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Objective: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics., Methods: A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%., Results: Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR., Conclusions: This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas., Competing Interests: Disclosures A.K. has received speaker fees from Cook Inc., & W.L. Gore & Associates, and is a consultant for Bentley Innomed. M.A.F. has received clinical trial support and is a Consultant for Cook, W. L. Gore & Associates, Getinge, and ViTAA. He has received research support from Cook and has stock options in Centerline Biomedical. M.E. is a paid consultant for W. L. Gore & Associates and Silk Road Medical. M.G. is a consultant for Cook Medical, W. L. Gore & Associates and Medtronic and a proctor for Cook Medical., (Copyright © 2024 Society for Vascular Surgery. All rights reserved.)

Objective: The formation of postaortic coarctation aneurysms (pCoAA) is well-described in the literature and carries a significant risk of rupture and death. Treatment strategies include open surgical, hybrid, and endovascular repair, depending on the clinical presentation, risk assessment, and anatomy. The aim of this study was to report the early and midterm results of open surgical and endovascular repair of pCoAA., Methods: This is an international multicenter retrospective study including patients who underwent open surgical or endovascular repair for pCoAA between 2000 and 2021 at 14 highly specialized academic cardiovascular centers. The preoperative, intraoperative, and postoperative data were recorded and analyzed., Results: A total of 74 patients (46 male; median age, 44 years; interquartile range [IQR], 35-53 years) underwent pCoAA repair. All patients had previously undergone surgical repair of aortic coarctation at a median age of 11 years for the index procedure (IQR, 7-17 years). The most common first surgical correction was synthetic patch aortoplasty in 48 patients, followed by graft interposition in 11. The median pCoAA diameter was 54 mm (IQR, 44-63 mm). The median time from the aortic coarctation repair to the pCoAA diagnosis was 33 years (IQR, 25-40 years). A total of 33 patients had symptoms at presentation, including thoracic or back pain in 8 patients. Open surgical repair was performed in 28 patients, including four frozen elephant trunk procedures and one Bentall. The remaining 46 patients underwent endovascular repair of the pCoAA. Two in-hospital deaths were observed (one frozen elephant trunk and one endovascular). After a median follow-up of 50 months (IQR, 14-127 months), there were a total of seven reinterventions., Conclusions: This international multicenter study demonstrates that patients with pCoAA can be safely treated with either open surgical or endovascular interventions. Because the median time between the coarctation repair and the aneurysm formation was more than 30 years, life-long surveillance of these patients is warranted., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We aimed to assess the 5-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft., Methods: Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and abdominal aortic aneurysm diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months., Results: Demographic characteristics of ENGAGE patients treated outside (225 [17.8%]) and within (1038 [82.2%]) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs 8.7%; P < .001). The outside IFU group presented with lower rates of coronary artery disease and cardiac revascularization and a greater number of symptomatic patients compared with the within IFU group (21.3% vs 15.0%; P = .020). Technical success was achieved in more than 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs 1.2%; P = 1.00) and type III endoleak (0.4% vs 0.3%; P = .54) immediately after device implantation. The 5-year freedom from type IA endoleaks was 89.4% vs 96.7% (P < .0001) for those patients outside and within the IFUs, respectively, although both groups had similar type III endoleaks through 5 years (P = .61). Stent graft limb occlusion estimated overall survival, and freedom from aneurysm-related mortality and endovascular interventions were comparable in both patient groups through the 5-year follow-up. The Kaplan-Meier estimates at 5 years showed a trend for low but increased need for type I or III endoleak correction procedures in the outside IFU group compared with the within IFU group (7.2% vs 5.2%; P = .099)., Conclusions: Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within and outside IFU patients through a 5-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside IFU, and the cohort had increased incidence of type IA endoleaks. Despite the challenges presented from the broad range of aortic and abdominal aortic aneurysm morphologies, the Endurant stent graft showed promising 5-year outcomes., (Crown Copyright © 2020. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date., Methods: Patients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak., Results: Through 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up., Conclusions: In the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Carotid artery atherosclerotic stenosis is a preventable major cause of stroke, but there is still a need for definition of high-risk plaque in asymptomatic patients who might benefit from interventional therapies. Several image markers are recommended to characterize unstable plaques. The measurement of serum biomarkers is a promising method to assist in decision making, but the lack of robust evidence in the carotid environment burdens their potential as a standard of care. The goal of this review was to offer an updated state-of-the-art study of available serum biomarkers with clinical implications, with focus on those that may predict carotid symptom development., Methods: The Cochrane Library and MEDLINE databases were searched (all until September 2018) for studies on carotid plaque and serum biomarkers of atherosclerosis. Nonhuman, basic science, and histology studies were excluded, focusing on clinical studies. Selected abstracts were screened to include the most relevant articles on atherosclerotic plaque presence, progression, instability or symptom development., Results: Some well-established biomarkers for coronary disease are not relevant to carotid atherosclerosis and other inflammatory biomarkers, lipids, interleukins, homocysteine, and adipokines may be useful in quantifying carotid disease-related risk. Some serum biomarkers combined with image features may assist vascular specialists in selecting patients at high risk for stroke and in need of intervention., Conclusions: Prospective studies applying a combination of biomarkers are essential to prove clinical usefulness., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study is to identify which endograft-parallel stent combinations and which degree of oversizing result in the most adequate fit in a juxtarenal abdominal aneurysmal neck, when using a double or triple parallel-stent (chimney) technique., Methods: In vitro silicon, juxtarenal, abdominal aortic aneurysmal neck models of different diameters, with two and three side-branches (simulating both the renal and superior mesenteric arteries), were constructed. Two different endografts of three diameters each, with two or three parallel stents (of 6 mm and 6 mm; or 6 mm, 6 mm, and 8 mm) were tested (Endurant-II endograft [Medtronic Inc, Santa Rosa, Calif] with balloon-expandable BeGraft stent [Bentley InnoMed, Hechingen, Germany] and an Excluder endograft [W. L. Gore and Associates, Flagstaff, Ariz] with self-expanding Viabahn stent [W. L. Gore and Associates]), applying three endograft-oversizing degrees: recommended (15%), excessive (30%), and over-excessive (40%). After remodeling, using the kissing-balloon technique at 37°C (98.6°F), 36 endograft-stent-oversizing models were scanned by computed tomography. The area of the gutters, parallel-stent compression, and main endograft infolding were recorded., Results: Increasing oversizing (15%, 30%, and 40%) revealed a nonsignificant propensity toward smaller gutters and similar parallel-stent compression, but it significantly augmented infolding, more in three parallel-stent models (0%, 0%, 67% and 0%, 33%, 83% of cases; P = .015 and .018, for two and three parallel-stent models; n = 36) and mainly for the Excluder-Viabahn combination. The Excluder-Viabahn showed significantly smaller gutters, but with higher stent compression, than Endurant-BeGraft combinations for both two and three parallel stents (8.2 mm 2 , 22.6 mm 2 ; P = .002 and 14.4 mm 2 , 23.3 mm 2 ; P = .009 gutter area; and 18%, 2%; P < .001 and 15%, 2%; P = .007 relative stent area compression, respectively)., Conclusions: Better endograft stent apposition was usually attained when using 30% oversizing during two and three parallel-stent techniques. Higher oversizing was related to nonsignificant smaller gutters but higher rates of infolding. Smaller gutters, but higher stent compression and risk of infolding, were achieved with the Excluder-Viabahn than with the Endurant-BeGraft combination., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To assess safety, performance, and efficacy of the RELAY thoracic stent graft (Bolton Medical, Barcelona, Spain) in the treatment of patients who require elective thoracic endovascular aortic repair including aneurysms and dissections., Methods: The RELAY Endovascular Registry for Thoracic Disease II (RESTORE II) is a multicenter, prospective, international cohort study involving 21 centers in 12 countries worldwide. All consecutively included patients underwent elective thoracic endovascular aortic repair with a RELAY or RELAY NBS stent graft (including off the shelf and custom-made devices) to repair thoracic aortic aneurysms or dissections. Demographic, clinical, and aortic parameters were Web-based registers. Safety and efficacy data were collected for a follow-up period of 24 months. RESTORE was a precedent registry involving European sites that used RELAY first-generation devices., Results: A total of 173 patients were enrolled in the registry from October 2010 to September 2014 (aneurysm [n = 99]/dissection [n = 74]). Overall technical success of the intervention reached 97.1% irrespective of the etiology and geographic origin of patients. Baseline clinical heterogeneity was observed between devices concerning the etiology of the disease and certain comorbidities and/or risk factor distribution (diabetes, hypertension, myocardial infarction, angina pectoris). An average of 1.36 stent graft components were used per patient, with mean intended treatment length of 197.0 ± 87.7/188.7 ± 103.1 mm and mean access site diameter of 10.3 ± 8.2/9.7 ± 1.7 mm in aneurysms/dissections, respectively. The rate of all-cause 30-day mortality was lower than in the RESTORE registry (4.0% vs 7.2%). Perioperative neurologic complications were infrequent: paraplegia/paraparesis (2.9%) and stroke (0.6%) (vs 2.0% and 1.6% in the RESTORE registry). Freedom from all-cause mortality at 2 years was 93.6%. At the final completion angiography, device-associated complications were detected in 4.6% of the patients (vs 5.3% in the RESTORE) and endoleak rate was 6.4% (type I 5.8% and type II 1.7%)., Conclusions: The worldwide results of the RESTORE II registry show the safety and effectiveness of RELAY and RELAY NBS stent grafts for elective endovascular thoracic aortic repair. Compared with the RESTORE registry, the device presents a lower rate of perioperative complications., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Endovascular abdominal aortic aneurysm repair (EAR) can be performed in patients whose conditions were previously considered unfit for conventional treatment of the aneurysm. However, because the life span in this category of patients often is limited because of serious comorbidity, the efficacy of EAR in prolonging life expectancy remains uncertain. This study involves the evaluation of preoperative risk classification and an assessment of the outcome of interventions., Methods: The data of 3075 patients, who underwent operation in 101 European institutions that collaborated in the EUROSTAR Registry, were assessed. Only the patients who had been prospectively enrolled in the registry were used for this analysis. Patient characteristics, operative risk factors, procedural details, and types of devices were correlated with preoperative estimates of operative risk, early and late mortality, complications, and primary and secondary outcome success rates. In addition, the intermediate-term survival rates in patients with unfit conditions with EAR (observed series) and with conservative approaches of the aneurysms (rupture rates as derived from the literature) were compared in a mathematical model., Results: Of the overall study group, 2525 patients were at "normal" risk for a surgical procedure (group A), 399 patients had conditions that were considered unfit for open surgery (group B), and 151 patients had conditions that were unfit for general anesthesia (group C). Both unfit categories had significantly more comorbid factors and larger aneurysms than did the patients in good medical condition. Differences were observed in comorbidities between the two high-risk categories, groups B and C. Factors that influenced the abdominal approach (previous laparotomies, hostile abdomen, and obesity) and local anatomic factors (eg, retroperitoneal fibrosis, inflammatory aneurysm, dissections, and enterostomy) were present in 19% of the patients with conditions that were unfit for open surgery and in only 1% of the category unfit for anesthesia. In contrast, severe pulmonary disease was present in 33% of the patients with conditions that were unfit for anesthesia as opposed to 11% of the patients with conditions that were unfit for open surgery. The early and late mortality rates were significantly higher in the unfit categories (groups B and C). Life table results showed a 3-year survival rate of 83% in patients at normal operative risk and of 68% in patients with unfit conditions (P =.0001). An independent correlation with late death was shown for the clinical classification into high-risk groups B and C, pulmonary disease, team experience of less than 60 procedures, and the diameter of the aneurysm. In groups B and C, aneurysms smaller than 6.0 cm were associated with a 2-year survival rate of 80% and larger aneurysms with a rate of 68% (P =.02). This difference was caused by an increased non-aneurysm-related mortality rate in the group with aneurysms of more than 6 cm. The mathematical model showed an advantage of EAR with regard to the reduction of the death rate in patients with unfit conditions as compared with no intervention after 1 year. The advantage of EAR was observed in patients with AAAs between 5 and 6 cm and with larger aneurysms., Conclusion: Early and late mortality rates were increased in patients with the preoperative clinical diagnosis "unfit for open surgery and general anesthesia" as compared with patients at "normal" operative risk. EAR appeared of potential benefit in patients with unfit conditions, regardless of the aneurysm diameter. The life expectancy of patients at high risk who are considered for EAR should be longer than 1 year before any realistic gain in life span can be anticipated.