Aggressive Risk Factor Reduction Study for Atrial Fibrillation Implications for Ablation Outcomes

Importance: Atrial fibrillation (AF) ablation outcomes demonstrate attrition over time. Although observational studies have reported reduced arrhythmia recurrence after AF ablation with aggressive lifestyle and risk factor modification, evidence from randomized clinical trials is lacking. Objective: To determine the impact of risk factor and weight management on AF ablation rhythm outcomes. Design, Setting, and Participants: This was an open-label, multicenter, randomized clinical trial with 12-month follow-up conducted from July 2014 to September 2018. The setting included 3 sites in Adelaide, South Australia. Included in the analysis were consecutive patients with nonpermanent symptomatic AF undergoing first-time catheter ablation with a body mass index (BMI) greater than or equal to 27 (calculated as weight in kilograms divided by height in meters squared) and 1 or more additional cardiometabolic risk factors. Data were analyzed from September 2023 to August 2024. Interventions: Patients were randomized 1:1 to lifestyle and risk factor management (LRFM) or usual care (UC) at catheter ablation. The LRFM group was treated in a structured, physician-led tailored clinic to reduce modifiable risk factors. The UC group was given information on management of risk factors by their treating physician but were not enrolled into the risk factor modification clinic. Both groups received guideline-directed care for management of AF by a team blinded to randomization. Pulmonary vein isolation was undertaken in each patient with additional ablation considered at the discretion of the electrophysiologist. Main Outcomes and Measures: Proportion of patients free from AF in the 12-month period after ablation. Results: Of 122 participants (mean SD age, 60 10 years; 82 male 67%; mean SD BMI, 33 5), 62 were randomized to LRFM, and 60 were randomized to UC. Primary end point at 12 months after ablation was observed in 38 patients (61.3%) in the LRFM group and 24 (40%) in the control group (P = .03). The hazard for recurrent arrhythmia over 12 months was 0.53 (95% CI, 0.32-0.89) for LRFM vs UC. AF symptom severity was significantly improved in the LRFM group compared with the UC group (mean difference, -2.0; 95% CI, -3.7 to -0.3). Patients in the LRFM group achieved a significantly improved risk factor profile compared with those in the UC group (mean difference, body weight, -9.0 kg; 95% CI, -11.1 to -6.8 kg and waist circumference, -7.0 cm; 95% CI, -9.4 to -4.5 cm were lower at 12 months in the LRFM group; systolic BP was lower at 12 months in the LRFM group, -10.8 mm Hg; 95% CI, -16.1 to -5.5 mm Hg, although there was no difference in diastolic BP, -3.5 mm Hg; 95% CI, -7.2 to 0.2 mm Hg). Conclusions and Relevance: Among patients with AF, elevated BMI, and 1 or more additional cardiometabolic risk factors, aggressive risk factor management reduced arrhythmia recurrence over the 12-month period after catheter ablation. These findings demonstrate the importance of LRFM for the maintenance of sinus rhythm after catheter ablation. Trial Registration: ANZCTR Registry Identifier: ACTRN12613000444785.