Conservative observational management with selective delayed repair for large abdominal aortic aneurysms in high risk patients.

AIM: Abdominal aortic aneurysms (AAAs) larger than 5.5 cm should generally undergo elective repair. However, some of these patients have serious comorbid conditions, which greatly increase operative risk. This study evaluated the outcomes of nonoperative, observational management and selective delayed AAA repair in high-risk patients with large infrarenal and pararenal AAAs. METHODS: Among 226 patients with AAAs >5.5 cm, we selected 72 with AAAs 5.6-12.0 cm (mean 7.0 cm) for periods of nonoperative management because of their prohibitive surgical risks. Comorbid factors included a low ejection fraction of 15-34% (mean 22%) in 18 patients; FEV1 <50% (mean 38%) in 25; prior laparotomy in 10; and morbid obesity in 22. Follow-up was complete in the 72 patients for the 6-76 months (mean 23 months) that they were treated nonoperatively. Fifty-three patients ultimately underwent repair because of AAA enlargement or onset of symptoms after 6-72 months (mean 19 months) of observational treatment. RESULTS: Of the 72 selected patients, 54 (75%) are living and 18 (25%) are dead. Seven patients undergoing only nonoperative treatment presently survive after 28-76 months (mean 48 months). Of the 18 deaths, AAA rupture occurred in only 3 patients (4%) who had been observed for 12, 31, and 72 months before rupture. Nine other deaths (13%) occurred after 6-72 months from comorbidities unrelated to the patient's AAA. Six of the 53 patients undergoing delayed AAA repair died within 30 days of operation (11% mortality). The mortality for the 154 good risk AAA patients, who underwent prompt open or endovascular repair, was 2.2%. CONCLUSION: These data indicate that some patients with large AAAs and serious comorbidities are acceptably managed for long periods (6-76 months) by nonoperative means. Substantial delays of 12 to 76 months resulted in an AAA rupture rate of only 4%, while 13% of these patients (9 of 72) died of their comorbidities unrelated to AAA rupture or surgery and mortality in this group of patients, when operated on, was 11% (6 of 53). These findings support the selective use of nonoperative observational management in some patients with large AAAs and serious comorbidities.

Overt colon ischemia after endovascular aneurysm repair: the importance of microembolization as an etiology.

OBJECTIVE: The purpose of this study was to analyze the incidence, severity, and etiologic factors of the development of colon ischemia after endovascular aortoiliac aneurysm repair (EVAR). METHODS: During the last 9 years we performed 278 elective EVARs using a variety of grafts. To facilitate these repairs, one hypogastric artery (HA) was coil embolized in 109 patients and both HAs were coil embolized in 13 patients. The preprocedural status of the inferior mesenteric, hypogastric, and iliac arteries as well as anatomical characteristics of the abdominal aortic aneurysm were determined arteriographically and by computerized tomographic scans. Postoperative colon ischemia was documented by colonoscopy or operative findings. RESULTS: Colon ischemia occurred in eight patients (2.9%). Three patients with colon ischemia died and had evidence of widespread (cutaneous, renal, small bowel, and/or lower extremity) microembolization. One of these three had a colectomy and microscopic emboli were present. One other patient who required a colectomy also had pathologic evidence of colonic microembolization but survived. Four other patients with colon ischemia were treated conservatively and survived. In one patient, previous colectomy with interruption of mesenteric collaterals may have been a contributory cause of colon ischemia. Of the eight patients with colon ischemia, only one had unilateral HA occlusion, and none had bilateral HA occlusion. The other 121 patients with unilateral and bilateral HA occlusion had no evidence of colon ischemia. CONCLUSIONS: Colon ischemia occurs after EVAR with an incidence approximating that of open repair. Colon ischemia was unrelated to HA interruption. Embolization appears to be a major cause of colon ischemia, although inadequate mesenteric collateral circulation may also play an etiologic role. Mortality with colon ischemia accompanied by widespread embolization was high, whereas colon ischemia without it was often mild and amenable to nonoperative management.

Limited role for IVUS in the endovascular repair of aortoiliac aneurysms.

BACKGROUND: To determine the need for routine versus selective intraoperative IVUS during endovascular aortoiliac aneurysm (AIA) repair. METHODS: One-hundred and eighty-eight endovascular AIA repairs performed over a 5-year period were reviewed and included in the study. Surgeon-made aorto-uni-femoral grafts (n=78) and industry-made bifurcated or tube grafts (n=110) were used. In the initial 51 cases IVUS was routinely performed. In the latter 137 cases IVUS was used selectively. In this group graft deformities suspected on completion angiography or pullback pressure measurements were treated with balloon dilatation and stenting. IVUS was then performed only in the presence of a persistent pressure gradient or inconclusive angiographic findings. RESULTS: In the initial 51 cases IVUS revealed 20 lesions of which 8 were not initially detected angiographically and which required further treatment. In the latter 137 cases IVUS was necessary in only 1 case, and guided the treatment of an angiographically undetectable lesion. There have been no late episodes of graft compression, kinking, or thrombosis in the selective IVUS group. CONCLUSIONS: The use of pullback pressure measurements with a low threshold for angioplasty and stenting, especially in unsupported grafts, followed by the selective use of IVUS decreases the overall requirement for IVUS and its associated costs.

Endoscopically assisted in situ lower extremity bypass graft: a preliminary report of a new minimally invasive technique.

OBJECTIVE: Lower extremity arterial reconstructions with in situ greater saphenous vein (GSV) are an important component of limb salvage surgery. Initially, the procedure was performed through continuous skin incisions for side branch occlusion and valve lysis with a wound complication rate of 5% to 25%. To decrease these complications, we used endoscopic GSV harvest equipment in 25 in situ vein bypass grafts in 25 patients performed over 24 months. METHODS: The procedures were performed with three skin incisions: two for arterial access and a 2-cm incision above the knee to insert the Endopath device (Ethicon) to locate and clip the GSV side branches. After completion of the proximal anastomosis, the valves were lysed through the distal end of the vein with a flexible valvulotome. Completion cineangiography was performed to confirm side branch occlusion and evaluate the entire reconstruction. The results of this technique were compared with our last 25 in situ bypass grafts done with standard long incisions. RESULTS: In the endoscopic group there was one (4%) minor wound complication (cellulitis). No postoperative arteriovenous fistulas were detected by means of duplex examination, and the average hospital stay was 6.2 +/- 1 days. One graft closed at 9 months as a result of distal vein hyperplasia, but the other grafts have remained patent, with follow-up from 6 to 30 months (mean, 18 months). Patients with the standard in situ bypass grafts had significantly (P < .05) more wound complications (20%) and longer average hospital stay (9.2 +/- 2 days) than the endoscopic group. Patency rates were comparable for both groups. CONCLUSION: These results show that less invasive endoscopic in situ bypass grafting minimizes wound complications and reduces the need for hospitalization without decreasing patency or increasing operative time.

Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms: a note of caution based on a 9-year experience.

OBJECTIVE: To analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors' institution since November 1992. SUMMARY BACKGROUND DATA: Recently, the use of endovascular grafts for the treatment of AAAs has increased dramatically. However, there is little midterm or long-term proof of their efficacy. METHODS: During the past 9 years, 239 endovascular graft repairs were performed for nonruptured AAAs, many (86%) in high-risk patients or in those with complex anatomy. The grafts used were Montefiore (n = 97), Ancure/EVT (n = 14), Vanguard (n = 16), Talent (n = 47), Excluder (n = 20), AneuRx (n = 29), and Zenith (n = 16). All but the AneuRx and Ancure repairs were performed as part of a U.S. phase 1 or phase 2 clinical trial under a Food and Drug Administration investigational device exemption. Procedural outcomes and follow-up results were prospectively recorded. RESULTS: The major complication and death rates within 30 days of endovascular graft repair were 17.6% and 8.5%, respectively. The technical success rate with complete AAA exclusion was 88.7%. During follow-up to 75 months (mean +/- standard deviation, 15.7 +/- 6.3 months), 53 patients (22%) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and were surgically repaired, with one death. Other late complications included type 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/stenosis (n = 7), limb separation or fabric tear with a subsequent type 3 endoleak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary intervention or surgery was required in 23 patients (10%). These included deployment of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3). CONCLUSION: With longer follow-up, complications occurred with increasing frequency. Although most could be managed with some form of endovascular reintervention, some complications resulted in a high death rate. Although endovascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-term surveillance and prospective studies to prove the effectiveness of endovascular graft repair.

Diameter changes in isolated iliac artery aneurysms 1 to 6 years after endovascular graft repair.

OBJECTIVE: Precise diameter changes in iliac artery aneurysms (IAAs) after endovascular graft (EVG) repair are yet to be determined. This report describes the midterm size changes in isolated IAAs 13 to 72 months after treatment with an EVG. METHODS: From January 1993 to April 1999, 31 patients with 35 true isolated IAAs (32 common iliac and 3 hypogastric) had these lesions treated with EVGs and coil embolization of the hypogastric artery or its branches. The EVG used in this study consisted of a balloon-expandable stent attached to a polytetrafluoroethylene graft. Contrast-enhanced spiral computed tomographic scans were performed at 3- to 6-month intervals to follow the aneurysms for change in diameter and endoleaks. RESULTS: Thirty patients had a decrease in the size of their iliac aneurysms with EVG repair. All EVGs remained patent. All patients, except for one, were followed up for 13 to 72 months (mean, 31 months). The pretreatment aneurysm size ranged from 2.5 to 11.0 cm in diameter (mean, 4.6 +/- 1.62 cm). After EVG treatment, the aneurysms ranged from 2.0 to 8.0 cm in diameter (mean, 3.8 +/- 1.36 cm). The change in aneurysm diameter ranged from 0.5 to 3.1 cm (mean, 1.1 +/- 0.62 cm) with an average change of -0.516 +/- 0.01 cm/y for the first year. Five patients died of their intercurrent medical conditions during the follow-up period. One of the patients had a new endoleak and an increase in common iliac aneurysm size 18 months after EVG treatment, despite an early contrast-enhanced computed tomographic scan that showed no endoleak. This patient's aneurysm ruptured, and a standard open surgical repair was successfully performed. Another patient had a decrease in hypogastric aneurysm size after EVG treatment and no radiographic evidence of an endoleak, but eventually the aneurysm ruptured. He was successfully treated with a standard open surgical repair. CONCLUSIONS: EVGs can be an effective treatment for isolated IAAs. Properly treated with EVGs, IAAs decrease in size. The enlargement of an IAA, even if no endoleak can be detected, appears to be an ominous sign suggestive of an impending rupture. IAAs that enlarge should be closely evaluated for an endoleak. If an endoleak is detected, it should be eliminated if possible. If an endoleak cannot be found, open surgical repair should be considered.

Unilateral and bilateral hypogastric artery interruption during aortoiliac aneurysm repair in 154 patients: a relatively innocuous procedure.

OBJECTIVE: Hypogastric artery (HA) occlusion during aortic aneurysm repair has been associated with considerable morbidity. We analyzed the consequences of interrupting one or both HAs in the standard surgical or endovascular treatment of aortoiliac aneurysms (AIAs). METHODS: From 1992 to 2000, 154 patients with abdominal aortic aneurysms (n = 66), iliac aneurysms (n = 28), or AIAs (n = 60) required interruption of one (n = 134) or both (n = 20) HAs as part of their endovascular (n = 107) or open repair (n = 47). Endovascular treatment was performed with a variety of industry- or surgeon-made grafts in combination with coil embolization of the HAs. The standard surgical techniques included oversewing or excluding the origins of the HAs and extending the prosthetic graft to the external iliac or femoral artery. RESULTS: There were no cases of buttock necrosis, ischemic colitis requiring laparotomy, or death when one or both HAs were interrupted. Persistent buttock claudication occurred after 16 (12%) of the unilateral and 2 (11%) of the bilateral HA interruptions. Impotence occurred in 7 (9%) of the unilateral and 2 (13%) of the bilateral HA interruptions. Minor neurologic deficits of the lower extremity were observed in 2 (1.5%) of the patients with unilateral HA interruption. CONCLUSIONS: Although HA flow should be preserved if possible, selective interruption of one or both HAs can usually be accomplished safely during endovascular and open repair of anatomically challenging AIAs. We believe other comorbid factors such as shock, distal embolization, or the failure to preserve collateral branches from the external iliac and femoral arteries may have contributed to the morbidity in other reports of HA interruption.

Does the endovascular repair of aortoiliac aneurysms pose a radiation safety hazard to vascular surgeons?

OBJECTIVES: Endovascular aortoiliac aneurysm (EAIA) repair uses substantial fluoroscopic guidance that requires considerable radiation exposure. Doses were determined for a team of three vascular surgeons performing 47 consecutive EAIA repairs over a 1-year period to determine whether this exposure constitutes a radiation hazard. METHODS: Twenty-nine surgeon-made aortounifemoral devices and 18 bifurcated devices were used. Three surgeons wore dosimeters (1) on the waist, under a lead apron; (2) on the waist, outside a lead apron; (3) on the collar; and (4) on the left ring finger. Dosimeters were also placed around the operating table and room to evaluate the patient, other personnel, and ambient doses. Exposures were compared with standards of the International Commission on Radiological Protection (ICRP). RESULTS: Total fluoroscopy time was 30.9 hours (1852 minutes; mean, 39.4 minutes per case). Yearly total effective body doses for all surgeons (under lead) were below the 20 mSv/y occupational exposure limit of the ICRP. Outside lead doses for two surgeons approximated recommended limits. Lead aprons attenuated 85% to 91% of the dose. Ring doses and calculated eye doses were within the ICRP exposure limits. Patient skin doses averaged 360 mSv per case (range, 120-860 mSv). The ambient (> 3 m from the source) operating room dose was 1.06 mSv/y. CONCLUSIONS: Although the total effective body doses under lead fell within established ICRP occupational exposure limits, they are not negligible. Because radiation exposure is cumulative and endovascular procedures are becoming more common, individuals performing these procedures must carefully monitor their exposure. Our results indicate that a team of surgeons can perform 386 hours of fluoroscopy per year or 587 EAIA repairs per year and remain within occupational exposure limits. Individuals who perform these procedures should actively monitor their effective doses and educate personnel in methods for reducing exposure.

Can a tissue-engineered skin graft improve healing of lower extremity foot wounds after revascularization?

A bilayered tissue-engineered skin graft composed of human neonatal foreskin fibroblasts and keratinocytes in a type I bovine collagen matrix has been developed. We sought to determine if this graft improves wound healing after lower extremity revascularization. Thirty-one previously ischemic foot wounds were randomly assigned to moist dressing changes or tissue-engineered skin graft within 60 days of revascularization. In the grafted group, 10 received meshed and 11 received unmeshed graft. Wound healing was followed by wound area measurements and photography. There were no statistically significant differences between groups in patient age, sex, diabetes or renal failure risk factors, revascularization procedure, or wound location or size. Treatment with tissue-engineered skin graft was significantly more effective than moist dressing in the percentage of wounds healed (62 vs. 0% at 8 weeks, 86 vs. 40% at 12 weeks, p < 0.01) and the median time to complete wound closure (7 vs. 15 weeks, p = 0.0021, rank-sum test). There was no difference in the wound closure rate of meshed and unmeshed graft at 4, 8, 12, or 24 weeks (p > 0.05). Three indolent localized wound infections in the tissue-engineered skin graft group were the only complication. Tissue-engineered skin grafting can be used safely in previously ischemic wounds after lower extremity revascularization. Treatment with this graft promotes healing more rapidly and in more patients than standard moist dressings. It obviates the risk, inconvenience, and expense of donor skin harvesting, anesthesia, and hospitalization associated with autologous skin grafting. This graft may represent an advance in the treatment of previously ischemic lower extremity foot wounds.

Midterm experience with the endovascular treatment of isolated iliac aneurysms.

PURPOSE: This report describes our 5-year experience with the endovascular repair of isolated iliac aneurysms and pseudoaneurysms. METHODS: Between June 1993 and July 1998, 40 isolated iliac aneurysms and pseudoaneurysms were treated with endovascular grafts in 39 patients. Thirty-seven aneurysms were treated with endovascular grafts composed of polytetrafluoroethylene grafts and balloon expandable stents, and the other three underwent repair with a polycarbonate urethane endoluminal graft. RESULTS: All the patients underwent initially successful endovascular treatment of isolated iliac aneurysms and pseudoaneurysms and were followed from 1 to 51 months (mean, 18 months). The 4-year primary patency rate was 94.5% +/- 10%. The perioperative complications included one episode of distal embolization, an episode of colonic ischemia, five episodes of kinking or compression of the endovascular graft, and one early postoperative graft thrombosis. There was only one perioperative death in a patient whose aneurysm ruptured in the operating room just before endovascular repair. The median postoperative length of hospital stay was 3.0 +/- 1.3 days in this group of patients at moderate and high risk. The long-term complications included one graft thrombosis and two endoleaks. One small endoleak was followed until the patient died of unrelated causes, and the other one led to aneurysm rupture in the only patient temporarily lost to follow-up examination. This patient successfully underwent treatment in the standard open surgical fashion. To date, all the other aneurysms have remained stable or have decreased in size during the follow-up examinations with duplex or contrast-enhanced computed tomographic scans. CONCLUSION: Endovascular repair of iliac aneurysms and pseudoaneurysms is a safe and effective technique with good midterm results in patients at standard and high risk. These grafts are particularly beneficial for patients with medical, surgical, or anatomic contraindications for open surgical repair.

When is urokinase treatment an effective sole or adjunctive treatment for acute limb ischemia secondary to native artery occlusion?

BACKGROUND: Intra-arterial thrombolytic therapy is currently a therapeutic option for the treatment of acute limb ischemia. A recent large prospective randomized trial (TOPAS) comparing lytic therapy and operative intervention showed that both forms of treatment had similar results in terms of amputation-free survival. However, the exact role for lytic treatment is unclear. METHOD: Over a 4-year period we treated 60 cases of acute limb ischemia in 57 patients secondary to native artery occlusion with thrombolytic therapy with urokinase. All patients were evaluated at 1 week, 1 month, and then at 3-month intervals posttreatment. Follow-up evaluations included pulse examination, pulse volume recordings, and duplex examinations to confirm arterial patency. No patients were lost to follow-up with a range of 8 to 54 months (mean 26). RESULTS: Of these 60 native arterial occlusions, complete lysis was achieved in 46 cases (76%). Of these 46 cases, 18 required lysis only, 19 cases (9 iliac, 7 superficial femoral artery (SFA), and 3 popliteal) required angioplasty of lesions uncovered by clot lysis, and 9 patients had lysis and angioplasty of iliac arteries followed by infrainguinal bypasses. Eight of the 57 patients (14%) who had been asymptomatic presented with symptoms limited to new onset claudication, all of which were successfully lysed. Cumulative patency for the 43 successful cases was 90% +/- 5% at 1 year and 75% +/- 4% at 2 years. The 1-year amputation-free survival for all native artery occlusions was 85% +/- 6%. CONCLUSION: Thrombolysis with urokinase simplified the treatment of native arterial occlusion proving to be the sole therapy in 18 (29%) patients or a valuable adjunct by facilitating the angioplasty of arterial lesions and avoiding open surgery in 60% of patients treated. In addition, the correction of inflow lesions reduced the magnitude of required subsequent bypass procedures to achieve limb salvage. In conclusion, successful thrombolysis of native artery occlusion provided durable arterial patency and limb salvage, particularly in patients with new onset claudication.

Analysis of endovascular graft treatment for aortoiliac occlusive disease: what is its role based on midterm results?

OBJECTIVE: To analyze the authors' midterm results (up to 4 years) using endovascular grafts to treat aortoiliac occlusive disease in patients with limb-threatening ischemia. SUMMARY BACKGROUND DATA: Endovascular grafts are being used to manage some aortoiliac lesions formerly treated by aortofemoral or extraanatomic bypass grafts. However, widespread acceptance of these new grafts depends on their late patency and clinical utility. METHODS: Between January 1993 and December 1997, 52 patients with aortoiliac occlusive disease were treated with endovascular grafts. The primary indication for treatment was gangrene or ulceration in 42 patients (81%) and rest pain in 10 patients (19%). Sixteen patients had symptomatic contralateral limbs that were also treated, and 27 (52%) patients required a synchronous infrainguinal bypass. Results up to 4 years were evaluated by life table analysis. RESULTS: Forty-six (88%) of the patients had complete follow-up of 3 to 57 months (median 22 months). Six patients were lost to follow-up at a mean of 20 months after surgery. The 4-year primary and secondary patency rates for the endovascular grafts were 66.1% and 72.3% respectively. Six patients required a major amputation, and the limb salvage rate was 88.7%. Four-year patient survival was 37%, with 23 patients dying during this follow-up period. CONCLUSIONS: Endovascular grafts can often be used when conventional procedures are contraindicated or technically impractical. These grafts are a valuable alternative to extraanatomic and aortofemoral bypasses in high-risk patients with aortoiliac occlusive disease and critical ischemia.

Antisense oligonucleotides to c-fos and c-jun inhibit intimal thickening in a rat vein graft model.

BACKGROUND: C-fos and c-jun are 2 immediate early genes that have been implicated in the stimulation of vascular smooth muscle cell proliferation and migration. In previous experiments in our laboratory with a rat vein graft model a 2- to 3-fold increase of messenger RNA of c-fos and c-jun were noted 1 hour after vein graft perfusion. Because c-fos and c-jun are up-regulated after the perfusion of vein grafts, the purpose of this study was to delineate the temporal expression of c-fos and c-jun protein and to study the effect of antisense oligonucleotides (ASO) to c-fos and c-jun on intimal thickening observed in this model. METHODS: Sprague-Dawley rats underwent bilateral interposition femoral artery grafts with use of the superficial epigastric vein, which was harvested from 15 minutes up to 2 weeks and analyzed by Western blot for Fos and Jun protein. Additional rats underwent bypasses and at the time of the procedure 1 graft was treated with a pluronic gel containing an ASO to c-fos, c-jun, or sense and the contralateral side was treated with pluronic gel only. The vein grafts were harvested 2 weeks after the procedure and perfusion fixed. After longitudinal sectioning, the intimal and total wall thicknesses were measured in the perianastamotic and midgraft regions by a morphometric digitizing microscope and the statistics were analyzed by a paired Student's t test. RESULTS: Protein analysis by Western blot showed that c-fos levels rose quickly within 2 hours and leveled at 6 hours 40-fold above basal levels after vein graft perfusion. Similarly, c-jun levels rose 10-fold above basal levels after 15 minutes and peaked at 2 hours 120-fold above basal levels. The treatment of the vein grafts with these ASOs resulted in a reduction of about 30% in the thickness of the intimal layer and the total wall thickness in both the perianastomotic and the midgraft regions, which was statistically significant different from control veins. CONCLUSION: These results indicate a possible therapeutic role for ASO to immediate early genes in the treatment of vein graft intimal hyperplasia.

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.

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.

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.