Ross T. Lyon

Transluminally placed endovascular stented graft repair for arterial trauma

PURPOSE Intravascular stents have become important tools for the management of vascular lesions; however, stents in combination with vascular grafts have only recently reached clinical application. This report describes an experience with stented grafts for the treatment of penetrating arterial trauma. METHODS Seven transluminally placed stented grafts were used to treat one arteriovenous fistula and six pseudoaneurysms. These grafts were successfully inserted percutaneously or through open arteriotomies that were remote from the site of vascular trauma. The devices were composed of balloon-expandable stainless steel stents covered with polytetrafluoroethylene grafts. RESULTS Patency up to 14 months was achieved (mean follow-up 6.5 months) with these stented grafts. The use of stented grafts appears to be associated with decreased blood loss, a less invasive insertion procedure, reduced requirements for anesthesia, and a limited need for an extensive dissection in the traumatized field. These advantages are particularly important in patients with central arteriovenous fistulas or false aneurysms who are critically ill from other coexisting injuries or medical comorbidities. CONCLUSIONS The use of stented grafts already appears justified to treat traumatic arterial lesions in critically ill patients. Although the early results with the seven cases in this report are encouraging, documentation of long-term effectiveness must be obtained before these devices can be recommended for widespread or generalized use in the treatment of major arterial injuries.

Ex vivo human carotid artery bifurcation stenting: Correlation of lesion characteristics with embolic potential

PURPOSE To develop an ex vivo human carotid artery stenting model that can be used for the quantitative analysis of risk for embolization associated with balloon angioplasty and stenting and to correlate this risk with lesion characteristics to define lesions suitable for balloon angioplasty and stenting. METHODS Specimens of carotid plaque (n = 24) were obtained circumferentially intact from patients undergoing standard carotid endarterectomy. Carotid lesions were prospectively characterized on the basis of angiographic and duplex findings before endarterectomy and clinical findings. Specimens were encased in a polytetrafluoroethylene wrap and mounted in a flow chamber that allowed access for endovascular procedures and observations. Balloon angioplasty and stenting were performed under fluoroscopic guidance with either a Palmaz stent or a Wallstent endoprosthesis. Ex vivo angiograms were obtained before and after intervention. Effluent from each specimen was filtered for released embolic particles, which were microscopically examined, counted, and correlated with various plaque characteristics by means of multivariate analysis. RESULTS Balloon angioplasty and stenting produced embolic particles that consisted of atherosclerotic debris, organized thrombus, and calcified material. The number of embolic particles detected after balloon angioplasty and stenting was not related to preoperative symptoms, sex, plaque ulceration or calcification, or artery size. However, echolucent plaques generated a higher number of particles compared with echogenic plaques (p < 0.01). In addition, increased lesion stenosis also significantly correlated with the total number of particles produced by balloon angioplasty and stenting (r = 0.55). Multivariate analysis revealed that these two characteristics were independent risk factors. CONCLUSIONS Echolucent plaques and plaques with stenosis > or = 90% produced a higher number of embolic particles and therefore may be less suitable for balloon angioplasty and stenting. This ex vivo model can be used to identify high-risk lesions for balloon angioplasty and stenting and can aid in the evaluation of new devices being considered for carotid balloon angioplasty and stenting.

Endoleaks after endovascular graft treatment of aortic aneurysms: Classification, risk factors, and outcome

PURPOSE Incomplete endovascular graft exclusion of an abdominal aortic aneurysm results in an endoleak. To better understand the pathogenesis, significance, and fate of endoleaks, we analyzed our experience with endovascular aneurysm repair. METHODS Between November 1992 and May 1997, 47 aneurysms were treated. In a phase I study, patients received either an endovascular aortoaortic graft (11) or an aortoiliac, femorofemoral graft (8). In phase II, procedures and grafts were modified to include aortofemoral, femorofemoral grafts (28) that were inserted with juxtarenal proximal stents, sutured endovascular distal anastomoses within the femoral artery, and hypogastric artery coil embolization. Endoleaks were detected by arteriogram, computed tomographic scan, or duplex ultrasound. Classification systems to describe anatomic, chronologic, and physiologic endoleak features were developed, and aortic characteristics were correlated with endoleak incidence. RESULTS Endoleaks were discovered in 11 phase I patients (58%) and only six phase II patients (21%; p < 0.05). Aneurysm neck lengths 2 cm or less increased the incidence of endoleaks (p < 0.05). Although not significant, aneurysms with patent side branches or severe neck calcification had a higher rate of endoleaks than those without these features (47% vs 29% and 57% vs 33%, respectively), and patients with iliac artery occlusive disease had a lower rate of endoleaks than those without occlusive disease (18% vs 42%). Endoleak classifications revealed that most endoleaks were immediate, without outflow, and persistent (71% each), proximal (59%), and had aortic inflow (88%). One patient with a persistent endoleak had aneurysm rupture and died. CONCLUSIONS Endoleaks complicate a significant number of endovascular abdominal aortic aneurysm repairs and may permit aneurysm growth and rupture. The type of graft used, the technique of graft insertion, and aortic anatomic features all affect the rate of endoleaks. Anatomic, chronologic, and physiologic classifications can facilitate endoleak reporting and improve understanding of their pathogenesis, significance, and fate.

Percutaneous transluminal angioplasty for the treatment of limb threatening ischemia : Do the results justify an attempt before bypass grafting?

PURPOSE Results of percutaneous transluminal angioplasty (PTA) in selected cases have been reported to be equal or superior to those of arterial bypass graft surgery, with a lower morbidity and mortality. We performed PTA of stenotic or occlusive lesions in patients with limb-threatening ischemia, hoping to improve our overall success and decrease morbidity in this group of patients. The results of PTA in the limb-salvage setting was evaluated. METHODS From 1992 to 1995, 307 PTAs were performed in 257 patients. One hundred sixty-one (63%) patients had diabetes mellitus, and 32 (12%) patients had renal failure. All patients were evaluated by means of pulse volume recordings and ankle brachial indices at 1 and 6 weeks after PTA and at 3 month intervals thereafter. Seventeen patients (9%) were lost to follow-up. The continued success or failure of PTA was defined by means of noninvasive vascular laboratory criteria, patency by means of pulse examination, the need for subsequent bypass grafting across the index lesion, and limb salvage. RESULTS The 1-year patency rates for external iliac PTAs (56%) were significantly lower (P <.05) than those for common iliac PTAs (87%). Infrainguinal PTAs at the femoral, popliteal, and tibial level had 1-year patency rates of less than 15%. CONCLUSION Common iliac artery PTA is justified in most cases in which it is feasible. However, when PTAs are performed below the inguinal ligament, the results are markedly worse. One-year patency rates of PTA in this group of patients with threatened limbs are inferior to the patency rates of arterial bypass grafts, even when these bypasses are performed with a prosthetic material. PTA should not be considered as a primary treatment modality for patients with infrainguinal arterial occlusive disease who also have limb-threatening ischemia, except in unusual circumstances.

Endovascular graft repair of ruptured aortoiliac aneurysms.

BACKGROUND The feasibility of endovascular graft (EVG) repair of ruptured aortoiliac aneurysms (AIAs) has yet to be demonstrated. There are inherent limitations in EVG repair, including the need for preoperative measurements of the aneurysmal and adjacent arterial anatomy to determine the appropriate size and type of graft and the inherent delay to obtain proximal occlusion. We developed an EVG system with broad versatility that largely eliminates these problems. STUDY DESIGN Between 1993 and 1998, within an experience of 134 endovascular AIA repairs, 12 ruptured AIAs were treated using EVGs that facilitated intraoperative customization and eliminated the need for preoperative measurements. The EVGs consisted of either a Palmaz stent and a PTFE graft deployed by a compliant balloon (n = 9) or a self-expanding covered stent graft (n = 3). Both grafts were cut to the appropriate length intraoperatively. The mean age of the patients was 72 years (range 40 to 86 years). The mean size of the aneurysms was 7.6 cm (range 3 to 16 cm). Preoperative symptoms were present in all patients and included abdominal or back pain (n = 9), syncope (n = 4), and external bleeding (n = 2). All patients were high surgical risks because of comorbid disease (n = 10) or previous abdominal operations (n = 6), and nine experienced hypotension. RESULTS All EVGs were inserted successfully and excluded the aneurysms from the circulation. The mean operating time was 263 minutes, the mean blood loss was 715 mL, and the mean length of hospital stay was 6.5 days. There were two deaths (16%), one from the preexisting acute myocardial infarction and one from multiple organ failure. There were three minor complications (25%). Two patients required evacuation of an intraabdominal hematoma from the initial rupture. All but one of the grafts was functioning at a mean followup of 18 months. CONCLUSIONS This study demonstrates the feasibility of EVG repair for ruptured AIAs using a graft that can be customized intraoperatively for each patient. Such repairs currently are valuable in patients with ruptured AIAs and serious comorbidities and may be applicable in other circumstances as well.

Transfemoral Endovascular Repair of Iliac Artery Aneurysms

PURPOSE This report evaluates the application of transfemoral endovascular repair of iliac artery aneurysms. PATIENTS AND METHODS Over a 20-month period, 11 patients with serious comorbid illnesses and a total of 14 iliac artery aneurysms were treated with endovascular grafts composed of polytetrafluoroethylene conduits combined with balloon expandable iliac artery stents (Palmaz). Nine right common, 3 left common, and 2 right internal iliac artery aneurysms were treated. The patients were men between 58 and 89 years of age (mean 72). Eight patients had isolated aneurysms and 3 had multiple iliac artery aneurysms. RESULTS Endovascular iliac grafts were successfully placed in all 11 patients. No procedural deaths occurred. Follow-up ranged from 3 to 21 months (mean 11). No acute or late graft thromboses occurred. CONCLUSIONS Transluminally placed endovascular stented grafts can be used to successfully exclude iliac artery aneurysms from the circulation while maintaining lower-extremity arterial perfusion. However, longer follow-up in more patients is necessary to confirm the durability of this technique.

Protection from atherosclerotic lesion formation by reduction of artery wall motion

We have studied mechanical factors that could determine how stenosis protects against distal atherosclerosis in cynomolgus monkeys fed an atherogenic diet. Critical aortic stenosis was produced by coarctation of the thoracic aorta. After 3 months, coarcted monkeys had a mean aortic pressure gradient of 25 +/- 1 mm Hg and a 76% +/- 2% lumen stenosis. Aortic wall motion was measured by means of in vivo ultrasonic sonomicrometry. Dynamic tracings of aortic pressure and diameter were recorded simultaneously at standard locations proximal and distal to the stenosis and at comparable sites in noncoarcted control animals. In the proximal aorta, mean blood pressure and pulse pressure were increased (p less than 0.05), but wall motion and intimal lesion area were not different from those determined in control monkeys. In the aorta distal to the coarct, mean blood pressure was no different from that in control animals but pulse pressure was diminished; in addition, there was marked reduction of arterial wall motion (p less than 0.001). This was accompanied by a significant reduction of intimal plaque area (p less than 0.05) and acid lipase activity (p less than 0.001). Thus, inhibition of plaque formation in the distal aorta coincided with reduction of pulse pressure and aortic wall motion rather than with blood pressure or hypercholesterolemia. Inhibition of arterial wall motion may account for the sparing effect often encountered in human arteries distal to stenosing atherosclerotic plaques.

Polytetrafluoroethylene bypasses to infrapopliteal arteries without cuffs or patches: A better option than amputation in patients without autologous vein

PURPOSE This study was undertaken to evaluate our results of polytetrafluoroethylene (PTFE) tibial and peroneal artery bypasses done for limb salvage. METHODS Within a group of patients undergoing infrainguinal limb salvage bypasses at our institution between January 1986 and May 1995, 63 patients faced an immediate amputation, had no autologous vein on duplex examination and operative exploration, and had only a tibial or peroneal artery as an outflow vessel for bypass. Most of these patients (82%) had two or more prior ipsilateral infrainguinal bypasses. These 63 patients underwent 66 PTFE bypasses to a tibial or peroneal artery without a distal anastomotic vein cuff or an adjunctive arteriovenous fistula. Our results were then compared with those reported from infrapopliteal (crural) bypasses performed with alternate autologous vein sources or PTFE in conjunction with various recommended adjuncts. RESULTS The 3- and 5-year cumulative primary graft patency rates for our PTFE infrapopliteal bypasses were 39%+/-7% and 28%+/-9%, respectively. Secondary graft patency rates were 55%+/-8% and 43%+/-10% at 3 and 5 years, respectively. Limb salvage rates were 71%+/-7% at 3 years and 66%+/-8% at 5 years. Two-year actuarial patient survival rate was only 67%+/-7%. CONCLUSIONS These results indicate that a PTFE bypass to an infrapopliteal artery remains a worthwhile option in patients without usable autologous vein. The secondary patency and limb salvage rates were acceptable in this setting and were not significantly different from the best results reported with prosthetic tibial/peroneal bypasses with distal vein cuffs or patches (74% at 1 year; 58% at 3 years), arteriovenous fistulas (71% at 1 year) or composite arm vein grafts (39% and 29% at 3 and 5 years, respectively).

Human transluminally placed endovascular stented grafts: preliminary histopathologic analysis of healing grafts in aortoiliac and femoral artery occlusive disease.

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.

Can duplex scan arterial mapping replace contrast arteriography as the test of choice before infrainguinal revascularization

PURPOSE Arteriography is the diagnostic test of choice before lower extremity revascularization, because it is a means of pinpointing stenotic or occluded arteries and defining optimal sites for the origin and termination of bypass grafts. We evaluated whether a duplex ultrasound scan, used as an alternative to arteriography, could be used as a means of accurately predicting the proximal and distal anastomotic sites in patients requiring peripheral bypass grafts and, therefore, replace standard preoperative arteriography. METHODS Forty-one patients who required infrainguinal bypass grafts underwent preoperative duplex arterial mapping (DAM). Based on these studies, an observer blinded to the operation performed predicted what operation the patient required and the best site for the proximal and distal anastomoses. These predictions were compared with the actual anastomotic sites chosen by the surgeon. RESULTS Whether a femoropopliteal or an infrapopliteal bypass graft was required was predicted correctly by means of DAM in 37 patients (90%). In addition, both anastomotic sites in 18 of 20 patients (90%) who had femoropopliteal bypass grafts and 5 of 21 patients (24%) who had infrapopliteal procedures were correctly predicted by means of DAM. CONCLUSION DAM is a reliable means of predicting whether patients will require femoropopliteal or infrapopliteal bypass grafts, and, when a patient requires a femoropopliteal bypass graft, the actual location of both anastomoses can also be accurately predicted. Therefore, DAM appears able to replace conventional preoperative arteriography in most patients found to require femoropopliteal reconstruction. Patients who are predicted by means of DAM to require crural or pedal bypass grafts should still undergo preoperative contrast studies to confirm these results and to more precisely locate the anastomotic sites.