Influence of body mass index on pulsed field ablation: insights from the FARADISE global registry

Introduction Pulsed field ablation (PFA) has become a preferential atrial fibrillation (AF) treatment modality, and as its use has expanded, patients with more complex comorbidities have undergone ablation. Obesity is associated with an increased risk of AF, challenging ablation procedures, and an increase in AF recurrence. However, limited evidence is available as to how body mass index (BMI) influences patient safety and outcomes following PFA. The FARADISE registry provides insights into real-world data after PFA. Purpose To assess safety and long-term outcomes of AF patients in relation to BMI. Methods The FARADISE registry is a prospective, real-world registry enrolling AF patients clinically indicated for a pentaspline PFA procedure across sites in Europe, Middle East, and Asia Pacific. All patients were treated per hospital standard-of-care. Patients were categorized by BMI (<25, ≥25 and <30, ≥30 and <35, ≥35 kg/m2), and procedural characteristics, safety, and one-year clinical effectiveness were assessed across BMI cohorts. Clinical effectiveness was defined as freedom from arrhythmia recurrence, repeat procedure, or cardioversion. Results The FARADISE registry treated 1159 patients, including 358 with a BMI <25, 478 with a BMI ≥25 and <30, 237 with a BMI ≥30 and <35, and 86 with a BMI ≥35. CHA2DS2-VA scores were consistent across patient BMI cohorts, while patient age inversely correlated with BMI (Table 1). Female sex (<25: 35%, ≥25 and <30: 30%, ≥30 and <35: 31%, ≥35: 49%, p<0.01) and diabetes history (<25: 8%, ≥25 and <30: 9%, ≥30 and <35: 16%, ≥35: 27%, p<0.01) increased with BMI, whereas paroxysmal AF indication decreased with BMI (<25: 72%, ≥25 and <30: 67%, ≥30 and <35: 57%, ≥35: 49%, p<0.01). Procedure times were similar across cohorts, although left atrial dwell time modestly increased with BMI (<25: 30 [24, 40] minutes, ≥25 and <30: 31 [23, 40] minutes, ≥30 and <35: 31 [25, 39] minutes, ≥35: 36 [27, 53] minutes, p<0.01). The pulmonary vein isolation (PVI)-only ablation strategy was not statistically different between BMI groups (<25: 75%, ≥25 and <30: 73%, ≥30 and <35: 72%, ≥35: 65%, p=0.36). Early-onset serious adverse events were low across BMI groups, ranging from 1.2% and 1.7% (p=0.98). Within the four BMI groups, clinical effectiveness decreased with increasing BMI, although the trend was not statistically significant (<25: 80%, ≥25 and <30: 76%, ≥30 and <35: 74%, ≥35: 69%, p=0.07) (Figure 1). Conclusion These findings highlight the applicability of the pentaspline PFA catheter among patients with elevated BMI, traditionally considered a high-risk and low-success population. This evidence supports the use of the pentaspline PFA catheter as an inclusive treatment strategy, with safe and effective procedures across a broad patient population.