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Obstruction involving the iliac veins and/or inferior vena cava is highly co-morbid in patients with chronic venous leg ulcers and is a barrier to healing. Intervention with venous stenting is recommended to promote wound healing, however, there is limited data to quantify the effects of venous outflow restoration on wound healing. We retrospectively identified patients with venous ulcers and co-morbid venous outflow obstruction. Data regarding demographics, wound size, degree of obstruction, interventions, wound healing, and recurrence were collected. Intervention was performed when possible and patients were grouped based on whether or not the venous outflow was reopened successfully and maintained for at least one year. Outcomes including time to wound healing, wound recurrence, stent patency, and ulcer free time were measured. Patients who maintained a patent venous outflow tract experienced higher rates of wound healing (79.3%) compared to those with persistent outflow obstruction (22.6%) at 12 months (p0.001). Ulcer free time for the first year was also greater with patent venous outflow (7.6 4.4 months versus 1.8 3.0 months, P0.0025). Patients with severe obstruction of the venous outflow tract experience poor healing of VLUs despite appropriate wound care. Healing time is improved and ulcer free time increased after venous intervention with stenting to eliminate obstruction This article is protected by copyright. All rights reserved.

Venous thromboembolism (VTE) is a well-known post-surgical complication, however the incidence of VTE after peripheral vascular intervention (PVI) is not well described. Despite the minimally invasive nature of these procedures, patients undergoing PVI harbor significant risk factors for the development of VTE. In this study, our objective was to describe the short-term incidence of VTE status post PVI, identify differences in sex, and examine peri-procedural antiplatelet and anticoagulation regimens.We identified adults (age66) who underwent PVI between January 1, 2008-September 30, 2015, in inpatient Medicare claims data. Patients were followed 365 days from the date of procedure. VTE events during follow-up were identified using ICD-9 diagnosis codes. Covariate-standardized 30- and 90-day cumulative incidence of VTE events, overall and by sex, were estimated using Aalen-Johansen estimators accounting for death as a competing risk. Differences in sex between females and males were identified using Gray's test. Any antiplatelet or anticoagulant prescription fill was defined as any fill from 14 days prior to the endovascular intervention through the date of the VTE event. Persistence on antiplatelet and anticoagulant therapy was assessed by creating daily logs of antiplatelet and anticoagulant coverage based on dispensing dates and day supply. Over the counter medications, namely aspirin, were not evaluated.We identified 31,593 qualifying patients with a mean age of 76.8 (SD 7.4) years. Forty-six percent were male and 12% had a history of VTE. Post-procedure, DVT was a commonly diagnosed complication: 3.8% and 4.8%, at 30- and 90-days, respectively. Cumulative incidence of pulmonary embolism was 0.9% and 1.2% at 30- and 90-days post procedure, respectively. Throughout the 90-day post procedure period females had a slightly increased risk of DVT compared to males (30-day RD 0.007, p-value0.01; 90-day RD 0.008, p-value 0.02). There was no sex-based difference in risk of pulmonary embolism. Among patients who developed VTE at 90 days, 970 (55%), had no prescription fill for an antiplatelet or anticoagulation. Assuming all patients are taking aspirin, only 15% of patients who developed VTE were taking prescribed dual-antiplatelet medication persistently after PVI. In addition, among patients who developed VTE at 90 days, females were less likely to have a prescription fill for an anticoagulant.Our cohort demonstrates the incidence of VTE after PVI is high, and there is an increased risk of DVT among females. We also found that females were less likely to be prescribed an anticoagulant post procedure. Future studies should aim to characterize variables associated with an increased risk of post-intervention VTE and identify strategies to increase dual antiplatelet therapy or anticoagulant prescription adherence to reduce the risk of this complication.

Gender disparities have been previously reported in aortic aneurysm and critical limb ischemia outcomes; however, limited info is known about disparities in aortoiliac occlusive disease. We sought to characterize potential disparities in this specific population.Patients who underwent aortobifemoral bypass and aortic thromboendarterectomy (Current Procedural Terminology codes 35646 and 35331) between 2012 and 2019 were identified in the National Surgical Quality Improvement Program database. A binomial regression model was used to estimate gender differences in 30-day morbidity and mortality. Inverse probability weighting was used to standardize demographic and surgical characteristics.We identified 1,869 patients, of which 39.8% were female and the median age was 61 years. Age, body composition, and other baseline characteristics were overall similar between genders; however, racial data were missing for 26.1% of patients. Females had a higher prevalence of preexisting chronic obstructive pulmonary disease (20.9% vs. 14.7%, prevalence difference 6.1%, P 0.01), diabetes mellitus (25.4% vs. 19.4%, prevalence difference 6.0%, P 0.01), and high-risk anatomical features (39.4% vs. 33.7%, prevalence difference 5.8%, P = 0.01). Preprocedural medications included a statin in only 68.2% of patients and antiplatelet agent in 76.7% of patients. Females also had a higher incidence of bleeding events when compared to males (25.2% vs. 17.5%, standardized risk difference 7.2%, P 0.01), but were less likely to have a prolonged hospitalization greater than 10 days (18.2% vs. 20.9%, standardized risk difference -5.0%, P = 0.01). The 30-day mortality rate was not significantly different between genders (4.7% vs. 3.6%, standardized risk difference 1.2%, P = 0.25).Female patients treated with aortobifemoral bypass or aortic thromboendarterectomy are more likely to have preexisting chronic obstructive pulmonary disease, diabetes mellitus, and high-risk anatomical features. Regardless of a patient's gender, there is poor adherence to preoperative medical optimization with both statins and antiplatelet agents. Female patients are more likely to have postoperative bleeding complications while males are more likely to have a prolonged hospital stay greater than 10 days. Future work could attempt to further delineate disparities using databases with longer follow-up data and seek to create protocols for reducing these observed disparities.

Peripheral artery disease (PAD) is a common pathology that affects millions worldwide, yet the medical community lacks robust data and in-depth understanding of how PAD specifically impacts female patients. This review describes the epidemiology and riskfactors for PAD, with a focus on how gender may impart differential risks. The nuances in diagnosis, treatment, and outcomes are discussed, with a lens on gender differences. The available data are not robust, and women are underrepresented in trials, so few definitive conclusions can be made. More work must be done to identify the root causes of the many clinical deficits in the diagnosis and treatment of PAD in female patients.

BackgroundPeople undergoing revascularization for symptomatic peripheral artery disease (PAD) have a high incidence of major limb amputation in the year following their surgical procedure. The incidence of limb amputation is particularly high in patients from racial and ethnic minority groups. The purpose of our study was to investigate the role of sub-optimal prescription of preoperative antiplatelets and statins in producing disparities in risk of major amputation following revascularization for symptomatic PAD.MethodsWe used data from adult (≥18 years old) patients in the Vascular Quality Initiative (VQI) registry who underwent a revascularization procedure from 2011-2018. Patients were categorized as non-Hispanic Black, non-Hispanic White, and Hispanic. We estimated the crude probability of a patient being prescribed a preoperative antiplatelet and preoperative statin. We calculated one year risk incidence of amputation by prescription groups and by race/ethnicity. We estimated the amputation risk difference between race/ethnicity groups (the proportion of disparity) that could be eliminated under a hypothetical intervention where a pre-operative antiplatelet and statin was provided to all patients.ResultsAcross 100,579 revascularizations recorded in the Vascular Quality Initiative, a vascular procedure-based registry in the United States and Canada, 1-year risk of amputation was 2.5% (95% CI: 2.4%,2.6%) in White patients, 5.3% (4.9%,5.6%) in Black patients and 5.3% (4.7%,5.9%) in Hispanic patients. Black (57.5%) and Hispanic patients (58.7%) were only slightly less likely than White patients (60.9%) to receive recommended antiplatelet and statin therapy prior to their procedures. However, the effect of antiplatelets and statins was greater in Black and Hispanic patients such that, had all patients received the appropriate guideline recommended medications, the estimated risk difference comparing Black to White patients would have reduced by 8.9% (−2.9%,21.9%) and the risk difference comparing Hispanic to White patients would have been reduced by 17.6% (−0.7%,38.6%).ConclusionsEven though guideline-based care appeared evenly distributed by race/ethnicity, increasing access to such care may still decrease health care disparities in major limb amputation.

Randomized controlled trials (RCTs) are widely considered to provide the highest-quality evidence for the comparative efficacy and safety of competing clinical strategies. The strength of using RCTs for causal inference is derived from random treatment assignment and prospective data collection. Randomization eliminates confounding at the time of treatment group assignment, achieving exchangeability of the baseline study groups, such that they are the same, on average, except for the study intervention. Prospective data collection helps ensure that eligibility assessment, treatment assignment, and the start of follow-up are aligned temporally. Temporal alignment prevents biases that are common in observational research (eg, immortal time bias). In ideal settings, the results of an RCT provide the average causal effect of the intervention on the selected outcomes in the study population. Although observational research can estimate similar causal effects, observational designs require more assumptions and more advanced analytic frameworks than an RCT designed to answer the same question. Emerging trial designs, also discussed here, seek to address certain limitations of traditional RCT designs. The purpose of this review was to provide a broad overview of the central concepts in RCT design, implementation, conduct, and data analysis.

Enhanced recovery programs (ERPs) have gained wide acceptance across multiple surgical disciplines to improve postoperative outcomes and to decrease hospital length of stay (LOS). However, there is limited information in the existing literature for vascular patients. We describe the implementation and early results of an ERP and barriers to its implementation for lower extremity bypass surgery. Our intention is to provide a framework to assist with implementation of similar ERPs.Using the plan, do, check, adjust methodology, a multidisciplinary team was assembled. A database was used to collect information on patient-, procedure-, and ERP-specific metrics. We then retrospectively analyzed patients' demographics and outcomes.During 9 months, an ERP (n = 57) was successfully developed and implemented spanning preoperative, intraoperative, and postoperative phases. ERP and non-ERP patient demographics were statistically similar. Early successes include 97% use of fascia iliaca block and multimodal analgesia administration in 81%. Barriers included only 47% of patients achieving day of surgery mobilization and 19% receiving celecoxib preoperatively. ERP patients had decreased total and postoperative LOS compared with non-ERP patients (n = 190) with a mean (standard deviation) total LOS of 8.32 (8.4) days vs 11.14 (10.1) days (P = .056) and postoperative LOS of 6.12 (6.02) days vs 7.98 (7.52) days (P = .089). There was significant decrease in observed to expected postoperative LOS (1.28 [0.66] vs 1.82 [1.38]; P = .005). Variable and total costs for ERP patients were significantly reduced ($13,208 [$9930] vs $18,777 [$19,118; P .01] and $29,865 [$22,110] vs $40,328 [$37,820; P = .01], respectively).Successful implementation of ERP for lower extremity bypass carries notable challenges but can have a significant impact on practice patterns. Further adjustment of our current protocol is anticipated, but early results are promising. Implementation of a vascular surgery ERP reduced variable and total costs and decreased total and postoperative LOS. We believe this protocol can easily be implemented at other institutions using the pathway outlined.

Valid risk stratification schemes are key to performing comparative effectiveness research; however, for chronic limb-threatening ischemia (CLTI), risk stratification schemes have limited efficacy. Improved, accurate, comprehensive, and reproducible risk stratification models for CLTI are needed.To evaluate the use of topic model cluster analysis to generate an accurate risk prediction model for CLTI.This multicenter, nested cohort study of existing Project of Ex Vivo Vein Graft Engineering via Transfection (PREVENT) III clinical trial data assessed data from patients undergoing infrainguinal vein bypass for the treatment of ischemic rest pain or ischemic tissue loss. Original data were collected from January 1, 2001, to December 31, 2003, and were analyzed in September 2021. All patients had 1 year of follow-up.Supervised topic model cluster analysis was applied to nested cohort data from the PREVENT III randomized clinical trial. Given a fixed number of clusters, the data were used to examine the probability that a patient belonged to each of the clusters and the distribution of the features within each cluster.The primary outcome was 1-year CLTI-free survival, a composite of survival with remission of ischemic rest pain, wound healing, and freedom from major lower-extremity amputation without recurrent CLTI.Of the original 1404 patients, 166 were excluded because of a lack of sufficient feature and/or outcome data, leaving 1238 patients for analysis (mean [SD] age, 68.4 [11.2] years; 800 [64.6%] male; 894 [72.2%] White). The Society for Vascular Surgery Wound, Ischemia, and Foot Infection grade 2 wounds were present in 543 patients (43.8%), with rest pain present in 645 (52.1%). Three distinct clusters were identified within the cohort (130 patients in stage 1, 578 in stage 2, and 530 in stage 3), with 1-year CLTI-free survival rates of 82.3% (107 of 130 patients) for stage 1, 61.1% (353 of 578 patients) for stage 2, and 53.4% (283 of 530 patients) for stage 3. Stratified by stage, 1-year mortality was 10.0% (13 of 130 observed deaths in stage 1) for stage 1, 13.5% (78 of 578 patients) for stage 2, and 20.2% (105 of 521 patients) for stage 3. Similarly, stratifying by stage revealed major limb amputation rates of 4.2% (5 of 119 observed major limb amputations in stage 1) for stage 1, 10.8% (55 of 509 patients) for stage 2, and 18.4% (81 of 440 patients) for stage 3. Among survivors without a major amputation, the rates of CLTI recurrence were 9.2% (11 of 119 observed recurrences in stage 1) for stage 1, 24.9% (130 of 523 patients) for stage 2, and 29.6% (132 of 446 patients) for stage 3.The topic model cluster analysis in this cohort study identified 3 distinct stages within CLTI. Findings suggest that CLTI-free survival is an end point that can be accurately and reproducibly quantified and may be used as a patient-centric outcome.

Objective: Claudication is an early-stage subtype of peripheral artery disease that may result in surgical intervention. The purpose of this study was to compare the types of elective bypass in a population of Black and White patients with claudication and to identify actionable areas that may explain the higher limb amputation rates observed in Black patients. Methods: We identified Black and White patients undergoing elective infrainguinal bypass for claudication using data from the Vascular Quality Initiative registry (2011-2018). Distal bypass target was classified as 1) at or above the popliteal artery (above-knee) or 2) below the popliteal, including all tibial, peroneal, dorsalis pedis and tarsal/plantar arteries (below-knee). Graft conduit was categorized as vein or prosthetic. We calculated one-year risk of major lower limb amputation with 95% confidence intervals (CI) for all combinations of target and conduit, stratified by race. We then forced an intervention on the data to estimate the post-intervention incidence of amputation and the proportion of racial disparity eliminated and 95% CI if everyone received the gold standard treatment (above-knee, vein). Results: We identified 8,401 infrainguinal bypass revascularizations for claudication (12% Black/88% White); 82% were performed above-knee and 44% of those used a vein conduit. The remaining 18% of bypasses were to below-knee arteries, of which 78% used a vein conduit. The remaining 1,534 (18.3%) bypasses were to below-knee arteries, including 1,197 (78.4%) using vein and 330 (21.6%) using prosthetic material. One-year incidence of major limb amputation was 1.6% (1.3%,1.9%) among all grafts, 1.2% (1.0%,1.5%) in above-knee grafts, and 3.3% (2.4%,4.2%) in below-knee grafts. Black patients had higher incidence of amputation across bypass target/conduit groups compared to White patients; the difference was greatest for below-knee revascularizations (8.9%, 95% CI: 4.8%,12.3% v 2.1%, 95% CI: 0.9%,2.9%). Pre-intervention amputation incidence was 1.3% (1.0%,1.5%) in White patients and 3.6% (1.9%,5.2%) in Black patients. Overall amputation incidence decreased significantly after our gold standard intervention was applied for both White (1.0%; 0.7%,1.2%) and Black (2.0%; 0.7%,3.2%) patients. The risk difference (i.e. the disparity gap) between Black and White patients was lessened post-intervention by 56.8% (31.9%,116.3%). Conclusions: We observed risk of amputation higher than would be expected based on other studies of the natural history of claudication without bypass surgery; future work should identify the mechanisms that alter the natural history of claudication via open bypass surgery. Interventions below-knee or using a prosthetic graft were particularly harmful and their harm was concentrated in Black patients.

Objective: Peripheral artery disease (PAD) is a common atherosclerotic disorder that reduces blood flow to the lower extremities. There are significant racial disparities in the outcomes of patients with PAD. Ideally, understanding the result of inadequate implementation of proven interventions on health disparities might provoke a policy and culture shift in the provision of care for minoritized persons. We demonstrate a method that leverages knowledge of interventions that we know should be implemented to optimize care for people with PAD, to identify the extent to which disparities might be mitigated by more universal uptake of those interventions. Methods: We compare racial disparities as they exist currently with disparities that would exist under complete uptake of interventions to improve PAD and vascular care. This counterfactual world is modeled by upweighting people who received the proposed interventions to represent the study population at the start of follow-up. It relies on the assumption that we have measured (and adjusted for) all confounders of the intervention (a hypothesized mediator of the observed health disparities) and the outcome. A unique feature of the application of this method to this problem is our ability to demonstrate how, even when guideline-based care appears evenly distributed by race/ethnicity, increasing access to such care may still decrease health disparities. This method was previously proposed for estimating potential reductions in racial disparities for people with HIV. Results: Across 100,579 infrainguinal revascularizations among Black (n=15,442), Hispanic (n=5,506) and White (n=67,651) patients treated for symptomatic PAD, Black (56.5%) and Hispanic patients (57.6%) were slightly less likely than White patients (59.8%) to receive Class I recommended aspirin and statin therapy prior to their procedures. One-year risk of amputation was 2.7% (95% CI: 2.6%,2.8%) in White patients, 5.8% (5.4%,6.2%) in Black patients and 5.6% (5.0%,6.2%) in Hispanic patients. Had all patients received the appropriate anti-ischemic medications, amputation risk would have been lower across all three race-ethnicity groups. However, specifically, the risk difference (RD) for Black vs White patients would have reduced by 8% (-3%,20%) and the RD for Hispanic vs White patients would have reduced by 18% (-1%,36%). Conclusions: Not only is provision of aspirin and statin for infrainguinal revascularization good for all PAD patients, it is also a social justice imperative.

BACKGROUND: The traditionally reported outcomes for patients with ischemic wounds have centered on amputation-free survival. However, that discounts the importance of other patient-centered outcomes such as the wound healing time (WHT) and wound-free period (WFP). We evaluated the long-term wound outcomes of patients treated for chronic limb-threatening ischemia at our institution. METHODS: From 2014 to 2017, we identified all patients with chronic limb-threatening ischemia and ischemic wounds using symptomatic and hemodynamic criteria. The primary data included the wound size, wound location, WIfI (wound, ischemia, foot infection) grade, WHT, WFP, minor and major amputation, and death. Wounds were not considered healed if the patient had required a major amputation or had died before wound healing. The WHT was calculated as the interval in days between the diagnosis and determination of a healed wound. The WFP was calculated as the interval in days between a healed wound and wound recurrence, major amputation, death, or the end of the study period. A comparison of the wound healing parameters stratified by revascularization status was performed using the Student t test. A generalized linear model adjusted for age, sex, initial wound size, and WIfI grade was used to evaluate the risk of wound healing with and without revascularization. RESULTS: A total of 256 patients had presented with 372 wounds. Of the 256 patients, 48% had undergone revascularization. During the study period, 97 minor amputations and 100 major amputations had been required, and 132 patients had died. The average wound size was 13.9 ± 52.0 cm(2); however, for the 155 wounds that had healed, the average size was only 4.0 ± 9.6 cm(2) (P = .002). No differences were found in the wound size when stratified by revascularization status (P = .727). Adjusted for the initial wound size, the risk of wound healing was not different when stratified by revascularization (risk ratio, 1.22; 95% confidence interval, 0.80–1.87; P = .354). For those whose wounds had healed, the average WHT and WFP were 173 ± 169 days and 775 ± 317 days, respectively. The WHT was not faster for the revascularized group (155 days vs 188 days; P = .221). When stratified by revascularization status, the rate of wound recurrence was 4.6 vs 8.9 wounds per 100 person-years for the revascularized and nonrevascularized groups, respectively (P = .125). CONCLUSIONS: In our study, we found that, except for patients who presented with severe ischemia, revascularization was not associated with improved rates of wound healing. Among the wounds that healed, regardless of the initial ischemia grade, revascularization was not associated with a faster WHT or longer WFPs.

Background Enhanced Recovery After Surgery (ERAS) pathways improve healthcare quality, safety, and cost-effectiveness. We hypothesized that the RAND Method (a hybrid Delphi approach), involving anonymous sequential surveys and face-to-face meetings, would allow for more rapid agreement and initiation of new ERAS pathways. Methods Using the ERAS Society guidelines for cesarean section as a baseline, our institution’s ERAS Leadership Team (ELT) compiled published literature and institutional practices to design a 32-component survey that was sent to obstetricians, nurse midwives, anesthesiologists, pharmacists, and nurses. Components that did not reach 90% consensus were included in a second survey the following week, and meetings were held to review results. At the conclusion of this process, time to agreement was retrospectively compared to the colorectal ERAS pathway process at this institution. Results ERAS pathway components were compiled and reviewed by 121 stakeholders at 7 hospitals using iterative surveys with review meetings over a 13-week period. Survey response rates were 61% and 50% in the initial and follow-up surveys, respectively. There was agreement on 28/32 and 32/32 items on the initial and follow-up surveys. Using the RAND Method, time to agreement decreased by 54.1% (24 vs 13 weeks) compared to prior system-wide efforts to standardize the colorectal surgery ERAS pathway. Discussion With rapidly expanding healthcare systems, effective methods to gain consensus and adopt ERAS pathways are critical to implementation of ERAS guidelines. We demonstrate that the RAND Method allows for a transparent and efficient means of agreement across a diverse group of clinicians practicing in several settings.

Background Racial and ethnic disparities in outcomes following lower limb revascularization for peripheral artery disease have been ascribed to disease severity at presentation for surgery. Methods and Results We calculated 1‐year risk of major adverse limb events (MALEs), major amputation, and death for patients undergoing elective revascularization for claudication or chronic limb‐threatening ischemia in the Vascular Quality Initiative data (2011–2018). We report hazard ratios according to race and ethnicity using Cox (death) or Fine and Gray subdistribution hazards models (MALE and major amputation, treating death as a competing event), adjusted for patient, treatment, and anatomic factors associated with disease severity. Among 88 599 patients (age, 69 years; 37% women), 1‐year risk of MALE (major amputation and death) was 12.8% (95% CI, 12.5–13.0) in 67 651 White patients, 16.5% (95% CI, 5.8–7.8) in 15 442 Black patients, and 17.2% (95% CI, 5.6–6.9) in 5506 Hispanic patients. Compared with White patients, we observed an increased hazard of poor limb outcomes among Black (MALE: 1.17; 95% CI, 1.12–1.22; amputation: 1.52; 95% CI, 1.39–1.65) and Hispanic (MALE: 1.22; 95% CI, 1.14–1.31; amputation: 1.45; 95% CI, 1.28–1.64) patients. However, Black and Hispanic patients had a hazard of death of 0.85 (95% CI, 0.79–0.91) and 0.71 (95% CI, 0.63–0.79) times the hazard among White patients, respectively. Worse limb outcomes were observed among Black and Hispanic patients across subcohorts of claudication and chronic limb‐threatening ischemia. Conclusions Black and Hispanic patients undergoing infrainguinal revascularization for chronic limb‐threatening ischemia and claudication had worse limb outcomes compared with White patients, even with similar disease severity at presentation. Additional investigation aimed at eliminating disparate limb outcomes is needed.

Although the publication of randomized clinical trials defining the benefit of carotid endarterectomy (CEA) for asymptomatic carotid stenosis, medical management of carotid stenosis has changed significantly. With antiplatelet agents and statins, some question whether these trials are still relevant, suggesting that asymptomatic patients with70% internal carotid artery (ICA) stenosis may do better with medial management alone, lessening the need for CEA and carotid stenting. The Vascular Quality Initiative (VQI) registry has shown that there are wide practice variations regarding the degree of stenosis that prompts surgical intervention but there are few reports of outcomes in patients who do not undergo intervention. We sought to determine the clinical outcomes of the70% carotid stenosis patients who are treated with medical management alone at our institution.We identified all patients with ICA stenosis70% based on hemodynamic consensus criteria (peak systolic velocity230 cm/s) in our peripheral vascular laboratory from January 2013 through December 2016. With a retrospective chart review, demographics, comorbid conditions, medications, radiographic studies, clinical follow-up, interventions, and outcomes at 2 years were included. Descriptive statistics were used to define these variables.One hundred and seventy three patients were identified with medically managed asymptomatic70% ICA stenosis based on hemodynamic criteria on duplex ultrasound. The mean age was 67.5 years, 49% were male, 64% were White, 14% were Black, 13% race was undisclosed, 89% were prescribed antiplatelet therapy, 85% were prescribed a statin, and 60% had hypertension controlled to140/90. Twenty patients (11.5%) experienced a cerebrovascular event during the 2-year study period. There were eight patients with transient ischemic attack, 10 with ipsilateral strokes, and 2 with strokes in unrelated territories.Despite good adherence to current recommendations for medical therapy, patients at our institution are developing symptomatic carotid disease at a rate similar to that reported in historical clinical trials. These data supports the concept that advances in medical management have not resulted in reduced stroke rates in asymptomatic patients with high-grade carotid stenosis at a large academic institution located in the southeastern United States. CEA and stenting provide a significant risk reduction and should be considered more often in this patient population.

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

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

Dilation throughout the brachial artery in the setting of an arteriovenous fistula is a common occurrence, but focal aneurysmal dilation is not often visualized. Progressive enlargement of a focal arterial segment warrants intervention before negative sequelae. We present the case of a 38-year-old man with history of left upper extremity brachiocephalic fistula who had an enlarged brachial artery and progressive aneurysmal dilation of the distal aspect after ligation and excision of a dilated venous outflow component. The patient was successfully treated with resection and end-to-end reconstruction of the brachial artery, with resolution of pain and improvement in the functionality of his extremity. This case highlights the possible challenges encountered in such situations, when the anatomy is so distorted that it is difficult to clearly delineate on preoperative imaging. Keywords: Arteriovenous fistula, Aneurysmal dilatation, Arteriomegaly, Venous outflow

Background To set therapeutic benchmarks, in 2009 the Society for Vascular Surgery defined objective performance goals (OPG) for treatment of patients with chronic limb threatening ischemia (CLTI) with either open surgical bypass or endovascular intervention. The goal of these OPGs are to set standards of care from a revascularization standpoint and to provide performance benchmarks for 1 year patency rates for new endovascular therapies. While OPGs are useful in this regard, a critical decision point in the treatment of patients with CLTI is determining when revascularization is necessary. There is little guidance in the comprehensive treatment of this patient population, especially in the nonoperative cohort. Guidelines are needed for the CLTI patient population as a whole and not just those revascularized, and our aim was to assess whether CLTI OPGs could be attained with nonoperative management alone. Methods Our cohort included patients with an incident diagnosis of CLTI (by hemodynamic and symptomatic criteria) at our institution from 2013–2017. The primary outcome measured was mortality. Secondary outcomes were limb loss and failure of amputation-free survival. Descriptive statistics were used to define the 2 groups – patients undergoing primary revascularization and patients undergoing primary wound management. The risk difference in outcomes between the 2 groups was estimated using collaborative-targeted maximum likelihood estimation. Results Our cohort included 349 incident CLTI patients; 60% male, 51% white, mean age 63 +/- 13 years, 20% Rutherford 4, and 80% Rutherford 5. Most patients (277, 79%) underwent primary revascularization, and 72 (21%) were treated with wound care alone. Demographics and presenting characteristics were similar between groups. Although the revascularized patients were more likely to have femoropopliteal disease (72% vs. 36%), both groups had a high rate of infrapopliteal disease (62% vs. 57%). Not surprisingly, the patients in the revascularization group were less likely to have congestive heart failure (34% vs. 42%), complicated diabetes (52% vs. 79%), obesity (19% vs. 33%), and end stage renal disease (14% vs. 28%). In the wound care group, 2-year outcomes were 65% survival, 51% amputation free survival, 19% major limb amputation, and 17% major adverse cardiac event. The wound care cohort had a 13% greater risk of death at 2 years; however, the risk of limb loss at 2 years was 12% less in the wound care cohort. Conclusions A comprehensive set treatment goals and expected amputation free survival outcomes can guide revascularization, but also assure that appropriate outcomes are achieved for patients treated without revascularization. The 2-year outcomes achieved in this cohort provide an estimate of outcomes for nonrevascularized CLTI patients. Although multi-center or prospective studies are needed, we demonstrate that equal, even improved, limb salvage rates are possible.

Background Women have been historically under-represented in vascular surgery and cardiovascular medicine trials. The rate and change in representation of women in trials of common vascular diseases over the last decade is not understood completely. Methods We used publicly available data from ClinicalTrials.gov to evaluate trials pertaining to carotid artery stenosis (CAS), peripheral arterial disease (PAD), thoracic and abdominal aortic aneurysms (TAA and AAA), and type B aortic dissections (TBAD) from 2008 to the present. We evaluated representation of women in these trials based on the participation-to-prevalence ratios (PPR), which are calculated by dividing the percentage of women among trial participants by the percentage of women in the disease population. Values of 0.8 to 1.2 reflect similar representation. Results The sex distribution was reported in all 97 trials, including 11 CAS trials, 68 PAD trials, 16 TAA/AAA trials, and 2 TBAD trials. The total number of participants in these trials was 41,622 and the median number of participants per trial was 150.5 (interquartile range [IQR], 50-252). The percentage of women in the disease population was 51.9% for CAS, 53.1% for PAD, 34.1% for TAA/AAA, and 30.9% for TBAD. Industry sources funded 76 of the trials (77.6%), and the Veterans Affairs Administration (n = 4 [4.1%]), unspecified university (n = 7 [7.1%]), and extramural sources (n = 11 [11.2%]) funded the remainder of the trials. The overall median PPR for all four diseases was 0.65 (IQR, 0.51-0.80). Women were under-represented for all four conditions studied (CAS, 0.73 [IQR, 0.62-0.96]; PAD, 0.65 [IQR, 0.53-0.77]; TAA/AAA, 0.59 [IQR, 0.38-1.20]; and TBAD, 0.74 [IQR, 0.65-0.84]). There was no significant difference in PPR among the diseases (P = .88). From 2008 to the present, there was no significant change in PPR values over time overall (r2 = 0.002; P = .70). When examined individually, PPR did not change significantly over time for any of the diseases studied (for each, r2 .45). The PPR did not vary significantly over time for any of the funding sources (for each, r2 .08). There was appropriate representation (PPR of 0.8-1.2) in a minority of trials for each disease except TBAD (CAS, 27.3%; PAD, 15.9%; TAA/AAA, 18.8%; and TBAD, 50%). Trials that were primarily funded from university sources had the highest median PPR (1.04; IQR, 0.21-1.27), followed by industry-funded (0.67; IQR, 0.54-0.81), and extramurally funded (0.60; IQR, 0.34-0.73). Studies funded by Veterans Affairs had the lowest PPR (0.02; IQR, 0.00-0.11; P = .004). Conclusions Participation of women in US trials of common vascular diseases remains low and has not improved since 2008. Therefore, the generalizability of recent trial results to women with these vascular diseases remains unknown. An improved understanding of the underlying root causes for poor female trial participation, advocacy, and education are required to improve the generalizability of trial results for female vascular patients.

With the rapid evolution of endovascular tools and ability to treat increasingly complex anatomic lesions, it has been very difficult to compare the efficacy of different endovascular options for each specific clinical scenario. Women have been routinely underrepresented, and there has been little describing how patient characteristics contribute to treatment choices and outcomes. Women are more likely to be treated with endovascular revascularization for infrainguinal PAD compared with men but have higher rates of complications, particularly at the access site. However, there is evidence of equal if not better 1-year patency rates, regardless of the location of the occlusive disease and type of endovascular intervention performed.

Objective The first annual Women's Vascular Summit highlighted sex- and gender-related knowledge gaps in vascular disease diagnosis and treatment. This finding suggests an opportunity for further research to improve care and outcomes in people who identify as women, specifically. The purpose of this study was to a large national dataset to identify all operations performed for abdominal aortic aneurysm (AAA), carotid artery stenosis (CAS), and peripheral arterial disease (PAD) in the United States, and to provide data on sex-related disparities in treatment. Methods All hospitalizations of adult patients (≥18 years old) diagnosed with AAA, CAS, or PAD who underwent vascular surgery from 2000 to 2016 were identified in the Healthcare Cost and Utilization Project National Inpatient Sample. Sex-stratified U.S. Census data and sex-specific population disease prevalence estimates from the National Institute of Health and Agency for Healthcare Research and Quality were used to calculate the number of U.S. adults with AAA, CAS, and PAD. Sex-stratified rates of surgery and incidence rate ratios were estimated using Poisson regression. Among those undergoing surgery, multivariable logistic regression was used to assess differences in endovascular vs open approach. Results Over 16 years, there were 1,021,684 hospitalizations for vascular surgery: 13% AAA (21% female, 79% male), 40% CAS (42% female, 58% male), and 47% PAD (42% female, 58% male). Females were older than males at time of surgery (median age, 71.3 years vs 69.7 years) and less likely to have private insurance (18% vs 23%); minimal differences were seen across race/ethnicity, comorbidities, and hospital characteristics. After accounting for disease prevalence, females were still 25% less likely to undergo surgery for AAA and 30% less likely to undergo surgery for PAD compared with males with the same disease. These results were consistent over time. After adjustment, females, compared with males, were less likely to receive an endovascular procedure compared with open for AAA or CAS, and more likely to receive one for PAD. Conclusions From 2000 to 2016 in the United States, females were less likely to undergo intervention for AAA and PAD than males. This finding is particularly significant for PAD, because the prevalence is the same for both sexes, indicating that females are likely undertreated for PAD. Additionally, females were less likely to undergo endovascular surgery for AAA and more likely to undergo endovascular surgery for PAD than males. These findings suggest that improvement in AAA and PAD identification and management in females may improve outcomes.

BACKGROUND: Stenting of the iliac venous system is often performed for symptomatic obstruction, with high patency rates reported. However, patients with post-thrombotic disease and those with more extensive obstruction have experienced poorer outcomes, including a higher rate of early post-stent thrombosis. In the present study, we examined the outcomes of patients with complete venous outflow occlusion. We focused on the variables associated with early post-stenting thrombosis to identify opportunities to reduce its incidence. METHODS: From 2010 to 2020, the patients who had undergone stenting for chronic obstruction of the common femoral vein, iliac veins, and/or inferior vena cava were retrospectively reviewed. The pre- and intraoperative imaging studies were examined to identify those who had had total occlusion of one venous outflow segment (type III disease) or multiple venous outflow segments (type IV disease). The patient characteristics and procedural and post-stent variables were recorded. The post-procedure follow-up visits and imaging studies were reviewed to determine stent patency and thrombotic complications. Key variables were studied to determine their association with early stent reocclusion. RESULTS: A total of 106 patients were identified, including 43 with type III (40.6%) and 63 with type IV (59.4%) disease. The mean patient age was 49.8 ± 13.7 years, and the mean stented length was 177.3 ± 63 mm. Stainless steel Wallstents were used solely in 44% of the cases, with a variety of nitinol stents used in the remainder. Femoral vein inflow was minimally diseased in 50% of the cases, moderately diseased in 26%, and severely diseased or occluded in 24%. Antiplatelet medications were prescribed after intervention for 52.8% and anticoagulation medication for 95.3% of the patients. Occlusion of the stented segment occurred within 3 months in 25.5%. Primary patency was 74.5% at 3 months, 63.9% at 12 months, and 58.5% at 3 years. Secondary patency was 93.4% at 3 months and 76.1% at 3 and 5 years. Univariate analysis of variables related to early stent thrombosis identified the presence of a hypercoagulable state, type IV obstruction, and the type of anticoagulation used after stenting were associated with early stent thrombosis. On multivariate analysis, each of these variables was independently associated with early stent thrombosis. The presence of type IV obstruction (odds ratio [OR], 4.596; 95% confidence interval [CI], 1.424–18.109) or a hypercoagulable state (OR, 3.835; 95% CI, 1.207–12.871) was associated with significantly greater odds of reocclusion than was class III obstruction and no hypercoagulable state. Treatment with low-molecular-weight heparin for >10 days was associated with significantly lower odds (OR, 0.012; 95% CI, 0.001–0.130) of reocclusion. CONCLUSIONS: Patients who require recanalization of a completely occluded venous outflow tract before stenting have a high rate of early reocclusion. Patients with more extensive occlusion and a hypercoagulable state have greater odds of reocclusion. Treatment with low-molecular-weight heparin for >10 days reduced the odds of early reocclusion. (J Vasc Surg Venous Lymphat Disord 2021;9:1399–407.)

Surgical site infection (SSI) after open lower extremity revascularization is a relatively common complication associated with increased hospital stays, graft infection, and in severe cases, graft loss. Although the short-term effects of SSI can be significant, it has not been considered a complication that increases major limb amputation. The purpose of this study was to determine the association of SSI with outcomes in patients undergoing surgical revascularization for peripheral arterial disease.We analyzed nationwide Vascular Quality Initiative (VQI) data from the infrainguinal bypass module from 2003 to 2017. The cohort included adults who underwent open lower extremity bypass for symptomatic peripheral arterial disease and had at least one follow-up record. Weighted Kaplan-Meier curves and Cox proportional hazards regression were used to assess the association between SSI and 1-year mortality and major limb amputation. Inverse-probability of treatment weights were used to account for differences in demographics and patient characteristics and allow for 'adjusted' Kaplan-Meier curves.The analysis included 21,639 patients, and 1155 (5%) had a reported SSI within 30 days of surgery. Patients with SSI were more likely be obese (41% vs 30%), but there were no other clinically relevant differences between demographics, comorbidities, and bypass details. After weighting, patients with SSI were almost twice as likely to undergo major amputation by 6 months (hazard ratio, 1.84; 95% confidence interval, 1.07-3.17). The association with SSI and increased amputation rates persisted at 1 year. The association of SSI on amputation was no different based on preoperative Rutherford class (P = .91). The association between SSI and 1-year mortality rate was not statistically significant (hazard ratio, 1.15; 95% confidence interval, 0.91-1.46).SSI is more common in obese patients, and patients who develop an SSI are observed to have a significantly increased rate of limb amputation after open lower extremity revascularization.

Objective The objective of this study was to compare the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. Methods Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and had data analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (interquartile range). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test. P value Results During the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoracoabdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, Ind) devices. The median age was 71 years (interquartile range, 66-79 years); 70% were male, and 81% were white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2% respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, P = .66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, P = .33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, P = .77) were similar between groups. Conclusions This initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in a high-volume, experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with a larger cohort and longer follow-up are necessary to validate these findings.

Major limb amputations are physiologically stressful and subject patients to peri-operative cardiovascular risk. Up to 90% of major lower extremity amputations (LEAMP) are being performed under general anaesthesia, despite regional anaesthesia being an acceptable option in most cases. Obtaining a better understanding of who would benefit from regional vs. general anaesthesia could reduce complications and help establish best evidence based practice. It was hypothesised that patients undergoing LEAMP with regional anaesthesia would have better post-operative outcomes than patients receiving general anaesthesia.This retrospective cohort study used the U.S. Vascular Quality Initiative lower extremity amputation module to identify patients (≥18 years) who underwent LEAMP from 2013 to 2018. Outcomes included 30 day incidence of major adverse cardiac events (MACE) and all cause mortality. Multivariable logistic regression models were used to compute odds ratios (OR) and 95% confidence intervals (CI). Time to death was analysed using standard survival analysis.The final sample included 5 567 patients (median age: 65 years, 67% white, 65% male). Only 719 (13%) of patients received regional anaesthesia. Compared with patients undergoing general anaesthesia, patients in the regional group were older (67 vs. 65 years, p .001) and more likely to have diabetes (78% vs. 69%; p .001), end stage renal disease (26% vs. 18%; p .001), congestive heart failure (33% vs. 27%; p .01) and coronary artery disease (35% vs. 30%; p .01). The overall incidence of MACE, death, and MACE or death was 5%, 6%, and 9%, respectively. There was no statistically significant difference by anaesthesia groups for MACE (OR 0.98, 95% CI 0.69-1.39) or mortality (HR 1.03, 95% CI 0.90-1.17).There was no difference in outcomes between regional or general anaesthesia techniques in patients undergoing LEAMP, despite the regional group having more comorbidities. Regional anaesthesia may be under used for high risk patients undergoing LEAMP. Further studies are needed to establish best practices in LEAMP procedures.

Enhanced recovery after surgery (ERAS) pathways have been beneficial for many surgical specialties, but these coordinated care pathways have yet to be developed for patients undergoing vascular operations. Vascular surgery patients present specific challenges due to their advanced age, frailty, and multiple comorbidities as well as the highly invasive operations that are sometimes required. This combination of factors results in complex management strategies, increased utilization of healthcare resources, and high rates of postoperative complications leading to prolonged hospitalizations, chronic pain, rehabilitation needs, and frequent hospital readmissions. ERAS, with its aim of delivering high-quality perioperative care and accelerating recovery, appears well-suited to address the needs of this demanding population.

Background: Enhanced Recovery After Surgery (ERAS) programs are multimodal care pathways designed to minimize the physiologic and psychological impact of surgery for patients. Increased compliance with ERAS guidelines is associated with improved patient outcomes across surgical types. As ERAS programs have proliferated, an unintentional effect has been significant variation in how ERAS-related studies are reported in the literature. Methods: To improve the quality of ERAS reporting, the ERAS® USA and the ERAS® Society launched an effort to create an instrument to assist authors in manuscript preparation. Criteria to include were selected by a combination of literature review and expert opinion. The final checklist was refined by group consensus. Results: The Societies present the Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist. The tool contains 20 items including best practices for reporting clinical pathways, compliance auditing, and formatting guidelines. Conclusions: The RECOvER Checklist is intended to provide a standardized framework for the reporting of ERAS-related studies. The checklist can also assist reviewers in evaluating the quality of ERAS-related manuscripts. Authors are encouraged to include the RECOvER Checklist when submitting ERAS-related studies to peer-reviewed journals.

Screening for abdominal aortic aneurysms can prevent life-threatening rupture. The Screening Abdominal Aortic Aneurysms Very Efficiently Act was implemented in 2007. This provides for a one-time abdominal aortic aneurysm screening. We hypothesize that the Screening Abdominal Aortic Aneurysms Very Efficiently Act has increased the screening rate and identified more abdominal aortic aneurysms, leading to fewer ruptured abdominal aortic aneurysms.Centers for Medicare and Medicaid Services data were used to estimate the number of Medicare enrollees eligible for screening and the number screened. The Nationwide Inpatient Sample database was queried for discharges involving abdominal aortic aneurysm rupture and/or repair from the years 2000 to 2015 to assess national trends in abdominal aortic aneurysm admissions. The main outcomes were abdominal aortic aneurysm screening rates and standardized yearly incidence of abdominal aortic aneurysm rupture and abdominal aortic aneurysm repairs (stratified by open and endovascular).The number of patients screened increased from 9,884 (2007) to 95,243 (2015). The screening rate increased from 0.2% (2007) to 1.4% (2015) (P.001) of eligible patients. The number of abdominal aortic aneurysm ruptures increased slightly after the initiation of the Screening Abdominal Aortic Aneurysms Very Efficiently Act from 8.3 per 100,000 to 9.4 per 100,000 (incidence rate ratio 1.12, 95% confidence interval 1.06-1.19). The average yearly change in abdominal aortic aneurysm ruptures was not significant (95% confidence interval -0.01 to 0.00, P = .30). The number of open abdominal aortic aneurysm repairs declined, while endovascular repairs increased during the study period.The Screening Abdominal Aortic Aneurysms Very Efficiently Act has increased the number of patients being screened; however, screening rates remain low. The number of patients presenting with rupture has not decreased. Screening strategies need to be reassessed or made more widely available for this legislation to have an impact.

Major lower limb amputation is an important cause of morbidity and mortality in the USA. Little is known about the prevalence of the various indications for amputation, or if these indications have changed over time. The purpose of this study was to assess the indications for major amputation over a 17 year period and to determine whether surgical indications have shifted over this time period.A retrospective, population based analysis of patients undergoing major amputation between 2000 and 2016 was performed using the National Inpatient Sample. Surgical indications for major amputation were classified as chronic ischaemia, acute limb ischaemia (ALI), infection, oncological, trauma, other, or any combination of these indications. Prevalence rates of surgical indications were calculated using logistic regression. Prevalence differences across years were assessed using likelihood ratio tests to determine statistical significance.Of 1 002 119 weighted hospitalisations for patients undergoing major amputation during the study period, the majority had chronic ischaemia (72%) or infection (15%) as the primary indication for amputation. Patients were predominantly male (60%) and diabetic (61%). Renal insufficiency was the only measured comorbidity that changed significantly over time (from 6% to 39%), although changes in coding procedures are partially responsible for the increase. From 2000 to 2016, the proportion of amputations done for chronic ischaemia alone decreased from 60% to 40% (p .001), while the proportion of amputations that included infection in the presence of chronic ischaemia nearly doubled from 20% to 40% (p .001). Major amputation due to ALI, oncology, or trauma was stable across the study period.Surgical indications for major amputation have changed between 2000 and 2016. Infection related amputations increased significantly during the study period. Further evaluation and modification of treatment protocols for limb infection are crucial to decreasing infection related major limb amputation.

Objective Understanding modifiable risk factors to improve surgical outcomes is increasingly important in value-based health care. There is an established association between peripheral artery disease (PAD), diabetes, and limb loss, but less is known about expected outcomes after revascularization relative to the degree of glycemic control. The purpose of this study was to determine the association between hemoglobin A1c (HbA1c) management in diabetics and surgical outcomes after open infrainguinal bypass. Methods The Vascular Quality Initiative infrainguinal bypass module was used to identify adult patients (≥18 years) with a history of diabetes who underwent bypass for PAD between 2011 and 2018. Exclusion criteria included missing or illogical HbA1c values and if the indication for the limb treated was not PAD. Patients were categorized by preoperative HbA1c levels as low severity/controlled ( 10.0%). Primary outcomes were 30-day incidence of major adverse cardiac events (MACEs), major adverse limb events (MALEs), ipsilateral amputation, and 1-year all-cause mortality. Thirty-day outcomes were calculated using multivariable regression to compute odds ratios; hazard ratios were calculated for all-cause mortality. All analyses were adjusted for demographics, comorbidities, and clinical characteristics. Results The final sample included 30,813 operations (27,988 unique patients): 17,517 (57%) nondiabetic patients, 5194 patients with low-severity/controlled diabetes, and 8102 (26%) patients with poorly controlled diabetes, including 5531 (70%) treated with insulin. There were 6439 (21%) patients with high-severity HbA1c values and 1663 (5%) patients with very-high-severity HbA1c values. Those with a very high HbA1c level were more likely to be nonwhite, insulin dependent, and active smokers. Compared with nondiabetics, patients with very-high-severity HbA1c had an 81% increase in MACEs and 31% increase in MALEs, whereas patients with high-severity HbA1c only had a 49% increase in MACEs and a 12% increase in MALEs. Each one-step increase in severity category (eg, low to high to very high) was associated with an average 29% increase in the odds of MACEs and an 8% increase in the odds of MALEs. Conclusions Uncontrolled diabetes with an HbA1c value >10.0% was associated with significantly worse 30-day surgical outcomes. Patients with incrementally better glycemic control (HbA1c level of 7.0%-10.0%) did not suffer the same rate of complications, suggesting that preoperative attempts at improving diabetes management even slightly could lead to improved surgical outcomes in open infrainguinal bypass patients.

Context: Enhanced recovery after surgery (ERAS) aims to improve surgical outcomes by integrating evidence-based practices across preoperative, intraoperative, and postoperative care. Data in electronic medical records (EMRs) provide insight on how ERAS is implemented and its impact on surgical outcomes. Because ERAS is a multimodal pathway provided by multiple physicians and health care providers over time, identifying ERAS cases in EMRs is not a trivial task. To better understand how EMRs can be used to study ERAS, we describe our experience with using current methodologies and the development and rationale of a new method for retrospectively identifying ERAS cases in EMRs.Case Description: Using EMR data from surgical departments at the University of North Carolina at Chapel Hill, we first identified ERAS cases using a protocol-based method, using basic information including the date of ERAS implementation, surgical procedure and date, and primary surgeon. We further examined two operational flags in the EMRs, a nursing order and a case request for OR order. Wide variation between the methods compelled us to consult with ERAS surgical staff and explore the EMRs to develop a more refined method for identifying ERAS cases.Method: We developed a two-step method, with the first step based on the protocol definition and the second step based on an ERAS-specific medication definition. To test our method, we randomly sampled 150 general, gynecological, and urologic surgeries performed between January 1, 2016 and March 30, 2017. Surgical cases were classified as ERAS or not using the protocol definition, nursing order, case request for OR order, and our two-step method. To assess the accuracy of each method, two independent reviewers assessed the charts to determine whether cases were ERAS.Findings: Of the 150 charts reviewed, 74 were ERAS cases. The protocol only method and nursing order flag performed similarly, correctly identifying 74 percent and 73 percent of true ERAS cases, respectively. The case request for OR order flag performed less well, correctly identifying only 44 percent of the true ERAS cases. Our two-step method performed well, correctly identifying 98 percent of true ERAS cases.Conclusion: ERAS pathways are complex, making study of them from EMRs difficult. Current strategies for doing so are relatively easy to implement, but unreliable. We have developed a reproducible and observable ERAS computational phenotype that identifies ERAS cases reliably. This is a step forward in using the richness of EMR data to study ERAS implementation, efficacy, and how they can contribute to surgical care improvement.