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Evaluation Of A Novel Cryoablation System Based On Liquid Nitrogen: Safety And Efficacy In The In-vivo Study
Mariusz Kowalewski
1, Grzegorz Wroblewski
2, Paul F. Gründeman
3, Adam S. Budzikowski
4,
Piotr Suwalski1.
1Department of Cardiac Surgery and Transplantology, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland,
2Warsaw University of Technology, Warsaw, Poland,
3Deptartment of Cardiothoracic Surgery, UMC Utrecht, Utrecht, Netherlands,
4Division of Cardiology, SUNY Downstate Health Sciences University, New York, NY, USA.
BACKGROUND:Cryoablation is widely used in the surgical treatment of atrial fibrillation due to its effectiveness and minimal destructiveness to heart tissue. However, there are limited studies evaluating the macroscopic and histological changes following cryoablation. The aim of this study was to assess the efficacy of a novel cryoablation device in creating transmural endocardial lesions on a beating heart in a porcine model.
METHODS:In six domestic pigs, the right atrial appendage and inferior vena cava were isolated using a bipolar radiofrequency clamp to establish areas of known conduction block (Figure 1). Connecting ablation lines were created endocardially via a purse-string approach using a novel, malleable 10 cm cryoprobe set to −100°C for 30 seconds. Additional ablation lines were performed at the free wall edge of the right atrium. Electrophysiological and histological studies were conducted four weeks postoperatively to evaluate the effectiveness of the ablation lines.
Figure 1. Diagram illustrating ablation lines, and energies.
RESULTS:All animals survived the surgical ablation procedure and the four-week postoperative period. No intraoperative or postoperative cardiac arrhythmias were observed, and all animals remained in sinus rhythm until sacrifice. Transmural lesions were confirmed in all cross-sections of the cryoablation lines. Microscopically, scarring consistently involved the full thickness of the right atrial wall, with necrotic or degenerated myocardial cells evident in the surrounding scar tissue.
CONCLUSIONS:The liquid nitrogen-based cryoablation device successfully created transmural lesions in the right atrium on a beating heart, resulting in sustained conduction delay. While cryoablation with this device is feasible, further studies are necessary to confirm its effectiveness in human patients cryoablation with this device is feasible, further studies are necessary to confirm its effectiveness in human patients.
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