Early survival benefit of a low-profile endograft in blunt traumatic aortic injury.

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.

Room for improvement in patient compliance during peripheral vascular interventions.

Introduction: For patients receiving Procedural Sedation and Analgesia (PSA), patient cooperation is crucial as patients remain continuously aware of operating room activity and can be asked to perform tasks such as prolonged breath-holds. This survey aimed to collect information on patient compliance with on-table instructions and its relation to periprocedural outcomes from surgeons nationwide performing peripheral vascular interventions (PVI) under PSA. Methods: A 9-question online survey was sent to 383 vascular surgeons (including both vascular surgery attendings and trainees) across the United States through REDCap from August 30 to September 21, 2021, with responses closed on October 30, 2021. The survey response was analyzed with descriptive statistics. Results: 83 (21.6%) vascular surgeons responded to the survey, of which 67 (80.7%) were attending vascular surgeons and 16 (19.3%) were vascular surgery trainees. 41 (49.4%) respondents performed 11-20 PVI cases under PSA every month, while 31 (41.0%) respondents performed 1-10 PVI cases under PSA every month. 41 (49.4%) respondents reported that in 1-10% of their cases, additional contrast and/or radiation was administered because patient moved on the table or did not cooperate with breath holds; 25 (30.1%) reported that this occurred in 11-20% of their cases, 12 (14.5%) reported that this occurred in 21-50% of their cases and 4 (4.8%) reported that this occurred in over 50% of their cases. In such cases, the majority of respondents reported a 1-10% increase in contrast volume (59.0%), radiation dosage (62.7%), sedative/analgesia administration (46.3%) and procedural time (54.9%). Of cases being converted to general anesthesia due to inadequate patient cooperation, 35 (42.2%) respondents reported between 1-5 per month, and 3 (3.6%) respondents reported between 6-10 per month. Of cases being aborted due to inadequate patient cooperation, 25 (30.1%) respondents reported between 1-5 per month, and 1 (1.2%) respondents reported between 6-10 per month. Conclusion: A significant fraction of PVI cases performed under PSA result in increased radiation and contrast exposure, sedative administration and procedural time due to inadequate patient cooperation. In certain cases, conversion to general anesthesia or case abortion is required. Further research should be performed to investigate strategies to minimize such adverse patient safety events.

Preoperative proteinuria is independently associated with mortality after fenestrated endovascular aneurysm repair.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) has become a mainstay in treating complex aortic aneurysms, though baseline patient factors predicting long-term outcomes remain poorly understood. Proteinuria is an early marker for chronic kidney disease and associated with adverse cardiovascular outcomes, but its utility in patients with aortic aneurysms is unknown. We aimed to determine whether preoperative proteinuria impacts long-term survival after FEVAR. METHODS: A single-institution, retrospective review of all elective FEVAR was performed. Preoperative proteinuria was assessed by urinalysis: negative (0-29 mg/dL), 1+ (30-100 mg/dL), 2+ (101-299 mg/dL), and 3+ (≥300 mg/dL). The cohort was stratified by patients with proteinuria (≥30 mg/dL) vs those without (<30 mg/dL). Baseline, perioperative, and long-term outcomes were compared. The primary outcome, all-cause mortality, was evaluated by Kaplan-Meier analysis and independent predictors with Cox proportional hazards modeling. RESULTS: Among 181 patients who underwent standard FEVAR from 2012 to 2022 (mean follow-up 33 months), any proteinuria was noted in 30 patients (16.6%). Patients with proteinuria were more likely to be Black (10.0% vs 1.3%) with a lower estimated glomerular filtration rate (eGFR) (52.7 ± 24.7 vs 67.7 ± 20.5 mL/min/1.73 m2), higher Society for Vascular Surgery comorbidity score (10.9 ± 4.3 vs 8.2 ± 4.7) and calcium channel blocker therapy (50.0% vs 29.1%), and larger maximal aneurysm diameter (67.2 ± 16.9 vs 59.8 ± 9.8 mm) (all P < .05). Thirty-day mortality was higher in the proteinuria group (10.0% vs 1.3%; P = .03). Overall survival at 1 and 5 years was significantly lower for those with proteinuria (71.5% vs 92.3% and 29.5% vs 68.1%; log-rank P < .001). On multivariable analysis, preoperative proteinuria was independently associated with over threefold higher hazard of mortality (hazard ratio [HR]: 3.21, 95% confidence interval [CI]: 1.66-6.20; P < .001), whereas preoperative eGFR was not predictive (HR: 0.99, 95% CI: 0.98-1.01; P = .28). Additional significant predictors included chronic obstructive pulmonary disease (HR: 2.04), older age (HR: 1.05), and larger maximal aneurysm diameter (HR: 1.03; all P < .05). CONCLUSIONS: In our 10-year experience with FEVAR, preoperative proteinuria was observed in 17% of patients and was significantly associated with worse survival. In this cohort, proteinuria was independently associated with all-cause mortality, whereas eGFR was not, suggesting that urinalysis may provide an additional simple metric for risk-stratifying patients before FEVAR.

Association of Baseline Chronic Kidney Disease Stage With Short- and Long-Term Outcomes After Fenestrated Endovascular Aneurysm Repair.

BACKGROUND: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established treatment approach for juxtarenal and short-neck infrarenal aortic aneurysms. Recommendations and clinical outcomes are lacking for offering FEVAR in patients with chronic kidney disease (CKD). We aimed to compare short- and long-term outcomes for patients with none-to-mild versus moderate-to-severe CKD undergoing FEVAR. METHODS: We retrospectively reviewed consecutive patients undergoing standard FEVAR with Cook devices at a single institution. The cohort was stratified by preoperative CKD stage none-to-mild or moderate-to-severe (CKD 1-2 and CKD 3-5, respectively). The primary outcome was postoperative acute kidney injury (AKI). Secondary outcomes included 30-day perioperative complications, 1- and 5-year rates of overall survival, dialysis, renal target artery patency, endoleak, and reintervention assessed by the Kaplan-Meier method. Aneurysm sac regression, number of surveillance computed tomography (CT) scans, and CKD stage progression were assessed at latest follow-up. Multivariate Cox proportional hazards modeling was used to evaluate the association of CKD stage 3 and stage 4-5 with all-cause mortality, controlling for differences in baseline characteristics. RESULTS: From 2012- to 2022, 184 patients (of which 82% were male) underwent FEVAR with the Cook ZFEN device (mean follow-up 34.3 months). Group CKD 3-5 comprised 77 patients (42%), was older (75.2 vs. 73.0 years, P = 0.04), had increased preoperative creatinine (1.6 vs. 0.9 mg/dL, P < 0.01), and demonstrated increased renal artery ostial calcification (37.7% vs. 21.5%, P = 0.02) compared with Group CKD 1-2. Perioperatively, CKD 3-5 sustained higher estimated blood loss (342 vs. 228 ml, P = 0.01), longer operative times (186 vs. 162 min, P = 0.04), and longer length of stay (3 vs. 2 days, P < 0.01). Kaplan-Meier 1- and 5-year survival estimates were lower for CKD 3-5 (82.3% vs. 95.1%, P < 0.01 and 55.4% vs. 70.8%, P = 0.02). Fewer CKD 3-5 patients remained free from chronic dialysis at 1 year (94.4% vs. 100%, P = 0.015) and 5 years (84.7% vs. 100%, P < 0.01). There were no significant differences in postoperative AKI rate (CKD 1-2 6.5% vs. CKD 3-5 14.3%, P = 0.13), long-term renal artery patency, reinterventions, type I or III endoleak, mean sac regression, or total follow-up CT scans between groups. CKD stage progression occurred in 47 patients (31%) at latest follow-up but did not differ between stratified groups (P = 0.17). On multivariable modeling, age (hazard ratio 1.05, 95% confidence interval 1.01-1.09, P = 0.02) and CKD stage 4-5 (hazard ratio 6.39, 95% confidence interval 2.26-18.05, P < 0.01) were independently associated with mortality. CONCLUSIONS: Preoperative CKD status did not negatively impact the durability or technical success related to aneurysm outcomes after FEVAR. Worsening CKD stage was associated with lower 1- and 5-year overall survival and freedom from dialysis after FEVAR with no statistically significant differences in 30-day or long-term technical aneurysm outcomes.

Precocious Rupture of Abdominal Aortic Aneurysms Below Size Criteria for Repair: Risk Factors and Outcomes.

BACKGROUND: Practice guidelines recommend elective repair for abdominal aortic aneurysms (AAAs) ≥ 5.5 cm in men and ≥ 5 cm in women to prevent rupture; however, some rupture at smaller diameters. We identify risk factors for rupture AAA (rAAA) below this threshold and compare outcomes following rAAA repair above/below size criteria. METHODS: The Vascular Quality Initiative (2013-2019) was queried for patients undergoing repair for rAAA and stratified based on diameter into small and large cohorts [Small: < 5.5 cm (men), < 5.0 cm (women)]. Univariate analysis was performed, and Kaplan-Meier analysis compared overall survival, aneurysm-related mortality, and reintervention at 12 months. RESULTS: Five thousand one hundred sixty two rAAA were identified. Small rAAA patients [n = 588] were more likely to have hypertension (81.3% vs. 77.0%, P < 0.02), diabetes (18.2% vs. 14.9%, P < 0.04), and end-stage renal disease (2.9% vs. 0.9%, P < 0.01) and be on optimal medical therapy (32.1% vs. 26.8%, P < 0.01). Women were more likely to rupture at smaller diameters compared to men (P < 0.01). Small rAAA patients were more likely to undergo endovascular aortic repair (EVAR) (70.2% vs. 56.0%, P < 0.01) and had lower in-hospital mortality (17.7% vs. 27.7%, P < 0.01) and fewer perioperative complications across all categories. At 12 months, small rAAA patients had better overall survival, freedom from aneurysm-related mortality, and freedom from reintervention, largely driven by EVAR approach. CONCLUSIONS: More than 11% of patients presenting with ruptured AAA were below the recommended size threshold for repair, and they tended to be younger, non-White, and have hypertension, diabetes, and/or renal failure. Patients with small rAAA experienced lower in-hospital morbidity and mortality and improved 1-year survival, and EVAR was associated with better outcomes than open repair. However, women more frequently rupture at smaller diameters compared to men. Given contemporary elective outcomes for women, a randomized controlled trial for EVAR versus surveillance at a sex-specific size threshold is needed.

A fenestrated, double-barrel technique for proximal reintervention after open or endovascular abdominal aortic aneurysm repair.

Objective: Proximal endovascular reintervention after prior endovascular aortic repair (EVAR) or open abdominal aortic aneurysm repair (OR) can be challenging due to the short distance to the visceral branches. We present a novel solution to allow the use of the commercially available ZFEN device using a double-barrel, kissing-limb technique. Methods: Patients who underwent fenestrated repair for proximal failure after EVAR or OR were identified. The ZFEN device is deployed above the prior graft flow divider. Once the visceral branches are secured, kissing limbs are used to connect with the prior graft limbs. The distal diameter of the standard ZFEN is 24 mm, accommodating two 20 mm components according to the formula 2πDLIMB = πDZFEN + 2DZFEN. Results: Of 235 patients who underwent repair using ZFEN from 2012 to 2021 at a single institution, 28 were treated for proximal failure of prior repairs, with 13 treated using the double-barrel technique (8 EVAR, 5 OR). The distance from the flow divider to the lowest renal artery was 67 ± 24.4 mm (range, 39-128 mm), and the distance to the superior mesenteric artery (SMA) was 87 ± 30.5 mm (range, 60-164 mm). Technical success was 100%. Seven patients had standard ZFEN builds (2 renal small fenestrations, SMA large fen/scallop). The minimum distance to the lowest renal artery and SMA to accommodate a standard ZFEN build was 56 and 60 mm, respectively. Four patients required adjunctive snorkel grafts and two required laser fenestrations. Two patients had gutter leaks at 1 month that self-resolved; one patient developed a late type 1a endoleak. Freedom from reintervention was 90%, 72%, and 48% at 1, 2, and 3 years, respectively. Conclusions: This double-barrel technique allows for distal seal of commercial ZFEN devices into prior open or endovascular repairs with good technical success. Long-term outcomes remain to be quantified.

Validity of the Global Vascular Guidelines in Predicting Outcomes Based on First-Time Revascularization Strategy.

BACKGROUND: The Global Vascular Guidelines (GVG) recommend selecting an endovascular versus open-surgical approach to revascularization for chronic limb-threatening ischemia (CLTI), based on the Global Limb Anatomic Staging System (GLASS) and wound, ischemia, and foot infection (WIfI) classification systems. We assessed the utility of GVG-recommended strategies in predicting clinical outcomes. METHODS: We conducted a single-center, retrospective review of first-time lower-extremity revascularizations within a comprehensive limb-preservation program from 2010 to 2018. Procedures were stratified by (1) treatment concordance with GVG-recommended strategy (concordant versus nonconcordant groups), (2) GLASS stages I-III, and (3) endovascular versus open strategies. The primary outcome was 5-year freedom from major adverse limb events (FF-MALE), defined as freedom from reintervention or major amputation, and secondary outcomes included 5-year overall survival, freedom from major amputation, freedom from reintervention, and immediate technical failure (ITF) during initial revascularization. Kaplan-Meier (KM) survival analysis and multivariate analysis with Cox proportional hazard models were performed on the primary and secondary outcomes. RESULTS: Of 281 first-time revascularizations for CLTI, 251 (89.3%) were endovascular and 186 (66.2%) were in the concordant group, with a mean clinical follow-up of 3.02 ± 2.40 years. Within the concordant group alone, 167 (89.8%) of revascularizations were endovascular. The concordant group had a higher rate of chronic kidney disease (60.8% vs. 45.3%, P = 0.02), WIfI foot infection grade (0.81 ± 1.1 vs. 0.56 ± 0.80, P = 0.03), and WIfI stage (3.1 ± 0.79 vs. 2.8 ± 1.2, P < 0.01) compared to the non-concordant group. After both KM and multivariate analyses, there were no significant differences in 5-year FF-MALE or overall survival between concordant and non-concordant groups. There was higher freedom from major amputation in the non-concordant group on KM analysis (83.9% vs. 74.2%, P = 0.025), though this difference was non-significant on multivariate analysis (hazard ratio [HR]: 0.49, 95% confidence interval [CI]: 0.21-1.15, P = 0.10). The open group had lower MALE compared to the endovascular group (HR: 0.39, 95% CI: 0.17-0.91, P = 0.029) attributed to a lower reintervention rate in the open group (HR: 0.31, 95% CI: 0.11-0.87, P = 0.026). GLASS stage was not associated with significant differences in outcomes, but the severity of GLASS stage was associated with ITF (2.1% in stage 1, 6.4% in stage 2, and 11.7% in stage 3, P = 0.01). CONCLUSIONS: In this study, CLTI treatment outcomes did not differ significantly based on whether treatment was received in concordance with GVG-recommended strategy. There was no difference in overall survival between the endovascular and open groups, though there was a higher reintervention rate in the endovascular group. The GVG guidelines are an important resource to help guide the management of CLTI patients. However, in this study, both concordance with GVG guidelines and GLASS staging were found to be indeterminate in differentiating outcomes between complex CLTI patients treated primarily with an endovascular-first approach. The revascularization approach for a CLTI patient is a nuanced decision that must take into account patient anatomy and clinical status, as well as physician skill and experience and institutional resources.

Female sex is independently associated with reduced inpatient mortality after endovascular repair of blunt thoracic aortic injury.

BACKGROUND: Female sex has been associated with decreased mortality after blunt trauma, but whether sex influences the outcomes of thoracic endovascular aortic repair (TEVAR) for traumatic blunt thoracic aortic injury (BTAI) is unknown. METHODS: In this retrospective study of a prospectively maintained database, the Vascular Quality Initiative registry was queried from 2013 to 2020 for patients undergoing TEVAR for BTAI. Univariate Student's t-tests and χ2 tests were performed, followed by multivariate logistic regression for variables associated with inpatient mortality. RESULTS: Of 806 eligible patients, 211 (26.2%) were female. Female patients were older (47.9 vs 41.8 years, P < .0001) and less likely to smoke (38.3% vs 48.2%, P = .044). Most patients presented with grade III BTAI (54.5% female, 53.6% male), followed by grade IV (19.0% female, 19.5% male). Mean Injury Severity Scores (30.9 + 20.3 female, 30.5 + 18.8 male) and regional Abbreviated Injury Score did not vary by sex. Postoperatively, female patients were less likely to die as inpatients (3.8% vs 7.9%, P = .042) and to be discharged home (41.4% vs 52.2%, P = .008). On multivariate logistic regression, female sex (odds ratio [OR]: 0.05, P = .002) was associated with reduced inpatient mortality. Advanced age (OR: 1.06, P < .001), postoperative transfusion (OR: 1.05, P = .043), increased Injury Severity Score (OR: 1.03, P = .039), postoperative stroke (OR: 9.09, P = .016), postoperative myocardial infarction (OR: 9.9, P = .017), and left subclavian coverage (OR: 2.7, P = .029) were associated with inpatient death. CONCLUSIONS: Female sex is associated with lower odds of inpatient mortality after TEVAR for BTAI, independent of age, injury severity, BTAI grade, and postoperative complications. Further study of the influence of sex on postdischarge outcomes is needed.

Large Fenestrations Versus Scallops for the Superior Mesenteric Artery during Fenestrated Endovascular Aneurysm Repair: Does it Matter?

BACKGROUND: Fenestrated endovascular aneurysm repair is an established customized treatment for aortic aneurysms with 3 current commercially available configurations for the superior mesenteric artery (SMA)-a single-wide scallop, large fenestration, or small fenestration, with the scallop or large fenestration most utilized. Outcomes comparing SMA single-wide scallops to large fenestrations with the Zenith fenestrated (ZFEN) device are scarce. As large fenestrations have the benefit of extending the proximal seal zone compared to scalloped configurations, we sought to determine the differences in seal zone and sac regression outcomes between the 2 SMA configurations. METHODS: We retrospectively reviewed our prospectively maintained complex endovascular aneurysm repair database and included all patients treated with the Cook ZFEN device with an SMA scallop or large fenestration configuration at its most proximal build. All first postoperative computed tomography scans (1-30 days) were analyzed on TeraRecon to determine precise proximal seal zone lengths, and standard follow-up anatomic and clinical metrics were tabulated. RESULTS: A total of 234 consecutive ZFEN patients from 2012 to 2021 were reviewed, and 137 had either a scallop or a large fenestration for the SMA as the proximal-most configuration (72 scallops and 65 large fenestrations) with imaging available for analysis. The mean follow-up was 35 months. The mean proximal seal zone length was 19.5 ± 7.9 mm for scallop versus 41.7 ± 14.4 mm for large fenestration groups (P < 0.001). There was no difference in sac regression between the scallop and large fenestration at 1 year (10.1 ± 10.9 mm vs. 11.0 ± 12.1, P = 0.63). Overall, 30-day mortality (1.3% vs. 2.5%, P = 0.51) and all-cause 3-year mortality (72.5% vs. 81.7%, P = 0.77) were not significantly different. Reinterventions within 30 days were primarily secondary to renal artery branch occlusions, with only 1 patient in the scallop group requiring reintervention for an SMA branch occlusion. CONCLUSIONS: Despite attaining longer proximal seal lengths, large SMA fenestrations were not associated with a difference in sac regression compared to scalloped SMA configurations at a one-year follow-up. There were no significant differences in reinterventions or overall long-term survival between the 2 SMA strategies.

Factors associated with sac regression after F/BEVAR for complex abdominal and thoracoabdominal aneurysms.

The behavior and remodeling of the residual aneurysm sac after endovascular repair is predictive of long-term outcomes. Although persistent growth is clearly a harbinger of complications, only recently has the relative advantage of sac regression over sac stability been recognized. There is a growing literature examining the prognostic implications of sac regression after standard infrarenal endovascular aortic repair, and various factors associated with increased likelihood of regression have been identified. However, there is a relative paucity of data on sac regression after more complex aneurysm repairs using fenestrated and/or branched technology. In this article, we aim to review sac regression and its importance as a whole, and specifically examine the role of regression after fenestrated and/or branched endovascular aortic repair for more extensive abdominal and thoracoabdominal aneurysms.

Multidisciplinary Extremity Preservation Program Improves Quality of Life for Patients with Advanced Limb Threat.

BACKGROUND: The need for multidisciplinary care of patients with advanced limb threat is well established. We examined patient reported outcomes and health-related quality of life (HR-QoL) for those who completed a multidisciplinary extremity preservation program (EPP) at our institution. METHODS: Patients with advanced limb threat, who had previously failed standard management at a tertiary-care center, were referred to EPP for evaluation by a multidisciplinary panel of vascular, plastic, orthopedic and podiatric surgeons, along with infectious disease, prosthetics, orthotics, imaging, palliative care, social work and wound nursing specialists. HR-QoL was quantified before and after EPP participation with the RAND-36 questionnaire. The validated RAND-36 assesses physical function, role limitations caused by physical and emotional health problems, social functioning, emotional well-being, energy, pain and general health perceptions. RESULTS: From 2018 to 2020, 185 patients were referred to EPP. After review by the multidisciplinary panel, 120 were accepted into the program, 63 of whom completed their course of care; 9 were one-time consultations. The median number of EPP in-person care visits was 23 (13-54) per participant; 87.3% of patients received one or more surgical procedure, including operative debridement (73%), revascularization (44%), soft-tissue reconstruction or transplantation (46%), as well as hyperbaric oxygen therapy (11%) during their course of treatment. 85.7% of patients achieved complete wound healing, 41.5% occurring within 6 months. Ultimately, 14.3% required a major amputation. Graduates noted improvement in all categories of the HR-QoL upon completion, including those undergoing major amputation. On adjusted multivariate regression analysis, patients with immunocompromised status were more likely to show greater improvement in their social function (OR: 10.1; P < 0.044) and emotional role limitation (OR: 8.1; P = 0.042), while, patients with larger wound volume at presentation were more likely to have greater improvement in their general health (OR: 1.1; P < 0.049). Conversely, patients with a smoking history had less improvement in energy level (OR: 0.4; P = 0.044) and patients with dialysis-dependence had less improvement in social function (OR: 0.2; P = 0.034). CONCLUSIONS: Coordinated, multidisciplinary extremity preservation program improves HR-QoL of patients with complex limb threat, including those who are immunocompromised with impaired social function and emotional role limitations. Furthermore, study is warranted to better characterize the generalizability of this approach, including considerations of cost-effectiveness, wound recidivism, and limiting the number of in-person visits required to achieve complete healing.

Reintervention does not affect long-term survival after fenestrated endovascular aneurysm repair.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is increasingly used in the treatment of juxtarenal aortic aneurysms and short-neck infrarenal aneurysms. Reinterventions (REIs) occur frequently, contributing to patient morbidity and resource utilization. We sought to determine whether REI affects long-term survival after FEVAR. METHODS: A single-institution retrospective review of all Cook Zenith fenestrated (ZFEN; Cook Medical, Inc, Bloomington, IN) repairs was performed. Patients with ≥6 months of follow-up and without adjunctive branch modifications were included. REI was defined as any aneurysm, device, target branch, or access-related intervention after the index procedure. REIs were categorized as early (<30 days) or late (≥30 days), by indication (ie, branch, endoleak, limb related, access related, other), and by target branch or device components. Patients were stratified into REI vs no REI groups and branch REI vs non-branch REI groups. RESULTS: Of 219 consecutive ZFEN repairs from 2012 to 2021, 158 patients met the inclusion criteria. Of these 158 patients, 41 (26%) required a total of 51 REIs (10 early and 41 late) during a mean follow-up of 33.9 months. The most common indication for REI was branch-related (31 of 51; 61%), with the renal arteries the most frequently affected (26 of 51; 51%). The only differences found in baseline, aneurysm, and device characteristics were a higher mean Society for Vascular Surgery comorbidity score (9.6 vs 7.9; P = .04) and larger suprarenal neck angle (23.3° vs 17.1°; P = .04) in the no REI group. In contrast, the REI group had a larger mean proximal seal zone diameter (26.3 mm vs 25.1 mm; P = .03) and device diameter (31.9 mm vs 30.0 mm; P = .002) compared with the no REI group. Technical success and operative characteristics were similar between the groups, except for a longer mean fluoroscopy time (74.9 minutes vs 60.8 minutes; P = .01) and longer median length of stay (2 vs 2 days; P = .006) for the REI group. Although the rate of early (<30 days) major adverse events was greater for the REI group (24.4% vs 6.0%; P = .001), the difference in 30-day mortality was not statistically significant (4.9% vs 0.9%; P = .10). On Kaplan-Meier analysis, freedom from REI at 1 and 5 years was 85.7% and 62.6%, respectively, for the overall cohort. No difference was found in the estimated 5-year survival between the REI and no REI groups (62.8% vs 63.5%; log-rank, P = .87) and branch REI and non-branch REI groups (71.8% vs 49.9%; log-rank, P = .16). On multivariate analysis, REI was not an independent predictor for mortality. However, age, Society for Vascular Surgery comorbidity score, and preoperative maximum aneurysm diameter each increased the hazard of death (hazard ratio [HR], 1.07; 95% confidence interval [CI], 1.02-1.12 [P = .007]; HR, 1.10; 95% CI, 1.01-1.18 [P = .02]; HR, 1.05; 95% CI, 1.02-1.08 [P = .003], respectively). CONCLUSIONS: After ZFEN, 41 patients (26%) had required a total of 51 REIs, with most occurring ≥30 days after the index procedure, and 61% were branch related, with no influence on 5-year survival. Age, comorbidity, and baseline aneurysm diameter independently predicted mortality. The use of FEVAR mandates lifelong surveillance and protocols to maintain branch patency. Despite their relative frequency, REIs did not influence 5-year postprocedural survival.

Aortoiliac occlusive disease.

Aortoiliac occlusive disease, or peripheral artery disease affecting the suprainguinal vessels, can lead to a range of clinical symptoms from claudication to more severe, chronic limb-threatening ischemia. Although open surgical reconstruction has traditionally been the reference standard, endovascular options have become significantly more robust in recent years, owing to both improved devices and increasing experience with advanced techniques. This review will discuss the demographics, presentation, and evaluation of chronic aortoiliac occlusive disease, as well as explore the options, both open and endovascular, for revascularization.

Trends in annual open abdominal aortic surgical volumes for vascular trainees compared with annual national volumes in the endovascular era.

OBJECTIVE: A prior analysis predicted a shortfall in open abdominal aortic repair (OAR) experience for vascular trainees resulting from the rapid adoption, and increased anatomic suitability, of endovascular aortic aneurysm repair (EVAR) technology. We explored how EVAR has transformed contemporary open aortic surgical education for vascular trainees. METHODS: We examined the Accreditation Council for Graduate Medical Education case volumes of open abdominal aortic aneurysm (AAA) repair and reconstruction for aortoiliac occlusive disease via aortoiliac or femoral bypass (AFB) from integrated vascular surgery residents (VSRs) and fellows (VSFs) graduating from 2006 to 2017 and compared them to the national estimates of total OAR (open AAA repair plus AFB) in the Agency for Healthcare Research and Quality National Inpatient Sample using the International Classification of Diseases, 9th and 10th revision, procedural codes. Changes over time were assessed using the χ2 test, Student's t test, and linear regression. RESULTS: During the 12-year study period, the national annual total OAR and open AAA repair estimates had decreased: total OAR by 72.5% (estimate ± standard error: 2006, 24,255 ± 1185; vs 2017, 6690 ± 274; P < .001) and open AAA repair by 84.7% (estimate ± standard error: 2006, 18,619 ± 924; vs 2017, 2850 ± 168; P < .001). The AFB estimates had decreased by 33.0% (P < .001). The percentage of total OAR, open AAA repair, and AFB performed at teaching hospitals had significantly increased, from ∼55% to 80% (P < .001 for all). A 40.9% decrease was found for open AAA repairs performed by graduating VSFs (mean, 18.6 vs 11) but only a 6.9% decrease in total OAR cases (mean, 27.6 vs 25.7) owing to increasing AFB volumes (mean, 9.0 vs 14.7). The VSR graduates had consistently logged an average of ∼10 open AAA repairs, with a 31.0% increase in total OARs (mean, 23.2 vs 30.4), again secondary to increasing AFB volumes (mean, 11.4 vs 17.5). Although an absolute decrease was found in open aortic experience for VSFs, the rate of decline for the total OAR case volumes was not significantly different after VSR programs had been established (P = .40). CONCLUSIONS: As the incidence has decreased nationally, the use of OAR has been shifting toward teaching hospitals. Although open AAA procedures for trainees have been declining with the increased use of EVAR, open aortic reconstruction for aortoiliac occlusive disease has been increasing, playing an important role in ensuring that vascular trainees continue to have satisfactory OAR experience sufficient for meeting minimum graduation requirements. Strategies to maintain and maximize the education and experience from these cases should be the top priority for vascular surgery program directors.

Cost-effectiveness of computed tomography versus ultrasound-based surveillance following endovascular aortic repair of intact infrarenal abdominal aortic aneurysms.

BACKGROUND: While Society for Vascular Surgery guidelines recommend computed tomography angiography (CTA) or ultrasound for surveillance following infrarenal endovascular aortic repair (EVAR), there is a lack of consensus regarding optimal timing and modalities. We hypothesized that ultrasound-based approaches would be more cost-effective and developed a cost-effectiveness analysis to estimate the lifetime costs and outcomes of various strategies. METHODS: We developed a decision tree with nested Markov models to compare five surveillance strategies: yearly CTA, yearly CDU, yearly CEU, CTA at first year followed by CDU, and CTA at first year followed by CEU. The model accounted for differential sensitivity, specificity, and risk of acute kidney injury after CTA, and was implemented on a monthly cycle with a willingness-to-pay threshold of $50,000 per quality-adjusted life year (QALY) and 3% annual discounting. RESULTS: Under base case assumptions, the CTA-CDU strategy was cost effective with a lifetime cost of $77950 for 7.74 QALYs. In sensitivity analysis, the CTA-CDU approach remained cost-effective when CEU specificity was less than 95%, and risk of acute kidney injury following CTA was less than 20%. At diagnostic sensitivities below 75% for CEU and 55% for CDU, a yearly CTA strategy maximized QALYs. CONCLUSIONS: A hybrid strategy in which CTA is performed in the first year and CDU is performed annually thereafter is the most cost-effective strategy for infrarenal EVAR surveillance in patients with less than a 20% risk of contrast-induced nephropathy. If the sensitivity of CEU and CDU are at the lower end of plausible estimates, a yearly CTA strategy is reasonable. Further research should aim to identify patients who may benefit from alternative surveillance strategies.

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms.

OBJECTIVE: Physician-modified endografts (PMEG) and parallel grafting (PG) are important techniques for endovascular repair of complex aortic aneurysms using off-the-shelf devices. However, there are few data regarding the relative efficacy and outcomes of these techniques in thoracoabdominal extent aneurysms. This study sought to compare the outcomes of PG and PMEG across different extents of thoracoabdominal aneurysms (TAAAs) for which they can be used. METHODS: The Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair/complex endovascular aortic repair module was queried for all patients undergoing repair of an unruptured, TAAA (extents I-IV) from 2012 to 2020; aneurysm types were defined by repair extent as determined by proximal and distal seal zones. Patients were differentiated based on whether they underwent repair with a PMEG or PG. The primary outcomes for this study were overall survival and freedom from aneurysm- or procedure-related mortality at 1 year determined via Kaplan-Meier analysis, with a Cox hazard regression analysis conducted to examine the independent association of repair modality with primary outcomes. RESULTS: There were 813 patients who met the inclusion criteria (TAAA I-III, n = 362; TAAA IV, n = 451; PG, n = 426; PMEG, n = 387). PMEG repairs were performed at centers with a nearly two- to three-fold higher annual volume of endovascular TAAA repairs. Type Ia endoleaks were reduced with PMEG repair, most significantly in TAAA IV (TAAA I-III, 2.2% PMEG vs 10% PG [P = .2]; TAAA IV, 1.2% PMEG vs 21.6% PG [P < .001]). Thoracoabdominal repairs demonstrated improved survival at 1 year with PMEG devices, significant for TAAA I to III repairs (TAAA I-III, PMEG 85% vs PG 74% [P = .01]; TAAA IV, 84% PMEG vs PG 78% [P = .08]). Freedom from aneurysm- or procedure-related mortality was also improved with PMEG repairs, remaining significant at 1 year in the case of TAAA IV (TAAA I-III:, PMEG 94% vs PG 86% [P = .06]; TAAA IV, PMEG 94% vs PG 88% [P = .02]). PMEG demonstrated decreases in several measures of postoperative morbidity, including stroke, death, major adverse cardiovascular events, and postoperative complications. In the multivariate analysis, repair modality was not associated with either primary outcome; rather, several perioperative complications conveyed the greatest hazard for both primary outcomes across repair extents. CONCLUSIONS: Survival after endovascular TAAA repair is improved with the use of PMEG compared with PG. Several key factors of this study demonstrate the shortcomings of PG in complex aneurysm repair, namely, high rates of critical endoleaks, the need for adjunctive access sites, and an increase in perioperative complications that influence longer term outcomes.

Fenestrated Aortic Aneurysm Repair in Patients Treated Inside Versus Outside of Instructions for Use.

OBJECTIVES: The aim of this study was to compare outcomes of patients treated with the Cook Zenith Fenestrated (ZFEN) device for juxtarenal aortic aneurysms inside versus outside the IFU. METHODS: We retrospectively reviewed our institutional ZFEN database for cases performed between 2012 and 2018, with analysis performed in 2020 in order to report midterm outcomes. The cohort was stratified based on treatment inside (IFU group) and outside (non-IFU group) the IFU for criteria involving the proximal neck: neck length 4 to 14 mm, neck diameter 19 to 31 mm, and neck angulation ≤45°. Patients with thoracoabdominal aneurysms or concurrent chimney grafting were excluded. The primary outcomes in question were mortality, type 1a endoleak, and reintervention. Univariate and multivariate analyses were performed to determine associations between adherence to IFU criteria and outcomes. RESULTS: We identified 100 consecutive patients (19% female, mean age 73.6 years) for inclusion in this analysis. Mean follow-up was 21.6 months. Fifty-four patients (54%) were treated outside the IFU because of inadequate neck length (n=48), enlarged neck diameter (n=10), and/or excessive angulation (n=16). Eighteen patients were outside IFU for two criteria, and one patient was outside IFU for all three. Non-IFU patients were exposed to higher radiation doses (3652 vs 5445 mGy, p=0.008) and contrast volume (76 vs 95 mL, p=0.004). No difference was noted between IFU and non-IFU groups for 30-day mortality (0% vs 3.7%, p=0.18), or type 1a endoleak (0% vs 1.9%, p=0.41). Reintervention was also similar between cohorts (13% vs 27.8%, p=0.13). Being outside IFU for neck diameter or length was each borderline significant for higher reintervention on univariate analysis (p=0.05), but this was not significant on multivariate Cox proportional hazard modeling (HR 1.82 [0.53-6.25]; 2.03 [0.68-7.89]), respectively. No individual IFU deviations were associated with the primary outcomes on multivariate analysis, nor being outside IFU for multiple criteria. CONCLUSIONS: Patients with juxtarenal aortic aneurysms may be treated with the ZFEN device with moderate deviations from the IFU. While no differences were seen in mortality or proximal endoleak, larger studies are needed to examine the potential association between IFU nonadherence and reinterventions and close follow-up is warranted for all patients undergoing such repair.

Predictors of sac regression after fenestrated endovascular aneurysm repair.

OBJECTIVE: Aneurysm sac regression after standard endovascular aortic repair is associated with improved outcomes, but similar data are limited after fenestrated endovascular aortic repair (FEVAR). We sought to evaluate sac regression after FEVAR, and identify any predictors of this favorable outcome. METHODS: Patients undergoing elective FEVAR using the commercially available Zenith Fenestrated device (ZFEN; Cook Medical, Bloomington, IN) from 2012 to 2018 at a single institution were reviewed retrospectively. The maximal aortic diameter was compared between the preoperative scan and those obtained in follow-up. Patients with of 5 mm or more sac regression were included in the regression (REG) group, with all others in the nonregression (NONREG) group. Outcomes were compared between groups using univariate analysis, and logistic regression analysis was performed to identify any predictive factors for sac regression. RESULTS: We included 132 patients undergoing FEVAR in the analysis. At a mean follow-up of 33.1 months, 65 patients (49.2%) had sac regression of 5 mm or more and comprised the REG group (n = 65 [49.2%]). The REG group had smaller diameter devices, and were less likely to have had concomitant chimney grafts placed (P < .05). The NONREG group had a higher incidence of type II endoleak (35.8% vs 12.3%; P = .002). Sac regression was associated with a significant mortality benefit on Kaplan-Meier analysis (log rank P = .02). Multivariate analysis identified adjunctive parallel grafting (odds ratio [OR], 0.01; 95% confidence interval [CI], 0.03-0.36; P < .01), persistent type II endoleak (OR, 0.13; 95% CI, 0.02-0.74; P < .01), and a greater number of target vessels (OR, 0.25; 95% CI, 0.10-0.62; P = .002) as independent predictors of failure to regress. CONCLUSIONS: Sac regression after FEVAR occurred in nearly one-half of patients, but seems to be less common in patients with persistent type II endoleaks and those undergoing concomitant parallel grafting. Sac regression was associated with a significant survival advantage, and can be used as a clinical marker for success after FEVAR.

Fenestrated Endovascular Repair With Large Device Diameters (34-36 mm) is Associated With Type 1 and 3 Endoleak and Reintervention.

BACKGROUND: Patients with abdominal aortic aneurysms undergoing EVAR with larger device diameters (34-36 mm) have worse outcomes due to proximal fixation failure and need for reintervention. We examine outcomes relating to standard fenestrated repair (FEVAR) with larger device diameters, and investigate whether a similar relationship exists. METHODS: Retrospective review of a prospectively maintained, single institution database of patients treated with the Cook ZFEN device between 2012-2017. Outcomes were stratified by device diameter into normal-diameter (ND,≤ 32 mm) and large-diameter (LD,34-36 mm). Primary endpoints were need for reintervention and composite type I/III endoleak. RESULTS: One-hundred consecutive patients treated were identified for inclusion. Overall mean age was 73.6 years and mean aortic diameter was 59.1 mm. Mean follow-up was 22 months. A total of 26 (26%) patients were treated with LD devices. Number of target vessels per patient was 2.8 in both groups. Infrarenal neck length and diameter were significantly different in the LD and ND patients, respectively (2.6 mm vs. 4.7 mm (P < 0.01) and 30.1 mm vs. 23.4 mm (P < 0.01)). Percent graft oversizing was lower in the LD cohort (19% vs. 24%; P = 0.006). No difference was seen in overall mortality at 30-days (0% vs. 2%; P = 0.4) or at latest follow up (6% vs. 14%; P = 0.6). Reinterventions were not significantly different at 30 days, but were significantly higher over the follow-up period in the LD cohort (46.2 vs. 17.6%; P = 0.002). LD diameter was associated with reintervention on univariate (HR 1.19, 95% CI 1.04-1.37), but not multivariate analysis. The composite endpoint of type I/III endoleak was higher in the LD cohort (15.4% vs. 2.7%; P = 0.004). CONCLUSIONS: FEVAR requiring 34- or 36-mm device diameters is associated with an increased risk of composite type I/III endoleak and reintervention. Patients undergoing fenestrated repair requiring LD devices should be closely monitored, with consideration for proximal or open repair.

Female sex is independently associated with in-hospital mortality after endovascular aortic repair for ruptured aortic aneurysm.

BACKGROUND: Endovascular aortic repair (EVAR) can treat anatomically compatible ruptured abdominal aortic aneurysms (rAAA), but registry data suggests that women undergo more open abdominal aneurysm repairs than men. We evaluate in-hospital outcomes of EVAR for rAAA by sex. METHODS: The Vascular Quality Initiative (VQI) registry was queried from 2013 to 2019 for rAAA patients treated with EVAR. Univariate analysis was performed with Student's t-test and chi-squared tests. Multivariable logistic regression was then performed to assess the association between female sex and inpatient mortality. RESULTS: A total of 1775 patients were included (23.8% female). Female rAAA patients were older (P< 0.01) and weighed less (P < 0.01). They were less likely to have smoked (P <.0 001) and had lower creatinine (1.29 vs. 1.43, P < 0.01) and hemoglobin (10.7 vs. 11.7, P < 0.01). Women had smaller maximum aortic diameters (74 vs. 66 mm, P < 0.01) and were less likely to have iliac aneurysms (P < 0.001). Women were more likely to have concomitant femoral endarterectomy (8.5% vs. 4.6%, P = 0.03). Despite having no significant difference in complication or reintervention rates, women had higher rates of in-hospital mortality (45.9% vs. 34.5%, P < 0.01). In a logistic regression model for predictors of in-hospital mortality (χ2 < .01), increased age (OR 1.08, P < 0.01), female sex (OR 1.7, P = 0.02), preoperative cardiac arrest (OR 5.29, P < 0.01), concurrent iliac stenting (OR 2.38, P = 0.02), postoperative mesenteric ischemia (OR 2.51, P < 0.01) and postoperative transfusion (OR 1.06, P < 0.01) were independently associated with in-hospital mortality. Increased preoperative hemoglobin was protective (OR 0.89, P < 0.01) CONCLUSIONS: Female sex is independently associated with in-hospital mortality after EVAR for rAAA, suggesting a relationship beyond anatomical, biochemical, and procedural covariates.