Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies

Abstract Aims The ultra-low-temperature cryoablation (ULTC) ablation system using −196°C N2 cryogen has been reported to create lesions with freeze duration–dependent depth titratable to over 10 mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evalua...

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Published inEuropace (London, England) Vol. 26; no. 4
Main Authors Verma, Atul, Essebag, Vidal, Neuzil, Petr, Dyrda, Katia, Balt, Jippe, Dinov, Borislav, Darma, Angeliki, Arya, Arash, Sacher, Frederic, Reddy, Vivek Y, Boersma, Lucas, Grigorov, Ilya, De Potter, Tom
Format Journal Article
LanguageEnglish
Published UK Oxford University Press 30.03.2024
Subjects
Aged
Cardiomyopathies - complications
Cardiomyopathies - diagnosis
Cardiomyopathies - surgery
Catheter Ablation - adverse effects
Cicatrix - complications
Clinical Research
Cryosurgery - adverse effects
Humans
Middle Aged
Prospective Studies
Tachycardia, Ventricular - diagnosis
Tachycardia, Ventricular - etiology
Tachycardia, Ventricular - surgery
Temperature
Treatment Outcome
Ventricular tachycardia
Clinical trial
Cryoablation
Ultra-low
Ablation
Outcomes
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Summary:Abstract Aims The ultra-low-temperature cryoablation (ULTC) ablation system using −196°C N2 cryogen has been reported to create lesions with freeze duration–dependent depth titratable to over 10 mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evaluating the safety and efficacy of a novel, purpose-built ULTC catheter in endocardial ablation of scar-dependent ventricular tachycardias (VTs). Methods and results This prospective, multi-centre study enrolled patients referred for de novo or second ablations of recurrent monomorphic VT of both ischaemic and non-ischaemic aetiologies. Primary safety and efficacy endpoints of the study were freedom from device- or procedure-related major adverse events (MAEs) up to 30 days post-ablation, acute non-inducibility of clinical VTs at the end of the procedure, and freedom from sustained VT or implantable defibrillator intervention at 6 months. Ultra-low-temperature cryoablation was performed in 64 patients (age 67 ± 11 years, 78% ischaemic, ejection fraction = 35 ± 10%) at 9 centres. The primary acute effectiveness endpoint was achieved in 94% (51/54) of patients in whom post-ablation induction was attempted. There were no protocol-defined MAEs; four procedure-related serious adverse events resolved without clinical sequelae. At 6-month follow-up, 38 patients (60.3%) remained VT-free, and freedom from defibrillator shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts. In 47 patients with defibrillator for at least 6 months prior to the ablation, the VT burden was reduced from median of 4, inter-quartile range (IQR, 1–9) to 0, IQR (0–2). Conclusion In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients with both ischaemic-cardiomyopathy and non-ischaemic-cardiomyopathy. Clinical Trial Registration NCT04893317. Graphical Abstract Graphical Abstract
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Conflict of interest: A.V. reports being a consultant for Biosense Webster, Medtronic, Adagio Medical, Medlumics, and Abbott. L.B. reports being a consultant for Medtronic, Boston Scientific, and Adagio Medical. All fees go to the cardiology department. V.E. is supported by a Clinical Research Scholar Award from the Fonds de Recherche du Quebec Santé (FRQS) and reports honoraria from Abbott, Biosense Webster, Boston Scientific, and Medtronic. V.Y.R. reports serving as a consultant to Adagio Medical, unrelated to this manuscript. V.Y.R. has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, 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-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare, unrelated to this work. V.R. has served as a consultant for Abbott, AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, and Pulse Biosciences, unrelated to this work, V.R. has equity in Atraverse, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. I.G. is an employee of Adagio Medical. T.D.P. reports receiving institutional payments related to study activities from Adagio Medical, unrelated to this manuscript and reports receiving institutional payments for consultancy from Abbott, Boston Scientific, GE, J&J, and Medlumics. All remaining authors have declared no conflicts of interest.
ISSN:1099-5129
1532-2092
DOI:10.1093/europace/euae076