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

• Published in: Europace (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
• Language: English
• 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
• DOI: 10.1093/europace/euae076
• ISSN: 1099-5129

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