Development of Simple and Safe System for Percutaneous Left Heart Bypass

本研究的主要目的是开发一种新的经皮左心转流系统，并评价该系统在临床患者中的实用性和安全性。1992年，我们与日本东京的MEDIKIT公司合作开发了一种经皮左心搭桥系统，该系统由经皮左心房插管(18Fr.)股动脉插管(14Fr.)左房插管在距插管尖端3.5 cm处有20个小孔(Phi 1.5 mm)，在距尖端50 mm处成60度角。该系统在经食道超声心动图(TEE)的引导下，使用类似于井上的二尖瓣球囊成形术的技术，设计成容易和安全地安装。为了确定建立该系统的技术程序，我们用狗进行了一系列的动物实验。在确认了该系统的设置过程的简便性和安全性之后，我们将该系统应用于一名患有严重缺血性心脏病和CA…的患者。在患者及其家人完全知情同意的情况下，于1992年在经皮冠状动脉腔内成形术中发生更多心脏衰竭)。1992~1994年间，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著的恢复，然而，我们最终失去了6名患者，这是由于应用该系统之前已经存在的心功能恶化。尸检未发现与该系统有关的并发症，包括房间隔穿刺点。TEE引导需要增加一名专家来操作TEE系统，并且患者有明显的不适，因此我们于1994年引入了心内超声系统(ICUS)来指导房间隔穿刺术。我们可以证实，在TEE或ICU的指导下，即使在没有X光安排的重症监护病房中，我们的PLHB系统也可以在很短的时间内非常容易地建立起来。较少

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