Department of Mechanical Engineering, Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD, 21218, USA.
Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National Hospital, Washington, USA.
Biomed Eng Online. 2023 Feb 28;22(1):19. doi: 10.1186/s12938-023-01085-z.
Pericardial access is necessary for the application of epicardial cardiac therapies including ablation catheters, pacing and defibrillation leads, and left atrial appendage closure systems. Pericardial access under fluoroscopic guidance is difficult in patients without pericardial effusions and may result in coronary artery damage, ventricular injury, or perforation with potentially life-threatening pericardial bleeding in up to 10% of cases. There is a clinical need for a pericardial access technique to safely deliver epicardial cardiac therapies.
In this paper, we describe the design and evaluation of a novel videoscope and tool kit to percutaneously access the pericardial space under direct visualization. Imaging is performed by a micro-CMOS camera with an automatic gain adjustment software to prevent image saturation. Imaging quality is quantified using known optical targets, while tool performance is evaluated in pediatric insufflation and pericardial access simulators. Device safety and efficacy is demonstrated by infant porcine preclinical studies (N = 6).
The videoscope has a resolution of 400 × 400 pixels, imaging rate of 30 frames per second, and fits within the lumen of a 14G needle. The tool can resolve features smaller than 39.4 µm, achieves a magnification of 24x, and has a maximum of 3.5% distortion within the field of view. Successful pericardial access was achieved in pediatric simulators and acute in vivo animal studies. During in vivo testing, it took the electrophysiologist an average of 66.83 ± 32.86 s to insert the pericardial access tool into the thoracic space and visualize the heart. After visualizing the heart, it took an average of 136.67 ± 80.63 s to access the pericardial space under direct visualization. The total time to pericardial access measured from needle insertion was 6.7 × quicker than pericardial access using alternative direct visualization techniques. There was no incidence of ventricular perforation.
Percutaneous pericardial access under direct visualization is a promising technique to access the pericardial space without complications in simulated and in vivo animal models.
在心外膜心脏治疗中，包括消融导管、起搏和除颤导线以及左心耳封堵系统，都需要进行心包穿刺。在没有心包积液的患者中，在透视引导下进行心包穿刺较为困难，可能导致冠状动脉损伤、心室损伤或穿孔，潜在危及生命的心包出血发生率高达 10%。目前临床上需要一种心包穿刺技术，以安全地提供心外膜心脏治疗。
在本文中，我们描述了一种新型内窥镜和工具包的设计和评估，以在直接可视化下经皮进入心包腔。成像由具有自动增益调节软件的微 CMOS 相机进行，以防止图像饱和。使用已知的光学靶标来量化成像质量，同时在儿科膨胀和心包穿刺模拟器中评估工具性能。通过婴儿猪的临床前研究（N=6）证明了设备的安全性和有效性。
该内窥镜的分辨率为 400×400 像素，成像速度为每秒 30 帧，可容纳在 14G 针的管腔中。该工具可分辨小于 39.4μm 的特征，实现 24 倍放大，在视场中最大失真度为 3.5%。在儿科模拟器和急性体内动物研究中成功进行了心包穿刺。在体内测试过程中，电生理学家平均需要 66.83±32.86s 将心包穿刺工具插入胸腔并观察心脏。在观察到心脏后，平均需要 136.67±80.63s 才能在直接可视化下进入心包腔。从针插入开始测量的心包穿刺总时间比使用替代直接可视化技术的心包穿刺时间快 6.7 倍。没有出现心室穿孔的情况。
在模拟和体内动物模型中，直接可视化下心包穿刺是一种有前途的进入心包腔的技术，没有并发症。
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