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Background: The Global Iliac Branch Study (NCT05607277) is an international, multicenter, retrospective cohort study of anatomic predictors of adverse iliac events (AIEs) in aortoiliac aneurysms treated with iliac branch devices (IBDs)., Methods: Patients with pre-IBD and post-IBD computed tomography imaging were included. We measured arterial diameters, stenosis, calcification, bifurcation angles, and tortuosity indices using a standardized, validated protocol. A composite of ipsilateral AIE was defined, a priori, as occlusion, type I or III endoleak, device constriction, or clinical event requiring reintervention. Paired t-test compared tortuosity indices and splay angles pretreatment and post-treatment for all IBDs and by device material (stainless steel and nitinol). Two-sample t-test compared anatomical changes from pretreatment to post-treatment by device material. Logistic regression assessed associations between AIE and anatomic measurements. Analysis was performed by IBD., Results: We analyzed 297 patients (286 males, 11 females) with 331 IBDs (227 stainless steel, 104 nitinol). Median clinical follow-up was 3.8 years. Iliac anatomy was significantly straightened with all IBD treatment, though stainless steel IBDs had a greater reduction in total iliac artery tortuosity index and aortic splay angle compared to nitinol IBDs (absolute reduction -0.20 [-0.22 to -0.18] vs. -0.09 [-0.12 to -0.06], P < 0.0001 and -19.6° [-22.4° to -16.9°] vs. -11.2° [-15.3° to -7.0°], P = 0.001, respectively). There were 54 AIEs in 44 IBDs in 42 patients (AIE in 13.3% of IBD systems), requiring 35 reinterventions (median time to event 41 days; median time to reintervention 153 days). There were 18 endoleaks, 29 occlusions, and 5 device constrictions. There were no strong associations between anatomic measurements and AIE overall, though internal iliac diameter was inversely associated with AIE in nitinol devices (n AIE, nitinol  = 8)., Conclusions: Purpose-built IBDs effectively treat aortoiliac disease, including that with tortuous anatomy, with a high patency rate (91.5%) and low reintervention rate (9.1%) at 4 years. Anatomic predictors of AIE are limited., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Female patients undergoing endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysms present with more challenging anatomy and historically have worse outcomes compared with men. The Ovation Abdominal Stent Graft platform (Endologix, Irving, Calif) contains a polymer-filled proximal sealing ring and has a low-profile delivery system, potentially beneficial in female patients. We therefore investigated differences in long-term outcomes between men and women treated with this device., Methods: We used data collected prospectively in the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, comprising five trials and the European Post-Market Registry. Anatomic characteristics of the proximal aneurysm neck and iliac arteries were compared between male and female patients. Outcomes were 5-year freedom from type IA and type I/III endoleaks, abdominal aortic aneurysm-related reinterventions, and overall survival. We used Kaplan-Meier analysis to estimate survival proportions and tested univariate differences in survival using log-rank tests. Cox proportional hazards modeling was used to adjust for baseline differences., Results: We identified 1045 (81%) male and 251 (19%) female patients undergoing EVAR. Female patients were older (mean age, 75 ± 8.4 years vs 73 ± 8.1 years; P < .006). Aneurysm diameter (52 ± 7.5 mm vs 55 ± 9.2 mm; P < .001) and proximal neck diameter (21 ± 3.3 mm vs 23 ± 2.9 mm; P < .001) were smaller in female patients, but adjusted for body surface area, female patients had relatively larger aneurysms and aneurysm necks. Furthermore, female patients presented with shorter proximal necks, smaller iliac artery diameters, more angulated necks, and higher rates of reverse-tapered necks. Five-year freedom from type IA endoleak was similar between men and women (97% vs 96%; P = .38), as was freedom from type I/III endoleaks (91% vs 94%; P = .37) and reinterventions (91% vs 93%; P = .67). Five-year survival was 81% for female patients, similar to the 79% in male patients (P = .55), with one aneurysm-related death in female patients (0.4%) and five in male patients (0.8%; P = .76). Risk-adjusted analyses showed no association between sex and type IA endoleak (hazard ratio [HR], 1.4; 95% confidence interval [CI], 0.6-3.1; P = .41), type I/III endoleak (HR, 1.4; 95% CI, 0.7-2.8; P = .33), reintervention (HR, 1.0; 95% CI, 0.6-2.0; P = .77), and overall mortality (HR, 0.7; 95% CI, 0.4-1.1; P = .14)., Conclusions: Female patients undergoing EVAR with the Ovation platform presented with substantially more adverse proximal neck characteristics. Despite these differences, 5-year freedom from endoleaks and overall survival did not differ between sexes., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Endovascular abdominal aortic aneurysm repair (EVAR) has been rigorously compared with open repair for the treatment of abdominal aortic aneurysms in randomized trials and observational studies, but a comparison of individual devices is lacking, and single-device registries and trials are limited by small sample size. Here we report a descriptive analysis of the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, pooled results of multiple studies evaluating the midterm results of EVAR with the Ovation Abdominal Stent Graft Platform., Methods: This is a retrospective analysis of the ENCORE database, a cohort of patients undergoing EVAR with the Ovation platform composed of pooled, prospectively collected data from 1296 patients from five clinical trials and the prospectively maintained European Union Post-Market Registry. The primary outcomes were 5-year rates of type IA and type I or III endoleak. Secondary outcomes included were 30-day mortality, 30-day major adverse event, technical success (successful deployment of the aortic body and iliac limbs), as well as 5-year survival, and freedom from aneurysm-related mortality, type II endoleak, device-related intervention, aneurysm rupture, sac expansion, and conversion to open repair., Results: A total of 1296 patients were included in the analysis. The average age was 73 ± 8 years and 81% of patients were male. Fifty percent of patients had complex aortic anatomy, (neck length <10 mm, neck diameter >28 mm, neck angle >60°, reverse neck taper >10%, distal common iliac artery diameter <10 mm, or external iliac artery diameter <6 mm). Technical success was 99.7%. Thirty-day mortality was 0.3%, 30-day rate of major adverse event was 1.6%, and polymer leak rate was 0.2%. Freedom from type IA endoleak at 1, 3, and 5 years was 97.6%, 97.1%, and 95.8%, respectively; type I or III endoleak at 1, 3, and 5 years was 96.9%, 95.7%, and 94.0%, respectively. Freedom from device-related reintervention at 1, 3, and 5 years was 96.2%, 94.4%, and 92.4% and primary freedom from sac expansion was 97.0% at 1 year, 90.3% at 3 years, and 84.9% at 5 years. Freedom from all-cause mortality and aneurysm-related mortality at 5 years were 78.9% and 99.3%, respectively., Conclusions: This analysis of the ENCORE database demonstrates that EVAR with the Ovation platform has favorable midterm durability evidenced by successful aneurysm exclusion and 5-year freedom from aneurysm-related mortality., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The incidence of failed endovascular aneurysm repair (EVAR) is increasing, and understanding the different methods of management and repair is paramount. The objective of this study was to evaluate the clinical management and rescue of failed EVAR by either explantation or fenestrated-branched EVAR (F/B-EVAR)., Methods: A retrospective analysis (1999-2016) of 247 patients who underwent either explantation (n = 162) or F/B-EVAR (n = 85) for failed EVAR was performed. F/B-EVAR was performed under a physician-sponsored investigational device exemption. Demographics of the patients, clinical presentation and failure etiology, perioperative management, rate of reinterventions, morbidity, and mortality were analyzed. Those undergoing surgical explantation were compared with those undergoing F/B-EVAR conversion. Statistical analysis included multivariable logistic regressions, Fisher exact test, and χ 2 test., Results: The majority of patients were male (n = 216 [87%]), with a mean age of 75 years (range, 50-93 years). The mean time from primary EVAR was higher in F/B-EVAR (46 ± 7 months vs 69 ± 41 months; P < .001). Graft manufacturer did not differ between those requiring explantation and those having endovascular rescue (P = .170). All emergencies (n = 24 [10%]) and infections (n = 28 [11%]) were treated with open conversion. Endoleak was the most common reason for failure in both explantation and F/B-EVAR groups (75% vs 64%, respectively; P = .052). Type I endoleak was the most common endoleak reported in both groups, occurring more frequently in F/B-EVAR (64% vs 40%; P < .001); type II endoleak was more common in those undergoing open repair (28% vs 2%; P < .001). Graft migration (12% vs 26%; P = .005) and neck degeneration/disease progression (14% vs 59%; P < .001) were more prevalent in F/B-EVAR, but aneurysm enlargement was more common in explantation (68% vs 33%; P < .001). Thirty-day reintervention rates did not differ between F/B-EVAR and explantation (odds ratio, 0.6258; 95% confidence interval, 0.2-1.86; P = .4115); however, 30-day mortality was lower in the F/B-EVAR group (5% vs 10%; P = .0192). Similarly, aneurysm-related mortality was also lower in the F/B-EVAR group (hazard ratio, 0.0683; 95% confidence interval, 0.01-0.44; P = .0048). A subset analysis excluding emergencies and infections did not alter the lack of difference in terms of freedom from reinterventions (P = .1175), 30-day mortality (P = .6329), or aneurysm-related mortality (P = .7849)., Conclusions: Explantation and F/B-EVAR are necessary options in treating patients with failed EVAR, and both techniques have competitive results. Different modes of failure may point to a preferred method of treatment; consequently, rescue of failed EVAR should be individualized according to each patient's presentation and resources available., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: To evaluate the aneurysm-related complications and device issues in patients who underwent partial endograft explantation during late conversion of endovascular aneurysm repair (EVAR) to open repair., Methods: A retrospective analysis was performed on patients who had partially explanted endografts during late conversion between 1999 and 2012. Medical records were reviewed for patient demographics, subsequent operations, and aneurysm-related complications. Postoperative abdominal X-ray films and computed tomography scans were analyzed for endograft migration, component separation, device fracture, and arterial growth or aneurysm issues., Results: Between 1999 and 2012, 22 patients had late conversion after EVAR with portions of the device left in situ. Five of the partially removed devices were Zenith, 6 Talent, 5 Ancure, 3 AneuRx, 2 Excluder endografts, and 1 Cook Aorto uni-iliac (AUI) graft. There were 4 in hospital mortalities. There were no graft migrations, component separations, device fractures, new aneurysmal degeneration, or ruptures with a median follow-up of 26.5 months., Conclusions: Partial endograft removal during late conversion is not associated with complications from the remaining device pieces during follow-up. We recommend further study of this patient population., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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.)

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: 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.)

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

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.

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.

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.

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.