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Objective: With more than a decade of use of endovascular aneurysm repair (EVAR), we expect to see a rise in the number of failing endografts. We review a single-center experience with EVAR explants to identify patterns of presentation and understand operative outcomes that may alter clinical management., Methods: A retrospective analysis of EVARs requiring late explants, >1 month after implant, was performed. Patient demographics, type of graft, duration of implant, reason for removal, operative technique, length of stay, complications, and in-hospital and late mortality were reviewed., Results: During 1999 to 2012, 100 patients (91% men) required EVAR explant, of which 61 were placed at another institution. The average age was 75 years (range, 50-93 years). The median length of time since implantation was 41 months (range, 1-144 months). Explanted grafts included 25 AneuRx (Medtronic, Minneapolis, Minn), 25 Excluder (W. L. Gore & Associates, Flagstaff, Ariz), 17 Zenith (Cook Medical, Bloomington, Ind), 15 Talent (Medtronic), 10 Ancure (Guidant, Indianapolis, Ind), 4 Powerlink (Endologix, Irvine, Calif), 1 Endurant (Medtronic), 1 Quantum LP (Cordis, Miami Lakes, Fla), 1 Aorta Uni Iliac Rupture Graft (Cook Medical, Bloomington, Ind), and 1 homemade tube graft. Overall 30-day mortality was 17%, with an elective case mortality of 9.9%, nonelective case mortality of 37%, and 56% mortality for ruptures. Endoleak was the most common indication for explant, with one or more endoleaks present in 82% (type I, 40%; II, 30%; III, 22%; endotension, 6%; multiple, 16%). Other reasons for explant included infection (13%), acute thrombosis (4%), and claudication (1%). In the first 12 months, 23 patients required explants, with type I endoleak (48%) and infection (35%) the most frequent indication. Conversely, 22 patients required explants after 5 years, with type I (36%) and type III (32%) endoleak responsible for most indications., Conclusions: The rate of EVAR late explants has increased during the past decade at our institution. Survival is higher when the explant is done electively compared with emergent repair. Difficulty in obtaining a seal at the initial EVAR often leads to failure ≤1 year, whereas progression of aneurysmal disease is the primary reason for failure >5 years., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The pattern and magnitude of the hyperglycemic response to surgical stress, the added effect of low-dose steroids, and whether these differ in diabetics and nondiabetics remain unclear. We therefore tested 2 hypotheses: (1) that diabetics show a greater increase from preoperative to intraoperative glucose concentrations than nondiabetics; and (2) that steroid administration increases intraoperative hyperglycemia more so in diabetics compared with nondiabetics., Methods: Patients scheduled for major noncardiac surgery under general anesthesia were enrolled and randomized to preoperative IV 8 mg dexamethasone or placebo, stratified by diagnosis of diabetes. Patients were part of a larger underlying trial (the Dexamethasone, Light Anesthesia and Tight Glucose Control [DeLiT] Trial). IV insulin was given when glucose concentration exceeded 215 mg/dL. The primary outcome measure was the change in glucose from the preoperative to maximal intraoperative glucose concentration. We also report the time-dependent pattern of intraoperative hyperglycemia., Results: Ninety patients (23% with diabetes) were randomized to dexamethasone, and 95 (29% with diabetes) were given placebo. The mean ± SD change from preoperative to maximal intraoperative glucose concentration was 63 ± 69 mg/dL in diabetics and 72 ± 45 mg/dL in nondiabetics. The mean covariable-adjusted change (95% confidence interval) in nondiabetics was 29 (13, 46) mg/dL more than in diabetics (P < 0.001). For all patients combined, mean glucose increased slightly from preoperative to incision, substantially from incision to surgery midpoint, and then remained high and fairly stable through emergence, with nondiabetic patients showing a greater increase (P < 0.001). For nondiabetics, the mean increase in glucose concentration (97.5% CI) was 29 (9, 49) mg/dL more in patients given dexamethasone than placebo (P = 0.0012). However, there was no dexamethasone effect in diabetics (P = 0.99)., Conclusions: Treatment of intraoperative hyperglycemia should account for the hyperglycemic surgical stress response trend depending on the stage of surgery as well as the added effects of steroid administration. Denying steroid prophylaxis for postoperative nausea and vomiting for fear of hyperglycemic response should be reconsidered given the limited effect of steroids on intraoperative blood glucose concentrations.

Introduction: Successful endovascular exclusion of abdominal aortic aneurysms is largely dependent on adequate apposition of the stent graft to the aortic wall. Proximal endoleaks at the time of stent graft placement are uncommon but are more prevalent in patients with challenging neck anatomy. If these initial leaks do not respond to simple balloon angioplasty, Palmaz stents (Cordis Endovascular, Warren, NJ) and covered stent graft cuffs both have been used to seal the endoleak. Long-term data regarding the efficacy of one method over the other, however, is lacking., Methods: We retrospectively reviewed a database of all infrarenal aortic aneurysm repairs with an intraoperatively diagnosed type Ia endoleak requiring Palmaz stent or covered stent graft cuff placement. Fenestrated and branch grafts were excluded. All records and appropriate imaging studies were reviewed. The primary end points were technical success of aneurysm exclusion, recurrence of a type Ia leak, and need for reintervention., Results: At the time of the initial aneurysm repair, 72 patients required an adjunctive covered extension or Palmaz stent; of these, 24 (33%) underwent sole placement of a Palmaz stent, 45 (62.5%) underwent placement of a covered stent graft cuff, and 3 required both a cuff and a Palmaz stent. Aneurysmal exclusion was successful in all patients before leaving the operating room. No recurrent type Ia endoleak developed in patients who underwent Palmaz stent placement. Of the 45 patients who underwent cuff placement, proximal leaks developed in 3 that required reintervention: 1 was managed with a Palmaz stent and the other 2 required open surgical revision., Conclusions: Palmaz stent placement and stent graft cuff placement are frequently used to seal immediate proximal endoleaks that do not resolve with balloon angioplasty. Both methods appear to be durable long-term options to facilitate endovascular exclusion of abdominal aortic aneurysms., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Venous hypertension is a significant cause of patient morbidity and decreased quality of life. Common etiologies of venous hypertension include deep venous thrombosis (DVT) or congenital abnormalities resulting in chronic outflow obstruction. We have implemented an aggressive endovascular approach for the treatment of iliac venous occlusion with angioplasty and stenting. The purpose of this study was to determine the patency rates with this approach at a large tertiary care center., Materials/methods: All patients undergoing iliofemoral venous angioplasty and stenting over a 4-year period were identified from a vascular surgical registry. Charts were reviewed retrospectively for patient demographics, the extent of venous system involvement, the time course of the venous pathology, and any underlying cause. Technical aspects of the procedure including previous angioplasty or stenting attempts and presence of collaterals on completion venogram were then recorded. Patency upon follow-up was determined using primarily ultrasound scans; other imaging methods were used if patency was not clear using an ultrasound scan., Results: A total of 36 patients (40 limbs) were stented from January 2005 through December 2008. Of these patients, 27 were women (75%). Both lower extremities were involved in 4 patients. Thrombolysis was performed in 19 patients (52.8%). Thrombosis was considered acute (<30 days) in 13 patients (38%). The majority of patients who had a recognized underlying etiology were diagnosed with May-Thurner syndrome (15 patients; 42%). In 9 patients, an etiology was not determined (25%). The mean follow-up time period in the study population was 10.5 months. One stent in the study occluded acutely and required restenting. Primary patency rates at 6, 12, and 24 months were 88% (75.2-100), 78.3% (61.1-95.4), and 78.3% (61.1-95.4), respectively. Secondary patency rates for the same time frames were 100% (100.0, 100.0), 95% (85.4, 100.0), and 95% (85.4, 100.0). Better outcomes were seen in stenting for May-Thurner syndrome and idiopathic causes, whereas external compression and thrombophilia seemed to portend less favorable outcomes (P < .001). Symptomatic improvement was reported in 24 of 29 patients (83%) contacted by telephone follow-up., Conclusion: Iliofemoral venous stenting provides a safe and effective option for the treatment of iliac venous occlusive disease. Acceptable patency rates can be expected through short-term follow-up, especially in the case of May-Thurner syndrome. Further experience with this approach and longer-term follow-up is necessary. Thrombophilia workup should be pursued aggressively in this population, and further studies should be undertaken to determine the optimal length of anticoagulation therapy after stent placement., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Perioperative proximal endoleaks during endovascular aneurysm repair potentiate graft migration, aneurysm sac expansion, and stent-graft failure. Adjunctive placement of a Palmaz stent at the proximal landing zone can improve proximal seal and eliminate perigraft flow; however, the long-term sequelae associated with this maneuver are unknown. We sought to evaluate the effect of Palmaz stent placement for type Ia endoleaks on delayed endoleak formation, graft migration, and aneurysm expansion., Methods: A retrospective cohort review of a prospectively maintained database was performed. Between 2000 and 2005, all consecutive patients who had undergone infrarenal endovascular aneurysm repair were evaluated for a type I endoleak that was treated with Palmaz stent placement. Fenestrated, juxtarenal, and investigational devices were excluded from the analysis. Postoperative and follow-up axial imaging were analyzed for the following three primary endpoints: type I endoleak formation, stent-graft migration, and aneurysm sac expansion. In addition, a paired analysis was performed comparing suprarenal aortic diameters, infrarenal aortic neck diameters, aortic neck lengths, and proximal seal zones., Results: In all, 36 consecutive patients were identified with intraoperative type I endoleaks that were treated with Palmaz stenting. Five patients with ruptured abdominal aortic aneurysms died before discharge; the remaining 31 patients comprised the cohort for analysis. During a median follow-up period of 53 months (interquartile range: 14-91 months), no type I endoleak developed after Palmaz stent placement. Despite patients experiencing shortening of aortic neck length (26%) and loss of the proximal seal zone (35%), no stent-graft migration was seen in this population. Continued aortic degeneration accounted for proximal seal zone loss. At a distance 15 mm below the lowest renal artery, the mean aortic diameter increased by 3.2 mm (95% confidence interval: 0.4-6, p < 0.5), and 63% of patients demonstrated an increase of >10%. Mean aortic sac regression was 5.8 mm (95% confidence interval: 0.5-11.0, p < 0.05). Overall, at the final follow-up evaluation, aortic sac regression was found to have occurred in 55% of patients, aortic sac increased up to 10% in 20% of the patients, and by more than 10% in 25% of the patients., Conclusions: Proximal neck reinforcement with a Palmaz stent serves as an effective endovascular adjunct to treat intraoperative type I endoleaks, and has a very high technical success rate. Most importantly, it has a clinical effect on delayed type I endoleak formation and stent-graft migration., (Copyright © 2011 Annals of Vascular Surgery Inc. All rights reserved.)

Acute limb ischemia occurs in 15% to 20% of patients with chronic peripheral arterial disease. Off-label use of tissue plasminogen activators is the most common approach for patients with ischemic limbs that can wait 24 to 48 hours to restore flow. In the past decade, mechanical thrombectomy devices that use aspiration, maceration, or ultrasound waves have been developed to allow more rapid restoration of flow. Combination therapy with both mechanical and pharmacologic thrombolysis has become commonplace without randomized data to support its use. This article reviews acute limb ischemia and data regarding pharmacologic and mechanical thrombolysis.

Interventional therapy for tibial arteries is a key part of the vascular specialist armamentarium. Tibial artery interventional therapy has been proven to lead to limb salvage with low morbidity and mortality in patients with critical limb ischemia and should be used as a first line treatment mode in the majority of patients, especially in those with significant medical comorbidities. The exceptions are the patients with extensive tissue loss and infection, where endovascular therapy may not restore enough flow to achieve rapid healing and limb salvage, and those patients with tissue loss in the setting extensive, multi-level, occlusive disease, where patency to the completion of wound healing will be unlikely. However, differences in outcome between available devices are unknown and ways to increase long term patency remain poorly defined.

Compared to conventional percutaneous transluminal angioplasty (PTA) and stent implantation for arterial occlusive diseases, atherectomy offers the theoretical advantages of eliminating stretch injury on arterial walls and reducing the, rate of restenosis. Historically, however, neither rotational nor directional atherectomy, whether used alone or with adjunctive PTA, has shown any significant long-term benefit over PTA alone in the coronary or peripheral arteries. However, the SilverHawk Plaque Excision System has produced positive results in single-center prospective registries of patients with femoropopliteal and infrainguinal lesions, with reduced adjunctive PTA, minimal adjunctive stenting, and competitive 6-month and 12-month patency rates. In the observational nonrandomized TALON (Treating Peripherals with SilverHawk: Outcomes Collection) registry, freedom from target lesion revascularization was 80% for 87 patients at 12 months. Questions remaining for further research with this device include more accurate determination of an event rate for distal embolization, the appropriate use of distal protection, the value of and appropriate circumstances for adjunctive angioplasty, and definitive patency and clinical outcomes. Other atherectomy devices are discussed.

Objectives: The frequency of late removal of endovascular abdominal aortic repair (EVAR) parallels the rise of endovascular aortic repair. Evaluation of outcomes for EVAR explants may identify risks for complications and alter clinical management., Methods: A patient database was used to identify EVAR patients requiring explant >1 month after implant. A retrospective analysis was conducted of the type of graft, duration of implant, reason for removal, operative technique, death, and length of stay., Results: During 1999 through 2007, 1606 EVARs were performed, and 25 patients required explantation, with an additional 16 referred from other institutions (N = 41). The average age was 73 years (range, 50-87 years); 90% were men. Grafts were excised after a median of 33.3 months (range, 3-93 months). Explanted grafts included 16 AneuRx (40%), 7 Ancure (17%), 6 Excluder (15%), 4 Zenith (10%), 4 Talent (10%), 1 Cook Aortomonoiliac rupture graft, 1 Endologix, 1 Quantum LP, and 1 homemade tube graft. Overall hospital mortality was 19% and occurred after conversion for rupture in 4, and in infected graft, aortoenteric fistula, repair of new aneurysm of the visceral segment, and claudication due to graft stenosis in one patient each. Elective EVAR-related mortality was 3.3%. Mortality was higher in patients with rupture compared with nonrupture (4 of 6 vs 3 of 35, P

Purpose: To review our experience with the endovascular treatment of chronic infrarenal aortic occlusion with regard to technical success and midterm patency, as well as perioperative mortality and morbidity., Methods: A retrospective review was performed of patients who presented from January 1, 2000, to December 31, 2005, with a diagnosis of chronic infrarenal aortic occlusion (TASC D) treated with endovascular techniques. In this time period, 31 patients (22 women; mean age 63 years) underwent attempted recanalization of the occluded aorta and iliac arteries. Claudication was the most common presenting symptom (14, 45%). Patients were treated solely with angioplasty and stenting or thrombolysis followed by angioplasty/stenting based on surgeon preference., Results: Technical success was 93%. The 2 failures were individual cases of wire-induced iliac artery perforation and failed access; both patients were treated with bypass grafting. Nine (29%) patients had thrombolysis prior to angioplasty. There were no perioperative deaths. Postoperative ankle-brachial indexes increased significantly from preoperative values (p<0.0001). There were 3 technical complications: 1 (3%) iatrogenic iliac artery injury and 2 (6%) perioperative limb thromboses requiring intervention. Other complications included 6 (19%) access site events and 5 (16%) episodes of acute renal dysfunction, 2 requiring permanent dialysis. Over a mean follow-up of 12 months, there was no limb loss. At 1 and 3 years, the primary/secondary patency rates were 85%/100% and 66%/90%, respectively., Conclusion: Endovascular therapy for chronic infrarenal aortic occlusion has a high technical success rate, with good midterm primary and secondary patency rates. However, renal dysfunction can occur; the etiology is likely multifactorial from contrast volumes, embolization, and/or renal arterial disease.

Objective: Aortobifemoral bypass (ABF) grafting has been the traditional treatment for extensive aortoiliac occlusive disease (AIOD). This retrospective study compared the outcomes and durability of recanalization, percutaneous transluminal angioplasty, and stenting (R/PTAS) vs ABF for severe AIOD., Methods: Between 1998 and 2004, 86 patients (161 limbs) underwent ABF (n = 75) or iliofemoral bypass (n = 11), and 83 patients (127 limbs) underwent R/PTAS. All patients had severe symptomatic AIOD (claudication, 53%; rest pain, 28%; tissue loss, 12%; acute limb ischemia, 7%). The analyses excluded patients treated for aneurysms, extra-anatomic procedures, and endovascular treatment of iliac stenoses. Original angiographic imaging, medical records, and noninvasive testing were reviewed. Kaplan-Meier estimates for patency and survival were calculated and univariate analyses performed. Mortality was verified by the Social Security database., Results: The ABF patients were younger than the R/PTAS patients (60 vs 65 years; P = .003) and had higher rates of hyperlipidemia (P = .009) and smoking (P < .001). All other clinical variables, including cardiac status, diabetes, symptoms at presentation, TransAtlantic Inter-Society Consensus stratification, and presence of poor outflow were similar between the two groups. Patients underwent ABF with general anesthesia (96%), often with concomitant treatment of femoral or infrainguinal disease (61% endarterectomy, profundaplasty, or distal bypass). Technical success was universal, with marked improvement in ankle-brachial indices (0.48 to 0.84, P < .001). Patients underwent R/PTAS with local anesthesia/sedation (78%), with a 96% technical success rate and similar hemodynamic improvement (0.36 to 0.82, P < .001). At the time of R/PTAS, 21% of patients underwent femoral endarterectomy/profundaplasty or bypass (n = 5) for concomitant infrainguinal disease. Limb-based primary patency at 3 years was significantly higher for ABF than for R/PTAS (93% vs 74%, P = .002). Secondary patency rates (97% vs 95%), limb salvage (98% vs. 98%), and long-term survival (80% vs 80%) were similar. Diabetes mellitus and the requirement of distal bypass were associated with decreased patency (P < .001). Critical limb ischemia at presentation (tissue loss, hazard ratio [HR], 8.1; P < .001), poor outflow (HR, 2; P = .023), and renal failure (HR, 2.5; P = .02) were associated with decreased survival., Conclusion: R/PTAS is a suitable, less invasive alternative to ABF for the treatment of severe AIOD. Repair of the concomitant femoral occlusive disease is often needed regardless of open or endovascular treatment. Infrainguinal disease negatively affects the durability of the procedure and patient survival.

Objective: Little data exist to support the durability of thoracic endovascular repair during prolonged periods of follow-up. This study examines the durability and long-term results with the Zenith TX1 and TX2 thoracic devices (Cook Inc, Bloomington, Ind) in high-risk patients., Methods: Data were collected prospectively from 2001 to 2007 on high-risk patients who presented with thoracic aneurysms, chronic aortic dissection, or fistulas treated with a Zenith thoracic device. Surgical modifications of proximal or distal landing zones were performed when necessary. Computed tomography follow-up scans were performed before discharge, at 1, 6, and 12 months, and yearly thereafter. Three-dimensional reconstruction software with central line of flow measurements was used to assess aortic morphologic characteristics. Kaplan-Meier analysis was used to assess survival, freedom from reintervention, predictive factors of poor outcome, and morphologic changes, including aneurysm sac behavior., Results: A total of 160 patients (44% women; mean age, 70) were treated for 130 thoracic aneurysms, 25 aortic dissections with aneurysm, 2 fistulas, and 3 symptomatic or aortic ruptures, or both. Mean follow-up was 36 months, and aneurysm size was 67 mm. Seventy-five patients (47%) had undergone prior aortic aneurysm repair. Surgical modifications were required to create adequate landing zones in 33% patients, including 28 elephant trunk/arch reconstruction, 22 carotid-subclavian bypasses, and seven visceral vessel bypasses. Iliac conduits were required in 31 patients. Early mortality (<30 days) occurred in 11 patients (6.9%). Overall mortality at 1 year was 16%. Aneurysm sac increase (>5 mm) requiring intervention was observed only in one patient in the settings of component separation and type III endoleak that was treated; the sac is now stable. Twenty-seven endoleaks were detected in 25 patients: 15 primary endoleaks (9.4%) <30 days and 12 secondary endoleaks (7.5%) >30 days. Secondary interventions were required in 42 patients (26%)., Conclusion: Endovascular treatment of thoracic aortic pathologies with the Zenith TX1 and TX2 devices is feasible and durable. The mid- to long-term results are encouraging, with acceptable low reintervention rates and with good survival within high-risk patients.

Femoropopliteal bypass is the traditional management of superficial femoral artery lower extremity athero-occlusive disease for lifestyle-limiting claudication and critical limb ischemia. Over the last decade, with the advent of new technologies, an increasing number of endovascular interventions are being used to treat femoropopliteal disease. Endovascular interventions are attractive to patients and physicians because of their decreased morbidity and mortality, despite the possibility of reduced durability. A multitude of techniques are available, without a clear consensus as to which one is best. This article reviews the current endovascular management options available for femoropopliteal occlusive disease, and the published results with each modality.

Most patients with lower extremity peripheral arterial disease (PAD) are asymptomatic. Although intermittent claudication is the classic presenting symptom in those who are symptomatic, PAD often presents atypically as a result of associated comorbidities. The differential diagnosis involves consideration of many nonvascular and nonatherosclerotic causes of exercise-associated leg pain. Weak or absent pulses are the hallmark physical finding of PAD, and the ankle-brachial index is the most efficient objective test for documenting it. PAD may progress to acute limb ischemia (acute deterioration of limb flow) or critical limb ischemia (chronic compromise in limb perfusion which resulting in rest pain and tissue loss), both of can lead to limb loss without timely treatment.

Percutaneous transluminal angioplasty of the superficial femoral and popliteal arteries has been an accepted therapy for short focal stenosis. Elastic recoil and flow-limiting dissection have limited the durability of angioplasty, especially in long lesions and total occlusions. Cryoplasty couples cold therapy with angioplasty to induce mechanical and biologic effects to reduce elastic recoil and potentially to reduce restenosis. The mechanical and biologic mechanisms of this therapy are discussed. The results of cryoplasty for femoropopliteal lesions from a single-center series and a multicenter registry are reviewed. Cryoplasty appears to improve patency over conventional angioplasty and to reduce the need for bailout stenting in femoropopliteal stenoses and occlusions < 10 cm in length. Cryoplasty appears to be promising to treat critical limb ischemia in patients with tibial disease.

Objective: To validate a means by which migration of thoracic stent grafts can be reliably detected and quantified., Methods: Patients treated for thoracic aneurysms (without dissections) with either the Cook Zenith TX1/TX2 or the Gore TAG device were retrospectively reviewed. Patients with digital imaging data at a baseline study (discharge or 1-month computed tomographic scan) and a minimum of 6 months' follow-up were evaluated on a three-dimensional workstation. Centerline of flow (CLF) calculations were used to determine length measurements to establish distances from native vascular landmarks (left common carotid artery, left common carotid artery, and celiac artery) to the proximal and distal aspects of the fixation systems of stent grafts. Patients with evidence of fixation system migration (>10 mm of movement) or increasing thoracic aortic lengths (left common carotid artery to celiac artery distance) were subjected to more detailed reviews., Results: Of 194 patients evaluated (133 Zenith and 61 TAG), 46 were treated for dissections and excluded. Fifty-seven patients did not have a digital baseline study and available DICOM data for follow-up imaging at 6 months or later or had died before such follow-up imaging. The remaining 91 patients underwent assessment for device migration. Analyses were conducted on 19 patients at 6 months, on 42 at 12 months, on 12 at 24 months, on 13 at 36 months, and on 5 at 48 months. CLF analysis noted more than 10 mm of caudal movement of the proximal device in 10 patients and cranial movement of the distal device in 3 patients. When this subset was further scrutinized with regard to morphologic changes remote from the prosthesis and in the context of the overall aortic repair (such as elephant trunk grafts), only four patients had movement of the proximal or distal fixation system with respect to the initially deployed location. Two-dimensional axial image analysis identified migration in only one of the four patients with CLF-detected fixation system movement., Conclusions: The importance of early migration detection cannot be overstated given the potential to avert consequences as evidenced by analyses of counterpart abdominal aortic aneurysm devices. In vivo thoracic device analysis is more complex than that for devices used for infrarenal aneurysms. Distance calculations based on CLF measurements may overestimate the frequency of true migration, yet they serve as a reasonable initial screening tool. The resultant subset of patients then must undergo a more detailed evaluation of device position in the context of the aortic morphology to differentiate true migration from devices that maintain stable fixation system positions.

Objectives: To evaluate the use of novel technology to treat complex aortic aneurysms involving branches that provide critical end-organ blood supply., Methods: A prospective study was conducted in patients with thoracoabdominal, suprarenal, or common iliac aneurysms (TAA, SRA, or CIA) at high risk for open surgical repair. An endovascular graft using the Zenith platform was customized to fit patient anatomy (TAA or SRA) and combined with Jomed balloon-expandable stent-grafts. Prefabricated hypogastric branches were used with a Zenith abdominal aortic aneurysm (AAA) or Fluency self-expanding fenestrated device in conjunction with a self-expanding stent-graft. Analyses were conducted in accordance with the endovascular aneurysm reporting standards document. Follow-up studies occurred at discharge, 1, 6, and 12 months, and included computed tomography and duplex ultrasound scans, and flat plate radiography., Results: Fifty patients were treated (9 TAA, 20 SRA, 21 CIA). The mean aneurysm size was 7.6 cm (TAA), 7.2 cm (SRA), and 6.1 cm AAA size associated with a mean CIA size of 3.8 cm. Bilateral CIA aneurysms were present in 86% (18/21) of patients with CIA aneurysms. Perioperative mortality was 2% (1/50) and resulted from a myocardial infarction after a planned conduit and iliac endarterectomy required for device access. Five late deaths occurred (2 TAA, 2 SRA, 1 CIA), three of which (2 TAA, 1 SRA) were aneurysm related. Failure to access internal iliac arteries occurred in three cases, and two late hypogastric branch thromboses occurred. No visceral branches were lost acutely or occluded during follow-up. Sac shrinkage (>5 mm) was noted in 65% of patients at 6 months and in all patients (10/10) by 12 months. There were no ruptures or conversions, but nine patients required secondary interventions., Conclusions: Branch vessel technology has made it technically feasible to preserve critical end-organ perfusion in the setting of CIA, SRA, and TAA aneurysms. The relatively low acute mortality rate and lack of short-term branch vessel loss are encouraging and merit further investigation. These advances have the potential to markedly diminish the complications associated with conventional management of complex aneurysms.

Objective: The preferential use of endovascular techniques to treat complex aortoiliac disease has increased in recent years. The purpose of this study was to review the outcomes and durability of recanalization, percutaneous transluminal angioplasty, and stenting for iliac occlusions based on the patient's TransAtlantic Inter-Society Consensus (TASC) stratification., Methods: Between 1998 and 2004, more than 628 patients with a clinical diagnosis of aortoiliac atherosclerotic disease underwent arteriography. The endovascular treatment of 89 consecutive patients (mean age, 66 years; 58% male) with symptomatic iliac occlusions (TASC-B, -C, and -D) was the basis for this study. Original angiographic imaging was evaluated for lesion grade and runoff. Electronic and hard copy medical records were reviewed for demographic data, clinical variables, and noninvasive vascular laboratory testing. Kaplan-Meier estimators were used to determine patency rates according to Society for Vascular Surgery criteria. Univariate and multivariate analyses were performed. P values of <.05 were considered significant., Results: Recanalization and percutaneous transluminal angioplasty/stenting (total, 178 stents) of occluded iliac arteries was technically successful in 84 (91%) of 92 procedures. Patients in the TASC-C and -D groups often required multiple access sites (50%) and femoral artery endarterectomy/patch angioplasty for diffuse disease (24%). The mean ankle-brachial index increased from 0.45 to 0.83. Distal embolization led to major amputation and eventual death in one patient. Two other deaths occurred in the perioperative period secondary to cardiorespiratory causes. Three-year primary patency, secondary patency, and limb salvage rates were 76%, 90%, and 97%, respectively, and progression of infrainguinal disease led to late limb loss in two patients. Diabetes as a risk factor was significantly associated with decreased primary patency (57% vs 83%; P = .049). Critical ischemia at presentation was associated with decreased patency rates as well (P = .002), but TASC classification did not significantly alter patency rates., Conclusions: Complex long-segment and bilateral iliac occlusions can be safely treated via endovascular means with high rates of symptom resolution. Initial technical success, low morbidity, and mid-term durability are comparable to results with open reconstruction. A liberal posture to open femoral artery reconstruction extends the ability to treat diffuse TASC-C and -D lesions via endovascular means.

A 69-year-old man with previous ascending aortic repair combined with valve replacement for an ascending aortic aneurysm presented with a type 2 thoracoabdominal aneurysm and a 4.4-cm aneurysm of the right subclavian artery. Because of the anatomic location of the aneurysm and his previous operation, an innominate to carotid artery stent graft and a carotid-subclavian bypass and vertebral artery bypass were performed. Postoperative computed tomographic angiography confirmed good flow in the right carotid and vertebral artery, and the patient recovered without complication.

Aortoenteric fistula (AEF) has been described after endovascular stent graft repair of abdominal aortic aneurysms (EVAR). AEF after EVAR has been associated with aneurysm growth, endoleak, migration, and aortic inflammation. We report a patient with an AEF presenting 2 years after EVAR with two abscesses in the right leg. A computed tomographic scan showed a gas-filled thrombus lining the right limb of his graft. At conversion, no endoleak, device migration, or residual aneurysm sac was found. AEF can occur after endoluminal stent graft (ELG) in the absence of aneurysm growth, endoleak, migration, or inflammation. AEF can cause ELG infection and extremity infection.

Purpose: This prospective study was designed to assess the technical success and outcome after patients with thoracic aortic pathology at high risk for conventional therapy were treated with the Zenith TX1 and TX2 endovascular graft., Methods: Between 2001 and 2004, patients at high risk for conventional surgical therapy presenting with chronic aortic dissections, thoracic aneurysms, or aortobronchial or aortoesophageal fistulas were treated with a single- or multiple-piece endovascular grafts. Surgical modification of proximal or distal fixation sites was performed when necessary to establish adequate regions for device landing zones. Follow-up studies included radiographic evaluation before discharge and at 1, 6, 12, and 24 months. Aortic morphologic characteristics were determined by using three-dimensional imaging studies and centerline of flow measurements. Statistical analyses were performed with Kaplan Meier analysis to assess survival, factors predictive of poor outcome, and morphologic changes, including sac shrinkage., Results: A total of 100 patients (42% women) were treated, including 81 aneurysms, 15 aortic dissections (with aneurysms), 2 patients with fistulous connections (1 aortobronchial and 1 aortoesophageal), 1 subclavian artery aneurysm, and 1 aortic rupture. Mean follow-up and aneurysm size were 14 months and 62 mm, respectively. Most patients (55%) had undergone prior aortic aneurysm repair. Surgical modifications were required to create adequate implantation sites in 29% patients, including 14 elephant trunk/arch reconstructions, 18 carotid-subclavian bypasses, and 4 visceral vessel bypasses. Iliac conduits were required in 19 patients. Overall mortality was 17%, and aneurysm-related mortality was 14% at 1 year. Sac regression (>5 mm maximum diameter decrease) was observed in 52% and 56% at 12 and 24 months. Growth was noted in one patient (1.6%) at 12 months. Endoleaks were detected in eight patients (8.5%) at 30 days and three patients (6%) at 12 months. Secondary interventions were required in 15 patients. Migration (>10 mm) of the proximal or distal stent was noted in three patients (6%) (two proximal and one distal), none of which required treatment or resulted in an adverse event., Conclusions: Acceptable intermediate-term outcomes have been achieved in the treatment of high-risk patients in the setting of both favorable and challenging anatomic situations with these devices. The complexity of the patient population, in contrast to endovascular infrarenal repair, attests to the differences in the pathophysiology aortic disease in the anatomic beds.

Background: Fenestrated endovascular aneurysm repair uses the visceral aortic segment, in the setting of a suboptimal proximal neck, for sealing and fixation. This technique requires the placement of visceral stents and might be hampered by the deleterious effects of such interventions. This study was performed to define outcomes related to renal events., Materials and Methods: Consecutive clinical records and radiographic studies of patients treated primarily with an endovascular approach with a fenestrated endograft were reviewed. The population was divided into groups with and without baseline renal dysfunction based on the National Kidney Foundation definition of chronic kidney disease. Morphologic measurements and the detection of postoperative renal events such as renal artery stenosis or occlusion, need for dialysis, deterioration of renal function by using estimated glomerular filtration rate (GFR), and secondary interventions related to the renal arteries were assessed. Preoperative and postprocedural factors predictive for the development of renal dysfunction were assessed by using a Fisher exact test, t test, and logistic regression., Results: A total of 72 patients were treated between 2001 and 2004 with a mean age, aneurysm size, and follow-up of 75 years, 6.2 cm, and 6 months (range, 1 to 24 months), respectively. No ruptures and five deaths (two procedure-related) were observed. There were 23 patients with baseline renal insufficiency and 49 patients without insufficiency. Twenty-four patients had deterioration in GFR >30% during the follow-up period, and 17 patients experienced 19 renal-related events (more common in patients with baseline insufficiency, 39% vs 16.3%; P = .04; relative risk, 2.4). Four patients required dialysis (two permanent), and all had preoperative renal dysfunction ( P = .002); similarly, death was also more common in this group (17.4% vs 2%; P = .02; relative risk, 8.52). Renal events in most patients occurred within the first postoperative month (59%). However, mean GFR stabilized after 6 months., Conclusion: Aneurysm repair with fenestrated endovascular grafts is associated with a significant risk for adverse renal events (16% in those without renal dysfunction, although none developed a creatinine >2 mg/dL, and 39% for patients with preoperative renal dysfunction). These patients must be meticulously followed, particularly within the first month after such a procedure. When renal artery restenosis is suspected or diagnosed, aggressive approach might be warranted to limit the extent of late renal dysfunction.

Objective: The purpose of this study was to determine the differences in outcome related to initial management of aortic endograft limb occlusion (ELO)., Methods: During a 7-year period, 823 endovascular aneurysm repairs (EVARs) resulted in 25 ELOs in 22 patients. The initial management and outcome of these ELOs were reviewed. Median follow-up after ELO was 24.2 +/- 16.8 months., Results: Initial EVARs included both unsupported unibody (n = 5) and supported modular (n = 17) devices. ELO was significantly more common in the unsupported unibody graft design (P <.024) and with extension of the graft limb to the external iliac artery (P <.001). ELO was managed with an endovascular approach (EVA), including some combination of mechanical thrombectomy (n = 8), angioplasty with or without stenting (n = 8), and thrombolysis (n = 2) in 12 patients and bypass procedures (femoral-femoral bypass, n = 11; axillofemoral bypass, n = 1; and aortofemoral bypass, n = 1) in 13. At 12-month follow-up, freedom from secondary procedures with EVA was 80.2 +/- 17.7% versus 53.2 +/-17.1% with extra-anatomic bypass (EB) (P = NS). Secondary patency was 100% with EVA and 80.6 +/- 14.4% with EB (P = NS). Of the 12 EVAs, there was 1 (8.3%) perioperative mortality with EVA and none with EB. EB failure was directly attributed to donor limb occlusion in 4 of 6 EVAs (67%), and when this occurred it resulted in bilateral lower extremity ischemia. Amputation was required in 2 of 12 (16.7%) EBs versus none of the 12 EVAs (P = NS). EVA never resulted in graft dislodgement or endoleak but did identify an underlying treatable cause in 8 of 12 (67%)., Conclusion: Both EVA and EB are acceptable management strategies for ELO. The potential risk of graft dislodgement was not observed with an EVA. If EB is employed, assessment of the donor limb and treatment of any underlying lesions is advisable in an attempt to minimize future donor limb occlusion.

Purpose: To demonstrate the need for a radiographic definition of migration that accurately describes a specific failure mode of an aortic stent-graft., Methods: The diagnosis of endograft migration, as defined by the Society for Vascular Surgery/American Association for Vascular Surgery (SVS/AAVS) standards, requires a synthesis of clinical and/or radiographic observations. Radiographic studies and clinical reports of 704 consecutive patients treated over a 6-year period with abdominal aortic endografts were retrospectively reviewed. According to the current SVS/AAVS standards, 25 patients were identified as having endograft migration. Follow-up computed tomographic scans and radiographs available for 24 of these patients were scrutinized from discharge to the time of any observed proximal or distal fixation system movement based upon the discharge or 30-day CT scan. Proximal migration was defined with respect to the origin of the superior mesenteric artery (SMA) as movement in a caudal or cranial direction of >/=10 mm or >2 times the reconstructed resolution of the imaging study (whichever measurement was less). Distal migration was similarly defined using the aortic bifurcation and respective hypogastric artery origin as reference points. In an effort to assess the scan-to-scan variation, the distance between the SMA and lowest renal artery, which was expected to remain consistent, was measured., Results: Film analysis with application of the revised migration definition confirmed fixation system failure with respect to the native arterial system in 12 (50%) of the 24 patients. Subjects judged to have endograft migration according to the reporting standards but not to have radiographic evidence of migration based on the modified criteria included 2 proximal endoleaks without evidence of device movement treated with proximal extensions, 1 procedure-related migration, 2 type III endoleaks treated with a second prosthesis implanted within the first, 1 distal endoleak treated with a limb extension, 1 rupture with presumed distal limb migration, and 2 cases of component separation. Three limb extensions were placed in the absence of leak or migration. These 12 patients all had radiographic evidence that the proximal and distal aspects of the originally implanted device did not move with respect to the native arterial vasculature, thus confirming stability of the respective fixation system., Conclusions: Adherence to this comprehensive definition of device migration, which differs from the published reporting standards, allows differentiation of the specific mechanisms of device failure. Data viewed in this context will aid in the understanding of device strengths and weaknesses, potentially improve patient assessment, and encourage design modifications to address specific aspects relating to fixation failure.

Purpose: To evaluate the technical feasibility and short-term results of juxtarenal aneurysm repair with an endovascular graft that incorporated the visceral aortic segment with graft material., Methods: Patients were studied prospectively after the implantation of an endovascular device with graft material extending proximal to the renal arteries, variably incorporating the superior mesenteric and celiac arteries. All patients were deemed to be high risk with respect to open surgical repair and had compromised proximal neck anatomy. Proximal neck lengths were

Objectives: The behavior of the aneurysm sac after endovascular grafting has been the subject of significant speculation. The importance of sac behavior is manifested by the correlation between aneurysm size or size change and risk for rupture, and potentially further extrapolated to define the need for secondary intervention. This study was undertaken to define graft-specific differences and the effect of endoleak on sac remodeling., Methods: Core laboratory data were obtained for three US Phase II clinical trials. Patients were included if they met anatomic inclusion criteria and underwent placement of the latest version of a bifurcated endovascular prosthesis. Unsupported Dacron (Ancure), supported Dacron (Zenith), and expanded polytetrafluoroethylene (Excluder) grafts were evaluated. Digitized images were electronically assessed for aneurysm size (area, maximum, minimum diameter) with National Institutes of Health Image software. Two blinded reviewers analyzed each radiographic study to ensure accurate image selection and establish the presence or absence of endoleak. A third reviewer adjudicated discrepancies. chi(2) analysis and mixed nonlinear modeling were used to analyze the results., Results: Of 1506 patients evaluated, 723 (227 Ancure, 343 Excluder, 153 Zenith) met inclusion criteria for the study. Mean follow-up was 23.2 months (Ancure, 31.3 months; Excluder, 19.6 months; Zenith, 19.3 months). The incidence of any endoleak was 39.1% (Ancure, 58.1%; Excluder, 34.7%; Zenith, 20.9%; P <.001). Type of prosthesis, presence or absence of endoleak, and baseline size were determinants of rate of aneurysm shrinkage. Reduction in sac size was greatest with the Zenith graft, followed by the Ancure and Excluder grafts. Presence of endoleak had a moderating effect on rate of sac shrinkage with the Zenith and Ancure grafts; however, sac size increased in the presence of endoleak with the Excluder graft. Finally, baseline size was positively correlated with rate of aneurysm shrinkage., Conclusions: The behavior of the aneurysm sac depends on the type of prosthesis, presence or absence of endoleak, and baseline size of the sac. Differential sac behavior must be considered when determining the need for secondary interventions, timing follow-up studies, and assessing success or failure of endovascular repair.

Approximately 6 months after the successful implantation of an abdominal aortic endovascular graft, a patient suffered an acute aortic dissection. The false lumen of the dissection terminated in the excluded aneurysm sac, resulting in a lack of outflow. Extreme true lumen compression eliminated blood flow within the distal aorta, resulting in the patient's demise.

Objectives: The outcome for a wide variety of diseases and treatment methods varies by gender. In an effort to determine whether gender has a role in the outcome of endovascular aortic aneurysm repair, we analyzed data from consecutive patients treated at a single institution over 6 years., Methods: Over 6 years ending in March 2002, 704 patients underwent endovascular repair of an infrarenal abdominal aortic aneurysm at The Cleveland Clinic. Six hundred six patients (86.1%) were men and 98 patients (13.9%) were women. Preprocedure and postprocedure imaging studies were evaluated to determine the frequency of aneurysm sac shrinkage or growth, defined as diameter change equal to or greater than 5 mm. Presence and type of endoleak was assessed with non-contrast material-enhanced, post-contrast-enhanced, and delayed post-contrast-enhanced computed tomography scans. These and other clinical variables were assessed with the Kaplan-Meier method and the Cox-Mantel log-rank test, and values were expressed as mean +/- SE., Results: Male and female patients were comparable with respect to baseline comorbid conditions. Women, however, were slightly older (76.7 +/- 0.7 years vs 74.4 +/- 0.3 years; P =.009), and had slightly smaller aneurysms (5.2 +/- 0.1 cm vs 5.4 +/- 0.04 cm; P =.033). There were no gender-specific differences in perioperative mortality (men, 1.3%; women, 3.1%; P =.197) or mid-term (24 months) survival (men, 80% +/- 2.6%; women, 78% +/- 8.1%). Similarly, there were no differences at 24 months in risk for graft migration (7.5% +/- 2.0% vs 5.4% +/- 3.2%), need for secondary remedial procedures (24% +/- 2.9% vs 21% +/- 6.3%), conversion to open surgery (3.9% +/- 1.5% vs 3.8% +/-2.7%), or post-repair aneurysm rupture (1.1% +/- 0.9% vs 2.2% +/-2.2%) in male and female patients, respectively. In contrast, risk for graft limb occlusion at 24 months was significantly higher in women than in men (11% +/- 5.2% vs 3.3% +/- 1.1%; P =.022). While frequency of endoleak of any type did not differ among male and female patients, aneurysm sac shrinkage at 24 months was more rapid in women (76% +/- 8.1% vs 57% +/- 3.5%; P =.019)., Conclusions: With the exception of slightly older age and somewhat smaller aneurysm, female patients are similar to male patients undergoing endovascular aneurysm repair. A greater frequency of graft limb occlusion was observed in female patients, but no statistically significant differences were detected in survival, rupture risk, or need for secondary procedures. Moreover, a more rapid rate of aneurysm sac shrinkage was detected in women. These observations suggest that endovascular aneurysm repair should be offered to suitable candidates irrespective of gender.

Objectives: The size of an abdominal aortic aneurysm is the most important parameter for determining whether repair is appropriate. This decision, however, must be considered in the context of long-term outcome of treatment, balancing risk for rupture with mortality from the initial procedure and all subsequent secondary procedures necessary when durability is not ideal. Information on the results of endovascular repair of small versus large aneurysms has not been available., Methods: Preoperative imaging studies and postoperative outcome were assessed in 700 patients who underwent endovascular repair of abdominal aortic aneurysm over 6 years at a single institution. Patients were divided into two groups: 416 patients (59.4%) with aneurysms smaller than 5.5 cm in diameter and 284 patients (40.6%) with aneurysms 5.5 cm or larger in diameter. Outcome variables were assessed with the Kaplan-Meier method and the log-rank test., Results: Patients with small and large aneurysms were comparable with regard to all baseline parameters assessed, with the single exception of a small increase in age (2.3 years) in patients with large aneurysms (P =.031). While there were no differences in rate of type II endoleaks, mid-term changes in sac diameter, or aneurysm rupture between the two groups, at 24 months patients with large aneurysms had more type I leaks (6.4% +/- 2.3% vs 1.4% +/- 0.6%; P =.011), device migration (13% +/- 4.0% vs 4.4% +/- 1.8%; P =.006), and conversion to open surgical repair (8.2% +/- 3.2% vs 1.4% +/- 1.1%; P =.031). Of greatest importance, at 24 months patient survival was diminished (71% +/- 4.6% vs 86% +/- 2.8%; P <.001) and risk for aneurysm-related death was increased (6.1% +/- 2.6% vs 1.5% +/- 1.0%; P =.011) in the group with large aneurysms., Conclusions: Outcome after endovascular repair of abdominal aortic aneurysm depends on size; results appear inferior in patients with larger aneurysms. These differences attain importance when choosing between observation and repair, balancing risk for rupture against size-dependent outcome.

Objectives: Endovascular stent grafting offers a potentially less invasive option for treatment of abdominal aortic aneurysm. Clinical benefit has been demonstrated with respect to early parameters such as blood transfusion, return of gastrointestinal function, and length of hospital stay. Endovascular repair, however, has been criticized on the basis of inferior long-term outcome. Secondary procedures may be necessary to address durability issues such as migration, high-pressure endoleak, graft limb thrombosis, and degeneration of the stent-fabric structure itself, issues that may compromise the primary goal of aneurysm repair, protection from rupture., Methods: Between 1996 and 2002, 703 patients underwent endovascular treatment of infrarenal abdominal aortic aneurysm at The Cleveland Clinic Foundation. During this time, five devices were used: Ancure, AneuRx, Excluder, Talent, and Zenith. Outcome was assessed with physical examination, lower extremity arterial studies, plain abdominal radiography, and computed tomography at discharge, at 1, 6, and 12 months postoperatively, and annually thereafter. Secondary procedures were defined as any procedure, exclusive of diagnostic angiography, performed after stent graft implantation, directed at treatment of aneurysm-related events. Multivariable statistical techniques for censored data (Cox proportional hazards modeling) were used to determine baseline parameters associated with need for secondary procedures over follow-up, with calculation of hazards ratio (HR) and 95% confidence interval (CI)., Results: Patient follow-up averaged 12.2 +/- 11.7 months. Patient survival was 90% +/- 1.4% at 1 year, 78% +/- 2.6% at 2 years, and 70% +/- 3.8% at 3 years. Aneurysm rupture occurred in 3 patients (0.4%), accounting for rupture risk of 1.4% over the first 2 years of follow-up (Kaplan-Meier method). Overall, 128 secondary procedures were required in 104 patients (15%), with a cumulative risk of 12% +/- 1.5% at 1 year, 24% +/- 2.8% at 2 years, and 35% +/- 4.4% at 3 years after stent graft implantation. Among the secondary procedures, new stent grafts and extensions were placed in 34 patients (27%), embolization of endoleak was performed in 33 patients (26%), and open surgical conversion was undertaken in 11 patients (9%). Periprocedural mortality of secondary procedures was 8% overall, but was 18% for patients undergoing open surgical conversion. Multivariable modeling identified the date the procedure was performed (HR, 1.53 per 3-month period of study; CI, 1.22-1.92; P <.001) and aneurysm size (HR, 1.35 per centimeter of minor axis; CI, 1.13-1.60; P <.001) as independent predictors of need for secondary procedures., Conclusions: Current endovascular devices are associated with a relatively high rate of complications over mid-term follow-up, culminating in frequent need for secondary remedial procedures. With strict follow-up imaging compliance, however, risk for rupture and aneurysm-related death remain exceedingly low. Newer technology may achieve improved durability and a lower requirement for secondary procedures, while maintaining the minimally invasive nature of presently available devices.

Objectives: Endovascular repair of abdominal aortic aneurysms, while advantageous because of its minimally invasive nature, falls short of achieving the long-term durability of traditional open surgical repair. Problems such as device migration, continued sac pressurization from endoleak, and graft limb thrombosis culminate in a high rate of secondary procedures and failure to protect against aneurysm rupture. While prior studies hint at a correlation between these postprocedural events and specific device design, a single comparative analysis that correlates device attributes with clinical outcome has not been performed., Methods: Over 6 years ending in 2002, 703 patients underwent endovascular treatment of infrarenal abdominal aortic aneurysms. During this time, five devices were used, ie, Ancure, AneuRx, Excluder, Talent, and Zenith, and six device-specific groups were analyzed; the Zenith group was subdivided into those placed as part of the multicenter trial (Zenith-MCT) and those under a sponsor-investigator investigational device exemption trial (Zenith-SIT). Results were assessed with the Kaplan-Meier method for censored data, and the log-rank test was used to ascertain differences between device groups., Results: While overall survival was diminished in the Zenith-SIT group (P =.046), risk for aneurysm-related death was similar in all groups (P =.336), averaging 2% or less at 12 months. Among the total cohort of patients, freedom from rupture was 98.7% +/- 0.9% at 24 months, without demonstrable differences between groups (P =.533). There were no statistically significant differences in rate of secondary procedures, conversion to open repair, or migration. There were, however, significant differences in risk for graft limb occlusion and rate of endoleak between groups. Limb occlusion occurred most often with Ancure devices (11% +/- 4.6% at 12 months, P =.009). Endoleak of any type was most common with Excluder devices (64% +/- 11% at 12 months, P =.003), a finding directly related to increased frequency of type II leaks in that group (58% +/- 11% at 12 months, P =.001). While there were no differences in frequency of type I or type III endoleak, a trend toward increased risk for microleak was observed with AneuRx devices (4.0% +/- 1.3%, P =.054), and more modular separations were observed with Zenith devices (3.5% +/- 2.3%, P =.032). Shrinkage at 12 months correlated with frequency of endoleak in the device groups, and was most common in the two Zenith groups (54% +/- 7.3% in the Zenith-MCT group and 56% +/- 7.8% in the Zenith-SIT group) and the Talent group (52% +/- 9.7%) and was least in the Excluder group (15% +/- 7.9% at 12 months, P <.001). By contrast, sac growth occurred most often in the Zenith-SIT group (13% +/- 4.5% at 12 months, P =.034), possibly as a result of the challenging aortoiliac anatomy frequently present in these patients., Conclusions: There are significant differences in frequency of limb occlusion and endoleak between groups with different endovascular devices. Knowledge of these and other differences is instructional in development of next-generation endovascular devices, incorporating design features linked to satisfactory outcome while abandoning those associated with device failure.

Introduction: The endovascular repair of abdominal aortic aneurysms has become increasingly common during the past decade. Despite aggressive attempts to treat endoleak and graft failure with endovascular salvage procedures, some grafts necessitate surgical removal. We reviewed our experience with late endograft explantation in an effort to identify technical maneuvers critical for success., Methods: Of 110 patients treated with aortic abdominal endografts at the University of Rochester Medical Center between August 1997 and June 2001, five (4.5%) needed late graft removal. Medical records, radiographic files, and case report forms were retrospectively reviewed., Results: One Talent (Medtronic AVE, Santa Rosa, Calif) and four Vanguard (Boston Scientific, Natick, Mass) grafts were removed at a mean of 32.7 months (range, 18 to 44 months) after implantation. One patient underwent conversion for rupture, three for endoleaks (one each with types I, II, and III), and one for stent separation from the graft material without endoleak or aneurysm expansion. Three cases were approached via the midline, one through a bilateral subcostal incision, and one through a retroperitoneal incision. Supraceliac aortic control was used in all patients. Removal of two of the Vanguard grafts necessitated extension of the aortotomy above the level of the renal orifices. One perioperative death occurred. The mean operative blood loss was 4700 mL (range, 1850 to 9000 mL), and length of stay was 19.8 days (range, 7 to 42 days)., Conclusion: The morbidity and mortality rates associated with late removal of endografts are significant. Removal of Vanguard devices can necessitate extension of the aortotomy above the renal arteries. We believe that control of the aorta well above the proximal fixation site is the key to removal and that continuous aortic exposure via retroperitoneal exposure is the best option in this situation.

Patients without renal function are living longer than in the past, and the provision of dialysis access is a growing problem. The distal end of the greater saphenous vein can be anastomosed to the femoral artery, creating a transposed saphenous vein thigh arteriovenous fistula, which offers the theoretical advantages of autologous conduit and a native venous 'anastomosis.' This is a rarely performed procedure, however, in part because of the morbidity of vein harvest and the risk of groin infection. We have been favorably impressed by the reduction in morbidity and wound infection following endoscopic vein harvest for lower extremity bypass, and believe that the success of this technique merits a reevaluation of this procedure.

Vascular endothelial growth factor (VEGF) is a potent neovascular inducer. Gene therapeutic delivery of a plasmid DNA encoding VEGF has been shown to impart collateral vessel development in animal models of hindlimb ischemia. Constitutive, long-lived expression of VEGF through gene transfer, however, may result in hypervascularization and/or leaky blood vessels. To that end, the introduction of regulated VEGF gene transfer technology may provide a safer and more controlled therapy for ischemic tissues. We developed a glucocorticoid-regulated plasmid vector (pNGVL-hAP/GRE(5)-vegf-pA) for modulating VEGF gene expression. This plasmid possessed five tandem repeats of the glucocorticoid-responsive element and adenovirus major-late promoter driving the expression of the VEGF(165) cDNA. Intramuscular delivery of this plasmid to mice, and subsequent treatment with the synthetic glucocorticoid dexamethasone (DEX), led to greatly enhanced VEGF expression. Similar delivery to the gracillis muscle of New Zealand white rabbits that had undergone ligation of their femoral artery to induce ischemia exhibited increased VEGF expression and collateral vessel development only in the presence of DEX. Additionally, reintroduction of DEX at a time point during which initial VEGF transgene levels had subsided resulted in a vigorous reinduction of VEGF transgene expression. This new iteration of VEGF gene delivery provides for fine-tuned angiogenic factor-based therapy for tissues requiring neovascularization.

Objective: The objective of this study was to define differences in perioperative hemodynamics and associated outcomes in patients who undergo carotid endarterectomy (CEA) with regional and general anesthesia., Methods: All the patients who underwent CEA during a 25-month period were reviewed, with a comparison of those who underwent operation with cervical block anesthesia (CB) with those who underwent operation with general anesthetic (GA). Baseline intraoperative and postoperative blood pressure and heart rate were recorded, and deviation from initial values was calculated. The administration of vasoactive medications was assessed. Operative time, intensive care unit admission, postoperative length of stay, and cardiac/neurologic morbidity were recorded., Results: From October 16, 1998, to December 1, 2000, 550 nonemergent CEAs were performed in 527 patients (226 with CB and 324 with GA). The patients in both groups were similar in age, presentation, and associated comorbidities. Although baseline blood pressure and heart rates were similar in both groups, those patients who underwent operation with GA had significantly greater intraoperative and postoperative hemodynamic variability and received more vasoactive medications during surgery (87% versus 51%; P <.001) and in the recovery room (36% versus 21%; P =.0009). Major postoperative blood pressure derangements were more common in the GA group (18% versus 10%; P <.05). Patients who underwent operation with GA more frequently needed intensive care unit admission (16% versus 7%; P =.01) and had more frequent delays in discharge (20% versus 11%; P =.008; postoperative length of stay, 2.1 versus 1.6 days; P =.01). Although no difference was seen in neurologic morbidity rates between groups (combined major stroke/death rate, 1.8%), the major cardiac morbidity rate was noted to be lower in the CB group (1% versus 4%; P =.05). The total in-room time was shorter in the CB group (108 versus 122 minutes; P <.001)., Conclusion: CEA performed with CB is associated with significantly less perioperative hemodynamic instability than with GA. This results in fewer major adverse cardiac events. Ultimately, decreased critical care resource use is realized as is a shortened length of stay.

To determine the reason for differing shunt rates based on electroencephalographic (EEG) and neurologic changes during general and regional anesthetic, respectively, we compared simultaneous EEG tracings and neurologic status in 135 patients undergoing carotid endarterectomy (CEA) under cervical block over a 30-month period. The decision to shunt in these patients was made on the basis of neurologic changes only irrespective of EEG findings. This group was then compared to the 288 patients undergoing CEA under general anesthetic with EEG monitoring over the same period. EEG changes occurred in 7.4% of awake patients and 15.3% of asleep patients (p < 0.03). The rates of ipsilateral hemispheric changes were similar, but no awake patient manifested global EEG changes with clamping while 3.5% of patients under general anesthesia did (p < 0.04). Global, but not hemispheric, changes were correlated with systolic blood pressure variability during clamping. This implies that global EEG changes in anesthetized patients may be the result of the anesthetic technique itself, and that cervical block may in fact be cerebroprotective.

To determine whether external beam irradiation delivered immediately after graft implantation can inhibit anastomotic intimal hyperplasia (IH) 1 month following polytetrafluoroethylene (PTFE) bypass in a sheep carotid artery model, 23 sheep underwent bilateral bypass of the ligated common carotid artery with 8-mm PTFE immediately followed by a single dose of irradiation (15, 21, or 30 Gy) to one side. The 15 animals with bilaterally patent grafts were euthanized at 1 month and graft-arterial anastomoses harvested. Using computer-aided image analysis, IH areas and thicknesses were measured. Graft patency in this model was 83% at 1 month and did not differ according to treatment administered. In the control animals, IH was greatest at mid-anastomosis, but minimal within the native vessel. All three radiation doses markedly inhibited mid-anastomotic IH area and thickness. At the proximal anastomosis, 30 Gy reduced the IH area 20-fold, from 2.06 to 0.14 mm2 (p < 0.0001 by ANOVA), and IH thickness 70-fold, from 29.0 to 0.4 micron (p < 0.0002); similar effects were seen at the distal anastomosis. No adverse effects of radiation treatment were observed. External beam irradiation in doses of 15 to 30 Gy delivered in a single fraction immediately after operation markedly inhibits development of intimal hyperplasia 1 month following end-to-side anastomosis with PTFE in sheep.

To overcome constraints imposed by iliac artery anatomy, the anatomic inclusion criteria for endovascular aortic aneurysm repair can be extended by means of intentional coil occlusion of one or both internal iliac arteries and extension of the distal limb of the graft into an external iliac artery. We reviewed our experience with this intervention to determine the safety and efficacy of this approach to aneurysm repair. Over a 30-month period, 84 patients underwent endovascular abdominal aortic aneurysm repair; 23 underwent intentional unilateral (22) or bilateral (1) internal iliac artery occlusion. Morbidity, mortality, and long-term clinical outcomes were evaluated in these 23 patients. Patients were specifically questioned about exercise-induced buttock and extremity symptoms. Our results showed that intentional internal iliac artery embolization to allow endovascular repair of abdominal aortic aneurysms is accompanied by significant morbidity and should be approached with caution.

Renal artery injury is a rare complication of blunt abdominal trauma. Increasing use of CT scans to evaluate blunt abdominal trauma identifies more blunt renal artery injuries (BRAIs) that may have otherwise been missed. We identified patients with BRAI to examine the incidence and to evaluate the current diagnosis and management strategies. Patients admitted from 1986 to 2000 at a regional Level I trauma center sustaining BRAI were evaluated. Patients undergoing revascularization or nonoperative management were followed for renovascular hypertension. Twenty-eight patients with BRAI were identified out of 36,938 blunt trauma admissions between 1986 and 2000 (incidence 0.08%). Most renal artery injuries were diagnosed by CT scans (93%) with seven confirmatory angiograms. Nine patients had nephrectomy (one bilateral), and three patients with unilateral injuries were revascularized. Sixteen were managed nonoperatively including one patient who had endovascular stent placement. Three patients died from shock and sepsis. Follow-up for all patients ranged from one month to 8 years. Two patients developed hypertension: one who was revascularized (33%) and one was managed nonoperatively (6%). The frequency of diagnosis of BRAI is increasing because of the increased use of CT. Nonoperative management of unilateral injuries can be successful with a 6 per cent risk for developing renovascular hypertension. The role of endovascular stenting is promising, and further study is necessary.

Reperfusion syndrome refers to the damage done by restoration of blood flow to ischemic tissues and is distinct from the original ischemic insult itself, whereas compartment syndrome refers to the damage resulting from increased pressure within an enclosed fascial compartment that occurs after blood flow has been restored. Despite extensive experimental work directed toward the treatment of established reperfusion injury and prevention of compartment syndrome, clinical outcome over the past decade has not appreciably changed. Although the systemic insult, thought to be an inevitable result of reperfusion injury, may be less injurious than "conventional wisdom" would suggest, no better strategy for treating compartment syndrome other than early recognition and decompression has yet been developed., (Copyright 2001 by W.B. Saunders Company)

This study was designed to test the hypothesis that unexpected alcohol withdrawal-like syndrome (AWLS) is more common following aortic, but not other, vascular or nonvascular procedures. All patients undergoing open aortic surgery at our institution in 1997 who survived at least 48 hr were identified, as were those undergoing carotid endarterectomy, infrainguinal bypass, and total colectomy. AWLS was defined as prolonged confusion or agitation and response to conventional treatment for withdrawal, providing that all other sources had been ruled out or a significant history was present. Our results show that, for unknown reasons, AWLS is more common after aortic surgery than after other vascular and high-stress, nonaortic intraabdominal procedures at our institution, and is associated with increased length of stay and morbidity. Because prophylaxis may improve outcome, better efforts to identify patients at risk are required.

Background: The goals were (1) to characterize physiologic changes after a combined insult of hemorrhage plus sepsis in a large animal model and (2) to determine whether transient inhibition of the neutrophil CD18 adherence receptor during fluid resuscitation impairs host defense during recovery from this injury., Methods: Two series of experiments were performed in anesthetized swine. In the first series (n = 22), the cecum was ligated and incised immediately before 35% hemorrhage. After 1 hour, shed blood plus supplemental fluid was administered to restore and stabilize hemodynamics. On the basis of these results, a second series examined effects of anti-CD18 (2 mg/kg R15.7; n = 9) or its saline placebo (n = 10) administered during fluid resuscitation., Results: In the first series the mortality rate was 41% (9 of 22). Early deaths occurred 3.0 +/- 0.8 days after injury and were distinguished by significantly lower neutrophil counts on resuscitation. Those alive a 7 days had intraabdominal abscesses and bacteremia. Alveoli and peribronchial spaces were congested, with edema and fibrin deposition in capillaries and alveoli. Livers were congested with biliary stasis. Despite these pathologic findings, hemodynamic, electrolyte, and serum enzyme changes were minimal. In the second series the mortality rate at 4 days was 30% with placebo (3 of 10) versus 33% with anti-CD18 (3 of 9). Lung changes (i.e., pneumonia, pleuritis, thrombosis, and edema) were similar in both groups, but liver congestion and hemorrhage were attenuated by anti-CD18. Some aspects of host defense were altered by anti-CD18. At 24 and 48 hours the oxidative burst potential for circulating granulocytes was 208% +/- 57% and 383% +/- 73% with placebo versus 1273% +/- 351% and 762% +/- 226% in anti-CD18. At 72 hours the granularity of circulating neutrophils was unchanged from baseline with placebo but was reduced to 82% +/- 5% by anti-CD18. At 48 hours lipopolysaccharide-evoked tumor necrosis factor production in vitro was reduced to 62% +/- 22% with placebo but was increased to 148% +/- 16% with anti-CD18., Conclusions: Anti-CD18 during fluid resuscitation did not increase vulnerability to endogenous pathogens because the transient inhibition of neutrophil demargination was balanced by enhanced oxidative burst, degranulation, and production of tumor necrosis factor in circulating cells later during recovery. Thus a single administration of antiadhesion therapy does not worsen posttrauma outcome even if given during ongoing sepsis.

A single hind limb was irradiated with 12, 18, 24, or 30 Gy in mdx and C57 mice aged 12, 21, or 42 days to determine regeneration inhibition dose-response curves in different aged dystrophic mice and to characterize radiation side-effects in normal mice. The anterior tibial muscle mass (8 weeks postirradiation) and percent central nucleated (i.e., regenerated) muscle fibers were measures of regeneration inhibition. Twenty-one-day-old mdx mice irradiated with 18 Gy had complete inhibition of muscle regeneration, but 30 Gy only partially blocked regeneration in mdx mice irradiated at 12 and 42 days in age. In working to produce a clinically relevant model for Duchenne dystrophy, it is crucial to regard mouse age as a major factor in determining radiation effects on mdx muscle regeneration.

We compared mdx and C57BL10 anterior tibial muscle force in situ (single pulse, multiple pulse, staircase, posttetanic potentiation, and fatiguing stimulation patterns) to define muscle strength, physiology, and fatigue resistance. The relatively hypertrophied mdx muscle showed: reduced strength (N/cm2), an increased twitch-tetanus ratio, and resistance to post-fatigue twitch slowing. These differences implicate altered mdx calcium regulation, and emphasize the importance of measuring both muscle function and morphology in mdx treatment trials.