Epicardial Pulsed Field Ablation of Ganglionated Plexi: Computational and Pre-Clinical Evaluation of a Bipolar Sub-Xiphoid Catheter for the Treatment of Atrial Fibrillation

Barry O'Brien; John Reilly; Ken Coffey; Ana González-Suárez; Piotr Buchta; Piotr P Buszman; Karolina Lukasik; Jason Tri; Martin van Zyl; Samuel Asirvatham

doi:10.3390/bioengineering11010018

Epicardial Pulsed Field Ablation of Ganglionated Plexi: Computational and Pre-Clinical Evaluation of a Bipolar Sub-Xiphoid Catheter for the Treatment of Atrial Fibrillation

Bioengineering (Basel). 2023 Dec 24;11(1):18. doi: 10.3390/bioengineering11010018.

Authors

Barry O'Brien¹, John Reilly¹, Ken Coffey¹, Ana González-Suárez^{2

3}, Piotr Buchta^{4

5

6}, Piotr P Buszman^{6

7}, Karolina Lukasik⁶, Jason Tri⁸, Martin van Zyl⁹, Samuel Asirvatham⁸

Affiliations

¹ AtriAN Medical Ltd., Unit 204, Business Innovation Centre, Upper Newcastle, H91 W60E Galway, Ireland.
² Translational Medical Device Laboratory, School of Medicine, University of Galway, H91 YR71 Galway, Ireland.
³ Valencian International University, Valencia, Spain.
⁴ 3rd Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, 40-055 Katowice, Poland.
⁵ Silesian Center for Heart Diseases, 41-800 Zabrze, Poland.
⁶ Center for Cardiovascular Research and Development, American Heart of Poland, Kostkowice, Poland.
⁷ Andrzej Frycz Modrzewski Kraków University, 30-705 Kraków, Poland.
⁸ Mayo Clinic, Rochester, MN 55905, USA.
⁹ Royal Jubilee Hospital, University of British Columbia, Victoria, BC, Canada.

Abstract

Epicardial pulsed field ablation (PFA) of ganglionated plexi (GPs) is being explored as a potential treatment for atrial fibrillation. Initial work using open-chest access with a monopolar ablation device has been completed. This study describes the early development work for a device that can be used with subxiphoid access and deliver bipolar ablation pulses. Electric field computational models have been used for the initial guidance on pulse parameters. An in vivo assessment of these ablation parameters has been performed in an open-chest canine study, while subxiphoid access and navigation of the device has been demonstrated in a porcine model. Results from this acute study have demonstrated the promising potential of this approach.

Keywords: atrial fibrillation; epicardial; ganglionated plexi; pulsed field ablation; subxiphoid.

Grants and funding

This research was funded by AtriAN Medical Ltd., with additional grant funding as follows: Government of Ireland, Disruptive Technologies Innovation Fund (grant No. DT20180123); Science Foundation Ireland (grant No. 22/PATH-S/10719); Spanish Ministerio de Ciencia e Innovación, Agencia Estatal de Investigación, Fondo Europeo de Desarrollo Regional (grant PID2022-136273OA-C33 funded by MCIN/AEI/10.13039/501100011033/FEDER, UE). The APC was funded by AtriAN Medical Ltd.