A previously published review focused on generic and disease-specific patient-reported outcome measures (PROMs) relevant to vascular surgery but limited to arterial conditions. The objective of this project was to identify all available PROMs relevant to diseases treated by vascular surgeons and to evaluate vascular surgeon perceptions, barriers to widespread implementation, and concerns regarding PROMs. We provide an overview of what a PROM is and how they are developed, and summarize currently available PROMs specific to vascular surgeons. We also report results from a survey of 78 Society for Vascular Surgery members serving on committees within the Policy and Advocacy Council addressing the barriers and facilitators to using PROMs in clinical practice. Finally, we report the qualitative results of two focus groups conducted to assess granular perceptions of PROMS and preparedness of vascular surgeons for widespread implementation of PROMs. These focus groups identified a lack of awareness of existing PROMs, knowledge of how PROMs are developed and validated, and clarity around how PROMs should be used by the clinician as main subthemes for barriers to PROM implementation in clinical practice.

The U.S. healthcare system is undergoing a broad transformation from the traditional fee-for-service model to value-based payments. The changes introduced by the Medicare Quality Payment Program, including the establishment of Alternative Payment Models, ensure that the practice of vascular surgery is likely to face significant reimbursement changes as payments transition to favor these models. The Society for Vascular Surgery Alternative Payment Model taskforce was formed to explore the opportunities to develop a physician-focused payment model that will allow vascular surgeons to continue to deliver the complex care required for peripheral arterial disease (PAD).

Multiple vascular anomalies may be encountered in patients with nutcracker syndrome; further compounding the surgical complexity in managing this condition. A 28-year-old male presented with persistent flank pain and hematuria. Imaging revealed narrowing of the left renal vein at the aortomesenteric junction, and a dilated vein consistent with the left gonadal vein. On surgical exploration, a duplicated IVC was found. The patient underwent a right caval-to-left caval bypass using a cryopreserved femoral vein homograft. The surgery was well tolerated and completely resolved the patient's symptoms.

Patients with coronavirus disease 2019 (COVID-19) seem to be at high risk for venous thromboembolism (VTE) development, but there is a paucity of data exploring both the natural history of COVID-19–associated VTE and the risk for poor outcomes after VTE development. This investigation aims to explore the relationship between COVID-19–associated VTE development and mortality. A prospectively maintained registry of patients older than 18 years admitted for COVID-19–related illnesses within an academic health care network between March and September 2020 was reviewed. Codes from the tenth revision of the International Classification of Diseases for VTE were collected. The charts of those patients with a code for VTE were manually reviewed to confirm VTE diagnosis. There were 2,552 patients admitted with COVID-19–related illnesses. One hundred and twenty-six patients (4.9%) developed a VTE. A disproportionate percentage of patients of Black race developed a VTE (70.9% VTE v 57.8% non-VTE; P = .012). A higher proportion of patients with VTE expired during their index hospitalization (22.8% VTE v 8.4% non-VTE; P < .001). On multivariable logistic regression analysis, VTE was independently associated with mortality (odds ratio = 3.17; 95% confidence interval, 1.9–5.2; P < .001). Hispanic/Latinx ethnicity was associated with decreased mortality (odds ratio = 0.45; 95% confidence interval, 0.21–1.00; P = .049). Hospitalized patients of Black race with COVID-19 were more prone to VTE development, and patients with COVID-19 who developed in-hospital VTE had roughly nearly threefold higher odds of mortality. Further emphasis should be placed on optimizing COVID-19 anticoagulation protocols to reduce mortality in this high-risk cohort.

Objective The external carotid artery (ECA) can be an important source of cerebral blood flow in cases of high-grade internal carotid artery stenosis or occlusion. However, the treatment of the ECA is fundamentally different between carotid endarterectomy (CEA) and carotid artery stenting (CAS). CEA is routinely associated with endarterectomy of the ECA, whereas CAS excludes the ECA from direct flow. We hypothesize that these differences make ECA occlusion more common after CAS. Further, the impact of CAS on blood flow into the ECA is interesting because the flow from the stent into the ECA is altered in a way that may promote local inflammation and may influence in-stent restenosis (ISR). Thus, our objective was to use our institutional database to identify whether CAS increased the rate of ECA occlusion and, if it did, whether ECA occlusion was associated with ISR. Methods Patients undergoing CAS or CEA from February 2007 to February 2012 were identified from our institutional carotid therapy database. Preoperative and postoperative images of patients who followed up in our institution were included in the analysis of ECA occlusion and rates of ISR. Results There were 210 (67%) CAS patients and 207 (60%) CEA patients included in this analysis. Despite CAS patients being younger (68 vs 70 years), having shorter follow-up (12.5 vs 56.2 months), and being more likely to take clopidogrel (97% vs 35%), they had an increased rate of ECA occlusion (3.8%) compared with CEA patients (0.4%). CAS patients who went on to ECA occlusion had an increased incidence of prior neck irradiation (50% vs 15%; P =.03), but we did not identify an association of ECA occlusion with ISR > 50%. Conclusions Whereas prior publications have identified increased rates of external carotid stenosis, this is the first demonstration of increased ECA occlusion after CAS. However, ECA occlusion is uncommon (∼4%) and did not have an association with ISR > 50%. Future work modeling ECA flow patterns before and after CAS will be used to further test this interaction.

Objective Over the past decade, thoracic endovascular aortic repair (TEVAR) has increased as a treatment option for a variety of aortic pathologies. Despite this rise in the use of thoracic stent grafts, real-world outcomes from a robust, adjudicated, contemporary dataset have yet to be reported. Previous studies have shown peri-procedural mortality rates between 1.5%-9.5% and procedure-related stroke rates of 2.3%-8.2%. With advances in device engineering and increased physician experience, we hypothesized that the rates of these complications would be reduced in a more recent sample set. The purpose of this study was to determine current rates of mortality and stroke after TEVAR, identify risk factors that contribute to thirty-day mortality, and develop a simple scoring system that allows for risk stratification of patients undergoing TEVAR. Methods We examined the 30-day mortality rate following TEVAR using the 2013-2014 American College of Surgeons National Surgical Quality Improvement Program database. Patients undergoing TEVAR for all aortic pathology were identified using procedure codes. Bivariate analyses were performed to evaluate the association of pre-, intra- and post-operative variables with 30-day mortality, followed by multivariable logistic analysis using pre-operative variables only, with P<.10 as criteria for model entry. The predictive logistic model was internally validated by cross validation. Variables included in the multivariable model were used to develop a risk score. Results Eight hundred twenty-six patients were included. The thirty-day mortality and stroke rate were 7.63% (n=63) and 4.5% (n= 37), respectively. In regression analysis, mortality was independently associated with age ≥80 years (odds ratio [OR] 2.32, 95% confidence interval [CI] 1.25-4.31), emergency case (OR 2.61, 95% CI 1.39-4.90), ASA classification >3 (OR 2.89, 95% CI 1.34-6.24), transfusion >4 units in the 72 hours prior to surgery (OR 2.86, 95% CI 1.30-6.28), pre-operative creatinine ≥1.8 mg/dL (OR 2.07, 95% CI 1.05-4.08), and pre-operative white blood cell count ≥12 × 109/L (OR 2.65, 95% CI 1.41-4.96). Incorporating these factors, a six-point risk score was generated and demonstrated high predictability for overall thirty-day mortality. Conclusions Recent data from a national, retrospective dataset demonstrate that high perioperative mortality and stroke rates have persisted over the last decade. The risk score derived from this dataset is simple and convenient and serves as a prognostic tool in the pre-operative risk stratification of patients being evaluated for thoracic endovascular aortic repair.

Background: Abdominal aortic aneurysm (AAA) rupture is an adverse arterial remodeling event with high mortality risk. Since females have increased rupture risk with smaller AAAs (<5.5 cm), many recommend elective repair prior to 5.5 cm. Elective repair improves survival for large AAAs, but long-term benefits of endovascular aneurysm repair (EVAR) for small AAAs in females remains less understood. The objective of this study is to identify if differences in late mortality exist between females undergoing elective EVAR at our institution for small/slow-growing AAAs compared to those who meet standard criteria. Methods: We retrospectively analyzed all patients that underwent EVAR for infrarenal AAA from 6/2009–6/2013. We excluded patients that were male, treated emergently or for iliac artery aneurysm, and that received renal/mesenteric artery stenting. Patients did not meet anatomic criteria if preoperative AAA diameter was <5.5 cm or enlarged <0.5 cm over 6 months. Late mortality was assessed from the Social Security Death Index. Results: 36/162 (22.2%) elective EVAR patients were female (mean follow-up 37.2 months). 20 (55.6%) patients met AAA size/growth criteria while 16 (44.4%) did not meet criteria. Despite comparable demographics, comorbidities, and complications, patients that did not meet criteria had higher late mortality (37.5% vs. 5%; P= .03) with a trend towards increased reoperation rate (25% vs. 5%; P= .48). Meeting size/growth criteria decreased odds of late death (OR .09; 95% CI 0.01–0.83). Conclusion: There is increased late mortality in females receiving elective EVAR at our institution for small/slow-growing AAAs. This late mortality may limit the benefits of EVAR for this population.

Background: Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. Methods: We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up. Conclusion: GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.

Objective: Controversy exists about the optimal treatment of acute uncomplicated type B aortic dissection (auTBAD). Optimal medical therapy (OMT) provides excellent short-term outcomes, but long-term results are poor. Ideally, auTBAD patients who will fail to respond to OMT in the chronic phase could be identified and undergo thoracic endovascular aortic repair. The purpose of this study was to identify radiographic predictors of auTBAD patients who will fail to respond to OMT. Methods: A review of the Emory aortic database from 2000 to 2017 identified 320 auTBAD patients initially treated with OMT. From this cohort, 121 patients with two or more contrast-enhanced imaging scans were available for analysis. These patients were initially divided into groups based on growth of the thoracic aorta ≥10 mm or intervention due to aneurysmal growth: growth (n = 72) and no growth (n = 49). TeraRecon (Foster City, Calif) imaging software was used to analyze characteristics of the primary intimal tear (PIT), false lumen, and overall aortic size. Finally, Cox proportional hazards models were constructed to estimate hazard ratios and to identify predictors of OMT failure. Results: The mean age of all patients was 54 ± 11 years, and 67% were male. Thirty-eight patients (53%) in the growth group underwent intervention. There were no differences between groups in age, hypertension, diabetes mellitus, tobacco abuse, or chronic obstructive pulmonary disease. The distance of the PIT from the left subclavian artery in patients with auTBAD was significantly shorter in the growth group (growth, 27 mm [9-66 mm]; no growth, 77 mm [26-142 mm]; P <.01). Multivariable Cox regression analysis identified the distance of the PIT from the left subclavian artery and a thoracic aortic diameter >45 mm as independent predictors of failure of OMT. Partial false lumen thrombosis was not a predictor of aortic growth. Conclusions: The distance of the PIT from the left subclavian artery is a predictor of aortic growth in auTBAD. Patients with a primary tear located in zone 3 of the proximal descending thoracic aorta should be monitored closely and may be considered for early thoracic endovascular aortic repair in the setting of auTBAD.

Objective—Diabetes mellitus (DM) and peripheral arterial disease (PAD) are independently associated with increased risk of amputation. However, the effect of poor glycemic control on adverse limb events has not been studied. We examined the effects of poor glycemic control (high hemoglobin A1c) on the risk of amputation and modified major adverse limb events (mMALE) after lower extremity revascularization. Methods—Patients undergoing PAD revascularization who had HbA1c levels available within 6 months were identified in the VA database 2003– 2014 (N=26799). The diagnosis of preoperative DM (PreopDM) was defined using DM diagnosis codes and evidence of treatment. Amputation and modified MALE (mMALE) risk was compared for HbA1c levels using Kaplan Meier analysis. Cox proportional hazards models were created to assess the effect of high HbA1c on amputation/mMALE (adjusted for age, gender, race, SES, comorbidities, cholesterol levels, creatinine, supra/infrainguinal procedure, open/endovascular procedure, severity of PAD, year of cohort entry and medications) for all patients and stratified on PreopDM. Results—High HbA1c levels were present in 33.2% of the cohort while 59.9% had PreopDM. Amputations occurred in 4,359 (16.3%) patients and 10,580 (39.5%) had mMALE. Kaplan Meier curves showed worst outcomes in patient with PreopDM and high HbA1c. In the Cox model, incremental HbA1c levels of 6.1–7.0%, 7.1–8.0% and >8% were associated with 26% (HR 1.26, 95% CI 1.15– 1.39), 53% (HR 1.53, 95%CI 1.37–1.7) and 105% (HR 2.05, 95% CI 1.87–2.26) higher risk of amputation respectively. Similarly, the risk of mMALE also increased by 5% (HR 1.05, 95%CI 0.99–1.11), 21% (HR 1.21, 95%CI 1.13–1.29) and 33% (HR 1.33, 95%CI 1.25–1.42) with worsening HbA1c levels of 6.1–7.0%, 7.1–8.0% and >8% respectively (versus HbA1c ≤6.0%). In stratified analysis by established by PreopDM, the relative risk of amputation/mMALE was much higher with poor glycemic control (HbA1c >7.0%) in patients without PreopDM. Conclusion—PAD patients with worse perioperative glycemic control have a significantly higher risk of amputation and mMALE. Incremental increases in HbA1c levels are associated with higher hazards of adverse limb outcomes independent of PreopDM status. Poor glycemic control (HbA1c> 7.0%) in patients without a preoperative diagnosis of DM carries twice the relative risk of amputation and mMALE than those with good glycemic control. These results suggest that screening of diabetic status and better management of glycemic control could be a target for improvement of perioperative and long term outcomes in PAD patients.