Real-world comparison of spherical pulsed field and point-by-point radiofrequency ablation for pulmonary vein isolation: insights from the best ablate registry
V Tscholl, C Baldauf, T Chiba, N Wainstejn, R Haetasch, T Althoff, T Hohendanner, N Dagres, G Hindricks, A Sepehri ShamlooAbstract
Background
Pulsed field ablation (PFA) with a Spherical large-footprint catheter has recently been introduced as an alternative to conventional point-by-point radiofrequency ablation (RFA) for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Comparative real-world data on procedural efficiency and efficacy are limited.
Methods
This prospective observational analysis included all consecutive patients who underwent first-time PVI with either spherical PFA (AFFERA) or point-by-point RFA. A 4:1 propensity score-matching was performed with a maximum score difference of 10%. All patients underwent clinical follow-up for at least 12 months. The primary endpoint was freedom from atrial arrhythmia recurrence. Secondary endpoints included procedural efficiency and safety parameters.
Results
The final propensity-matched cohort comprised 185 patients treated with either spherical PFA (n = 37) or RFA (n = 148). Baseline characteristics were comparable between groups. Total procedure duration did not differ significantly between PFA and RFA (84.5 [74.0–100.0] min vs 78.0 [63.0–98.0] min; p = 0.129), whereas total ablation time was markedly shorter with spherical PFA (5.0 [4.6–5.6] min vs 18.4 [15.4–22.1] min; p < 0.001). Fluoroscopy time was numerically lower in the PFA group but not statistically significant. Periprocedural and early postoperative complication rates were low and comparable (stroke/TIA within 48 h: 0% vs 1.4%; groin complication: 1 in each group). After the blanking period, AF recurrence occurred in 7 (21.9%) PFA and 38 (29.2%) RFA patients (p = 0.511). Kaplan–Meier analysis showed similar 12-month arrhythmia-free survival (log-rank p = 0.479).
Conclusions
In this real-world, propensity-matched analysis, spherical PFA demonstrated comparable arrhythmia-free survival to conventional RFA while significantly reducing ablation time. These findings suggest that spherical PFA may offer a more efficient yet equally effective approach for pulmonary vein isolation in routine clinical practice.