Patient-reported outcome measures following pulsed-field ablation versus thermal ablation of atrial fibrillation: results of the prospective PROMs-PFA study

Background Pulsed field ablation (PFA) has emerged as a novel non-thermal energy source for atrial fibrillation (AF) ablation, demonstrating favourable safety, efficacy and procedural efficiency profiles. However, comparative data on early post-procedural symptom burden and recovery experience between PFA and conventional thermal ablation are limited. Early patient-reported symptoms are clinically relevant, as they may influence recovery trajectories and patient satisfaction. Purpose This study aimed to prospectively evaluate patient-reported outcome measures (PROMs) within the first three months following PFA or thermal AF ablation, using a novel smartphone-based digital platform. Methods Patients undergoing first-time pulmonary vein isolation were prospectively enrolled and completed the newly-developed Cardiac Ablation Recovery Evaluation (CARE) questionnaire at baseline, day 1, day 7, day 30, and day 90. Symptoms were rated on a 7-point Likert scale (0 = not at all; 6 = extremely). Health-related quality of life was assessed using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire at baseline and day 90. Results A total of 202 patients were included (PFA: 66; radiofrequency: 64; cryoballoon: 72). Baseline characteristics were comparable between groups, except for a lower prevalence of paroxysmal AF in the PFA cohort. Adherence to the digital PROMs platform was high, with 94.7% of all scheduled questionnaires completed. Median AFEQT scores improved from 64 [47–82] at baseline to 86 [72–95] at day 90 (p<0.001), with no difference between ablation modalities (p=0.841). However, the CARE questionnaire revealed modality-specific differences in early recovery. Chest pain was lowest following PFA at day 1 (median: 1 [0–2]) compared with radiofrequency (2 [1–2]) and cryoballoon (2 [1–2]) ablation (p<0.001) [Figure 1], and remained lower than cryoballoon at day 7 (p=0.019), before converging by day 30. Moderate-to-severe chest pain (score ≥ 3) occurred in 12.3% of PFA patients versus 26.2% radiofrequency and 21.2% cryoballoon (p<0.001). Palpitations at day 1 were less frequent after PFA than radiofrequency ablation (p=0.040) [Figure 2]. Groin discomfort was lower after radiofrequency than PFA or cryoballoon at day 1 (p=0.006) and day 7 (p<0.001), consistent with differences in sheath size. Conclusion PFA was associated with a lower incidence and severity of early post-procedural chest pain compared with thermal ablation, while quality-of-life improvements at 90 days were comparable across modalities. Smartphone-based PROMs collection using the CARE questionnaire was highly feasible, enabling granular assessment of symptom recovery trajectories following AF ablation.