Anatomical suitability for branched endovascular aortic arch repair and balloon-expandable bridging stent grafts in a cohort of patients previously treated with a hybrid approach.

OBJECTIVE: We assessed the suitability of two triple branch arch devices (aBranch) (Terumo aortic and Cook Medical) and a balloon-expandable covered stent (VBX, W. L. Gore & Associates, Johnson & Johnson) to incorporate the brachiocephalic trunk (BCT) in a cohort previously treated with hybrid thoracic endovascular repair (TEVAR). METHODS: This is a single-center, retrospective, all-comers, preclinical suitability study. We conducted an analysis of preoperative computed tomography scans in surgical patients between 1999 and 2022 in a single vascular surgery unit. The primary outcome was the aortic suitability of aBranch devices and VBX as mating stent for BCT in previous hybrid TEVAR. Hybrid repair of the aortic arch included TEVAR, fenestrated or branched TEVAR associated with any surgical debranching of the supra-aortic trunks and chimney TEVAR with proximal landing in zones 0 to 2. Secondary outcomes included (i) suitability assessment when excluding minor instruction for use (IFU) criteria, (ii) a comparison of suitable and nonsuitable patients, (iii) risk factors analysis for nonsuitability, and (iv) a description of the exclusion causes. RESULTS: During the study period, 120 patients were treated. Among elective patients (n = 73), the suitability of any aBranch was 82.2% (60/73) and VBX was suitable in 64.4% of BCTs (47/73). The aBranch suitable patients had a significantly longer sinotubular-BCT length (P = .017) and smaller distal ascending aorta (P = .043) as compared with nonsuitable ones. The suitability of Terumo Aortic and Cook Medical devices was 52.1% (38/73) and 46.6% (34/73), respectively. When minor IFU criteria were ignored, suitability increased to 82.2% (60/73) and 63.0% (46/73), respectively. Left common carotid artery diameter and sinotubular-BCT length were significant nonsuitability risk factors for Terumo Aortic aBranch in multivariable analysis. No associations were found for Cook Medical device. The outcomes were tested in the entire cohort demonstrating a global suitability of 82.9%, increasing to 86.3% when ignoring minor IFUs. VBX was anatomically suitable to use in BCT in 73.2% of patient BCTs. CONCLUSIONS: aBranch devices are anatomically suitable in a vast majority of patients (86%) undergoing hybrid TEVAR. The innominate artery seems eligible for incorporation with VBX in almost two-thirds of patients. This mating stent may help to overcome some minor IFU restrictions.

Comparison of bridging stent grafts in branched endovascular aortic repair.

BACKGROUND: Endovascular treatment of thoracoabdominal aortic aneurysms has become common, with satisfactory results. Nevertheless, long-term durability remains an issue mainly because of target visceral vessel (TVV) instability. Currently, no covered stent has been approved as a bridging stent graft (BSG), demanding continuous research on this topic. METHODS: This was a multicenter observational retrospective cohort study comparing the midterm results of the Bard Covera Plus and Gore VBX as BSGs during branched endovascular aneurysm repair. The primary outcome was the comparison of the target vessel instability between the two groups. Primary patency, freedom from branch-related type I and III endoleaks and reintervention, and technical and clinical success were considered secondary outcomes. Logistic regression analysis was used to assess the association between selected baseline factors and TVV instability. TVV instability during follow-up was then evaluated using the Kaplan-Meier cumulative function. RESULTS: Three hundred forty-five TVVs in 106 patients were considered suitable for the analysis. Two hundred twenty vessels were stented with the Covera stent graft (64%) and 125 with VBX (36%). Two hundred ninety-nine TVVs received a single BSG, 45 two BSGs, and only 1 three BSGs. Bare metal stent relining was required in 36% of TVVs, mostly in the Covera group (89 [41%] vs 36 [29%]) (P = .030). The primary technical success rate was 96% (331/345), and the assisted primary technical success rate was 99% (342/345). The TVV instability rate within 30 days was 2% (one Covera and five VBX; P = .015). Three BSG occlusions (one Covera and two VBX) and three type Ic endoleaks (three VBX) were detected. The median follow-up was 13.9 months (range, 5.8-25.5 months). Sixteen TVV instabilities were detected during the follow-up. Twelve BSG occlusions (six Covera and six VBX), three type Ic endoleaks (one Covera and two VBX), and one type IIIc endoleak (VBX). The overall target vessel instability rate was 5% (16/342). TVV instability was associated with the use of Gore VBX in the univariable logistic regression (odds ratio, 3.0; 95% confidence interval, 1.1-8.0; P = .027). Aneurysm rupture and aneurysm diameter were also associated with TVV instability in the univariable analysis (P = .002 and P = .008, respectively). The only factor predisposing to TVV instability in the multivariable logistic regression analysis was the use of Gore VBX as a BSG (odds ratio, 2.9; 95% confidence interval, 1.0-8.0; P = .043). Kaplan-Meier analysis showed a significantly higher risk of TVV instability in the VBX group (P < .001). CONCLUSIONS: Overall midterm outcomes in this cohort were satisfactory. Patency rates were similar between the two stents. Nevertheless, VBX seems to be associated with worse TVV instability. These results may be correlated with a higher incidence of type Ic endoleaks, which require an extensive learning curve for correct stent selection and deployment.

The sac evolution imaging follow-up after endovascular aortic repair: An international expert opinion-based Delphi consensus study.

OBJECTIVE: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. METHODS: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document. RESULTS: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. CONCLUSIONS: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.

Nationwide Study of the Outcome of Treatment of Lower Extremity Atherosclerotic Lesions With Endovascular Surgery With or Without Drug Eluting Methods in Patients With Diabetes.

CLINICAL IMPACT: This retrospective observational registry trial combines national registries for vascular surgical procedures and diabetes mellitus to clarify results of drug eluting technology in treating diabetic subjects with intermittent claudication or chronic limb threatening ischemia compared to treatment of non-diabetic subjects. As earlier proposed and showed in this trial, there may be an implication for a beneficial treatment efficacy with drug eluting therapy in the diabetic population with PAD compared to the non-diabetic population. A finding worth further exploration.

Certification of Basic Skills in Endovascular Aortic Repair Through a Modular Simulation Course With Real Time Performance Assessment.

OBJECTIVE: Endovascular aortic repair (EVAR) is being used increasingly for the treatment of infrarenal abdominal aortic aneurysms. Improvement in educational strategies is required to teach future vascular surgeons EVAR skills, but a comprehensive, pre-defined e-learning and simulation curriculum remains to be developed and tested. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), an assessment tool for simulation based education (SBE) in EVAR, has previously been designed to assess EVAR skills, and a pass limit defining mastery level has been set. However, EVARATE was developed for anonymous video ratings in a research setting, and its feasibility for real time ratings in a standardised SBE programme in EVAR is unproven. This study aimed to test the effect of a newly developed simulation based modular course in EVAR. In addition, the applicability of EVARATE for real time performance assessments was investigated. METHODS: The European Society of Vascular Surgery (ESVS) and Copenhagen Certification Programme in EVAR (ENHANCE-EVAR) was tested in a prospective cohort study. ENHANCE-EVAR is a modular SBE programme in EVAR consisting of e-learning and hands-on SBE. Participants were rated with the EVARATE tool by experienced EVAR surgeons. RESULTS: Twenty-four physicians completed the study. The mean improvement in EVARATE score during the course was +11.8 (95% confidence interval 9.8 - 13.7) points (p < .001). Twenty-two participants (92%) passed with a mean number of 2.8 ± 0.7 test attempts to reach the pass limit. Cronbach's alpha coefficient was 0.91, corresponding to excellent reliability of the EVARATE scale. Differences between instructors' EVARATE ratings were insignificant (p = .16), with a maximum variation between instructors of ± 1.3 points. CONCLUSION: ENHANCE-EVAR, a comprehensive certifying EVAR course, was proven to be effective. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE) is a trustworthy tool for assessing performance within an authentic educational setting, enabling real time feedback.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

Limb graft occlusion after endovascular aneurysm repair with the Cook Zenith Alpha abdominal graft.

OBJECTIVE: Prior reports of the low profile Zenith Alpha abdominal graft (Cook Medical Inc, Bloomington, IN) have shown impaired limb graft patency to be the primary causes of reintervention. Special notices from the manufacturer have indicated certain instructions for use (IFU) violations as the main reasons for these complications. In the present study, we assessed the incidence of limb graft occlusion (LGO) and analyzed the effects of the detailed anatomic risk factors for LGO highlighted in the IFU and previously reported studies. METHODS: A retrospective study was performed of 241 patients treated with the low profile Zenith Alpha at a single institution from October 1, 2015 to September 30, 2018. All computed tomography angiograms were analyzed using three-dimensional software. Data were extracted from the electronic medical records until the end of the study period (December 31, 2020). The cumulative incidence of LGO and LGO-related reinterventions were assessed. A regression analysis was performed to evaluate the possible risk factors associated with the development of LGO at specified time points. These included aortic and iliac diameters, graft component oversizing, iliac tortuosity and calcification, overlap of graft components, proximal alignment of ipsilateral and contralateral legs, and sealing zone in the external iliac artery. Reader agreement of iliac calcification and tortuosity was assessed in patients with LGO. RESULTS: A total of 33 limbs (7%) in 27 patients (11%) had become occluded. The cumulative incidence of LGO was 7% (95% confidence interval [CI], 5%-9%) per limb up to 3 years postoperatively. The previously described risk factors for LGO were studied using regression analysis; however, no positive association with LGO was identified. Heavily calcified common iliac arteries (CIAs) and external iliac arteries were protective against LGO compared with noncalcified vessels up to 3 years postoperatively (decreased risk, 17% [95% CI, -27% to -7%]; P = .001; and 15% [95% CI, -26 to -5]; P = .005, respectively). The reader agreement of iliac calcification and tortuosity showed substantial agreement (CIA intrareader kappa = 0.75; CIA interreader kappa = 0.62) and almost perfect agreement (intrareader kappa = 0.85; interreader kappa = 0.84), respectively. CONCLUSIONS: The cumulative incidence of LGO after endovascular aneurysm repair with the Zenith Alpha graft was 7% per limb up to 3 years postoperatively. None of the analyzed risk factors suggested by the IFUs or current literature were positively associated with LGO.

Systematic review and meta-analysis of long-term reintervention following thoracic endovascular repair for blunt traumatic aortic injury.

OBJECTIVE: To investigate the long-term reinterventions of thoracic endovascular repair (TEVAR) after blunt traumatic aortic injury. METHODS: MEDLINE, EMBASE, and Cochrane databases were interrogated until June 2021. Inclusion criteria were blunt traumatic aortic injury treated with TEVAR and mean follow-up of more than 60 months. A systematic review was conducted and data were pooled using a random effects model of proportions applying the Freeman-Tukey transformation. Late reintervention was the primary outcome. Secondary outcomes were procedure-related complications (endoleak, in-stent thrombosis, occlusion, infolding/collapse, bird-beak, migration, and left arm claudication), overall and aortic-related mortality, and aortic diameter changes. RESULTS: Eleven studies with a low quality assessment were included. Four hundred eight patients were collected and the 389 surviving more than 30 days were included. The mean follow-up was 8.2 years (95% confidence interval [CI], 5.7-10.8; I2 = 40.2%). Late reintervention was 2.1% (95% CI, 0.6-3.9; I2 = 0.0%; 11/389 cases) with 0.1% (95% CI, 0.0-1.2; I2 = 0.0%; 3/389) occurring after 5 years. Bird-beak was identified in 38.7% (95% CI, 16.4-63.6; I2 = 86.6%). Left arm claudication occurring after 30 days was 3.1% (95% CI, 0.1-8.6; I2 = 26.9%; 11/140 cases). In-stent thrombosis was 1.9% (95% CI, 0.1-5.2; I2 = 51.8%; 11/389 cases). Endoleak was 0.5% (95% CI, 0.0-1.9; I2 = 0.0%; 5/389 cases). Infolding, occlusion, and migration were reported in 2 of 389, 1 of 389, and 0 of 389 patients, respectively. Overall late survival was 95.6% (95% CI, 88.1-99.8; I2 = 84.7%; 358/389 patients) and only one patient accounted for aortic related mortality. The increase in proximal and distal aortic diameters was estimated at 2.7 mm (95% CI, 1.2-4.3; I2 = 0.0%) and 2.5 mm (95% CI, 1.1-3.9; I2 = 0.0%), respectively. CONCLUSIONS: TEVAR demonstrates remarkably good long-term results and reinterventions are rarely required. Aortic reinterventions tend to occur within the first and after the fifth year.

Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe). METHODS: This post-market observational study was conducted at three European sites with ambispective enrollment from 2012 to 2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal (RRA) arteries. Follow-up was through 2 years, per sites' standard of care. Procedural and 1-year results were reported previously. RESULTS: Eighty patients (mean age, 71.0±7.4 years; 70.0% men) were enrolled; six patients had symptomatic TAAAs, and 15 patients had contained ruptures. Technical success was achieved in 98.8% of patients (79/80). Median follow-up was 22.2 months (interquartile range, 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, four patients had five imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency was 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months, respectively. A total of 298 vessels were targeted, of which 12 were occluded over the study period. CONCLUSIONS: Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Iliac Branch Devices in the Repair of Ruptured Aorto-iliac Aneurysms: A Multicenter Study.

PURPOSE: To evaluate the outcomes of preserving the internal iliac artery (IIA) with iliac branched devices (IBDs) during acute endovascular repair of ruptured aortoiliac aneurysms. MATERIAL AND METHODS: This is a multicenter retrospective review of all consecutive patients undergoing acute endovascular repair of ruptured aortoiliac aneurysm with an IBD at 8 aortic centers between December 2012 and June 2020. A control group was used where the IIA was intentionally occluded from the same study period. The main outcome measures were 30-day mortality, major adverse events, technical success, and clinical success. Secondary outcomes were buttock claudication, primary patency, primary-assisted and secondary patency of the IBD, occurrence of endoleak types I/III, and reintervention. Values are presented as numbers and percentages or interquartile range in parenthesis. RESULTS: Forty-eight patients were included in the study: 24 with IBD and 24 with IIA occlusion. There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. Twenty (83%) of them were hemodynamically stable during the procedure as opposed to 14 (58%, p=.23) with the IIA occlusion. Technical success was achieved in all cases with a procedure time of 180 (133-254) minutes, 45 (23-65) of which were from IBD. There were 2 (8%) deaths during the first 30 days and 2 (8%) major complications unrelated to the IBD, whereas in the IIA occlusion, the figures were 10 (42%) and 7 (29%), respectively. No patient in the IBD group developed buttock claudication compared to 8 (57%, p<.0001) in the IIA occlusion group; 1 (4%) patient developed bowel ischemia on both groups, with 1 in the IIA occlusion group needing resection. The median follow-up duration was 17 months (interquartile range 2-39) for the IBD group, with a primary patency of 60±14% at 3 years that went up to 92±8% with reinterventions (8 reinterventions in 6 patients). When the first 90 days were disregarded, there were no differences in survival between the groups. CONCLUSION: IBD is a valid alternative for maintaining the pelvic circulation for endovascular aortic aneurysm repair of ruptured aortoiliac aneurysms. The technical success and midterm outcomes are very satisfactory but require patient selection particularly regarding hemodynamic stability. The reintervention rate is considerable, mandating continuous follow-up. CLINICAL IMPACT: This multicenter study demonstrates that ruptured aortoiliac aneurysms do not necessarily require mandatory occlusion of hypogastric arteries. Iliac branch devices are shown to be a valid alternative in highly selected cases, with good midterm results, even if reinterventions are required in a significant proportion of patients.

Danish Nationwide Study on Surgical Treatment of Infective Native Abdominal Aortic Aneurysms.

OBJECTIVE: This study aimed to describe surgical trends, survival, and infection related complications (IRC) in a Danish cohort of patients with infective native aortic aneurysms (INAAs). METHODS: A retrospective nationwide cohort study including all patients in Denmark who were surgically treated for abdominal INAA between 2000 and 2020 was conducted. Patients were identified through the Danish vascular registry, Karbase, which is a database registering all patients treated with vascular surgery in Denmark. Subsequent data on clinical presentation, treatment, all cause mortality, and complications were obtained from the electronic patient charts. RESULTS: Seventy-five patients were included in the study, of whom 60 (80%) were male, with a median age of 69 (IQR 64, 75) years. Open surgical repair (OSR) was performed in 54 (72%) patients and endovascular aortic repair (EVAR) in 21 (28%). Median follow up was 52 (IQR 32, 103) months. Open repair was consistently the most frequent treatment modality throughout the study period, but EVAR became more frequent over time. The 30 day survival of the total cohort was 97% (94 - 100%). Kaplan-Meier survival estimates for the cohort were 92% (95% CI 85 - 98%), 80% (95% CI 71 - 91%), 63% (95% CI 52 - 78%), and 48% (95% CI 35 - 66%) at one, three, five and 10 years, respectively. Patients treated by EVAR had comparable long term survival to patients treated by OSR, with a hazard ratio of 0.35 (95% CI 0.10 - 1.22), but was associated with better short term survival up to five years. The most common cause of death was sepsis. Five (9%) OSR patients had IRC compared with one (5%) EVAR patient. CONCLUSION: In this nationwide study of patients treated for abdominal INAA, an increasing number of patients were surgically treated during the study period. Patients treated by EVAR demonstrated long term survival comparable to OSR. The incidence of post-operative IRC was low. These results should be interpreted with caution and prospective registries are needed.

Editor's Choice - Infective Native Aortic Aneurysms: A Delphi Consensus Document on Terminology, Definition, Classification, Diagnosis, and Reporting Standards.

OBJECTIVE: There is no consensus regarding the terminology, definition, classification, diagnostic criteria, and algorithm, or reporting standards for the disease of infective native aortic aneurysm (INAA), previously known as mycotic aneurysm. The aim of this study was to establish this by performing a consensus study. METHODS: The Delphi methodology was used. Thirty-seven international experts were invited via mail to participate. Four two week Delphi rounds were performed, using an online questionnaire, initially with 22 statements and nine reporting items. The panellists rated the statements on a five point Likert scale. Comments on statements were analysed, statements revised, and results presented in iterative rounds. Consensus was defined as ≥ 75% of the panel selecting "strongly agree" or "agree" on the Likert scale, and consensus on the final assessment was defined as Cronbach's alpha coefficient > .80. RESULTS: All 38 panellists completed all four rounds, resulting in 100% participation and agreement that this study was necessary, and the term INAA was agreed to be optimal. Three more statements were added based on the results and comments of the panel, resulting in a final 25 statements and nine reporting items. All 25 statements reached an agreement of ≥ 87%, and all nine reporting items reached an agreement of 100%. The Cronbach's alpha increased for each consecutive round (round 1 = .84, round 2 = .87, round 3 = .90, and round 4 = .92). Thus, consensus was reached for all statements and reporting items. CONCLUSION: This Delphi study established the first consensus document on INAA regarding terminology, definition, classification, diagnostic criteria, and algorithm, as well as reporting standards. The results of this study create essential conditions for scientific research on this disease. The presented consensus will need future amendments in accordance with newly acquired knowledge.

Characterizing incidental mass lesions in abdominal dual-energy CT compared to conventional contrast-enhanced CT.

BACKGROUND: Incidental findings are common in abdominal computed tomography (CT) and often warrant further investigations with economic implications as well as implications for patients. PURPOSE: To evaluate the potential of dual-energy CT (DECT) in the identification and/or characterization of abdominal incidental mass lesions compared to conventional contrast-enhanced CT. MATERIAL AND METHODS: This retrospective study from a major tertiary hospital included 96 patients, who underwent contrast-enhanced abdominal DECT. Incidental lesions in adrenals, kidneys, liver, and pancreas were evaluated by two board-certified abdominal radiologists. Observer 1 only had access to standard CT reconstructions, while observer 2 had access to standard CT as well as DECT reconstructions. Disagreements were resolved by consensus review and used as a reference for observers using McNemar's test. RESULTS: Observers 1 and 2 identified a total of 40 and 34 findings, respectively. Furthermore, observer 1 registered 13 lesions requiring follow-up, of which seven (two renal and five adrenal lesions) were resolved following consensus review using DECT (P = 0.008). The inter-observer agreement was near perfect (κ = 0.82). CONCLUSION: DECT has the potential to improve the immediate characterization of incidental findings when compared to conventional CT for abdominal imaging.

Long-term outcomes after fenestrated endovascular aortic repair for juxtarenal aortic aneurysms.

OBJECTIVE: Fenestrated endovascular aortic aneurysm repair (FEVAR) for juxtarenal aortic aneurysm (jAAA) disease is safe and effective with good short- and mid-term outcomes. The durability issues have mainly focused on the proximal and distal seal and target vessel (TV) instability, and long-term data are scarce. In previous studies, we have reported the short-term outcomes after FEVAR and compared our early and late experience and the long-term results for the early cohort. In the present report, we have provided the long-term outcomes for our late experience cohort who had undergone FEVAR at the Vascular Center (Skåne University Hospital, Malmö, Sweden). METHODS: Consecutive patients who had undergone FEVAR for jAAAs from 2007 to 2011 were included in the present study. Data were collected retrospectively from the medical and imaging records. The follow-up protocol consisted of a clinical examination 1 month postoperatively and computed tomography angiography combined with plain abdominal radiography at 1 and 12 months and annually thereafter. The primary endpoints were TV instability, reinterventions, and survival. Changes in the aneurysm diameter and renal function and the incidence and type of endoleaks were also analyzed. RESULTS: A total of 94 patients were included in the present study. The median follow-up time was 89 months (range, 0-152 months). A total of 280 fenestrations or scallops were used, of which 205 were stented. Technical success was 89.4%. Primary TV patency was 94% ± 1% at 1 year, 90% ± 2% at 3 years, and 89% ± 2% at 5 years. Of the 94 patients, 37 (39.4%) had required a total of 70 reinterventions. The mean time to the first reintervention was 21 ± 3.97 months. Five patients (5.3%) had died of aneurysm-related causes. Overall survival was 95.7% ± 2.1% at 1 year, 87.1% ± 3.5% at 3 years, and 71.0% ± 4.7% at 5 years. A stable or decreasing aortic diameter after treatment was seen in 91% of the cases. The mean glomerular filtration rate had decreased from 59.2 ± 14.9 mL/min/1.73 m2 preoperatively to 50.0 ± 18.6 mL/min/1.73 m2 at the end of follow-up. CONCLUSIONS: The results of the present study have shown that the long-term results after treatment of jAAAs with FEVAR remain good and the treatment is safe and effective. Although the need for reintervention remained high, long-term renal function and survival support the use of FEVAR as a valid treatment option for jAAA disease.

Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.

OBJECTIVE: Outcome reports after endovascular aneurysm repair (EVAR) using the low-profile Zenith Alpha Abdominal Endovascular grafts (Cook Medical, Bjæverskov, Denmark) are sparse. We present results from a single-center cohort treated with the Zenith Alpha, from a period where the graft was the primary EVAR device choice. The aim of the study was to evaluate short- and midterm outcomes of patients treated with the Zenith Alpha. METHODS: A retrospective single-center study was performed including all patients treated with the Zenith Alpha graft from October 1, 2015 to September 30, 2018. All patients underwent computed tomography angiography (CTA) imaging preoperatively as well as at 3 and 12 months postoperatively. Hereafter, patients were followed yearly with duplex ultrasound and clinical exams. Additional imaging was performed on indication. All CTAs were analyzed using three-dimensional reconstruction software (Aquarius, TeraRecon, Durham, NC). Data was extracted from electronic charts according to a protocol that remained unchanged until the end of the study (December 31, 2020). The following outcomes were assessed according to Society for Vascular Surgery/International Society of Cardiovascular Surgeons reporting criteria: aortic-related and all-cause mortality, reinterventions, instruction for use (IFU) violations, endoleaks (ELs), and aneurysm shrinkage. RESULTS: A total of 241 patients were treated with the Zenith Alpha, and 214 (89%) were asymptomatic repairs. Technical success was achieved in 238 patients (99%). One hundred fifty-seven patients (65%) received implantation outside IFU. The median hospital length of stay was 2 days (interquartile range, 2-3 days). The median clinical follow-up was 35.1 months (interquartile range, 28.8-47.5 months). The 4-year Kaplan-Meier estimate of freedom from reintervention was 66% (95% confidence interval, 59%-73%). The main reasons for reinterventions were iliac limb stenosis and occlusion (n = 30; 12%) and type 2 EL (n = 13; 5%). Overall, significantly more patients with grafts implanted outside distal IFU developed type 1B ELs (n = 10/11; P = .009). Aneurysm sac shrinkage was observed in 48 patients (25%) 1 year postoperatively. The Kaplan-Meier estimate of freedom from aortic-related mortality was 99% (95% confidence interval, 98%-100%) 4 years postoperatively. CONCLUSIONS: EVAR with the Zenith Alpha shows acceptable freedom from aortic-related mortality up to 4 years postoperatively. The majority of patients were treated outside IFU, and significantly more type 1B ELs appeared in this subgroup of patients. The leading cause for reintervention was impaired limb patency. The root cause for impaired limb patency requires further investigation.

Simulation-Based Education of Endovascular Scrub Nurses Reduces Stress and Improves Team Performance.

INTRODUCTION: Endovascular procedures have become commonplace in vascular surgery. This development calls for new training strategies for future specialists. Most simulation-based education (SBE) programs have a monodisciplinary focus on physicians, although successful surgery is a multidisciplinary team effort. Mental stress impairs the learning process and surgical performance and heart rate variability (HRV) can be measured as a proxy for both mental and physical stress. This study aims to assess how SBE of endovascular scrub nurses affects team performance and HRV during endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Prospective interventional study in which EVAR-inexperienced scrub nurses followed a focused SBE EVAR program. During real-life EVAR procedures, HRV was continuously recorded with a wireless electrocardiogram patch and multidisciplinary team performance was assessed with the Imperial College Error CAPture (ICECAP) tool, before and after the SBE program, allowing each scrub nurse to serve as their own control. Eight scrub nurses with experience in lower limb endovascular procedures, but not EVAR, were invited to participate. RESULTS: Seven participants completed the study. In five of seven scrub nurses, HRV-derived stress levels during real-time EVAR procedures were lower after SBE compared to before SBE. Mean HRV increased from 24 msec to 35 msec (P < 0.001), indicating stress level reduction. Before SBE, the mean number of errors/hour was 7.3 (standard deviation ± 1.8) compared to 3.6 (standard deviation ± 2.7) after SBE. Most errors were categorized as technical (58 %) and communicative (23 %). CONCLUSIONS: SBE of scrub nurses may improve team performance and may lower mental stress during EVAR procedures. In this small study, we suggest using mental stress, as evaluated with HRV, and multidisciplinary team performance, as evaluated with ICECAP, to assess SBE effectiveness in real-case EVAR procedures. This SBE program and live ICECAP observations and electrocardiogram patches was well-accepted by scrub nurses and the entire team.

Total Percutaneous Endovascular Aortic Arch Repair With a Triple Inner-Branch Device (the Innominate Approach).

PURPOSE: To describe a completely percutaneous approach for endovascular arch repair (arch-percutaneous endovascular aortic repair [PEVAR]) with a triple inner-branch device: the "Innominate Approach." TECHNIQUE: After right axillary and single common femoral arteries percutaneous access, the arch stent-graft is introduced and deployed transfemorally using fusion overlay. The brachiocephalic artery (BCA) and the corresponding inner branch are cannulated from the axillary access. Through this access, a steerable-sheath guides antegrade cannulation of the left common carotid artery (LCCA) through its inner branch. Optionally, a wire preloaded through the left subclavian artery (LSA) and the LCCA branch, is snared from the BCA access providing LCCA through and through access. A 10 Fr sheath is then positioned from the BCA branch in the LCCA branch and a second, trans-axillary wire through the same sheath is used to catheterize the LCCA. The LCCA is then stented antegradely (regardless of approach). Finally, the BCA and LSA are bridged to complete the procedure. An additional novelty described is the use of VBX (W. L. Gore) as a bridging stent for the BCA. CONCLUSION: Arch-PEVAR is feasible with the use of adjuncts that are well-known for physicians performing complex endovascular repair. The "Innominate Approach" avoids access and exposure of the carotid arteries. CLINICAL IMPACT: We aim to describe the feasibility of the axillary artery as the main route to perform the brachiocephalic artery (BCA) and the left common carotid artery bridging stenting in case of arch endovascular repair (arch-EVAR) with a triple Inner-Branch Device. According to the present "Innominate Approach", percutaneous arch-EVAR is feasible using either a steerable sheath or a preloaded through-&-through wire. The Innominate approach, including a VBX bridging stent for the BCA, avoids carotid access and exposure, reduces the number of vascular accesses, and allows the downsizing of the trans-axillary devices.

Editor's Choice - European Society for Vascular Surgery Clinical Practice Guideline Development Scheme: An Overview of Evidence Quality Assessment Methods, Evidence to Decision Frameworks, and Reporting Standards in Guideline Development.

OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.

Endovascular Treatment of Post Type A Chronic Aortic Arch Dissection With a Branched Endograft: Early Results From a Retrospective International Multicenter Study.

OBJECTIVE: The objective of this study was to evaluate the outcome of endovascular aortic arch repair for chronic dissection with a custom-made branched endograft. BACKGROUND: Acute type A aortic dissections are often treated with prosthetic replacement of the ascending aorta. During follow-up, repair of an aneurysmal evolution of the false lumen distal to the ascending prosthesis can be a challenge both for the surgeon and the patient. METHODS: We conducted a multicenter, retrospective study of consecutive patients from 14 vascular units treated with a custom-made, inner-branched device (Cook Medical, Bloomington, IN) for chronic aortic arch dissection. Rates of in-hospital mortality and stroke, technical success, early and late complications, reinterventions, and mortality during follow-up were evaluated. RESULTS: Seventy consecutive patients were treated between 2011 and 2018. All patients were considered unfit for conventional surgery. In-hospital combined mortality and stroke rate was 4% (n = 3), including 1 minor stroke, 1 major stroke causing death, and 1 death following multiorgan failure. Technical success rate was 94.3%. Twelve (17.1%) patients required early reinterventions: 8 for vascular access complication, 2 for endoleak correction, and 2 for pericardial effusion drainage. Median follow-up was 301 (138-642) days. During follow-up, 20 (29%) patients underwent secondary interventions: 9 endoleak corrections, 1 open repair for prosthetic kink, and 10 distal extensions of the graft to the thoracic or thoracoabdominal aorta. Eight patients (11%) died during follow-up because of nonaortic-related cause in 7 cases. CONCLUSIONS: Endovascular treatment of aortic arch chronic dissections with a branched endograft is associated with low mortality and stroke rates but has a high reintervention rate. Further follow-up is required to confirm the benefits of this novel approach.