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

Al-Kaisey, AM; Parameswaran, R; Bryant, C; Anderson, RD; Hawson, J; Chieng, D; Segan, L; Voskoboinik, A; Sugumar, H; Wong, GR; Finch, S; Joseph, SA; McLellan, A; Ling, LH; Morton, J; Sparks, P; Sanders, P; Lee, G; Kistler, PM; Kalman, JM

doi:10.1001/jama.2023.14685

Arrhythmias & electrophysiology

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

JAMAPublished 12 Sep 2023Randomised controlled trial

Primary result · Combined HADS scoreResultBetween-group difference −4.17 95% CI −7.04 to −1.31

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Authors' conclusion

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.

Study context

Population: Symptomatic Atrial Fibrillation (AF), Australia, June 2018–March 2021
Participants: 100 participants

Comparison: AF catheter ablation vs medical therapy
Ablationn = 52
Medical therapyn = 48reference
Primary endpoint: Hospital Anxiety and Depression Scale (HADS) score
Follow-up: 12 months

Methodological details2 AF centres in Australia

2 AF centres in Australia

Primary result

Combined HADS score

Between-group difference

−4.17

95% CI −7.04 to −1.31

P = 0.005

By group

Ablation

7.6

SD 5.3

Medical therapy

11.8

SD 8.6

Ablationvs Medical therapy

between-group difference −4.17 (95% CI −7.04 to −1.31); P = 0.005

As reported in the abstract

Secondary outcomes

Severe psychological distress (HADS score >15) · 12 months · 12 months; 6 months P = .02

P = 0.01

Ablation10.2%

Medical therapy31.9%

6 months

Ablation14.2%

Medical therapy34%

Outcome	Ablation	Medical therapy	P value
Combined HADS score · 6 months	8.2 (SD 5.4)	11.9 (SD 7.2)	P = 0.006
Anxiety HADS score · 12 months12 months; 6 months P = .02	4.5 (SD 3.3)	6.6 (SD 4.8)	P = 0.02
6 months	4.7 [3.2]	6.4 [3.9]
Depression HADS score · 12 months12 months; 3 months P = .047; 6 months P = .004	3.1 (SD 2.6)	5.2 (SD 3.9)	P = 0.004
3 months	3.7 [2.6]	5.2 [4.0]
6 months	3.4 [2.7]	5.5 [3.9]
BDI-II score · 12 months12 months; 6 months P = .01	6.6 (SD 7.2)	10.9 (SD 8.2)	P = 0.01
6 months	7.2 [6.1]	11.5 [9.0]
AF burdenMedian	0% (IQR 0%–3.22%)	15.5% (IQR 1.0%–45.9%)	P < 0.001

Successful pulmonary vein isolation

Achieved in all participants in the ablation group

Original publication

Atrial Fibrillation Catheter Ablation vs Medical Therapy and Psychological Distress: A Randomized Clinical Trial. JAMA. Published 12 September 2023. doi:10.1001/jama.2023.14685

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