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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.)

Background: Numerous endovascular options have been used for the repair of juxtarenal aortic aneurysms (JRAAs) over the last 15 years. This study aims to compare the performance between the Zenith p-branch device and custom-manufactured fenestrated-branched devices (CMD) for the treatment of asymptomatic JRAA., Methods: A single-center retrospective analysis of prospectively collected data was performed. Patients with a diagnosis of JRAA submitted to endovascular repair between July 2012 and November 2021 were included in the study, being divided into 2 groups: CMD and Zenith p-branch. The following variables were analyzed: preoperative information: demographics, comorbidities, and maximum aneurysm diameter; procedural data: contrast volume, fluoroscopy time, radiation dose, estimated blood loss, and technical success; and postoperative data: 30-day mortality, duration of intensive care unit and hospital stay, major adverse events, secondary interventions, target vessel instability, and long-term survival., Results: From a total of 373 physician-sponsored investigational device exemption (Cook Medical devices) cases performed at our institution, 102 patients presented the diagnosis of JRAA. Of these, 14 patients were treated with the p-branch device (13.7%) and 88 (86.3%) with a CMD. Both groups presented similar demographic composition and maximum aneurysm diameter. All devices were successfully deployed, with no type I or III endoleaks observed at procedure completion. The contrast volume (P = 0.023) and radiation dose (P = 0.001) were significantly higher in the p-branch group. No significant difference was observed between the groups for the remaining intraoperative data. No paraplegia or ischemic colitis has been observed during the first 30 days after the surgical procedures. There was no 30-day mortality in either group. One major cardiac adverse event was registered in the CMD group. Early outcomes were similar in both groups. No significant difference was found between the groups with respect to the presence of type I or III endoleaks during the follow-up. From a total of 313 target vessels stented in the CMD group (mean of 3.55 per patient) and 56 in the p-branch group (mean of 4 per patient), 4.79% and 5.35% presented instability, respectively, with no difference observed between the groups (P = 0.743). Secondary interventions were required in 36.4% of the CMD cases and 50% of the p-branch group, but this was not statistically different (P = 0.382). In the p-branch cohort, 2 of 7 reinterventions (28.5%) were target vessel-related and in the CMD group, 10 of 32 secondary interventions (31.2%) were target vessel-related., Conclusions: Comparable perioperative outcomes were obtained when appropriately selected patients were treated with either the off-the-shelf p-branch or CMD for JRAA. The long-term target vessel instability does not appear impacted by the presence of pivot fenestrations in comparison to other target vessel configurations. Given these outcomes, delay in CMD production time should be considered when treating patients with large juxtarenal aneurysms., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Thoracic aortic injury (TAI) is rare in the pediatric population. Thoracic endovascular aortic repair (TEVAR) is the recommended standard of care for treatment in the adult population given its association with lower rates of mortality and morbidity than traditional open repairs for treatment of TAI. However, there are unique anatomic challenges in treating pediatric patients with TEVAR which may impact the outcomes and pediatric guidelines. We aimed to compare current management trends and outcomes between different pediatric age groups using data from the National Trauma Data Bank (NTDB)., Methods: We analyzed the NTDB from 2007 to 2019 using International Classification of Diseases (ICD)-9 and -10 codes to identify patients with a TAI. We excluded patients older than 21 years and any patients who died in the emergency department. The pediatric patients were stratified by age group: children (1-11 years), adolescent (12-17 years), and mature (18-21 years) patients. Patient characteristics compared included injury mechanism and severity, TAI intervention, and outcomes between the 3 groups using bivariate analysis (analysis of variance for parametric and Kruskal-Wallis for nonparametric variables). These characteristics and outcomes were also compared by TAI intervention and injury mechanism. ICD-9 and -10 procedural codes were used to identify patients who underwent TEVAR, open aortic repair (OAR), or both. The modified Poisson regression was performed with relative risk (RR) to evaluate our primary outcome measure-mortality during the trauma admission., Results: A total of 2,431 pediatric TAI were identified in the NTDB that met the inclusion criteria. This included 134 children (5.5%), 733 adolescent (30.2%), and 1,564 mature (64.3%) patients. Children had significantly lower median Injury Severity Scores (34.1) than the adolescent (38) or mature population (36.1) (P = 0.001). The mechanism of injury differed between age groups. Children had higher rates of blunt trauma (90.3% children, 89.6% adolescent, and 86.8% mature patients) and mature patients had higher rates of penetrating trauma (6% children, 10.1% adolescent, and 12.5% mature patients) (P < 0.001). TAI management also differed significantly between pediatric age groups. Mature patients had significantly higher rates of TEVAR (3% children, 25.2% adolescent, and 29.2% mature patients) and children were most likely to be treated with nonoperative management (NOM) (94% children, 67.9% adolescent, and 64.8% mature patients) (P < 0.001). Patients who were treated with TEVAR were discharge home most frequently (31.8% NOM, 54.1% TEVAR, 44.3% OAR, 22.2% both TEVAR and OAR). Upon modified Poisson regression analysis, patient age was not associated with an increased risk of in-hospital mortality. Intervention with TEVAR (RR: 0.22, 95% CI: 0.15-0.33, P < 0.001) and OAR (RR: 0.58, 95% CI: 0.36-0.93, P = 0.024) were associated with a lower risk of mortality than NOM., Conclusions: TAI is less prevalent in children compared to adults. TEVAR for TAI is associated with lower risk of in-hospital mortality compared to both NOM and OAR without differences between pediatric subgroups. Further studies should be completed to determine the most appropriate management guidelines., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: This study compared complications in patients undergoing fenestrated-branched endovascular aneurysm repair (F-BEVAR) without and with stenting of the superior mesenteric artery (SMA) or celiac artery (CA), with particular attention to the length of coverage above the CA., Methods: A retrospective review was performed of a prospectively maintained database of patients treated with F-BEVAR for thoracoabdominal aortic aneurysms between July 2012 and May 2017. Data included demographics, risk factors, comorbidities, preoperative aneurysm characteristics, procedural data, and outcomes. Patients were grouped as follows: group 1, no SMA or CA stent; group 2, SMA or CA stent and <5 cm of coverage above the CA; and group 3, SMA or CA stent and ≥5 cm of coverage above the CA. Complications measured included death, myocardial infarction, respiratory failure, stroke or transient ischemic attack, paraplegia, acute kidney injury, mesenteric ischemia, and vascular complications. Individual and composite complications were compared between groups., Results: There were 223 patients who had data analyzed (group 1, 53 [24%]; group 2, 101 [45%]; and group 3, 69 [31%]). Mean age was 72 years (76% male). There was no difference in patients' characteristics between groups, except for hypertension (less common in group 2) and history of previous aortic surgery (more common in group 3). Group 2 (15%) and group 3 (90%) had higher spinal drain use than group 1 (2%; P < .0001). Mean operative time was longer in groups 2 and 3 compared with group 1 (group 1, 224 minutes; group 2, 253 minutes; and group 3, 313 minutes; P < .0001). Group 1 had more intraoperative complications, without difference in the technical success and mortality rates. Failure to deliver a bridging stent occurred in only 3 of 695 vessels (0.4%) intended, without difference between groups (P = .79). The incidence of major complications (individually and composite analysis) was similar between groups. On 30-day computed tomography angiography, there was no difference in type I or type III endoleaks (2%, 3%, and 6%) and branch patency (98%, 99%, and 99%) for groups 1, 2, and 3, respectively. At 3 years of follow-up, there was no difference in survival, stent patency, and branch instability. Group 3 had a higher reintervention rate compared with groups 1 and 2 (P < .0001); however, there was no difference between groups 1 and 2 (P = .31)., Conclusions: Patients who needed SMA or CA incorporation with stents during F-BEVAR for aortic repair had more complex procedures, as assessed by operative time, brachial access, number of vessels incorporated, and spinal drain use. However, the extension of the repair did not affect the outcomes, demonstrated by similar mortality and morbidity rates between groups., (Published by Elsevier Inc.)

Objective: To report the outcomes of patients enrolled in a physician-sponsored investigational device exemption trial for endovascular treatment of complex thoracoabdominal aortic aneurysms with fenestrated and/or branched devices., Methods: This study represents a retrospective analysis of a prospectively maintained database of patients enrolled in a physician-sponsored investigational device exemption trial for endovascular treatment of complex thoracoabdominal aneurysms between July 2012 and July 2017. Subjects included high-risk patients for open repair and patients with unsuitable anatomy for either standard endovascular aneurysm repair or Zenith (Cook Medical, Bloomington, Ind) fenestrated device. Aneurysm classification was based upon Crawford classification. We included the pararenal and paravisceral aneurysms in the type IV aneurysm group, because the repair of these aneurysms usually involved treatment of all four visceral branches. The endografts implanted were custom manufactured devices or off-the-shelf devices based on the Cook Zenith platform. Variables analyzed included preoperative demographics and comorbidities, anatomic aneurysmal characteristics, procedural details, and perioperative complications., Results: One -hundred fifty patients with a mean age of 71 ± 7.9 years were treated; 69% were male. Tobacco use (93%) and hypertension (91%) were the most common risk factors. Fifty-seven patients (38%) had a history of previous aortic repair. The mean aneurysm diameter was 62 ± 12 mm and 14 (9%) aneurysms were associated with chronic dissection. A total of 573 visceral vessels were incorporated (celiac artery/superior mesenteric artery [287 vessels], renal arteries [275 vessels], and 11 additional vessels) and 539 were stented. The celiac artery/superior mesenteric artery received a fenestrated design in 76.1% of cases. Branch designs were used in the renal artery in 13.2%, with the remainder treated with fenestrations. Spinal cord drainage was used in 51% of patients (76/150). The mean operative time, fluoroscopy time, and estimated blood loss were 283 ± 89 minutes, 83 ± 38 minutes, and 417 ± 404 mL, respectively. There were five patients (3.3%) with intraoperative complications, resulting in one intraoperative death. The early mortality was 2.7% (4/150). Major complications included respiratory failure in 7% (10/150), stroke and myocardial infarction in 0.7% each (1/150), and paraplegia in 2.7% (4/150). Acute kidney injury occurred in 4.7% of patients (7/150), two of whom required temporary dialysis. Thirty-nine percent of patients experienced at least one complication. Early branch vessel patency was 99.8% (525/526). Survival, primary, and primary-assisted branch patency at 2 years of follow-up were 79%, 97%, and 99%, respectively., Conclusions: Endovascular repair of complex aneurysms is safe and effective when performed in a high-volume center experienced in aortic disease management. Branch vessels patency and the low incidence of paraplegia and mortality support expanded use to treat most complex thoracoabdominal aortic aneurysms., (Published by Elsevier Inc.)

Background: The mortality of ruptured abdominal aortic aneurysms (rAAAs) has been reported as high as 90%. Loss of consciousness and a systolic blood pressure of <80 mm Hg on presentation are the most important predictors of mortality after emergent open repair (OR). Endovascular repair of abdominal aortic aneurysm (EVAR) has reduced short-term operative mortality and morbidity for elective abdominal aortic aneurysm repair, and may be advocated for wider application of EVAR for rAAA. The objective of this study is to compare our experience with OR and EVAR management of rAAA., Methods: Retrospective review of all rAAAs presenting to a tertiary care center between January 1, 2000 and December 31, 2011 was performed. Patients were grouped based on the surgical approach (OR versus EVAR). Patient demographics, intraoperative details, and postoperative mortality and morbidity rates were compared. Statistical analyses were conducted with Stata, version 12., Results: One hundred twenty-six patients presented with rAAA over the study period. Patients who declined repair (n = 14) or died before repair (n = 13) were excluded from this study. Of the 99 patients who underwent repair, 25 patients (25.3%) received EVAR and 74 (74.7%) underwent OR. One patient required conversion to OR from EVAR (1.0%). Overall, 30-day and 1-year mortality was 35.4% and 41.4%, respectively, with no difference seen between the 2 types of repair (30-day mortality: EVAR = 24.0%, OR = 39.2%, P = 0.17; 1-year mortality: EVAR = 32.0%, OR = 44.6%, P = 0.27). Major morbidity also did not differ between the 2 repair procedures (EVAR = 60.0%, OR = 60.8%, P = 0.94). However, patients undergoing EVAR had significantly less estimated blood loss (median: 0.3 vs. 3.0 L, P < 0.0001) and transfusion requirement (median: 5.0 vs. 9.0 U, P = 0.0041). Furthermore, although there was no significant difference in length of overall hospital stay between the 2 groups (8.5 vs. 15 days in the OR group, P = 0.18), significantly more patients in the EVAR group were discharged to home (66.7% vs. 57.1% in the OR group, P = 0.03)., Conclusions: In contrast to recently published series, this series shows no differences in morbidity or mortality between EVAR or OR of rAAAs. EVAR is appropriate in stable patients with a rAAA and favorable anatomy., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Traumatic aortic injuries in children and adolescents are rare. Although endovascular repair has become the preferred approach for such injuries in adults, open repair has endured as the gold standard in children owing mainly to the smaller aortic and access vessel diameter and the scarcity of long-term follow-up data. We report a successful endovascular repair of a traumatic thoracic aortic injury in an 8-year-old girl using a Zenith Alpha thoracic endograft (Cook Medical, Bloomington, IN). We also review the literature on endovascular treatment of traumatic aortic injuries in the pediatric population., (Copyright © 2016 Elsevier Inc. All rights reserved.)