Early clinical experience with single-catheter map-and-ablate pentaspline PFA workflows in Europe: findings from the OPALISE Sub-Study of the FARAVERSE Registry
S C Yap, G Massoullie, D G Latcu, A Da Costa, G Szeplaki, G Andrikopoulos, N Perez Castellano, A Lepillier, S Boveda, R Schoenbauer, J D Martinez Alday, N Fragakis, M Martens, P DefayeAbstract
Background
Pulsed field ablation (PFA) is an established non-thermal energy modality for the treatment of atrial fibrillation (AF). As clinical adoption expands, focus has shifted toward workflow efficiency and procedural precision, including accurate lesion delivery and consistent tissue contact. Technologies that integrate electroanatomical mapping (EAM) and PFA within a single catheter enable streamlined map-and-ablate workflows and may reduce procedure time, radiation exposure and reliance on adjunctive imaging modalities. Although feasibility has been demonstrated, real-world European data utilizing the second-generation mapping-integrated pentaspline PFA catheter remains limited.
Purpose
To characterize procedural metrics and early safety outcomes associated with adoption of an integrated map-and-ablate PFA workflow in routine clinical practice across the European Union.
Methods
OPALISE is a prospective, observational sub-protocol of the FARAVERSE global registry enrolling up to 550 patients treated with a second-generation mapping-integrated pentaspline PFA catheter. Consecutive patients undergoing AF ablation were included, with procedures performed according to local standard practice. Procedural characteristics and acute safety outcomes were analyzed, including a predefined sub-analysis of de novo and redo cases.
Results
At submission, 346 patients were enrolled (mean age 65.0±11.5 years; 34.3% female; 56.9% paroxysmal AF), including 78.9% de novo and 21.1% redo cases. A map-and-ablate workflow was more frequently used in de novo versus redo cases (74.3% vs. 52.1%; p<0.01) and was associated with shorter mapping times (6±6 vs. 9±10 minutes; p=0.01). Pulmonary vein isolation (PVI)-only strategies predominated in de novo cases (57.0% vs. 25.4%; p<0.01), whereas PVI-plus approaches were more common in redo procedures (74.6% vs. 43.0%; p<0.01). De novo cases resulted in more PV PFA lesions (53±23 vs. 44±21; p=0.02), with no differences in the total number of non-PV lesions. Despite greater substrate modification in redo cases, overall efficiency was maintained, with similar procedure duration (57±24 vs. 61±26 minutes; p=0.30), left atrial dwell time (35±18 vs. 36±17 minutes; p=0.99), fluoroscopy time (12±7 vs. 11±6 minutes; p=0.29). Acute procedural success was comparable between cohorts. No device-related coronary spasm, transient ischemic attack, or phrenic nerve injury have been reported. Enrollment and monitoring are ongoing, complete acute procedural and safety data will be available at presentation.
Conclusions
In this prospective European registry, early adoption of an integrated EAM-guided PFA workflow was associated with consistent procedural efficiency in both de novo and redo AF ablation. These findings demonstrate that the second-generation mapping-integrated pentaspline PFA catheter supports implementation of map-and-ablate strategies across diverse European practice settings.