The endopass: an endovascular bypass for treatment of occlusion of the A. femoralis and A. poplitea –

Abstract

Background: The implantation of a femoro-popliteal bypass graft represents the gold standard in the management of arteriosclerotic occlusive disease in the femoro-popliteal region. Application of interventional techniques has permitted the development of a novel, endovascular implantable bypass system. The device is placed within the lumen of the superficial femoral artery. The present study investigated the technical properties of the new system in cadavers, with subsequent evaluation of its application in humans. Methods: The endopass consists of a thin-wall polycarbourethane tube with a total length of 53 cm. The distal end is connected with a self-expanding stent prothesis 4 cm in length. Endovascular implantation is performed through a groin incision. Following antegrade ringstripper-TEA, the endopass is introduced into the femoral artery after placement of a guide wire. The proximal anastomosis is performed surgically. Results: The technical requirements and feasibility of the system were tested on 12 cadaver extremities. Implantation of the device proved technically successful in seven of eight extremities with significant occlusion of the superficial femoral artery. The most important problems included the complete ringstripper-TEA, the placement of the guide wire following the TEA, and the expansion of the endopass. Following approval by the ethics commission, the endopass was implanted in five patients between June 1997 and March 1998. In three patients, the endopass remained patent and has functioned well. One patient with poor vascular outflow suffered an early noncorrectable occlusion, while in the remaining case, perforation secondary to the ringstripper procedure forced us to abandon the attempt. Conclusion: Experience from the cadaver study and initial human applications confirm the feasibility of this method. Further development and methodological improvement, however, are necessary requiring additional, larger studies on patients.