Effect of Family History of Aortic Disease on Outcomes of Fenestrated/Branched Endovascular Aneurysm Repair of Complex Aortic Aneurysms.

OBJECTIVE: The clinical significance of family history (FH) of aortic disease on the outcomes of fenestrated/branched endovascular aneurysm repair (FB-EVAR) has not been well described. This study aimed to assess how FH of aortic disease affects outcomes following FB-EVAR for complex aortic aneurysms (CAAs). METHODS: This study retrospectively reviewed the clinical data of consecutive patients enrolled in 10 ongoing, prospective, non-randomised, physician sponsored, investigational device exemption studies to evaluate FB-EVAR (2005 - 2022) in the United States Aortic Research Consortium database. Patients were stratified by presence or absence of FH of any aortic disease in any relative. Patients with confirmed genetically triggered aortic diseases were excluded. Primary outcomes were 30 day major adverse events (MAEs) and late survival. Secondary outcomes included late secondary interventions and aneurysm sac enlargement. RESULTS: During the study period, 2 901 patients underwent FB-EVAR. A total of 2 355 patients (81.2%) were included in the final analysis: 427 (18.1%) with and 1 928 (81.9%) without FH of aortic disease. Patient demographics, clinical characteristics, and aneurysm extent were similar between the groups. Patients with FH of aortic disease more frequently had prior open abdominal aortic repair, but less frequently had prior endovascular aneurysm repair (p < .050). There were no statistically significant differences in 30 day mortality (4% vs. 2%; p = .12) and MAEs for patients with or without FH of aortic disease (12% vs. 12%; p = .89). Three year survival estimates were 71% (95% confidence interval [CI] 0.67 - 0.78%) and 71% (95% CI 0.68 - 0.74%), respectively (p = .74). Freedom from secondary intervention and aneurysm sac enlargement were also not statistically significantly different between groups. CONCLUSION: A family history of aortic disease had no impact on 30 day and midterm outcomes of FB-EVAR of CAAs. In the absence of an identified genetically triggered aortic disease, treatment selection for CAAs should be based on clinical risk and patient anatomy rather than FH of aortic disease.

Prospective randomized pilot trial comparing prophylactic vs therapeutic cerebrospinal fluid drainage during complex endovascular thoracoabdominal aortic aneurysm repair.

BACKGROUND: Endovascular techniques have transformed the management of thoracoabdominal aortic aneurysms (TAAAs). However, spinal cord ischemia (SCI) remains a prevalent and devastating complication. Prophylactic drainage of cerebrospinal fluid (CSF) is among the proposed strategies for prevention of SCI. Although prophylactic CSF drainage is widely used and conceptually attractive, prophylactic CSF drains have not been demonstrated to definitively prevent the occurrence nor mitigate the severity of SCI in endovascular TAAA repair. Whether or not outcomes of prophylactic drains are superior to therapeutic drains remains unknown. This pilot study was performed to determine the feasibility of a randomized clinical trial designed to investigate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair using branched and fenestrated endovascular aortic repair (FBEVAR). METHODS: This was a prospective multicenter randomized pilot clinical trial conducted at The University of Alabama at Birmingham and The University of Massachusetts. Twenty patients were enrolled and randomized to either the prophylactic drainage or therapeutic drainage groups, prior to undergoing FBEVAR for extensive TAAAs and arch aortic aneurysms. This was a pilot feasibility study that was not powered to detect statistical differences in clinical outcomes. The primary outcome was feasibility of randomization and compliance with a shared lumbar drain protocol. Secondary outcomes included rate of drain complications and SCI. RESULTS: Twenty patients were enrolled and successfully randomized, without any crossovers, to either the control cohort (n = 10), without prophylactic drains, or the experimental cohort (n = 10), with prophylactic drains. There were no differences in age, comorbidities, or history of prior aortic surgery across the cohorts. All patients were treated with FBEVAR. Aneurysm classifications were as follows: Extent I (10%), Extent II (50%), Extent III (35%), and Extent IV (5%). The average length of aortic coverage was 207 ± 21.6 mm. The length of aortic coverage did not vary across cohorts, nor did procedural times or blood loss volume. Compliance with the SCI prevention protocol was 100% across both groups. Within the prophylactic drain cohort, one patient experienced an adverse event related to lumbar drain placement, manifested as an epidural hematoma requiring laminectomy, without neurologic deficit (n = 1/10; 10%). There was one SCI event (n = 1/20; 5%), which occurred in the prophylactic drain cohort on postoperative day 9 following an episode of hypotension related to a gastrointestinal bleed. CONCLUSIONS: The role of prophylactic CSF drains for the prevention of SCI following endovascular TAAA repair is a topic of ongoing research, with many current practices based on expert opinion and experience, rather than rigorous scientific data. This study demonstrates the feasibility of a multicenter randomized clinical trial to evaluate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.

Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent.

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.

Current outcomes following upper and lower extremity arterial trauma from the National Trauma Data Bank.

OBJECTIVE: The modern treatments of trauma have changed in recent years. We aim to evaluate the factors associated with limb salvage and mortality after extremity arterial trauma, especially with respect to the type of conduit used in revascularization. METHODS: The National Trauma Data Bank was queried to identify patients with upper and lower extremity (UE and LE) arterial injuries between 2016 and 2020. The patients were stratified by the types of arterial repair. The primary outcome was in-hospital mortality. RESULTS: 8780 patients were found with 5054 (58%) UE and 3726 (42%) LE injuries. Eighty-three percent were men, and the mean age was 34 ± 15 years. Penetrating mechanism was the predominant mode of injury in both UEs and LEs (73% and 67%, respectively) with a mean injury severity score of 14 ± 8. For UEs, the majority underwent primary repair (67%, P < .001), whereas the remainder received either a bypass (20%) or interposition graft (12%). However, LEs were more likely to receive a bypass (52%, P < .00001) than primary repair or interposition graft (34% and 14%, respectively). Compared with the extremely low rates of amputation and mortality among UE patients (2% for both), LE injuries were more likely to result in both amputation (10%, P < .001) and death (6%, P < .001). Notably, compared with primary repair, the use of a prosthetic conduit was associated with a 6.7-fold increase in the risk of amputation in UE and a 2.4-fold increase in LE (P < .0001 for both). Synthetic bypasses were associated with a nearly 3-fold increase in return to the operating room (OR) in UE bypasses (P < .05) and a 2.4-fold increase in return to the OR in LE bypasses (P < .0001). CONCLUSIONS: In recent years, most extremity vascular trauma was due to penetrating injury with a substantial burden of morbidity and mortality. However, both limb salvage rates and survival rates have remained high. Overall, LE injuries more often led to amputation and mortality than UE injuries. The most frequently used bypass conduit was vein, which was associated with less risk of unplanned return to the OR and limb loss, corroborating current practice guidelines for extremity arterial trauma.

Case Series on Double-Barrel Stenting for the Renal Arteries Associated With Fenestrated Repair (FEVAR) of Complex Anatomy Aortic Aneurysms.

The double-barrel stenting (DBS) is a technique in which 2 parallel stents are simultaneously deployed through the same reinforced fenestration, into 2 adjacent target vessels. Prior reports describe the application of this technique for the treatment of superior mesenteric artery dissection with aneurysmal degeneration, coronary artery bifurcations, aortic arch branches, and intracranial aneurysms. The DBS technique is particularly useful in the context of fenestrated repair (FEVAR) of complex anatomy aortic aneurysms when the origin of visceral arteries branch off the aorta very close to each other or present early branches. We herein describe a case series including 7 patients who underwent a FEVAR procedure for thoracoabdominal and juxtarenal aortic aneurysms in which the presence of accessory renal arteries (ARA) or early renal branches was the reason for the application of this technique. Technical success was 100% and all stents were patent in the last follow-up CT scan (follow-up range: 1.8-62.8 months). There was only 1 small endoleak from indetermined source potentially related to the DBS, but the aneurysm sac decreased in size during follow-up and no secondary intervention was needed. Therefore, the DBS technique is a viable option for the incorporation of ARA or early renal branches to a fenestrated repair of aortic aneurysms with complex anatomy.

Rare Case of Abdominal Aortic and Multiple Visceral Aneurysms in a Pediatric Patient With PIK3CA Mutation and Vasculitis.

Abdominal aortic aneurysms (AAA) are most commonly observed in elderly male patients and are particularly rare in children. Among the pediatric population, they are usually diagnosed in the context of connective tissue disorders, genetic mutations, or vasculitis. The same is true of visceral arteries aneurysms. This case report describes the staged management of an 11-year-old patient presenting PIK3CA mutation and a 5.8 cm infrarenal AAA associated with bilateral common iliac arteries and multiple visceral aneurysms, the largest observed in the superior mesenteric artery (SMA = 3.2 cm). After careful evaluation, decision was made to first approach the most life-threatening lesion (the infrarenal AAA due to the large diameter) and the remaining aneurysms in secondary procedures, with special attention to the SMA aneurysm. The patient underwent a staged repair, with the first phase consisting of an aortobi-iliac graft with the distal anastomosis made at the left common iliac artery and right external iliac artery. The right hypogastric artery was ligated. The second procedure consisted of SMA aneurysm repair with a plication technique, as 7 branches were visualized coming off the aneurysm sac. Postoperative pathology analysis of the aortic and SMA aneurysms sac revealed vasculitis with a mixed inflammatory pattern and a COL3A1 gene heterozygote variant. He is currently in his 18th month after the last surgical intervention, receiving immunomodulatory therapy, with a planned follow-up by the interdisciplinary team to monitor the medications' side effects and the diameter of the remaining visceral aneurysms.

Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

OBJECTIVE: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. METHODS: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. RESULTS: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). CONCLUSIONS: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Differential impact of missed initial wound clinic visit on 6-month wound healing by race/ethnicity among patients with chronic limb-threatening ischemia.

Chronic limb-threatening ischemia (CLTI) is associated with significant morbidity, including major limb amputation, and mortality. Healing ischemic wounds is necessary to optimise vascular outcomes and can be facilitated by dedicated appointments at a wound clinic. This study aimed to estimate the association between successful wound care initiation and 6-month wound healing, with specific attention to differences by race/ethnicity. This retrospective study included 398 patients with CLTI and at least one ischaemic wound who scheduled an appointment at our wound clinic between January 2015 and July 2020. The exposure was the completion status of patients' first scheduled wound care appointment (complete/not complete) and the primary outcome was 6-month wound healing (healed/not healed). The analysis focused on how this association was modified by race/ethnicity. We used Aalen-Johansen estimators to produce cumulative incidence curves and calculated risk ratios within strata of race/ethnicity. The final adjustment set included age, revascularization, and initial wound size. Patients had a mean age of 67 ± 14 years, were 41% female, 46% non-White and had 517 total wounds. In the overall cohort, 70% of patients completed their first visit and 34% of wounds healed within 6-months. There was no significant difference in 6-month healing based on first visit completion status for White/non-Hispanic individuals (RR [95% CI] = 1.18 [0.91, 1.45]; p-value = 0.130), while non-White individuals were roughly 3 times more likely to heal their wounds if they completed their first appointment (RR [95% CI] = 2.89 [2.66, 3.11]; p-value < 0.001). In conclusion, non-White patients were approximately three times more likely to heal their wound in 6 months if they completed their first scheduled wound care appointment while White/non-Hispanic individuals' risk of healing was similar regardless of first visit completion status. Future efforts should focus on providing additional resources to ensure minority groups with wounds have the support they need to access and successfully initiate wound care.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Gender disparities in patients with aortoiliac disease requiring open operative intervention.

OBJECTIVE: Peripheral artery disease is known to affect males and females in different proportions. Disparate surgical outcomes have been quantified after endovascular aortic aneurysm repair, arteriovenous fistula creation, and treatment of critical limb ischemia. The aim of this study is to objectively quantify the sex differences in outcomes in patients undergoing open surgical intervention for aortoiliac occlusive disease. METHODS: Patients were identified in the aortoiliac occlusive disease Vascular Quality Initiative database who underwent aorto-bifemoral bypass or aortic thromboendarterectomy as determined by Current Procedural Terminology codes between 2012 and 2019. Patients with a minimum of 1-year follow-up were included. Risk differences (RDs) by sex were calculated using a binomial regression model in 30-day and 1-year incidence of mortality and limb salvage. Additionally, incidence of surgical complications including prolonged length of stay (>10 days), reoperation, and change in renal function (>0.5 mg/dl rise from baseline), were recorded. Inverse probability weighting was used to standardize demographic and medical history characteristics. Multivariate logistic regression models were employed to conduct analyses of the before mentioned clinical outcomes, controlling for known confounders. RESULTS: Of 16,218 eligible patients from the VQI data during the study period, 6538 (40.3%) were female. The mean age, body mass index, and race were not statistically different between sexes. Although there was no statistically significant difference detected in mortality between males and females at 30 days postoperatively, females had an increased crude 1-year mortality with an RD of 0.014 (95% confidence interval, 0.01-0.02; P value < .001. Males had a higher rate of a postoperative change in renal function with an RD of -0.02 (95% confidence interval, -0.03 to -0.01; P < .001). CONCLUSIONS: Although there was no sex-based mortality difference at 30 days, there was a statistically significant increase in mortality in females after open aortoiliac intervention at 1 year based on our weighted model. Male patients are statistically significantly more likely to have a decline in renal function after their procedures when compared with females. Postoperative complications including prolonged hospital stay, reoperation, and wound disruption were similar among the sexes, as was limb preservation rates at 1 year. Further studies should focus on elucidating the underlying factors contributing to sex-based differences in clinical outcomes following aortoiliac interventions.

Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair.

OBJECTIVE: Acute kidney injury (AKI) occurs frequently in complex aortic surgery and has been implicated in perioperative and long-term survival. This study sought to characterize the relationship between AKI severity and mortality after fenestrated and branched endovascular aortic aneurysm repair (F/B-EVAR). METHODS: Consecutive patients enrolled by the US Aortic Research Consortium in 10, prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/B-EVAR, between 2005 and 2023, were included in this study. Perioperative AKI during hospitalization was defined by and staged using the 2012 Kidney Disease Improving Global Outcomes criteria. Determinants of AKI were evaluated with backward stepwise mixed effects multivariable ordinal logistic regression. Survival was analyzed with conditionally adjusted survival curves and backward stepwise mixed effects Cox proportional hazards modelling. RESULTS: In the study period, 2413 patients with a median (interquartile range [IQR]) age of 74 years (IQR, 69-79 years) underwent F/B-EVAR. The median follow-up duration was 2.2 years (IQR, 0.7-3.7 years). The median baseline estimated glomerular filtration rate (eGFR) and creatinine were 68 mL/min/1.73 m2 (IQR, 53-84 mL/min/1.73 m2) and 1.1 mg/dL (IQR, 0.9-1.3 mg/dL), respectively. Stratification of AKI identified 316 patients (13%) with stage 1 injury, 42 (2%) with stage 2 injury, and 74 (3%) with stage 3 injury. Renal replacement therapy was initiated during the index hospitalization in 36 patients (1.5% of cohort, 49% of stage 3 injuries). Thirty-day major adverse events were associated with AKI severity (all P ≤ .0001). Multivariable predictors of AKI severity included baseline eGFR (proportional odds ratio, 0.9 per 10 mL/min/1.73 m2 [95% confidence interval (CI), 0.85-0.95 per 10 mL/min/1.73 m2]; P < .0001), baseline serum hematocrit (0.58 per 10% [95% CI, 0.48-0.71 per 10%]; P < .0001), renal artery technical failure during aneurysm repair (3 [95% CI,1.61-5.72]; P = .0006), and total operating time (1.05 per 10 minutes [95% CI, 1.04-1.07 per 10 minutes]; P < .0001). One-year unadjusted survivals for AKI severity strata were 91% (95% CI, 90%-92%) for no injury, 80% (95% CI, 76%-85%) for stage 1 injury, 72% (95% CI, 59-87%) for stage 2 injury, and 46% (95% CI, 35-59%) for stage 3 injury (P<.0001). Multivariable determinants of survival included AKI severity (stage 1, hazard ratio [HR], 1.6 [95% CI, 1.3-2]); stage 2, HR, 2.2 [95% CI, 1.4-3.4]); stage 3 HR, 4 [95% CI, 2.9-5.5]; P < .0001), decreased eGFR (HR, 1.1 [95% CI, 0.9-1.3]; P = .4), patient age (HR, 1.6 per 10 years [95% CI, 1.4-1.8 per 10 years]; P < .0001), baseline chronic obstructive pulmonary disease (HR, 1.5 [95% CI, 1.3-1.8]; P < .0001), baseline congestive heart failure (HR, 1.7 [95% CI, 1.6-2.1]; P < .0001), postoperative paraplegia (HR, 2.1 [95% CI, 1.1-4]; P = .02), and procedural technical success (HR, 0.6 [95% CI, 0.4-0.8]; P = .003). CONCLUSIONS: AKI, as defined by the 2012 Kidney Disease Improving Global Outcomes criteria, occurred in 18% of patients after F/B-EVAR. Greater severity of AKI after F/B-EVAR was associated with decreased postoperative survival. The predictors of AKI severity identified in these analyses suggest a role for improved preoperative risk mitigation and staging of interventions in complex aortic repair.

Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms.

OBJECTIVE: This multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). METHODS: We reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or ≥12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). RESULTS: A total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. CONCLUSIONS: FB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.

Comparison of Landmark-Guided Versus Fluoroscopy-Guided Cerebrospinal Fluid Drain-Related Complications After Aortic Repairs.

OBJECTIVE: Cerebrospinal fluid drains (CSFDs) are efficacious in preventing spinal cord injury after thoracic or thoracoabdominal aortic repair with extensive coverage. Increasingly, fluoroscopy is used to guide placement instead of the traditional landmark-based approach, but it is unknown which approach is associated with fewer complications. DESIGN: A retrospective cohort study. SETTING: In the operating room. PARTICIPANTS: Patients having undergone thoracic or thoracoabdominal aortic repair with a CSFD over a 7-year period at a single center. INTERVENTIONS: No intervention. MEASUREMENTS AND MAIN RESULTS: Groups were reviewed and statistically compared with respect to baseline characteristics, ease of CSFD placement, and major and minor complications directly related to placement. A total of 150 CSFDs were placed with landmark guidance as opposed to 95 with fluoroscopy guidance. Compared to the landmark group, patients with fluoroscopy-guided CSFDs were older (p < 0.008), had lower American Society of Anesthesiologists physical status scores (p = 0.008), required fewer CSFD placement attempts (p = 0.011), had the CSFD in place for longer duration (p < 0.001), and had a similar incidence of CSFD-related complications (p > 0.999). Composites of both major (4.5% of cases) and minor CSFD-related complications (6.1% of cases), the primary outcomes of the study, occurred with similar incidences between the 2 groups (p > 0.999 for both comparisons) after adjusting potential confounders. CONCLUSIONS: In patients undergoing thoracic or thoracoabdominal aortic repairs, there were no significant differences in the risk of major and minor CSFD-related complications between fluoroscopic guidance and the landmark approach. Although the authors' institution is a high-volume center for this type of procedure, the study was limited by a small sample size. Hence, regardless of the technique used for the placement of CSFD, the risks related to the placement should be balanced carefully against the potential benefits resulting from spinal cord injury prevention. Fluoroscopy-aided insertion of CSFD requires fewer attempts and, hence, may be better tolerated by patients.

Physiologic risk stratification is important to long-term mortality, complications, and readmission in thoracic endovascular aortic repair.

Use of the American Society of Anesthesiologists (ASA) physical status classification is important for periprocedural risk stratification. However, the collective effect after adjustment for the Society for Vascular Surgery (SVS) medical comorbidity grading system on long-term all-cause mortality, complications, and discharge disposition is unknown. We examined these associations in patients after thoracic endograft placement. Data from three thoracic endovascular aortic repair (TEVAR) trials through 5 years of follow-up were included. Patients with acute complicated type B dissection (n = 50), traumatic transection (n = 101), or descending thoracic aneurysm (n = 66) were analyzed. The patients were stratified into three groups according to the ASA class: I-II, III, and IV. Multivariable proportional hazards regression models were used to examine the effect of ASA class on 5-year mortality, complications, and rehospitalizations after adjustment for SVS risk score and potential confounders. The largest proportion of patients treated by TEVAR across the ASA groups (n = 217) was ASA IV (n = 97; 44.7%; P < .001), followed by ASA III (n = 83; 38.2%) and ASA I-II (n = 37; 17.1%). Among the ASA groups, the ASA I-II patients were, on average, 6 years younger than those with ASA III and 3 years older than those with ASA IV (ASA I-II: age, 54.3 ± 22.0 years; ASA III: age, 60.0 ± 19.7 years; ASA IV: age, 51.0 ± 18.4 years; P = .009). Multivariable adjusted 5-year outcome models showed that ASA class IV, independent of the SVS score, conferred an increased risk of mortality (hazard ratio [HR], 3.83; 95% confidence interval [CI], 1.19-12.25; P = .0239) and complications (HR, 4.53; 95% CI, 1.69-12.13; P = .0027) but not rehospitalization (HR, 1.84; 95% CI, 0.93-3.68; P = .0817) compared with ASA class I-II. Procedural ASA class is associated with long-term outcomes among post-TEVAR patients, independent of the SVS score. The ASA class and SVS score remain important to patient counseling and postoperative outcomes beyond the index operation.

Gore thoracoabdominal branched endoprosthesis: early results and impressions.

The remarkable advances in technology and devices in the last two decades have made possible the endovascular repair of complex abdominal (cAAA) and thoracoabdominal (TAAA) aortic aneurysms with challenging anatomy. To date, despite the creation of multiple fenestrated/branched endografts intended to treat these difficult cases, in the USA, many of them remain available only under physician sponsored investigational device exemption (PSIDE) protocols in few institutions. The Gore Thoracoabdominal Branched Endoprosthesis (TAMBE; W.L. Gore & Associates, Flagstaff, AZ, USA) investigational device is a four-branched off-the-shelf (OTS) endograft that concluded an early feasibility study in 2016 and is currently finalizing a pivotal trial in pursuit of approval from the Food and Drug Administration. This article discusses the TAMBE early feasibility multicenter study results, the most relevant features of this device, its anatomical feasibility, and the impressions about this endograft as an OTS option for the treatment of CAAA and TAAA.

Outcome Analysis Comparing Asymptomatic Juxtarenal Aortic Aneurysms Treated with Custom-Manufactured Fenestrated-Branched Devices and the "Off-The-Shelf" Zenith p-Branch Device.

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.

Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium.

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

Mid-term Renal and Mesenteric Artery Outcomes During Fenestrated and Branched Endovascular Aortic Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms in the United States Aortic Research Consortium.

OBJECTIVE: To report mid-term outcomes of renal-mesenteric target arteries (TAs) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal and thoracoabdominal aortic aneurysm. BACKGROUND: TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. METHODS: Data from consecutive patients enrolled in 9 prospective nonrandomized physician-sponsored investigational device exemption studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability. RESULTS: A total of 1681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%), and 194 scallops (3%). Mean follow was 23 ± 21 months. At 5 years, TAs incorporated by fenestrations had higher primary (95 ± 1% vs 91 ± 1%, P < 0.001) and secondary patency (98 ± 1% vs 94 ± 1%, P < 0.001), and higher freedom from TAI (87 ± 2% vs 84 ± 2%, P = 0.002) compared with TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts had significantly lower freedom from TAI (78 ± 4% vs 88 ± 1%, P = 0.006), TA endoleak (87 ± 3% vs 97 ± 1%, P < 0.001), and TA reintervention (83 ± 4% vs 95 ± 1%, P < 0.001) compared with those targeted by self-expandable stent-grafts. CONCLUSIONS: Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for self-expandable stent grafts as compared with balloon-expandable stent grafts.

Aneurysm extent-based mortality differences in complex endovascular repair of thoracoabdominal aneurysms in the Vascular Quality Initiative and the United States Aortic Research Consortium.

BACKGROUND: Endovascular management of thoracoabdominal aneurysms (TAAA) is becoming more common. Technological advances including custom devices under the Physician-Sponsored Investigational Device Exemption (PS-IDE), physician-modified endografts (PMEG), and parallel stenting techniques have expanded the extent of disease that is amenable to endovascular treatment. Patients within the PS-IDE studies are a highly selected group of patients, whereas patients treated with PMEG as captured within the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) represent a real-world experience. Research within both the SVS VQI on PMEG and the US Aortic Research Consortium (US-ARC) has demonstrated a relationship between extent of aneurysmal disease and mortality after complex endovascular TAAA repair, but no direct comparison of these cohorts has been conducted. In this study, we sought to compare outcomes of custom PS-IDE devices with off-label uses of commercially available devices for the endovascular management of TAAAs. METHODS: A retrospective review of patients presenting for elective endovascular TAAA repair for asymptomatic disease between 2011 and 2019 was conducted within both the SVS VQI registry and the US-ARC. Patients within the SVS VQI registry were treated with either PMEG or with parallel stenting techniques. Patients within the US-ARC were treated with PS-IDE custom devices. The extent of aneurysm disease was defined by the deployment zones documented for the devices entered in the registry using Crawford extents I to V. Primary outcomes were 30-day and 1-year mortality rates. RESULTS: A total of 3212 patients were included in the study: 1571 PMEG/parallel stenting within the VQI registry and 1641 with PS-IDE within the US-ARC database. The majority of patients presented with extent IV aneurysms (n = 1827 [57%]), with extent IV aneurysms being slightly more prevalent within the US-ARC cohort. Maximal aneurysm diameter within each extent did not vary between the US-ARC and VQI cohorts. Across all patients, the 30-day mortality was 4.4% and the 1-year mortality was 12.2%. Unadjusted mortality at 30-days was 6.7% within the VQI, and 2.2% in the US-ARC (P < .001). The unadjusted 1-year mortality was 14.3% within the VQI and 10.2% within the US-ARC (P < .001). When adjusted for aneurysm extent, similar differences in 30-day and 1-year survivals were identified. CONCLUSIONS: Patients treated in PS-IDE studies had better 30-day and 1-year survival rates compared with those treated with a similar extent of disease using off-label approaches in a real-world registry. These differences are complex and likely associated with a number of factors, including arterial anatomy, patient comorbidities, device construct, and volume outcomes, as well as complex and unmeasurable surgeon- and patient-specific factors.