Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms.

OBJECTIVE: The objective of this study was to report long-term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms. METHODS: Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of intended branch vessels; and freedom from: type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion. RESULTS: Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49-124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9-92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d), and intensive care unit length of stay (mean, 1.6 d).A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%. CONCLUSIONS: PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available.

Modified Harborview Risk Score improves ease in predicting mortality after ruptured abdominal aortic aneurysm repair.

OBJECTIVE: The Harborview Risk Score (HRS) is a simple, accurate 4-point preoperative risk scoring system used to predict 30-day mortality following ruptured abdominal aortic aneurysm (rAAA) repair. The HRS assigns 1 point for each of the following: age >76 years, pH <7.2, creatinine >2 mg/dL, and any episode of severe hypotension (systolic blood pressure <70 mmHg). One potential limitation of this risk scoring system is that arterial blood gas (ABG) analysis is required to determine arterial pH. Because ABG analysis is not routinely performed prior to patient transfer or rAAA repair, we sought to determine if the HRS could be modified by replacing pH with the international normalized ratio (INR), a factor that has been previously shown to have a strong and independent association with 30-day death after rAAA repair. METHODS: A retrospective review of all rAAA repairs done at a single academic medical center between January 2002 and December 2018 was performed. Our traditional HRS was compared with a modified score, in which pH <7.2 was replaced with INR >1.8. Patients were included if they underwent rAAA repair (open or endovascular), and if they had preoperative laboratory values available to calculate both the traditional and modified HRS. RESULTS: During the 17-year study period, 360 of 391 repairs met inclusion criteria. Observed 30-day mortality using the modified scoring system was 17% (18/106) for a score of 0 points, 43% (53/122) for 1 point, 54% (52/96) for 2 points, 84% (27/32) for 3 points, and 100% (4/4) for 4 points. Receiver operating characteristic analysis revealed similar ability of the two scoring systems to predict 30-day death: there was no significant difference in the area under the curve (AUC) comparing the traditional (AUC = 0.74) and modified (AUC = 0.72) HRS (P = .3). CONCLUSIONS: Although previously validated among a modern cohort of patients with rAAA, our traditional 4-point risk score is limited in real-world use by the need for an ABG. Substituting INR for pH improves the usefulness of our risk scoring system without compromising accuracy in predicting 30-day mortality after rAAA repair.

Modified Harborview Risk Score accurately predicts mortality for patients with ruptured abdominal aortic aneurysm.

OBJECTIVE: The modified Harborview Risk Score (HRS) is a simple measure initially derived from a single institutional dataset used to predict ruptured abdominal aortic aneurysm (rAAA) repair survival preoperatively using basic labs and vital signs collected upon presentation. However, validation of this widely applicable scoring system has not been performed. This study aims to validate this scoring system using a large multi-institutional database. METHODS: All patients who underwent repair of an rAAA from 2011 to 2018 in the National Surgical Quality Improvement Program (NSQIP) and at a single academic medical center were included. The modified HRS was calculated by assigning 1 point for each of the following: age >76 years, creatinine >2 mg/dL, international normalized ratio >1.8, and any systolic blood pressure less than 70 mmHg. Assessment of the prediction model was then completed. Using a primary outcome measure of 30-day mortality, the receiver operating characteristic area under the curve was calculated. The discrimination between datasets was compared using a Delong test. Mortality rates for each score were compared between datasets using the Pearson χ2 test. Comparative analysis for patients with a score of 4 was limited due to a small sample size. RESULTS: A total of 1536 patients were identified using NSQIP, and 163 patients were assessed in the institutional dataset. There were 518 patients with a score of 0 (455 NSQIP, 63 institutional), 676 patients with a score of 1 (617 NSQIP, 59 institutional), 391 patients with a score of 2 (364 NSQIP, 27 institutional), 106 with a score of 3 (93 NSQIP, 13 institutional), and 8 patients with a score of 4 (7 NSQIP, 1 institutional). No difference was found in the receiver operating characteristic area under the curves between datasets (P = .78). Thirty-day mortality was 10% NSQIP vs 22% institutional for a score of 0; 28% NSQIP vs 36% institutional for a score of 1; 41% NSQIP vs 44% institutional for a score of 2; 45% NSQIP vs 69% institutional for a score of 3; and 57% NSQIP vs 100% institutional for a score of 4. Score 0 was the only score with a significant mortality rate difference between datasets (P = .01). CONCLUSIONS: The modified HRS is confirmed to be broadly applicable as a clinical decision-making tool for patients presenting with rAAAs. Therefore, this easily applicable model should be applied for all patients presenting with rAAAs to assist with provider and patient decision-making prior to proceeding with repair.

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.

Using Multidisciplinary Teams to Improve Outcomes for Treating Chronic-Limb Threatening Ischemia.

Multidisciplinary teams are necessary to treat complex patients with chronic limb-threatening ischemia (CLTI). The need for adequate wound care and control of comorbid conditions cannot be accomplished by the vascular specialist alone. Numerous specialties have a role in this group to include surgical podiatrists, orthopedic surgery, plastic and reconstructive surgery endocrinology, and wound care. However, the vascular specialist must drive this team as the patients are usually referred to them and numerous studies have shown a direct correlation between major amputations and the lack of vascular involvement. Creating these teams is unique in each community and must consider practice patterns that are relevant in the local region. CLTI is a challenging disease to manage, and multidisciplinary teams have demonstrated an ability to improve outcomes and deliver superior care to this patient population.

Practice Patterns and Barriers to Vascular Genetic Testing Among Vascular Surgeons.

INTRODUCTION: Engaging patients living with or at risk of aortic dissection via the Aortic Dissection Collaborative, physician education in vascular genetics was identified as a research priority. We surveyed vascular surgeons to characterize practice patterns, motivations, and barriers regarding aortopathy genetic testing. METHODS: An anonymous 27-question survey was distributed on social media platforms between November and December 2022. Domains included demographics, vascular genetic education, testing attitudes and utilization, and experience in treating patients with genetic vascular aortopathies. The analysis included summary statistics and unpaired t-test to compare responses by interest in incorporating testing and practice type. RESULTS: A total of 171 vascular surgeons from 15 countries responded to the survey (23% trainees). Over half received vascular genetics education during training (59%), and most (86%) were interested in incorporating genetic testing into their practice. Academic surgeons were more likely to have cared for a patient with a known genetic aortopathy over the past year than surgeons in hospital-based and private practices (83% vs. 56% vs. 27%; P < 0.01), to have ever made a referral to a medical geneticist (78% vs. 51% vs. 9%; P < 0.01), and have access to genetic counselors or geneticists (66% vs. 46% vs. 0%; P < 0.01). Barriers to genetic testing were rated as more significant by surgeons in nonacademic practices, with top barriers being insurance coverage of testing, cost of genetic testing, and access to genetic counselors. Evidence-based professional society guidelines were the strongest rated motivating factor for testing incorporation among respondents. CONCLUSIONS: Vascular surgeon attitudes are not major barriers to incorporating genetic testing for patients with aortopathies; however, practical challenges regarding genetic testing and counseling are barriers to implementation especially for vascular surgeons in nonacademic practices. Future efforts should focus on evidence-based society guidelines, continuing medical education to increase adoption, and facilitating access to genetic counseling.

Patterns in Complex Aortic Vascular Surgery Training and Early Career Practice.

BACKGROUND: Recent literature has suggested a decreasing experience with open aortic surgery among recent vascular surgery graduates. While trainees have a wide exposure to endovascular aortic repair, experience with both endovascular and open management of thoracoabdominal aneurysms, as well as the early career surgeon comfort with these procedures, remains unknown. Thus, we sought to evaluate early practice patterns in the surgical treatment of complex aortic surgery among recent US vascular surgery graduates. METHODS: An anonymous survey was distributed among all vascular surgeons who completed vascular surgery residency or fellowship in 2020. Self-reported data assessed the number and type of cases performed in training, surgeon experience in early practice, and surgeon desire for additional training in these areas. RESULTS: A total of 62 surgeons completed the survey with a response rate of 35%. Seventy-nine percent of respondents completed fellowship training (as compared to integrated residency), and 87% self-described as training in an academic environment. Sixty-six percent performed less than 5 open thoracoabdominal aortic surgeries and 58% performed less than 5 4-vessel branched/fenestrated aortic repairs (F/BEVARs), including 56% who completed less than 5 physician modified endovascular grafts repairs. Only 11% of respondents felt adequately prepared to perform open thoracoabdominal operations following training. For both open and F/BEVAR procedures, more than 80% respondents plan to perform such procedures with a partner in their current practice, and the majority desired additional open (61%) and endovascular (59%) training for the treatment of thoracoabdominal aneurysms. CONCLUSIONS: The reported infrequency in open thoracoabdominal and multivessel F/BEVAR training highlights a desire and utility for an advanced aortic training paradigm for surgeons wishing to focus on this area of vascular surgery. Further research is warranted to determine the optimal way to provide such training, whether through advanced fellowships, junior faculty apprenticeship models, or regionalization of this highly complex patient care. The creation of these programs may provide pivotal opportunity, as vascular surgery and the management of complex aortic pathology continues to evolve.

Reinterventions after physician-modified endovascular grafts for treatment of juxtarenal aortic aneurysms are non-detrimental to long-term survival.

OBJECTIVE: Reintervention after endovascular aortic aneurysm repair is common. However, their frequency and impact on mortality after physician-modified endografts (PMEGs) is unknown. This study aims to describe reinterventions after PMEG for treatment of juxtarenal aneurysms and their effect on survival. METHODS: Data from a prospective investigational device exemption clinical trial (Identifier #NCT01538056) from 2011 to 2022 were used. Reinterventions after PMEG were categorized as open or percutaneous and major or minor by Society for Vascular Surgery reporting standards and as high or low magnitude based on physiologic impact. Reinterventions were also categorized by timing, based on whether they occurred within 30 days of PMEG as well as within 1 week of PMEG. Survival was compared between patients who did and did not undergo reintervention and between reintervention subcategories. RESULTS: A total of 170 patients underwent PMEG, 50 (29%) of whom underwent a total of 91 reinterventions (mean reinterventions/patient, 1.8). Freedom from reintervention was 84% at 1 year and 60% at 5 years. Reinterventions were most often percutaneous (80%), minor (55%), and low magnitude (77%), and the most common reintervention was renal stenting (26%). There were 10 early reinterventions within 1 week of PMEG. Two aortic-related mortalities occurred after reintervention. There were no differences in survival between patients who underwent reintervention and those who did not. However, survival differed based on the timing of reintervention. After adjusted analysis, reintervention within one week of PMEG was associated with an increased risk of mortality both compared with late reintervention (hazard ratio, 11.1; 95% confidence interval, 2.7-46.5) and no reintervention (hazard ratio, 5.2; 95% confidence interval, 1.6-16.8). CONCLUSIONS: Reinterventions after PMEG were most commonly percutaneous, minor, and low magnitude procedures, and non-detrimental to long-term survival. However, early reinterventions were associated with increased mortality risk. These data suggest that a modest frequency of reinterventions should be expected after PMEG, emphasizing the critical importance of lifelong surveillance.

Vascular Surgery In-Training Examination performance following implementation of the Vascular Surgical Council on Resident Education curriculum.

OBJECTIVE: The Vascular Surgery Surgical Council on Resident Education (VSCORE) program is a standardized curriculum intended to prepare Vascular Surgery trainees for the annual Vascular Surgery In-Training Examination (VSITE). This study evaluated the performance of 0+5 and 5+2 Vascular Surgery trainees on the VSITE prior to and following implementation of the VSCORE curriculum. METHODS: VSITE scores, measured as percentage of questions correct, were collected for Vascular Surgery trainees at a United States academic medical center between 2015 and 2022. The VSITE scores were compared for the periods prior to (2015-2021) and following (2022) implementation of the VSCORE curriculum. RESULTS: Fifty-seven VSITE scores were evaluated, including 46 examinations completed prior to and 11 after the implementation of the VSCORE curriculum. The mean VSITE score across all training levels (post-graduate year [PGY] 1-7) increased significantly from 68.4% ± 1.5% prior to implementation of VSCORE curriculum to 76.5% ± 3.1% following implementation (P = .03). Two-way analysis of variance identified pre- and post-VSCORE implementation as a statistically significant categorical variable when residents were stratified into junior (PGY 1-2), senior (PGY 3-5), and fellow (PGY 6-7) training levels (P < .001). The mean change in score between consecutive years also increased following VSCORE implementation (14.1% ± 2.3%) compared with the pre-VSCORE era (5.7% ± 1.7%; P = .002) CONCLUSIONS: The implementation of the VSCORE curriculum at an academic medical center improved VSITE scores across vascular surgery trainees at all levels.

Perioperative complications following open or endovascular revascularization for chronic limb-threatening ischemia in the BEST-CLI Trial.

OBJECTIVE: Anticipated perioperative morbidity is an important factor for choosing a revascularization method for chronic limb-threatening ischemia (CLTI). Our goal was to assess systemic perioperative complications of patients treated with surgical and endovascular revascularization in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial. METHODS: BEST-CLI was a prospective randomized trial comparing open (OPEN) and endovascular (ENDO) revascularization strategies for patients with CLTI. Two parallel cohorts were studied: Cohort 1 included patients with adequate single-segment great saphenous vein (SSGSV), whereas Cohort 2 included those without SSGSV. Data were queried for major adverse cardiovascular events (MACE-composite myocardial infarction, stroke, death), non-serious (non-SAEs) and serious adverse events (SAEs) (criteria-death/life-threatening/requiring hospitalization or prolongation of hospitalization/significant disability/incapacitation/affecting subject safety in trial) 30 days after the procedure. Per protocol analysis was used (intervention received without crossover), and risk-adjusted analysis was performed. RESULTS: There were 1367 patients (662 OPEN, 705 ENDO) in Cohort 1 and 379 patients (188 OPEN, 191 ENDO) in Cohort 2. Thirty-day mortality in Cohort 1 was 1.5% (OPEN 1.8%; ENDO 1.3%) and in Cohort 2 was 1.3% (2.7% OPEN; 0% ENDO). MACE in Cohort 1 was 4.7% for OPEN vs 3.13% for ENDO (P = .14), and in Cohort 2, was 4.28% for OPEN and 1.05% for ENDO (P = .15). On risk-adjusted analysis, there was no difference in 30-day MACE for OPEN vs ENDO for Cohort 1 (hazard ratio [HR] 1.5; 95% confidence interval [CI], 0.85-2.64; P = .16) or Cohort 2 (HR, 2.17; 95% CI, 0.48-9.88; P = .31). The incidence of acute renal failure was similar across interventions; in Cohort 1 it was 3.6% for OPEN vs 2.1% for ENDO (HR, 1.6; 95% CI, 0.85-3.12; P = .14), and in Cohort 2, it was 4.2% OPEN vs 1.6% ENDO (HR, 2.86; 95% CI, 0.75-10.8; P = .12). The occurrence of venous thromboembolism was low overall and was similar between groups in Cohort 1 (OPEN 0.9%; ENDO 0.4%) and Cohort 2 (OPEN 0.5%; ENDO 0%). Rates of any non-SAEs in Cohort 1 were 23.4% in OPEN and 17.9% in ENDO (P = .013); in Cohort 2, they were 21.8% for OPEN and 19.9% for ENDO (P = .7). Rates for any SAEs in Cohort 1 were 35.3% for OPEN and 31.6% for ENDO (P = .15); in Cohort 2, they were 25.5% for OPEN and 23.6% for ENDO (P = .72). The most common types of non-SAEs and SAEs were infection, procedural complications, and cardiovascular events. CONCLUSIONS: In BEST-CLI, patients with CLTI who were deemed suitable candidates for open lower extremity bypass surgery had similar peri-procedural complications following either OPEN or ENDO revascularization: In such patients, concern about risk of peri-procedure complications should not be a deterrent in deciding revascularization strategy. Rather, other factors, including effectiveness in restoring perfusion and patient preference, are more relevant.

Dynamic Imaging is the Ideal Modality for the Diagnosis of Popliteal Artery Entrapment Syndrome.

BACKGROUND: Popliteal Artery Entrapment Syndrome (PAES) is a rare vascular condition with significant equipoise on how to properly diagnose and evaluate relevant imaging. This can lead to misdiagnosis and delay in surgical management. The objective of this study is to describe and compare distinct imaging features of dynamic versus static images to help determine the ideal imaging modality for diagnosis of PAES. METHODS: This is a retrospective review of patients referred for PAES at a single institution. We reviewed noninvasive imaging studies, diagnostic arteriograms, and cross-sectional images which include computed tomography angiography (CTA) or magnetic resonance angiography (MRA). For each affected and unaffected extremity, the characteristic collaterals for PAES were named and measured on arteriogram using Picture Archiving and Communication Software. Available cross-sectional images were also analyzed and compared with arteriogram and intraoperative findings during surgical exploration. RESULTS: There were 23 patients referred for PAES who underwent diagnostic evaluation and surgical management between 2013 and 2022. All patients had a duplex ultrasound that revealed a mean popliteal peak systolic velocity of 78 cm/sec at rest. With forced plantar flexion, the peak systolic velocity increased to a mean 175 cm/sec. A total of 12 extremities had complete loss of flow with provocation during duplex ultrasound. All patients underwent diagnostic angiography of 46 extremities. All limbs with PAES (n = 35) exhibited complete popliteal artery occlusion during angiography with forced plantar flexion. Distinct angiographic findings on resting images included a well-developed medial sural artery in 100% of limbs with PAES with a mean diameter of 2.7 mm. In limbs without PAES, only 80% had a visualized medial sural artery on arteriogram with a mean diameter of 2.0 mm (P = 0.1). A lateral sural artery was seen in 85% of affected extremities (mean diameter of 1.8 mm), while an anterior tibial recurrent artery was seen in 59% of affected extremities (mean diameter of 1.3 mm). In unaffected limbs, there were no visible lateral sural or anterior tibial recurrent arteries. The mean contrast used with diagnostic arteriograms was 58 milliliters (range 10-100 milliliters). Axial imaging was available for 9 affected extremities. Five had a previous MRA with only 1 being truly positive for arterial compression. Four extremities had previous CTA with 3 being falsely negative despite having type 3 PAES discovered during surgical exploration. CONCLUSIONS: Dynamic imaging with angiography provides immediate surgeon feedback by visualizing popliteal artery compression and enlarged sural collaterals during resting arteriography. The medial sural collateral is enlarged in patients with PAES and often the lateral sural and anterior tibial recurrent arteries can be visualized as well. CTA and MRA are associated with high false-negative rates, and therefore cause delays in diagnosis and surgical management of PAES. Dynamic imaging should, therefore, be the gold standard for the diagnosis of PAES.

Vascular trainee perceptions of diversity, equity, and inclusion within United States vascular surgery training programs.

OBJECTIVES: Vascular surgery training programs face multiple pressures, including attracting and retaining trainees. Current knowledge of trainees' views with respect to diversity and equity in vascular training programs is limited. We sought to understand United States vascular surgery trainees' perceptions and expectations regarding diversity, equity, and inclusion (DEI). METHODS: The Association of Program Directors in Vascular Surgery designed and administered the Annual Training Survey to specifically address DEI and administered it to all trainees (Integrated Residents/Fellows; n = 637) at 122 institutions in August 2020. RESULTS: Of the 637 vascular trainees, 227 (35%) responded. The respondents included 115 male and 62 female trainees, with 50 not disclosing or not answering the question. The majority of respondents (96.9%) believed their programs incorporated a diverse background of trainees. Of the trainees, 89.8% felt that the faculty were similarly comprised of a diverse background. The majority of respondents (63.6%) felt that their training program was both more diverse and focused on inclusion compared with other training programs at their institution. However, 20% of respondents had experienced discrimination. Seventy-three percent (n = 143) of trainees felt empowered to disagree or engage in a discussion should they observe a faculty member make a disparaging remark about a patient's background/race/gender, although 27% (n = 35) trainees expressed fear of retaliation as a reason to not engage. Trainees view their program director (82.6%), faculty mentor (60.9%), and Graduate Medical Education office (52.7%) as potential resources for support. Overall, 83.7% (n = 160) of trainees believe that their program has been open to discussion of race relations within the medical community. CONCLUSIONS: Trainees are committed to multifaceted diversity and inclusion. The perception of trainees regarding DEI issues within vascular surgery training programs appears to be positive; however, trainees did describe discrimination and gender biases in their institutions. This data has the potential to improve institutional education of faculty and trainees about the multidimensional levels of diversity and increased awareness and incorporation of this philosophy can assist in the recruitment of diverse vascular surgeons.

Society for Vascular Surgery appropriate use criteria for management of intermittent claudication.

The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.

Clinical Outcomes of a Diagnostic and Management Protocol for Popliteal Artery Entrapment Syndrome at a Large Referral Center.

BACKGROUND: Popliteal Artery Entrapment Syndrome (PAES) is a rare clinical entity without a standardized algorithm for diagnosis and treatment. The objective of this study was to evaluate the clinical outcomes of a unique diagnostic and management algorithm for patients with PAES managed at a quaternary referral center. METHODS: We retrospectively reviewed patients diagnosed with PAES at a single institution between 2013 and 2021. Demographics, physical exam findings, noninvasive imaging results, and angiographic images were assessed to validate a diagnostic and management algorithm (Figure 1). Surgical findings, operative technique, post-operative complications, and symptomatic improvement were assessed to validate this clinical algorithm. RESULTS: There were 35 extremities in 23 patients treated for PAES (Table I). The mean age was 28, and 82.6% of patients were female. Physical exam revealed a decrement in pedal pulse with provocative maneuvers in 90% of treated limbs. Noninvasive studies to include treadmill exercise testing revealed a mean Ankle-brachial indices (ABI) drop of 0.28 and positional duplex demonstrated that the mean peak systolic velocity (PSV) in the popliteal artery was 78 cm/sec at rest which increased to 175 cm/sec with provocation. Diagnostic arteriography was performed in all patients and revealed awell-developed geniculate and sural collaterals in 100% of the treated limbs and complete effacement of the popliteal artery with active provocative maneuvers in all treated limbs (Figure 2). Surgical exposure was performed via a posterior approach and intraoperative completion duplex was performed in all cases. Type III PAES was discovered in 89% of cases. Arterial reconstruction was required in 2 patients who presented with an occluded popliteal artery. All but one patient was discharged on post-operative day one. Wound complications occurred in 4 limbs (3 patients) and included seroma and hypertrophic scarring. All patients experienced symptomatic relief with a median follow-up of 4 months. CONCLUSIONS: We reported 100% technical and clinical success in patients with PAES diagnosed and managed using our clinical algorithm. Cross-sectional imaging is not necessary for the diagnosis. Dynamic angiography confirms the diagnosis and intraoperative duplex is essential for successful clinical outcome by confirming complete release of the popliteal artery.

Significant aortic neck dilation occurs after repair of juxtarenal aneurysms with fenestrated endovascular aneurysm repair.

OBJECTIVE: Aortic neck dilation is a reported mode of failure and can be associated with aneurysm sac expansion after standard endovascular abdominal aortic aneurysm repair (EVAR). Fenestrated EVAR (FEVAR) of the juxtarenal segment increases the seal zone length and is often used to treat this disease progression. However, the frequency and risk factors for neck dilation after FEVAR is unknown. METHODS: We evaluated 124 consecutive FEVARs performed under an investigational device exemption clinical trial for juxtarenal aneurysms (ClinicalTrials.gov identifier, NCT01538056). The aortic diameter at the level of the superior mesenteric artery (SMA; highest fenestration) and lowest renal artery (lowest fenestration) was assessed from computed tomography angiography preoperatively, at 30 days, and annually thereafter. A subgroup analysis was performed to assess aortic neck dilation by the graft type used, degree of oversizing, infrarenal neck length, effective seal zone length, and aortic diameter at the level of the lowest and highest fenestration. Multivariable analysis was then performed to evaluate for predictors of aortic neck dilation. RESULTS: Of the 124 patients, 56 had complete anatomic detail and follow-up data available for ≥3 years. Those without preoperative or follow-up data available were excluded. The aortic diameter had increased significantly by 3 years at the level of both the SMA (2.4 mm; P < .01) and the lowest renal artery (3.2 mm; P < .01). When those with and without aortic dilation (>3 mm) were compared, only oversizing differed at the level of the SMA (14% vs 19%; P < .01). At the level of the lowest renal artery, the graft diameter differed (30 mm vs 28 mm; P = .02). However, after adjusted analysis, these differences were not significant. Finally, a subgroup analysis was performed to evaluate aortic dilation over time stratified by anatomic factors and should that aortic dilation occurred across differing aneurysm diameters, percentage of oversizing, graft types, and seal zone lengths. CONCLUSIONS: Aortic neck dilation in the visceral segment can occur after endovascular repair of juxtarenal aneurysms using FEVAR. Further research is warranted to determine how these changes might affect the long-term outcomes.

Initial experience with the Terumo aortic Treo device for fenestrated endovascular aneurysm repair.

OBJECTIVE: The Terumo aortic (TA) Treo device (Terumo, Somerset, NJ) is an endograft with unique features that lends itself to fenestrated endovascular aneurysm repair (FEVAR), including a low device profile, a wide amplitude stent design, and an increased interstent distance. We have described our initial experience with the Treo device for FEVAR to treat short neck and juxtarenal abdominal aortic aneurysms. METHODS: As part of an ongoing physician-sponsored investigational device exemption clinical trial (ClinicalTrials.gov identifier, NCT01538056), subjects were prospectively enrolled and underwent elective FEVAR using a variety of devices. Demographic and procedural details were collected. The data from subjects treated specifically with the Treo device from November 3, 2016 to May 2, 2019 were collected and analyzed. RESULTS: Of a cohort of 161 patients who had undergone elective FEVAR, 46 had been treated with the TA Treo device. Most patients were men (70%), with a mean age of 75 years and high rates of hypertension (74%), hyperlipidemia (83%), coronary artery disease (33%), and chronic obstructive pulmonary disease (33%). The mean aneurysm size was 66 mm, the mean preoperative infrarenal neck length was 5 mm, and the mean final seal zone length was 45 mm. The average hospital and intensive care unit lengths of stay were 2.4 and 1.5 days, respectively. A total of 129 fenestrations were created for 44 superior mesenteric and 85 renal arteries (2.8 fenestrations per patient). Technical success, defined as successful implantation of the device with all target vessels preserved, was 98% (45 of 46), with only one renal artery not successfully preserved. The mean follow-up period was 598 days. During the study period, 18 endoleaks were detected (17 type II and 1 type III), with one patient with a type III endoleak requiring reintervention. Three subjects had died within 30 days, one of intracranial hemorrhage, one of respiratory failure, and one of ischemic colitis. The graft modification times for the TA Treo were significantly shorter (43 minutes) than those for other commercially available devices (Cook Zenith, 55 minutes; Medtronic Endurant, 54 minutes; P < .0001). CONCLUSIONS: Our institution has reported exclusive worldwide experience using the TA Treo device for FEVAR. This device provides for a highly efficient and technically successful procedure for most patients. The procedural and fluoroscopy times were low even in the setting of high complexity. The technical success rates and simplification of the FEVAR procedure have made this approach a preferred technique for most patients at our institution.

Outcomes of femoral artery ligation for treatment of infected femoral pseudoaneurysms due to drug injection.

OBJECTIVE: Infected femoral artery pseudoaneurysms (IFAPs) are a known complication of illicit intravenous drug injection. As the opioid crisis in our country continues to worsen, we will likely see more IFAPs and algorithms for management of these patients will need to be elucidated. The aim of this study was to describe the surgical management and outcomes of patients presenting with IFAPs treated with femoral artery ligation. METHODS: This is a single-center, retrospective study of consecutive patients presenting to our institution with IFAPs associated with illicit drug injection between 2004 and 2017 and treated with primary ligation. Primary end points included major adverse limb events (MALE) and death. Baseline demographics, clinical features, and long-term outcomes were recorded. RESULTS: Over the study period, 60 IFAPs were managed with arterial ligation in 58 patients. Fifty-two percent of patients underwent common femoral artery ligation, 30% of patients underwent a triple ligation (ligation of the common femoral artery, profunda femoris artery, and superficial femoral artery), and 18% of patients underwent ligation of the superficial femoral artery only. The average postoperative ankle-brachial index was 0.47. None of the patients underwent revascularization at the index procedure. In our early experience, four patients (6.6%) underwent delayed revascularization with a prosthetic bypass. Two of the patients subsequently re-presented with infected bypass grafts and required the only major amputations in our series. The mean follow-up was 51.3 months and four patients were lost to follow-up. No differences were identified in MALE between patients undergoing a femoral artery ligation vs a triple ligation. Nine patients (15%) died during the follow-up period and all deaths were unrelated to IFAP treatment; the mean survival from procedure to death was 28 months. CONCLUSIONS: We describe the largest series in the United States of IFAP related to illicit drug use treated with femoral artery ligation and found it is a safe procedure associated with low MALE. Reconstruction is not recommended and is associated with graft infection. Although the mortality rate in these patients was high, it was not related to the ligation procedure.

Preoperative risk score accuracy confirmed in a modern ruptured abdominal aortic aneurysm experience.

OBJECTIVE: Various risk score calculators used to predict 30-day mortality after treatment of ruptured abdominal aortic aneurysms (rAAAs) have produced mixed results regarding their usefulness and reproducibility. We prospectively validated the accuracy of our preoperative scoring system in a modern cohort of patients with rAAAs. METHODS: A retrospective review of all patients wiith rAAAs who had presented to a single academic center from January 2002 to December 2018 was performed. The patients were divided into three cohorts according to when the institutional practice changes had occurred: the pre-endovascular aneurysm repair (EVAR) era (January 2002 to July 2007), the pre-Harbor View risk score era (August 2007 to October 2013), and the modern era (November 2013 to December 2018). The primary outcome measure was 30-day mortality. Our preoperative risk score assigns 1 point for each of the following: age >76 years, pH <7.2, creatinine >2 mg/dL, and any episode of hypotension (systolic blood pressure <70 mm Hg). The previously reported mortality from a retrospective analysis of the first two cohorts was 22% for 1 point, 69% for 2 points, 78% for 3 points, and 100% for 4 points. The goal of the present study was to prospectively validate the Harborview scoring system in the modern era. RESULTS: During the 17-year study period, 417 patients with rAAAs were treated at our institution. Of the 118 patients treated in the modern era, 45 (38.1%) had undergone open aneurysm repair (OAR), 61 (51.7%) had undergone EVAR, and 12 (10.2%) had received comfort measures only. Excluding the 12 patients without aneurysm repair, we found a statistically significant linear trend between the preoperative risk score and subsequent 30-day mortality for all patients combined (P < .0001), for OAR patients alone (P = .0003), and for EVAR patients alone (P < .0001). After adjustment for the Harborview risk score, the 30-day mortality was 41.3% vs 31.6% after OAR vs EVAR, respectively (P = .2). For all repairs, the 30-day mortality was 14.6% for a score of 0, 35.7% for a score of 1, 68.4% for a score of 2, and 100% for a score of 3 or 4. CONCLUSIONS: Our results, representing one of the largest modern series of rAAAs treated at a single institution, have confirmed the accuracy of a simple 4-point preoperative risk score in predicting 30-day mortality in the modern rAAA patient. Such tools should be used when discussing the treatment options with referring physicians, patients, and their family members to help guide transfer and treatment decision-making.

Intraoperative consultation of vascular surgeons is increasing at a major American trauma center.

OBJECTIVE: Vascular surgeons are often called to aid other surgical specialties for complex exposure, hemorrhage control, or revascularization. The evolving role of the vascular surgeon in the management of intraoperative emergencies involving trauma patients remains undefined. The primary aims of this study included determining the prevalence of intraoperative vascular consultation in trauma, describing how these interactions have changed over time, and characterizing the outcomes achieved by vascular surgeons in these settings. We hypothesized that growing endovascular capabilities of vascular surgeons have resulted in an increased involvement of vascular surgery faculty in the management of the trauma patient over time. METHODS: A retrospective review of all operative cases at a single level I trauma center where a vascular surgeon was involved, but not listed as the primary surgeon, between 2002 and 2017 was performed. Cases were abstracted using Horizon Surgical Manager, a documentation system used in our operating room to track staff present, the type of case, and use. All elective cases were excluded. RESULTS: Of the 256 patients initially identified, 22 were excluded owing to the elective or joint nature of the procedure, leaving 234 emergent operative vascular consultations. Over the 15-year study period, a 529% increase in the number of vascular surgery consultations was seen, with 65% (n = 152) being intraoperative consultations requiring an immediate response. Trauma surgery (n = 103 [44%]) and orthopedic surgery (n = 94 [40%]) were the most common consulting specialties, with both demonstrating a trend of increasing consultations over time (general surgery, 1400%; orthopedic surgery, 220%). Indications for consultation were extremity malperfusion, hemorrhage, and concern for arterial injury. The average operative time for the vascular component of the procedures was 2.4 hours. Of patients presenting with ischemia, revascularization was successful in 94% (n = 116). Hemorrhage was controlled in 99% (n = 122). In-hospital mortality was relatively low at 7% (n = 17). Overall, despite the increase in intraoperative vascular consultations over time, a concomitant increase in the proportion of procedures done using endovascular techniques was not seen. CONCLUSIONS: Vascular surgeons are essential team members at a level I trauma center. Vascular consultation in this setting is often unplanned and often requires immediate intervention. The number of intraoperative vascular consultations is increasing and cannot be attributed solely to an increase in endovascular hemorrhage control, and instead may reflect the declining experience of trauma surgeons with vascular trauma. When consulted, vascular surgeons are effective in quickly gaining control of the situation to provide exposure, hemorrhage control, or revascularization.

The Impact of a Limb Preservation Service on the Incidence of Major Amputations for All Indications at a Level I Trauma Center.

BACKGROUND: Multidisciplinary limb preservation services (LPS) have improved the care of patients with limb-threatening vascular disease. However, the impact of an LPS on major amputations for nonvascular etiologies is unknown. We sought to characterize the trends in major amputations performed at a level I trauma center following the institution of an LPS. METHODS: A retrospective review of all patients undergoing amputation at a level I trauma center from January 2009 to December 2018 was performed. Patients were divided into 2 cohorts: those undergoing amputation pre-LPS (2009-2013) and post-LPS (2014-2018). Major amputations were defined as any amputation at or proximal to the below-knee level. Indications for amputation included chronic limb-threatening ischemia (CLTI), acute limb ischemia (ALI), trauma, infection, and revision amputations. RESULTS: During the study period, 609 major amputations were performed, 490 pre-LPS and 119 post-LPS, representing a 76% reduction. Reductions were seen for every indication, including trauma (95%), ALI (90%), chronic infection (83%), revision (79%), CLTI (68%), and acute infection (62%). CONCLUSIONS: Although previous work has validated the role of an LPS in advanced vascular disease, its value extends beyond vascular disease alone. The drastic reductions seen in the number of amputations performed for a variety of indications, including trauma and diabetic foot infections, further validate the use of a multidisciplinary LPS.