Development of Simple and Safe System for Percutaneous Left Heart Bypass

本研究的主要目的是首先开发一种新的经皮左心旁路系统，其次评估该系统在临床患者中的实用性和安全性。1992年，我们与日本东京Medikit公司合作，研制了一种经皮左心转流系统。和股动脉插管（14 Fr.）。左心房插管有20个小孔（φ 1.5 mm），距离插管头端3.5 cm内，与头端50 mm处成60度角。该系统设计为在经食管超声心动图（TEE）引导下使用与Inoue球囊二尖瓣成形术方法相似的技术轻松安全地设置。为了确认建立该系统的技术程序，我们使用狗进行了几个系列的动物实验。在确认了该系统的设置过程和安全性后，我们将该系统应用于严重缺血性心脏病患者， ...更多信息 1992年经皮腔内冠状动脉成形术期间的RDIAC失败），患者及其家属完全知情同意。1992 ~ 1994年，我们应用该系统治疗了9例心源性休克或严重心力衰竭患者。所有患者的血流动力学状况都得到了显着的恢复，然而，我们最终失去了6名患者，由于心脏功能的恶化，在应用该系统之前已经存在。尸检显示没有与该系统相关的并发症，包括房间隔穿刺部位。TEE引导需要一名额外的专家来操作TEE系统，并且患者有一定的不适感，因此我们于1994年引进了心内超声系统（ICUS）来引导房间隔穿刺。我们可以证实，即使在重症监护室，在TEE或ICUS引导下，在没有X线安排的情况下，我们的PLHB系统也可以在很短的时间内轻松设置。少

The main purpose of this research is firstly to develop anew system for percutaneous left heart bypass and secondly to evaluate the utility and safety of this system in clinical patients. In 1992, we developed a system of percutaneous left heart bypass in collaborating with Medikit company (Tokyo, Japan) which consists of a percutaneous left atrial cannula (18Fr.) and a femoral arterial cannula (14Fr.). The left atrial cannula has 20 small holes (phi 1.5mm) within 3.5 cm from the tip of the cannula and angled 60 degree at 50mm from the tip. This system was designed to be set up easily and safely with guidance of transesophageal echocardiography (TEE) using similar technique of Inoue's balloon mitral valuvuloplasty method. To confirm the technical procedure to set up this system we performed several series of animal experiment using dogs. After confirming the ease of set-up procedure and safety of the system, we applied this system for a patient with severe ischemic heart disease and ca … More rdiac failure during percutaneous trans luminal coronary angioplasty in 1992) with complete informed consent of the patient and his family. During the period of 1992 and 1994, we applied this system for 9 patients with cardiogenic shock or severe heart failure. A dramatic recovery of hemodynamic condition was obtained in all patients, however, we lost 6 patients ultimately due to the deterioration of the cardiac function which already existed prior to apply this system. Autopsy demonstrated no complication relating to this system including the the atrial septal punctured site. The TEE guidance requires an additional specialist to operating TEE system and a definite discomfort of the patient, therefore we r introduced intracardiac ultrasound system (ICUS) for the guidance of atrial transseptal puncture for set-up this system in 1994. We could confirm our PLHB system can be set up very easily even in the intensive care unit without X-ray arrangement within very short period with TEE or ICUS guidance. Less