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Purpose: Patients with a hyperangulated (>60°) proximal aortic neck and at high risk of open surgery have been treated with endovascular aortic repair (EVAR). However, long-term outcomes are not well reported. The aim of this study is to compare the technical and clinical success of EVAR in angulated (45°-60°) and hyperangulated (>60°) proximal neck angulation., Materials and Methods: The data of all consecutive patients undergoing EVAR treated between November 2007 and February 2020 were collected. A retrospective analysis of this prospective database was performed. The primary measure outcome was technical and clinical success. In addition, we evaluated sack evolution, type IA endoleak, secondary procedures, aneurysm rupture, mortality, aneurysm-related mortality, and migration., Results: In all, 246 of 1353 EVAR patients presented with an angulation of the proximal neck >45°, 130 patients presented with an infrarenal angulation >60°, while 116 patients had an angulation between 45° and 60°. Patients with a hyperangulated infrarenal aortic neck were significantly more often women (8.6% vs 26.9%), older (73.9 vs 76.7 years), and had less often diabetes mellitus (20.7% vs 10.8%). Suprarenal neck angulation and reversed tapered neck were significantly more frequent in the hyperangulated group so that propensity scores were generated using these anatomical parameters to create a matched cohort group. No significant differences in technical (87.9% vs 94.8%) and clinical success (66.4% vs 69.8%) were observed. After a mean clinical follow-up of 58.9 months significantly more secondary procedures were performed in the hyperangulated group (23.3% vs 12.9% p=0.04); however, neck-related secondary procedures were comparable (1.7% vs 6.0%; p=0.09). Also, all-cause and aneurysm-related mortality, sack evolution, type IA endoleak, aneurysm rupture, and migration were comparable for both groups., Conclusion: Compared with less angulated proximal aortic neck, hyperangulated neck anatomy did not reduce the technical and clinical success of EVAR but increased the risk of secondary procedures. In patients who are not good candidates for open surgery, EVAR is a reasonable alternative.

Background: A critical step in the endovascular treatment of complex aortic aneurysms is the cannulation and stenting of renovisceral vessels, especially in cases with a complex anatomy or atherosclerotic lesions. This study aimed to demonstrate the results of renovisceral vessel cannulation using a steerable sheath in fenestrated or branched endovascular aortic procedures (FB-EVAR)., Methods: Patients undergoing elective FB-EVAR for asymptomatic thoracoabdominal or juxtarenal aneurysm at a single tertiary referral center from 2016 to 2019 were included in this study. Underlying pathologies, renovisceral target vessels (TV), technical success (TS), freedom from reintervention (FFR), and TV patency were assessed. Target vessels were categorized as challenging or nonchallenging TV., Results: Fifty-three patients (median age 73 (Q1, Q3 (68-80)); 43 male (81%)) who underwent elective FB-EVAR were included. Indications comprised thoracoabdominal aneurysms (Crawford I-IV) (n = 26; 49%), juxtarenal aneurysms (n = 23; 43.5%) and penetrating aortic ulcers (PAU) (n = 4; 7.5%). Two patients (4%) had prior open aortic surgery, and three patients (6%) had undergone a failed standard EVAR before. Of the 196 treated TV, 131 (67%) were categorized as challenging. Cannulation was successful in 194 of 196 vessels (99%). A total of 3 TV (1.5%) showed periprocedural complications. No significant difference was found in the rate of intraoperative complications between challenging versus nonchallenging TV (P = 0.457). One patient died within 30 days of the procedure (1.9%). No stroke or intestinal ischemia occurred. After 12, 24, and 36 months, the survival rate was 87%, 87%, and 81%, respectively. Primary patency after 12 months was 98.6%, and 97.9% of vessels remained FFR during follow-up., Conclusions: Transfemoral, retrograde cannulation of renovisceral vessels using a steerable sheath is feasible and safe and provides good mid-term results, especially in cases with challenging renovisceral vessels. The potential complications of antegrade vascular access can be avoided., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Abdominal aortic aneurysms can either be treated by open surgery or endovascular repair. In both cases, prostheses are implanted to prevent potentially lethal aortic ruptures., Objectives: Studies seeking to identify the optimal treatment came to diverging conclusions. The goal of this article is to shed light on the discussion of which treatment option is to be preferred., Materials and Methods: This article summarizes the relevant studies on elective and emergency abdominal aortic aneurysm repair. The presented studies are discussed, and results are interpreted and compared., Results: While most studies indicate lower short-term mortality rates in endovascular aneurysm repair (EVAR), mortality rates converged in multiple trials and even showed a lower mortality rate for open repair in mid-term analyses. Most recent studies indicate long-term equivalence in terms of mortality and a higher rate of secondary interventions in EVAR patients., Conclusions: The current body of literature indicates no real advantage of one therapy over another. The choice of therapy should depend on anatomic, clinical, and logistic criteria., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: In the last decade, new stent graft designs have evolved to tackle challenges in thoracic endovascular aortic repair. A specific focus on access vessel issues has led to the introduction of new low-profile endograft designs for most of the major products., Objective: The main objective of this article is to provide an overview of the available publications on new stent graft designs., Materials and Methods: Assessing recent publications on the major reiterations of thoracic endografts, benefits and drawbacks are discussed., Results: Recent reiterations of major endografts for thoracic aortic endovascular repair have focused mainly on the development of low-profile devices. Through alterations on graft fabric as well as stent material and design, delivery systems were reduced in profile, thus, reducing access vessel complications or enabling an endovascular procedure altogether. Long-term data are already available for one endoprosthesis. Other refinements include in situ adaptation of the stent graft to the aortic arch curvature as well as the option of staged deployment to allow more precision and reduce manipulation close to supra-aortic branches., Conclusions: Especially in the case of low-profile endografts, preliminary and long-term results of access vessel complications are promising. In order to draw final conclusions as to how durable the results of aneurysm exclusion are, more long-term studies are warranted., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Purpose: We hypothesized that extending the proximal landing zone with the chimney technique could be beneficial in patients with a hyperangulated proximal aortic neck, defined as more > 60 degrees., Material and Methods: We retrospectively analyzed the outcome of prospectively collected data of patients treated by endovascular aneurysm repair (EVAR) for infrarenal aortic aneurysm with a hyperangulated proximal aortic neck. In all, 104 out of 130 patients were treated without (Group A) and 24 with the chimney endovascular aortic repair (ChEVAR, Group B). Primary outcome was technical and clinical success according to the reporting standards of the Society of Vascular Surgery., Results: The use of the chimney technique was associated with a significantly longer operation duration (167 vs. 93 min, p < .001), longer fluoroscopy time (44 vs.30 min, p = < .001), and larger amount of contrast medium used (149 vs. 127 ml, p = .03) but did not significantly improve technical (79.2% vs. 87.7%) and clinical success (54.2% vs. 68.9%). Aneurysm-related mortality was higher in group B (8.3% vs. = 0%, p < .001). Type IA endoleak was high in both groups at completion angiography (11.3% in Group A vs. 12.5% in Group B) and at follow-up (10.4% in Group A vs. 4.5% in Group B) without significant difference between the groups., Conclusions: Our data did not show a benefit of the primary use of the chimney technique in patients with a hyperangulated and short neck, although more studies are required to support this conclusion. Other strategies or new technologies are required for improving EVAR results in aneurysm patients with severe angulated proximal and short neck.

Objectives: The results of branched endovascular repair of thoracoabdominal aneurysms are mainly dependent on durability of the graft used. The purpose of this study was to evaluate postoperative aortic main body and bridging stent-graft remodeling, and their impact on bridging stent-graft instability at one year., Methods: Computed tomoangiographies of 43 patients (43 aortic main body mated with 171 bridging stent-grafts) were analyzed before and after branched endovascular repair as well as after a follow-up of 12 months. Primary endpoint was aortic main body remodeling (migration >5 mm, shortening >5 mm, scoliosis >5° or lordosis >5°). Shortening was defined as a reduced length in the long axis, scoliosis as left-right curvature, and lordosis as antero-posterior curvature. Aortic main body remodeling, aneurysm sac changes, and bridging stent-graft tortuosity were evaluated to study their correlations and the impact on the bridging stent-graft instability., Results: At 12 months, aortic main body remodeling was observed in 72% of the cases, migration in 39.5% (mean 5.21 mm), shortening in 41.9% (mean 5.79 mm), scoliosis in 58.1%, (mean 10.10°), lordosis in 44.2% (mean 5.78°). Migration, shortening, and scoliosis were more frequent in patients with larger aneurysms ( p  = .005), while scoliosis was significantly more frequent in type II thoracoabdominal aneurysm ( p  = .019). Aortic main body remodeling was significantly associated to bridging stent-graft remodeling (r: 0.3-0.48). The bridging stent-graft instability rate was 9.3%. Despite a trend toward significance ( p  = .07), none of the evaluated aortic main body and bridging stent-graft changes were associated with bridging stent-graft instability at 12 months., Conclusions: Aortic main body remodeling is frequent especially in large and extended thoracoabdominal aneurysm aneurysms. Aortic main body and bridging stent-graft remodeling was significantly correlated. While these geometric changes had no significant impact on bridging stent-graft instability at one year, a close long-term follow-up after branched endovascular repair could predict bridging stent-graft failures.

Purpose: Bridging stent stability is crucial for efficacy and safety of branched aortic endovascular repair (bEVAR) of thoracoabdominal aortic aneurysms (TAAAs). In this study, we assess the performance of the new Viabahn Balloon-Expandable endoprosthesis (VBX) in bEVAR. Based on our learning curve we give recommendations for a safe and effective use of the device., Materials and Methods: We prospectively collected the data of patients with TAAAs undergoing bEVAR between December 2017 and December 2019. All patients with implantation of at least 1 VBX stent-graft as bridging stent were included in our single-center analysis. Demographic, comorbidity, and computed tomography angiography (CTA) data of 112 patients were retrospectively evaluated. Primary endpoint was a composite of branch-related technical success and freedom from target vessel instability. Secondary endpoints were clinical and ongoing clinical success., Results: Primary endpoint: technical success was achieved in all patients (100%) with a freedom from target vessel instability of 96.3% after a median follow-up of 18 months. Overall mortality was 13.4% (n=15) and 13 patients underwent secondary interventions, 12 of them are still alive and 1 suffered from aneurysm sac expansion, consequently an ongoing clinical success of 75.9% was reached. After modification of the implantation technique during the course of the study by selecting longer stent lengths after accurate estimation of vessel curvature and expected adaptation of the flexible endoskeleton to the specific anatomical conditions, no type Ic endoleaks were observed in the last 70 cases., Conclusions: The VBX stent-graft can be safely used as bridging stent for branched thoracoabdominal repair. However, learning curve should be considered to avoid type Ic endoleak and edge stenosis. Based on this experience longer landing zones and 2-step deployment of VBX are useful for successful bridging also of challenging target vessels.

Background: Durability of low-profile branched aortic stent-grafts (LPSG) in the treatment of patients with thoracoabdominal aortic aneurysms (TAAA) remains unclear. Objective of this study is to compare the outcomes of LPSG with standard profile branched aortic stent-grafts (SPSG)., Methods: Between January 2016 and January 2020, 225 consecutive patients with TAAA were treated by branched endovascular aortic repair (BEVAR). Twenty-four patients who were treated with a LPSG were compared to 24 patients who received SPSG as a control group. Control patients were selected according to aneurysm size (maximum aneurysm diameter) and extension (Crawford classification) as well as availability of adequate preoperative and postoperative CT-angiograms at 24 months. The primary endpoint was ongoing clinical success defined as successful implantation and freedom from aneurysm- or procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion or rupture and conversion. Secondary endpoints were radiological changes of the branched endograft (migration, shortening, scoliosis, lordosis, and fracture)., Results: After a median follow-up of 22.6 (LPSG) and 26.2 months (SPSG), no significant difference was found in terms of technical success (100% in both groups), late mortality (4.2% vs 0%), aneurysm diameter increase (4.2% in both groups) and reinterventions (25% vs 37.5%). Infection, thrombosis, aneurysm expansion or rupture and conversion were not observed. Radiological analysis of aortic graft remodeling showed no fracture and no significant migration, shortening, scoliosis and lordosis of the LPSG (6.1 mm, 7.5 mm, 12.8° and 6.1°) compared to SPSG (3.9 mm, 5.1 mm, 7.9° and 5.6°) after 2 years., Conclusion: The clinical and radiological findings of the present study showed no increased mortality and complications for the matched patients who underwent treatment with low-profile vs standard-profile BEVAR. This study provides preliminary evidence of safety and efficacy of low-profile branched endografts in patients with demanding iliac access vessels., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: Bridging stents undergo millions of cycles during respiratory movements of the kidneys throughout the patient's life. Thus, understanding the response of fabric and endoskeleton of the stent to cyclic loading over the time is crucial. In this study, we compare the fatigue resistance of the Viabahn Balloon-Expandable stent-graft (VBX) with the widely used Advanta V12/iCast under prolonged stress induction., Materials and Methods: A polyester test sheet with 10 fenestrations was used simulating a fenestrated endograft. Five 6×59 mm VBX stent-grafts and five 6×58 mm Advanta stent-grafts were implanted into 6×6 mm fenestrations. The stents were flared with a 10×20 mm PTA (percutaneous transluminal angioplasty) catheter and connected with a fatigue stress machine. All stent-grafts were evaluated by microscopy and radiography at baseline and after regular intervals until 50,000,000 cycles were applied, simulating a life span of approximately 75 months. Freedom from fracture (FF), freedom from initial polytertafluoroethylene (PTFE) changes (FIC), and from PTFE breakpoint (FBP, all-layer defect) were calculated., Results: Digital radiographic images did not show any stent fracture in both groups after 50,000,000 cycles. The VBX stent-graft was free from any all-layer defects at the conclusion of 50,000,00 cycles resulting in a significant higher FBP compared with Advanta V12 (50,000,000 vs 33,400,000; p<0.01). All-layer defects were observed only in the Advanta group. Two of 5 Advanta stents showed early penetration of the nitinol ring causing a defect of PTFE. Regarding FIC, there was no significant difference between the stents (3,400,000 in VBX vs 3,200,000 in Advanta)., Conclusions: In fatigue tests simulating respiration movements, VBX and Advanta V12 performed equally well in terms of fracture resistance and freedom from initial PTFE changes. VBX maintained freedom from PTFE breakpoint throughout the full 50,000,000 cycles. All-layers defects were detected only in Advanta and were mainly caused by penetration of the nitinol ring through the PTFE.

Objective: The aim was to identify predictors of adequate pre-operative sizing and planning for chimney endovascular aortic repair (ChEVAR) in order to reduce the incidence of persistent type Ia endoleaks (IaELs) without influencing chimney graft (CG) patency., Methods: Consecutive patients who underwent ChEVAR between January 2009 and December 2017 at a single centre were evaluated retrospectively. Included were patients treated with one device combination (Medtronic Endurant mated with Getinge Advanta V12/iCast) and placement of single or double CG. The freedom from IaEL related re-interventions and primary CG patency was estimated by measuring aortic stent graft oversizing (OS), total neck length (TNL), and a composite parameter (L-OS: TNL [mm] + OS [%])., Results: Seventy-three patients who underwent placement of 101 CGs (45 single, 28 double) met the inclusion criteria. The median radiological follow up was 25.5 (interquartile range [IQR] 12-48) months. Freedom from IaEL related re-intervention was achieved in 94.6% with a median OS of 38.5% (IQR 30%-44%, p = .004), TNL 19 mm (16-25 mm, p = .62), and L-OS 59 (51-65, p = .018). Primary CG patency was achieved in 95% of the cases with a median OS of 36% (29%-42%, p = .008), TNL 19 mm (15.5-26 mm, p = .91), and L-OS 57 (50-64, p = .005). By using the receiver operating characteristic curve, an optimal cut off to prevent IaEL related re-interventions was identified by an OS of 30% (p < .001; L-OS 55, p = .006) and to avoid CG stenosis/occlusions by OS 42% (p < .001; L-OS 65, p < .001). In multivariable analysis, aortic endograft OS was the only independent parameter preventive for IaEL related re-intervention (odds ratio, 0.78; 95% confidence interval, 0.61-0.99)., Conclusion: With the Endurant-Advanta V12/iCast combination, an aortic stent graft OS of at least 30% (range 30%-42%) should be used to avoid type Ia endoleaks and likewise to ensure CG patency., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Purpose: To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy., Materials and Methods: A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications., Results: The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears., Conclusion: Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.

Objective: Until today, no dedicated bridging stent graft (BSG) has been available for use in fenestrated and branched endovascular aneurysm repair (F/BEVAR). The purpose of this study was to evaluate the clinical performance of the well-known Advanta/iCast V12 (Getinge Maquet, Rastatt, Germany) and the new Viabahn VBX (W. L. Gore & Associates, Flagstaff, Ariz) balloon-expandable stent graft in F/BEVAR., Methods: Retrospective analysis of prospectively collected data was performed. Inclusion criteria were treatment with fenestrated or branched endografts for complex aortic diseases, implantation of at least one VBX stent graft as a BSG in one of the target vessels, and clinical or radiologic follow-up of 6 months. The primary end point of the study was technical success of all BSGs, defined as placement of the BSG in the desired position with absence of endoleak on final angiography. Secondary end points were freedom from perioperative major adverse events and freedom from reinterventions and mortality at 6 months. Procedural and postoperative data were analyzed., Results: Between December 2017 and July 2018, there were 50 patients (40 male; mean age, 71 years) included. A total of 145 VBX stent grafts were implanted, followed by 57 Advanta V12, 29 Viabahn, and 28 bare-metal stents. There were 126 branches (celiac trunk, 27; superior mesenteric artery, 25; renal arteries, 74) sealed exclusively with VBX. Technical success rate was 98.6%. There were six device-related reinterventions due to type IC endoleaks (n = 4), target vessel stenosis distal to the BSG, and stent graft occlusion in a left renal artery in one case. The perioperative and aneurysm-related mortality was 0%; the 6-month all-cause mortality was 2%., Conclusions: The used BSGs demonstrated promising preliminary results in F/BEVAR. Further evaluation is mandatory to determine durability of the VBX., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to evaluate long-term results of self-expanding vs balloon-expandable hypogastric stent grafts in conjunction with iliac branch devices (IBDs) for aortoiliac aneurysm repair in a multicenter experience (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation [pELVIS] Registry)., Methods: All patients electively treated for aortoiliac aneurysm with the Cook IBD (Cook Medical, Bloomington, Ind) in nine European centers were reviewed. Clinical and imaging data were prospectively collected in each center, and a multicenter database was created and interrogated. The primary outcome was the primary patency of the IBDs. For the purpose of this investigation, three subgroups were identified: patients receiving a hypogastric balloon-expandable stent graft (BESg); those with a self-expanding stent graft (SESg); and those with any stent graft plus relining with a bare-metal stent (RESg)., Results: Between 2005 and 2017, there were 691 patients who underwent 747 elective endovascular repairs of aortoiliac aneurysms (n = 518 [75.0%]) or isolated iliac aneurysms (n = 173 [25.0%]) with Cook IBDs (n = 56 bilateral) in nine European centers. Mean age was 72 years (range, 41-93 years); 658 (95.2%) patients were male. In 364 patients (52.7%), BESg was used; in 127 (18.4%), SESg; and in 200 (28.9%), RESg. At 30 days, there were 3 (0.4%) perioperative deaths, 3 (0.4%) technical failures, 7 (1.0%) graft thromboses, 30 (4.3%) reinterventions, and 1 (0.1%) conversion to open repair. After a mean follow-up of 32 months (range, 0-128 months), 28 (3.7%) IBD occlusions and 17 (2.3%) IBD-related endoleaks occurred. In 10 patients, iliac diameter increased >5 mm (1.4%). Overall primary patency was 99.2% at 1 month, 97.9% at 12 months, and 95.1% at 72 months. Primary patency was not significantly different in the BESg vs SESg or RESg cohorts (P = .4). During follow-up, there were 126 (18.2%) reinterventions, 93 (13.5%) of which were IBD related, including 11 (1.6%) conversions. Overall, freedom from reintervention and conversion was 90.4% at 12 months and 71.0% at 72 months. IBD-related reinterventions during follow-up in the three cohorts were not significantly different (P = .3) Overall survival was 71.3% at 72 months without differences between the subgroups. At multivariate analysis, aneurysmal hypogastric artery (P < .001; Exp [B] = 4.44) and bilateral treatment (P = .02; Exp [B] = 1.87) were associated with an increase in late failure., Conclusions: In this wide real-world experience, long-term results of endovascular treatment of aortoiliac aneurysms with the IBD are favorable, with a low rate of late graft occlusion and aneurysm-related death. No significant differences in clinical outcomes were observed in patients receiving hypogastric BESg vs SESg or endovascular relining., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry ( ClinicalTrials.gov ; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

Purpose: To compare experimentally the biomechanical properties of the Viabahn Balloon-Expandable Stent Graft (VBX) with the widely used Advanta V12/iCast in the role of bridging stent-grafts for fenestrated endovascular aortic repair. Materials and Methods: Test sheets made of polyester having 2 rows of 5 fenestrations in 6-mm and 8-mm diameters were used to simulate a commercially made fenestrated aortic endograft. In total, 40 stent-grafts measuring 6×39 mm and 8×39 mm (10 of each size for each stent-graft) were implanted in fenestration sheets immersed in a 37°C water bath. After flaring, all stent-grafts were evaluated using microscopy and radiography. Biomechanical evaluation included pullout and the shear stress force testing; results are reported in Newtons (N) as the median (minimum-maximum). Results: After flaring, no damage or fracture to the stent-graft structures were detected. Pullout forces for the 6-mm stent-grafts were 27.1 N (20.0-28.9) for the VBX and 16.6 N (14.7-19.2) for the Advanta (p=0.008). Pullout forces for the 8-mm stent-grafts were 20.1 N (14.8-21.5) for the VBX and 15.8 N (12.4-17.5) for the Advanta (p=0.095). The shear stress forces necessary to dislocate the device at 150% stent diameter displacement was 12.5 N (VBX) vs 14.7 N (Advanta) for the 6-mm devices and 23.3 N (VBX) vs 20.2 N (Advanta) for the 8-mm stents (p>0.99 and p=0.222, respectively). Conclusion: In vitro tests simulating external pull and shear forces on bridging stent-grafts implanted in fenestrations showed that the VBX had resistance to dislocation equivalent to a well-known control device.

Purpose: To investigate 2 generations of balloon-expandable covered stents as potential bridging devices using an in vitro model of stent-graft fenestrations. Materials and Methods: Twenty BeGraft and 20 BeGraft+ cobalt-chromium stents covered in expanded polytetrafluoroethylene (ePTFE) in 6- and 8-mm diameters were tested in sheets mimicking stent-graft fenestrations. Microscopy and radiography were employed to evaluate stent morphology after flaring. In vitro bench tests measured maximum pullout (perpendicular displacement) and the shear stress (axial displacement) forces needed to dislocate the stents. Results: No alteration of ePTFE coverage was detected in the flared stents. Digital radiography and computed tomography showed marked alteration of the stent geometry, which was more pronounced in the BeGraft group. No fractures were detected. Median (minimum-maximum) pullout forces for the 6-mm stent-grafts were 17.1 N (15.8-19.6) for the BeGraft device and 30.4 N (20.2-31.9) for the BeGraft+ device (p=0.006). Median (minimum-maximum) pullout forces for the 8-mm stent-grafts were 11.3 N (11-12.1) for the BeGraft device and 21.8 N (18.2-25.5) for the BeGraft+ device (p<0.001). The shear stress test showed median forces of 10.5 vs 15.28 N at 150% of the stent diameter for the 6-mm BeGraft and BeGraft+ stent-grafts, respectively, and 15.23 vs 20.72 N at 150% stent diameter for the 8-mm models (p=0.016 and 0.017, respectively). Conclusion: Flaring changed the stent geometry but did not provoke stent fractures. The BeGraft+ is superior to the BeGraft in terms of pullout and shear stress forces, demonstrating greater resilience.

Purpose: To compare balloon-expandable covered stents (BECS) available for use as renal chimney grafts to the Advanta V12 approved for use with the Endurant endograft. Materials and Methods: A silicone model was manufactured based on preoperative computed tomography angiography (CTA) scans of a patient with a 7-cm juxtarenal aneurysm treated with an Endurant bifurcated endograft and an Advanta V12 covered stent for the 6-mm-diameter right renal artery. The model was placed in a flow box filled with a 37°C blood-mimicking solution equipped with a pulsatile pumping system (140/60 mm Hg). The tested BECS were the Advanta V12, the VBX, and the BeGraft+. A 36-mm-diameter Endurant II endograft with a 16-mm-diameter contralateral limb and a 6×59-mm BECS chimney graft were used in 9 consecutive tests (3 for each combination). After each implantation, the model was placed in the CT scanner, and 2 radiologists blinded to the test device independently measured the gutter areas and the patent chimney graft lumen at the level of the Endurant's suprarenal stent, at the level of the chimney's maximum curvature, and 10 mm inside the renal artery. The intraclass correlation coefficients (ICC) were calculated to assess interreader reliability. Results: The mean gutter areas were 19.3±7, 20.2±8, and 22.3±8 mm 2 for the Advanta, VBX, and BeGraft+, respectively (all p>0.05). At the level of the aortic endograft's suprarenal stent struts, the mean diameter of the Advanta V12, VBX, and BeGraft+ were 4.46±0.3, 4.12±0.4, and 4.12±0.3 mm, respectively (all p>0.05). At the level of the maximum chimney graft angulation, the mean diameters were 3.77±0.3, 4.16±0.1, and 3.74±0.3 mm, respectively (all p>0.05). In the right renal artery, the mean diameters were 3.91±0.2, 4.05±0.9, and 4.3±0.4 mm, respectively (all p>0.05). The ICCs varied between 0.7 and 0.9, indicating good agreement between readers. Conclusion: These in vitro findings showed comparable results between the Advanta V12 and the available BECS used in conjunction with the Endurant endograft according to the instructions for use. Further clinical evaluation is needed to confirm these results.

Purpose: To evaluate chimney stent-graft position and morphological changes of the aneurysm sac as visualized by postoperative computed tomography angiography (CTA) over a minimum 24-month follow-up period. Materials and Methods: Twenty-one patients (mean age 75.7±8.6 years; 20 men) with juxtarenal aortic aneurysms who underwent successful chimney endovascular aneurysm repair (ch-EVAR) with the Endurant stent-graft and had 2 postoperative CTAs separated by at least 24 months were included in the study. CTA-based measurements of aortic stent-graft migration, target vessel angle, and chimney angle were compared between the serial scans. Results: During a mean follow-up of 34.9 months (range 24-69.2), the mean migration of the aortic stent-grafts was under 5 mm (2.76±2.4 mm). The average migration distance per year was 1.15 mm. The aneurysm diameter reduced a mean 3.25 mm (p=0.048). The right renal artery angle moved significantly upward 6.72° (p=0.025), while the right renal chimney stent-graft moved significantly downward 7.83° (p=0.042). The left renal artery angle also moved upward 1.87° (p=0.388) and the corresponding chimney moved downward 5.68° (p=0.133). During the study period, no type I/III endoleak or chimney occlusion was observed. Conclusion: Midterm morphometric assessment of ch-EVAR using CTA showed significant aneurysm sac shrinkage and a stable 3-year position of the abdominal devices, with the mean downward migration of the aortic stent-graft being <5 mm in the majority of cases. The chimney grafts seem to be prone to take an oblique rather than parallel configuration during follow-up. However, there was no relevant clinical consequence related to this phenomenon.

Purpose: To evaluate the safety and integrity of a new stent-graft as a potential bridging device in fenestrated stent-grafts using an in vitro fenestrated model., Materials and Methods: Polyester test sheets with ten 6-mm- or 8-mm-diameter fenestrations were used to simulate a fenestrated main body endoprosthesis. In total, 50 Viabahn balloon-expandable (VBX) stent-grafts of varying lengths (29 and 39 mm) and diameters (6, 7, and 8 mm) were implanted in the fitting fenestrations. After release, the 6- and 7-mm-diameter stent-grafts were flared with a 10×20-mm angioplasty balloon; a 12×20-mm balloon was used in the 8-mm-diameter devices. Safety of the devices was defined as absence of fractures detected on radiography or computed tomography (CT), as well as material failure detected by microscopy and water permeability testing. The forces (in Newtons, N) needed for perpendicular dislocation (pullout force) and axial dislocation (shear stress force) were also evaluated., Results: Forty VBX stent-grafts were subjected to digital radiographic imaging and multiplanar CT. None showed any stent fracture. Subsequent microscopy indicated no damage to the fabric or separation of the graft after flaring. Ten VBX stent-grafts underwent water permeability testing after flaring; no water passed through the graft wall during a 10-minute period under an intraluminal pressure at 120 mm Hg. Testing of 25 VBX stent-grafts revealed initial pullout forces between 11.3 and 31 N. Shear stress tests showed that the average force needed to dislocate the stent-grafts by 50% of their diameter ranged between 5.75 and 6.91 N (mean 6.1±0.5 N) for the 6-mm stents and between 3.31 and 5.4 N (mean 4.4±0.8) for the 8-mm stents., Conclusion: This preliminary study demonstrated the applicability of the VBX as a bridging stent-graft in a simulated fenestration model. A comparison with other stent-grafts and clinical assessment are required.

Objective: The objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults., Methods: Clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. We included newly diagnosed aortic coarctation (NCO), recurrent coarctation, and aneurysmal/pseudoaneurysmal degeneration (ANE) after prior open surgical repair (OSR) of coarctation. Primary end points were morbidity and mortality. Secondary end points were stent patency and freedom from reintervention., Results: There were 54 (58%) male and 39 (42%) female patients with a mean age of 44 ± 17 years. Thirty-two patients had NCO (mean age, 48 ± 16 years) and 61 had endovascular reinterventions after prior OSR during childhood (mean, 30 ± 17 years after initial repair), including 50 patients (54%) with recurrent coarctation and 11 (12%) with ANE. Clinical presentation included asymptomatic in 31 patients (33%), difficult to control hypertension in 42 (45%), and lower extremity claudication in 20 (22%). Endovascular treatment was performed using balloon-expandable covered stents in 47 (51%) patients, stent grafts in 36 (39%) patients, balloon-expandable uncovered stents in 9 (10%) patients, and primary angioplasty in 1 (1%) patient. Mean lesion length and diameter were 64.5 ± 50.6 mm and 19.5 ± 6.7 mm, respectively. Mean systolic pressure gradient decreased from 24.0 ± 17.5 mm Hg to 4.4 ± 7.4 mm Hg after treatment (P < .001). Complications occurred in nine (10%) patients, including aortic dissections in three (3%) patients and intraoperative ruptures in two patients; type IA endoleak, renal embolus, spinal headache, and access site hemorrhage occurred in one patient each. The aortic dissections and ruptures were treated successfully by deploying an additional covered stent proximal to the site of dissection or rupture. Two patients died within 30 days of the index procedure. After a mean follow-up of 3.2 ± 3.1 years, nearly all patients (98%) were clinically improved and all stents were patent. Reintervention was needed in 10 (11%) patients. Freedom from reintervention at 5 years was 85%. Two additional patients died during follow-up of coarctation-related causes, including rupture of an infected graft and visceral ischemia. Patient survival at 5 years was 89%., Conclusions: Endovascular repair is effective with an acceptable safety profile in the treatment of NCO and postsurgical complications of coarctation after initial OSR. Aortic rupture is an infrequent (2%) but devastating complication with high mortality. Balloon-expandable covered stents are preferred for NCO, whereas stent grafts are used for ANE. The rate of reinterventions is acceptable, with high procedural and long-term clinical success., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to analyze radiation risk to patients during endovascular aneurysm repair (EVAR) using mobile C-arm (MA) or fixed C-arm (FA) fluoroscopes and to describe the dose distribution during the different phases of the procedure., Methods: Patients treated with EVAR using a single stent graft system between November 2009 and June 2016 were included in this study. The patients were divided into one of two groups (MA or FA) according to the type of C-arm used in the procedure. Data regarding patients' demographics and the total amount of contrast agent (CA) used, dose-area product, and fluoroscopy time for the procedures were prospectively recorded. Based on the dose report from the FA system, five standard and two optional phases of the procedure were identified to determine the dose distribution., Results: Overall, 160 patients were included (mean age, 73.30 ± 8.97 years; 146 men); of these, 107 were treated with an MA system and 53 were treated with an FA system. The mean amounts of CA used were 108.55 ± 42.28 mL in the MA group and 85.37 ± 38.79 mL in the FA group (P = .0014). The mean total dose-area product values were 49.93 ± 38.06 Gy·cm 2 in the MA group and 168.34 ± 146.92 Gy·cm 2 in the FA group (P < .0001). There was no significant difference in fluoroscopy time between the groups. Per-phase analysis demonstrated that identification of the proximal landing zone and main body deployment required the most radiation, accounting for 24% of the total radiation dose. Overall, 47.6% of the exposure was due to digital subtraction angiography., Conclusions: Use of an FA system can significantly reduce the amount of CA needed but may also lead to higher radiation doses in EVAR procedures. Dose monitoring remains crucial for the safety of both patients and operators. A detailed analysis of dose distribution is possible with modern systems, which may improve the quality of monitoring in the future., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The introduction of lower profile endografts expanded the application of aortic endovascular repair. However, evidence about their durability is still scarce. The objective of this study was to assess longer term durability of the Zenith Alpha Thoracic Stent Graft (Cook Inc, Bloomington, Ind) after thoracic endovascular aortic repair., Methods: Prospectively collected data of all patients treated for thoracic aortic aneurysms or penetrating aortic ulcers and having computed tomography angiography-based follow-up of ≥12 months were retrospectively analyzed. The primary end point was ongoing clinical success. Among the secondary end points, stent graft migration and fracture were analyzed., Results: Between August 2010 and October 2015, 70 consecutive patients were treated in a single center with the Zenith Alpha stent graft. With computed tomography angiography-based follow-up of 22.3 ± 15.9 months, ongoing clinical success was 87.1%. There were three cases of type IA endoleak (4.3%), two cases of type IB endoleak (2.9%), and one case of aneurysm sac enlargement (1.4%). Five patients died postoperatively (7.1%). No type III or type IV endoleak was detected; there was one case of distal stent graft migration and no stent fracture. Reintervention was necessary in one case (1.4%) of a combined type IA and type II endoleak. There were no conversions to open repair and no ruptures or intraoperative deaths. All-cause mortality was 17.1% at 76 months., Conclusions: The Zenith Alpha Thoracic Stent Graft appears to maintain favorable results in a longer time frame with a low incidence of aneurysm sac growth and migration. Results from multicenter prospective trials are needed to validate these data., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The INCRAFT system is a new device that has become available in Europe in September 2014 after the announcement of the 2-year results of the INNOVATION trial. However, no data in the "real-world" practice exist. Herein, we report our early series of consecutive patients treated with the INCRAFT after its launch on the market., Methods: Prospectively collected data of patients enrolled in the INNOVATION trial (group IT) and consecutive patients from CE Mark approval to April 2015 (group CM) were retrospectively evaluated and compared. Main outcomes were any device- or procedure-related major adverse event (MAE) within 30 days and survival and reinterventions during follow-up., Results: Seventeen patients were included in group IT (median follow-up [95% CI]; 60.4 months [55-63]), and 24 patients were in group CM (12.5 [6.6-13.5]). The patients' comorbidities were comparable between the groups. The average diameter of aortic bifurcation and the bilateral external iliac arteries was significantly smaller in group CM. Adjunctive interventions for iliac artery disease were performed in 8 patients (33%) in group CM, whereas no adjunctive was required in group IT. MAEs within 30 days were not significantly different between 2 groups. Survival and reintervention rates were also equivalent after a median follow-up of 13 months., Conclusions: Compared to our patients recruited for the INNOVATION trial, the patients after CE Mark approval had significantly more challenging access routes reflecting the difficulties of "real-world" conditions. Despite frequent adjunctive procedures in group CM, the early performance of the endograft was encouraging so far. Long-term surveillance of those patients remains mandatory., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: To assess the usability of a fully automated fusion imaging engine prototype, matching preinterventional computed tomography with intraoperative fluoroscopic angiography during endovascular aortic repair., Methods: From June 2014 to February 2015, all patients treated electively for abdominal and thoracoabdominal aneurysms were enrolled prospectively. Before each procedure, preoperative planning was performed with a fully automated fusion engine prototype based on computed tomography angiography, creating a mesh model of the aorta. In a second step, this three-dimensional dataset was registered with the two-dimensional intraoperative fluoroscopy. The main outcome measure was the applicability of the fully automated fusion engine. Secondary outcomes were freedom from failure of automatic segmentation or of the automatic registration as well as accuracy of the mesh model, measuring deviations from intraoperative angiography in millimeters, if applicable., Results: Twenty-five patients were enrolled in this study. The fusion imaging engine could be used in successfully 92% of the cases (n = 23). Freedom from failure of automatic segmentation was 44% (n = 11). The freedom from failure of the automatic registration was 76% (n = 19), the median error of the automatic registration process was 0 mm (interquartile range, 0-5 mm)., Conclusions: The fully automated fusion imaging engine was found to be applicable in most cases, albeit in several cases a fully automated data processing was not possible, requiring manual intervention. The accuracy of the automatic registration yielded excellent results and promises a useful and simple to use technology., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Use of endovascular means is gaining ever greater acceptance in the treatment of aorto-iliac aneurysms. Especially, the treatment of patients with common iliac aneurysms (CIAs) may be very challenging due to the complexity of the underlying disease with often involvement of the hypogastric artery. Additionally, the variety of endovascular therapeutic options such as the use of iliac branch devices, parallel grafts, the bell-bottom technique or coil embolization of the hypogastric artery and overstenting of the origin represents significant limitation regarding the presentation of a clear and robust endovascular therapeutic algorithm. Aim of the present article was the demonstration of the institutional experience with the endovascular management of CIAs in order to provide a clinical recommendation and algorithm.

Objective: The chimney/snorkel endovascular aortic repair (ch-EVAR) is gaining ever-greater acceptance in the treatment of pararenal pathologic processes. However, the published experience includes mainly short-term clinical results with combinations of several abdominal devices and types of chimney grafts. The aim of this study was the midterm evaluation of the Endurant stent graft (Medtronic, Santa Rosa, Calif) as a standard abdominal device for ch-EVAR., Methods: Between January 2009 and January 2013, prospectively collected data of high-risk patients with pararenal pathologic processes who underwent ch-EVAR with placement of the Endurant abdominal device were analyzed. The chimney graft intended for use was a balloon-expandable covered stent. Main outcome measures were aneurysm sac regression and chimney graft patency., Results: A total of 187 snorkel/chimney grafts were successfully placed in 128 patients (mean age, 76.6 years). The technical success was 100%. The mean preoperative proximal neck length and aneurysm size were 4.7 mm and 64.8 mm (range, 48-135 mm), respectively. The postoperative new neck length after use of chimney grafts was 18.7 ± 6.3 mm. The mean aneurysm sac decreased significantly (60.8 mm; 95% confidence interval, 2.036-7.084; P = .001) after a mean radiologic follow up of 24.6 ± 17.4 months. Thirty-day mortality and midterm mortality were 0.8% and 17.2%, respectively. Two patients (1.6%) with single chimneys presented with late new onset of type Ia endoleak and underwent additional tube and multiple chimney placement. Primary chimney graft patency was 95.7%. Freedom from chimney graft-related reinterventions was 93.1%., Conclusions: Standard use of the Endurant abdominal device for ch-EVAR in >120 patients is associated with high technical success, significant aneurysm sac regression, and low incidence of secondary procedures after 2-year radiologic follow-up. These results will give significant impetus to device selection, facilitating the standardization of technique., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess safety and short-term efficacy of endovascular repair of the thoracic aorta with the new Zenith Alpha stent-graft., Methods: Between August 2010 and May 2014, 33 patients (21 men; mean age 73.2±9.0 years) were treated Zenith Alpha stent-graft (group ZA). Outcomes of this group were compared with those of 34 patients (25 men; mean age 70.3±8.5 years) treated contemporaneously with the Zenith TX-2 for the same pathologies (group TX). The primary outcome measure was technical success. Data on iliac tortuosity, minimum access vessel diameter, and previous unsuccessful treatment with other endografts was also recorded., Results: Technical success was 93.9% in group ZA and 91.2% in group TX (p=0.67). There was no case of surgical death or conversion to open repair in either group. Two (6%) type I endoleaks occurred in group ZA and 3 (9%) in group TX (p=0.67). Three patients died within 30 days in group ZA vs. none in group TX (p=0.07). Mean minimum access vessel diameter was significantly smaller (5.07 vs. 6.65 mm, p=0.002) and iliac tortuosity indices significantly higher in group ZA (1.34 vs. 1.25, p=0.02). Access vessel complications occurred in 1 (3%) patient in group ZA and 4 (12%) patients in group TX (p=0.17). Significantly more patients in group ZA (6, 18%) were unsuccessfully treated previously with other endografts vs. none in group TX (p=0.01)., Conclusion: The new Zenith Alpha appears to be equally as safe and efficacious as the Zenith TX-2 while being used in patients with demanding access vessel morphology., (© The Author(s) 2015.)

Purpose: To assess early and midterm outcomes after thoracic endovascular aortic repair (TEVAR) with the Valiant Thoracic Stent Graft., Methods: Data were reviewed retrospectively for 92 patients (69 men; mean age 65+/-14.5 years) who underwent TEVAR in 52.2% elective and 47.8% urgent/emergent procedures for treatment of 56 degenerative aneurysms, 32 aortic dissections, and 4 traumatic injuries at 4 German centers between June 2005 and March 2008., Results: The technical success rate was 86.9%. Through 30 days, there were 3 (3.3%) deaths. Periprocedural complications included endoleak (n = 6), systemic complications (n = 6), arterial rupture or dissection (n = 6), device-related complications (n = 5), retrograde aortic dissection (n = 1), aortic rupture (n = 1), spinal cord ischemia (n = 1), and stroke (n = 1). Cumulative survival was 95.5% at 1 year, 87.4% at 2 years, and 76.4% at 3 years. The rate of aneurysm-related mortality was 2.2% (n = 2). For aneurysm and dissection patients, respectively, the rates of major complications were 9.3% and 15.6%, and secondary procedures were required in 7.4% and 12.5%. Type I endoleaks were detected in 4 aneurysm and 2 dissection patients, and graft migration occurred in 1 patient each from the aneurysm and dissection groups. No patients were converted to open surgery during follow-up. Aortic diameter reduction >5 mm was confirmed for 58.4% of patients overall., Conclusion: The high technical and clinical success, the low all-cause and aneurysm-related mortality, the negligible rates of neurological complications and spinal cord ischemia, and the low incidence of endoleak support the safety and effectiveness of TEVAR with the Valiant Thoracic Stent Graft. However, some deployment-related complications could be avoided by enhancements of the deployment mechanism.

Purpose: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system., Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72+/-6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin)., Results: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n = 16) or late (n = 7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p<0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p<0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p<0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p<0.05). Obesity was not a risk factor for any complication., Conclusion: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.

Purpose: To evaluate safety and cost benefits of the percutaneous technique for treatment of aortic aneurysm, a prospective randomized study was performed that compared the endovascular suture technique with conventional cutdown access and repair., Materials and Methods: From January 2002 through July 2002, 30 endografts, including 14 Talent stent-grafts (Medtronic, Sunrise, Fla) and 16 Zenith endografts (Cook, Bloomington, Ind) were implanted in 30 patients for endovascular aneurysm treatment. The patients were randomized to either percutaneous technique (group A) or conventional cutdown (group B). Fifty-five femoral arteries were cannulated with large-bore (14F-25F) introducers and were included in the study. Safety and efficiency of both techniques were assessed by recording the complication rates, operation time, discharge, and time to ambulation. Comparison of selected estimated costs included both variable and fixed costs for femoral access and expenses for treatment of complications., Results: No operative deaths occurred. The complication rates were similar and included 1 arterial thrombosis in each group, 3 lymphoceles in group B, and 1 conversion to cutdown because of bleeding in group A. Mean surgery time (86.7 +/- 27 minutes vs 107.8 +/- 38.5 minutes; P <.05) and time to ambulation (20.1 +/- 4.3 hours vs 33.1 +/- 18.4 hours; P <.001) were significantly shorter in the group treated percutaneously. Because of the cost of the closure device, total cost of the percutaneous technique averaged 99.2 euro; more than cutdown., Conclusions: The percutaneous technique decreases the invasiveness of endovascular therapy of aortic aneurysm and reduces operative time and time to ambulation. Complications were roughly equivalent in severity. The additional cost for the device appears to justify its use for this form of aneurysm treatment.