmia recurrence and AF burden 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 Hospital Anxiety and Depression Scale (HADS) score was lower in the ablation group versus the medical treatment group at 6 months (8.2 [5.4] vs. 11.9 [7.2] ; P = 0.006) and at 12 months (7.6 [5.3] vs 11.8 [8.6]; difference between groups, −4.17 [95% CI, −7.04 to −1.31]; P = 0.005).
Similarly, the prevalence of serious psychological distress was lower in the ablation group versus the medical therapy group at 6 months (14.2% versus 34%; P = 0.02) and at 12 months (10.2 % versus 31.9%; P = 0.01), as did the HADS anxiety score at 6 months (4.7 [3.2] versus 6.4 [3.9]; P = 0.01). 02) and 12 months (4.5 [3.3] vs. 6.6 [4.8]; p = 0.02); HADS depression score at 3 months (3.7 [2.6] vs 5.2 [4.0]; P = 0.047), at 6 months (3.4 [2.7] vs 5 .5 [3.9]; P = 0.004) and at 12 months (3.1 [2.6] ] vs. 5.2 [3.9]; p = 0.004); and BDI-II score at 6 months (7.2 [6.1] vs. 11.5 [9.0]; p = 0.01) and at 12 months (6.6 [7.2] vs. to 10.9 [8.2]; p = 0.01).
The median (IQR) AF burden in the ablation group was lower than that in the medical treatment group (0% [0%-3.22%] vs. 15.5% [1.0%-45, 9%]; P < 0.001).
Conclusion and relevance In this trial of participants with symptomatic atrial fibrillation (AF), improvement in psychological symptoms of anxiety and depression was seen with catheter ablation, but not with medical treatment. |
Test Record ANZCTR Identifier: ACTRN12618000062224
