PulseSelect vs FARAPULSE pulsed field ablation: Comparative analysis of myocardial, neural-injury and hemolysis biomarkers and short-term outcomes.

BACKGROUND

Randomized trials have demonstrated safety and efficacy of pulsed field ablation (PFA) for atrial fibrillation (AF) using the FARAPULSE™ system (PFA-F). We evaluated implementation of the PulseSelect™ system (PFA-P) in a PFA-F experienced center.

METHODS

This single-center study included 150 consecutive patients undergoing first pulmonary vein isolation (PVI) with PFA-P (n = 75) or PFA-F (n = 75). Procedural characteristics, acute efficacy, safety endpoints, AF recurrence rate, myocardial, neural and hemolysis biomarkers (high-sensitive troponin T, creatine kinase (CK), creatine kinase MB, bilirubin, haptoglobin, lactate dehydrogenase and S100) post ablation were analyzed and compared.

RESULTS

Baseline characteristics were comparable, except for a higher proportion of males in the PFA-F group. Acute PVI was comparable between groups (98% vs. 100%). Skin-to-skin time and radiation dose were similar, while fluoroscopy (14.3 vs. 11.9 min, p = 0.009) and LA-dwell time (18 vs. 14 min, p < 0.001) were higher in PFA-P. No major complication occurred, while minor complication rates were comparable. Cardiac biomarker release was significantly higher in PFA-P (ΔCK: 203 vs. 127 U/l, p = 0.005; Δtroponin: 1212 vs. 1014 pg/ml, p = 0.035 (day 1)), whereas neural injury markers were similar. Hemolysis markers indicated greater changes with PFA-F (Δbilirubin: 0.3 vs. 0.2 mg/dl, p = 0.004; Δhaptoglobin: -46.5 vs. -27.5 mg/dl, p = 0.001 (day1)). Procedural parameters improved with increasing PFA-P experience.

CONCLUSION

Implementation of PFA-P is feasible with an evident learning curve in a PFA-F experienced center. Higher post-procedural cardiac biomarker levels may suggest a greater extent of local myocardial tissue damage after PFA-P. The impact of biomarkers on long-term outcome requires further studies.