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. 2023 Aug;9(8 Pt 3):1786-1801.
doi: 10.1016/j.jacep.2023.04.002. Epub 2023 Apr 16.

A Focal Ablation Catheter Toggling Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation

Vivek Y Reddy  1 , Petr Peichl  2 , Elad Anter  3 , Gediminas Rackauskas  4 , Jan Petru  5 , Moritoshi Funasako  5 , Kentaro Minami  5 , Jacob S Koruth  6 , Andrea Natale  7 , Pierre Jais  8 , Germanas Marinskis  4 , Audrius Aidietis  4 , Josef Kautzner  2 , Petr Neuzil  5
Affiliations
Free article

A Focal Ablation Catheter Toggling Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation

Vivek Y Reddy et al. JACC Clin Electrophysiol. 2023 Aug.
Free article

Abstract

Background: Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI.

Objectives: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF.

Methods: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55).

Results: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention.

Conclusions: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307).

Keywords: atrial fibrillation; catheter ablation; cavotricuspid isthmus; lattice tip; lesion durability; mitral isthmus; pulmonary vein isolation; pulsed field ablation; roof line; temperature controlled.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by a research grant from Affera Inc. Drs Reddy and Anter have received research grants from Affera, Inc. Drs Reddy, Anter, Koruth, and Jais hold stock options in Affera, Inc. Dr Reddy has served as a consultant to Kardium Inc (including Equity); is a consultant to Abbott, Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, AtiAN, Autonomix, Axon Therapies, Backbeat, BioSig, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, CardiaCare, Cardiofocus, Cardionomic, CardioNXT / AFTx, Circa Scientific, CoreMap, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EBR, EPD-Philips, EP Frontiers, Epix Therapeutics, EpiEP, Eximo, Farapulse-Boston Scientific, Fire1, Focused Therapeutics, Gore & Associates, HRT, Impulse Dynamics, Intershunt, Javelin, Keystone Heart, LuxMed, Medlumics, Medtronic, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Philips, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath, and Valcare; and has equity from Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT / AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics, EpiEP, Eximo, Farapulse-Boston Scientific, Focused Therapeutics, HRT, Intershunt, Javelin, Keystone Heart, LuxMed, Manual Surgical Sciences, Medlumics, Middlepeak, Neutrace, Newpace, Nuvera-Biosense Webster, Nyra Medical, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Surecor, Valcare, and Vizaramed. Dr Peichl has received speaker honoraria from Abbott, Biosense Webster, Biotronik, Medtronic, MSD, Pfizer, and ProMed sro. Dr Anter has received research grants from Biosense Webster and Boston Scientific; and stock options from Itamar Medical. Dr Natale has received speaker honoraria from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik, and Medtronic; and is a consultant for Biosense Webster, Baylis Medical, Boston Scientific, Bristol-Myers Squibb, Biotronik, St. Jude Medical, and Medtronic. Dr Kautzner has received personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, Merck Sharp & Dohme, Merit Medical, and St. Jude Medical (Abbott) for participation in scientific advisory boards; and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Medtronic, Merck Sharp & Dohme, Mylan, Pfizer, ProMed sro, and St. Jude Medical (Abbott). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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