Safety and Chronic Atrial Lesion Formation With a Large-Tip, Contact-Force-Sensing Multipolar Pulsed Field Ablation Catheter: Effect of Application Number in a Porcine Beating Heart Model
BACKGROUND: Integration of catheter-tissue contact force with pulsed field ablation (PFA) dosing is essential for achieving safe and durable lesion formation with contact force sensing catheters in ventricular models. However, data on the use of these catheters for atrial ablation remain limited. This study evaluated the procedural safety and 30-day lesion characteristics of atrial PFA delivered with the OMNYPULSE ablation catheter in a porcine model. METHODS: Twelve pigs were randomized to receive either 6 (×6 or Group A) or 12 (×12 or group B) PFA applications per ablation. Following 3-dimensional electroanatomic mapping, PFA was delivered to the right superior and inferior pulmonary veins, cavotricuspid isthmus, right atrial posterior wall, left atrial roof, and mitral annulus. Procedural safety was assessed acutely, and lesion characteristics were evaluated on 30-day histology. Maximum transmurality extent (MTE) was defined as >80% of the lesion span exhibiting continuous endocardial-to-epicardial fibrosis within representative histological sections. RESULTS: <0.001). Increasing the number of PFA applications (×12) resulted in a remarkable improvement in MTE at these locations, with MTE increases of up to 68% compared with ×6 dosing at these sites. CONCLUSIONS: Atrial PFA using the OMNYPULSE catheter was feasible and safe in a porcine model. However, lesion transmurality varied by atrial location and was dose-dependent at select sites, underscoring the need for site-specific PFA dosing strategies. Further studies are warranted to define optimal PFA parameters for consistent atrial lesion formation.
Authors
- Paras Parikh (ORCID: https://orcid.org/0009-0003-1744-6375)
- Sanghamitra Mohanty (ORCID: https://orcid.org/0000-0001-6601-944X)
- M Schiavone
- Aung Lin (ORCID: https://orcid.org/0000-0002-8624-7084)
- Jacopo Marazzato (ORCID: https://orcid.org/0000-0003-1205-5925)
- Hiroshi Nakagawa (ORCID: https://orcid.org/0000-0001-9368-519X)
- Fengwei Zou (ORCID: https://orcid.org/0000-0001-6355-8843)
- Assaf Govari
- Domingo Y Ynoa
- Christopher Beeckler
- Vincenzo Mirco La Fazia (ORCID: https://orcid.org/0000-0001-7548-4685)
- Taylor Spangler (ORCID: https://orcid.org/0009-0009-9394-293X)
- Tushar Sharma (ORCID: https://orcid.org/0000-0001-5857-4996)
- Luigi Di Biase
- Jonathan Hsu
- Xiaodong Zhang
- William Maddox (ORCID: https://orcid.org/0000-0002-5529-3221)
- Rahul Bhardwaj
- Devi Nair
- Andrea Natale
- Terrence Troutman
- Qi Chen
- Kevin Okarski
Institutions
- Cleveland Clinic (US)
- Montefiore Medical Center (US)
- University of San Diego (US)
- Loma Linda University (US)
- University of California San Diego (US)
- Centro Cardiologico Monzino (IT)
- St Bernard's Hospital (GI)
- Humanitas Mater Domini (IT)
- Texas Cardiac Arrhythmia (US)
- Hesco (United States) (US)
- Amec Foster Wheeler (United States) (US)
- SPX Corporation (United States) (US)
Publication Details
- Journal
- Circulation Arrhythmia and Electrophysiology
- Published
- 2026-04-01
- DOI
- https://doi.org/10.1161/circep.125.014473
- Primary Topic
- Cardiac Arrhythmias and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00