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Randomized Controlled Trial
. 2023 Sep 12;330(10):925-933.
doi: 10.1001/jama.2023.14685.

Atrial Fibrillation Catheter Ablation vs Medical Therapy and Psychological Distress: A Randomized Clinical Trial

Ahmed M Al-Kaisey  1   2   3 , Ramanathan Parameswaran  1   2   3 , Christina Bryant  4 , Robert D Anderson  1   2 , Joshua Hawson  1   2 , David Chieng  3   5 , Louise Segan  3   5 , Aleksandr Voskoboinik  3   5 , Hariharan Sugumar  3   5 , Geoffrey R Wong  1   2 , Sue Finch  6 , Stephen A Joseph  1   7 , Alex McLellan  1 , Liang-Han Ling  3   5 , Joseph Morton  1 , Paul Sparks  1 , Prashanthan Sanders  8 , Geoffrey Lee  1   2 , Peter M Kistler  2   3   5 , Jonathan M Kalman  1   2
Affiliations
Randomized Controlled Trial

Atrial Fibrillation Catheter Ablation vs Medical Therapy and Psychological Distress: A Randomized Clinical Trial

Ahmed M Al-Kaisey et al. JAMA. .

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.

Trial registration: ANZCTR Identifier: ACTRN12618000062224.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ling reported receiving grants from Abbott Australia outside the submitted work. Dr Sanders reported serving on an advisory board for or receiving research grants to the institution from Medtronic, Abbott, CathRx, Pacemate, Boston Scientific, and Becton Dickinson outside the submitted work and receiving an investigator grant from the National Health and Medical Research Council of Australia. Dr Kistler reported receiving personal fees from Abbott Medical outside the submitted work. Dr Kalman reported receiving grants from National Health and Medical Research Council of Australia during the conduct of the study and grants from Medtronic, Mooney, and Biosense Webster outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow of Participants in a Trial of Atrial Fibrillation Catheter Ablation vs Medical Therapy and Psychological Distress
Figure 2.
Figure 2.. Hospital Anxiety and Depression Scale Score, Atrial Fibrillation Burden, and Atrial Fibrillation Symptom Severity Score
See this image and copyright information in PMC

Comment in

References

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