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ObjectiveThe objective of this study was to compare multibranched endovascular aneurysm repair (MBEVAR) of postdissection thoracoabdominal aortic aneurysms (TAAAs) and pararenal aortic aneurysms (PRAAs) with MBEVAR of degenerative TAAAs and PRAAs and to assess the role played by the preoperative correction of potential complicating factors, such as true lumen compression and false lumen origin of vital branches, using adjunctive maneuvers.MethodsFrom July 2005 to July 2017, there were 162 patients who underwent elective MBEVAR of TAAAs and PRAAs. Data on demographics, procedural details, and outcomes were collected prospectively.ResultsThe mean age was 73 ± 8 years, and 119 of 162 (74%) were men; 19 of 162 (12%) had prior aortic dissections. Patients with dissections were younger (65 ± 11 years vs 74 ± 7 years; P = .002) and were less likely to have smoked (13/19 [68%] vs 135/143 [94%]; P = .002) or to have peripheral artery disease (0/19 [0%] vs 35/143 [24%]; P = .01) compared with those without dissections. Patients with prior dissections were more likely to have Crawford type II (10/19 [53%] vs 22/143 [15%]; P = .001) and type III (6/19 [32%] vs 16/143 [11%]; P = .03) TAAAs and were more likely to require at least one pre-MBEVAR adjunctive procedure (14/19 [74%] vs 55/143 [38%]; P = .006) compared with those without dissection. There was no difference in perioperative death, stroke, or paraplegia rates between the two groups. Median follow-up was 2.4 years (interquartile range, 0.8-4.7) and did not differ significantly between the two groups. There were no significant differences in branch vessel occlusion, endoleak rate, or aneurysm-related death between the two groups.ConclusionsPatients with chronic type B aortic dissection are more likely to have extensive aneurysms and more likely to require adjunctive procedures to provide the appropriate anatomic substrate for MBEVAR, but this does not appear to affect the conduct of MBEVAR or its outcomes.

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 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.)

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.)

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.)

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.)

Competing Interests: Disclosures L.M.D. has been a paid consultant for Boston Scientific.

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: 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: 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: Complex endovascular procedures are now recognized as the gold standard treatments for extensive aortic diseases. Bridging stents (covered stents used to couple the aortic graft to the visceral vessels) play a pivotal role, yet there is currently no dedicated device available on the market. The aim of the study was to evaluate the midterm performance of the Gore Viabahn balloon-expandable (VBX) stent graft as a bridging stent for target visceral vessels (TVVs)., Methods: Data from all consecutive patients who underwent a fenestrated and branched endovascular aortic repair and received the VBX stent graft as a bridging stent between July 2018 and September 2022 were prospectively collected and subsequently analyzed retrospectively. Primary end points included freedom from TVV instability and freedom from TVV-related reinterventions, both overall and in comparison between branched and fenestrated graft configurations. Secondary end points were overall survival, procedure and TVV-related (in an intent-to-treat basis) technical success, freedom from type IC/IIIC endoleak, and freedom from TVV patency loss., Results: Sixty-three patients were treated with a fenestrated and branched endovascular aortic repair using the VBX stent graft as a bridging stent, of whom 47 (74.6%) presented an atherosclerotic aneurysm, 7 (11.1%) a post-dissecative aneurysm, and 9 (14.3%) an anastomotic pseudoaneursym or a type IA endoleak in a previous endovascular aortic repair. Included in the aortic repair were 231 of 243 (95.1%) total visceral vessels. The intraoperative requirement of 13 additional VBX stent grafts determined a TVV-related technical success of 94.4%. The mean follow-up was 26.1 ± 16.4 months. The estimated overall survival at 36 months was 73% ± 7.5%. The estimated rates at 36 months for freedom from type IC/IIIC endoleaks and TVV primary patency were 90.6% ± 3.9% and 99% ± 0.7%, respectively. The estimated rate at 36 months for freedom from TVV instability was 92.1% ± 3% and did not differ between branched and fenestrated configurations, whereas freedom from TVV-related reinterventions was 90.6% ± 3.1% and significantly in favor of fenestrations (69.4% vs 96.8%, P < .001). Multivariate analyses confirmed fenestrated configuration as a protective factor against TVV-related reinterventions (hazard ratio: 0.079; 95% confidence interval: 0.016-0.403)., Conclusions: The VBX stent graft proves to be a reliable bridging stent for complex aortic procedures involving both fenestrated and branched endografts. Although immediate results are deemed satisfactory, they favor fenestrations regarding the need of reinterventions through 3 years. The success of the procedure heavily relies on a thorough understanding of the unique characteristics of this stent., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: This systematic literature review compares the clinical outcomes of heparin-bonded expanded polytetrafluoroethylene with autologous saphenous vein in the management of patients undergoing below-the-knee bypass to treat peripheral arterial disease., Methods: An electronic literature search was conducted in MEDLINE and Embase to identify comparative studies in patients who underwent below-the-knee surgical bypass. Studies were screened at abstract and full text review using predefined inclusion criteria by two independent reviewers and critically appraised for risk of bias. Meta-analyses were conducted using Review Manager 5 software (Nordic Cochrane Centre)., Results: Eight retrospective cohort studies were identified. Meta-analysis of primary patency demonstrated no significant difference between heparin-bonded expanded polytetrafluoroethylene and autologous saphenous vein grafts after 1 (odds ratio: 0.91, 95% confidence interval: [0.52-1.59]; P = .74), 2 (1.12 [0.60-2.10]; P = .77), 3 (0.62 [0.26-1.48]; P = .28), and 4 years (0.70 [0.36-1.39]; P = .31). Similarly, for secondary patency, no significant difference was detected at 1 (0.62 [0.33-1.15]; P = .13), 2 (0.83 [0.32-2.13]; P = .69), 3 (0.60 [0.27-1.32]; P = .20), and 4 years (0.66 [0.32-1.36]; P = .26). There was no significant difference between autologous veins and heparin-bonded expanded polytetrafluoroethylene for limb salvage and mortality at all time points. A sensitivity analysis to compare outflow vessels was conducted in only tibial bypass and identified no differences. All analyses were considered at high-risk bias because of heterogeneity in study populations and attrition in follow-up., Conclusions: This meta-analysis demonstrates similar outcomes between autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene for patency, limb salvage, and mortality through 4 years. The use of heparin-bonded expanded polytetrafluoroethylene synthetic grafts is a satisfactory option to prevent amputation, particularly when autologous saphenous vein grafts are not available. Controlled clinical studies are needed to further inform future decision-making and economic modeling related to the choice of conduit for below-the-knee graft construction., Competing Interests: Disclosures D.J.D. is a clinical investigator for Gore Medical. F.O. is a former employee of W. L. Gore and Associates. R.F.N is on the WL Gore Scientific Advisory Board., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The use of standard bifurcate pieces in fenestrated/branched endovascular aortic repair (F/BEVAR) requires adequate length from the lowest branch or fenestration to the aortic bifurcation. In patients with prior aortic surgery, the aortic bifurcation is often artificially established in a more proximal position, compromising the infrarenal length, which hinders the placement of a standard bifurcate component below the fenestrated/branched component. Short bifurcate bodies using an inverted contralateral limb have been purpose-built to address this challenge. However, reported outcomes for this device remain limited, with specific concerns about the durability of the inverted iliac limb sealing region. We sought to evaluate outcomes of F/BEVAR using an investigational inverted iliac limb bifurcate, manufactured by Cook Medical., Methods: This study was a retrospective review of prospectively maintained data from the US-Aortic Research Consortium from 2005 to 2022. Patients were included if they underwent F/BEVAR for thoracoabdominal or complex abdominal aortic aneurysms. Patients were excluded if they did not have a bifurcate device placed. Patients were then compared based on the use of an inverted iliac limb or standard bifurcate component. The primary outcome for this study was technical success. Secondary outcomes included 30-day mortality, freedom from ischemic leg complications, freedom from type I endoleaks (TIELs), freedom from type II endoleaks (TIIELs), freedom from type III endoleaks (TIIIELs), and graft component separations., Results: A total of 1944 patients met study criteria with 442 (22.8%) inverted iliac limb bifurcates and 1502 (77.2%) standard bifurcates. Patients who received inverted iliac limbs were more likely to have had prior aortic surgery (63.8% vs 28.5%; P < .001). Patients receiving inverted iliac limbs had longer procedure times (265 minutes; interquartile range [IQR], 201-342 minutes vs 241 minutes; IQR, 186-313 minutes; P < .001), more contrast use (89 mL [IQR, 55-135 mL] vs 109 mL [IQR, 75-156 mL]; P < .001), and higher estimated blood loss (250 mL [IQR, 150-500 mL] vs 250 mL [IQR, 110-400 mL]; P = .042). There were no differences in rates of technical success (97.3% vs 96.1%; P = .310), rates of endoleaks upon completion of the case (18.0% vs 21.4%; P = .123), or 30-day mortality rates (1.8% vs 2.5%; P = .466) between patients receiving inverted iliac limb and standard bifurcated components. There were no differences in cumulative survival, freedom from limb ischemia, freedom from aneurysm rupture, and freedom from TIIIELs over the course of 5 years between patients receiving inverted bifurcates and standard bifurcated components. Patients with inverted iliac limb bifurcate components had decreased freedom from reinterventions, TIELs, and TIIELs. After adjustment for potential confounders, the use of an inverted iliac limb was not associated with reinterventions (hazard ratio,1.044; 95% confidence interval, 0.849-1.285; P = .682). There was a total of 2 component separations (0.1%) of the bifurcate component from the fenestrated/branched component over the study period, both of which occurred in the standard bifurcate components., Conclusions: The use of investigational inverted iliac limb bifurcate components is a safe option with favorable mid-term outcomes in patients who are not anatomical candidates for standard bifurcate components. Patients undergoing investigational inverted iliac limb bifurcate component implantation had decreased freedom from reinterventions, which likely corresponds with the complexity of repair associated with them., Competing Interests: Disclosures A.S. reports a relationship with Cook Medical, Philips, and Artivion; C.T. reports a relationship with Cook Medical and W. L. Gore & Associates; D.B.S. reports a relationship with Cook Medical, W. L. Gore & Associates, Endologix, and Medtronic; M.F. reports a relationship with Cook Medical, W. L. Gore & Associates, ViTaaa, Centerline, and Getinge; A.B. reports a relationship with Artivion, Cook Medical, Medtronic, W. L. Gore & Associates, and Terumo; M.P.S. reports a relationship with Artivion; G.S.O. has received consulting fees and grants from Cook Medical, W. L. Gore & Associates, Centerline Biomedical, and GE Healthcare., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Endovascular repair of complex abdominal aortic aneurysms (CAAAa) and thoracoabdominal aortic aneurysms (TAAAs) with fenestrated and branched devices (F/BEVAR) represents the first-line treatment in old or unfit patients. Currently, the widespread diffusion of these techniques has led to a progressive increase of complex endovascular procedures also in younger and fitter patients, but the related results have been only minimally reported, without long-term data. We investigated the long-term results of F/BEVAR for CAAA and TAAA repair in young and fit patients., Methods: All consecutive patients, aged ≤70 years, who underwent F/BEVAR for CAAA and TAAA over the last 13 years at two tertiary institutions were included in the study. All subjects presented a low to intermediate risk according to the Society for Vascular Surgery clinical comorbidity grading system. The primary end points were technical and clinical success and late overall and aortic-related survival. Major complications and specific target vessel-related outcomes were investigated as secondary end points., Results: A total of 183 patients (155 males [84.7%]; mean age, 64.5 ± 5.7 years; range, 33-70 years) underwent F/BEVAR during the study period, for a total of 167 degenerative (91.3%) and 16 postdissection (8.7%) aneurysms, including 44 (24%) juxtarenal, 33 (18%) pararenal, and 106 (58%) TAAAs. Technical and clinical success were achieved in 176 patients (96.2%) and 171 patients (93.4%), respectively. Four patients (2.2%) died perioperatively, of which two (1.1%) operated in emergency. Postoperatively, five patients (2.7%) presented permanent grade 3 spinal cord injury and three (1.6%) renal failure needing permanent dialysis. The mean follow-up was 65.7 ± 39.6 months (range, 1-158 months). The estimated overall and aortic-related survival at 12, 60, and 120 months was 94.0%, 85.1%, 72.2%, and 97.8%, 97.8%, 96.2%, respectively, and reintervention and branch instability-free survival at the same time points were 84.4%, 71.8%, 71.8%, and 93.2%, 86.3%, 72.2%, respectively. An aneurysm growth of >5 mm was detected in six patients (3.3%), and a sac shrinkage of >5 mm was achieved in 118 cases (64.5%). The Cox regression analysis demonstrated the need for unplanned procedure as the only risk factor for overall mortality (odds ratio, 3.331; 95% confidence interval, 1.397-7.940; P < .01]., Conclusions: F/BEVAR in young and fit patients led to low perioperative mortality and major morbidity rates and a favorable overall survival rate in the long-term, making this technique particularly appealing in such a subgroup of patients. The availability of long-term data derived from the results of young patients, may additionally provide helpful information to redefine the indications for treatment and allow future targeted device and technique improvements., Competing Interests: Disclosures C.F. is clinical proctor for Terumo Aortic, and is investigator of the EMBRACE Registry. E.G. is a clinical proctor for Cook Medical. M.G. is a clinical proctor for Cook Medical, and is PI of the EXPAND Registry. R.G. is an investigator of the EMBRACE Registry., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms. Physician-modified endografting (PMEG) and the Gore thoracoabdominal multibranch endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution., Methods: A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician-sponsored investigational device exemption at a single institution between 2020 and 2022 were completed. Patient demographics, characteristics, and perioperative and midterm outcomes were compared., Results: A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often thoracoabdominal aortic aneurysm in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%; P = .013) and longer mean procedure time (247 ± 36 minutes vs 189 ± 49 minutes; P < .001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P = .412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, whereas in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. Although the overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG; P = .57), type II endoleaks accounted for all of the endoleaks in the TAMBE group, whereas type I or III endoleaks were seen in 11% of PMEG patients. At a median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P = .401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P = .646). Estimated freedom from reintervention rates at 3 years were similar (56% TAMBE vs 62% PMEG, log-rank P = .910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P = .459). The Kaplan-Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P = .157)., Conclusions: At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG., Competing Interests: Disclosures G.M. is a consultant for W. L. Gore & Associates, Cook Medical, and Silk Road Medical. S.H. is a consultant for W. L. Gore & Associates, Terumo, and Vestek, and is on the board for W. L. Gore & Associates and Vestek., (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.)

Objective: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up., Methods: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality., Results: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR., Conclusions: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery., Competing Interests: Disclosures L.v.W. received speaker fees from W.L. Gore & Associates. M.B. reports consulting for Cook Medical. K.D. reports consulting for W.L. Gore & Associates and Cook Medical. C.J.Z. reports research support, honoraria, and travel support from W.L. Gore & Associates and Cook Medical. M.R. reports consulting for W.L. Gore & Associates., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

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

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.)

Competing Interests: Disclosures None.

Competing Interests: Disclosures None.

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: 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.)

Objective: There are a variety of methods used today to treat common iliac aneurysms with endovascular techniques. Of these approaches, little is known about whether a particular limb strategy influences endoleak, reintervention, or aneurysm regression rates. We present 5-year data comparing endoleak, stent graft migration, fracture, aneurysm sac dynamics, and aortic rupture rates among patients treated with bell bottom limbs (BB), iliac branch endoprosthesis (IBE), and coil and cover (CC) approaches from the Global Registry for Endovascular Aortic Treatment registry. Secondary end points were all-cause mortality, stroke, reintervention, and paraplegia., Methods: Subjects from the GORE Global Registry for Endovascular Aortic Treatment were enrolled over a 5-year period from October 2017 to August 2022. We included 924 subjects in this study. Statistical data was generated on R software and limb groups were compared using the Pearson's χ 2 test and the Kruskal-Wallis rank-sum test., Results: We found no statistical difference in endoleak rates, stent graft migration, fracture, or aortic rupture when stratified by limb strategy. There was no difference between limb approaches with regard to aneurysm sac dynamics among those with abdominal aortic aneurysms and common iliac aneurysms. Similarly, no statistical difference between limb strategies was found in all-cause mortality, stroke, paraplegia, or reintervention rates. Among patients that required an additional graft during reintervention, the highest rates were found within the IBE group 8.6%, compared with BB group 2.2% and CC group 1.3% (P = .006)., Conclusions: Overall, there was no difference among limb strategies in endoleak rates, stent graft migration, aneurysm sac dynamics, aortic rupture rates, or our secondary end points. Increased rates of reintervention requiring an additional graft within the IBE group is noteworthy and must be weighed against the adverse effects of hypogastric sacrifice with the CC approach or potentially less advantageous seal zones in the BB approach. This finding suggests that all limb approaches have equivalent effectiveness in managing the aneurysmal common iliac artery; thus, the choice of limb strategy should be individualized and remain at physician discretion. Future research should include a more robust sample size to reproduce these findings., Competing Interests: Disclosures A.G. is a consultant for Cydar and Shockwave. J.M.M.H. is a consultant for Cydar and W. L. Gore & Associates. R.M. is a consultant for Cydar, CyndRx, Endoron, Endospan, Medtronic, Silk Road, ViTAA, Shockwave, and W. L. Gore & Associates., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The high frequency of reinterventions after fenestrated endovascular aortic repair (FEVAR) with physician-modified endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal., Methods: We performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the United States Food and Drug Administration in support of an investigational device exemption trial. We excluded patients with aortic dissection (n = 5), type I to III thoracoabdominal aneurysms (n = 13), non-elective procedures (n = 4), and prior aortic surgery other than EVAR (n = 8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary FEVAR). The primary outcomes were freedom from reintervention and sac dynamics (regression as ≥5 mm decrease, expansion as ≥5 mm increase, and stability as <5 mm increase or decrease) at 3 years. Secondary outcomes were perioperative mortality and 3-year survival., Results: Of the 92 patients included, 56 (61%) underwent primary FEVAR and 36 (39%) underwent secondary FEVAR. Secondary FEVAR patients were older (78 years [interquartile range (IQR), 74.5-83.5 years] vs 73 years [IQR, 69-78.5 years]; P < .001), more frequently male (86% vs 68%; P = .048), and had larger aneurysms (72.5 mm [IQR, 65.5-81 mm] vs 59 mm [IQR, 55-65 mm]; P < .001). Perioperative mortality was 1.8% for primary FEVAR and 2.7% for secondary FEVAR (P = .75). At 3 years, overall survival was 84% for primary FEVAR and 71% for secondary FEVAR (P = .086). Freedom-from reintervention was significantly higher for primary FEVAR than secondary FEVAR, specifically 82% vs 38% at 3 years (P < .001). Primary FEVAR also had more desirable sac dynamics relative to secondary FEVAR at 3 years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded; P = .038)., Conclusions: FEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary FEVAR, less than a quarter of patients have undergone reintervention at 3 years, and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary FEVAR, over one-half of patients have undergone reintervention and over one-third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary FEVAR., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

ObjectiveRandomized trials and retrospective data suggest that covered balloon-expandable (CBE) stents have better short-term patency compared with balloon-expandable bare-metal stents (BMSs) in the treatment of iliac artery disease. This study evaluated midterm outcomes of BMSs vs CBE stents placed in the common iliac artery (CIA) for aortoiliac occlusive disease.MethodsAll endovascular interventions for symptomatic peripheral arterial occlusive disease performed at a single institution from 2006 to 2012 were reviewed. Patients undergoing stent placement in the CIA segment were included in the analysis. Demographic data, TransAtlantic Inter-Society Consensus (TASC) classification, stent type, patency, and limb reinterventions were compared.ResultsFor treatment of de novo distal aorta or CIA stenosis, 254 procedures were performed in 162 patients. BMSs were used in 190 arteries; CBE stents were used in 64 arteries. There was no difference in age, gender, or TASC classification between the two groups. Mean follow-up was 22 ± 16 months. Primary patency, assisted patency, and secondary patency were significantly better in the BMS group. CIAs treated with covered stents were more likely at 1 year or longer to require repeated intervention (hazard ratio, 2.5; 95% confidence interval, 1.2-5.3; P = .009). TASC classification did not predict need for reintervention in either group. Multivariate analysis revealed dual antiplatelet therapy to be the only other factor to affect patency during long-term follow-up.ConclusionsIn this study, BMSs had significantly better patency compared with CBE stents for treatment of aortoiliac occlusive disease. A randomized trial comparing patency as well as restenosis rates with long-term follow-up is needed to determine if there is any benefit from use of covered stents in the aortoiliac segment.

Objective: Thoracic endovascular aortic repair (TEVAR) has been used extensively in the management of thoracic aortic diseases. Numerous efforts have been made to enhance clinical outcomes through the use of stent grafts. This study aimed to investigate the effectiveness and safety of physician-manufactured partial micropore stent grafts (PSMGs) in TEVAR., Methods: Between December 2017 and June 2022, data were collected from 56 patients who underwent TEVAR using physician-manufactured PSMGs. The evaluation encompassed technical success, perioperative and follow-up morbidity and mortality, stroke incidence, and branch artery patency., Results: In this investigation, 56 patients received treatment with physician-manufactured PSMGs. Of these patients, 46 were male, with a mean age of 62.1 ± 11.2 years. Aortic pathologies comprised aortic dissection (n = 31 [55.4%]), aortic aneurysms (n = 10 [17.9%]), penetrating aortic ulcer (n = 8 [14.3%]), and intramural hematoma (n = 7 [12.5%]). During a median follow-up of 18 months (interquartile range, 13-25 months), the stroke rate, supra-aortic branch patency rate, and endoleak rate were 0%, 100%, and 7.1%, respectively. There were no occurrences of all-cause mortality, stroke, or the necessity for open conversion., Conclusions: TEVAR with physician-manufactured PSMGs is a viable alternative for addressing aortic arch pathologies in proficient medical centers. The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality., Competing Interests: Disclosures None., (Copyright © 2024. Published by Elsevier Inc.)

Background: Endovascular treatment of thoracoabdominal aortic aneurysms has become common, with satisfactory results. Nevertheless, long-term durability remains an issue mainly because of target visceral vessel (TVV) instability. Currently, no covered stent has been approved as a bridging stent graft (BSG), demanding continuous research on this topic., Methods: This was a multicenter observational retrospective cohort study comparing the midterm results of the Bard Covera Plus and Gore VBX as BSGs during branched endovascular aneurysm repair. The primary outcome was the comparison of the target vessel instability between the two groups. Primary patency, freedom from branch-related type I and III endoleaks and reintervention, and technical and clinical success were considered secondary outcomes. Logistic regression analysis was used to assess the association between selected baseline factors and TVV instability. TVV instability during follow-up was then evaluated using the Kaplan-Meier cumulative function., Results: Three hundred forty-five TVVs in 106 patients were considered suitable for the analysis. Two hundred twenty vessels were stented with the Covera stent graft (64%) and 125 with VBX (36%). Two hundred ninety-nine TVVs received a single BSG, 45 two BSGs, and only 1 three BSGs. Bare metal stent relining was required in 36% of TVVs, mostly in the Covera group (89 [41%] vs 36 [29%]) (P = .030). The primary technical success rate was 96% (331/345), and the assisted primary technical success rate was 99% (342/345). The TVV instability rate within 30 days was 2% (one Covera and five VBX; P = .015). Three BSG occlusions (one Covera and two VBX) and three type Ic endoleaks (three VBX) were detected. The median follow-up was 13.9 months (range, 5.8-25.5 months). Sixteen TVV instabilities were detected during the follow-up. Twelve BSG occlusions (six Covera and six VBX), three type Ic endoleaks (one Covera and two VBX), and one type IIIc endoleak (VBX). The overall target vessel instability rate was 5% (16/342). TVV instability was associated with the use of Gore VBX in the univariable logistic regression (odds ratio, 3.0; 95% confidence interval, 1.1-8.0; P = .027). Aneurysm rupture and aneurysm diameter were also associated with TVV instability in the univariable analysis (P = .002 and P = .008, respectively). The only factor predisposing to TVV instability in the multivariable logistic regression analysis was the use of Gore VBX as a BSG (odds ratio, 2.9; 95% confidence interval, 1.0-8.0; P = .043). Kaplan-Meier analysis showed a significantly higher risk of TVV instability in the VBX group (P < .001)., Conclusions: Overall midterm outcomes in this cohort were satisfactory. Patency rates were similar between the two stents. Nevertheless, VBX seems to be associated with worse TVV instability. These results may be correlated with a higher incidence of type Ic endoleaks, which require an extensive learning curve for correct stent selection and deployment., Competing Interests: Disclosures None., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR)., Methods: We conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes., Results: The median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016)., Conclusions: We found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR., Competing Interests: Disclosures None., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate outcomes and performance of inverted limbs (ILs) when used in conjunction with Zenith fenestrated stent grafts (Zfens) to treat patients with short distance between the lowest renal artery (RA) and aortic or graft bifurcation (A/GB)., Methods: This study was a multicenter, retrospective review of prospectively maintained database of patients with complex aortic aneurysms, failed endovascular aneurysm repair (EVAR), or open surgical repair (OSR) with short distance between LRA and A/GB treated using a combination of Zfen and an IL between 2013 and 2023. Endpoints included technical success, aneurysm sac regression, long-term device integrity, and target vessel patency. We defined technical success as implantation of the device with no endoleak, conversion to an aorto-uni-iliac or OSR., Results: During this time, 52 patients underwent endovascular rescue of failed repair. Twenty (38.5%) of them required relining of the failed repairs using IL due to lowest RA to A/GB length restrictions. Two patients had undergone rescue with a fenestrated cuff alone but developed type III endoleaks. One patient with no previous implant had a short distance between the lowest RA and aortic bifurcation to accommodate the bifurcated distal device, and two patients had failed OSR or anastomotic pseudoaneurysms. The majority (94%) were men with a mean age of 76.8 ± 6.1 years. The mean aortic neck diameter and aneurysm size were 32 ± 4 cm and 7.2 ± 1.3 cm, respectively. The median time laps between initial repair and failure was 36 months (interquartile range [IQR], 24-54 months). Sixteen patients (80%) were classified as American Society of Anesthesiologists class III, whereas four were class IV. Seventy-eight vessels were targeted and successfully incorporated. Technical success was 100%, and median estimated blood loss was 100 mL (IQR, 100-200 mL). Mean fluoroscopy time and dose were 61 ± 18 minutes and 2754 ± 1062 mGy, respectively. Average hospital length of stay was 2.75 ± 2.15 days. Postoperative complication occurred in one patient who required lower extremity fasciotomy for compartment syndrome. At a median follow-up of 50 months (IQR, 18-58 months), there were no device migration, components separation, aneurysmal related mortality, and type I or type III endoleak. Aneurysm sac regression (95%) or stabilization (5%) was observed in all patients, including in four patients (25%) with type II endoleak., Conclusions: The use of IL in conjunction with Zfen to treat patients with short distance between the lowest RA and A/GB is safe, effective, and has excellent long-term results. The technique expands the indication of Zfen, especially in patients with failed previous EVAR., Competing Interests: Disclosures J.M. reports use of investigational device in an United States Food and Drug Administration-approved clinical trial (IDE- G220004/NCT05531084); and consultation for L.W. Gore and Medtronic. A.R. reports consultation for GE imaging., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Increased angulation of the proximal aortic neck has been associated with complications following endovascular repair of infrarenal aortic aneurysms, including increased incidence of endoleaks, stent migration, secondary interventions, and conversions. However, knowledge on the impact of aortoiliac tortuosity on outcomes following fenestrated repair remains limited. This study aims to quantify the effect of aortoiliac tortuosity on outcomes following fenestrated repair., Methods: A single-center, retrospective review of all patients who underwent a physician-modified endovascular repair for the treatment of juxtarenal aortic aneurysms under a single physician-sponsored investigation device exemption study from 2011 to 2021 was performed. Center luminal lines and geometric distances were obtained using TeraRecon software (San Mateo, CA). A tortuosity index was calculated (tortuosity index = centerline distance/geometric line distance) for each iliac vessel as well as for the infrarenal aorta according to Society for Vascular Surgery reporting standards. Aortic and iliac tortuosity were assessed independently and stratified as low and high. Demographics, comorbidities, anatomic and operative details, and outcomes were compared using univariable and multivariable analysis., Results: A total of 135 patients were identified. Thirty-eight patients (28%) had high aortic tortuosity, and 55 patients (42%) had high iliac tortuosity. Patients with high tortuosity were older (aortic: 78 vs 76 years; P = .04; iliac: 78 vs 75 years; P = .01) and differed by sex. Twenty-two percent of men and 50% of women had high aortic tortuosity (P = .01). Forty-seven percent of men and 20% of women had high iliac tortuosity (P = .01). There were no differences in comorbidities based on aortic tortuosity, but coronary artery disease (high: 58% vs low: 36%; P = .01) and hypertension (high: 69% vs low: 86%; P = .02) differed based on iliac tortuosity. Aneurysm diameter was larger for patients with high iliac tortuosity (72 mm vs 64 mm; P < .01), and fluoroscopy time was longer for patients with high aortic tortuosity (41 vs 31 minutes; P = .02). When outcomes were assessed, high iliac tortuosity was associated with increased rate of reinterventions (hazard ratio, 2.6; 95% confidence interval, 1.2-6.0) and type 1 or 3 endoleak (hazard ratio, 5.2; 95% confidence interval, 1.7-16); however, all other outcomes were similar., Conclusions: Among patients treated with physician-modified endovascular repair for juxtarenal aneurysms, iliac tortuosity but not aortic tortuosity, is associated with increased reinterventions and type 1 or type 3 endoleaks. Long-term follow-up is critical for patients with high iliac tortuosity to ensure that high-risk endoleaks are identified and treated early to avoid the risk of rupture., Competing Interests: Disclosures B.W.S. reports consultant for Terumo Aortic. S.L.Z. reports consultant for W.L. Gore., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We assessed the suitability of two triple branch arch devices (aBranch) (Terumo aortic and Cook Medical) and a balloon-expandable covered stent (VBX, W. L. Gore & Associates, Johnson & Johnson) to incorporate the brachiocephalic trunk (BCT) in a cohort previously treated with hybrid thoracic endovascular repair (TEVAR)., Methods: This is a single-center, retrospective, all-comers, preclinical suitability study. We conducted an analysis of preoperative computed tomography scans in surgical patients between 1999 and 2022 in a single vascular surgery unit. The primary outcome was the aortic suitability of aBranch devices and VBX as mating stent for BCT in previous hybrid TEVAR. Hybrid repair of the aortic arch included TEVAR, fenestrated or branched TEVAR associated with any surgical debranching of the supra-aortic trunks and chimney TEVAR with proximal landing in zones 0 to 2. Secondary outcomes included (i) suitability assessment when excluding minor instruction for use (IFU) criteria, (ii) a comparison of suitable and nonsuitable patients, (iii) risk factors analysis for nonsuitability, and (iv) a description of the exclusion causes., Results: During the study period, 120 patients were treated. Among elective patients (n = 73), the suitability of any aBranch was 82.2% (60/73) and VBX was suitable in 64.4% of BCTs (47/73). The aBranch suitable patients had a significantly longer sinotubular-BCT length (P = .017) and smaller distal ascending aorta (P = .043) as compared with nonsuitable ones. The suitability of Terumo Aortic and Cook Medical devices was 52.1% (38/73) and 46.6% (34/73), respectively. When minor IFU criteria were ignored, suitability increased to 82.2% (60/73) and 63.0% (46/73), respectively. Left common carotid artery diameter and sinotubular-BCT length were significant nonsuitability risk factors for Terumo Aortic aBranch in multivariable analysis. No associations were found for Cook Medical device. The outcomes were tested in the entire cohort demonstrating a global suitability of 82.9%, increasing to 86.3% when ignoring minor IFUs. VBX was anatomically suitable to use in BCT in 73.2% of patient BCTs., Conclusions: aBranch devices are anatomically suitable in a vast majority of patients (86%) undergoing hybrid TEVAR. The innominate artery seems eligible for incorporation with VBX in almost two-thirds of patients. This mating stent may help to overcome some minor IFU restrictions., Competing Interests: Disclosures None., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We retrospectively compared the clinical outcomes of self-expanding covered stents (CSs) and bare metal stents (BMSs) in the treatment of aortoiliac occlusive disease (AIOD) at a single center between 2016 and 2022., Methods: All patients with AIOD receiving endovascular therapy at a single center from January 2016 to October 2022 were continuously analyzed, including patients with lesions of all classes according to the Trans-Atlantic Inter-Society Consensus II (TASC-II). Relevant clinical and baseline data were collected, and propensity score matching was performed to compare CSs and BMSs in terms of baseline characteristics, surgical factors, 30-day outcomes, 5-year primary patency, and limb salvage. The follow-up results were analyzed by Kaplan-Meier curves. Cox proportional hazard models were used to identify predictors of primary patency., Results: A total of 209 patients with AIOD were enrolled in the study, including 135 patients (64.6%) in the CS group and 74 patients (35.4%) in the BMS group. Surgical success rates (100% vs 100%; P = 1.00), early (<30-day) mortality rates (0% vs 0%; P = 1.00), cumulative surgical complication rate (12.0% vs 8.0%; P = .891), 5-year primary patency rate (83.4% vs 86.9%; P = .330), secondary patency rate (96% vs 100%; P = .570), and limb salvage rate (100% vs 100%; P = 1.00) did not exhibit significant differences between the two groups. Patients in the CS group had a lower preoperative ankle-brachial index (0.48 ± 0.26 vs 0.52 ± 0.19; P = .032), more cases of complex AIOD (especially TASC D) (47.4% vs 9.5%; P < .001), more chronic total occlusive lesions (77.0% vs 31.1%; P < .001), and more severe calcification (20.7% vs 14.9%; P < .036). After propensity score matching, 50 patients (25 with CS and 25 with BMS) were selected. The results showed that only severe calcification (32.0% vs 8.0%; P = .034) and ankle-brachial index increase (0.45 ± 0.15 vs 0.41 ± 0.22; P = .038) were significantly different between the groups. In terms of surgical factors, patients in the CS group had more use of bilateral femoral or combined brachial artery percutaneous access (60.0% vs 12.0%; P < .001), more number of stents used (2.3 ± 1.2 vs 1.3 ± 0.7; P < .001), longer mean stent length (9.3 ± 3.3 vs 5.8 ± 2.6 cm; P < .001), and more catheter-directed thrombolysis treatment (32.0% vs 4.0%; P = .009). Multivariate Cox survival analysis showed that severe calcification (hazard ratio, 1.32; 95% confidence interval, 1.04-1.85; P = .048) was the only independent predictor of the primary patency rate., Conclusions: All patients with AIOD who underwent endovascular therapy were included and achieved good outcomes with both CSs and BMSs. The influence of confounding factors in the two groups was minimized by propensity score matching, and the 5-year patency rates were generally similar in the unmatched and matched cohorts. Postoperative hemodynamic improvement was more obvious in patients in the CS group. For more complex lesions, CS is recommended to be preferred. Especially for severe calcification lesions, which is the only independent predictor of primary patency, CS showed obvious advantages. Further studies with more samples are needed to investigate the role of stent types in AIOD treatment., Competing Interests: Disclosures None., (Copyright © 2024. Published by Elsevier Inc.)