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Purpose: Significant disease or occlusion of the common femoral artery may preclude percutaneous therapy for aorto-iliac occlusive disease. In addition, aorto-iliac angioplasty may not reverse the ischemic symptoms when common femoral artery disease exists. The authors describe the feasibility of endoluminal stent-grafts to treat multilevel aortoiliofemoral occlusive disease., Materials and Methods: The authors placed 18 stent-grafts for aorto-iliac occlusive disease in 17 patients with limb-threatening ischemia and significant common femoral artery disease. These procedures were performed as a joint effort between vascular surgery and interventional radiology staff in the operating room. The common femoral artery was occluded in 10 or severely diseased in eight, necessitating endoluminal bypass to the superficial femoral or popliteal artery (n = 7) or to the deep femoral artery (n = 7), or necessitating patch angioplasty of the common femoral artery (n = 4). Stent-grafts were fabricated from 6-mm polytetrafluoroethylene and 29-mm Palmaz stents., Results: All 18 grafts were placed successfully. Follow-up ranged from 3 to 38 months (mean, 21 months). Seven patients died of myocardial infarction; two grafts occluded and one required angioplasty during follow-up, resulting in a primary patency rate of 81% at 2 years., Conclusion: Endoluminal stent-graft placement is a useful method of treatment for advanced atherosclerotic aorto-iliac disease, particularly in the presence of common femoral artery disease. This approach avoids an extra-anatomic bypass or a major transabdominal aortic bypass procedure. Longer follow-up with a larger series is needed to ensure the safety and late graft patency comparable to the traditional aortofemoral and iliofemoral bypass grafts.

Purpose: Although axillobifemoral bypass procedures have a lower mortality rate than aortobifemoral bypass procedures, they are limited by decreased patency, moderate hemodynamic improvement, and the need for general anesthesia. This report describes an alternative approach to bilateral aortoiliac occlusive disease using unilateral endovascular aortofemoral bypass procedures in combination with standard femorofemoral reconstructions., Methods: Seven patients who had bilateral critical ischemia and tissue necrosis in association with severe comorbid medical illnesses underwent implantation of unilateral aortofemoral endovascular grafts, which were inserted into predilated, recanalized iliac arteries. The proximal end of the endovascular graft was fixed to the distal aorta or common iliac artery with a Palmaz stent. The distal end of the graft was suture-anastomosed to the ipsilateral patent outflow vessel, and a femorofemoral bypass procedure was then performed., Results: All endovascular grafts were successfully inserted through five occluded and two diffusely stenotic iliac arteries under either local (1), epidural (5), or general anesthesia (1). The mean thigh pulse volume recording amplitudes increased from 9 +/- 3 mm to 30 +/- 7 mm and from 6 +/- 2 mm to 26 +/- 4 mm ipsilateral and contralateral to the aortofemoral graft insertion, respectively. In all cases the symptoms completely resolved. Procedural complications were limited to one local wound hematoma. No graft thromboses occurred during follow-up to 28 months (mean, 17 months)., Conclusions: Endovascular iliac grafts in combination with standard femorofemoral bypass grafts may be an effective alternative to axillobifemoral bypass in high-risk patients who have diffuse aortoiliac occlusive disease, particularly when bilateral axillary-subclavian disease is present.

Purpose: The occurrence of neointimal hyperplasia within a stent may result in restenosis with recurrent symptoms of end-organ ischemia. This study evaluated the potential of a nonporous covering of a stent to function as a barrier to the formation of intrastent neointimal hyperplasia., Materials and Methods: Twelve endovascular stent grafts were used to treat 12 high-risk patients with limb-threatening ischemia secondary to long-segment iliac artery occlusion. A 6-mm, thin-walled polytetrafluoroethylene graft was inserted and anchored to the common iliac artery with use of Palmaz stents. Each stent was covered by graft material over one-half of its length. Control angiograms obtained immediately after graft insertion were compared with follow-up angiograms obtained between 4 and 6 months after the initial procedure. On each angiogram, the region of the stent was magnified by 20x to permit computerized luminal diameter measurements., Results: The mean luminal diameter within the stent was significantly greater on the covered (7.7 mm +/- 0.33 standard deviation) compared with the uncovered (6.7 mm +/- 0.85 standard deviation) portions (P < .01)., Conclusions: Partially covered stents are a unique model for assessing the effects of an extrinsic stent covering on arterial healing and myointimal hyperplasia. These data suggest that a relatively nonporous covering of polytetrafluoroethylene may inhibit stent-related restenosis in iliac arteries.

Occlusive disease of the aorta and iliac and femoral arteries may lead to limb-threatening ischemia when multiple levels of disease are present. The combined treatment of severe aortoiliac and infrainguinal disease using standard techniques may be hazardous or contraindicated in patients with multiple, previous reconstructions or severe co-morbid medical illnesses. This report summarizes the technical feasibility and early results of aortoiliac endovascular stented grafts (ESGs) in combination with conventional surgical reconstructions for the treatment of multilevel arterial occlusive disease. Forty-two patients with multilevel aortoiliofemoral limb-threatening occlusive disease had an ESG inserted to treat long-segment, multilevel, occlusive disease. ESGs originated from either the aorta or the common iliac artery and were inserted into one of the femoral arteries. ESG lengths ranged from 16 to 30 cm (mean 21 cm). Conventional surgical bypasses were constructed, when necessary, from polytetrafluoroethylene (PTFE) or saphenous vein and were extended using standard techniques to the popliteal, tibial, or contralateral femoral arteries. Technical success of graft insertion was achieved in 39 of 42 attempted ESG procedures (93%). The 18-month primary and secondary cumulative patency rates for ESGs were 89 +/- 9 (SE) and 100%, respectively. Limb salvage was achieved in 94% of patients at 24 months. Four patients had minor postprocedure complications (10%), and there was one death. Endovascular aortoiliac grafts, often in combination with conventional surgical infrainguinal bypasses, are a technically feasible, potentially safe option for the treatment of limb-threatening aortoiliofemoral occlusive disease and have demonstrated encouraging early patency. Long-term follow-up is necessary before widespread application of this technique is instituted.

Purpose: Occlusive disease of the aortoiliac segment may lead to limb-threatening ischemia, if coexisting disease is present in the femoral, popliteal, or tibial arteries. The combined treatment of severe aortoiliac and infrainguinal disease with standard techniques may be hazardous or contraindicated in patients with multiple previous reconstructions, severe comorbid medical illnesses, or both. This report summarizes the technical feasibility and early results of aortoiliac endovascular stented grafts (ESGs) in combination with conventional surgical reconstructions for the treatment of multilevel arterial occlusive disease., Methods: Seventeen patients with multilevel aortoiliofemoral limb-threatening occlusive disease had an ESG inserted to treat long-segment occlusive disease followed by a conventional surgical bypass. ESGs originated from the aortoiliac junction (seven) or the common iliac artery (10) and were inserted into the common femoral (nine), superficial femoral (four), or deep femoral (four) artery. ESG lengths ranged from 16 to 30 cm (mean, 21 cm). Conventional surgical bypasses were constructed from polytetrafluoroethylene (15) or saphenous vein (two) and extended to the popliteal (12), tibial (two), or contralateral femoral (three) arteries., Results: Technical success in graft insertion was achieved in 17 (94%) of 18 attempted ESG procedures. The 1-year primary and secondary cumulative patency rates for ESGs were 94% +/- 10% and 100%, respectively, whereas the 1- and 2-year patency rates for the extravascular grafts were 92% +/- 10% and 100%, respectively. Four patients had minor postprocedure complications (23%), and no deaths occurred. One patient lost his limb at 16 months because of severe pedal sepsis., Conclusions: Transluminally placed stented grafts in combination with conventional surgical infrainguinal bypasses are a technically feasible and potentially safe option for the treatment of limb-threatening aortoiliofemoral occlusive disease and have demonstrated encouraging early patency. Long-term follow-up will be necessary before widespread application of this technique is advocated.

Purpose: The purpose of this study was to perform a preliminary histopathologic analysis of explanted human endovascular stented grafts from patients treated for occlusive disease., Methods: Over a 16-month period, 26 endovascular stented grafts were placed in 21 patients with limb-threatening ischemia caused by aortoiliac or femoral artery occlusive disease. All grafts were inserted through open arteriotomies remote from the region of primary disease. During the follow-up period, two patients died of preexisting heart disease 2 weeks and 7 months after grafting, and a portion of their endovascular grafts were the surrounding artery was explanted. Specimens from five other endovascular grafts were obtained during surgical revision for graft stenosis after 3 and 6 weeks and for outflow artery stenosis after 3, 5, and 6 months. All specimens were formalin fixed and studied with hematoxylin and eosin and trichrome staining and immunohistochemically for factor VIII-related antigen, alpha actin smooth muscle, macrophage antigen (MAC-387) and PC-10 (a mouse monoclonal antibody which specifically recognizes proliferating cell nuclear antigen in paraffin sections)., Results: Three weeks after placement of the stented grafts, organizing thrombus was present on both surfaces of the expanded polytetrafluoroethylene (PTFE) grafts. At 6 weeks, evidence of a neointima with overlying endothelium was seen in the perianastomotic region, and 3 months after grafting it was seen 1 to 3 cm from the anastomosis. The specimen explanted at 5 months demonstrated factor VIII-positive cells 8 cm from the anastomosis. The histopathologic condition of the external capsule appeared to vary, depending on the presence or absence of an external wrap on the PTFE graft and on which layer in the arterial wall the graft was inserted. A foreign body reaction characterized by multinucleated giant cells was seen adjacent to wrapped grafts or around those placed in an intraadventitial plane. Grafts inserted within the media were surrounded by orderly, arranged, smooth muscle cells and few mononuclear cells. Extensive smooth muscle cell proliferation (PC-10 activity) was not seen within native artery atherosclerotic plaques peripherally displaced and external to prosthetic endovascular grafts., Conclusions: These preliminary observations on the healing of PTFE endovascular stented grafts in human beings demonstrate limited plaque hyperplasia and the presence of endothelial cells on the luminal surface remote from the graft-artery anastomosis. It is unclear whether this is a unique manifestation of healing in prosthetic grafts inserted within the walls of arteries.

Endovascular grafting is a technique that combines the use of intravascular stents and prosthetic grafts to fabricate devices with unique properties. The purpose of this study is to describe the use of endovascular graft technology in the treatment of failed or failing standard aortoiliofemoral reconstructions. Over a 15-month period five patients with limb-threatening ischemia and failed aortofemoral or iliofemoral reconstructions underwent successful placement of six endovascular grafts to revascularize seven severely ischemic lower extremities. Standard thin-walled 6 mm polytetrafluoroethylene grafts and Palmaz balloon-expandable stents were used to fashion each reconstruction. In addition to the primary endovascular grafts, three patients underwent immediate femoropopliteal bypasses to improve distal outflow and one patient had a femorofemoral bypass graft to restore circulation to the contralateral ischemic extremity. The ankle/brachial indices of all patients significantly improved after the procedure (from a mean of 0.32 to a mean of 0.75) and all grafts are patent to date (mean follow-up 10 months). There were no deaths or limb loss in this group of patients. These favorable results indicate that this minimally invasive approach, which permits a new arterial graft to be inserted through a remote access site, is a valuable method for providing unobstructed arterial inflow after aortoiliofemoral graft failure. This procedure may be particularly valuable when there are contraindications to the use of axillary arteries or the thoracic aorta as alternatives to complex reoperative abdominal aortic surgery.