Curved pericardial puncture needle: a novel pericardial puncture device

Abstract Background Pericardial puncture is a common clinical procedure used in the management of pericardial tamponade and epicardial ablation. However, it carries significant risks and is technically challenging, particularly in cases of dry pericardial puncture without pericardial effusion. We have developed a novel, curved, electrically conductive pericardial puncture kit designed to reduce procedural complications and the learning curve associated with pericardial puncture (Figure 1). Purpose To evaluate the feasibility, safety, and ease of use of a novel curved pericardial puncture kit for dry pericardial access in an animal model. Methods Four adult Beagle dogs were selected as the study subjects, with pericardial punctures performed using the novel curved pericardial puncture kit at two access points: subxiphoid and apical, with 1–2 punctures at each site, under general anesthesia. The procedures were conducted by two electrophysiologists. Efficacy and operability of the device were assessed by measuring puncture success rate, procedure time, radiation dose, and electrical conductivity of the puncture kit. Safety was evaluated by monitoring for complications at 30 minutes and 24 hours post-procedure. This study was approved by the local animal ethics committee (IACUC approval number: IACUC-C2024047). Results A total of 12 punctures were performed in the four dogs, with six punctures at each site (subxiphoid and apical). The puncture success rate was 100%. The median procedure time was 37 seconds (P25, P75: 23.25–70.5 seconds). The first puncture attempt at each site required a mean of 105.5 seconds (61.5–221.5 seconds), with subsequent punctures showing a significantly reduced median time of 30.5 seconds (20.25–38 seconds, p=0.04; Figure 2). The device demonstrated good electrical conductivity, with a marked increase in amplitude on unipolar electrograms after penetrating the fibrous pericardium. Chest X-rays and echocardiography performed 30 minutes and 24 hours post-procedure revealed no pericardial effusion, pleural effusion, or pneumothorax. One dog underwent thoracotomy and macroscopic examination 30 minutes post-procedure, showing no effusion in the thoracic or pericardial cavities and no visible cardiac surface injury. Conclusion The novel curved pericardial puncture kit enables safe and efficient pericardial access, with a shortened procedure time and ease of use.figure 1-pericardial puncture kit figure 2-puncture time