A pulmonary vein and sleeve two-step strategy with occlusion-guided pulsed field ablation using a balloon-in-basket approach: the PEAR workflow
A Urbani, M G Melanie Gunawardene, J K Joseph Antoine Kheir, D S David Schaack, L U Lukas Urbanek, M R Matteo Rocchetti, S N Soroosh Aminolsharieh Najafi, A S Alexandra Steyer, A M Alexandra Marx, J L Julia Lurz, B S Boris Schmidt, J C Julian ChunAbstract
Background
Pulsed field ablation (PFA) is a novel non-thermal energy source for atrial fibrillation (AF) ablation. We evaluated a structured two-step Pulmonary vein and slEeve Ablation stRategy (PEAR workflow) using a balloon-in-basket PFA catheter with integrated occlusion guidance and mapping.
Purpose
To assess the feasibility, procedural efficiency, safety, and hemolysis profile of the PEAR workflow in consecutive AF patients.
Methods
Fifty consecutive patients undergoing first-time AF ablation were treated under deep sedation using the balloon-in-basket PFA catheter. The PEAR workflow comprised (1) four occlusion-guided antral PFA applications with full balloon inflation, followed by (2) two distal, partially deflated ("pear-shaped") applications targeting the PV sleeves. Procedural, efficacy, and laboratory parameters were analyzed.
Results
All 199 pulmonary veins were successfully isolated (100% acute PVI). Median procedure and fluoroscopy times were 50 min (IQR 41–60) and 7.2 min (IQR 5.8–11.4), respectively, with no major complications and two transient phrenic nerve palsies. Post-procedural laboratory testing showed minimal hemolysis: creatinine (pre-ablation 0.98 ± 0.25 mg/dl vs. post-ablation 0.98 ± 0.24 mg/dl, p=0.272), haptoglobin (pre: 110 ± 33 g/l vs. post: 105 ± 34 g/l post, p=0.061) and hemoglobin values (pre: 13 ± 1.5 g/dl vs. post: 13 ± 1.4 g/dl, p=0.377), before and one day after PFA did not differ.
Conclusion
The PEAR two-step workflow enables rapid, efficient, and safe PVI with minimal hemolysis and preserved renal function. Occlusion-guided positioning and sleeve-targeted ablation provide a reproducible, operator-friendly approach supporting streamlined clinical adoption.