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Purpose: To compare and contrast the midterm outcomes of the E-liac and Zenith (ZBIS) iliac branch devices (IBDs) for the preservation of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: Between January 2014 and December 2018, 84 consecutive patients (median age 74 years; 76 men) were electively treated with the E-liac (n=44) or ZBIS (n=40) IBDs and were retrospectively analyzed to evaluate the technical success, patency, need for reintervention, and mortality associated with these devices. Results: Technical success was achieved in 95 of 99 implantations (95.9%) without any statistically significant difference between the groups (93.7% vs 98.0%, p=0.114). During the first 30 days, 3 occlusions in the ZBIS group and 1 in the E-liac group were identified. There was 1 perioperative death in the ZBIS group. The median follow-up was 37 months for the ZBIS group and 28 months for the E-liac group (p=0.657). Six patients from the ZBIS group and 7 from the E-liac group were lost to follow-up. Among the remaining, there were 2 further deaths recorded, 1 in each group. Four further reinterventions in the E-liac group and 2 in the ZBIS group were performed during follow-up. The Kaplan-Meier estimates of freedom from reintervention were 87.2% (95% CI 82.6% to 90.2%) for the ZBIS group and at 86.0% (95% CI 83.7% to 89.1%) for the E-liac group (p=0.563); the freedom from occlusion estimates were 89.7% (95% CI 85.8% to 94.5%) and 95.3% (95% CI 92% to 98.7%; p=0.317), respectively. Conclusion: The E-liac and the ZBIS IBDs showed equally high technical success, midterm patency, and low reintervention rates.

Background: The aim of this study is to evaluate perioperative as well as long-term outcomes in patients operated with carotid endarterectomy (CEA) or stenting (CAS) due to symptomatic or asymptomatic high-grade restenosis of the internal carotid artery (ICA). Patients and methods: In a retrospective analysis of our electronic database including 2980 patients who underwent carotid endarterectomy or stenting due to a symptomatic or asymptomatic high-grade stenosis of the ICA, between 2000 and 2016, we enrolled 111 patients with recurrent ICA stenosis. Results: An ipsilateral 2nd time restenosis (> 80 % in the asymptomatic and > 50 % in the symptomatic patients according to NASCET criteria) of ICA was detected in 13 patients (12 %); 3 of them were symptomatic. These patients were managed with either CEA (n = 5/38 %) or CAS (n = 8/62 %) with no perioperative stroke or death. The stroke-free survival rates at 2 and 8 years for CEA were 98 % and 98 % versus 100 % and 100 % for CAS respectively (P = .271). The type of the initial procedure (patch, CAS or interposition) did not play any significant role for the development of a 2nd time restenosis (P = .841). Conclusions : Redo-CEA/CAS seem to have similar results as primary procedures (as reported in the literature) with favorable periprocedural and long-term outcomes.

Objectives: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side., Methods: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment., Results: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thrombo-embolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively., Conclusions: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability., (Copyright © 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: The aim of the present study was to define the possible anatomical and technical parameter that might predict the occurrence of gutter endoleak or type Ia endoleak (EL Ia) in patients treated with the chimney graft (CG) technique for the brachiocephalic trunk (BCT) and left common carotid artery (LCCA) due to aortic arch pathologies., Methods: We reviewed our institutional endovascular aortic database of patients, who between 2010 and 2018 had undergone thoracic endovascular aortic repair (TEVAR) with chimney graft technique (ChTEVAR) as a debranching method of the supraaortic arteries., Results: ChTEVAR was performed in 45 patients of whom a chimney in both the LCCA and the BCT was used in 32 patients, only in the LCCA in twelve patients, and only in the BCT in one patient. Eight patients (17.8%) had an EL Ia (based on postoperative computed tomography angiography). No late EL Ia was detected during the follow-up period. All patients with a postoperative EL Ia received 2 CGs with one each for the BCT, and LCCA had either no or a sealing ring distal to the most distal chimney of less than 10 mm versus patients with a longer sealing zone (P = 0.043). Patients with an endoleak did not differ from those without endoleak with respect to stent-graft oversizing, the diameter of the proximal and distal landing zones, or the aortic diameter directly proximal to the pathology., Conclusions: A sealing ring distal to the most distal chimney of more than 10 mm seems to be associated with a reduced risk of an EL Ia. The relatively few patients and the single-center nature require larger studies to verify the present results., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to evaluate the effect of image fusion (IF) technology in thoracic endovascular aortic repair (TEVAR) on reducing radiation exposure (dose and time), amount of injected iodinated contrast medium needed, and procedure time., Methods: We performed a review of our institutional endovascular aortic database of patients who had undergone TEVAR between 2008 and 2016 before and after the installation of a three-dimensional (3D) IF computed tomography system in our hybrid operating room. All patients were operated on using the same radiologic equipment with or without IF., Results: The 146 patients who had undergone elective or emergent TEVAR with preoperative computed tomography angiography done in 1-mm-thick slices were divided into two groups: the IF group (98 patients), in which TEVAR was performed using intraoperative IF with the two-dimensional-3D registration method; and 48 controls without the use of IF. The IF group received a significantly reduced dose of contrast material, with a median of 70 mL (interquartile range [IQR], 50-101 mL) compared with controls receiving 104 mL (IQR, 69-168 mL; P < .001).Patients who underwent hybrid TEVAR had a significantly reduced procedure time under IF guidance (n = 25) compared with controls (n = 11; median, 162 minutes [IQR, 139-199 minutes] vs 213 minutes [IQR, 189-298 minutes]; P = .015). In addition, the intraoperative fluoroscopy time was reduced to 9 minutes (IQR, 6-13 minutes) vs 23 minutes (IQR, 12-45 minutes; P < .005). However, the radiation dose (dose-area product) was similar for the two groups (P = .37).In patients who underwent plain TEVAR (n = 74) without a carotid-subclavian bypass, the IF group needed significantly less contrast material (median, 64 mL [IQR, 43-81 mL]) compared with the control group (median, 98 mL [IQR, 60-180 mL]; P = .003), whereas intraoperative radiation exposition, procedure time, and fluoroscopy time did not statistically significantly differ between the two groups., Conclusions: The IF technology using the two-dimensional-3D registration method was associated with reduced intraoperative contrast material volume in performing TEVAR. IF seemed to shorten the operation and radiation times in the more complicated (hybrid) TEVAR cases. However, a prospective study is needed to look at the dose-area product, fluoroscopy time, and procedure time in a larger cohort of patients., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The aim was to calculate the costs of EVAR and FEVAR procedures in a European academic hospital by cost retrieval based on a subcohort with known detailed costs through application of the individually detailed calculated costs to the total study population and to correlate these with corresponding reimbursements., Methods: A cost analysis was performed on 25 FEVAR and 100 EVAR cases based on the detailed cost analysis of a group of patients treated in 2012 and 2013 by applying the costs based on costs per time unit within 4 subgroups: (1) uncomplicated EVAR, (2) complicated EVAR, (3) uncomplicated FEVAR, and (4) complicated FEVAR., Results: Thirty cases (19 EVAR and 11 FEVAR) treated in 2012 and 2013 were used to determine the individual detailed costs for the entire study group consisting of 100 EVAR and 25 FEVAR cases. There were 14 repeat operations within the 100 EVAR cases and 3 repeat operations within the 25 FEVAR cases. A total of 14 EVAR-treated patients were readmitted, as was one FEVAR patient. The costs of the endografts were the largest contributor to the overall costs, followed by the costs of the surgery itself and the stay in the ward. The costs of an uncomplicated EVAR procedure summed up at €12,090; a complicated EVAR procedure costs €13,956. An uncomplicated FEVAR procedure costs €34,807, and a complicated FEVAR procedure costs €36,695. The difference between median reimbursements received for the uncomplicated EVAR and FEVAR procedures was significant with €13,374 for uncomplicated FEVAR and €11,486 for complicated FEVAR in favor of the FEVAR group (P < 0.05)., Conclusions: No financial loss was calculated in any of the subgroups. The costs of the endografts were the largest contributor to the overall costs, followed by the costs of the surgery itself and the stay in the ward., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: This study aimed to evaluate the accuracy and the effectiveness of 2D-3D registration method of image fusion (IF) technology in endovascular aneurysm repair (EVAR)., Methods: We performed a review of our institutional endovascular aortic database of patients who had undergone EVAR between 2011 and 2015 before and after the installation of a 3D IF computed tomography system in our hybrid operating room., Results: The accuracy was assessed in 14 endovascular procedures and showed a median registration error of 1.8 mm at the origin of the right renal artery and 1.0 mm at the origin of the left renal artery and a complete visual accuracy in 42% of the cases. EVAR was performed using the intraoperative IF technique with a 2D-3D registration method in 105 patients (group IF), whereas 47 patients done without served as controls. The IF group had a significantly reduced amount of used contrast compared with controls with a median of 58 mL and P < 0.0001. The intraoperative exposition to radiation was similar between the 2 groups with a median dose area product of 2,343.7 cGy cm 2 in the IF group and 3,219 cGy cm 2 among the controls (P = 0.457). The radiation dose in the sub group IF (including patients operated by the 2 most experienced surgeons) was lower than that in sub controls (median, 1,087 cG cm 2 vs. 2,705.3 cG cm 2 , P = 0.012). The procedure time and the time of intraoperative radiation did not differ between the study groups (P = 0.117 and 0.106, respectively), as did not fluoroscopy time in the sub group IF (median, 6.3 min, vs. 9.5 min, P = 0.067), but for the 2 most experienced surgeons, the procedural time was shortened when using IF (P = 0.002)., Conclusions: The 2D-3D registration method of IF guidance is accurate to delineate the vessels of interest and could help the execution of the EVAR procedures with a significantly reduced amount of contrast medium and also with reduced radiation and shorter procedural duration when surgeons are more familiar with EVAR and IF., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Purpose: To investigate the long-term outcomes of endovascular aneurysm repair (EVAR) and open surgical repair (OSR) of infrarenal abdominal aortic aneurysm in octogenarian patients and to compare them with the overall expected survival based on a sex- and age-matched German population., Methods: A total of 177 patients (median age 82 years; 149 men) ≥80 years old (range 80-92) who underwent primary elective repair of an infrarenal aortic aneurysm (≥5 cm) between 1998 and 2015 were identified in a database search. Two groups of patients were formed based on the type of procedure: 131 EVAR patients (median age 83 years; 114 men) and 46 OSR patients (median age 82 years; 35 men)., Results: The median follow-up was 5 years for the OSR group and 4.5 years for the EVAR group. Kaplan-Meier analysis showed no significant difference in survival between the EVAR and OSR groups at 78 months. The observed survival of all study patients was not statistically different from the expected survival of a sex- and age-matched German population, which was true separately for women and men., Conclusion: The patients in this study seemed to reach normal life expectancy in comparison to the age- and sex-matched general population with a similar cumulative survival in both study groups over 5 years of follow-up.

Objective/background: To investigate the prevalence of bovine arch (BA) among patients with type A and B aortic dissection, and to provide insight into the implication of this variation on the outcome of patients with acute or subacute type B aortic dissection (a/sTBAD)., Methods: This retrospective cohort analysis includes patients with a/sTBAD admitted between January 2006 and December 2016. Computed tomographic angiograms (CTAs) of patients referred because of type A aortic dissection were also re-evaluated with regard to the presence of BA. As a control group, 110 oncological patients who had undergone a chest CTA for disease staging during the study period were enrolled. A total of 154 patients with a/sTBAD and 168 with type A aortic dissection were identified during the study period., Results: An overall prevalence of 17.6% for BA variants was revealed. The comparison between patients with aortic dissection and the control group showed no statistically significant difference in BA prevalence (17.7% vs. 17.3%; p = 1.0). No statistically significant difference in BA prevalence was observed when comparing patients with type A aortic dissection with those with type B aortic dissection (16.6% vs. 18.8%; p = .66). During a median follow-up period of 27.8 months, 30 patients died. The mortality rate among patients presenting a BA variant was 34.5%, whereas among patients without, it was 16.0% (p = .04). Multivariate analysis revealed the presence of a BA as an independent predictor of mortality (adjusted odds ratio 3.4, 95% confidence interval 1.2-9.8)., Conclusion: The BA should be considered as a predictor of the outcome for patients with type B aortic dissection., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: The aim of this study was to provide a review of the literature on the use of chimney graft (CG) technique in treating arterial diseases of the aortic arch and to extrapolate conclusions by summarizing the reported outcomes in a meta-analysis., Methods: An extensive electronic search was made using PubMed/MEDLINE, Science Direct Databases, and the Cochrane Library. Included in this meta-analysis were all papers published up to February 2016 on endovascular chimney technique in the arch vessels with or without adjunct extra-anatomic debranching, in any language, providing data about at least one of the essential outcomes: early and late type I endoleak, 30-day mortality rate, development of perioperative stroke, patency, and retrograde aortic dissection., Results: Of the 478 reports yielded by the electronic search, a total of 11 publications (on 373 patients and 387 CGs) fulfilled the inclusion criteria and were included in this study. The overall estimated proportion of technical success was 91.3% (95% confidence interval [CI], 87.4%-94.0%). Of the 373 patients, 26 (7%) experienced a type Ia endoleak in the perioperative period. The overall estimated proportion of early type Ia endoleak was 9.4% (95% CI, 6.5%-13.4%). Among the 10 studies that provided data, a retrograde type A dissection was observed in 2 of 351 patients, resulting in an overall estimated proportion of 1.8% (95% CI, 0.8%-4.0%). The pooled 30-day mortality rate was 7.9% (95% CI, 4.6%-13.2%). The pooled estimation for reintervention was 10.6% (95% CI, 5%-21%); for major stroke, 2.6% (95% CI, 1.3%-5.0%); for early patency, 97.9% (95% CI, 95.8%-99%); and for late patency, 92.9% (95% CI, 87.3%-96%)., Conclusions: Treatment of aortic diseases involving the aortic arch poses a great challenge. The CG technique has been applied as an alternative treatment option. This meta-analysis shows that endovascular repair of aortic arch disease using a CG technique in the aortic arch vessels is technically feasible and effective but not without major risk of complications., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The purpose of the present study was to compare the long-term survival in matched cohorts of patients with infrarenal abdominal aortic aneurysm (AAA) undergoing an elective open repair (OR) or an endovascular aneurysm repair (EVAR)., Methods: Patients with a primary elective repair of an infrarenal aortic aneurysm between 1998 and 2006 were identified in a retrospective review of our single-center database. EVAR and OR patients were matched with respect to age, gender, renal disease, tobacco use, hypertension, chronic obstructive pulmonary disease, and coronary artery disease. The primary end points were the early mortality and all-cause mortality during follow-up., Results: A total of 465 patients with elective infrarenal aortic aneurysm repair were identified in the database. The EVAR and OR patients were matched according to the above-mentioned characteristics, and finally, 108 patients were included in each group. The early mortality encountered was only one death in the open group (P = 0.316). The Kaplan-Meier survival analysis by the log-rank test showed no difference in cumulative survival between OR group and EVAR group (P = 0.458). Seventeen reinterventions (16.7%) in the EVAR group vs. 7 (6.5%) in the OR group (P = 0.018) were necessary during follow-up., Conclusions: OR and EVAR can be performed safely for elective treatment of AAA. The reintervention rate is, as expected, significantly higher in the EVAR group, but the long-term survival remains equal in both groups., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms., Methods: The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow-up., Results: A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4-years of follow-up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow-up. At 4 years, 38 out of 39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4-year follow-up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae., Conclusions: The INCRAFT® AAA Stent-Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device-related events through 4 years of follow-up.

Introduction: Re-interventions are still the Achilles' heel of endovascular aneurysm repair (EVAR). Ectatic common iliac arteries (CIA) can be treated with flared iliac limbs but a dilated artery used as sealing zone could increase the risk of a late type 1b endoleak. The aim of the present analysis was to evaluate the risk of late type 1b endoleak after EVAR in patients with CIA limbs ≥20 mm compared with those <20 mm., Methods: A retrospective analysis was performed of patients treated by EVAR at the study institution between 2006 and 2012, including patients with available information about the type of iliac stent grafts and a minimum follow-up (FU) of 3 years with contrast enhanced CT, or those that had developed a type 1b endoleak earlier. The cohort was divided into two groups: Group I included iliac limbs with a distal diameter <20 mm, and Group II included all iliac limbs with a distal diameter ≥20 mm., Results: Of 692 limbs (346 patients), 239 limbs (34.5%) from 129 patients were included in the analysis. Mean CT FU was 53 months, 178 had an iliac stent graft diameter <20 mm (Group I), and 61 a diameter of ≥20 mm (Group II). Mean oversizing for iliac limbs was 17.2% (IQR 14) and there was no case of immediate type 1b endoleak. For the whole group, 18 type 1b endoleaks occurred during FU (7.5%) after a mean of 37.7 months (range 4-96). Eleven of 61 (18%) iliac limbs in Group II developed a type 1b endoleak during FU in contrast to 7/178 (3.9%) in Group I (OR 5.3, 95% CI 1.98-14.59, p = 0,001). The ROC curve analysis indicated a limb diameter of 19 mm as a cutoff value for a higher probability of developing a type 1b endoleak., Conclusion: Patients treated with iliac limbs ≥20 mm had a fivefold higher risk of late (mean 37 months) type 1b endoleak compared with patients treated with a distal iliac limb diameter <20 mm., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Background: This study aims to examine the relationship between weather changes (atmospheric pressure and temperature) and incidence of rupture of abdominal aortic aneurysm (AAA)., Methods: All patients with ruptured infrarenal AAA and who were referred to our institution between August 1998 and August 2015 were prospectively entered into a database of which a retrospective review of a ruptured AAA was performed. The needed information about the daily atmospheric pressure and air temperature could be extracted from the meteorological unit in Cologne., Results: During the study period (6,225 days), a total number of 154 patients with confirmed ruptured AAA were identified. Basic patients' characteristics are tabulated. The mean daily atmospheric pressure during the study was 1,004.04 ± 8.79 mBar ranging from 965.40-1031.80 mBar. The mean atmospheric pressure on the days of rupture was 1,004.03 vs. 1,004.68 on those days when no rupture occurred (P = 0.34). The mean atmospheric pressure on the day of rupture and that on the preceding day was not significantly different (1,004.78 vs. 1,005.44 with P = 0.13). The air temperature (10.62 ± 6.25 vs. 10.77 ± 6.83°C, P = 0.787) was equally distributed between days of rupture events and control days., Conclusions: The present study could not show a significant association between the monthly and seasonal difference in atmospheric pressure and the prevalence of AAA rupture as it has been supposed by previous studies., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to investigate the 1-year safety and efficacy of a new iliac side-branched device (IBD) for revascularization of the hypogastric arteries., Methods: Patients receiving the E-liac (Jotec GmbH, Hechingen, Germany) side-branched device at six German vascular centers either as a stand-alone procedure or in combination with abdominal aortic aneurysm exclusion were included in a prospectively created data bank. Collected data were analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) patency., Results: Between January 2012 and January 2015, a total of 70 patients (69 men [98.6%]) with a median age of 74 years (range, 51-87 years) were consecutively treated; 66 patients had aneurysmatic disease of the iliac arteries, 2 patients had a para-anastomotic aneurysm after aortobi-iliac reconstruction, and another 2 patients had a type Ib endoleak after endovascular aneurysm repair. A total of 82 IIAs were revascularized, 12 bilaterally. Technical success was achieved in 100% (82/82) of the revascularized IIAs. All IBDs were patent at the end of the procedure. No instances of myocardial infarction, stroke, conversion to open repair, mesenteric or spinal cord infarction, or buttock necrosis were observed. There was one perioperative death (1.4%) in a 70-year-old patient with intraoperative gastrointestinal bleeding leading to multiple organ failure, which resulted in the patient's death on the fifth postoperative day. Within 30 days, one symptomatic occlusion of a treated common iliac artery (CIA) was observed. In two other patients, an asymptomatic kinking of the CIA segment of the IBD was revealed in the predischarge follow-up duplex ultrasound examination and corrected with relining. Median follow-up was 12 months (range, 6-16 months). One patient was lost during the follow-up period. Survival at 1 year was 98.5% with all IIAs remaining patent, whereas two CIA and two external iliac artery limb occlusions occurred. According to life-table analysis, the freedom from occlusion in a patient was 92% at 1 year, and freedom from type I endoleak was 87% at 1 year., Conclusions: This first ever 1-year study reports the results with the new E-liac device and shows that it can be safely applied for the treatment of aortoiliac aneurysmatic disease with low reintervention rates and high patency rates. Long-term data are needed to confirm the durability of the device., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

A persistent sciatic artery is a very rare vascular anomaly with an estimated incidence of 0.025-0.06% and with less than 200 described cases in the literature. During early embryonic development, the sciatic artery delivers the major blood supply to the lower limb and usually disappears when the superficial femoral artery has developed properly. The usual form of presentation in adults is the aneurysmal degeneration of the sciatic artery or less frequently with another complication (thrombosis, embolism, neuralgia). We describe three cases of a complete sciatic artery (two cases are bilateral and one is unilateral) associated with lower limb ischemia caused by embolism from the aneurysmal degeneration of the sciatic artery at the buttock level in two cases and atherosclerotic degeneration of the lower limb arteries in the third case. We also describe two combined therapy methods consisted of limb revascularization with vein-graft bypass and endovascular embolization of the aneurysm with vascular plug in the first case, in the second case combination of localized thrombolysis therapy followed by a bypass and an ilio-pedal vein bypass in the third one. And we discuss later the reported clinical outcome after surgical and endovascular treatment of this anomaly in the literature., (© The Author(s) 2015.)

Background: The endovascular aneurysm repair (EVAR) is becoming the preferred method to treat an aortic aneurysm with its better short-term postoperative mortality and morbidity rates in comparison with the open repair. A main drawback of this method is the need to use a nephrotoxic iodinated contrast medium to visualize the aorta and its side branches., Case Report: An 83-year-old man with an asymptomatic infrarenal aortic aneurysm of a 51-mm diameter accompanied by a 42-mm aneurysm of the left common iliac artery was treated with combined fenestrated EVAR (FEVAR) and iliac side branch stent graft (ISBG) under guidance of image fusion (IF) without the intraoperative use of iodinated contrast agent., Conclusions: Complex EVAR (FEVAR and ISBG) using computed tomography angiography IF is feasible and together with the use of CO2 angiography may help to abstain from need to nephrotoxic contrast medium., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: We investigated the role of mannose-binding lectin (MBL) variant genotypes in patients with significant carotid restenosis after carotid endarterectomy (CEA) and who underwent a revision CEA., Methods: This was a cross-sectional analysis of 97 patients enrolled between 2001 and 2013. Three groups were investigated: group A included patients with internal carotid artery restenosis, group B included patients without restenosis after CEA, and group C included patients with peripheral arterial disease but without any signs of a carotid stenosis. Venous blood samples were drawn for the genotyping for MBL2 by polymerase chain reaction and for the determination of the MBL serum concentration by enzyme-linked immunoabsorbent assay., Results: The serum concentration of MBL was higher in patients with the normal genotype than in those with the genotype variants of MBL (95% confidence interval, 272.8-1008.7 μg/L; P = .001). There was no statistically significant difference among groups A, B, or C with respect to the presence of a variant genotype. Similarly, there was no significant gender difference regarding the presence of a variant genotype (P = .325)., Conclusions: The presence of a variant genotype of the MBL2 gene (and the correspondingly lower serum concentration of this molecule) was not correlated with the development of carotid restenosis after CEA beyond a follow-up of 12 months., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms., Methods: From March 2010 to June 2011, the INNOVATION prospective multicenter trial involving six centers in Europe enrolled and treated 60 asymptomatic patients (95% male; mean age, 74.4 ± 6.9 years) with the INCRAFT System. Main inclusion criteria included proximal aortic neck length of 15 mm or more with a diameter up to 27 mm; distal iliac landing zones with a length greater than 10 mm and a diameter between 9 and 18 mm; and aortic bifurcation >18 mm in diameter and access vessels large enough to accept the 14F outer diameter of the delivery system. The primary end point was technical success at 1 month; 2-year safety end points included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks, and maintenance of device integrity through 2 years of follow-up. Study oversight was provided by a Data Safety Monitoring Board with event adjudication by a Clinical Events Committee and imaging analysis by an independent core laboratory., Results: Of 60 successfully treated patients, two did not come back for their 1-month evaluation but remained enrolled in the study; 56 were evaluated at 1 year and 52 at 2 years. Of the 58 patients, 56 met the 1-month primary safety and effectiveness end point (97%; 95% confidence interval, 88%-100%). All patients were free from aneurysm enlargement through 2 years. There were no type I or III endoleaks at the 2-year time point. All-cause mortality at 2 years was 11.5%, and no death was device or procedure related. In total, three patients required a postprocedure intervention, two to repair a type I endoleak and one for limb occlusion. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration and stent fractures in all patients., Conclusions: The INCRAFT AAA Stent Graft System provides a durable solution for patients with abdominal aortic aneurysms, with a low frequency of device-related events through 2 years of follow-up., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aim: Endovascular repair has surpassed open surgical treatment as the most common procedure in patients with abdominal aortic aneurysms (AAA), yet its applicability remains limited to those with aortoiliac anatomy suitable for the introduction and deployment of the devices. The current study was performed to assess the safety and efficacy of INCRAFT® (Cordis Corporation, Bridgewater, NJ), an ultra-low-profile device for the treatment of AAA., Methods: The INNOVATION study is a first in human prospective, multicenter trial involving 6 centers in Europe. From March 2010 to June 2011 60 patients with asymptomatic AAA were treated with the INCRAFT® bifurcated Stent-Graft System. The main inclusion criteria were a proximal aortic neck of 15 mm or more in length and up to 27 mm in diameter; iliac landing zones greater than 10 mm in length and between 9 and 18 mm in diameter; an access vessel large enough to accept the 14F outer diameter of the delivery system; and an aortic bifurcation >18 mm in diameter. The primary endpoint was technical success at one-month; one-year safety endpoints included the absence of device- or procedure-related major adverse events; absence of type I or III endoleaks; and maintenance of device integrity through one year of follow-up., Results: Among 60 patients treated at six centers, the primary endpoint was met in 56 of 58 patients (97%; 95% CI, 88-100%) who came back for one month follow-up, two patients did not come back for their one month follow-up assessments but remained enrolled in the study. Fifty-six had one-year follow-up data showing 100% freedom from aneurysm enlargement with absence of type I and III endoleaks in all patients. There were two patients (3.6%) with a type Ia endoleak which was successfully treated with secondary endovascular intervention in both occasions. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration, stent fracture, or limb occlusion. A single patient (1.8%) died within one year due to sepsis unrelated to the AAA., Conclusion: The results of the INNOVATION study with the INCRAFT® Stent-Graft are encouraging, with satisfactory clinical outcome and device durability through one-year of follow-up. The INCRAFT® device is a novel ultra-low-profile endograft that holds promise to broaden the patient population eligible for endovascular aneurysm repair.

Objective: This multicenter, prospective, nonrandomized trial was undertaken to evaluate the first-in-human experience with the INCRAFT endograft (Cordis Corporation, Bridgewater, NJ), an ultralow-profile trimodular bifurcate device for the repair of abdominal aortic aneurysms., Methods: Patients with asymptomatic infrarenal abdominal aortic aneurysms were eligible for enrollment in the trial. Anatomic eligibility criteria included a proximal aortic neck at least 15 mm in length and up to 27 mm in diameter, and an aortic bifurcation ≥18 mm in diameter. Iliofemoral access vessels were required to be large enough to accept the 14F (4.7 mm) outer diameter of the delivery system. The primary efficacy end point was technical success, defined by successful device deployment during the conclusion of the procedure at the desired location without a type I, III, or IV endoleak. The primary safety end point was defined by the absence of a type I, III, or IV endoleak or a device- or procedure-related major adverse event at the 1-month follow-up point., Results: Over a 16-month period divided into two different phases, 57 men and three women with a mean age of 74.4 ± 6.9 years were enrolled at three German and three Italian centers. A percutaneous approach was used in 36 patients (60%). Successful graft deployment at the desired location was achieved in 59 patients (98%). A single patient had successful deployment of the device although it was located more distally than planned. Technical success was achieved in 54 patients (90%); one patient had a type I endoleak, four had type IV endoleaks, and one had an endoleak of undetermined origin. The primary safety end point was met in 56 of the 58 patients (97%) with complete core laboratory data at 1 month; two patients had type I endoleaks. There were no type III or IV endoleaks and no device or procedure-related major adverse events at 1 month. No limb thromboses or stent fractures were noted on postoperative imaging studies and no patient required rehospitalization, a secondary procedure, or open surgical conversion through 1 month of follow-up., Conclusions: The INCRAFT endograft device holds promise as an innovative alternative to currently marketed devices and broadens the eligibility for endovascular aneurysm repair. More definitive observations will be generated as longer-term data from this trial become available., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Case and single center reports have documented the feasibility and suggested the effectiveness of endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs), but the role and value of such treatment remain controversial., Objective: To clarify these we examined a collected experience with use of EVAR for RAAA treatment from 49 centers., Methods: Data were obtained by questionnaires from these centers, updated from 13 centers committed to EVAR treatment whenever possible and included treatment details from a single center and information on 1037 patients treated by EVAR and 763 patients treated by open repair (OR)., Results: Overall 30-day mortality after EVAR in 1037 patients was 21.2%. Centers performing EVAR for RAAAs whenever possible did so in 28% to 79% (mean 49.1%) of their patients, had a 30-day mortality of 19.7% (range: 0%-32%) for 680 EVAR patients and 36.3% (range: 8%-53%) for 763 OR patients (P < 0.0001). Supraceliac aortic balloon control was obtained in 19.1% +/- 12.0% (+/-SD) of 680 EVAR patients. Abdominal compartment syndrome was treated by some form of decompression in 12.2% +/- 8.3% (+/-SD) of these EVAR patients., Conclusion: These results indicate that EVAR has a lower procedural mortality at 30 days than OR in at least some patients and that EVAR is better than OR for treating RAAA patients provided they have favorable anatomy; adequate skills, facilities, and protocols are available; and optimal strategies, techniques, and adjuncts are employed.

Aneurysms of the inferior thyroid artery are rare. The natural course of these aneurysms seems to be unfavourable, why aneurysm exclusion is recommended in the literature. Open surgical repair is complex why endovascular exclusion seems to be an appealing alternative. We present a patient who developed dysphagia and respiratory distress caused by a ruptured aneurysm of the right inferior thyroid artery. Successful coil embolization of the aneurysm is described along with a review of the literature. Despite the very rare data of these aneurysms, all reported cases of endovascular treatment (n=3) showed favourable results, therefore aneurysm embolization seems to be a feasible and safe alternative to open surgery, especially in emergency cases.

Objectives: The aim of this study was to investigate if radiation therapy (RT) favorably modulates wound healing at vein graft anastomoses., Materials and Methods: Jugular vein grafts were sewn into carotid arteries in 32 rats which were randomly divided into two groups: RT (gamma source, 14 Gray, n=16) and control (C, sham irradiation, n=16). Grafts and adjacent arteries were analyzed at 2 (n=8) and 8 weeks (n=8) by histology, immunohistochemistry, and morphometry., Results: Although, RT did not reduce the overall occurrence of intimal hyperplasia, the distribution differed. RT led to a reduction of intimal hyperplasia in arterial segments (median: C: 41.873 microm2; RT: 6.452 microm2, p < 0.0007). In contrast, RT augmented intimal hyperplasia in vein grafts (median: C: 30.287 microm2; RT: 90.455 microm2, p < 0.014). Vein graft diameters after RT were enlarged (median: C: 2.098 microm; RT: 3.381, p < 0.031). Over 80% of the cells were of mesenchymal origin in both groups., Conclusions: RT reduced intimal hyperplasia in arterial segments. However, RT led to graft dilatation and increased intimal hyperplasia in vein grafts. RT did not favorably modulate the vascular wound healing response in this model.

Objectives: Photodynamic therapy (PDT) is a promising strategy to limit restenosis. PDT depletes the resident cells from the vessel wall without adventitial cell ingrowth. This study was undertaken to further explore the mechanisms by which PDT of matrix acts on key mechanisms in the development of restenosis., Materials and Methods: Control and PDT-treated collagen type-I matrix gels were prepared. Thereafter, untreated human fibroblasts were seeded on matrix gels (n=12). Fibroblast proliferation and invasive migration were quantified by calibrated phase contrast microscopy. Fibroblast bFGF and TGF-beta1 mRNA expression were analyzed using a quantitative real-time reverse transcription polymerase chain reaction., Results: Fibroblast proliferation on PDT-treated matrix gels was reduced by 30 and 76% after 3 and 7 days, respectively (3 days: P

The balance between prostacyclin and thromboxane has been suggested to be of great importance for the maintenance of patency in veins. In order to investigate prostacyclin and thromboxane release, segments from the human saphenous veins were investigated in 53 patients. Twenty-seven patients (10 males, 17 females) underwent surgery for varicose veins. Twenty-six patients (14 nondiabetics, 12 diabetics) underwent surgery for lower limb ischemia (rest pain or gangrene) with use of the saphenous vein as arterial conduit. Vein segments were gently excised and perfused ex vivo for five 15 minute periods, with a balanced salt solution and determination of the stable degradation products 6-keto-PGF1 alpha and TxB2. Saphenous veins from patients with varicose veins had an initial prostacyclin release of 61 +/- 13 pg/mm2/15 min declining to 4 +/- 1 pg/mm2/15 min after 60 min (p < 0.001) and increasing after addition to arachidonic acid to 37 +/- 7 pg/mm2/15 min (p < 0.001). Segments from nondiabetic patients with lower limb ischemia did not differ from those of varicectomy patients, but diabetic segments had a significantly lower prostacyclin release than both these groups, 34 +/- 11 pg/mm2/15 min, 1 +/- 1 pg/mm2/15 min, and 7 +/- 5 pg/mm2/15 min, respectively (p < 0.05). The addition of arachidonic acid failed to increase the prostacyclin release in diabetics. Three patients from each group were studied regarding thromboxane release and there was almost no detectable thromboxane in any group. These findings suggest that diabetics have a lowered prostacyclin release from the saphenous vein and that the deficiency is at the cyclo-oxygenase level.(ABSTRACT TRUNCATED AT 250 WORDS)

Operative manipulation of blood vessels might lead to spasm, thereby destroying the endothelial cell function: the spasm can be prevented by the vasodilator papaverine. To study if this was mediated via the prostanoid pathway the following investigation was undertaken: canine jugular veins and carotid arteries were dissected with or without papaverine. Vessel segments were then perfused with Hank's balanced salt solution for five times 15 min. Prostacyclin was measured as the stable degradation product 6-keto-PGF1 alpha and thromboxane as TXB2, by radioimmunoassay. Control arterial segments' 6-keto-PGF1 alpha release was initially 129.5 + 20.1 pg/mm2/15 min, and 29.7 + 10.4 after 60 min (p less than 0.05 vs initial value) and responded to arachidonic acid (AA) with an increase to 139.2 +/- 23.1 pg/mm2/15 min (p less than 0.05). Segments treated with papaverine had the same release as the controls. In venous segments there was a lower initial release (p less than 0.05) from segments given papaverine than from controls, but this was more likely an effect of papaverine on the assay. There was no difference in release of prostacyclin from segments given papaverine in the perfusate compared to controls when using 125I tracer. When using 3H tracer including absorption of free antigen to dextran coated charcoal, papaverine displaced the free tracer giving artificially low values. There was no effect of papaverine given intraoperatively on the TXB2 release, neither from arteries nor from veins. In another experiment the vessel wall tension was examined and the cyclooxygenase inhibitor diclofenac did not inhibit the vasodilating effect of papaverine.(ABSTRACT TRUNCATED AT 250 WORDS)

Prostacyclin release from endothelial cells in culture appears increased by the presence of plasma, but occurrence of a similar phenomenon in intact vessels has not been established. In the present investigation release of 6-keto-PGF1 alpha, the stable breakdown product of prostacyclin, was quantitated from canine veins perfused ex vivo for 15 minute periods, using three different perfusates: 1) Hank's balanced salt solution (HBSS), 2) 20% platelet poor plasma (PPP) derived from heparinized blood, in HBSS, and 3) 20% PPP in HBSS with added arachidonic acid (AA). No differences in initial 6-keto-PGF1 alpha release existed among the three perfusates. However, PPP and PPP + AA solutions were associated with lesser declines in release, than occurred with HBSS alone, these differences being statistically significant after 60 min of perfusion (p less than 0.05). When PPP derived from heparinized and citrated blood rather than from only heparinized blood was used, there was a significantly lower release of prostacyclin (p less than 0.05). The latter may be due to citrate binding of calcium. These data indicate that autologous plasma does not alter initial prostacyclin release from freshly harvested canine veins, but that it weakens the decline in release usually following prolonged periods of perfusion.

The effect of heparin, administered prior to vessel dissection and excision, on the luminal release of prostanoids from an excised vessel was assessed. Eight adult mongrel dogs underwent removal of the jugular vein and carotid artery on one side, followed by intravenous administration of heparin sodium (150 IU/kg) and subsequent removal of these same vessels from the contralateral neck. The excised vessels were perfused in an ex vivo system with Hanks' balanced salt solution for five consecutive 15-min periods. Prostacyclin release (measured as 6-keto-PGF1 alpha) and thromboxane A2 (measured as thromboxane B2) release into the perfusate were quantitated by radioimmunoassay. Vessel segments were studied with and without first period thrombin stimulation (2 U/ml) and with arachidonic acid (4 micrograms/ml) stimulation during the last perfusion period. Vein segments following heparin administration exhibited greater prostacyclin production than veins not exposed to heparin. This effect did not occur in arteries. Heparin did not influence thromboxane A2 release. Luminal endothelial cell coverage was not affected by the presence or absence of heparin. Thus heparin anticoagulation prior to dissection and excision of a vein, may enhance early preservation of its endothelial cell function as evident by increased luminal release of prostacyclin.

The influence of pressure, flow, and pulsatility on the release of prostacyclin (measured as 6-keto-PGF1 alpha) and thromboxane (measured as TxB2) was assessed in canine jugular veins perfused ex vivo with Hanks' balanced salt solution for five consecutive 15-minute periods. Control segments were perfused at 7 mm Hg with nonpulsatile flow at a rate of 90 ml/min, whereas experimental segments were perfused with pulsatile flow as well as nonpulsatile flow at pressures of 50 or 100 mm Hg and flow rates of 60 or 130 ml/min. Prostacyclin release from control segments during the first 15-minute period was 49.5 +/- 7.4 pg/mm2/15 min, which declined to 13.9 +/- 2.5 pg/mm2/15 min after 60 minutes (p less than 0.002). Arachidonic acid stimulation during the last 15-minute perfusion period increased the release to 56.1 +/- 9.4 pg/mm2/15 min (p less than 0.002). Thromboxane release from control segments was initially 4.4 +/- 1.2 pg/mm2/15 min, which declined to 0.8 +/- 0.2 pg/mm2/15 min after 60 minutes (p less than 0.002), and subsequently increased with arachidonic acid stimulation to 1.3 +/- 0.1 pg/mm2/15 min (p less than 0.01). In contrast to control perfusion conditions, changes in nonpulsatile flow rates did not affect prostacyclin release, whereas thromboxane release was lower when perfused at 60 ml/min. Pressures of 50 and 100 mm Hg increased the initial release of prostacyclin. Similarly, pulsatile flow enhanced prostacyclin release at both low and high pressures, being more pronounced with the latter.(ABSTRACT TRUNCATED AT 250 WORDS)

Certain experimental conditions are known to influence the release of prostacyclin and thromboxane from the vessel wall. The specific effects of altered pulsatility, pressure, and flow rate on intraluminal release of 6-keto-PGF1 alpha and thromboxane B2 were assessed in canine arteries perfused ex vivo for five 15 min periods with arachidonic acid (AA) added during the last period. Control arteries were perfused at 100 mmHg with pulsatile flow of 90 ml/min. Experimental arteries were perfused at 7, 50 and 200 mmHg with pulsatile flow of 90 ml/min, and at 100 mmHg pressure with pulsatile flow of 20, 60, 130 and 180 ml/min, as well as at 100 mmHg with 90 ml/min nonpulsatile flow. Perfusion pump rates of 44 and 96 beats/min were also assessed. The lowest perfusion pressure, 7 mmHg, resulted in a lesser initial release of prostacyclin compared to higher pressures, and there was a tendency to a higher release of prostacyclin with increasing pressures. There was also a tendency for a lesser response to AA in arteries perfused at 200 mmHg, perhaps due to endothelial cell damage. Nonpulsatile flow was associated with a decreased initial release of prostacyclin, and diminished release following addition of AA when compared to pulsatile flow. Altered flow rate elicited no difference in prostacyclin release, although there was a tendency towards a lesser release when perfused at 20 ml/min compared to 130 ml/min or 180 ml/min. Thromboxane release was decreased by nonpulsatile flow but was otherwise unaffected by the experimental conditions tested. It is concluded that pulsatility enhances release of prostacyclin from arteries.(ABSTRACT TRUNCATED AT 250 WORDS)

Intraluminal release of 6-keto-PGF1 alpha and TxB2 in ex vivo canine arteries and veins was assessed during five consecutive 15-min periods using static incubation and physiologic perfusion techniques. Arterial segments were perfused with 90 ml/min pulsatile flow at 100 mm Hg and vein segments with 90 ml/min nonpulsatile flow at 7 mm Hg. During the final 15-min period vessels were stimulated with arachidonic acid (AAS). Perfusion of vein segments caused a higher release of 6-keto-PGF1 alpha during the first 30 min (P less than 0.05) and following AAS (P less than 0.05) than did static incubation. Perfused arterial segments exhibited a higher release than did incubated segments of 6-keto-PGF1 alpha for 45 min (P less than 0.01) as well as following AAS (P less than 0.01). TxB2 release was higher during the entire observation period in perfused arteries and veins compared to incubated vessels (P less than 0.01 and less than 0.05, respectively). There was no correlation between the amounts of 6-keto-PGF1 alpha or TxB2 released when comparing values obtained by one technique to values obtained by the other (P greater than 0.1). These data suggest that flow related shear stress alters vascular prostanoid production, and that such should be accounted for when interpreting results of studies on prostacyclin and thromboxane release from intact vessels.

Regulation of prostanoid release from ex vivo perfused vessel segments is not fully understood. A series of perfusion experiments were performed with canine arteries and veins to define certain regulatory phenomena. Arteries were perfused with pulsatile flow of 90 ml/min at a pressure of 100 mmHg, and veins with nonpulsatile flow of 90 ml/min at a pressure of 7 mmHg. Segments were perfused with Hanks' balanced salt solution for five 15-min periods with the perfusate exchanged after each study period. With onset of perfusion, there was an initial burst of prostacyclin release to 127 +/- 40 pg/mm2, declining to 32 +/- 10 pg/mm2 after 60 minutes (p less than 0.005). If perfusion continued for 5.5 hours, there was a stable release period between 1 and 3 hours, followed by a very slow decline. At that time addition of arachidonic acid (AA) increased prostacyclin release six-fold (p less than 0.01). Vessels perfused for 1 hour and then rested for another hour, responded to reperfusion at the second onset of flow with a two-fold increase in prostacyclin release (p less than 0.01). Vessels perfused with thrombin, bradykinin or AA (either added to each perfusate or only to the last perfusate) exhibited greater prostacyclin release than did control segments. Release of thromboxane steadily declined with time in all parts of the study, and only increased with the addition of AA to the perfusate.(ABSTRACT TRUNCATED AT 250 WORDS)