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Background: Most studies describing the outcomes after endovascular abdominal aortic aneurysm repair (EVAR) explantation have been from single, high-volume, centers. We performed a multicenter cross-Canadian study of outcomes after EVAR stent graft explantation. Our objectives were to describe the outcomes after late open conversion and EVAR graft explantation at various Canadian centers and the techniques and outcomes stratified by the indication for explant., Methods: The Canadian Vascular Surgery Research Group performed a retrospective multicenter study of all cases of EVAR graft explantation at participating centers from 2003 to 2018. Data were collected using a standardized, secure, online platform (RedCap [Research Electronic Data Capture]). Univariate statistical analysis was used to compare the techniques and outcomes stratified the indication for graft explantation., Results: Patient data from 111 EVAR explants collected from 13 participating centers were analyzed. The mean age at explantation was 74 years, the average aneurysm size was 7.5 cm, and 28% had had at least one instructions for use violation at EVAR. The average time between EVAR and explantation was 42.5 months. The most common indication for explantation was endoleak (n = 66; type Ia, 46; type Ib, 2; type II, 9; type III, 2; type V, 7), followed by infection in 20 patients; rupture in 18 patients (due to type Ia endoleak in 10 patients, type Ib in 1, type II in 1, type III in 2, and type V in 1), and graft thrombosis in 7 patients. The overall 30-day mortality was 11%, and 45% of the patients had experienced at least one major perioperative complication. Mortality was significantly greater for patients with rupture (33.3%) and those with infection (15%) compared with patients undergoing elective explantation for endoleak (4.5%; P = .003). The average center volume during the previous 15 years was 8 cases with a wide range (2-19 cases). A trend was seen toward greater mortality for patients treated at centers with fewer than eight cases compared with those with eight or more cases (19% vs 9%). However, the difference did not reach statistical significance (P = .23). Overall, 41% of patients had undergone at least one attempt at endovascular salvage before explantation, with the highest proportion among patients who had undergone EVAR explantation for endoleak (51%). Only 22% of patients with rupture had undergone an attempt at endovascular salvage before explantation., Conclusions: The performance of EVAR graft explantation has increasing in Canada. Patients who had undergone elective explantation for endoleak had lower mortality than those treated for either infection or rupture. Thus, patients with an indication for explanation should be offered surgery before symptoms or rupture has occurred. A trend was seen toward greater mortality for patients treated at centers with lower volumes., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported., Methods: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes., Results: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m 2 ). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively., Conclusions: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR., (Copyright © 2020 Society for Vascular Surgery. All rights reserved.)

Background: Iliac limb stent grafting to the external iliac artery (EIA) is a commonly performed procedure in various situation during endovascular abdominal aneurysm repair (EVAR). However, this procedure is associated with a risk of graft occlusion. We evaluated risk factors affecting occlusion among patients who underwent iliac limb stent-graft extension to the EIA., Materials and Methods: We compared occluded limbs with patent limbs during the follow-up period using variables, including anatomical values, demographics, and other factors. Thereafter, we divided the occluded limbs into early and late occlusion subgroups. The main and subgroup analyses used the same variables. Survival analysis was performed to evaluate time-dependent risk factors for late limb occlusion., Results: From 2007 to 2016, 766 iliac limbs from 383 patients who underwent EVAR were initially included in our analysis. Among them, 134 iliac limbs underwent limb extension to the EIA. The limb extension was a significant risk factor for occlusion (hazard ratio = 6.34, P < 0.001). Occlusion occurred in 10 patients who underwent iliac limb extension. The size of common iliac artery (CIA) was associated with occlusion. The most significant factor was iliac bifurcation diameter (patent vs. occluded limbs, 21.6 ± 7.6 vs. 27.5 ± 9.5 mm, P = 0.005). Subgroup analysis revealed that the CIAs of the early occlusion subgroup were generally more tortuous (1.16 ± 0.33 vs. 1.47 ± 0.25, P = 0.091) and longer (53 ± 24 vs. 74 ± 9, P = 0.01) than those of the patent limb group. In addition, the EIA diameters of the late occlusion subgroup were narrower than those of the patent limb group (10.9 ± 1.6 mm vs. 9.1 ± 0.8 mm, P = 0.011). Using the log-rank test, those patients with an EIA diameter narrower than 10.1 mm had a higher risk for late limb occlusion (log-rank χ 2  = 5.73, P = 0.017) and the patients who did not take at least a single antiplatelet agent had a significantly higher chance of limb occlusion (log-rank χ 2  = 11.029, P = 0.001). In addition, the patients who did not take a statin had a higher risk for late limb occlusion (log-rank χ 2  = 7.41, P = 0.007)., Conclusions: Among patients who underwent EVAR with iliac limb extension, the CIA length affected early limb occlusion and predisposed patients to vessel injury or stent-graft kinking, and there was the possibility that CIA tortuosity was associated with a higher risk. The late occlusion subgroup had narrower EIAs than the patent limb group. Appropriate antiplatelet and statin therapy is expected to play a key role in the prevention of late limb occlusion after EVAR., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience., Methods: Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention., Results: Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034)., Conclusions: EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine the clinical outcomes of polytetrafluoroethylene covered balloon expandable stents (CBESs) in occlusive lesions of the aortic bifurcation in a kissing stent configuration., Materials and Methods: The study included 69 consecutive patients (29 men, 40 women) who underwent kissing stent procedures with CBESs between January 2003 and April 2009 in a single center. Patients who were previously treated with a CBES were excluded. Follow-up consisted of clinical investigation and duplex ultrasound examination., Results: The primary patency was 88.1% at 1 year and 71.5% at 4 years, with secondary patency rates of 88.1% and 75.3%, respectively. For patients receiving a stent for the first time, primary patency was 91.3% at 1 year and 77.1% at 4 years. For patients who had received previous stents, patency was 83.6% at 1 year and 65.2% at 4 years (P = .83). There were no differences in secondary patency and freedom from target lesion reintervention (TLR). Loss of primary patency was mainly caused by stent occlusions (14 cases [78%]). The freedom from TLR at 4 years was 76.8%., Conclusions: Patency rates and freedom from TLR of CBESs in the kissing stent configuration with up to 4 years of follow-up were satisfying and mainly affected by stent occlusions. Studies focusing on optimizing stent configuration and medical care to reduce the incidence of thrombosis are indicated to improve results further., (Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To review the literature on pararenal endovascular aneurysm repair (EVAR) to determine the frequency and clinical relevance of chimney graft occlusions., Methods: A comprehensive search of the English-language literature abstracted in the Medline and the Cochrane Library databases was performed to identify case series involving pararenal aortic pathologies (degenerative aneurysms, penetrating atherosclerotic ulcers, type Ia endoleaks, and para-anastomotic aneurysms) treated with EVAR and chimney grafts; thoracoabdominal, iliac, or aortic arch chimney graft placements were excluded, as were case reports in which the total number of chimney grafts implanted at the reporting center could not be determined. The literature search identified 83 studies regarding chimneys/snorkels for pararenal pathologies published between January 2007 and March 2014. Of these, 7 studies met the inclusion criteria and were included in the analysis., Results: There were 15 (4.5%) occlusions in the overall 334 renovisceral vessels in which chimney grafts were deployed. The mean time to chimney graft occlusion was 3.5 months (range 1-270 days) over a mean follow-up of 1.4 months (range 9-24). The target arteries were the renal artery (n=12) and the superior mesenteric artery (SMA; n=3). Seven patients were asymptomatic, and no description was given in 5 cases. In the other 3 patients, the symptoms were acute renal failure, intestinal ischemia, and malignant hypertension. The treatment strategy included open conversion and iliorenal bypass (n=1), exploratory laparotomy to revascularize the SMA (n=1), hemodialysis (n=1), placement of bare metal stents (n=4), conservative treatment (n=2), and unknown (n=6). One (6.7%) patient died (an occluded SMA). Two patients with renal chimney occlusion suffered from temporary renal function deterioration., Conclusion: The present analysis identified a low rate of chimney graft occlusions, which appear to occur generally a few months after placement. Involvement of the renal artery had no severe clinical consequences, while occlusion of the SMA can be associated with life-threatening complications. More detailed information regarding occluded chimney grafts will be needed in future publications to help identify the causes., (© The Author(s) 2015.)

Background: Many centers choose endovascular intervention as their first-line treatment for crural occlusions in patients with critical limb ischemia (Rutherford 4-6). However, unsuccessful interventions often result in major amputation. Therefore, pedal bypass surgery should be considered as an alternative first-line treatment. We reviewed the impact of a prior endovascular intervention on the outcome of our patients' pedal bypass procedures., Methods: A retrospective analysis was conducted for all patients who had undergone pedal bypass surgery in our department from February 2008 to October 2012. We performed 75 pedal bypass operations in 71 patients (male, 54; female, 17; median age, 72 years; range, 29-90 years). In 36 of those cases, patients had undergone a prior infrapopliteal endovascular intervention (PEI group). In 39 cases, patients underwent bypass surgery as first-line treatment because their prior angiography had resulted in either unsuccessful endovascular intervention, or intervention had been deemed 'not feasible' (BSF group). Only autologous vein grafts were used, and no retrograde intervention was done via the pedal arteries. Endpoints of the analysis were primary and secondary patency rates, mortality, and limb salvage at 1 year postoperatively., Results: Overall primary patency at 1 year was 58.3%, and secondary patency was 61.3%. Limb salvage was 76.8% and survival was 80.4%. Graft occlusion within 30 days was 18.7%. Revision in those cases was futile and 78.6% of patients had to undergo major amputation. Primary patency at 1 year was 67.0% in PEI group vs 48.3% in BSF group (P = .409) and secondary patency was 73.5% vs 48.6% (P = .100). Prior endovascular intervention had no significant impact on either limb salvage (82.3% vs 71.6% at 1 year; P = .515) or graft occlusions within 30 days (19.4% vs 17.9%; P = .547). Survival rate at 1 year was 79.5% in PEI group and 81.3% in BSF group (P = .765). Risk factors and indications were similar in both groups., Conclusions: Crural endovascular intervention does not seem to have a negative impact on the outcome of subsequent pedal bypass surgery. Requirements are avoiding a destruction of the target vessel and opting for timely bypass surgery whenever endovascular treatment does not achieve a sufficient perfusion for wounds to heal. Early graft occlusions are associated with a higher risk for major amputation., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Despite advances in endovascular techniques, infrapopliteal bypasses are still required for limb salvage. Short-term graft patency is an important outcome parameter reflecting technical considerations and acute graft thrombosis. Both are important prerequisites for long-term patency. In this analysis, we compared the 30-day patency of all conduit configurations for infrapopliteal bypasses., Methods: All primary infrapopliteal bypasses from the American College of Surgeons-National Surgical Quality Improvement Program database between 2005 and 2010 were divided into six groups: (1) great saphenous vein (GSV); (2) prosthetic conduit (prosthetic); (3) prosthetic conduit with a distal anastomotic venous adjunct (ADJ), such as a cuff or patch (prosthetic + ADJ); (4) composite graft of prosthetic and a vein segment (composite); (5) spliced autogenous vein (spliced vein); and (6) arm vein. Thirty-day graft failure, patient demographics, and operative details were compared among groups. A multivariate model was used for statistical analysis., Results: A total of 5375 infrapopliteal bypasses were analyzed by conduit: GSV, 3983 (75%); prosthetic, 898 (17%); spliced vein, 160 (3%); prosthetic + ADJ, 112 (2%); arm vein, 93 (2%); and composite, 91 (2%). The difference among groups in demographics and comorbidities was not statistically significant. Perioperative mortality rates were similar among different conduits. After adjusting for sex, age, weight, race, and previous cardiac surgery, the bypass conduit had a significant independent association with 30-day graft patency (P = .006). The GSV failure rate was 7.5%. Composite had a significantly higher 30-day failure rate (15.4%, P = .006). There was no significant difference in 30-day failure rate of spliced vein (5.6%, P = .37) or arm vein (4.3%, P = .24) conduits compared with GSV. Prosthetic had significantly higher 30-day failure rate than GSV (10.5%, P = .004). The addition of adjuvant venous tissue at the distal anastomosis of prosthetic bypasses did not significantly improve their 30-day patency (failure rate of 9.8% for prosthetic + ADJ and 10.5% for prosthetic). There was no significant difference in graft patency between alternative venous conduits (arm vein/spliced vein) and prosthetic + ADJ., Conclusions: Venous conduits (GSV, spliced vein, arm vein) deliver the best 30-day patency for infrapopliteal bypasses, and GSV remains the most commonly used graft. Prosthetic grafts had a higher 30-day failure rate. Composite grafts should be abandoned because their early patency is not better than pure prosthetic conduits. The addition of a distal venous adjunct did not seem to improve acute prosthetic graft patency, which may reflect lack of effect on thrombogenicity rather than the myointimal hyperplastic response that effects long-term failure of infrapopliteal bypass., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: The Endurant endograft (Medtronic Inc, Minneapolis, Minn) is a new-generation device specifically developed to perform well in complex abdominal aortic aneurysm anatomy. Previous reports on the 1- and 2-year results of endovascular aneurysm repair (EVAR) with the Endurant endograft showed excellent outcome, including prevention of migration and type I endoleaks, but occurrence and outcome of post-EVAR occlusion have not been determined in a large multicenter patient cohort with midterm follow-up, which is the objective of this study., Methods: Data of consecutive patients treated with the Endurant from December 2007 to April 2012 in three Dutch tertiary vascular referral hospitals were prospectively gathered and retrospectively analyzed. Follow-up consisted of regular office visits, computed tomography angiography at 1 and 12 months after EVAR, and subsequently, duplex ultrasound imaging or computed tomography angiography at regular intervals. Patients with ruptured aneurysms or with earlier abdominal aortic surgery were excluded. The incidence and clinical outcome of endograft occlusions were analyzed. An expert review board assessed all cases in the search for possible causes of occlusion., Results: Included were 496 patients (87.7% male), who were a median age of 74 years (range, 68-78 years). Median follow-up was 1.7 years (range, 0-4.6 years). Twenty graft occlusions (4.0%) occurred during follow-up. Median time between primary EVAR and detection of the occlusion was 1 month, with 55% occurring ≤ 60 postoperative days and 90% ≤ 1 year. No association was found between occlusion and sex (P = .28), age (P = .96), or use of an aortouniiliac device (P = .66). Technical error was the considered cause of the occlusion in 12 patients (60%). The estimated freedom from occlusion was 98.4% at 30 days, 95.7% at 1 year, and 95.3% at 3 years. Presenting symptoms of occlusion were acute limb ischemia in 50%. Treatment was surgical (75%) or percutaneous (25%). Successful revascularization was achieved in 17 of 20 patients, but reocclusions occurred in five, resulting in a transfemoral amputation in one patient. Occlusion-related mortality was 0.6% (3 of 496)., Conclusions: At a median follow-up of 1.7 years, Endurant endograft occlusion occurred in 4.0% of 496 patients. Most occlusions occurred ≤ 2 months after EVAR, and rarely after 1 year. A technical justification for occlusion could be found for 60% of patients. A more liberal intraoperative and early postoperative (re)intervention strategy may reduce the occlusion rates and improve outcome., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives The EUCon study was designed to identify risk factors for distal anastomotic stenosis after bovine jugular vein (Contegra) implantation in children. Methods Between March 2006 and August 2008, 104 devices were implanted in nine European centers. Preoperative, intraoperative, and follow-up data (at discharge, 6, 12, 24 months) including standardized echocardiography were prospectively registered, source data verified and collected in a central database. Main endpoint was distal stenosis (either postvalvular gradient of ≥50 mm Hg or need for intervention for distal stenosis). Eight potential risk factors (age <2 years, diagnosis, running suture, use of glue, flapless anastomosis, oversizing less than + 2 z, anticoagulation, implantation site) were investigated. Cox regression, decision tree analyses, and "Clustering by Response" were applied. Results Patient age ranged from 0 to18 years, mean 6.0 ± 6.1, median 3.2 years. Implantation reasons: 88% congenital malformations, 12% Ross operations. Follow-up was 88.3% complete. Durability (freedom from death, reoperation, degeneration, endocarditis, and explantation) compared well to corresponding homograft literature. Sixteen patients reached study endpoints. Age <2 years was the only invariably significant risk factor (p = 0.044); "Clustering By Response" found young anticoagulated patients with oversized conduits to be at a higher risk than the others (p = 0.018, OR = 3.2). Conclusion Patient age is the main risk factor for development of distal anastomosis stenosis after Contegra implantation. The influence of the other investigated factors is too small to be proven in 104 patients after 2 years, or other risk factors must be taken into consideration to explain outcome differences among recipients under 2 years., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Purpose: To describe our experience with balloon dilatation and stenting of modified systemic-to-pulmonary artery (PA) shunts in relation to an assessment and interpretation of the mechanical properties of thin-walled expandable polytetrafluoroethylene (ePTFE) stretch vascular grafts., Methods: Our pediatric cardiology/cardiac surgery database was reviewed to identify all infants and children with a modified systemic-to-PA shunt who underwent cardiac catheterization. Reports and images were reviewed. Thin-walled stretchable and regular Gore-Tex vascular grafts were mechanically compared using tensiometry., Results: 11 patients underwent dilatation or stenting procedures of a systemic-to-PA shunt. No major complications occurred and none of our patients died during or due to this intervention. High pressures in balloons and stents with diameters larger than the graft were used. Shunt diameters and oxygen saturation levels increased from 2.05 +/- 1.25 mm to 4.75 +/- 0.88 mm and with 12 +/- 6.8%, respectively. In 6 patients re-catheterizations were performed. Four patients died, all with patent shunts. The fail-stress and the fail-strain in the circumferential direction of the stretchable graft were significantly higher than in the non-stretchable graft., Conclusions: Dilatation and stenting of stenosed modified systemic-to-PA shunts is feasible and safe. Dilatation and stenting of these shunts to calibers larger than those provided by the manufacturer is possible. Results of our technical study posit a great advantage for the use of the thin-walled stretch configuration of ePTFE.

Introduction: A limitation of drug-eluting stent (DES) use to FDA-approved indications has been suggested to reduce the risk of stent thrombosis. This study evaluated predictors of stent thrombosis in clinical practice after the use of drug-eluting as well as bare-metal stents (BMS), including adherence to the FDA indications for DES., Methods: Between July 2002 and October 2006 percutaneous coronary intervention (PCI) was performed on 5,945 patients using BMS (68%) or DES (32%). Patients had 1-year follow-up for definitive stent thrombosis (ARC criteria). 76 patients (1.27%) developed definitive stent thrombosis. Clinical, procedural, and angiographic parameters were related to those of 786 patients without stent thrombosis to define predictors of stent thrombosis. Off-label or on-label implantation of stents according to the FDA-approved indications for DES was included as parameter in the analysis., Results: In 434 patients, stent implantation was performed within FDA-approved indications and in 428 patients outside of FDA-approved indications for DES. Predictors of stent thrombosis were PCI in acute myocardial infarction (OR = 4.51, P < 0.001), treatment of bifurcation lesions (OR = 4.43, P < 0.001), stent length per mm (OR = 1.07, P < 0.001), implantation of multiple stents (OR = 3.67, P < 0.001), and stent implantation outside of FDA indications (OR = 6.13, P < 0.001). The risk was increased for DES as well as BMS. In a multivariate analysis, PCI in acute myocardial infarction (OR = 2.56, P = 0.014), LV-EF < 30% (OR = 3.60, P < 0.001), treatment of bifurcation lesion (OR = 3.65, P = 0.004), stent length in mm (OR = 1.04, P = 0.015), and implantation of multiple stents (OR = 2.64, P = 0.002) remained predictors of stent thrombosis. Off-label stent implantation was no independent additional predictor as it is a combined parameter of the above-mentioned predictors., Conclusions: Implantation of coronary stents outside of the FDA-approved indications for DES is associated with an increased risk of stent thrombosis using DES and BMS.

Despite advances in the design of balloons and stents, restenosis remains a major drawback of coronary angioplasty. Multiple randomised trials have demonstrated that drug-eluting stents (DES) can significantly reduce rates of restenosis by 60-75% across both lesion and patient subsets. In recent years there has been an exponential increase in the worldwide use of DES. This expansion has occurred as a result of an enthusiastic extrapolation of results from randomised trials leading to "off-label" use of DES in anatomical or clinical high-risk scenarios, or both. However, emerging medium- to long-term follow-up data have raised concerns about the safety of DES. A number of analyses have recently shown increased rates of late stent thrombosis in patients with DES. The exact mechanisms leading to stent thrombosis remain unclear. This article critically reviews the available efficacy and safety data on DES and discusses the factors influencing our current practice and perception of the net value of DES.

Purpose: Placement of a carotid artery stent (CAS) is an appealing treatment option for patients who have undergone neck irradiation or endarterectomy. Early outcomes and restenosis rates in these patients were analyzed and compared with those in de novo lesions., Materials and Methods: Single-center, retrospective review of 269 CAS procedures that used cerebral embolic protection and nitinol stents was conducted from May 2001 through July 2006. In this cohort, 66 procedures were performed in patients with a history of external-beam neck irradiation (n=26) or carotid endarterectomy (CEA; n=40), designated as the "hostile neck" group. Mean follow-up was 16 months., Results: The 30-day event rate for the entire group included major ipsilateral stroke (1.1%), minor posterior stroke (1.1%), and myocardial death (0.4%); none occurred in the hostile neck group. The rate of restenosis or occlusion for all 269 arteries was 2.6%. There was no significant difference in restenosis or occlusion rates between de novo lesions (2.0%, four of 203) and the hostile neck group (4.5%, three of 66; P=.17). Repeat angioplasty with or without stent implantation was employed for all patients with restenosis and resulted in no periprocedural stroke, death, or subsequent restenosis., Conclusions: Periprocedural outcomes of CAS procedures are similar in de novo lesions as in patients with a history of neck irradiation or CEA. Importantly, restenosis requiring repeat intervention remains uncommon, and its incidence is comparable between groups.

Objective: Results of short- and midterm follow-up studies of the patency rate of the Symmetry aortic connector systems (St Jude Medical, Inc, Minneapolis, Minn) are controversial. Long-term follow-up studies are still lacking (so far, the longest mean follow-up period was 19 months). The aim of our study was (1) to evaluate the patency rate of this device over a longer time-period and (2) to analyze risk factors for graft occlusion., Methods: Between November 2000 and July 2003, 76 Symmetry aortic connector systems were implanted in 42 patients. At follow-up, 24 patients with 44 mechanical connectors were studied with 64-slice cardiac computed tomography. Eight patients had died previously, 6 patients refused to undergo a computed tomographic scan, and 4 patients had to be excluded because of impaired renal function., Results: From a total of 44 mechanical connectors studied, 24 (55%) were occluded, 20 (45%; confidence intervals 31%-61%) were patent, and 7 of these grafts showed stenosis in the area of the connector. Mean follow-up was 41 +/- 10 months (18-52 months). Sex, age, left main stenosis, hyperlipidemia, hypertension, renal failure, target vessel, stenosis of the target vessel, diameter of the target vessel, type of surgical intervention, diabetes, ejection fraction, postoperative anticoagulation regimen, and the connector size showed no significant influence on the bypass graft patency (P > .05). The bypass graft flow was recognized to be the only risk factor for bypass graft occlusion (P = .0256)., Conclusion: Midterm follow-up data show a high number of occluded Symmetry aortic connector system vein grafts. On the basis of these observations, the use of the connector was abandoned at our institution.

Objectives: The aim of this study was to find out whether carbon impregnated ePTFE vascular grafts have better long-term patency or limb salvage rates than Standard ePTFE vascular grafts in crural revascularization in patients with chronic critical ischemia., Design: Prospective randomized multicenter trial. Study endpoints were 36 months follow-up, major amputation or death., Materials: We used 6mm carbon ePTFE (Carboflo) and 6mm standard ePTFE vascular grafts (both C.R. BARD Inc./IMPRA)., Methods: From June 1995 to November 1998, 283 patients were randomly assigned either to carbon (C) (n=140) or to standard (St) ePTFE (n=143) vascular grafts at 19 centres. A standard protocol was used with lateral extra-anatomic course of the graft to the anterior tibial artery and of a distal vein patch or cuff. More than 90% of the patients had rest pain or gangrene., Results: Two hundred and sixty-five (C=130; St=135) patients could be analysed in the intention-to-treat (ITT) group. Primary patency, secondary patency and limb salvage rates after 36 months were 33, 43 and 67% in the carbon- and 30, 38 and 58% in the standard PTFE group, respectively, (log-rank test: p=0.20, 0.12 and 0.16). Additional analyses were made per protocol (PP) and as-treated (AT). The retrospective power of the study was calculated as 79 and 83%., Conclusion: The ITT, PP and AT analysis, showed no statistically significant advantage of the carbon ePTFE vascular graft in terms of patency or limb salvage over the standard ePTFE vascular graft at 36 months.

Purpose: To evaluate the intra-operative performance and clinical outcome of a new commercially available stent-graft for the treatment of thoracic aortic diseases., Methods and Patients: From January 2003 to October 2004, 45 consecutive patients received endovascular treatment with the Zenith TX1 device for diseases of the thoracic aorta at a single center in northern Italy. Indications included disease of the descending thoracic aorta in 26 cases, of the aortic arch in 17 cases and of the thoraco-abdominal aorta in two cases. We treated 38 atherosclerotic aneurysms, two post-traumatic aortic ruptures, two penetrating ulcers, two chronic dissections and one case was treated for aortic bleeding after voluntary acid ingestion for attempted suicide. General anesthesia was used in 20 cases. Combined or hybrid endovascular and open surgical repair was performed in 11 patients. Mean follow-up was 7 months (range 1-22 months)., Results: Technical success was obtained in 44 patients (98%). One primary type I endoleak occurred (2%). ICU was used in 12 cases with a mean stay of 1 day. The mean hospital stay was 6 days (range 4-13 days). There were no hospital deaths or strokes but one transient paraplegia (2%). A type II endoleak was observed in one case and resolved spontaneously 1 month later. No aneurysm enlargement, endograft migration or structural failures were observed during follow-up. Two late unrelated-deaths were observed., Conclusions: This stent-graft does not fulfill all the characteristics of the ideal graft, however, it proved to be safe and allowed satisfactory short term results in this group of patients treated at a single center.

Background/aims: To analyze the long-term outcome of the calibrated portacaval shunt in the treatment of portal hypertension., Methodology: Between 1991 and 1996 we undertook a prospective non-randomized study, including 37 cirrhotic patients who underwent small diameter portacaval shunt with polytetrafluoroethylene H-graft, 24 cases with 8 mm and 13 cases with 10 mm. Early and late complications, and survival were analyzed., Results: Overall, 28 corresponded to Child-Pugh class A, 5 to class B and 4 to class C. The cause of cirrhosis was alcoholic in 16 cases, postnecrotic in 12, mixed in 5, primary biliary cirrhosis in 2 and unknown in 1. Postoperative mortality was 10%. Long-term results, after a follow-up of 3-8 years, have shown a rebleeding rate of 12%, mainly after the third postoperative year. Some degree of encephalopathy occurred in 23% of the patients, but in no case was this chronic or incapacitating. The rate of early thrombosis was 5%, but in all cases it was repermeabilized with local thrombolysis. The late thrombosis rate was 6%. The 3-, 5- and 7-year survival rates were 79%, 57%, and 36%, respectively. These rates were not statistically related with the shunt diameter or the etiology of the cirrhosis., Conclusions: Partial portacaval shunt is a safe option for the treatment of variceal bleeding due to portal hypertension. We consider it to be the treatment of choice in a selected group of cirrhotic patients with well-preserved liver function, after previous failure of medical therapy. Furthermore, it can also be used as a bridge until liver transplantation.

Background: Stent coating with turbostratic carbon was supposed to minimize the local inflammatory response after stent implantation and to thereby also reduce the rates of restenosis and clinical events., Methods and Results: From October, 1999 to February, 2002, a total of 329 patients with symptomatic coronary artery disease (CAD) eligible for single-lesion PCI were randomized for implantation of either a CarboStent (C; n = 168) or a stainless-steel stent (S; n = 161). The stainless-steel stents were Tristar stents in 60.2%, Tetra stents in 17.4% and Penta stents in 22.4%. Both groups showed no differences in baseline clinical and angiographic characteristics. Angiographic follow-up (FU) was obtained after 6 months in 287 patients (87.2%), clinical FU in 295 patients (89.7%). With the exception of a smaller post-procedure minimal luminal diameter (MLD) in the C group (2.59 0.43 mm versus 2.72 0.46 mm in the S group; p = 0.01), there were no significant differences between the C and S groups in lesion length (10.28 4.45 mm versus 10.37 4.79 mm, respectively), reference diameter (2.92 0.59 mm versus 2.89 0.53 mm, respectively), pre-procedure MLD (0.77 0.36 mm versus 0.84 0.36 mm, respectively), MLD at FU (1.67 0.64 mm versus 1.68 0.57 mm, respectively), late loss (0.93 0.63 mm versus 1.05 0.59 mm, respectively), late loss index (0.51 0.32 versus 0.57 0.32, respectively) and restenosis rate (18.1% versus 20.6%, respectively). There were also no significant differences regarding major adverse cardiac events (MACE) between the C and S groups, i.e., occurrence of death (0% versus 0.7%, respectively), myocardial infarction (0% versus 0.7%, respectively), coronary artery bypass graft (0.7% versus 1.4%, respectively) and target lesion revascularization (16.4% versus 21.5%, respectively)., Conclusion: Coronary stents coated with turbostratic carbon gave no clinically relevant reduction of in-stent restenosis and MACE rates when compared to uncoated stents.

Research in vitro and in animal models suggested that gold electroplating of stents can attenuate neointimal hyperplasia and reduce thrombogenicity. The objective of this study was to evaluate the safety and efficacy of the gold-coated NIROYAL stent in the treatment of stenosed coronary arteries and bypass grafts. We retrospectively studied 181 consecutive patients undergoing deployment of NIR (n = 87) or NIROYAL (n = 94) coronary stents in a single tertiary referral center from July 1997 to December 1998. Mean follow-up duration for the NIR and NIROYAL patient groups were 11.6 and 11.4 (range, 3-12) months, respectively. Stent thrombosis rates were 3/87 (3%) in the NIR and 0/94 (0%) in the NIROYAL group (P = 0.07). The need for target lesion revascularization (TLR) in the NIR patient group was 8/87 (9%) compared to 11/94 (12%) in the NIROYAL patient group (P = 0.6). The overall MACE rates for the NIR and NIROYAL patient groups were 24/87 (28%) and 22/94 (23%), respectively (P = 0.5). The present study, hence, implies equivalence between the stainless steel NIR and the gold-plated NIROYAL stent with no significant difference in immediate and long-term clinical performance profiles., (Copyright 2001 Wiley-Liss, Inc.)

Background: The aim of this study was to evaluate the determinants of access patency and revision, including the effects of reducing the placement of prosthetic hemodialysis access., Methods: A retrospective cohort study of all hemodialysis accesses placed at the Veteran's Administration Puget Sound Health Care System between 1992 and 1999 was conducted. A policy was instituted in 1996 that maximized the use of autogenous hemodialysis access. The impacts of the policy change, demographics, and comorbid factors on access type and patency, were examined. Primary and secondary patency rates were examined using the Kaplan--Meier method, and factors associated with failure and revision were examined using Cox proportional hazard models and Poisson regression., Results: During the study, 104 accesses (61 prosthetic grafts and 43 autogenous fistulas) were placed prior to 1996, and 118 (31 prosthetic grafts and 87 autogenous fistulas) were placed after 1996. There was a significant increase in autogenous fistulas placed after 1996 (87 out of 118) compared with before 1996 (43 out of 104, P < 0.001). At one year, autogenous fistulas demonstrated superior primary patency (56 vs. 36%, P = 0.001) and secondary patency (72 vs. 58%, P = 0.003) compared with prosthetic grafts. After adjustment for age, race, side of access placement, and history of prior access placement, patients with a prosthetic graft were estimated to experience a 78% increase in the risk of primary access failure when compared with similar patients having an autogenous access [adjusted relative risk (aRR) = 1.78, 95% CI 1.21--2.62, P = 0.003)]. Similarly, the adjusted relative risk of secondary access failure for comparing prosthetic grafts with autogenous fistulas was estimated to be 2.21 (95% CI 1.38--3.54, P = 0.001). The adjusted risk of access revision was 2.89-fold higher for prosthetic grafts than for autogenous fistulas (95% CI 1.88--4.44, P < 0.001)., Conclusions: Autogenous conduits demonstrated superior performance when compared with prosthetic grafts in terms of primary and secondary patency and number of revisions. A policy emphasizing the preferential placement of autogenous fistulas over prosthetic grafts may result in improved patency and a reduction in the number of procedures required to maintain dialysis access patency.

Background: Aggressive reoperation for failing or failed femoropopliteal (FP) bypass has been affirmative despite graft material. There has been no report regarding results of reoperation for FP bypass with externally supported knitted Dacron prosthesis (EXS). The aim of this study is to justify aggressive reoperation of FP bypass with EXS and to examine risk factors affecting the result of reoperation., Methods: A retrospective review was performed on 204 patients undergoing 212 FP bypasses (with EXS between January 1982 and December 1997 and 34 FP EXSes of 32 patients underwent reoperation for graft failure until March 1998. The cumulative graft patency (GP) and limb salvage (LS) rate after first reoperation for 34 FP bypass EXS were calculated and the importance of each perioperative factor on GP or LS was estimated by uni- and multivariate analysis., Results: Reoperated 34 FP EXSes included 12 failing and 22 failed grafts and 14 limbs with failed grafts underwent reoperation for limb salvage. The GP of 34 grafts and LS of 14 limbs rate were 58 and 67% at 2 years, respectively. Univariate analysis identified graft thrombosis (2 years GP; failing graft: failed graft=78: 48%) and continuance of smoking (2 years LS; smoker: non-smoker=43: 100%) as a significant risk factor of GP and IS, respectively, neither of which was significant by multivariate analysis., Conclusions: Early diagnosis and treatment, before graft thrombosis, can lead to superior durability of GP and discontinuance of smoking is important for LS.

Purpose: To report a > 3-year experience with a modular, balloon-expandable endovascular graft used for aneurysm exclusion in the aorta and other arteries., Methods: The customized White-Yu Endovascular GAD Graft, a woven polyester prosthesis with an intrinsic Elgiloy wire graft attachment system along the body of the graft, is a flexible endograft design available in straight, tapered, and bifurcated versions that can be delivered transluminally through 18F to 24F sheaths., Results: Since July 1993, 93 patients have received the White-Yu endograft for treatment of 76 abdominal aortic, 3 thoracic aortic, 13 iliac, and 1 popliteal aneurysms. Of the 79 aortic procedures, 39 involved straight tube grafts, 20 were tapered aortoiliac models, and 20 were bifurcated devices. Success rates for tube grafts were 81% in the abdominal aorta and 100% for the thoracic aorta; 5 primary endoleaks (14%) and 2 conversions to surgery (5.6%) occurred with this graft type. Aortoiliac grafts were deployed successfully in 95% (19/20) of cases with 1 conversion (5%) due to thrombosis. Seventy-five percent of the bifurcated endograft procedures were successful, with 4 conversions (20%) for technical failures and 1 graft thrombosis. Four additional endografts were deployed to treat two primary and two secondary endoleaks in tube graft patients. Two access-related arterial injuries were treated surgically. There was one case of embolus to the distal femoral artery but no microembolization. Overall perioperative (30-day) mortality was 3.1%. Over a mean 18-month follow-up (range 2 to 39), no late graft thrombosis, stenosis, or graft migration has been seen on CT scans or X ray. Endoleak has not been detected in any aortoiliac or bifurcated graft. Aneurysm size has diminished consistently in successfully treated cases., Conclusions: The White-Yu endograft appears to offer a safe, efficacious, and minimally invasive means of excluding aneurysms from the circulation. Improvements in patient selection, surgical techniques, and equipment have reduced the incidence of endoleak and conversion to open repair over the course of the evaluation.

The purpose of this study was to review our results with axillofemoral by-passes performed for aorto-iliac occlusive disease. Fifty patients receiving 51 axillofemoral by-passes from January 1989 to December 1994 were retrospectively reviewed. The 30-day post-operative mortality was 4%. Seven patients (14%) presented graft-related local complications and all but one required reoperation. Five patients were lost to follow-up, the mean length of which was 36 months (16-74 months). Forty-nine per cent of the patients died during the follow-up period. At 36 months, the primary patency rate was 51%, the secondary patency rate was 69%, and limb valvage rate was 87%. A statistical difference was seen in the secondary patency rate between axillobifemoral by-pass (87%) and axillo-unifemoral by-pass (56%) at 36 months (P < 0.01), but no difference was seen in the limb salvage rate at 36 months between the two configurations of the by-pass (94% vs 81%) (P = NS). Twenty patients (40%) operated upon for acute ischemia had a significantly higher post-operative mortality rate (10% vs 0), a significantly higher amputation rate (20% vs 6.6%) and a significantly lower patency rate of by-pass (26% vs 63%) (P < 0.01), than the 30 patients (60%) operated on for claudication, rest pain or trophic ulcers. Our findings indicate that the results of axillofemoral by-pass are significantly influenced by the selection of patients for operation, namely the clinical status of ischaemic symptoms, and that since the overall results of axillofemoral by-pass are inferior to those of aortofemoral by-pass, this treatment should be restricted to patients at high risk of aortic clamping.

Purpose: The purpose was to determine the early and late mortality and morbidity rates associated with infrainguinal arterial prosthetic graft infection (IAPGI) and to identify optimal methods of management., Methods: The study included 53 men and 14 women (mean age, 61 years) in whom a total of 68 IAPGIs developed in the years 1959 to 1993. IAPGI involved 58 femoropopliteal grafts (85%), six femorodistal grafts (9%), and four other grafts or synthetic patches (6%). Graft material was dacron in 36 (53%), polytetrafluoroethylene in 28 (41%), and human umbilical vein in four (6%). Sixteen IAPGIs (24%) involved limbs that had required amputations before IAPGI was diagnosed. Twenty-six (38%) of the 68 grafts were thrombosed, and 14 (88%) of the 16 amputees had occluded grafts., Results: Staphylococcal organisms were isolated from 34 (58%) of the 59 IAPGIs for which culture data were available. The median intervals until IAPGI was diagnosed were 3 months after implantation and 1 month after the last procedure involving the original graft. Initial management consisted of local measures only in 13 (19%), partial removal or in situ graft replacement in 15 (22%), and total graft excision in 40 (59%). Total excision was performed in 15 (94%) of the 16 patients with prior amputations and in only 25 (48%) of the 52 intact limbs. The overall postoperative mortality rate was 18%; seven (58%) of the 12 early deaths were related to sepsis, and all 12 occurred within the group of 51 patients (24%) for whom limb salvage was still being attempted (p = 0.056). IAPGI ultimately led to amputations in 21 (40%) of 52 intact limbs within the first year. Twenty-three (82%) of the 28 IAPGIs managed with incomplete graft removal required subsequent operations for continued sepsis, compared with five (13%) of the 40 treated with complete excision (p < 0.001). The cumulative 5-year survival rate (77%) for 53 patients who survived operation was less than that (89%) for the normal, age-matched U.S. male population., Conclusions: IAPGI is associated with substantial early mortality and amputation rates. Complete excision of infected graft material results in a significant reduction in the incidence of recurrent sepsis.

Purpose: We analyzed a current 78-month experience with externally supported (ringed) polytetrafluoroethylene (PTFE) axillobifemoral (AxBF) and axillounifemoral (AxUF) bypass grafts to address the controversy about whether the addition of a femorofemoral limb to an axillofemoral bypass graft improves the patency results., Methods: Between January 1988 and June 1994, 36 AxBF and 22 AxUF externally supported PTFE ringed bypass grafts were performed at our institution. The age of the patients in the AxBF group was 67 +/- 11 years and 69 +/- 11 years in the AxUF group. The male/female ratio was 22:13 (AxBF) and 8:9 (AxUF). In 71% of cases (29/36 AxBF, 12/22 AxUF), the operations were performed for aortoiliac atherosclerotic occlusive disease in patients with significant medical risk factors or a "hostile" abdomen. The remaining 29% were patients requiring revascularization during treatment of an infected aortic graft. Bypass patency was assessed in the follow-up period by clinical evaluation, color-flow duplex imaging, or segmental limb pressure measurements., Results: There was no significant difference in the 30-day operative mortality rate for all AxBF bypasses (11%) and all AxUF bypasses (6%) (p = 0.89 by chi-squared testing). The primary and secondary patency rates for the whole group of bypasses were 80% and 89% at 3 years, respectively (SE < 0.1). Between the AxBF and AxUF groups, there were no significant differences in either primary patency (80% for each group) or secondary patency (91% in AxBFs vs 85% in AxUFs) (SE < 0.1) at 2 years (Wilcoxon rank sum test)., Conclusions: These data show no differences in the patency of externally supported PTFE AxBF and AxUF bypass grafts up to 2 years after implantation.

Several patients with chronic critical limb ischemia show angiographically an isolated popliteal segment (IPS) and a single calf vessel (SCV) with no direct communication to the former. In this situation a bypass can be inserted from the common femoral artery to the IPS or to the SCV. The results of 73 bypass procedures--40 to an isolated popliteal segment and 33 to a single calf vessel for limb salvage--were prospectively evaluated. Eighty percent of the grafts were performed with an autogenous saphenous vein (ASV), the rest with a thin wall polytetrafluoroethylene (PTFE) prosthesis. The mean age of our patients was 75 years and many suffered from cardiovascular disease. The operative mortality rate was 3% and the mean postoperative survival 32 months. Three year patency and limb salvage rates for ASV grafts was 83% and 87% (IPS) respectively 77% and 76% (MCV); for PTFE grafts 58% and 88% (IPS) respectively 17% and 50% (MCV). There was no significant difference found in patency and limb salvage rates of the two procedures if the graft was an autogenous saphenous vein (p > 0.05). The PTFE prosthesis was only suitable for grafts inserted to the isolated popliteal segment.

Purpose: Since Blaisdell et al. first described axillobifemoral bypass and aortic exclusion to treat patients at high risk with abdominal aortic aneurysms in 1965, this approach has been controversial. To help define the appropriate application of this procedure, the recent experience of the authors was reviewed., Methods: Twenty-six patients underwent operation between March 1980 and August 1992. Mean age was 71 +/- 7 years. Average aneurysm diameter was 7.0 +/- 1.5 cm. Sixty-nine percent of the aneurysms were symptomatic; 21% were suprarenal. All patients had serious comorbid factors. All underwent axillobifemoral bypass with iliac artery ligation; the infrarenal aorta was also ligated in 62%., Results: There were two postoperative deaths (7.7%). One- and two-year survival rates were 59% and 38%, respectively. Three patients died of aneurysm rupture (11.5%); the aorta had not been ligated in two of these patients. The remaining late deaths were due to comorbid conditions. Extraanatomic bypass grafts thrombosed in five patients; no limbs were lost., Conclusions: Axillobifemoral bypass without aortic ligation does not effectively reduce the risk of aneurysm rupture. However, axillobifemoral bypass with aortic ligation is an acceptable treatment for patients with severe medical problems and symptomatic, anatomically complicated, or large abdominal aortic aneurysms. Because the risk of aneurysm rupture is not completely eliminated, this procedure should be reserved for patients with high-risk aneurysms who would not tolerate direct aortic replacement.

Purpose: The purpose of this study was to review the treatment of patients with failed or infected axillofemoral bypass grafts and to determine the efficacy of remedial procedures in maintaining graft patency and limb preservation., Methods: Thirty-four patients with 37 failed or infected axillofemoral grafts were retrospectively reviewed. In nine cases there was no attempt at revascularization, and in the remaining 28 cases, a total of 52 remedial procedures was performed. Nine were performed in patients with graft infection and 43 in patients with graft thrombosis. In patients with axillofemoral graft failure, 21 thrombectomies, 13 graft revisions, and 9 secondary reconstructions were performed. Eighty-eight percent of patients were monitored at least 2 years or until graft failure., Results: Eight of nine patients receiving no remedial procedure required major amputation. The limb salvage rate was 64% +/- 11% at 30 months in the 25 patients undergoing remedial procedures. Twenty-eight percent of failed axillofemoral grafts remained patent at 2 years after initial failure with single or multiple thrombectomies or revisions. Life-table primary patency after secondary reconstructions (81% +/- 10.9% at 24 months) was significantly better than after thrombectomy alone (10% +/- 4.2% at 24 months) or graft revision (16% +/- 10.6% at 24 months) by log-rank test (p < 0.001 and p < 0.005, respectively). Patients undergoing reconstruction with descending thoracic aorta to femoral artery bypass had an 89% +/- 11% patency rate at 24 months. Graft infection resulted in a perioperative mortality rate of 22% and amputation in 57% of survivors., Conclusion: Axillofemoral graft failure most often results in limb loss without remedial procedures. Thrombectomy and revision procedures had poor long-term patency rates and salvaged only a minority of grafts despite multiple procedures. Reconstruction by use of an alternate source of inflow such as the descending thoracic aorta resulted in better long-term patency rates in patients well enough to tolerate a major reoperative procedure.

Purpose: The purpose of this study was to evaluate the results of infrainguinal reconstructions with arm vein, lesser saphenous vein, and remnants of greater saphenous vein (ectopic vein grafts)., Methods: The records of 222 patients who underwent 257 bypasses were restrospectively reviewed. Most of the grafts were placed for rest pain or tissue loss (88%) and were secondary reconstructions (70%) to the infrapopliteal level (90%). Single-length vein grafts were constructed in 66% of cases, whereas 34% were composite vein grafts., Results: Secondary graft patency was 70%, 52%, and 43% at 1, 3, and 5 years. Single-length grafts had significantly better patency rates at all intervals: 78% versus 56% at 1 year (p = 0.001), 60% versus 39% at 3 years (p = 0.004), and 52% versus 29% at 5 years (p = 0.002). The limb salvage rate was 69% at 5 years., Conclusions: Ectopic vein grafts with primarily arm vein are an acceptable alternative for infrainguinal reconstruction in the absence of suitable ipsilateral greater saphenous vein.

Late complications following aortic graft replacement are rare. Within 5 years these severe complications have to be expected in about 1-3%. A staged but adequate treatment is necessary. If the renal arteries are included besides technical and anesthesiological experiences a refinement of vascular surgical technique is required. Nevertheless a high morbidity and mortality rate remains, depending on the expertise of the vascular surgeon, on an early and precise diagnosis as well as on the severity of additional organ diseases. Routine yearly ultrasound examinations following aortic graft replacement are recommended, to detect late complications before the events of rupture, graft enteric fistula or severe bleeding complications require extensive surgical procedures. Any vascular surgeon performing abdominal and thoracoabdominal aortic surgery has to be familiar with the basic diagnostic and therapeutic approaches managing late complications following aortic graft replacement.

Fifty-five vascular graft infections were personally managed by the author over an 8-year period. For 22 patients with aortic graft infection, Staphylococcus epidermidis was the most common pathogen (18 of 22 patients), presenting as limb thrombosis in nine and pseudoaneurysm in five. All patients underwent staged extra-anatomic reconstruction and graft resection 4-5 days later. For 33 patients with peripheral infection, S. aureus was the most common pathogen (29 of 33 patients), presenting as clinical graft sepsis usually within months of initial operation. Local therapy was successful in seven of nine patients, whereas graft resection with autologous reconstruction achieved limb salvage in all 11 patients involved. Overall, the mortality rate was 9.1% for 22 aortic and zero for 33 peripheral infections; amputation rates were 14 and 12%, respectively.

In this retrospective study, 21 patients requiring treatment for primary infection of an aortic prosthesis between 1981 and 1991 were identified from a prospective register. Ten of the 21 patients had had additional peripheral reconstructive vascular surgery before the diagnosis of aortic graft infection. The median interval between aortic graft insertion and diagnosis of graft infection was 16 months (range 1-84). Infected grafts were removed and an extra-anatomic bypass constructed in all patients. All but three patients had axillodistal reconstruction. Six patients had simultaneous operations, whilst the other 15 patients had a staged procedure with extra-anatomic reconstruction preceding graft removal. Two patients died before discharge from the hospital (9.5%). No patient required extremity amputation in the perioperative period. By life-table analysis patient survival (including perioperative deaths) was 80% at 1 year, 55% at 3 years and 40% at 5 years. Primary patency was 62% at 1 year, 51% at 3 years and 40% at 5 years. Limb salvage rate was 89% at 1 year, 63% at 3 years and 63% at 5 years. The median length of follow-up was 24 months. Extra-anatomic reconstruction in patients with aortic graft infection can be performed with low perioperative mortality. Limb salvage rates following extra-anatomic reconstruction are determined not only by the mode of reconstruction, but also by the primary disease.

Between 1980 and 1988, 263 patients received 307 femorocrural bypass grafts. 180 were primary infrainguinal grafts, 106 secondary, 18 tertiary and three quaternary. Rest pain or tissue loss was the indication in 96% of cases. Outflow vessels were the tibioperoneal trunk (n = 34), posterior tibial artery (n = 115), peroneal artery (n = 89) and anterior tibial artery (n = 69). 88 primary vein grafts were completed. 201 polytetrafluoroethylene (PTFE) grafts were inserted (92 primary and 109 subsequent reconstructions). There were no direct PTFE to crural vessel anastomoses. A Miller cuff was used in the majority (n = 175). The three year primary patency for primary vein grafts (36%) was similar to primary PTFE grafts (29%), but significantly higher than subsequent PTFE grafts (20%) (p = 0.03). Three year foot salvage for primary vein grafts (65%) was similar to primary PTFE (64%), but significantly better than subsequent PTFE (42%) (p = 0.02). The results support both redo femorocrural grafting for critical ischaemia, as judged by foot salvage rates, and the use of PTFE with a distal vein cuff in primary and subsequent femorocrural reconstruction if autologous vein is not available.

The axillodistal extra anatomic bypass is not an operation commonly performed and the only reason for performing it is to attempt limb salvage for a reasonable period of time or until death in patients with critical ischaemia. During the period 1983-1991 we performed 67 such bypasses where no other form of reconstructive arterial surgery was feasible. There were 27 axillopopliteal (15 below and 12 above the knee), five crossover, seven bilateral, 11 axillotibial and 17 jump (sequential bypasses). The first 34 procedures (1983-1987, early period) had a 5-year cumulative secondary graft patency of 20%, which increased to 33% for the 33 bypasses performed during the second period (1987-1991). The primary graft patency of the 67 bypasses was 13%. Our clinical results show that even in these patients with diffuse occlusive arterial lesions, limb salvage is possible in a reasonable number even when axillodistal bypass is used. Improvements in the technique, better selection of patients, the performance of jump grafts and the aggressive treatment of early and late graft occlusions have led to much better results being achieved.

In patients over 70 years of age with disabling leg ischaemia, femorofemoral crossover bypass with an externally supported polytetrafluoroethylene (PTFE) graft is the treatment of choice for unilateral occlusion of the iliac artery. Over a 6-year period, 18 elderly patients underwent femorofemoral bypass, six of whom had received percutaneous transluminal angioplasty before surgery for stenosis of the contralateral external iliac artery (donor artery). Symptoms of ischaemia recurred in three patients because of deterioration of the donor iliac artery more than 2 years after surgery, although all three grafts were well visualized by angiography. Revascularization was attempted in these three patients by an axillary bypass. Disabling symptoms of ischaemia were completely relieved by this procedure, although two patients underwent reoperation 9 and 16 months after the axillary bypass respectively. All three patients are now free from symptoms of ischaemia. It is concluded that: deterioration of the donor iliac artery after femorofemoral bypass does occur, although it has been considered unlikely because of decreased peripheral resistance; in spite of complete occlusion of the donor artery, grafts remain patent, proving the excellent antithrombogenic activity of externally supported PTFE; and revascularization using additional axillary bypass is a feasible procedure in such cases.

From October 1978 to December 1989, 51 patients underwent lower-limb revascularization from the supracoeliac aorta through a transcrural approach. Symptoms were related to lower-limb ischaemia in all patients: 20 had critical ischaemia (three with severe acute ischaemia) and 31 claudication. One patient had renal failure with hypertension and stenosis of the renal arteries associated with an infrarenal aneurysm induced by Takayasu's disease. Indications for exposure of the supracoeliac aorta were Takayasu's disease in two patients and atheroma in 34 (implantation of the graft on the supracoeliac aorta because of the status of the aortic wall (calcification, inflammation) in 25 and because antegrade revascularization of the visceral arteries was required in nine). In 15 patients repeat aortic surgery was performed; four of these had undergone three previous aortic approaches. The postoperative mortality rate at 30 days was 2%. There were four (8%) acute postoperative graft occlusions and four late occlusions, which occurred between 13 months and 6 years. Life-table analysis showed a 5-year primary patency rate(s.d.) of 83(10)% and a 5-year secondary patency rate(s.d.) of 88(8)%. There are few indications for the transcrural approach to the supracoeliac aorta. Nevertheless, this technique can prove useful in selected cases, for example in those with a calcified aorta, for repeat aortic surgery and for aortic thrombosis near the renal arteries. It is also useful when combined revascularization of the lower limb and right renal or hepatic artery is being considered.

Between 1973 and 1991, 12 patients with mycotic aneurysm of the abdominal aorta underwent operation. There were four elective and eight emergency procedures. In situ reconstruction was performed in six patients and extra-anatomic reconstruction with axillobifemoral bypass grafting in six. The hospital mortality rate was 25% (three patients) and another three died during the follow-up period of mean 5.5 years. Descending aorta-bifemoral bypass was performed in two patients without signs of chronic local infection 1 and 2 years after previous axillobifemoral bypass. Late complications were peripheral embolization in one patient after in situ reconstruction and a total of five thromboses of the axillofemoral bypass in three patients. Extra-anatomic bypass grafting remains the method of choice for the majority of patients with mycotic aneurysm of the abdominal aorta. In situ reconstruction seems to be an appropriate procedure for a highly selected group of patients.

In 179 patients receiving prosthetic grafts for abdominal aortic aneurysmectomy, an attempt was made to preserve or restore continuity of at least two vessels, including the patent inferior mesenteric artery (IMA) and bilateral hypogastric arteries (HGAs), so as to prevent colorectal ischaemia. Adjunctive reconstruction of the IMA and/or HGAs was performed in 60 patients; a total of 40 HGAs and 31 IMAs were reconstructed. The hospital mortality rates of patients with elective and ruptured aneurysm repair were 3.9 and 22% respectively. There were no deaths related to colorectal ischaemia. The mean(s.d.) IMA stump blood pressure was 66(18) mmHg and the mean(s.d.) IMA stump pressure index (the ratio of mean peak systolic IMA pressure to mean systolic systemic pressure) was 0.58(0.15). The IMA was revascularized in all patients whose stump pressure was < 40 mmHg and whose index was < 0.4. Postoperative angiography revealed a 94% patency rate for the IMA and 92% for the HGAs. Colorectal ischaemia did not develop in any patient in whom aneurysmectomy was performed electively or in any who had colonoscopy because of watery diarrhoea after surgery. These results indicate the significance of adjunctive reconstruction of the IMA and HGA during abdominal aortic aneurysmectomy.

Although the quality of the distal run-off has been considered as an important factor affecting the success of bypass grafting, reasonable results have nevertheless been reported for bypass grafts to a popliteal artery with no direct communication with the tibial or peroneal vessels (isolated popliteal segment, IPS). The use of autogenous vein has produced the best results in this situation with most authors finding polytetrafluoroethylene (PTFE) less satisfactory. Improved results have nevertheless been shown for femoropopliteal and femorotibial PTFE grafts by the incorporation of vein patches into the anastomoses. In this paper, the influence of this technique on the patency of PTFE grafts to IPS is evaluated. Thirty-three PTFE grafts to an IPS and 67 to the below knee (BK) popliteal artery with one or more run-off vessels were studied. All IPS grafts were carried out for limb salvage and in the BK popliteal group, 46 (69%) were for limb salvage and 21 (31%) were for severe claudication. Groups were matched in terms of age, smoking history and prevalence of diabetes mellitus. Cumulative patency rates of 84% at 1 year and 76% at 3 years were achieved in the IPS group compared to 90 and 81% for the BK popliteal group with one or more run-off vessels. Using the Taylor patch technique, comparable 3 year patency rates can be expected for PTFE grafts to IPSs and to BK popliteal arteries with patient tibial or peroneal run-off.

Purpose: The purpose of this study was to review our experience with externally supported, knitted Dacron grafts used for axillofemoral bypass., Methods: Retrospective analysis was performed on records of 79 consecutive axillofemoral bypass graft operations performed on 77 patients from January 1978 to April 1990., Results: The mortality rate within 30 days of operation was 5% (four of 79); 36 patients died in the follow-up period; none died of graft causes. During this 12-year period (mean follow-up 42 months) three patients were unavailable for follow-up. The primary patency rate was 78% at 5 years and 73% at 7 years, with no change thereafter. Neither the graft configuration (i.e., axillounifemoral [n = 50] vs axillobifemoral [n = 29]) nor patency of the superficial femoral artery had an impact on the primary patency rate. Patients who underwent surgery for disabling claudication (n = 30 grafts) had a primary patency rate of 80% at 6 years compared with 65% at 6 years for those who required surgery for limb salvage (n = 49 grafts); the difference was not significant (p = 0.37). Actuarial survival of patients with axillofemoral grafts was 23% at 10 years compared with 72% in a concurrent population of patients with aortofemoral bypass (p < 0.001)., Conclusion: These findings indicate that axillofemoral bypass grafts may be appropriate for high-risk patients with severe aortoiliac disease who require revascularization for either limb salvage or incapacitating claudication.

Forty-two patients with total juxtarenal aortic occlusion were offered aortobifemoral bypass over a 6 year period. The majority presented with claudication and males predominated. In all patients, aortobifemoral bypass was successfully performed. The groins were initially explored and the aorta was then thrombectomised prior to the standard aortobifemoral bypass. Follow-up period ranged between 6 months and 5 years. There was a 4.8% perioperative mortality. Graft occlusion occurred in two patients in the immediate postoperative period, resulting in major amputation in one patient. Three patients developed graft occlusion during the period of follow-up, none of whom required amputation. Graft sepsis occurred in one patient and one patient developed a false aneurysm. We conclude that angiography cannot predict the feasibility of bypass in the presence of total aortic occlusion, and in our hands aortobifemoral bypass is feasible in all these patients. Early results are no different from the rest of the patients with aortoiliac disease.

Axillofemoral bypass grafting is an accepted method for the treatment of vascular insufficiency of the lower limb. It is especially useful in high risk patients whose conditions preclude aortofemoral bypass grafting. The goal of our study is to evaluate whether the benefit of this operation outweigh the potential risks in the age group "sixty-plus". We performed 23 axillofemoral bypass grafting procedures (axillofemoral in 20, axillobifemoral in 3 cases) mainly be mean of 8 mm Dacrom prosthesis. The 30-day operative mortality rate was 8.7% and the cumulative 5-year patient survival rate was 52.2%. Overall the 1- and 5-year life table patency rate were 80% and 64%, respectively. The cumulative limb salvage was 90% and 72% at 1 and 5 years. We obtained an average reduction in Fontaine classification of 2 stages in the first year and 1.3 stages after 5 years. The comparison of the cumulative survival rate with the limb salvage rate indicates that advanced age should not be considered a contraindication to performing an axillofemoral bypass graft. The reduction in Fontaine stage means a remarkable improvement in quality of life.

Twenty-seven patients with mycotic aneurysms of the aorta and its major branches were operated on between 1969 and 1991. There were 24 males and three females ranging in age from 6 to 84 years (mean age for adults 63 years). Sixteen of the 27 (59%) aneurysms were ruptured and in situ repair was undertaken in 20 (74%) patients. The mean follow-up was 5.8 years (range: 8 months to 16 years). Four patients (15%) died during the hospital stay and 23 survived. There were eight late deaths, two of which were a direct result of the aneurysm. The estimated 1- and 5-year survival rates were 62 and 36%, respectively. Extra-anatomic reconstruction is the method of choice for the majority of patients with mycotic aneurysm of the infrarenal abdominal aorta and iliac arteries. In situ repair after an extensive debridement of the aneurysmal wall and all infected tissue combined with antibiotic therapy is a satisfactory method of treating mycotic aneurysms of other locations, and for a highly selected group of patients with infrarenal mycotic aortic aneurysms.

In a retrospective analysis 12 patients treated for aorto-femoral vascular infections between 1984 and 1990 were evaluated. They were all male with a mean age of 63 years. Indications for treatment were: mycotic aneurysms-3, primary aorto-enteric fistula-2 and graft infection-7. Surgical treatment consisted of implantation of an extra-anatomic bypass, carefully avoiding the infected area, followed by removal of the infected graft and tissue at the same session. There was no early mortality (less than 30 days) but the first year mortality was 42% (n = 5). Causes of death were: aortic stump disruption (n = 1), recurrence of aorto-enteric fistula (n = 2), axillary anastomosis disruption (n = 1), cardiac failure (n = 1). Orthotopic reconstruction of the aorta after 12 months, as we advocate, was accomplished in two patients and is scheduled in another one. In two patients their poor condition precluded this second step, and in two further patients above-knee amputation with subsequent extra-anatomic graft removal was needed. Only one of the 12 extra-anatomic bypasses became infected. Reconstruction by axillo-femoral bypass combined with removal of the aorto-femoral graft at the same session is a practicable procedure with good early results. However, the rate of successful orthotopic reconstruction of the aorta after 12 months is low because of a high mortality rate, especially in the presence of aorto-enteric fistulas, and because some patients with well functioning axillo-femoral grafts are in too poor condition for another large operation.

Between 1978 and 1990, 53 consecutive modified Blalock-Taussig (MBT) shunts were performed on 51 neonates with cyanotic congenital heart disease using 3 mm-5 mm Gore-Tex grafts. Only 4 of these children had uncomplicated tetralogy of Fallot. The remainder had more complicated pathology requiring urgent intervention. Retrospective analysis of the acute and long term results was performed with 100% follow-up, ranging from 1 month to 12 years (mean 3 years). There were 3 (6%) early deaths (within 30 days of operation) and 17 (33%) late deaths. Of the late deaths, 2 died after further palliation, 2 died after total correction and 13 died suddenly at home. Post mortem examination of the 13 sudden deaths revealed blocked shunts in only 3. Actuarial survival at 2 years was 58%. Shunt patency at 12 months was 87% and at 2 years, 62%. No patient used their initial MBT shunt for more than 40 months. Although this shunt provides good initial palliation, there is a high incidence of late sudden death. We are also concerned about the limited life span of the shunt which partly (3/13) explains the sudden deaths. Therefore we have adopted an aggressive approach to re-study by angiography within 3 months of surgery.

Since January 1983 one surgeon of our team has performed 200 infrainguinal arterial reconstructions. Our patients had a mean age of 72 years and suffered from multiple concomitant diseases (coronary heart disease 35%, cerebro-vascular insufficiency 15%, hypertension 49% and diabetes mellitus 34%). The indication for arterial reconstruction was a chronic critical ischemia in every case. 154 autologous veins and 46 PTFE prosthesis had to be implanted. The former consisted in 64% in a femoropopliteal and in 35% femorodistal bypass graft; respective values of the latter group were 80% and 20%. The cumulative survival rates of two collectives were nearly identical. More than 50% of our patients died in the 4 years observation period. The life table patency rates differed statistically significant (p less than 0.001). The cumulative 5 year patency amounted to 85% in case of a vein graft and to 43% if a PTFE prosthesis was inserted. Extremely poor results were achieved in case of a PTFE prosthesis with a distal anastomosis to a single crural artery; just one out of 6 procedures was successful after two years.

In this retrospective study the results of 518 prosthetic aorto-iliac reconstructions (PRS) and of 229 thrombo-endarterectomies (TEA) were evaluated, with inclusion of follow-up results up to 20 years after surgery. Patients in the PRS group had presented with more severe ischaemic symptoms and more extensive arterio-sclerotic obstructions than the patients in the TEA group. Results in the TEA group were further analysed according to the extension of arterio-sclerotic disease: there were 93 patients with obstructions limited to the aorta or common iliac arteries and 136 patients with more extensive lesions. Patients with limited obstructions were younger, proportionally more often female, had fewer risk factors, and presented with less severe ischaemic symptoms than patients with more extensive obstructions. Operative mortality and early technical and functional results were similar in the PRS and TEA group, but long-term survival and patency rates were significantly better, and the need for late, additional operations was less in the TEA group. Late functional success rates were similar in both groups. The differences in outcome were explained by patient selection. Within the TEA group significantly superior results regarding survival, patency, need for late, additional surgery, and functional success were observed in the subset of patients with obstructions limited to the aorta or common iliac arteries. Considering these results and the risks inherent in a prosthetic reconstruction, such as prosthetic infection and the chance for false aneurysms, we advocate the use of an aorto-iliac TEA in properly selected patients.