Abstract Body (Do not enter title and authors here): Introduction: Atrial fibrillation (AF) ablation outcome demonstrates attrition. Although observational studies have demonstrated reduced arrhythmia recurrence after AF ablation with aggressive modification of lifestyle and risk factors, evidence from randomized clinical trials (RCT) is lacking.
Hypothesis and Purpose: We hypothesise that risk factor modification (RFM) will improve outcomes of AF ablation. RCT to evaluate the impact of risk factor and weight management on AF ablation rhythm outcomes.
Population Studied: Consecutive patients with paroxysmal or persistent symptomatic AF undergoing catheter ablation with a body mass index (BMI) ≥27 kg/m² and one additional cardiometabolic risk factor. Exclusions were severe structural heart or systemic disease and contraindication to ablation.
Power Calculation: A sample size of 120 patients were recruited to detect a 25% absolute difference between groups (80% power, alpha = 0.05) in the proportion of patients free from AF at 12-months follow-up.
Intervention(s): Patients were randomized 1:1 to either RFM or usual care (UC) at ablation. The RFM group were managed in a physician-led clinic to reduce modifiable risk factors in accordance with AHA guidelines. Both groups received guideline-directed care for management of AF. Pulmonary vein isolation was undertaken in each patient with additional ablation considered at the discretion of the electrophysiologist.
Endpoints: Primary endpoint was the percentage of patients free from AF after ablation. Secondary endpoints include AF symptom severity, risk factor profile, exercise capacity and need for redo ablation.
Outcomes: Of 122 participants (age 60±10, 67% male, BMI 33±5Kg/m²), 62 were randomized to RFM and 60 to UC. Primary endpoint at 12 months after ablation was observed in 41 patients (66%) in the RFM group and 25 (42%) in the UC group (HR 2.18, 95% CI 1.25-3.70, p=0.004). AF symptom severity was significantly improved in RFM group comparted to UC (p=0.009). Patients in the RFM group achieved significantly improved risk factor profile compared to UC: body weight (p=0.005), Systolic blood pressure (p=0.055), glycemic control (p=0.04) and exercise capacity (p=0.04).
Conclusion: Amongst patients with AF, elevated BMI and one additional cardiometabolic risk factor, aggressive risk factor management reduces arrhythmia recurrence in the 12-months following catheter ablation when compared with usual care. (Clinical Trial Registration: ACTRN12613000444785)