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Objective: To report outcomes of urgent juxtarenal/pararenal aneurysms (J/P-AAAs) managed by off-the-shelf multibranched thoracoabdominal endografts (Cook, T-branch)., Methods: In this observational, multicenter, retrospective study, patients with J/P-AAAs treated by urgent endovascular repair by T-branch in 23 European aortic centers, from 2013 to 2023, were analyzed. Contained J/P-AAAs rupture, presence of related symptoms, and aneurysm diameter of >70 mm were considered as indication for urgent repair. Technical success (TS), spinal cord ischemia (SCI), and 30-day/hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions, and target artery instability (TAI) were evaluated during follow-up., Results: Overall, 197 patients (J-AAAs, n = 64 [33%]; P-AAAs, n = 95 [48%]; previous failed endovascular aneurysm repair (EVAR), n = 38 [19%]) were analyzed. The mean age and aneurysm diameter was 75 ± 8 years and 76 ± 4 mm, respectively. The American Society of Anesthesiologists score was 3 and 4 in 118 (60%) and 79 (40%) patients. Rupture, symptoms, and diameter of >70 mm were present in 51 (26%), 110 (56%), and 53 (27%) patients, respectively. An adjunctive proximal thoracic endograft was used in 28 cases (14%). The mean aortic coverage between the upper portion of the endograft and the lowest renal artery was 154 ± 49 mm. Single-stage repair and cerebrospinal fluid drainage were reported in 144 (73%) and 53 (27%) cases, respectively. TS was achieved in 182 (92%) cases (rupture, 84% vs no rupture, 95%; P = .02). Failures consist of TA loss (11 [6%]: renal artery, 9; celiac trunk, 2), type I to III endoleaks (2 [1%]), and 24-h mortality (2 [1%]). Rupture was a risk factor for technical failure (P = .02; odds ratio [OR], 3.8; 95% confidence interval [CI], 1.1-12.1). Overall, 15 patients (8%) had persistent SCI (rupture, 14% vs no rupture, 5%) with 11 (6%) , of paraplegia (rupture, 10% vs no rupture, 5%; P = .001). Rupture (P = .04; OR, 3.1; 95% CI, 1.1-8.9) and adjunctive proximal thoracic endograft (P = .01; OR, 4.1; 95% CI, 1.3-12.9) were risk-factors for SCI. Twenty-two patients (11%) died within 30 days or during a prolonged hospitalization. Previous failed EVAR (P = .04; OR, 3.6; 95% CI, 1.1-12.3), paraplegia (P < .001; OR, 9.9; 95% CI, 1.6-62.2) and postoperative mesenteric complications (P = .03; OR, 10.4; 95% CI, 1.2-93.3), as well as cardiac (P = .03; OR, 8.2; 95% CI, 2.0-33.0) and respiratory (P < .001; OR, 10.1; 95% CI, 2.9-35.2) morbidities were associated with 30-day/hospital mortality. The mean follow-up was 19 ± 5 months. The estimated 3-year survival and freedom from reinterventions was 58% and 77%, respectively. TAI occurred in 27 patients (14%) (occlusion, 15; endoleak, 14) with an estimated 3-year freedom from TAI of 72%., Conclusions: Urgent repair of J/P-AAAs by T-branch is feasible and effective with satisfactory TS and 30-day/hospital mortality in high-risk patients. However, extensive aortic coverage is necessary, leading to a non-negligible SCI rate, especially in case of aortic rupture or when adjunctive thoracic endografts are necessary. Previous failed EVAR and postoperative mesenteric complications, as well as cardiac and respiratory morbidities were associated with 30-day/hospital mortality and should be subjected to more research for the purposes of improving outcomes., Competing Interests: Disclosures E.G., G.F., M.A., N.T., G.M., G.S., A.K., K.O., K.M., L.M.P., and M.G. are proctors for Cook Medical and received travel, educational grants, or speaker's fees. T.K., N.D., and S.H. are consultants for Cook Medical and they have intellectual property with Cook Medical and received speaking fees, and research, travel, and educational grants., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR)., Methods: A retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8 × 6 mm) and 2 (6 × 6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level., Results: A total of 796 patients were included in this study, 71.7% male, with a mean age of 73.3 ± 8.1 years. The mean follow-up was 30.0 ± 20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8 × 6 mm, and 52.4% were 6 × 6 mm. At the 30-day landmark, primary patency (99.9% vs 98.0%; P value < .001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%; P value < .001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%; P value = .022 for groups 1 and 2, respectively) were higher in 8 × 6 compared with 6 × 6 fenestrations, and the incidence of acute kidney injury was similar across the groups (92.6% vs 92.7%; P value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8 × 6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, P values = .010 and .021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6 × 6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, P value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3% and 1.6% for 8 × 6 and 6 × 6mm fenestrations, respectively, P = .689). The 6 × 6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8 × 6 fenestrations (7.6%) at 5 years (P < .001). The risk of type IIIc endoleak was significantly higher among 8 × 6 fenestrations at 5 years (4.9% and 2% for 8 × 6 and 6 × 6 mm fenestrations, respectively; P = .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857; P < .001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929; P < .001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921; P = .034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979; P < .001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948; P = .572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938; P = .036)., Conclusions: Fenestration configuration for the renal arteries impacts outcomes. The 8 × 6 small fenestrations have better patency at 30 days, 1 year, and 5 years, whereas 6 × 6 small fenestrations are associated with lower rates of SIs, primarily due to a lower incidence of type IIIc endoleaks. FG ≥5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak, and 5-year patency independently of the fenestration size or vessel diameter., Competing Interests: Disclosures F.E.P. reports stock options from Centerline Biomedical. G.O. reports consulting for Gore, Cook, GE, and Centerline Biomedical. B.M. reports research funding from Gore and Cook; and aortic advisory board for Medtronic (all paid to Mayo Clinic). M.A.F. reports consulting and clinical trial support from WL Gore; consulting for Getinge; research support and clinical trial support from Cook; consulting and clinical trial support from ViTTA; and stock options and clinical trial support from Centerline Biomedical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: This study aimed to assess the impact of urgency on early and midterm outcomes of the Candy-Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair for aortic dissection., Methods: The CP registry was reviewed, and patients were categorized into elective and urgent/emergent groups for analysis. End points included technical success, clinical success, early (30-day) computed tomography angiography findings, early (30-day) mortality, adverse events, and aortic remodeling in patients with available computed tomography angiography follow-up and reintervention., Results: A total of 155 patients received a custom-made CP, of whom 32 patients (44% male, mean age 61 ± 9 years) were treated urgently and 123 patients (63% male, mean age 62 ± 11 years) electively. The primary CP rate was higher in the urgent group (28/32, 88%, in the urgent group vs 96/123, 78%, in the elective group, P = .051). The mean contrast volume was higher in the urgent group (157 ± 56 mL in the urgent group vs 130 ± 71 mL in the elective group, P = .017). Technical success was achieved in all patients in both groups. Clinical success was achieved in 25 of 32 (78%) patients in the urgent group vs 113 and 123 (92%) in the elective group (P = .159). The early mortality rate was 13% (4 of 32 patients) in the urgent group vs 1% (1 of 123 patients) in the elective group (P = .120). There was no statistically significant difference regarding the early adverse events between the urgent and elective CP groups. Early aortic-related reinterventions were required in 6 of 32 (19%) patients in the urgent group vs 6 of 123 (5%) in the elective group (P = .094). Thoracic aortic aneurysm sac regression was lower in the urgent group (5/28, 18%, in the urgent group vs 63/114, 55%, in the elective group, P = .001). Stable thoracic aortic aneurysm sac was higher in the urgent group (22/28, 79%, in the urgent group vs 47/114, 41%, in the elective group, P = .000). An increase in thoracic aortic aneurysm sac occurred in 1 of 28 (4%) patients in the urgent group vs 4 of 114 (4%) patients in the elective group (P = .096)., Conclusions: The urgent use of the CP technique for distal FL occlusion in aortic dissection was feasible and effective. The decrease in aortic FL sac diameter may be affected by the urgent use of CP due to limited sizing availability. However, it achieved a high rate of aortic remodeling., Competing Interests: Disclosures T.K. has intellectual property with Cook Medical; and receives royalties, research, travel and educational grant, speaking fees from and is a consultant and proctor for Cook Medical. S.H. is a consultant for Cook Medical, GE Healthcare, and Bentley. L.B. is a proctor and consultant for Cook Medical. S.T. is a consultant and speaker for WL Gore and Medtronic. T.L. is a proctor and consultant for Cook Canada. T.J. has travel grants, consultation fees, and proctorship fees from Cook Medical and Hammered (Polish representative of Cook Medical). J.S. is a speaker, proctor, and consultant for Cook Medical. N.T. is a proctor for Cook Medical and receives institutional grant from Cook Medical. G.P. is a proctor for Cook Medical. The remaining authors report no conflicts., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: This study aimed to determine the influences of varying severity of sleep apnea syndrome (SAS) on the outcomes after thoracic endovascular aorta repair (TEVAR) in patients with Stanford type B aortic dissection (TBAD)., Methods: This observational study focused on individuals with TBAD plus SAS who received TEVAR between January 2018 and December 2022. Patients were divided into groups according to the results of the portable sleep-breathing monitoring systems: mild SAS (MSAS) and moderate-to-severe SAS (MSSAS). Clinical profiles were collected and analyzed., Results: A total of 121 cases with TBAD plus SAS who underwent TEVAR were enrolled in this study. Two groups were formed by stratifying these cases: MSAS (74 cases) and MSSAS (47 cases). The MSSAS cases were found to be older relative to MSAS cases (51.7 ± 8.3 years vs 57.1 ± 12.8 years; P = .012) and had a higher body mass index (BMI; 25.7 ± 2.3 kg/m 2 vs 27.0 ± 2.3 kg/m 2 ; P = .038). The investigation did not find any appreciable differences between the MSAS and MSSAS groups in terms of complications (endoleak, P = .403; stent-induced new entry, P >.999; and stent displacement: P >.999). However, the MSSAS group exhibited a significantly higher overall mortality rate compared with the MSAS group (log-rank P = .027). The tendency continued when examining cases with Marfan syndrome combined with MSSAS, where the overall mortality rate was significantly greater compared with Marfan syndrome cases with MSAS (log-rank P = .037). The absence of a significant difference was noteworthy in the freedom from reintervention between the MSAS and MSSAS groups (log-rank P = .278). The overall mortality rate was significantly higher in MSSAS group even after adjusting for varying potential confounders in the multivariate cox regression analysis (hazard ratio [HR], 1.875; 95% confidence interval [CI], 1.238-2.586; P = .012). A markedly higher rate of distal stent dilation in the MSSAS group was also observed compared with the MSAS group (HR, 2.5 mm/year [95% CI, 2-3 mm/year] vs HR, 4 mm/year [95% CI, 2.0-5.5 mm/year]; P = .029)., Conclusions: MSSAS is associated with a significantly higher risk of overall mortality and dilation rate of the distal stent after TEVAR for TBAD patients. Hence, aggressive efforts to reverse the severity of SAS in time in these individuals seem to be necessary., Competing Interests: Disclosures None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: This study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch., Methods: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection., Results: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The proximal landing zone was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to III ELs and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) from nonaortic causes., Conclusions: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique., Competing Interests: Disclosures None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Several studies have reported short- and intermediate-term outcomes after thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA); however, reports on long-term (10 years) outcomes are sparse. Therefore, the aim of this study was to analyze predictors impacting long-term outcome after TEVAR for DTAA., Methods: Databases from four academic institutions were reviewed and consecutive cases of TEVAR for DTAA between 1999 and 2021 were included in this retrospective multicenter study (case series). Ethical approval from the institutional review board was obtained and patient demographics and treatment data, as well as follow-up information were retrieved and analyzed., Results: We identified 305 patients (mean age, 72 ± 10 years) who were treated with TEVAR for degenerative DTAA with a mean aortic diameter of 64 mm. Altogether 445 endografts were implanted via femoral access (93%) with a technical success of 94%. Operative mortality, stroke rate, and rate of spinal cord ischemia were 6% (5% for intact, 12% for ruptured DTAA), 4%, and 3%, respectively. Kaplan-Meier estimates for overall survival rates were 76%, 59% and 34% at 1, 5 and 10 years and freedom from reintervention rates were 84%, 73% and 58% at 1, 5 and 10 years, respectively. In multivariate analysis, American Society of Anesthesiologists grade 3 to 5 and nonelective case were identified as predictors for death, whereas as fusiform DTAA, proximal landing zone 2, and hypertension, but not device generation, were predictive for reintervention., Conclusions: This study is, to date, the largest reporting long-term (10 years) outcome on TEVAR for DTAA. We found acceptable rates for long-term survival and freedom from reintervention that were independent of endovascular device generation., Competing Interests: Disclosures B.D. received educational grants from Vascutek/Terumo Aortic and W. L. Gore & Associates and consultancy fees from Cook Medical. A.O. received an educational grant from Jotec; speaker and traveling fees from Cook Medical, Jotec, Lombard, Medtronic, W. L. Gore & Associates, and Endologix; and is proctor/part of the advisory board of Jotec. H.E.B. received an educational grant from W. L. Gore & Associates, and consultancy fees from Vascutek/Terumo Aortic., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Endovascular repair of aortic dissections may be complicated by inadequate sealing zones, persistent false lumen perfusion, and limited space for catheter manipulation and target artery incorporation. The aim of this study was to describe the indications, technical success, and early outcomes of transcatheter electrosurgical septotomy (TES) during endovascular repair of aortic dissections., Methods: We reviewed the clinical data of consecutive patients treated by endovascular repair of aortic dissections with adjunctive TES in two centers between 2021 and 2023. End points were technical success, defined by successful septotomy without dislodgment of the lamella or target artery occlusion, and 30-day rates of major adverse events (MAEs)., Results: Among 197 patients treated by endovascular repair for aortic dissections, 36 patients (18%) (median age, 61.5 years (interquartile range, 55.0-72.5 years; 83% male) underwent adjunctive TES for acute (n = 3 [8%]), subacute (n = 1 [3%]), or chronic postdissection aneurysms (n = 32 [89%]). Indications for TES were severe true lumen (TL) compression (≤16 mm) in 28 patients (78%), target vessel origin from false lumen in 19 (53%), creation of suitable landing zone in 12 (33%), and organ/limb malperfusion in four (11%). Endovascular repair included fenestrated-branched endovascular aortic repair (EVAR) in 18 patients (50%), thoracic EVAR/EVAR/PETTICOAT in 11 (31%), and arch branch repair in 7 (19%). All patients had dissections extending through zones 5 to 7, and 28 patients (78%) underwent TES across the renal-mesenteric segment. Technical success of TES was 92% (33/36) for all patients and 97% (32/33) among those with subacute or chronic postdissection aneurysms. There were three technical failures, including two patients with acute dissections with inadvertent superior mesenteric artery dissection in one patient and distal dislodgement of the dissection lamella in two patients. There were no arterial disruptions. The mean postseptotomy aortic lumen increased from 13.2 ± 4.8 mm to 28.4 ± 6.8 mm (P < .001). All 18 patients treated by fenestrated-branched EVAR had successful incorporation of 78 target arteries. There was one early death (3%) from stroke, and three patients (8%) had major adverse events. After a median follow-up of 8 months (interquartile range, 4.5-13.5 months), 13 patients (36%) had secondary interventions, and two (6%) died from non-aortic-related events. There were no other complications associated with TES., Conclusions: TES is an adjunctive technique that may optimize sealing zones and luminal aortic diameter during endovascular repair of subacute and chronic postdissection. Although no arterial disruptions or target vessel loss occurred, patients with acute dissections are prone to technical failures related to dislodgement of the lamella., Competing Interests: Disclosures C.H.T. and M.S.B. are consultants for and received research support from Cook Medical Inc., W. L. Gore & Associates, and Philips Medical Systems Netherland BV; G.S.O. has received consulting fees and/or grants from W. L. Gore & Associates, Centerline Biomedical, and GE Healthcare. G.S.O. has consulting and scientific advisory board agreement with Cook Medical Inc., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Short distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMDs) with a unibody bifurcated FB design for complex EVAR., Methods: Consecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB designs included FB bifurcated or fenestrated inverted limb devices. End points included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions., Results: Among 168 patients undergoing complex EVAR, 33 patients (19.6%; 78.7% male; mean age, 77 years) received unibody bifurcated FB PS-CMDs. FB bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. The median maximum aneurysm diameter was 61 mm (interquartile range [IQR], 55-69 mm). Prior EVAR was reported by 29 patients (87.9%), of whom 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 patients (90.9%), with median distance of 47 mm (IQR, 38-54 mm). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires and 5 (3.9%) with catheters. The median operative time was 238 minutes (226-300 minutes), with a median fluoroscopy time of 65.5 minutes (IQR, 56.0-77.7 minutes) and a median dose area product of 147 mGy∗cm 2 (IQR, 105-194 mGy∗cm 2 ). Exclusive femoral access was used in 14 procedures (42.4%). Technical success was 100%. Target vessel primary patency was 100% at a median follow-up time of 11.7 months (IQR, 3.5-18.6 months). Two patients (6.06%) required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 type II endoleaks (33.3%) and 1 type Ib endoleak (3.03%) were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred., Conclusions: Complex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB devices., Competing Interests: Disclosures M.S.B. and C.H.T. have been consultants for and received research support from Cook Medical Inc, W. L. Gore & Associates, Inc., and Phillips Healthcare. G.S.O has been a consultant for from Cook Medical Inc, W. L. Gore & Associates, Inc., Centerline Biomedical, and GE Healthcare., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion)., Methods: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months., Results: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year., Conclusions: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair., Competing Interests: Disclosures M.P. reports consulting agreement with Artivion. G.P. reports fee for employ tutoring with Artivion. M.A. reports consulting agreement with Artivion., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair., Methods: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines., Results: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m 2 . Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor., Conclusions: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure., Competing Interests: Disclosures M.F. is a consultant for W. L. Gore & Associates, Cook Medical, Getinge, and ViTAA; and has received research support from Cook Medical, clinical trial support from Centerline Biomedical, W. L. Gore Associates, Cook Medical, and ViTAA; an has stock options in Centerline Biomedical. J.M. has received a research grant from W. L. Gore Associates (granted to University of Colorado). S.H. is a consultant for Cook Medical, Terumo Aortic, and W. L. Gore & Associates (all honoraria paid to USC, no personal income); is on the scientific advisory board for Cook Medical, Terumo Aortic, W. L. Gore & Associates, and Vestek; and has received educational grants from W. L. Gore & Associates and Terumo Aortic, M.M. is on the advisory board of W. L. Gore & Associates. B.S. is a consultant for W. L. Gore & Associates, Cook Medical, Endologix, and Astute Imaging. C.T. has received consulting fees and research support from Cook Medical, W. L. Gore & Associates, and Philips Healthcare. B.M. reports payments to Mayo Clinic, with no personal income, for work on the advisory boards of Cook Medical and Medtronic; as a consultant for Cook Medical and W. L. Gore Associates; and research grants from W. L. Gore Associates and Cook Medical. G.O. reports a consulting agreement with Cook Medical, W. L. Gore Associates, GE Healthcare, and Centerline biomedical; and a research grant from GE Healthcare., (Published by Elsevier Inc.)

Objective: Adequate proximal and distal seal zones are necessary for successful thoracic endovascular aortic repair (TEVAR). Often, the achievement of an adequate distal seal zone requires celiac artery (CA) coverage by endograft with or without preservation of CA blood flow. The outcomes of CA coverage without its flow preservation were studied only in small case series. This study aims to determine the difference in outcomes between CA coverage with vs without preservation of CA blood flow during TEVAR using a multi-institutional national database., Methods: The Vascular Quality Initiative database was reviewed for all TEVAR patients distally landing in zone 6. The cohort was divided into TEVAR with vs without CA flow preservation. Demographic, clinical, and perioperative characteristics, as well as postoperative mortality, morbidities, and complications, were compared between the groups. Univariate and multivariate regression analyses were performed., Results: Of 25,549 reviewed patients, 772 had a distal landing in Zone 6, 212 of which (27.5%) had TEVAR without CA flow preservation, whereas 560 (72.5%) underwent TEVAR with CA flow preservation. Indications for TEVAR were aneurysm in 431 (55.8%), dissection in 247 (32.0%), or other in 94 (12.2%) cases. Patients who underwent TEVAR without CA flow preservation had statistically significantly higher rates of 30-day mortality (11.3% vs 5.9%; P = .010), 30-day disease/treatment-related mortality (8.0% vs 4.3%; P = .039), as well as a tendency of increased intestinal ischemia requiring intervention (1.9% vs 0.5%; P = .077). After adjusting for potential confounders, CA coverage without flow preservation was associated with more than a two-fold increase in the overall 30-day mortality (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.35-5.92; P = .006) and 30-day disease/treatment-related mortality (OR, 2.72; 95% CI, 1.11-6.72; P = .029). In a sub-group analysis based on disease pathology, these results persisted only in the aneurysm group (30-day mortality [OR, 2.36; 95% CI, 1.01-5.48; P = .047]; 30-day disease/treatment-related mortality [OR, 2.88; 95% CI, 1.08-7.67; P = .034]), whereas there was no significant association between CA flow preservation status and the endpoints in the dissection subgroup (30-day mortality [OR, 1.16; 95% CI, 0.22-6.05; P = .856], 30-day disease/treatment-related mortality [OR, 0.90; 95% CI, 0.16-5.19; P = .911])., Conclusions: CA coverage during TEVAR without preservation of its blood flow is associated with significantly higher mortality in patients with aortic aneurysm, but not dissection. In patients with aortic aneurysm, CA flow should be preserved during TEVAR whenever feasible, whereas in patients with dissection, it may be safe to cover CA without preservation of its flow. Prospective studies should be done to confirm these findings and compare the open vs endovascular revascularization techniques on outcomes., Competing Interests: Disclosures None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosures None.

Objective: Prevention of late type Ia endoleaks is the main concern in thoracic endovascular aortic aneurysm repair (TEVAR) for thoracic aortic aneurysm. Since 2017, we have performed zone 0 TEVAR with proximal fixation augmentation using a Najuta thoracic fenestrated stent graft in addition to zone 2 TEVAR for distal arch aneurysms. We report the early and midterm outcomes of TEVAR performed using this strategy., Methods: This single-center retrospective study enrolled 386 cases of TEVAR for thoracic aortic disease between January 2013 and December 2020. Patients with thoracic aortic aneurysm treated by TEVAR landing at zone 2 was referred to as the standard group, whereas those treated by TEVAR landing at zone 0 using a Najuta fenestrated stent graft in addition to zone 2 TEVAR was referred to as the augmentation group. We retrospectively compared the clinical outcomes between the two groups. The primary end point was secondary intervention for postoperative type Ia endoleaks. Secondary end points were technical success, aneurysm-related death, and major adverse events (MAEs), including stroke, paraplegia, endoleaks, and secondary interventions., Results: We performed TEVAR in 41 and 30 cases in the standard and augmentation groups, respectively. The mean aneurysm sizes in the standard and augmentation groups were 54.5 and 57.3 mm (P = .23), and the proximal neck lengths were 16.8 and 17.4 mm (P = .65), respectively. The anatomical characteristics seemed to be similar in both groups. The technical success rate in both groups was 100%. Three cases in the standard group had MAEs, including two stroke and one brachial artery pseudoaneurysm; whereas two cases had MAEs in the augmentation group, including one stroke and one paraplegia. There was no 30-day mortality or retrograde type A dissection in both groups. The mean observation periods in the standard and augmentation groups were 46 months (range, 1-123 months) and 35 months (range, 1-73 months), respectively. At 36 and 60 months after the procedure, the freedom from aneurysm-related death was 97.6% and 97.6% in the standard group, 100.0% and 100.0% in the augmentation group (P = .39); and the freedom from reintervention for type Ia endoleaks was 79.2% and 65.2% in the standard group, 100.0% and 100.0% in the augmentation group (P = .0087). A statistically significant decrease in reinterventions for type Ia endoleaks was observed in the augmentation group., Conclusions: Proximal fixation augmentation using the Najuta fenestrated stent graft during TEVAR for distal arch aneurysm is effective in preventing the postoperative late type Ia endoleaks., Competing Interests: Disclosures T.O. is a paid consultant for W. L. Gore & Associates., (Copyright © 2024. Published by Elsevier Inc.)

Objective: The Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD)., Methods: From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years., Results: We identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years., Conclusions: Results at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous., Competing Interests: Disclosures D.B. is a consultant and speaker for W. L. Gore & Associates. R.M. is a consultant and speaker Cydar, Endospan, Medtronic, Silk Road Medical, and W. L. Gore & Associates. A.A. is a consultant and speaker for W. L. Gore & Associates. S.T. is a consultant and speaker for and received research support from W. L. Gore & Associates, Medtronic, and Terumo Aortic. D.G. is a consultant and speaker for Medtronic, Silk Road Medical, Teleflex, Terumo Aortic, and W. L. Gore & Associates., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The Human Acellular Vessel (HAV) is a novel, off-the-shelf biologic conduit being evaluated for arterial reconstructions. Regulatory studies in peripheral arterial disease (PAD) to date have consisted of single-arm cohorts with no comparator groups to contrast performance against established standards. This study aimed to compare outcomes of the HAV with autologous great saphenous vein (GSV) in patients with advanced PAD undergoing infrageniculate bypass., Methods: Patients with advanced PAD and no autologous conduit who underwent bypass with the 6-mm diameter HAV (Group 1; n = 34) (March 2021-February 2024) were compared with a multicenter historical cohort who had bypass with single-segment GSV (group 2; n = 88) (January 2017-December 2022). The HAV was used under an Investigational New Drug protocol issued by the Food and Drug Administration (FDA) under the agency's Expanded Access Program., Results: Demographics were comparable between groups (mean age 69 ± 10 years; 71% male). Group 1 had higher rates of tobacco use (37 pack-years vs 28 pack-years; P = .059), coronary artery disease (71% vs 43%; P = .007), and prior coronary artery bypass grafting (38% vs 14%; P = .003). Group 1 had more patients classified as wound, ischemia, and foot infection clinical stage 4 (56% vs 33%; P = .018) and with previous index leg revascularizations (97% vs 53%; P < .001). Both groups had a similar number of patients with chronic limb-threatening ischemia (Rutherford class 4-6) (88% vs 86%; P = .693) and Global Anatomic Staging System stage III (91% vs 96%; P = .346). Group 1 required a composite conduit (two HAV sewn together) in 85% of bypasses. The tibial vessels were the target in 79% of group 1 and 100% of group 2 (P < .001). Group 1 had a lower mean operative time (364 minutes vs 464 minutes; P < .001). At a median of 12 months, major amputation-free survival (73% vs 81%; P = .55) and overall survival (84% vs 88%; P = .20) were comparable. Group 1 had lower rates of primary patency (36% vs 50%; P = .044), primary-assisted patency (45% vs 72%; P = .002), and secondary patency (64% vs 72%; P = .003) compared with group 2., Conclusions: Implanted under Food and Drug Administration Expanded Access provisions, the HAV was more likely to be used in redo operations and cases with more advanced limb ischemia than GSV. Despite modest primary patency, the HAV demonstrated resilience in a complex cohort with no autologous conduit options, achieving good secondary patency and providing major amputation-free survival comparable with GSV at 12 months., Competing Interests: Disclosures Humacyte Inc provides funding to Mayo Clinic to support the performance of this IND study. T.E.R. serves in a clinical advisory role for Humacyte, Inc., with funds paid to Mayo Clinic., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Hemodialysis access-induced distal ischemia (HAIDI) is a known complication of hemodialysis (HD) access. Distal revascularization and interval ligation (DRIL) is the preferred treatment for HAIDI by many surgeons. Proximalization of arterial inflow (PAI) is a promising alternative technique that, unlike DRIL, preserves the native arterial inflow. The purpose of this study is to report our experience with PAI on a series of 64 patients., Methods: This is a single-center, retrospective cohort study of patients with both arteriovenous (AV) fistulas and grafts who underwent PAI for HAIDI from 2017 to 2023. A 4 × 7 tapered polytetrafluoroethylene (PTFE) graft was used to connect HD access inflow to the axillary artery in the majority of cases. The primary outcome of the study is resolution of HAIDI (complete, partial, or no resolution). Secondary outcomes include functional patency (primary and secondary) and 30-day complications following PAI., Results: Of the 71 patients identified to have had PAI between May 2017 to August 2023, seven were lost to follow-up. In total, 64 patients were included, with an average age of 65 years (standard deviation, 15 years), 59.4% (38/64) female, and 37.5% (24/64) African American. The study population was notable for numerous comorbid conditions including 95.3% (61/64) hypertension; 50% (32/64) coronary artery disease; 79.7% (51/64) diabetes; and 43.8% (28/64) smoking history. Following PAI intervention for HAIDI, 55 of 64 patients (85.9%) experienced complete resolution of ischemic symptoms; five of 64 patients (7.8%) had partial resolution; two of 64 patients (3.1%) had no resolution, and two of 64 patients (3.1%) had unknown resolution. Primary patency at 1, 12, and 24 months was 94%, 81%, and 71%, respectively. Secondary patency at 1, 12, and 24 months was 97%, 87%, and 84%, respectively. The 30-day complication rate was 10.9% (7/64), with five of 64 (7.8%) thromboses, one of 64 (1.6%) thrombosis and infection, and one of 64 (1.6%) upper extremity swelling secondary to central venous stenosis (resolved with angioplasty of central venous system). Failure rate due to thrombosis at 12 and 24 months was 14% (9/64) and 15.6% (10/64), respectively., Conclusions: Our study, the largest case series of PAI to date, demonstrates that PAI is a reliable option for HAIDI intervention and has comparable safety and efficacy results to DRIL, despite the use of a synthetic graft. Furthermore, PAI has the added benefit of maintaining the native arterial pathway. Further investigation of PAI is warranted as a promising alternative to DRIL for HAIDI management., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Primary arteriovenous access such as radiocephalic and brachiocephalic fistulas are initial choices for creating vascular access in dialysis patients. When neither of these choices is an option, upper arm arteriovenous graft or brachiobasilic transposition is recommended. Although primary fistula is better than prosthetic graft for suitable patients, there is little data to guide the best treatment strategy in the absence of suitable vein for primary access creation. This study identifies factors that influence patency rates and compares outcomes of patients treated with brachiobasilic fistula vs upper arm graft in patients who have failed forearm access or are not candidates for primary access., Methods: A prospectively maintained database of patients with dialysis-dependent renal failure from 2010 to 2022 was analyzed. Primary, primary assisted, and secondary patency rates were calculated. Incidence rates of complications and reinterventions were compared., Results: There were 148 patients with brachiobasilic fistulas and 157 patients with upper arm grafts. The graft group was older (70.1 ± 14.7 vs 62.5 ± 14.6 years; P = .003) and had a higher incidence of pacemakers (11.9% vs 4.1%; P = .005). Brachiobasilic fistulas had higher 6-month (77.0% vs 64.3%; P = .02) and 1-year (68.2% vs 55.4%; P = .03) primary-assisted patency. Secondary patency rates were better for upper arm grafts at 1-year (82.2% vs 72.3%; P = .05). Access complications of non-maturation and aneurysm were higher in basilic vein transposition (21.6% vs 1.3%; P < .0001; 15.5% vs 6.4%; P = .017). Grafts had higher rates of occlusion (58.0% vs 25.7%; P < .0001). In terms of interventions, upper arm grafts had higher rates of thrombectomy (50.3% vs 18.9%; P < .0001), but there was no difference seen in angioplasty, stent, surgical revision, or steal procedures. Basilic vein transpositions had longer time to cannulation (104.6 ± 81.1 vs 32.5 ± 22.4 days; P < .0001), longer total catheter days (251.1 ± 181.7 vs 72.9 ± 56.3 days; P < .0001), and higher number of procedures to aid maturity (0.7 ± 0.7 vs 0.1 ± 0.3; P < .0001)., Conclusions: In this retrospective analysis, when forearm access or primary arteriovenous access is not an option, basilic vein transposition and upper arm grafts have fairly equivalent primary patency. Primary assisted patency is slightly better in basilic vein fistulas, but secondary patency is better in upper arm grafts at 1 year. Basilic fistulas also had longer time to cannulation, longer total catheter days, and more procedures to aid maturity., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to identify trends in hospital length of stay (HLOS) and intensive care unit length of stay (ICULOS), and the relationship with cerebrospinal fluid drainage (CSFD) protocols in patients undergoing fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms (TAAAs)., Methods: A retrospective review of patients who underwent elective FB-EVAR for extent I to IV TAAAs between 2008 and 2023 at a single aortic center of excellence was conducted. Patient demographics, cardiovascular comorbidities, surgical risk, technical details, CSFD strategy (prophylactic or therapeutic), procedural success, and perioperative outcomes were collected. Patients were divided into two groups based on CSFD protocol. Group 1 included patients treated before 2020 when prophylactic CSFD was performed widely, and Group 2 consisted of patients treated since 2020 with therapeutic CSFD. Primary end points were HLOS, ICULOS, major adverse events, and perioperative mortality., Results: FB-EVAR was performed in 702 patients; 412 underwent elective TAAA repair and were included in the analysis. Mean age was 73 ± 8 years and 68% were male. Patient-specific manufactured devices were used in 252 patients (61%), physician-modified endografts in 110 (27%), and 50 patients (12%) were treated with off-the-shelf devices. Demographics, aneurysm extent, major adverse events (including spinal cord ischemia [SCI]), and mortality were similar in both groups. A significant reduction in mean HLOS between the groups (9 ± 9 vs 6 ± 5 days; P = .02) coincided with decreased use of prophylactic CSFD (70% vs 1.2%; P < .001), with similar rates of SCI (7.6% vs 4.9%; P = .627) and ICULOS (3 ± 3 vs 2.5 ± 3; P = .19). Patients in the therapeutic drainage cohort (group 2) had a higher incidence of congestive heart failure (24% vs 11%; P = .003), hypercholesterolemia (91% vs 80%; P = .015), chronic obstructive pulmonary disease (55% vs 37%; P = .004), and peripheral artery disease (39% vs 19%; P < .001) compared with group 1, suggesting treatment of a more complex patient cohort. On adjusted multivariable analysis accounting for American Society of Anesthesiologists score, comorbidities, and device type, the difference in HLOS remained statistically significant (P = .01)., Conclusions: HLOS decreased over time in patients undergoing FB-EVAR for TAAA after transition from a prophylactic to a therapeutic CSFD protocol. This transition was the only modifiable, independent risk factor for a shorter HLOS, without an increase in SCI, albeit with similar ICULOS., Competing Interests: Disclosures B.C.M. receives consulting fees and research support from Cook Medical and W. L. Gore & Associates. He is an aortic advisor for Cook Medical, W. L. Gore & Associates, and Medtronic. All fees are paid to Mayo Clinic. G.S.O. receives consulting, speaking, and/or scientific advisory fees from Centerline Biomedical, Cook Medical, GE Healthcare, and W. L. Gore & Associates; receives research grant support from GE Healthcare and W. L. Gore & Associates paid to the University of Texas Health Science Center at Houston; and has a Global Principal Investigator agreement with Cook Medical. interest., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Antiplatelet and/or anticoagulant therapy are commonly prescribed after fenestrated/branched endovascular aortic repair (F/BEVAR). However, the optimal regimen remains unknown. We sought to characterize practice patterns and outcomes of antiplatelet and anticoagulant use in patients who underwent F/BEVAR., Methods: Consecutive patients enrolled (2012-2023) as part of the United States Aortic Research Consortium (US-ARC) from 10 independent physician-sponsored investigational device exemption studies were evaluated. The cohort was characterized by medication regimen on discharge from index F/BEVAR: (1) Aspirin alone OR P2Y12 alone (single-antiplatelet therapy [SAPT]); (2) Anticoagulant alone; (3) Aspirin + P2Y12 (dual-antiplatelet therapy [DAPT]); (4) Aspirin + anticoagulant OR P2Y12 + anticoagulant (SAPT + anticoagulant); (5) Aspirin + P2Y12 + anticoagulant (triple therapy [TT]); and (6) No therapy. Kaplan-Meier analysis and Cox proportional hazards modeling were used to compare 1-year outcomes including survival, target artery patency, freedom from bleeding complication, freedom from all reinterventions, and freedom from stent-specific reintervention., Results: Of the 1525 patients with complete exposure and outcome data, 49.6% were discharged on DAPT, 28.8% on SAPT, 13.6% on SAPT + anticoagulant, 3.2% on TT, 2.6% on anticoagulant alone, and 2.2% on no therapy. Discharge medication regimen was not associated with differences in 1-year survival, bleeding complications, composite reintervention rate, or stent-specific reintervention rate. However, there was a significant difference in 1-year target artery patency. On multivariable analysis comparing with SAPT, DAPT conferred a lower hazard of loss of target artery patency (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.27-0.84; P = .01). On sub-analyses of renal stents alone or visceral stents alone, DAPT no longer had a significantly lower hazard of loss of target artery patency (renal: HR, 0.66; 95% CI, 0.35-1.27; P = .22; visceral: HR, 0.31; 95% CI, 0.05-1.9; P = .21). Lastly, duration of DAPT therapy (1 month, 6 months, or 1 year) did not significantly affect target artery patency., Conclusions: Practice patterns for antiplatelet and anticoagulant regimens after F/BEVAR vary widely across the US-ARC. There were no differences in bleeding complications, survival or reintervention rates among different regimens, but higher branch vessel patency was noted in the DAPT cohort. These data suggest there is a benefit in DAPT therapy. However, the generalizability of this finding is limited by the retrospective nature of this data, and the clinical significance of this finding is unclear, as there is no difference in survival, bleeding, or reintervention rates amongst the different regimens. Hence, an "optimal" regimen, including the duration of such regimen, could not be clearly discerned. This suggests equipoise for a randomized trial, nested within this cohort, to identify the most effective antiplatelet/anticoagulant regimen for the growing number of patients being treated globally with F/BEVAR., Competing Interests: Disclosures A.S. reports consultant for Artivion, Cook Medical, and Philips; and receives research support from Cook Medical and Philips. All proceeds go to the UMass Memorial Hospital Foundation. A.W.B. reports onsultant for Artivion, Cook Medical, Medtronic, Philips, and Terumo Aortic; and receives research support from Cook Medical, Endospan, Medtronic, Philips, Terumo Aortic, and W.L. Gore & Associates. All proceeds go to the University of Alabama at Birmingham. M.A.F. reports consultant for WL Gore, Cook Medical, ViTAA, Centerline Biomedical, and Getinge; and receives research support from Cook Medical, WL Gore ViTAA, and Centerline Biomedical. W.A.L. reports consultant for Terumo Aortic. G.S.O. reports consultant for Cook, Centerline Biomedical, GE Healthcare, and Gore; and receives research support from GE Healthcare. F.E.P. reports stock options from Centerline Biomedical; and receives research support from Cook Medical. D.B.S. reports consultant for WL Gore, Cook Medical, Medtronic, and Philips; and receives research support from Cook Medical, Philips, and W.L. Gore. C.H.T. reports consultant for Cook Medical, WL Gore, and Philips; and receives research support from Cook Medical, Philips, and WL Gore., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate the impact of 1-year changes in aneurysm sac diameter on patient survival after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms or thoracoabdominal aortic aneurysms., Methods: We reviewed the clinical data of patients enrolled in a prospective nonrandomized study investigating FB-EVAR (2013-2022). Patients with sequential follow up computed tomography scans at baseline and 6 to 18 months after FB-EVAR were included in the analysis. Aneurysm sac diameter change was defined as the difference in maximum aortic diameter from baseline measurements obtained in centerline of flow. Patients were classified as those with sac shrinkage (≥5 mm) or failure to regress (<5 mm or expansion) according to sac diameter change. The primary end point was all-cause mortality. Secondary end points were aortic-related mortality (ARM), aortic aneurysm rupture (AAR), and aorta-related secondary intervention., Results: There were 549 patients treated by FB-EVAR. Of these, 463 patients (71% male, mean age, 74 ± 8 years) with sequential computed tomography imaging were investigated. Aneurysm extent was thoracoabdominal aortic aneurysms in 328 patients (71%) and abdominal aortic aneurysms in 135 (29%). Sac shrinkage occurred in 270 patients (58%) and failure to regress in 193 patients (42%), including 19 patients (4%) with sac expansion at 1 year. Patients from both groups had similar cardiovascular risk factors, except for younger age among patients with sac shrinkage (73 ± 8 years vs 75 ± 8 years; P < .001). The median follow-up was 38 months (interquartile range, 18-51 months). The 5-year survival estimate was 69% ± 4.1% for the sac shrinkage group and 46% ± 6.2% for the failure to regress group. Survival estimates adjusted for confounders (age, chronic pulmonary obstructive disease, chronic kidney disease, congestive heart failure, and aneurysm extent) revealed a higher hazard of late mortality in patients with failure to regress (adjusted hazard ratio, 1.72; 95% confidence interval, 1.18-2.52; P = .005). The 5-year cumulative incidences of ARM (1.1% vs 3.1%; P = .30), AAR (0.6% vs 2.6%; P = .20), and aorta-related secondary intervention (17.0% ± 2.8% vs 19.0% ± 3.8%) were both comparable between the groups., Conclusions: Aneurysm sac shrinkage at 1 year is common after FB-EVAR and is associated with improved patient survival, whereas sac enlargement affects only a minority of patients. The low incidences of ARM and AAR indicate that failure to regress may serve as a surrogate marker for nonaortic-related death., Competing Interests: Disclosures G.S.O. has received consulting fees and grants from Cook Medical, W. L. Gore & Associates, Centerline Biomedical, and GE Healthcare (all paid to Mayo Clinic and The University of Texas Health Science at Houston with no personal income). B.C.M. reports consulting fees and research grants from Cook Medical and W. L. Gore & Associates and scientific advisory board membership for Medtronic. H.J.M.V. is a consultant of Medtronic, W. L. Gore & Associates, Terumo Aortic, Endologix, Artivion, and Philips. F.B.G. has received speaker and proctoring fees from Medtronic, W. L. Gore & Associates, and Cook Medical., (Copyright © 2024. Published by Elsevier Inc.)

Objective: To evaluate the impact of celiac artery (CA) compression by median arcuate ligament (MAL) on technical metrics and long-term CA patency in patients with complex aortic aneurysms undergoing fenestrated/branched endograft repairs (F/B-EVARs)., Methods: Single-center, retrospective review of patients undergoing fenestrated/branched endovascular aortic aneurysm repairs and requiring incorporation of the CA between 2013 and 2023. Patients were divided into two groups-those with (MAL+) and without (MAL-) CA compression-based on preoperative computed tomography angiography findings. MAL was classified in three grades (A, B, and C) based on the degree and length of stenosis. Patients with MAL grade A had ≤50% CA stenosis measuring ≤3 mm in length. Those with grade B had 50% to 80% CA stenosis measuring 3 to 8 mm long, whereas those with grade C had >80% stenosis measuring >8 mm in length. End points included device integrity, CA patency and technical success-defined as successful implantation of the fenestrated/branched device with perfusion of CA and no endoleak., Results: One hundred and eighty patients with complex aortic aneurysms (pararenal, 128; thoracoabdominal, 52) required incorporation of the CA during fenestrated/branched endovascular aortic aneurysm repair. Majority (73%) were male, with a median age of 76 years (interquartile range [IQR], 69-81 years) and aneurysm size of 62 mm (IQR, 57-69 mm). Seventy-eight patients (43%) had MAL+ anatomy, including 33 patients with MAL grade A, 32 with grade B, and 13 with grade C compression. The median length of CA stenosis was 7.0 mm (IQR, 5.0-10.0 mm). CA was incorporated using fenestrations in 177 (98%) patients. Increased complexity led to failure in CA bridging stent placement in four MAL+ patients, but completion angiography showed CA perfusion and no endoleak, accounting for a technical success of 100%. MAL+ patients were more likely to require bare metal stenting in addition to covered stents (P = .004). Estimated blood loss, median operating room time, contrast volume, fluoroscopy dose and time were higher (P < .001) in MAL+ group. Thirty-day mortality was 3.3%, higher (5.1%) in MAL+ patients compared with MAL- patients (2.0 %). At a median follow-up of 770 days (IQR, 198-1525 days), endograft integrity was observed in all patients and CA events-kinking (n = 7), thrombosis (n = 1) and endoleak (n = 2) -occurred in 10 patients (5.6%). However, only two patients required reinterventions. MAL+ patients had overall lower long-term survival., Conclusions: CA compression by MAL is a predictor of increased procedural complexity during fenestrated/branched device implantation. However, technical success, long-term device integrity and CA patency are similar to that of patients with MAL- anatomy., Competing Interests: Disclosures J.M. repotrts the use of investigational device in an FDA-approved IDE (G220004) and is a consultant for W. L. Gore & Associates and Medtronic., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Aneurysm sac changes after fenestrated-branched endovascular aneurysm repair (FBEVAR) for postdissection thoracoabdominal aortic aneurysms (PD-TAAs) are poorly understood. Partial thrombosis of the false lumen and endoleaks may impair sac regression. To characterize sac changes after FBEVAR for PD-TAAs, this study examined midterm results and predictors for sac enlargement., Methods: FBEVARs performed for PD-TAAs in 10 physician-sponsored investigational device exemption studies from 2008 to 2023 were analyzed. The maximum aortic aneurysm diameter was compared between the 30-day computed tomography angiogram and follow-up imaging studies. Aneurysm sac enlargement was defined as an increase in diameter of ≥5 mm. Kaplan-Meier curves and Cox regression were used to evaluate sac enlargement and midterm FBEVAR outcomes., Results: Among 3296 FBEVARs, 290 patients (72.4% male; median age, 68.4 years) were treated for PD-TAAs. Most aneurysms treated were extent II (72%) and III (12%). Mean aneurysm diameter was 66.5 ± 11.2 mm. Mortality at 30 days was 1.4%. At a mean follow-up of 2.9 ± 1.9 years, at least one follow-up imaging study revealed sac enlargement in 43 patients (15%), sac regression in 115 patients (40%), and neither enlargement nor regression in 137 (47%); 5 (2%) demonstrated both expansion and regression during follow-up. Freedom from aneurysm sac enlargement was 93%, 82%, and 80% at 1, 3, and 5 years, respectively. Overall, endoleaks were detected in 27 patients (63%) with sac enlargement and 143 patients (58%) without enlargement (P = .54). Sac enlargement was significantly more frequent among older patients (mean age at the index procedure, 70.2 ± 8.9 years vs 66.5 ± 11 years; P = .04) and those with type II endoleaks at 1 year (74% vs 52%; P = .031). Cox regression revealed age >70 years at baseline (hazard ratio [HR], 2.146; 95% confidence interval [CI], 1.167-3.944; P = .010) and presence of type II endoleak at 1 year (HR, 2.25; 95% CI, 1.07-4.79; P = .032) were independent predictors of sac enlargement. Patient survival was 92%, 81%, and 68% at 1, 3, and 5 years, respectively. Cumulative target vessel instability was 7%, and aneurysm-related mortality was 2% at 5 years. At least 42% of patients required secondary interventions. Sac enlargement did not affect patient survival., Conclusions: Aneurysm sac enlargement occurs in 15% of patients after FBEVAR for PD-TAAs. Elderly patients (>70 years at baseline) and those with type II endoleaks at 1 year may need closer monitoring and secondary interventions to prevent sac enlargement. Despite sac enlargement in some patients, aneurysm-related mortality at 5 years remains low and overall survival was not associated with sac enlargement., Competing Interests: Disclosures A.W.B has been a consultant for Artivion Inc., Cook Medical Inc., Philips Healthcare, and Terumo Cardiovascular Group and received research support from Cook Medical Inc, Endospan Ltd, Medtronic PLC, Philips Healthcare, Terumo Cardiovascular Group, and W. L. Gore & Associates. A.S. has been consultant for Cook Medical Inc., Artivion Inc., and Philips Healthcare. G.S.O has been a consultant for Cook Medical Inc., W. L. Gore & Associates, Inc., GE HealthCare Technologies, Inc., and Centerline Biomedical Inc. C.H.T. has been a consultant for and received research support from Cook Medical Inc., W. L. Gore & Associates, Inc., and Phillips Healthcare. M.A.F is a consultant for WL Gore, Cook Medical, Getinge, Centerline Biomedical and ViTAA Medical and received research support from Cook Medical and clinical trial support from W. L. Gore & Associates, Cook Medical, and ViTAA Medical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States., Methods: Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98)., Results: A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA., Conclusions: Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Fenestrated and branched thoracic endovascular repair (f/bTEVAR) have been successfully applied in patients with diverse aortic arch pathologies. The aim of this study is to present the early and mid-term outcomes of patients with native proximal aortic landing (NPAL) managed with f/bTEVAR., Methods: A single-center retrospective analysis of patients with NPAL, managed with f/bTEVAR, between September 1, 2011, and June 30, 2022, was conducted. All patients were treated with custom-made devices (Cook Medical) with landing within Ishimaru zones 0 to 2. Primary outcomes were technical success, mortality, stroke, and retrograde type A dissection at 30 days. Follow-up outcomes were considered secondary., Results: A total of 126 patients were included (69.8% males; mean age, 70.8 ± 4.2 years; 18.3% urgent). The main indications (60.4%) for repair were aortic arch (29.4%) and thoracoabdominal aortic aneurysms (31.0%). Seventy-two patients (57.1%) were managed with fTEVAR. Proximal landing in zone 0 and 1 was chosen in 97.6%. Technical success was 94.4%, and 30-day mortality was 11.9%. Strokes were diagnosed in 13.5% of patients and major strokes were identified in 7.9% cases. Retrograde type A dissection rate was 3.9%. The multivariate analysis confirmed landing in Ishimaru zone 0 as an independently related factor for stroke (P = .005), whereas stroke (P < .001), pericardial effusion (P < .001), and acute kidney injury (P < .001) were independently related to 30-day mortality. Mean follow-up was 17.5 ± 9.3 months. The estimated survival rate and the freedom from reintervention rate were 72.6% (standard error, 4.4%) and 46.4% (standard error, 6.0%) at 24-month follow-up, respectively., Conclusions: Stroke rate after endovascular arch repair was alarming among patients with NPAL. Proximal landing to zone 0 was related to higher risk of stroke. Reinterventions were common within the 24-month follow-up., Competing Interests: Disclosures T.K. is a consultant and proctor for and has intellectual property with Cook Medical, receiving royalties, speaking fees, and research, travel, and educational grants., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To present a single-center prospective study of 126 consecutively treated patients who underwent endovascular repair of a thoracoabdominal aortic aneurysm with the physician-modified, nonanatomic-based Unitary Manifold (UM) device., Methods: Data were collected from 126 consecutive all-comer patients treated with the physician-modified, nonanatomic-based UM from 2015 to 2023. Treatment was performed at a single center by a single physician under a Physician Sponsored Investigation Exemption G140207., Results: The UM was indicated for repair of all Crawford extents including juxtarenal, pararenal, and short-neck infrarenal aneurysms (<10 mm) in 126 consecutive patients. Patients were not excluded from the study based on presentation, extent of aneurysm or dissection, or history of a spinal cord event. Patients with a thoracoabdominal aortic aneurysm were categorized by Crawford classification: types I and V (3.3%, n = 4), type II (3.3%, n = 4), type III (1%, n = 1), and type IV (93.3%, n = 117). The type IV classification patients were further categorized with 33 (28.2%) true type IV, 68 (58.1%) pararenal or infrarenal, and 16 (13.7%) with dissection. Technical success was 99.2% (n = 125). The most common major adverse event within both 30 days and 365 days of all patients was respiratory failure (11.9%, n = 15, and 13.5%, n = 17, respectively). One patient (0.8%) experienced persistent paraplegia at 365 days. Reintervention for patients at 365 days was 5.6% (n = 7). Of the 444 branches stented, the primary patency rate was remarkably high as only three patients (2.4%) required reintervention due to loss of limb patency within 365 days. Aneurysm enlargement (≥5 mm) occurred in 1.6% (n = 2) patients, and no patients experienced aneurysm rupture. No patients underwent conversion to open repair. The aneurysm-related mortality at 365 days for all patients was 4.0% (n = 5), whereas all-cause mortality was 16.7% (n = 21). Physician-modified endograft device integrity failure was not observed in any patient., Conclusions: The UM device demonstrated remarkable technical surgical success, treatment success, and device patency rates with very reasonable major adverse events and reintervention rates. This study is the most representative example of the general population in comparison with other studies of off-the-shelf devices, with 126 consecutive all-comer patients with diverse pathologies., Competing Interests: Disclosures A.V. and A.G. are employees of Sanford Health. P.W.K. and J.S. are prior employees of Sanford Health.P.W.K. is the inventor of the Unitary Manifold device. The remaining authors report no conflicts., (Copyright © 2024. Published by Elsevier Inc.)

Objective: Vascular access is difficult in patients without suitable arm veins and prior graft infections. The use of femoral vein translocation (FVT) to the upper extremity or contralateral lower extremity for hemodialysis access may be associated with low infection rates and high patency rates. FVT is used for patients without central venous occlusion who have failed prior access either owing to graft infection or repetitive graft thrombosis. The largest case series consists of 30 cases. The objective of this study is to determine the infection incidence, primary patency, primary-assisted patency, and secondary patency rates among FVTs., Methods: A retrospective chart review was performed on all patients who underwent FVT by a single vascular practice over a 10-year period (2013-2023). Study variables included length to last follow-up (months), prior access, prior graft infection, comorbid conditions, primary patency, primary-assisted patency, secondary patency, postoperative steal syndrome, postoperative graft infection, postoperative harvest site complication, and postoperative lower extremity compartment syndrome., Results: A total of 131 FVTs were performed from 2013 to 2023; 126 patients (47% male, 53% female; 76% Black, 24% White) with a mean age of 52 ± 14 years and a mean body mass index of 29 ± 8 had at least 1 month of follow-up and were included for analysis. The median follow-up was 46 months (interqurtile range, 19-72 months). The mean number of prior permanent accesses was 2.5 ± 1.4. Forty-eight percent of patients had prior graft infections. The primary, primary-assisted, and secondary patency rates were 66%, 93%, and 98%, respectively, at 6 months; 43%, 85%, and 96% at 12 months; 25%, 70%, and 92% at 24 months; 16%, 61%, and 88% at 36 months; and 14%, 56%, and 82% at 48 months. Postoperative steal syndrome and postoperative access infection requiring excision was observed 16% and 5% of patients, respectively. Harvest site complications requiring an additional procedure occurred in 19% of cases. Three patients developed lower extremity compartment syndrome postoperatively, requiring fasciotomy. Six patients developed chronic lower extremity edema after femoral vein harvest. The mean procedure time and hospital length of stay were 197 ± 40 minutes and 3.5 ± 2.8 days, respectively., Conclusions: FVT is associated with low infection rates and high long-term patency rates. Significant postoperative complications include steal syndrome and harvest site complications. FVT remains a viable option for patients who have failed prior access owing to graft infection or repetitive graft thrombosis., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury., Methods: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality., Results: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up., Conclusions: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury., Competing Interests: Disclosures All authors were principal investigators in the study and as such received research grants to conduct the study. B.S. has been paid a consulting fee by Terumo Corporation for an unrelated project., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Thoracic endovascular aneurysm repair (TEVAR) is widely used for the treatment of aortic dissection. Endograft oversizing is a risk factor for stent graft-induced new entry tears and retrograde type A aortic dissection. However, there is no clear consensus on the optimal graft size selection for Stanford type B acute or subacute aortic dissection (TBAD). Herein, we examined the safety and efficacy of TEVAR using an intentionally undersized endograft to treat TBAD., Methods: This retrospective chart review study included 82 patients who underwent TEVAR for acute or subacute Stanford TBAD between 2015 and 2022. We measured the true lumen diameter just distal to the subclavian artery and opted for a stent graft of the same diameter. In instances where deformation resulting from false lumen pressure displacement was pronounced, we measured the diameter at the site just proximal to the subclavian artery. Patients' characteristics, procedural, in-hospital, and follow-up data, and aortic remodeling were analyzed. The aortic diameter was analyzed using one-way analysis of variance followed by Dunnett's test. Survival and freedom from reintervention were estimated using Kaplan-Meier curves., Results: The follow-up rate was 98.4%. The mean age was 58.3 ± 12.3 years, and 76 were men (92.7%). The mean diameters of the stent graft and native proximal landing zone were 30.9 ± 3.2 mm and 30.8 ± 3.0 mm, respectively. The oversize rate of the stent graft in relation to the native proximal aortic diameter was 0.3% ± 4.7%. In-hospital mortality was observed in one patient, retrograde type A aortic dissection in one patient, distal stent graft-induced new entry tear in zero patients, and type 1a endoleak in 22 patients (26.8%). Type 1a endoleaks, characterized by antegrade false lumen blood flow originating from the primary entry, in 12 patients spontaneously disappeared within 1 year of follow-up. According to aortic remodeling, 59 patients (86.8%) achieved complete aortic remodeling at the aortic arch level and 51 (75.0%) at the eighth thoracic vertebral level. The diameters of the aortic arch and descending aorta were significantly reduced compared with the postoperative measurements (P <.001). Survival rates were 97.5% and 93.6% at 1 and 3 years, respectively. Freedom from reintervention was 84.7% and 84.7% at 1 and 3 years, respectively., Conclusions: Intentionally undersized TEVAR was safe and achieved acceptable aortic remodeling despite a high rate of type 1a endoleaks. A type 1a endoleak was acceptable as it primarily diminished during the mid-term follow-up., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: This study aimed to report the long-term outcomes beyond 10 years of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms using the low-profile INCRAFT device., Methods: This was a single-center, retrospective cohort study of all patients undergoing EVAR using the INCRAFT device as part of the regulatory trial between 2012 and 2013. Primary endpoint was aneurysm-related death. Secondary endpoints were all-cause death, reintervention, late open conversion, and aneurysm status (shrinkage, stable, and growth)., Results: Thirty patients with a mean age of 71.8 ± 7.7 years were included in this study. The median aneurysm diameter at EVAR was 54.5 mm (interquartile range, 53-56.8 mm). All abdominal aortic aneurysms in this study were treated following the device's instructions for use. At index EVAR, the INCRAFT device was successfully implanted in all patients using a percutaneous approach under local anesthesia. No patients experienced major adverse events or procedure-related complications 30 days after EVAR. During the median follow-up of 125 months (interquartile range, 98-131 months) with follow-up rates of 100% at 5 years and 96.7% at 10 years, aneurysm-related mortality was 0%, and freedom from all-cause mortality was 82.9% at 5 years and 75.3% at 10 years. Reintervention was required in 10 patients with 15 procedures. Sac growth was observed in 11 patients (36.7%), six of whom eventually required late open conversion; five of these patients underwent open aneurysmorrhaphy with stent graft preservation, and one underwent open surgical repair with endograft explantation. Late rupture was identified in one case, where type Ia endoleak led to rupture at 69 months, and open repair was successfully performed. Freedom from reintervention was 89.0% at 5 years but declined to 60.9% at 10 years; freedom from late open conversion was 100% at 5 years but declined to 70.8% at 10 years., Conclusions: Long-term outcomes of the INCRAFT stent graft showed no aneurysm-related deaths. However, sac growth occurred persistently throughout the follow-up period, resulting in a relatively high rate of reinterventions in the later periods, which highlights the importance of lifelong postoperative surveillance and appropriate reinterventions when indicated., Competing Interests: Disclosures T.O. serves as a consultant to W.L Gore and Associates, (Copyright © 2024. Published by Elsevier Inc.)

Objective: The aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent., Methods: Patients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions., Results: Of 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined., Conclusions: Larger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR., Competing Interests: Disclosures F.E.P. reports stock options from Centerline Biomedical. W.A.M. reports consulting for Intervene, Inc and Molnlycke, Inc; and research support and clinical trial support from Intervene and Reapplix Medical. K.L.M. reports speaker fees from Penumbra Inc and Shockwave Medical; consulting for Vascular Technology, Inc; and research support from NovoNordisk Foundation. M.A.F. reports consulting and clinical trial support from WL Gore and ViTTA; consulting for Getinge; research support and clinical trial support from Cook; and stock options and clinical trial support from Centerline Biomedical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: This study aims to report the efficacy and safety of double-fenestrated physician-modified endovascular grafts (PMEGs) for total aortic arch repair with at least 3 years of follow-up., Methods: All consecutive patients with a pathological aortic arch who underwent aortic arch repair combined with a homemade double-fenestrated stent graft from 2017 to 2020 were reviewed., Results: 74 patients were treated for pathological arch conditions with a double-fenestrated PMEG. Of these, 81% were male, the mean age was 69.9 years, and 59% were classified as American Society of Anesthesiology 3 or 4. Thirty-five percent were treated for a postdissection aneurysm, 36% for a degenerative aneurysm, and 14% for acute type B dissection. Fifteen percent had supra-aortic trunk dissection. Fenestration on the subclavian artery was performed in 96%; if not, a carotid-subclavian bypass was carried out. Technical success was 100%. The proximal landing zone is consistently in zone 0. Early outcomes revealed a 3% occurrence of type 1 endoleak, which was successfully treated by prompt reintervention. One retrograde dissection occurred, and one patient died from hemorrhage on an iliac conduit. A 5% stroke rate was reported. During long-term follow-up (mean time 40.7 months), one type 1 endoleak appeared and was successfully treated; no type 2 or type 3 endoleak requiring intervention occurred. No stent fractures or migrations were reported. Four percent of patients required reintervention, but no surgical conversion to open surgical repair was needed on the aortic arch. No patient died from a cause related to the main procedure., Conclusions: Total aortic arch repair with double-fenestrated PMEGs is associated with acceptable early and midterm major morbidity and mortality. It is suitable for the main aortic pathologies. Moreover, it is easily available for emergency situations., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: This study aims to present the medium-term outcomes of Extra-Design engineering endografts with inner branches (EDE-iBEVARs, Artivion) in endovascular aortic repairs of complex aneurysms building upon promising early results., Methods: A retrospective, international, multi-center study was conducted including consecutive patients who underwent complex endovascular aortic repairs using EDE-iBEVARs between 2018 and 2022. Patient demographics, aneurysm anatomical features, procedural details, reinterventions, complications, and endograft failures during follow-up were assessed. The primary outcome was aneurysm-related mortality. Secondary outcome measures included the freedom from all-cause mortality and reintervention, technical and clinical success, and late related complications including branch instability, endoleaks, and serious adverse events., Results: Our study encompassed a total of 260 patients across 13 European centers. The cohort included patients with thoracoabdominal aortic aneurysms (n = 116), suprarenal or juxta-renal aneurysms (n = 95), and those who had previous open repair or previous endovascular aortic repair with type 1A endoleak (n = 49). Of 982 possible inner branches (937 antegrade and 45 retrograde), 962 (98%) were successfully cannulated and bridged with covered stents during the index procedure. Overall, the endograft was successfully deployed in 98% of patients, and 93% were discharged from hospital following surgery. At 3 years, freedom from aneurysm-related mortality was 97%, whereas the freedom of all-cause mortality was 89%. Freedom from reinterventions was 91% and 76% at 1 and 3 years, respectively. The rate of late complications such as endoleaks or branch instability events was 12% (n = 30). The late branch occlusion rate during follow-up was 1.5% (n = 15), of which 12 were renal branches., Conclusions: EDE-iBEVARs demonstrate satisfactory medium-term outcomes with reintervention rates comparable to other endografts. Encouragingly, rates of branch patency were high, and major adverse events were low. This technology could expand the treatment options for patients with challenging complex aortic conditions., Competing Interests: Disclosures S.A., G.S., and G.I. have been paid consulting and proctoring fees by Artivion Company., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Clinical practice guidelines have recommended an endovascular-first approach (ENDO) for the management of patients with chronic mesenteric ischemia (CMI), whereas an open mesenteric bypass (OMB) is proposed for subjects deemed to be poor ENDO candidates. However, the impact of a previous failed endovascular or open mesenteric reconstruction on a subsequent OMB is unknown. Accordingly, this study was designed to examine the results of a remedial OMB (R-OMB) after a failed ENDO or a primary OMB (P-OMB) for patients with recurrent CMI., Methods: All patients who underwent an OMB from 2002 to 2022 at the University of Florida were reviewed. Outcomes after an R-OMB (ie, history of a failed ENDO or P-OMB) and P-OMB were compared. The primary end point was 30-day mortality, whereas secondary outcomes included complications, reintervention, and survival. The Kaplan-Meier methodology was used to estimate freedom from reintervention and all-cause mortality, whereas multivariable Cox proportional hazards modeling identified predictors of death., Results: A total of 145 OMB procedures (R-OMB, n = 48 [33%]; P-OMB, n = 97 [67%]) were analyzed. A majority of R-OMB operations were performed for a failed stent (prior ENDO, n = 39 [81%]; prior OMB, n = 9 [19%]). R-OMB patients were generally younger (66 ± 9 years vs P-OMB, 69 ± 11 years; P = .09) and had lower incidence of smoking exposure (29% vs P-OMB, 48%; P = .07); however, there were no other differences in demographics or comorbidities. R-OMB was associated with less intraoperative transfusion (0.6 units vs P-OMB, 1.4 units; P = .01), but there were no differences in conduit choice or bypass configuration.The overall 30-day mortality and complication rates were 7% (n = 10/145) and 53% (n = 77/145), respectively, with no difference between the groups. Notably, R-OMB had decreased cardiac (6% vs P-OMB, 21%; P < .01) and bleeding complication rates (2% vs P-OMB, 15%; P = .01). The freedom from reintervention (1 and 5 years: R-OMB: 95% ± 4%, 83% ± 9% vs P-OMB: 97% ± 2%, 93% ± 5%, respectively; log-rank P = .21) and survival (1 and 5 years: R-OMB: 82% ± 6%, 68% ± 9% vs P-OMB: 84% ± 4%, 66% ± 7%; P = .91) were similar. Independent predictors of all-cause mortality included new postoperative hemodialysis requirement (hazard ratio [HR], 7.4, 95% confidence interval [CI], 3.1-17.3; P < .001), pulmonary (HR, 2.7, 95% CI, 1.4-5.3; P = .004) and cardiac (HR, 2.4, 95% CI, 1.1-5.1; P = .04) complications, and female sex (HR, 2.1, 95% CI, 1.03-4.8; P = .04). Notably, R-OMB was not a predictor of death., Conclusions: The perioperative and longer-term outcomes for a remedial OMB after a failed intraluminal stent or previous open bypass appear to be comparable to a P-OMB. These findings support the recently updated clinical practice guideline recommendations for an endovascular-first approach to treating recurrent CMI due to the significant perioperative complication risk of OMB. However, among the subset of patients deemed ineligible for endoluminal reconstruction after failed mesenteric revascularization, R-OMB results appear to be acceptable and highlight the utility of this strategy in selected patients., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Vascular graft and endograft infections (VGEIs) are complicated by high morbidity, mortality, and recurrence rates, notably due to biofilm formation on the graft surface, hardly dislodgeable by the sole anti-infectious treatment. The characteristics of this biofilm are still poorly documented. The aim of this study was to evaluate ex vivo biofilm on removed infected vascular grafts and endografts (VGEs)., Methods: Explanted VGEs were prospectively collected from 2019 to 2022 at Bordeaux University Hospital, France. Two samples per graft were used for scanning electron microscopy imaging; one was sonicated, and both grafts' sides were imaged., Results: A total of 26 patients were included, 18 with VGEI, eight without any infection (endoleak and/or thrombosis), and 29 VGEs were collected. Microbial documentation was obtained in 83% of VGEIs. A thick layer of fibrin was visible on almost all grafts, mixed with a dense biofilm matrix on infected grafts visible as early as 1 month after the onset of infection. Bacteria were not always visualized on infected grafts' surface (80% on outer side and 85% on luminal side) but were surprisingly present on one-third of non-infected grafts. There was no significant difference between biofilm, fibrin, and microorganisms' distribution between the two grafts' sides. However, there were clear differences between infected and non-infected grafts, since immune cells, bacteria and biofilm were more frequently visualized on both sides of infected grafts (P < .05). Bacteria and immune cells although still visible, were significantly less present after sonication; the number of other elements including biofilm was not significantly different., Conclusions: The persistence of a thick layer of fibrin and biofilm embedding microorganisms on both sides of infected VGE even after 1 month of infection could be the explanation for the low success rates of conservative management and the usual need for graft removal to treat VGEIs., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Aortic dissection is common in patients undergoing open surgical repair of thoracoabdominal aortic aneurysms (TAAAs). Most often, dissection is chronic and is associated with progressive aortic dilatation. Because contemporary outcomes in chronic dissection are not clearly understood, we compared patient characteristics and outcomes after open TAAA repair between patients with chronic dissection and those with non-dissection aneurysm., Methods: We retrospectively analyzed data from 3470 open TAAA repairs performed in a single practice. Operations were for non-dissection aneurysm in 2351 (67.8%) and chronic dissection in 1119 (32.2%). Outcomes included operative mortality and adverse events, a composite variable comprising operative death and persistent (present at discharge) stroke, paraplegia, paraparesis, and renal failure necessitating dialysis. Logistic regression identified predictors of operative mortality and adverse events. Time-to-event analyses examined survival, death, repair failure, subsequent progressive repair, and survival free of failure or subsequent repair., Results: Compared with patients with non-dissection aneurysm, those with chronic dissection were younger, had fewer atherosclerotic risk factors, and were more likely to have heritable thoracic aortic disease and undergo extent II repair. The operative mortality rate was 8.5% (n = 296) overall and was higher in non-dissection aneurysm patients (n = 217; 9.2%) than in chronic dissection patients (n = 79; 7.1%; P = .03). Adverse events were less frequent (P = .01) in patients with chronic dissection (n = 145; 13.0%), 22 (2.0%) of whom had persistent paraplegia. Chronic dissection was not predictive of operative mortality (P = .5) or adverse events (P = .6). Operative mortality and adverse events, respectively, were independently predicted by emergency repair (odds ratio [OR], 3.46 and 2.87), chronic kidney disease (OR, 1.74 and 1.81), extent II TAAA repair (OR, 1.44 and 1.73), increasing age (OR, 1.04/year and 1.04/year), and increasing aortic cross-clamp time (OR, 1.02/minutes and 1.02/minutes). Patients with chronic dissection had lower 10-year unadjusted mortality (42% vs 69%) but more frequent repair failure (5% vs 3%) and subsequent repair for progressive aortic disease (11% vs 5%) than patients with non-dissection aneurysm (P < .001); these differences were no longer statistically significant after adjustment., Conclusions: Outcomes of open TAAA repair vary by aortic disease type. Emergency repairs and atherosclerotic diseases most commonly occur in patients with non-dissection aneurysm and independently predict operative mortality. Repair of chronic dissection is associated with low rates of adverse events, including operative mortality and persistent paraplegia, along with reasonable late survival and good durability. However, patients with chronic dissection tend to more commonly undergo subsequent repair to treat progressive aortic disease, which emphasizes the need for robust long-term imaging surveillance protocols., Competing Interests: Disclosures M.R.M. serves on the Edwards Advisory Board and the Medtronic Advisory Board; his work is supported in part by the Denton A. Cooley, MD, Chair in Cardiac Surgery at The Texas Heart Institute and Baylor St. Luke’s Medical Center. S.L. serves as a consultant for Cerus; has served as a principal investigator for clinical studies sponsored by Terumo Aortic and CytoSorbents; and his work is supported in part by the Jimmy and Roberta Howell Professorship in Cardiovascular Surgery at Baylor College of Medicine. J.S.C. serves as principal investigator, consults for, and receives royalties and a departmental educational grant from Terumo Aortic; consults and participates in clinical trials for Medtronic, Inc., and W.L. Gore & Associates; participates in clinical trials for Abbott Laboratories, CytoSorbents, Edwards Lifesciences, and Artivion; and his work is supported in part by the Cullen Foundation., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this multicenter national study was to compare the outcomes of primary open surgery by aorto-bifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by kissing stent technique for complex aortoiliac occlusive disease (AIOD) lesions (TransAtlantic Inter-Society Consensus [TASC] II C and D)., Methods: All consecutive ABFB cases carried out at 12 vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, perioperative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided into two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure., Results: Overall, 329 patients underwent ABFB during the study period (71% males; mean age, 64 years), of which 285 were primary treatment and 44 were after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and perioperative complications. At 5 years, primary patency rates were significantly higher for primary ABFB (88%; 95% confidence interval [CI], 93.2%-84%) as compared with ABFB after prior EVT (69%; 95% CI 84.9%-55%; log rank P value < .001); however, the 5-year rates of secondary patency (100% vs 95%; 95% CI, 100%-86%) and limb salvage (97%; 95% CI, 99%-96 vs 97%; 95% CI, 100%-94%) were similar between study groups., Conclusions: Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings., Competing Interests: Disclosures None., (Copyright © 2024. Published by Elsevier Inc.)

Objective: The aim of this study was to evaluate the initial and midterm outcomes of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) using the cuff-first technique (CFT) to prevent type II endoleak (T2EL)., Methods: CFT involves deploying an aortic cuff inside the AAA to cover the ostium of the aortic side branch vessels before deploying the main body. We performed a retrospective review of all patients undergoing EVAR with CFT or side branch embolization (SBE) for AAAs at The Jikei University Hospital between 2016 and 2022. Primary endpoint was the rate of aneurysm sac shrinkage. Secondary endpoints were procedure time, radiation exposure, technical and clinical success rates, occurrence of T2EL, and freedom from reintervention or aneurysm-related death., Results: Of 406 patients who underwent EVAR for AAAs, CFT was utilized in 56 (CFT group) and SBE in 35 (SBE group); all 91 patients were included in this study. There were no differences in patient demographics between groups, but there were differences in patency rate of the inferior mesenteric artery and absent intraluminal thrombus. The technical success rate per target vessel in the CFT and SBE group was 97.8% and 91.8%, and the clinical success rate was 91.0% and 100%, respectively. The median procedure time was shorter for CFT than for SBE: CFT, 10 (interquartile range [IQR], 6-14) minutes vs SBE, 25 (IQR, 18.5-45) minutes; P < .05), and median radiation exposure was lower for CFT than for SBE (CFT, 1455 (IQR, 840-2634) mGy vs SBE, 2353 (IQR, 1552-3586) mGy; P < .05). During the median follow-up of 25 months (IQR, 12.5-47 months), sac shrinkage occurred at similar rates in both groups (CFT, 37.5% vs SBE, 40.0%; P = .812), and there were no differences in freedom from reintervention (CFT, 96.2% and 91.4% at 12 and 36 months vs SBE, 100% and 89.5% at 12 and 36 months; log-rank P = .761) and freedom from aneurysm-related death (100% at 36 months in both groups; log-rank P = .440). The odds ratio of CFT vs SBE for sac regression was calculated by adjusting for inferior mesenteric artery patency and absent intraluminal thrombus, resulting in no statistical significance (odds ratio, 1.231; 95% confidence interval, 0.486-3.122)., Conclusions: CFT is feasible with a shorter procedure time and lower radiation exposure than SBE and comparable mid-term outcomes, including sac shrinkage rate, compared with SBE. We believe that CFT, if anatomically suitable, is an alternative to SBE for the prevention of T2EL during EVAR., Competing Interests: Disclosures T.O. serves as a consultant to W.L. Gore and Associates., (Copyright © 2024. Published by Elsevier Inc.)

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.)

Competing Interests: Disclosures None.

Objective: Adverse iliofemoral anatomy may preclude complex endovascular aortic aneurysm repair (EVAR). In our practice, staged iliofemoral endoconduits (ECs) are planned prior to complex EVAR to improve vascular access and decrease operative time while allowing the stented vessel to heal. This study describes the long-term results of iliofemoral ECs prior to complex EVAR., Methods: Between 2012 and 2023, 59 patients (44% male; median age, 75 ± 6 years) underwent ECs before complex EVAR using self-expanding covered stents (Viabahn). For common femoral artery (CFA) disease, ECs were delivered percutaneously from contralateral femoral access and extended into the CFA to preserve the future access site for stent graft delivery. Internal iliac artery patency was maintained when feasible. During complex EVAR, the EC extended into the CFA was directly accessed and sequentially dilated until it could accommodate the endograft. Technical success was defined as successful access, closure, and delivery of the endograft during complex EVAR. Endpoints were vascular injury or EC disruption, secondary interventions, and EC patency., Results: Unilateral EC was performed in 45 patients (76%). ECs were extended into the CFA in 21 patients (35%). Median diameters of the native common iliac, external iliac, and CFA were 7 mm (interquartile range [IQR], 6-8 mm), 6 mm (IQR, 5-7 mm), and 6 mm (IQR, 6-7 mm), respectively. Internal iliac artery was inadvertently excluded in 10 patients (17%). Six patients (10%) had an intraoperative vascular injury during the EC procedure, and six patients (10%) had EC disruption during complex EVAR, including five EC collapses requiring re-stenting and one EC fracture requiring open cut-down and reconstruction with patch angioplasty. In 23 patients (39%), 22 Fr OD devices were used; 20 Fr were used in 22 patients (37%), and 18 Fr in 14 patients (24%). Technical success for accessing EC was 89%. There was no difference in major adverse events at 30 days between the iliac ECs and iliofemoral ECs. Primary patency by Kaplan-Meier estimates at 1, 3, and 5 years were 97.5%, 89%, and 82%, respectively. There was no difference in primary patency between iliac and iliofemoral ECs. Six secondary interventions (10%) were required. The mean follow-up was 34 ± 27 months; no limb loss or amputations occurred during the follow-up., Conclusions: ECs improve vascular access, and their use prior to complex EVAR is associated with low rates of vascular injury, high technical success, and optimal long-term patency. Complex EVAR procedures can be performed percutaneously by accessing the EC directly under ultrasound guidance and using sequential dilation to avoid EC disruption., Competing Interests: Disclosures M.S.B. and C.H.T. have been consultants for and received research support from Cook Medical Inc, W. L. Gore & Associates, Inc, and Phillips Healthcare. The other authors of this article have no relevant financial relationships to disclose per the JVS policy., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Complex endovascular abdominal aortic aneurysm (AAA) repair techniques have evolved over the last decade, yet patterns of physician and hospital system adoption of fenestrated endovascular aneurysm repair (FEVAR) remain poorly defined. We investigated clinical outcomes, use trends, and surgeon and hospital experience for FEVAR in a large community hospital system., Methods: We conducted a retrospective cohort study of all FEVAR procedures within our 5-state hospital system between April 2012 and June 2021. AAA repair volumes (open, EVAR, and FEVAR) were captured at the hospital and surgeon levels using Current Procedural Terminology and International Classification of Diseases codes. Clinical and outcomes data were collected for FEVAR patients. To consider if surgeon or hospital experience influenced outcomes, sequential case number was used to divide patients into surgeon experience and hospital experience groups. Inverse probability weighted and generalized linear mixed models, adjusted for demographics and comorbidities, were built to examine risk-adjusted outcomes for surgeon and hospital experience groups., Results: Of 3850 patients treated with AAA procedures of any kind between 2012 and 2021, 160 (4.2%) underwent FEVAR. FEVAR procedures were performed by 34 different surgeons at 12 hospitals, with intraoperative complications and unplanned adjunctive procedures occurring in 18.8% (n = 30) and 19.4% (n = 31) of patients, respectively. Among FEVAR patients, in-hospital mortality was 1.3% (n = 2) and postoperative morbidity was 16.9% (n = 27). Renal function decline occurred postoperatively in 5.1% of patients. Early (<30 day) postoperative endoleaks occurred in 15.3% of patients (n = 21). Target vessel patency was 95.6% on initial postoperative imaging. Surgeon and hospital experience had a small positive impact on outcomes after the first one to three cases. Significant decreases in operative time, fluoroscopy time, and estimated blood loss were observed with increased surgeon experience, relative to a surgeon's first case (P < .05). There were lower odds of intraoperative complications after a surgeon's first case (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.03-0.77, for cases 2-3) or after a hospital's first one to three cases (OR, 0.19; 95% CI, 0.04-0.89, for cases 4-8; OR, 0.12; 95% CI, 0.03-0.55 for cases 9-49)., Conclusions: Clinical outcomes of FEVAR across our hospital system compare favorably with previously published reports. Although system-wide FEVAR adoption increased 3-fold over the last decade, FEVAR continued to be performed by a minority of hospitals in our system. The results from this cohort demonstrate low rates of adverse events, high rates of technical efficiency, and a small impact of surgeon and hospital experience, thereby supporting this advanced endovascular technology as a safe, efficacious, and generalizable treatment alternative to open repair for patients with complex aortic anatomy., Competing Interests: Disclosures B.U. is a consultant for Medtronic, Cook Medical, and W. L. Gore & Associates., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosures None.

Competing Interests: Disclosures None.

Objective: The aim of this study was to investigate the mid-term results of stented-assisted balloon-induced intimal disruption and relamination (STABILISE) in patients with aortic dissection with the implementation of volumetric analysis., Methods: This was a single-center retrospective analysis of prospectively collected data. From May 2017 to September 2022, 42 patients underwent STABILISE for acute complicated or subacute high-risk aortic dissection. STABILISE was completed with distal extended endovascular aortic repair in 24 patients. A computed tomography scan was performed at baseline, before hospital discharge, and at 1, 3, and 5 years. Perfused total aortic, true lumen, and false lumen volumes were assessed for thoracic, visceral, and aorto-iliac segment. The ratio between false lumen and total volume was named perfusion dissection index (PDI). Complete remodeling was defined as PDI = 0, and positive remodeling as PDI ≤0.1., Results: Technical success was 97.6%. No 30-day deaths, spinal cord injuries, or retrograde dissections were observed. Mean follow-up was 44 ± 19.4 months. Thoracic diameter was lower at last available computed tomography scan (36.7 vs 33.0 mm; P = .01). Aortic growth >5 mm was observed in 9.5% of the patients. Thoracic and visceral aortic complete remodeling were 92.8% and 83.3%, respectively, with no difference between acute and subacute group. Distal extended endovascular aortic repair significantly increased complete remodeling in the aorto-iliac segment, compared with STABILISE alone (69.6% vs 21.4%; P < .001). Freedom from vascular reinterventions at 3 years was 83.1% (95% confidence interval, 71.5%-96.6%). Total PDI ≤0.1 at first postoperative control was a predictor of vascular reinterventions (P < .0001)., Conclusions: STABILISE is a safe and feasible technique associated with high mid-term rates of complete remodeling in the thoracic and visceral aorta. Volumetric analysis allows the quantification of aortic remodeling and represents a predictor of aortic reinterventions., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: We investigated the early and midterm efficacy and safety of covered endovascular reconstruction of the aortic bifurcation (CERAB) in the treatment of aortoiliac disease (AID)., Methods: A systematic search on PubMed, Scopus, and Web of Science for articles published by August 2023 was performed. The primary end points were primary patency and secondary patency., Results: Eleven retrospective case series, involving 579 patients, were incorporated in the review with 88.9% of the included lesions being categorized as Trans-Atlantic Inter-Society Consensus (TASC) C or D. The pooled primary patency estimates at 12, 24 and 36 months were 94.4% (95% confidence interval [CI], 89.4-99.7), 84.4% (95% CI, 72.3-98.5) and 83.8% (95% CI, 71.4-98.3) respectively. The mean primary patency time, representing the period during which individuals remained event-free, was 51.9 months (95% CI, 43.6-55.4). The pooled 36 months primary patency for studies with a predominantly claudicant patient population (>75% of patients) was 89.4% (95% CI, 78.5-100.0), compared with 71.5% (95% CI, 45.6-100.0) for studies with a mixed population (50% of patients). The pooled 36 months primary patency for studies with a predominantly TASC D patient population (>82% of patients) was 70.4% (95% CI, 46.4-100.0) compared with 91.0% (95% CI, 79.1-100.0) for studies with a more homogenous cohort. The pooled secondary patency estimates at 12, 24, and 36 months were 98.6% (95% CI, 96.2-100.0), 97% (95% CI, 93.1-100.0), and 97% (95% CI, 93.1-100.0), respectively. The pooled technical success, 30-day mortality and 30-day systemic complications estimates were 95.9% (95% CI, 93.7- 97.4), 1.9% (95% CI, 1.0-3.5), and 6.4% (95% CI, 4.4-9.1), respectively. The pooled intraoperative and postoperative 30-day CERAB-related complications estimates were 7.3% (95% CI, 2.0-23.0) and 4.2% (95% CI, 0.7-21.0), respectively. The pooled major amputation and target lesion reinterventions by the end of follow-up were 1.9% (95% CI, 1.0-3.4) and 13.9% (95% CI, 9.9-19.2), respectively. The pooled access site complication estimate was 11.7% (95% CI, 5.9-21.7)., Conclusions: Although this review has showcased the safety and feasibility of the CERAB technique in treating AID, it has also highlighted the necessity for a close and prolonged follow-up period extending beyond 1 year. Moreover, the favorable secondary patency estimates predominantly attained via endovascular reinterventions emphasize a potentially advantageous characteristic of the CERAB technique, particularly valuable when addressing late-stage AID disease or anatomically complex lesions., Competing Interests: Disclosures None., (Copyright © 2023 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.)

Objective: Infected native aneurysms (INAs) of the abdominal aorta and iliac arteries are uncommon, but potentially fatal. Endovascular aneurysm repair (EVAR) has recently been introduced as a durable treatment option, with outcomes comparable to those yielded by conventional open repair. However, owing to the rarity of the disease, the strengths and limitations of each treatment remain uncertain. The present study aimed to separately assess post-open repair and post-EVAR outcomes and to clarify factors affecting the short-term and late prognosis after each treatment., Methods: Using a nationwide clinical registry, we investigated 600 patients treated with open repair and 226 patients treated with EVAR for INAs of the abdominal aorta and/or common iliac artery. The relationships between preoperative or operative factors and postoperative outcomes, including 90-day and 3-year mortality and persistent or recurrent aneurysm-related infection, were examined., Results: Prosthetic grafts were used in >90% of patients treated with open repair, and in situ and extra-anatomic arterial reconstruction was performed in 539 and 57 patients, respectively. Preoperative anemia and imaging findings suggestive of aneurysm-enteric fistula were independently associated with poor outcomes in terms of both 3-year mortality (hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.01-2.62; P = .046, and HR, 2.24; 95% CI, 1.12-4.46; P = .022, respectively) and persistent or recurrent infection (odds ratio [OR], 2.16; 95% CI, 1.04-4.49; P = .039, and OR, 4.96; 95% CI, 1.81-13.55; P = .002, respectively) after open repair, whereas omental wrapping or packing and antibiotic impregnation of the prosthetic graft for in situ reconstruction contributed to improved 3-year survival (HR, 0.60; 95% CI, 0.39-0.92; P = .019, and HR, 0.53; 95% CI, 0.32-0.88; P = .014, respectively). Among patients treated with EVAR, abscess formation adjacent to the aneurysm was significantly associated with the occurrence of persistent or recurrent infection (OR, 2.24; 95% CI, 1.06-4.72; P = .034), whereas an elevated preoperative white blood cell count was predictive of 3-year mortality (HR, 1.77; 95% CI, 1.00-3.13; P = .048)., Conclusions: Profiles of prognostic factors differed between open repair and EVAR in the treatment of INAs of the abdominal aorta and common iliac artery. Open repair may be more suitable than EVAR for patients with concurrent abscess formation., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Cryopreserved (CP) products are utilized during challenging cases when autogenous or prosthetic conduit use is not feasible. Despite decades of experience with cadaveric greater saphenous vein (GSV), there is limited available data regarding the outcomes and patency of other CP products, specifically arterial and deep venous grafts. This study was designed to evaluate outcomes of non-GSV CP conduits in patients undergoing urgent, emergent, and elective arterial reconstruction at our institution. We hypothesized that non-GSV CP allografts have adequate patency and outcomes and are therefore a feasible alternative to GSV in settings where autologous graft is unavailable or prosthetic grafts are contraindicated., Methods: This study was approved by the Institutional Review Board at our institution. We retrospectively reviewed charts of patients undergoing arterial reconstructions using CP conduits from 2010 to 2022. Data collected included demographics, comorbidities, smoking status, indications for surgery, indication for CP conduit use, anatomic reconstruction, urgency of procedure, and blood loss. Time-to-event outcomes included primary and secondary graft patency rates, follow-up amputations, and mortality; other complications included follow-up infection/reinfection and 30-day complications, including return to the operating room and perioperative mortality. Time-to-event analyses were evaluated using product-limit survival estimates., Results: Of 96 identified patients receiving CP conduits, 56 patients received non-GSV conduits for 66 arterial reconstructions. The most common type of non-GSV CP product used was femoral artery (31 patients), followed by aorto-iliac artery (22 patients), and femoral vein (19 patients), with some patients receiving more than one reconstruction or CP product. Patients were mostly male (75%), with a mean age of 63.1 years and a mean body mass index of 26.7 kg/m 2 . Indications for CP conduit use included infection in 53 patients, hostile environment in 36 patients, contaminated field in 30 patients, tissue coverage concerns in 30 patients, inadequate conduit in nine patients, and patient preference in one patient. Notably, multiple patients had more than one indication. Most surgeries (95%) were performed in urgent or emergent settings. Supra-inguinal reconstructions were most common (53%), followed by extra-anatomic bypasses (47%). Thirty-day mortality occurred in 10 patients (19%). Fifteen patients (27%) required return to the operating room for indications related to the vascular reconstructions, with 10 (18%) cases being unplanned and five (9%) cases planned/staged. Overall survival at 6, 12, and 24 months was 80%, 68%, and 59%, respectively. Primary patency at 6, 12, and 24 months was 86%, 70%, and 62%, respectively. Amputation freedom at 6 months, 12 months, and 24 months was 98%, 95%, and 86%, respectively for non-traumatic indications., Conclusions: Non-GSV CP products may be used in complex arterial reconstructions when autogenous or prosthetic options are not feasible or available., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Persistent type II endoleaks (pEL2s) are not uncommon after endovascular aneurysm repair and their impact on long-term outcomes is well-documented. However, their occurrence and natural history after fenestrated/branched endografting (F/B-EVAR) for juxtarenal and pararenal aneurysms (J/P-AAAs) have been scarcely investigated. Aim of this study was to report incidence, risk factors, and natural history of pEL2 after F/B-EVAR in J/P-AAAs., Methods: Between 2016 and 2022, all J/P-AAAs undergoing F/B-EVAR were prospectively collected and retrospectively analyzed. EL2 were assessed at the completion angiography, at 30 days and after 6 months as primary outcomes. Preoperative risk factors for pEL2, follow-up survival, freedom from reinterventions (FFR) and aneurysm shrinkage (≥5 mm) were considered as secondary outcomes., Results: Of 132 patients, there were 88 (67%) JAAAs and 44 (33%) PAAAs. Seventeen EL2 (13%) were detected at the completion angiography and 36 (27%) at 30-day computed tomography angiography. The mean follow-up was 28 ± 23 months. Eleven (31%) EL2 sealed spontaneously within 6 months and three new cases were detected, for an overall of 28 pEL2/107 patients (26%) with available radiological follow-up of ≥6 months. Preoperative antiplatelet therapy (odds ratio, 4.7; 95% confidence interval [CI[, 1-22.1; P = .05), aneurysm thrombus volume of ≤40% and six or more patent aneurysm afferent vessels (odds ratio, 7.2; 95% CI, 1.8-29.1; P = .005) were independent risk factors for pEL2. The estimated 3-year survival was 80%, with no difference between cases with and without pEL2 (78% vs 85%; P = .08). The estimated 3-year FFR was 86%, with no difference between cases with and without pEL2 (81% vs 87%; P = .41). Four cases (3%) of EL2-related reinterventions were performed. In 65 cases (49%), aneurysm shrinkage was detected. pEL2 was an independent risk factor for absence of aneurysm shrinkage during follow-up (hazard ratio, 3.2; 95% CI, 1.2-8.3; P = .014). Patients without shrinkage had lower follow-up survival (64% vs 86% at 3-year; P = .009) and FFR (74% vs 90% at 3 years; P = .014) than patients with shrinkage., Conclusions: PEL2 is not infrequent (26%) after F/B-EVAR for J/P-AAAs and is correlated with preoperative antiplatelet therapy, aneurysm thrombus volume of ≤40%, and six or more patent sac afferent vessels. Patients with pEL2 have a diminished aneurysm shrinkage, which is correlated with lower follow-up survival and FFR compared with patients with aneurysm shrinkage., Competing Interests: Disclosures E.G., G.L.F., and M.G. are clinical proctors for Cook Medical fenestrated and branched endografting., (Copyright © 2024. Published by Elsevier Inc.)