Catheter Ablation was favored for rhythm control in atrial fibrillation (Afib or AF) when considering its psychological benefits over medical therapy alone, the REMEDIAL randomized trial showed.

Psychological distress tended to be lower 12 months after ablation versus medical therapy, as indicated by reduced Hospital Anxiety and Depression Scale (HADS) scores between groups (7.6 vs 11.8 points, P=0.005), reported Jonathan Kalman, MBBS, PhD, Royal Melbourne Hospital, Australia, and colleagues.

In addition, patients were left with an Afib burden averaging 0% after ablation vs 15.5% after medical therapy (PJAMA.

The study adds to past reports of catheter ablation’s superiority over medical therapy in relieving psychological distress and improved physical symptoms and quality of life.

“A divergence in markers of psychological distress was observed starting at 6 months that continued to 12 months. The data indicate that low AF burden, absence of AF recurrence, and cessation of [antiarrhythmic drug]/β-blocker therapy were all significantly associated with improvements in psychological distress,” study authors observed.

Notably, catheter ablation had brought HADS down from a baseline score of 12.72 across the trial cohort — 100 people with symptomatic Afib — which had also started out with a 32% prevalence of severe psychological distress (HADS score >15).

“The REMEDIAL trial nicely demonstrates what happens when AF symptom burden is reduced: depression and anxiety symptoms concomitantly decrease while measures of quality of life significantly improve, promoting the freedom of patients to engage in physical and social activities,” commented Julia Lurz, MD, of Heart Center Leipzig, and Karl-Heinz Ladwig, MD, PhD, of Technical University Munich, both in Germany, in an accompanying editorial.

“Psychological distress conditions are independent risk factors for adverse cardiovascular outcomes (including stroke and major bleeding) in patients with AF and promote AF recurrence. Without doubt, these associations add more complexity to comprehensive treatment decisions for patients with AF,” the German duo observed.

The editorialists urged for more awareness of and screening for concomitant depression, stress, and anxiety in Afib patients. Which psychotherapies may best support these patients is unclear, they noted, citing “a need to prioritize this issue in future AF research.”

In any case, REMEDIAL’s “substantial improvement in important mental health factors clearly speaks in favor of effective rhythm control and moreover catheter ablation” in Afib patients, they concluded, though they cautioned that “attentive clinical acumen is important to establish individually tailored treatment strategies.”

REMEDIAL was conducted at two Australian centers from June 2018 to March 2021. Excluding those with baseline severe depression, investigators randomized people with symptomatic Afib to receive either catheter ablation (n=52) or antiarrhythmic medical therapy alone (n=48).

The 100-person cohort averaged 59 years of age, and 32% were women. The ablation and medical therapy groups appeared well-balanced at baseline, except for a slightly higher prevalence of persistent Afib in the former (53% vs 38%).

Ablation patients underwent radiofrequency ablation using irrigated contact force-sensing ablation catheters, the goal being persistent isolation of all pulmonary veins at the end of the procedure — which was achieved by all study participants. Additional ablation targets were allowed at the operator’s discretion during the index procedure.

Oral anticoagulation was mandated for a minimum of 3 months after ablation. Antiarrhythmic drug use was continued during the 3-month blanking period after ablation, then stopped when there was no Afib recurrence or low-burden asymptomatic Afib.

Afib burden was assessed twice-daily with the KardiaMobile echocardiogram monitoring device or 24-hour Holter monitoring, unless the patient had an existing intracardiac monitoring device.

According to Kalman’s group, various secondary psychological measures indicated some relief after Afib catheter ablation, especially related to anxiety and depression:

• Prevalence of severe psychological distress at 12 months: 10.2% after ablation vs 31.9% after medical therapy (P=0.01)
• Anxiety HADS score: 4.5 vs 6.6 points (P=0.01)
• Depression HADS score: 3.1 vs 5.2 points (P=0.004)
• Depression on Beck Depression Inventory-II score: 6.6 vs 10.9 points (P=0.01)

The trial was limited by its open-label design and lack of sham controls, Kalman and colleagues acknowledged.

“There is also a question of possible differences in sex. Because women with AF may be more likely than men to experience severe symptoms and worse quality of life, it is possible that women might respond differently to the intervention as well,” Lurz and Ladwig noted.