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Background: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms., Methods: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events., Results: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years., Conclusions: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis., Competing Interests: The following authors declare conflicts of interest regarding consulting, research grants, advisory boards and/or any compensation fees from the mentioned companies. N. Tsilimparis (Proctor fees, speaking fees and institutional research support), D.J. Adam (speaking, research and proctor fees), L. Mendes Pedro (speaking and proctor fees), L. Bertoglio (speaking and proctor fees), T. Kölbel (speaking and proctor fees, institutional research support, royalties and consulting), and G. Panuccio (proctor and speaking fees) are supported by Cook Medical. R. Gouveia e Melo is supported by Cook Medical (speaking fees), Cordis (speaking fees), and Abbott Laboratories (travel and accommodation for congress). S. Scali is supported by Medtronic Inc, Boston Scientific Corporation, and Cook Medical (food and beverage). B. Mendes is supported by WL Gore & Associates Inc, Cook Medical (consulting, speaker and research fees, all proceeds towards Mayo Clinic), Medtronic Inc (aortic advisory board); and Bolton Medical Inc (food and beverage). S. Han is supported by WL Gore & Associates Inc, Cook Medical, Bolton Medical Inc (research support and consulting with all proceeds towards University of San Diego); Medtronic Inc (travel and lodging); Artivion Inc (food and beverage), Guard Medical Inc (consulting fees), Bolton Medical Inc (food and beverage), Endologix LLC (food and beverage), Silk Road Medical Inc (food and beverage), and Viz.ai Inc(food and beverage). M. Schermerhorn is supported by WL Gore & Associates Inc, Silk Road Medical Inc (travel and lodging), Shape Memory Medical Inc and Medtronic Inc (food and beverage). M. Farber is supported by Cook Medical (research support, honoraria and clinical trial support), Centerline Biomedical Inc, WL Gore & Associates Inc and Merck Sharp & Dohme LLC (consulting), Medtronic Inc and Getinge USA Sales LLC (food and beverage). B. Starnes is supported by Bolton Medical Inc, Terumo Aortic (consulting and travel and lodging), Surmodics Inc, Abbott Laboratories and Medtronic Inc and Cook Medical(food and beverage). D. Branzan is supported by Artivion, Bentley InnoMed, Cook Medical, Endologix, Getinge, and Medtronic (consulting and research support).C. Timaran is supported by Cook Medical, WL Gore & Associates Inc, and Philips Healthcare (research support and consulting). F. Verzini is supported by Cook Medical, WL Gore & Associates Inc, and Medtronic (proctor and speaking fees). A.W. Beck is supported by Artivion, Cook Medical, Medtronic, Philips Healthcare, Terumo, and WL Gore & Associates (research and consulting fees with all proceeds towards the University of Alabama). J. Chait is supported by WL Gore & Associates, Bard Peripheral Vascular, and Medtronic Inc (food and beverage). A. Pyun is supported by Silk Road Medical Inc (food and beverage) and Medtronic Inc (education). G. Magee is supported by Silk Road Medical Inc (consulting, travel and lodging, food and beverage), Medtronic Inc (consulting fees, travel and lodging), WL Gore & Associates (consulting fees, food and beverage), ShockWave Medical Inc (travel and lodging and food and beverage), Penumbra Inc, Boston Scientific Inc and Bolton Medical Inc (food and beverage). N. Swerdlow is supported by Silk Road Medical Inc and Shape Memory Medical Inc (food and beverage). M. Juszczak is supported by Cook Medical (research support) and Terumo (research grant). A. Barleben is supported by Cook Medical (consulting; travel and lodging fees), Endologix LLC (consulting; food and beverage), WL Gore & Associates (food and beverage), Silk Road Medical Inc (food and beverage), Penumbra Inc (consulting; travel and lodging), Musculoskeletal Transplant Foundation Inc (food and beverage), Abbott Laboratories (food and beverage), Surmodics Inc (food and beverage), and Cagent Vascular Inc (food and beverage). R. Patel is supported by Silk Road Medical Inc (food and beverage). M.P. Sweet is supported by Artivion Inc and Bolton Medical Inc (food and beverage). S.L. Zettervall is supported by WL Gore & Associates Inc, Bolton Medical Inc, Cook Medical, and Terumo Aortic (consulting and research support), Silk Road Medical Inc and Artivion Inc (food and beverage). G.S. Oderich is supported by Cook Medical (consulting, travel and lodging, speaking fees), WL Gore & Associates (consulting, travel and lodging, education, food and beverage), GE HealthCare (speaking fees, food and beverage), Centerline Biomedical Inc (consulting), Atrium Medical Corporation, Silk Road Medical Inc, Bard Peripheral Vascular Inc, Medtronic Inc (food and beverage). The remaining authors have no conflict of interest to declare.

Objectives: Studies have demonstrated that socioeconomic status, insurance, race, and distance impact clinical outcomes in patients with abdominal aortic aneurysms. The purpose of this study was to assess if these factors also impact clinical outcomes in patients with thoracoabdominal aortic aneurysms (TAAAs)., Methods: We conducted a retrospective review of patients with TAAAs confirmed by computed tomography imaging between 2009 and 2019 at a single institution. Patients' zip codes were mapped to American Community Survey Data to obtain geographic poverty rates. We used the standard U.S. Census definition of high-poverty concentration as >20% of the population living at 100% of the poverty rate. Our primary outcome was overall survival, stratified by whether the patient underwent repair., Results: Of 578 patients, 575 had zip code data and were analyzed. In both the nonoperative (N = 268) and operative (N = 307) groups, there were no significant differences in age, race, comorbidities, clinical urgency, surgery utilization, or surgery modality between patients living in high-poverty areas (N = 95, 16.4%) vs not. In the nonoperative group, patients from high-poverty areas were more likely to have aneurysm due to dissection (37.5% vs 17.6%, P = .03). In multivariate analyses, patients from high-poverty zip codes had significantly worse nonoperative survival (hazard ratio [HR]: 1.9, 95% confidence interval [CI]: 1.1-3.3, P = .03). In the repair group, high poverty was also a significant predictor of reduced postoperative survival (HR: 1.65, 95% CI: 1-2.63, P = .04). Adding the Gagne Index, these differences persisted in both groups (nonoperative: HR: 1.93, 95% CI: 1.01-3.70, P = .05; operative: HR: 1.62, 95% CI: 1.03-2.56, P = .04). In Kaplan-Meier analysis, the difference in postoperative survival began approximately 1.5 years after repair. Private insurance was predictive of improved postoperative survival (HR: 0.42, 95% CI: 0.18-0.95, P = .04) but reduced nonoperative survival (HR: 2.05, 95% 1.01-4.14, P = .04). Data were insufficient to determine if race impacted survival discretely from poverty status. These results were found after adjusting for age, race, sex, maximum aortic diameter, coronary artery disease, distance from the hospital, insurance, and active smoking. Interestingly, in multivariate regression, traveling greater than 100 miles was correlated with increased surgery utilization (odds ratio: 1.58, 95% CI: 1.08-2.33, P = .02) and long-term survival (HR: 0.61, 95% CI: 0.41-0.92, P = .02)., Conclusions: Patients with TAAAs living in high-poverty areas had significantly more dissections and suffered a nearly doubled risk of mortality compared with patients living outside such areas. These data suggest that these disparities are attributed to the overall impacts of poverty and highlight the pressing need for research into TAAA disparities., Competing Interests: Disclosures S.L.Z. received financial compensation from Gore as a consultant. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The only commercially available thoracic branched endoprosthesis (TBE) for treatment of the aortic arch was released in 2022. Limited data outside of clinical trial results have been reported. This study describes the demographics, anatomic details, and outcomes for patients treated for zone 0 to 2 using TBEs outside of a clinical trial., Methods: All patients treated using TBEs for zone 0 to 2 were included. Patients treated as part of the clinical trial for zone 0 to 1 (n = 6) were excluded. Patient demographics, comorbidities, anatomic and operative details, and outcomes were reported. Outcomes and survival were then compared between groups., Results: Of 40 patients, six patients underwent repair of zone 0, three of zone 1, and 31 of zone 2. There were no differences in demographics, comorbidities, or operative details by zone of treatment; however, the frequency of genetic aortopathy differed (zone 0: 0%; zone 1: 67%; and zone 2: 6.4%; P < .01). Seventy-three percent of patients were treated for dissection vs 27% with isolated aneurysms. Of the patients, 2.5% were treated for rupture, 22% were treated for symptomatic aneurysms, and 75% were treated electively. Forty-eight percent of repairs included a proximal cuff, and 83% received distal extension. Technical success was achieved in 100% of patients. Mean fluoroscopy time was 18 minutes, and median fluoroscopy dose was 416 mGy. Sixty percent of patients had prior aortic ascending/arch repair. TBE was planned as part of a complete thoracoabdominal repair in 45% of patients. Thirty-day mortality was 2.5% overall, with a single death in a zone 0 patient that occurred at day 1 due to a myocardial infarction. There were no reinterventions within 30 days. All other outcomes were similar. The 30-day stroke rate was 5.0%. The strokes occurred at day 6 (zone 1) and day 15 (zone 2); however, both were due to occlusion of a prior proximal surgical bypass and unrelated to the TBE side branch or embolization. Specifically, both patients had occlusion of a branch of their prior zone 1 or zone 2 arch replacement. An endoleak occurred in 7.5% of patients at 30-day follow-up (type II: 5.0%; unknown: 2.5%). At a mean follow-up of 6.6 months, 100% of side branches were patent., Conclusions: Repair of the aortic arch including TBE can be performed electively and urgently with acceptable stroke and death rates. TBE provides a valuable tool for patients requiring complete repair of a thoracoabdominal aneurysm. Continued investigation is underway to assess long-term safety and efficacy outside of the clinical trial., Competing Interests: Disclosures S.Z. reports scientific advising and consulting for W.L. Gore, Cook Medical, and Terumo Aortic., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is., Methods: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends., Results: A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher., Conclusions: PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Endovascular treatment allows for the staging of thoracoabdominal aortic aneurysm repairs (eTAAAs) in an effort to decrease the risk of spinal cord ischemia (SCI), but data are limited., Methods: We studied all eTAAAs in the Vascular Quality Initiative from 2014 to 2021. Inverse probability weighting was used to compare perioperative and long-term outcomes of staged and single-stage repairs. Thoracoabdominal life-altering events (TALEs) are the composite endpoint consisting of death/stroke/permanent SCI/permanent dialysis., Results: There were 3,258 total operations during the study period. In total, 841 cases (26%) were staged repairs, and 2,417 (74%) were completed in a single stage, but in the cohort of patients with extensive aneurysms, 44% were staged. Staging methods included thoracic endograft (78%), branch (23%), and iliac (5%). Staged repairs were more often employed by high-volume surgeons at high-volume centers; for larger, more extensive aneurysms, with higher rates of prior aortic surgery. After adjustment, staged repair and single-stage treatment were associated with similar odds of all perioperative outcomes and including mortality, TALE, acute kidney injury, stroke, dialysis, and SCI, as well as long-term survival. This was consistent in the subgroups of patients with extensive aneurysms undergoing elective procedures. Of note, first-stage thoracic endografts were associated with 2.6% mortality, 7.3% TALE, 1.5% dialysis, and 4.1% SCI, and 25% of patients did not undergo a second stage. First-stage procedures accounted for one-third of perioperative complications including half of the deaths in the staged cohort., Conclusions: Staged eTAAA repairs were associated with similar perioperative and long-term complications to single-stage treatments. However, first stage procedures are associated with significant morbidity and mortality, and one-quarter of patients never complete their repairs. These data demonstrate the necessity of evaluating the outcomes of all patients planned for staged procedures, not only those who make it to the final stage. More data are needed as to the optimal method of spinal cord protection for these challenging aneurysms., (Copyright © 2023. Published by Elsevier Inc.)

Background: Recent literature has suggested a decreasing experience with open aortic surgery among recent vascular surgery graduates. While trainees have a wide exposure to endovascular aortic repair, experience with both endovascular and open management of thoracoabdominal aneurysms, as well as the early career surgeon comfort with these procedures, remains unknown. Thus, we sought to evaluate early practice patterns in the surgical treatment of complex aortic surgery among recent US vascular surgery graduates., Methods: An anonymous survey was distributed among all vascular surgeons who completed vascular surgery residency or fellowship in 2020. Self-reported data assessed the number and type of cases performed in training, surgeon experience in early practice, and surgeon desire for additional training in these areas., Results: A total of 62 surgeons completed the survey with a response rate of 35%. Seventy-nine percent of respondents completed fellowship training (as compared to integrated residency), and 87% self-described as training in an academic environment. Sixty-six percent performed less than 5 open thoracoabdominal aortic surgeries and 58% performed less than 5 4-vessel branched/fenestrated aortic repairs (F/BEVARs), including 56% who completed less than 5 physician modified endovascular grafts repairs. Only 11% of respondents felt adequately prepared to perform open thoracoabdominal operations following training. For both open and F/BEVAR procedures, more than 80% respondents plan to perform such procedures with a partner in their current practice, and the majority desired additional open (61%) and endovascular (59%) training for the treatment of thoracoabdominal aneurysms., Conclusions: The reported infrequency in open thoracoabdominal and multivessel F/BEVAR training highlights a desire and utility for an advanced aortic training paradigm for surgeons wishing to focus on this area of vascular surgery. Further research is warranted to determine the optimal way to provide such training, whether through advanced fellowships, junior faculty apprenticeship models, or regionalization of this highly complex patient care. The creation of these programs may provide pivotal opportunity, as vascular surgery and the management of complex aortic pathology continues to evolve., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs)., Background: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described., Methods: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair., Results: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001)., Conclusions: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment., Competing Interests: Consulting, research grants and/or advisory boards: T.J. (Medical University of Warsaw)—Artivion, Cook Medical; B.C.M. (Mayo Clinic)—Cook Medical, WL Gore, Medtronic; T.K. (University of Hamburg)—Cook Medical; J.S.—(University of Lille)—Cookmedical, WLGore, GE Healthcare; L.B. (Hospital San Raffaelle)—Cook Medical; B.M. (Maastricht UMC)—Cook Medical, WL Gore, Phillips, Bentley; M.G. (University of Bologna-DIMEC)—Cook Medical, WL Gore; N.D. (Lund University)—Cook Medical; A.S. (University of Massachusetts)—Cook Medical, Philips, Artivion; A.B. (University of Alabama)—Artivion, Cook Medical, Medtronic, WL Gore, Terumo; K.M. (Uppsala university)—Cook Medical; M.F. (University of North Carolina)—Cook Medical, WL Gore, ViTaaa, Centerline, Getinge; C.T. (University of Texas Southwestern)—Cook Medical, WL Gore; D.B.S. (University of Pennsylvania)—Cook Medical, WL Gore, Endologix, Medtronic; N.T. (Ludwig-Maximilians-University Hospital)—Cook Medical; S.H. (Université Paris Saclay)—Cook Medical, Bentley, and GE healthcare; M.P.S. (University of Washington)—Artivion; E.F. (Universidade NOVA de Lisboa)—Cook Medical, Medtronic; M.E. (Harvard Medical School)—Cook Medical; K.K.Y. (Amsterdam UMC)—Medtronic, W.L. Gore&Associates, Terumo Aortic; G.P. (University of Hamburg)—Cook Medical, Philips; A.K. (Vita-Salute University)—Alvimedica/CID, Boston Scientific, Cordis, Getinge, Medtronic, and Terumo; G.W.S. (Maastricht UMC)—Cook Medical, Philips; S.L.Z. (University of Washington)—WL Gore; G.S.O. (University of Texas Health Science Center)—Cook Medical, WL Gore, GE healthcare, Centerline. The remaining authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Endovascular aortic aneurysm repair (EVAR) has lower rates of postoperative mortality and morbidity when compared with open repair. However, endovascular repair still carries the risk of postoperative dialysis, paralysis, and stroke. This study examined the rates of postoperative mortality and morbidity stratified by type of endovascular aortic aneurysm repair., Methods: All patients who underwent EVAR in the Vascular Quality Initiative registry from January 2011 to May 2022 were identified. Patients were stratified by repair type: infrarenal EVAR, complex EVAR, thoracic endovascular aortic repair (TEVAR), extent I to III thoracoabdominal aortic aneurysm (TAAA) repair, or aortic arch repair. The primary outcome was postoperative thoracoabdominal aortic aneurysm life-altering events (TALE) across the different treatment groups. TALE was defined as a composite outcome of postoperative mortality, dialysis, paralysis, and/or stroke. Mixed effect logistic regression modeling was used to identify procedural and anatomic factors that were independently associated with TALE., Results: A total of 52,592 EVARs, 3768 complex EVARs, 3899 TEVARs, 1139 extent I to III TAAA repairs, and 479 arch repairs were identified. TALE was observed in 1.2% of EVARs, 4.8% of complex EVARs, 6.0% of TEVARs, 10% of extent I to III TAAA repairs, and 14% of arch repairs. More proximal landing zone was associated with higher odds of TALE after complex EVAR (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.2-3.1; P = .008), TEVAR (OR, 2.2; 95% CI, 1.4-3.5; P = .001), and extent I to III TAAA repair (OR, 2.7; 95% CI, 1.5-4.9; P = .001). Aortic diameter >65 mm was associated with higher odds of TALE after infrarenal EVAR (OR, 1.8; 95% CI, 1.4-2.3; P < .001), complex EVAR (OR, 1.6; 95% CI, 1.1-2.3; P = .010), TEVAR (OR, 2.7; 95% CI, 2.0-3.8; P < .001), and arch repair (OR, 2.4; 95% CI, 1.3-4.4; P = .007). The use of parallel grafting technique (chimney/snorkel/periscope) during extent I to III TAAA repair was also associated with higher odds of TALE (OR, 1.8; 95% CI, 1.1-3.2; P = .032). Preoperative chronic kidney disease was also associated with higher odds of TALE after infrarenal EVAR (OR, 4.3; 95% CI, 3.0-5.7; P < .001), complex EVAR (OR, 5.2; 95% CI, 3.3-8.2; P < .001), TEVAR (OR, 4.5; 95% CI, 2.8-7.1; P < .001), and extent I to III TAAA repair (OR, 3.2; 95% CI, 1.6-6.7; P = .001)., Conclusions: Although TALE was originally described for TAAA repairs, TALE may occur after complex EVAR, TEVAR, and arch repairs as well. Therefore, TALE and its component parts should be used to evaluate the efficacy of all aortic repairs and for preoperative counseling. Additionally, surgeons should be aware of anatomic and procedural characteristics that are associated with higher odds of TALE. The anticipated need for such interventions during aortic repair should be factored into preoperative risk assessment of patients., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to evaluate the effect of directional branches (DBs) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms., Methods: Patients enrolled in nine prospective physician-sponsored investigational device exemption studies in the United States between 2005 and 2020 were analyzed. All patients who had at least one TA incorporated by DB using either self-expandable (SESGs), balloon-expandable (BESGs), or hybrid stent graft combinations (HSGs). Endpoints were TA patency and freedom from TA endoleak, instability, and reintervention., Results: There were 800 patients with 2426 renal-mesenteric arteries incorporated by DBs. DB stent selection was SESGs in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSGs in 126 TAs (5%). SESGs were predominantly used in the first three quartiles of the study period, whereas BESGs comprised 75% of all stents between 2017 and 2020. The median follow-up was 15 months (interquartile range, 6-35 months). At 5 years, BESGs had significantly lower freedom from TA instability (78% ± 4% vs 88% ± 1% vs 96% ± 2%; log-rank P =.010), freedom from TA endoleaks (87% ± 3% vs 97% ± 1% vs 99% ± 1%; log-rank P < .001), and freedom from TA reintervention (83% ± 4% vs 95% ± 1% vs 99% ± 2%; log-rank P <.001) compared with SESGs or HSGs, respectively. For renal arteries, there was no difference in freedom from TA instability for BESGs, SESGs, or HSGs. However, freedom from TA endoleaks and reintervention were lower for renal arteries targeted by BESGs compared with DBs targeted by SESGs and HSGs (83% ± 6% vs 98% ± 1% vs 100%; log-rank P < .001; and 70% ± 10% vs 92% ± 1% vs 96% ± 4%; log-rank P = .022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSGs. In stent-specific analysis, iCAST BESGs had the lowest freedom from TA instability either for renal or mesenteric arteries, primarily due to higher rates of TA endoleaks. There was no difference in patency in any scenario. Independent predictors of TA instability were age (+1-year: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-0.99), stent diameter (+1 mm: HR, 0.67; 95% CI, 0.57-0.80), and BESG (HR, 1.8; 95% CI, 1.1-2.9)., Conclusions: DBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared with SESGs and HSGs. The patency of DBs was not affected by the type of stent construction. The observed performance disadvantage associated with BESGs appears to have largely been driven by iCAST usage., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Reports of endovascular treatment of chronic post-dissection aneurysms are limited to high volumes centres, posing questions about generalisability., Methods: All endovascular repairs of intact pararenal and thoraco-abdominal aneurysms in the Vascular Quality Initiative from 2014 to 2021 were studied, and peri-operative and long term outcomes were compared between repairs of degenerative and post-dissection aneurysms. Peri-operative outcomes were compared using mixed effects logistic regression, and long term outcomes using Medicare linkage., Results: There were 123 patients who completed treatment for post-dissection aneurysms and 3 635 for degenerative aneurysms, with 36% of post-dissection repairs and 6.7% of degenerative repairs performed in a staged fashion (p < .001). The majority (84%) of post-dissection aneurysms were extensive thoraco-abdominal aneurysms (TAAAs: Crawford Type 1, 2, 3, 5), compared with 22% of degenerative aneurysms (p < .001). Physician modified endografts were the primary repair type for post-dissection (73%), while commercially available fenestrated grafts were the dominant repair for degenerative (48%). The first stage of staged procedures was associated with a 2.8% peri-operative mortality rate, 5.1% spinal cord ischaemia, and 8.9% thoraco-abdominal life altering events (the composite of peri-operative death, stroke, permanent spinal cord ischaemia, and dialysis). Th final stage procedure and fluoroscopy times were similar, but technical success was lower in post-dissection repairs (75% vs. 83%, p = .018), both due to issues with the main endograft or bridging vessels (11% vs. 6.6%, p = .055), and types 1and 3 endoleak at completion (17% vs. 10%, p = .035). In addition, high volume surgeons had two fold higher odds of technical success than their low volume counterparts. Adjusted peri-operative outcomes were similar between pathology types, including when comparisons were restricted to extensive TAAAs. Crude and adjusted three year survival were similar, but three year re-interventions were significantly higher following post-dissection repairs (p < .001)., Conclusion: Complex endovascular repair of chronic post-dissection aneurysms is feasible but is associated with high rates of re-interventions and non-trivial rates of lack of technical success. More data are needed to evaluate the long term durability of these procedures, and the utility of centralising these complex procedures., (Copyright © 2023 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: Spinal cord ischemia (SCI) is a well-known complication of thoracoabdominal aortic aneurysm repair and is associated with profound morbidity and mortality. The purpose of this study was to describe predictors for the development of SCI, as well as outcomes for patients who develop SCI, after branched/fenestrated endovascular aortic repair in a large cohort of centers with adjudicated physician-sponsored investigational device exemption studies., Methods: We used a pooled dataset from nine US Aortic Research Consortium centers involved in investigational device exemption trials for treatment of suprarenal and thoracoabdominal aortic aneurysms. SCI was defined as new transient weakness (paraparesis) or permanent paraplegia after repair without other potential neurological etiologies. Multivariable analysis was performed to identify predictors of SCI, and life-table analysis and Kaplan-Meier methodologies were used to evaluate survival differences., Results: A total of 1681 patients underwent branched/fenestrated endovascular aortic repair from 2005 to 2020. The overall rate of SCI was 7.1% (3.0% transient and 4.1% permanent). Predictors of SCI on multivariable analysis were Crawford Extent I, II, and III distribution of aortic disease (odds ratio [OR], 4.79; 95% confidence interval [CI], 4.77-4.81; P < .001), age ≥70 years (OR, 1.64; 95% CI, 1.63-1.64; P = .029), packed red blood cell transfusion (OR, 2.00; 95% CI, 1.99-2.00; P = .001), and a history of peripheral vascular disease (OR, 1.65; 95% CI, 1.64-1.65; P = .034). The median survival was significantly worse for patients with any degree of SCI compared with those without SCI (any SCI, 40.4 vs no SCI, 60.3 months; log-rank P < .001), and also worse in those with a permanent deficit (24.1 months) vs those with a transient deficit (62.4 months) (log-rank P < .001). The 1-year survival for patients who developed no SCI was 90.8%, compared with 73.9% in patients who developed any SCI. When stratified by degree of deficit, survival was 84.8% at 1 year for those who developed paraparesis and 66.2% for those who developed permanent deficits., Conclusions: The overall rates of any SCI at 7.1% and permanent deficit at 4.1% observed in this study compare favorably with those reported in contemporary literature. Our findings confirm that increased length of aortic disease is associated with SCI and those with Crawford Extent I to III thoracoabdominal aortic aneurysms are at highest risk. The long-term impact on patient mortality underscores the importance of preventive measures and rapid implementation of rescue protocols if and when deficits develop., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Complex endovascular aortic surgery has been associated with increased fluoroscopic radiation exposure. The radiation dosage necessary for visualization is dependent on the amount of tissue penetration required. Elevation of a patient's arms above their head during endovascular surgery could improve visualization by removing the arms from the field of view. Furthermore, it might reduce the radiation dose required. In the present study, we sought to determine the effect of arm elevation on radiation exposure during endovascular treatment of thoracoabdominal aneurysms., Methods: All patients enrolled in a single-institution, physician-sponsored investigational device exemption study for endovascular treatment of thoracoabdominal aneurysms (fenestrated/branched endovascular aortic repair [F/BEVAR]) from 2012 to 2022 were assessed. The first 30 patients treated were excluded to account for the learning curve required with treatment. Patients treated after December 2020 were positioned with their arms elevated above their head using an overhead arm support (OAS). These patients were compared with those who had undergone F/BEVAR before the practice change. The radiation dose, fluoroscopy time, and contrast volume used were compared. A subgroup analysis was performed to assess the effect for patients with brachial access., Results: A total of 145 patients were included in the present study, of whom 43 (30%) had undergone F/BEVAR with their arms supported overhead. No differences were identified in age, body mass index, aneurysm size, or prior aortic intervention between the groups with and without the use of the OAS. A history of dissection (23% vs 7.8%; P = .01) was more frequent for the patients treated with their arms elevated. Arm elevation was associated with a significant reduction in the mean radiation exposure (2261 vs 3100 mGy; P = .01). No differences were observed in the fluoroscopy time or contrast volume used between the two groups. In addition, no patient experienced palsy of the brachial plexus. Of the 145 patients, 55 (38%) had required brachial arterial access, limiting their ability to elevate both arms. In the subgroup analysis, the patients without brachial access continued to show a significant reduction in radiation exposure with arm elevation (2159 vs 3179 mGy; P < .01)., Conclusions: Elevation of a patient's arms above their head using an OAS during F/BEVAR offered a low-cost, simple strategy that resulted in a 30% reduction in radiation exposure without added complications. This technique improved visualization and reduced radiation exposure for patients and physicians and should be included in abdominal aortic and visceral procedures work to improve patient and surgeon safety., (Copyright © 2023. Published by Elsevier Inc.)

Objective: The use of upper extremity (UE) access is an accepted and often implemented approach for fenestrated/branched endovascular aortic aneurysm repair (F-BEVAR). The advent of steerable sheaths has enabled the performance of F-BEVAR using a total transfemoral (TF) approach without UE access, potentially decreasing the risks of cerebral embolic events. The purpose of the present study was to assess the outcomes of F-BEVAR using UE vs TF access., Methods: Prospectively collected data from nine physician-sponsored investigational device exemption studies at U.S. centers were analyzed using a standardized database. All patients were treated for complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) using industry-manufactured fenestrated and branched stent grafts between 2005 and 2020. The outcomes were compared between patients who had undergone UE vs total TF access. The primary composite outcome was stroke or transient ischemia attack (TIA) and 30-day or in-patient mortality during the perioperative period. The secondary outcomes included technical success, local access-related complications, and perioperative mortality., Results: Among 1681 patients (71% men; mean age, 73.43 ± 7.8 years) who had undergone F-BEVAR, 502 had had CAAAs (30%), 535 had had extent IV TAAAs (32%), and 644 had had extent I to III TAAAs (38%). UE access was used for 1103 patients (67%). The right side was used for 395 patients (24%) and the left side for 705 patients (42%). UE access was preferentially used for TAAAs (74% vs 47%; P < .001). In contrast, TF access was used more frequently for CAAAs (53% vs 26%; P < .01). A total of 38 perioperative cerebrovascular events (2.5%), including 32 strokes (1.9%) and 6 TIAs (0.4%), had occurred. Perioperative cerebrovascular events had occurred more frequently with UE access than with TF access (2.8% vs 1.2%; P = .036). An individual component analysis of the primary composite outcome revealed a trend for more frequent strokes (2.3% vs 1.2%; P = .13) and TIAs (0.54% vs 0%; P = .10) in the UE access group. On multivariable analysis, total TF access was associated with a 60% reduction in the frequency of perioperative cerebrovascular events (odds ratio, 0.39; P = .029). No significant differences were observed between UE and TF access in the technical success rate (96.5% vs 96.8%; P = .72), perioperative mortality (2.9% vs 2.6%; P = .72), or local access-related complications (6.5% vs 5.5%; P = .43)., Conclusions: In the present large, multicenter, retrospective analysis of prospectively collected data, a total TF approach for F-BEVAR was associated with a lower rate of perioperative cerebrovascular events compared with UE access. Although the cerebrovascular event rate was low with UE access, the TF approach offered a lower risk of stroke and TIA. UE access will continue to play a role for appropriately selected patients requiring more complex repairs with anatomy not amenable to the TF approach., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Precise preoperative planning for fenestrated and branched endovascular repair of aortic aneurysms is essential for safe and successful surgery. Planning should begin with a high-quality computed tomography angiography of the chest abdomen and pelvis, which is input into post-processing software to create centerline formatting of the aorta, iliac, and target vessels. The aorta and its branches should then be assessed for aberrant anatomy, dissection, and extent of disease. In any patient with evidence of dissection, a plan should be established for intravascular ultrasound assessment of wire location to confirm the appropriately selected lumen. The proximal and distal seal zones should be selected in areas of a healthy, nonangulated, and parallel vessel free from degeneration calcification and atheroma. The proximal and distal devices can then be selected with 10% to 20% oversizing. Target vessels are evaluated for incorporation and assessed for vessel size, stenosis, dissection, and distance to branching vessels, all of which guide suitability for fenestrated and branched endovascular repair of aortic aneurysms and sizing for bridging stents. The celiac and superior mesenteric arteries should be incorporated for repair, even if evidence of proximal stenosis is identified, as should accessory renal arteries >4 mm. Although total femoral access is now widely used, all access options should be carefully evaluated for size, calcification, and dissection, including bilateral femoral, iliac, subclavian, and brachial vessels. Finally, optimal C-Arm gantry angles should be planned to clearly identify the orifice and first branch of target vessels, as well as proximal and distal sealing zones., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: Operative repair of thoracoabdominal aortic aneurysms (TAAAs) is high risk, and many patients will be unfit for intervention. Prior studies have noted lower rates of repair for women than for men. The reasons for this disparity have remained unknown but could include a greater burden of co-morbid illness or anatomic barriers. Frailty could also contribute to the lower intervention rates but has rarely been reported in preoperative risk assessments. The aim of the present study was to assess the sex-related differences in clinical comorbidities, anatomic suitability, and frailty among an unselected cohort of patients who had presented with TAAAs., Methods: All patients with extent I to V TAAAs confirmed by computed tomography imaging between 2009 and 2019 at a single institution were reviewed. Patients were included regardless of whether they had undergone repair. Clinical comorbidities, anatomic details, and metrics of frailty were collected and used to determine operative risk., Results: Of the 578 identified patients, 233 (40%) were women. The women were older than the men at diagnosis (71 years vs 68 years; P = .006) but had had similar comorbidities, with the exception of lower rates of coronary artery disease (37% vs 47%; P = .04) and higher rates of chronic obstructive pulmonary disease (45% vs 36%; P = .008). The Society for Vascular Surgery clinical comorbidity score was similar between the sexes. Women were less likely to have undergone prior aortic surgery (32% vs 53%; P < .0001) but had had more extensive aneurysms (P = .007) with greater rates of prohibitive anatomic risk factors (open repair, 31% vs 17% [P = .01]; endovascular repair, 33% vs 28% [P = .32]). The metrics of frailty were higher for the women, including recent unintentional weight loss (11% vs 5%; P = .002), limited physical activity tolerance (46% vs 31%; P < .0001), and the need for ambulatory assistance (13% vs 6%; P < .0001). Of the 578 patients, 55% of the women and 30% of the men had had at least one frailty metric that was prohibitive for open repair (P = .0006). The women had also scored higher on the modified frailty index (P = .009). For open repair, 74% of women and 61% of men had at least one prohibitive risk factor. The women were also more likely to have multiple types of prohibitive risk factors. Compared with the men, the women were less likely to be offered repair (60% vs 74%; P = .0009) and less likely to undergo repair (44% vs 62%; P = .0001)., Conclusions: Women with TAAAs had increased metrics of frailty and anatomic risk that were not captured by comorbidity-based risk assessments. This suggests that frailty, together with complex anatomy, could explain the lower intervention rates for women with TAAAs., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Secondary interventions are common after endovascular repair of aortic aneurysms. However, the frequency and procedural details of secondary interventions after fenestrated or branched endovascular abdominal aortic aneurysm repair (F/BEVAR) have been less well described, and the effects on long-term survival and aneurysm-related mortality are unknown., Methods: Consecutive patients enrolled as a part of a multicenter research consortium in nine independent physician-sponsored investigational device exemption studies from 2005 to 2020 were evaluated. All secondary interventions performed after the initial procedure were classified as open or percutaneous and as major or minor in accordance with the Society for Vascular Surgery reporting standards. Secondary interventions were further classified as high or low magnitude according to the physiologic effects of the intervention. The demographics, procedural details, and perioperative outcomes were compared between those who had and those who had not undergone secondary interventions. Kaplan-Meier and Cox proportional hazard ratio (HR) analysis were used to evaluate long-term survival., Results: Of 1681 patients who had undergone F/BEVAR, 385 (23%) had required a secondary intervention at any point during follow-up. Freedom from reintervention was 82% at 1 year and 59% at 5 years of follow-up. The mean follow-up period was 23 months. Most secondary interventions were percutaneous (84%), minor (70%), and of low magnitude (81%). Renal stenting (30%) and access-related procedures (24%) were the most frequent percutaneous and open procedures, respectively. High magnitude operations were required for 19% of the patients. Technical success was achieved for 94% of the secondary interventions, and mortality from the secondary interventions was <1%. Secondary interventions as a whole were associated with improved long-term survival (HR, 0.6; 95% confidence interval [CI], 0.5-0.7). In the subgroup analysis, major (HR, 0.6; 95% CI, 0.4-0.8), minor (HR, 0.6; 95% CI, 0.5-0.8), low magnitude (HR, 0.5; 95% CI, 0.4-0.7), and percutaneous (HR, 0.6; 95% CI, 0.5-0.7) secondary interventions were associated with improved survival. However, high magnitude (HR, 1.0; 95% CI, 0.7-1.5) and open (HR, 1.0; 95% CI, 0.7-1.5) secondary interventions were not. Similarly, when aneurysm-related survival was specifically assessed, low magnitude secondary interventions were found to improve survival (HR, 0.3; 95% CI, 0.1-0.7), and high magnitude secondary interventions (HR, 2.8; 95% CI, 1.4-5.8) and open secondary interventions (HR, 2.7; 95% CI, 1.3-5.5) were associated with increased mortality., Conclusions: Secondary interventions after F/BEVAR were frequent and were typically percutaneous, minor, and low magnitude procedures. Although uncommon, high magnitude and open secondary interventions were associated with decreased long-term survival and increased aneurysm-related mortality. These data highlight the importance of close, lifelong surveillance and suggest that a significant rate of secondary intervention should be anticipated but that these will not negatively affect survival., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Thoracic endovascular aortic repair (TEVAR) has become an alternative to open repair for the treatment of ruptured thoracic aortic aneurysms (rTAAs). The aim of this study was to assess national trends in the use of TEVAR for the treatment of rTAA and to determine its impact on perioperative outcomes., Methods: Patients admitted with an rTAA between 1993 and 2012 were identified from the National Inpatient Sample. Patients were grouped in accordance with their treatment: TEVAR, open repair, or nonoperative treatment. The primary outcomes were treatment trends over time and in-hospital death. Secondary outcomes included perioperative complications and length of stay. Trend analyses were performed using the Cochran-Armitage test for trend, and adjusted mortality risks were established using multivariable logistic regression analysis., Results: A total of 12,399 patients were included, with 1622 (13%) undergoing TEVAR, 2808 (23%) undergoing open repair, and 7969 (64%) not undergoing surgical treatment. TEVAR has been increasingly used from 2% of total admissions in 2003-2004 to 43% in 2011-2012 (P < .001). Concurrently, there was a decline in the proportion of patients undergoing open repair (29% to 12%; P < .001) and nonoperative treatment (69% to 45%; P < .001). The proportion of patients undergoing surgical repair has increased for all age groups since 1993-1994 (P < .001 for all) but was most pronounced among those aged 80 years with a 7.5-fold increase. After TEVAR was introduced, procedural mortality decreased from 36% in 2003-2004 to 27% in 2011-2012 (P < .001); mortality among those undergoing nonoperative treatment remained stable between 63% and 60% (P = .167). Overall mortality after rTAA admission decreased from 55% to 42% (P < .001). Since 2005, mortality for open repair was 33% and 22% for TEVAR (P < .001). In adjusted analysis, open repair was associated with a twofold higher mortality than TEVAR (odds ratio, 2.0; 95% confidence interval, 1.7-2.5)., Conclusions: TEVAR has replaced open repair as primary surgical treatment for rTAA. The introduction of endovascular treatment appears to have broadened the eligibility of patients for surgical treatment, particularly among the elderly. Mortality after rTAA admission has declined since the introduction of TEVAR, which is the result of improved operative mortality as well as the increased proportion of patients undergoing surgical repair., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)