Interventional vascular occlusion treatment for varicose veins in lower extremity : in vivo assessment and development of clinical techniques

首先进行检查，以确定急性期和亚急性期介入血管闭塞治疗的原则。显露猪的上腹部静脉，插入导管和激光纤维。激光照射自横隔膜水平至插入部。治疗前后分别行静脉造影和肺血管造影。检查时重复测量动脉血压和动脉血气。对处理后的静脉进行病理检查。照射后静脉立即闭塞。检查过程中动脉血压、动脉血气均无变化，无肺栓塞记录。病理上，照射后即刻可见血管壁破坏、血管周围水肿和血管内血栓闭塞。2周后血管闭塞，血栓变性，由肉芽组织变为纤维组织，血管壁…弹力纤维和平滑肌丢失观察到的人数更多。通过这次检查，建立了置入导管和激光纤维的操作方法，并证实了以下几点；局部安全，无肺栓塞风险，血管血栓闭塞。治疗后观察6个月的自然病程，评价弹性绷带防止治疗后血管再通畅的效果。中试实验证实血管闭塞持续2个月，而由于动物活跃度高，难以持续佩戴弹性绷带，以及生长过程中获得的病理数据的正确性，需要重新设计实验方案。在此报告的基础上，经我所伦理委员会批准后，开始临床申请。研究对象包括因大隐静脉不足而出现静脉曲张的患者。治疗前总是获得书面知情同意。目前，在所有的随访期(最长8个月)都观察到大隐静脉完全阻塞。2003年至2005年在日本和美国(日本放射学会、AJR、日本血液学学会等)多次发表研究结果，并将于2005年在欧洲心血管和介入放射学会上发表。较少

First examination was carried out to determine principles of the interventional vascular occlusion treatment in acute and sub-acute phases. The epigastric vein in a pig was exposed, and a catheter and a laser fiber were inserted. Laser irradiation was performed from diaphragm level to insertion part. Venograms and pulmonary angiograms were obtained before and after treatment. Arterial blood pressure and arterial blood gas were measured repeatedly during examination. The treated vein was examined pathologically. The vein was blocked right after the irradiation. Arterial blood pressure and arterial blood gas did not change during examination, and pulmonary embolism was not recorded. Pathologically, destruction of vessel wall, perivascular edema and intravascular thrombotic occlusion were observed just after the irradiation. Two weeks later, vessel occlusion, degeneration of thrombus, change from granulation tissue to fibrous tissue, loss of elastic fiber and smooth muscle in vessel wall … More were observed. By this examination, the maneuver to insert a catheter and a laser fiber was established, and followings were confirmed ; local safety, no risk of pulmonary embolism, strong thrombotic occlusion of the vessel.Next examination was carried out to observe a natural course after the treatment up to 6 months, and to assess the effect of elastic bandage to prevent re-canalization of the treated vessel Continuation of vascular occlusion was confirmed for two months in pilot experiments, while remodeling of experimental protocol was needed because of high activity of the animal, difficulty to wear the elastic bandage continuously, and validity of pathological data obtained from an animal in growth process.On the other hand, there was a report with long-term observation from United States. On basis of this report, clinical application was started after approval by the ethical committee of our institute. Patients with varicose veins due to insufficient great saphenous vein were included in the study. Written informed consent was always obtained before the treatment. At present, complete obstruction of the great saphenous vein has been observed through all follow-up period (up to 8 months). No severe side effect, such as pulmonary embolism, was recorded.The results was presented many times from 2003 to 2005,both in Japan and in United States (Japan Radiological Society, AJR, Japanese Society of phlebology, etc), and it will be presented in Cardiovascular and Interventional Radiological Society of Europe in 2005. Less