Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results

Martijn N Klaver, Tom J R De Potter, Konstantinos Iliodromitis, Alexander Babkin, David Cabrita, Davide Fabbricatore, Lucas V A Boersma, Martijn N Klaver, Tom J R De Potter, Konstantinos Iliodromitis, Alexander Babkin, David Cabrita, Davide Fabbricatore, Lucas V A Boersma

Abstract

Introduction: Cryoablation has evolved as a safe alternative to radiofrequency ablation in the treatment of several supraventricular arrhythmias and has potential advantages, yet is limited by the properties of the cryogen used. We investigated a novel ultralow temperature cryoablation (ULTC) system using nitrogen near its liquid-vapor critical point as a freezing source, achieving temperatures as low as -196 degrees Celsius in a long linear catheter with a continuous energy release. Initial safety, procedural and efficacy outcomes of ULTC are described in patients undergoing cavotricuspid isthmus (CTI) ablation.

Methods and results: The Cryocure studies (NCT02355106, NCT02839304) are prospective, single-arm, multi-center, first-in-human clinical studies in 17 patients with atrial flutter (AFL) and 13 patients with atrial fibrillation (AF). A total of 30 patients, mean age 65 ± 8 years old and 67% male, were enrolled and underwent ablation of the CTI. Acute success, defined as the confirmation of stable bidirectional conduction block across the CTI, was achieved in all 30 patients. After 12 months of follow-up, 14 out of 17 AFL patients remained free from any AFL. One (3.3%) procedure-related but not device-related serious adverse event was reported, involving transient inferolateral ST-elevation associated with temporary AV conduction block.

Conclusion: In this first-in-human clinical study the safety and performance results demonstrate the capabilities of ultralow temperature near-critical nitrogen as an effective energy source for CTI ablation. Ongoing, larger, studies should confirm our findings and evaluate the capabilities to create linear and focal transmural lesions in other arrhythmias.

Keywords: cavotricuspid isthmus; cryoablation; first-in-human; near-critical nitrogen; ultralow temperature.

Conflict of interest statement

Tom J. R. De Potter and Lucas V. A. Boersma report consultancy fees for Adagio. Alexander Babkin and David Cabrita acknowledge salary and stock options compensation as Adagio Medical employees. Alexander Babkin and David Cabrita acknowledge to be authors of Adagio Medical patents related to catheters using the technology described. David Cabrita acknowledges to be a current employee at Medtronic, a company that may closely compete with the devices used in this study.

© 2021 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals LLC.

Figures

Figure 1
Figure 1
Adagio cryoablation catheter and fluoroscopic images of catheter positioning. (A) Photograph and (B) illustration of the Adagio medical flutter catheter using a convex approach. (C) Fluoroscopic visualization in a right anterior oblique projection of the convex approach and (D) the linear approach is visualized on fluoroscopy in a left anterior oblique projection

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