Patient-Reported Outcome Measures Following Pulsed-Field Ablation Versus Thermal Ablation of Atrial Fibrillation: The PROMs-PFA Study.

BACKGROUND

Pulsed-field ablation (PFA) has transformed atrial fibrillation (AF) ablation, but how the early patient experience compares with thermal techniques remains unclear. This study aimed to assess patient-reported outcome measures (PROMs) in the first 3 months after PFA or thermal AF ablation, using a novel smartphone-based application.

METHODS

Patients undergoing first-time pulmonary vein isolation prospectively completed the Cardiac Ablation Recovery Evaluation (CARE) symptom questionnaire at five timepoints: 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). Patients also completed the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire at baseline and day 90.

RESULTS

Two hundred and two patients were included (pentaspline PFA: 66; radiofrequency: 64; cryoballoon: 72), with similar baseline demographics between groups, except for a lower prevalence of paroxysmal AF in the PFA group. Engagement with the smartphone-based platform was high, with a 94.7% completion rate. Median AFEQT scores improved from 64 (47-82) at baseline to 86 (72-95) at day 90 (p < 0.001), with no significant differences between modalities (p = 0.841). However, CARE detected differences in early symptom experience: chest pain was lowest with PFA at day 1 (median: PFA, 1 [0-2]; radiofrequency, 2 [1-2]; cryoballoon, 2 [1-2]; p < 0.001), and remained lower than cryoballoon at day 7 (p = 0.019), with differences resolving by day 30. Moderate-to-severe chest pain (score ≥ 3) occurred in only 12.3% of PFA patients at day 1, compared with 21.2% cryoballoon and 26.2% radiofrequency patients (p < 0.001). Palpitations at day 1 were less frequent with PFA than radiofrequency (p = 0.040). Groin discomfort was lower with radiofrequency than PFA or cryoballoon at day 1 (p = 0.006) and day 7 (p < 0.001), likely reflecting a smaller sheath size.

CONCLUSIONS

PFA was associated with a modest and transient reduction in early post-procedural chest pain compared with thermal ablation. Smartphone application-based PROMs collection using the CARE questionnaire was feasible, enabling structured assessment of symptom burden across multiple recovery timepoints.