Two decades of abdominal aortic aneurysm repair: have we made any progress?

PURPOSE: Over the past 20 years, there have been numerous advances in our ability to detect and to treat abdominal aortic aneurysms (AAAs). We hypothesized that these advances would lead to (1) an increase in the rate of elective repair and a decrease in the incidence of ruptured AAA (rAAA) and (2) a decrease in operative deaths for both elective AAA (eAAA) and rAAA. METHODS: To test these hypotheses, we investigated the incidence and outcomes of eAAA and rAAA surgery between 1979 and 1997, using the National Hospital Discharge Survey. This data set is a randomized, stratified sample representing discharges from the nation's acute care, nonfederally funded hospitals. Codes from the International Classification of Diseases, Ninth Revision were used to identify our study population. RESULTS: Over the past 19 years, there has been no change in the incidence rate of eAAA repair (range, 44.1-77.9 per 100,000). Moreover, the incidence of rAAAs presenting to the nation's hospitals has not changed (range, 6.6-16.3 per 100,000). There has been no consistent improvement over time in operative deaths associated with either eAAA or rAAA repair (average rates over the study period: eAAA, 5.6%; rAAA, 45.7%). Significant predictors of death from eAAA in patients included an age older than 80 years, African American race, congestive heart failure (CHF), and diabetes (P<.0001 for all). Significant predictors of death from rAAA in patients included age older than 70 years, African American race, female sex, renal failure, and a hospital bed size more than 500 (P<.05 for all). CONCLUSION: On a national level, over the past 19 years, our ability to identify and to treat patients with AAA has not improved. Advances in technology and critical care have not affected outcome. Regionalization of care, screening of high-risk populations, and endovascular repair are strategies that might allow further improvement in the outcome of patients with aneurysmal disease.

Alternative techniques for management of distal anastomoses of aortofemoral and iliofemoral endovascular grafts.

PURPOSE: Techniques for managing the distal anastomoses of aortofemoral and iliofemoral endovascular grafts are described. METHODS: Over a 2(1/2)-year period 46 endovascular grafts were successfully placed to treat severe iliac artery occlusive disease. Endovascular grafts were anchored proximally in the distal aorta or iliac arteries with Palmaz balloon-expandable stents. The distal anastomoses were performed with the use of open, sutured anastomotic techniques. In contrast to stented distal anastomoses, these techniques allowed us to (1) treat occlusive lesions extending from the distal aorta to below the inguinal ligament, (2) terminate endovascular grafts in the groin where stents are contraindicated, (3) vary the distal anastomotic site depending on the local pattern of disease, and (4) standardize the preinsertion length of the endovascular graft. RESULTS: Two distal perianastomotic stenoses and one graft occlusion were detected postoperatively in 11 bypass grafts that had distal anastomoses sewn endoluminally without an overlying patch angioplasty. Only one perianastomotic stenosis was found among 35 anastomoses performed with other techniques. There were no significant differences in primary and secondary patency between grafts originating in the distal aorta or iliac arteries. CONCLUSIONS: Hand-sewn distal anastomoses can simplify the insertion of endovascular grafts used for the treatment of aortoiliac occlusive disease. These anastomoses permit tailoring of the graft according to the patients' pattern of disease and eliminate the need to precisely measure the length of the graft preoperatively. In addition, because a distal stent is not required, endovascular grafts can be safely terminated in the groin instead of the external iliac artery where disease progression can lead to graft failure. Finally, endovascular distal anastomoses should be closed with a patch or the hood of a more distal bypass graft to prevent perianastomotic stenoses or occlusions in the postoperative period.

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.

Experience with endovascular grafts in the treatment of infrarenal aortic aneurysms associated with proximal aortic dissection.

BACKGROUND: Chronic abdominal and thoracic aortic dissections often present with concomitant infrarenal aortic dilatation. We conducted a retrospective review of 6 patients treated with endovascular stent grafts for coexisting aortic dissection and infrarenal aneurysm. METHODS: Six patients with suprarenal aortic dissections and infrarenal aortic aneurysms (AAA) had their AAAs treated with endovascular grafts. Grafts were constructed of balloon expandable Palmaz stents and expanded polytetrafluoroethylene graft. The device was inserted transfemorally and deployed under fluoroscopy. RESULTS: Successfully primary AAA exclusion was achieved in 5 patients. One patient required a supplemental stent placed above the endograft and into the true lumen to seal the endoleak. No aneurysm has enlarged, and all remain thrombosed for 9 to 24 months (mean 20). One type III dissection enlarged 2 weeks after endograft insertion. One patient had uncomplicated cephalad fenestration of a dissection by the endograft. CONCLUSIONS: Endovascular grafts may be used to treat coexisting AAA and aortic dissection. Attention to the site or sites of reentry of a dissection is essential to insure full aortic aneurysm exclusion. The fate of a chronic aortic dissection cephalad to an endovascularly treated AAA is unclear and will require longer follow-up.

Early experience with the Corvita endoluminal graft for treatment of arterial injuries.

The aim of this study was to evaluate our early experience with the Corvita endoluminal graft for the treatment of a variety of arterial injuries. Ten patients with arterial pseudoaneurysms (8) or arteriovenous fistulas (2) due to arterial injuries were followed prospectively after undergoing treatment with the endovascular graft. Our results showed that the Corvita low-profile endoluminal graft can be successfully used to treat arterial injuries but that it sometimes requires the placement of additional stents in patients with tortuous or tapering vessels. These grafts are extremely useful for the safe treatment of difficult and high-risk patients. Further improvements in available endovascular grafts and good long-term results will be necessary before considering these grafts the best treatment available for most patients with significant arterial injuries.

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.

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.

Clinical benchmark for healing of chronic venous ulcers. Venous Ulcer Study Collaborators.

BACKGROUND: To determine the results of standardized ulcer treatment regimes and effects of the oral thromboxane A2 antagonist Ifetroban (250 mg daily) on healing of chronic lower-extremity venous stasis ulcers. METHODS: In a prospective, randomized, double blind, placebo-controlled multicenter study, 165 patients were randomized to Ifetroban (n = 83) versus placebo (n = 82) for a period of 12 weeks. Both groups were treated with sustained graduated compression and hydrocolloid. Ulcer size was measured weekly by tracings and computerized planimetry. A total of 150 patients completed the study. RESULTS: Complete ulcer healing was achieved after 12 weeks in 55% of patients receiving Ifetroban and in 54% of those taking a placebo with no significant differences; 84% of ulcers in both groups achieved greater than 50% area reduction in size. CONCLUSIONS: These results are likely to be useful as a benchmark for comparison with other treatment protocols concerning the care of chronic lower-extremity stasis ulcers.

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.

Accuracy of duplex ultrasound in evaluating carotid artery anatomy before endarterectomy.

PURPOSE: Anatomic features, such as a high carotid bifurcation (< 1.5 cm from the angle of the mandible), excessive distal extent of plaque (> 2.0 cm above the carotid bifurcation), or a small diameter (< or = 0.5 cm) redundant or kinked internal carotid artery can complicate carotid endarterectomy. In the past, arteriography was the only preoperative study capable of imaging these features. This study assessed the ability of duplex ultrasound to evaluate their presence before surgery. METHODS: A consecutive series of 20 patients who underwent 21 carotid endarterectomies had preoperative duplex ultrasound evaluations of these anatomic features. These evaluations were correlated with operative measurements from an observer blinded to the duplex findings. RESULTS: The mean difference between duplex and operative measurements for the distance between the carotid bifurcation and the angle of the mandible, the distal extent of plaque, and the internal carotid artery diameter was 0.9 cm, 0.3 cm, and 0.8 mm, respectively. The correlation coefficient between the two methods was 0.86, 0.75, and 0.59, respectively. Duplex ultrasound predicted a high carotid bifurcation, excessive distal extent of plaque, or a redundant or kinked internal carotid artery with 100% sensitivity (p < 0.05, p < 0.01, and p < 0.001, respectively). The sensitivity of duplex ultrasound in predicting a small internal carotid artery diameter was 80%. The specificity of duplex ultrasound for predicting excessive distal extent of plaque, small internal carotid artery diameter, high carotid bifurcation, and a coiled or kinked carotid artery was 92%, 56%, 100%, and 100%, respectively. CONCLUSION: Duplex ultrasound can predict the presence of anatomic features that may complicate carotid endarterectomy. Preoperative duplex imaging of these features may be helpful in patients who undergo carotid endarterectomy without preoperative arteriography.

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.

An experimental model for the acute and chronic evaluation of intra-aneurysmal pressure.

PURPOSE: To develop an animal model for the acute and chronic monitoring of pressure within abdominal aortic aneurysms (AAAs) to be treated with endovascular grafts. METHODS: A strain-gauge pressure transducer was placed within an AAA created from a prosthetic vascular graft. Prosthetic aneurysms were implanted into 17 canine infrarenal aortas. The intra-aneurysmal pressure was monitored and correlated with noninvasive forelimb sphygmomanometry for 2 weeks. After this time, an intravascular manometer catheter was passed into the aneurysm. Simultaneous pressure measurements were obtained using the implanted strain-gauge pressure transducer, the manometer catheter, and the forelimb sphygmomanometer. Angiography was performed to assess intraluminal morphology, aneurysm anastomoses, and adjoining aortic vessels. In addition, two control animals underwent intra-aneurysmal pressure monitoring after standard surgical aneurysm repair. RESULTS: There was excellent correlation (r = 0.97) between the pressure measurements obtained with the implanted strain-gauge pressure transducer and the intravascular manometer. Close correlation was also observed between the implanted strain-gauge transducer and the forelimb sphygmomanometer (r = 0.88) during postprocedural monitoring. Intra-aneurysmal pressure was lowered dramatically by surgical exclusion (aneurysm: 15/5 +/- 7/4 mmHg; systemic: 124/66 +/- 34/17 mmHg; p < 0.001). The prosthetic aneurysms were successfully imaged with angiography. CONCLUSIONS: This animal model provides an accurate and reproducible means for measuring intra-aneurysmal pressure on an acute and chronic basis. It may be possible to use this model in the assessment of endovascular devices to determine their efficacy in reducing intra-aneurysmal pressure. Evaluation of complications associated with their use, such as patent aneurysm side branches, perigraft channels, and perianastomotic reflux, may also be possible.

Endovascular grafts for noninfected aortoiliac anastomotic aneurysms.

PURPOSE: This report describes our experience with endovascular repair of aortic and iliac anastomotic aneurysms. METHODS: Between June 1994 and March 1996, 12 noninfected aortic or iliac anastomotic aneurysms in 10 patients who had serious comorbid medical conditions that precluded or made difficult standard operative repair were treated using endovascular grafts. No patient in this study had a history of fever, leukocytosis, or computed tomographic evidence of a periprosthetic fluid collection that was suggestive of infection of the original graft. Endovascular grafts composed of polytetrafluoroethylene and balloon-expandable stents were introduced through a femoral arteriotomy and were placed using over-the-wire techniques under C-arm fluoroscopic guidance. RESULTS: Endovascular grafts were successfully inserted in all patients with aortic or iliac anastomotic aneurysms. There were no procedure-related deaths, and complications included one postprocedure wound hematoma and one perioperative myocardial infarction. Graft patency has been maintained for a mean of 16.1 months, with no computed tomographic evidence of aneurysmal enlargement or perigraft leakage. CONCLUSIONS: Endovascular grafts appear to be a safe and effective technique for excluding some noninfected aortoiliac anastomotic aneurysms in high-risk patients and may become a treatment option in all patients who have clinically significant lesions.

Anastomotic intimal hyperplasia: a comparison between conventional and endovascular stent graft techniques.

Endovascular grafts (EVGs) have been proposed as a treatment for a variety of vascular diseases; however, the impact of EVGs on graft healing has not been fully evaluated. The aim of this study is to compare anastomotic intimal hyperplasia (AIH) and endothelialization in EVGs and conventional bypass grafts (CGs). Seven mongrel dogs received an EVG in one iliac artery and a CG in the other iliac artery using a 5 mm x 4 cm polytetrafluoroethylene graft. The EVG was secured to the native vessel wall, with balloon expandable stents at either ends of the graft. CGs were anastomosed using running sutures. Intravascular ultrasound was performed at the time of sacrifice (8 weeks) to determine percentage of stenosis at the distal anastomosis. Specimens were divided longitudinally for light microscopic analysis (thickness of distal AIH) and scanning electron microscopic studies (percentage of endothelial coverage of the graft). Percentage of stenosis at the distal anastomosis was significantly higher in EVGs compared with CGs (28.2 +/- 18.2% versus 1.8 +/- 2.8%; P < 0.01) due to significantly greater mean intimal thickness in the EVGs (441.1 +/- 101.1 microns versus 82.4 +/- 41.9 microns; P < 0.01). The total percentage of area covered by endothelial cells was also significantly greater in EVGs compared with CGs (80.5 +/- 37.5% versus 30.3 +/- 37.1%; P < 0.05). Intraluminal location enhanced endothelialization of the polytetrafluoroethylene graft; however, it also resulted in greater AIH. Further device refinements including stent design may be required to maximize the potential of these endovascular procedures.

Endovascular grafting for aortoiliac occlusive disease.

Aortoiliac occlusive disease is a significant cause of lower extremity ischemic symptoms. Over the past two decades, most patients have been treated with a variety of surgical procedures, including aortofemoral and extra-anatomic bypasses. Most recently, percutaneous balloon angioplasty and stents have been successfully used for the treatment of limited iliac lesions. New endovascular grafts that combine vascular grafts with stents in a device with new characteristics may allow the successful treatment of patients with extensive aortoiliac occlusive disease in a less invasive fashion. In our early experience, the endovascular grafts were constructed with Palmaz balloon-expandable stents and standard polytetrafluoroethylene (PTFE) grafts. The 18-month primary and secondary patency rates were 89% and 100%, respectively, with a limb salvage rate of 94%. Endovascular grafts can be successfully used to treat patients with extensive aortoiliac occlusive disease, with excellent early results. Long-term results and further graft improvements will define their role in the treatment of patients with aortoiliac occlusive disease.

Comparison of endovascular and conventional vascular prostheses in an experimental infection model.

INTRODUCTION: The causes and management of prosthetic graft infections have been extensively studied for conventional bypass grafts; however, the infectivity and therapy for endovascular graft infections are completely unknown. The aim of this study was to compare the biologic properties of infected aortic grafts when inserted by endoluminal or standard transabdominal techniques. METHODS: Eighteen dogs underwent placement of polytetrafluoroethylene grafts in their infrarenal aortas either by an endovascular technique (8) or a standard interposition technique (10). Endovascular grafts were constructed from polytetrafluoroethylene (3 cm) and two balloon-expandable stents coaxially mounted onto a balloon catheter delivery system. The grafts were inserted through a left carotid arteriotomy under fluoroscopic control. Initially, seven grafts were infected with decreasing inocula of Staphylococcus aureus, starting at 10(7) organisms per ml for 30 minutes and then rinsed briefly (10 seconds) in normal saline solution, until a 50% infective dose for the standard grafts was determined to be 10(2) organisms per ml. After this initial experiment, a second group of 11 dogs were compared at a concentration of 10(2) S. aureus per ml. Five dogs underwent endovascular repair, and six dogs had standard graft interpositions after an identical period of bacterial exposure. All grafts were removed at 2 weeks under sterile conditions and were submitted for quantitative culture analysis. RESULTS: Three of the six dogs (50%) with standard grafts appeared to clear their infections, whereas only one of the five dogs (20%) with an endovascular graft was free of organisms at 14 days. This results was further manifested by statistically significant lower postmortem colony counts in the standard grafts (p < 0.01). CONCLUSIONS: The endoluminal position of the graft and its proximity to the arterial wall do not appear to provide protection against infection. These data suggest that if endovascular grafts become infected, they may be in a disadvantaged position for host defense mechanisms to be effective.

Endovascular aortounifemoral grafts and femorofemoral bypass for bilateral limb-threatening ischemia.

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.

Effect of polytetrafluoroethylene covering of Palmaz stents on the development of intimal hyperplasia in human iliac arteries.

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.

Immunolocalization and temporal distribution of cytokine expression during the development of vein graft intimal hyperplasia in an experimental model.

PURPOSE: Vein graft stenosis caused by intimal hyperplasia (IH) accounts for 30% to 50% of late bypass graft failures; however, the biochemical mediators of vein graft IH have been poorly defined. We attempted to evaluate the spatial and temporal distribution of five principal cytokines (interleukin-1 beta [IL-1 beta], platelet-derived growth factor-AA [PDGF-AA], basic fibroblast growth factor [bFGF], interferon gamma [INF gamma], and tumor necrosis factor alpha [TNF-alpha]) during the development of IH in a rat vein graft model. METHODS: Rat epigastric vein interposition grafts in the femoral artery were harvested at 6 hours, 2 days, 1 week, 2 weeks, and 4 weeks after the grafting procedure and studied with immunohistochemical and standard histologic techniques. The cytokine expression in the endothelium and media/neointima was quantified as the percentage of immunopositive cells per high-power field. RESULTS: Maximal hyperplasia occurred 2 weeks after the grafting procedure. Peak expression of IL-1 beta and bFGF occurred by 2 days. PDGF-AA expression paralleled the development of IH, peaking at 2 weeks and then declining. TNF-alpha expression increased at 1 week and remained elevated. INF gamma was seen only in control grafts. CONCLUSIONS: The coordinated early release of IL-1 beta and bFGF and the down-regulation of INF gamma seem to trigger an inflammatory response, thereby initiating IH. The process then is propagated by the release of PDGF-AA and TNF-alpha, with concomitant smooth muscle cell proliferation and production of extracellular matrix. It is likely that this complex milieu of local paracrine signaling is required to generate the hyperplastic response seen in failing vein grafts.

Endovascular repair of aortoiliac occlusive disease.

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.