Feasibility and safety of a novel blunt tip concealed needle device for pericardial access in porcine models.

BACKGROUND: Percutaneous pericardial access is the cornerstone of various procedures in clinical cardiology. The two commonly used methods utilizing large bore (LB) and smaller micropuncture (MP) needles often lead to inadvertent RV punctures. As both of these techniques push the pericardium inward, the novel blunt tip concealed needle device (BTCND) introduces the concept of bringing a small portion of the pericardium into a tube, where needle puncture and guidewire can be passed into the pericardial space all within the safety of the tube. METHODS: The BTCND (Via One®, CardioVia, Nazareth, Israel) is a tool designed to allow for safe percutaneous subxiphoid pericardial access. In this preclinical study, a total of 18 procedures were performed in 5 female pigs. All procedures were performed under general anesthesia and under fluoroscopic guidance with a team of veterinarians and cardiac electrophysiologists. A laparoscopic camera was used to demonstrate and record the procedure. The Institutional Animal Care and Use Committees approved all preclinical experiments. RESULTS: A total of 18 procedures were performed on five female pigs. In all procedures, the physicians safely introduced guidewire into the pericardial space. Device operation was not associated with any adverse events or bleeding, nor was any damage seen to the pericardium, the heart, or other organs during the procedure. CONCLUSION: The result of our preclinical report demonstrates that the device is intuitive, easy to use, and effective for its intended use. Large preclinical studies are needed to validate the results of the study.