Ultra-Low-Temperature Cryoablation promising in Treatment of Ventricular Tachycardias: Study
A recent first-in-human clinical trial, Cryocure-VT, has unveiled an amazing advancement in the treatment of scar-dependent ventricular tachycardias (VTs). The trial investigated the safety and efficacy of a novel ultra-low-temperature cryoablation (ULTC) catheter system utilizing nitrogen cryogen at a chilling -196°C, showcasing remarkable potential in addressing this cardiac arrhythmia.
The trial results were published in the journal EP Europace: EHJ Arrythmias and Electrophysiology.
Ventricular tachycardia ablation technique has potentially increased in recent times. Ultra-low temperature cryoablation (ULTC) may offer potential advantages for VT ablation over conventional Radiofrequency techniques. Hence researchers conducted a study, to assess both the acute and long-term outcomes of VT ablation in a first-in-human, multi-center trial of a novel ULTC system, comprised of the VT ablation catheter and the cryoablation console. The study conducted across multiple centers, enrolled patients requiring de novo or secondary ablations for recurrent monomorphic VTs of both ischaemic and non-ischaemic origins. The primary endpoints included the freedom from major adverse events (MAEs) related to the device or procedure within 30 days post-ablation, acute non-inducibility of clinical VTs at the procedure's conclusion, and freedom from sustained VT or implantable defibrillator interventions at the six-month mark.
Findings:
- Out of the 64 patients enrolled (with a mean age of 67 years and predominantly ischaemic etiology), ultra-low temperature cryoablation demonstrated impressive acute effectiveness, achieving the primary endpoint in 94% of cases where post-ablation induction was attempted.
- Importantly, the procedure exhibited an excellent safety profile, with no protocol defined MAEs reported. Even in cases where procedure-related serious adverse events occurred, they were promptly resolved without lasting clinical consequences.
- At the six-month follow-up, a significant proportion of patients remained free from VT, with a notable reduction in the burden of ventricular arrhythmias, particularly in those with prior implantable defibrillators.
- Notably, the efficacy of ULTC cryoablation was consistent across both ischaemic and non-ischaemic cardiomyopathy cohorts, underscoring its broad applicability in diverse patient populations.
- At 6-month follow-up, 60.3% remained VT-free, and freedom from ICD shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts.
These findings mark a pivotal milestone in the field of cardiac electrophysiology, offering new hope for patients suffering from scar dependent VTs. By leveraging ultra-low temperatures to create lesions with customizable depth and minimal scar attenuation, ULTC cryoablation presents a promising alternative to conventional ablation techniques. Moreover, its demonstrated safety and effectiveness pave the way for further exploration and refinement, with the potential to revolutionize the management of ventricular tachycardias and improve patient outcomes worldwide.
Further reading: Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. Doi: https://doi.org/10.1093/europace/euae076
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