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Objective: Implicit bias is an unconscious bias that may influence behavior, cognitive processes and decision-making. In clinical settings, implicit bias present in clinicians may influence the treatment that people receive and may be a root cause of health disparities. Our study measured implicit bias among vascular surgeons who participate in the management of individuals with peripheral artery disease (PAD). Methods: Our sampling frame included all vascular surgeons that contribute to the Vascular Quality Initiative (VQI) registry. We invited these individuals to take the race implicit association test (IAT) used to measure level of unconscious bias. The IAT asks participants to classify items presented on a computer by quickly pressing computer keys. The underpinning of the IAT is that people will match a representative group (images of African American or European American faces) to an attribute (good and bad words, such as excellent and angry) more quickly if there is already an implicit connection. Based on the differences in reaction time from several trials, participants are classified as having a no preference between African American and European Americans or a preference for one or the other. The level of preference can be slight, moderate, or strong. We stratified implicit findings by physician race/ethnicity. Results: Among 2765 vascular surgeons that participate in the VQI, 338 (12%) completed the IAT. Most participants (70%) showed an automatic preference for European Americans over African Americans, with more than half of participants (51%) showing a moderate or strong automatic preference. Of 195 participants who identified as Non-Hispanic White, 25% showed a slight automatic preference for European Americans, 41% showed a moderate automatic preference, and 34% showed a strong automatic preference. Of 16 participants who identified as Non-Hispanic Black, 38% showed an automatic preference for European Americans over African Americans and 31% showed an automatic preference for African Americans. We also found that participants were often unaware of their biases: More than two-thirds (n=64) of the 94 participants who disagreed with a statement asking if they are biased (“I am biased”) had an automatic preference upon testing. Conclusions: Implicit bias was found among vascular surgeons. The next step in our research will focus on the ability of implicit bias scores to predict a surgeon’s actual delivery of guideline care. Pending our findings, training and clinical support tools offer techniques to mitigate the impact of implicit biases on PAD-related health care.

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.

Background Peripheral artery disease (PAD) affects >10 million people in the United States. PAD is associated with poor outcomes, including premature death. Machine learning (ML) has been increasingly used on big data to predict clinical outcomes. This study aims to develop ML models to predict in‐hospital mortality in patients hospitalized for PAD based on a national database. Methods and Results Inpatient hospitalization data were obtained from the 2016 to 2019 National Inpatient Sample. A total of 150 921 inpatients were identified with a primary diagnosis of PAD and PAD‐related procedures using codes of the International Classification of Diseases, Tenth Revision, Clinical Modification ( ICD‐10‐CM ) and International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD‐10‐PCS) . Four ML models, including logistic regression, random forest, light gradient boosting, and extreme gradient boosting models, were trained to predict the risk of in‐hospital death based on a selection of variables, including patient characteristics, comorbidities, procedures, and hospital‐related factors. In‐hospital mortality occurred in 1.8% of patients. The performance of the 4 models was comparable, with the area under the receiver operating characteristic curve ranging from 0.83 to 0.85, sensitivity of 77% to 82%, and specificity of 72% to 75%. These results suggest adequate predictability for clinical decision‐making. In all 4 models, the total number of diagnoses and procedures, age, endovascular revascularization procedure, congestive heart failure, diabetes, and diabetes with complications were critical predictors of in‐hospital mortality. Conclusions This study demonstrates the feasibility of ML in predicting in‐hospital mortality in patients with a primary PAD diagnosis. Findings highlight the potential of ML models in identifying high‐risk patients for poor outcomes and guiding personalized intervention.

Summary Background Despite severe outbreaks of COVID-19 among colleges and universities across the USA during the Fall 2020 semester, the majority of institutions did not routinely test students. While high-frequency repeated testing is considered the most effective strategy for disease mitigation, most institutions do not have the necessary infrastructure or funding for implementation. Therefore, alternative strategies for testing the student population are needed. Our study detailed the implementation and results of testing strategies to mitigate SARS-CoV-2 spread on a university campus, and we aimed to assess the relative effectiveness of the different testing strategies. Methods For this retrospective cohort study, we included 6273 on-campus students arriving to a large public university in the rural USA (Clemson, SC, USA) for in-person instruction in the Fall 2020 semester (Sept 21 to Nov 25). Individuals arriving after Sept 23, those who tested positive for SARS-CoV-2 before Aug 19, and student athletes and band members were not included in this study. We implemented two testing strategies to mitigate SARS-CoV-2 spread during this period: a novel surveillance-based informative testing (SBIT) strategy, consisting of random surveillance testing to identify outbreaks in residence hall buildings or floors and target them for follow-up testing (Sept 23 to Oct 5); followed by a repeated weekly surveillance testing (Oct 6 to Nov 22). Relative changes in estimated weekly prevalence were examined. We developed SARS-CoV-2 transmission models to compare the relative effectiveness of weekly testing (900 daily surveillance tests), SBIT (450 daily surveillance tests), random surveillance testing (450 daily surveillance tests), and voluntary testing (0 daily surveillance tests) on disease mitigation. Model parameters were based on our empirical surveillance data in conjunction with published sources. Findings SBIT was implemented from Sept 23 to Oct 5, and identified outbreaks in eight residence hall buildings and 45 residence hall floors. Targeted testing of residence halls was 2·03 times more likely to detect a positive case than random testing (95% CI 1·67–2·46). Weekly prevalence was reduced from a peak of 8·7% to 5·6% during this 2-week period, a relative reduction of 36% (95% CI 27–44). Prevalence continued to decrease after implementation of weekly testing, reaching 0·8% at the end of in-person instruction (week 9). SARS-CoV-2 transmission models concluded that, in the absence of SBIT (ie, voluntary testing only), the total number of COVID-19 cases would have increased by 154% throughout the semester. Compared with SBIT, random surveillance testing alone would have resulted in a 24% increase in COVID-19 cases. Implementation of weekly testing at the start of the semester would have resulted in 36% fewer COVID-19 cases throughout the semester compared with SBIT, but it would require twice the number of daily tests. Interpretation It is imperative that institutions rigorously test students during the 2021 academic year. When high-frequency testing (eg, weekly) is not possible, SBIT is an effective strategy to mitigate disease spread among the student population that can be feasibly implemented across colleges and universities. Funding Clemson University, USA.

BACKGROUND AND AIMS: Previous community-based studies have demonstrated sex and race-based disparities in the risk of cardiovascular disease. We sought to examine the association of sex and race with incident peripheral artery disease (PAD) and critical limb ischemia (CLI) related hospitalizations. METHODS: In 13,451 Black and White ARIC participants without prevalent PAD at baseline (1987–89), we estimated the cumulative incidence of PAD- and CLI-related hospitalization over a median follow-up of 26 years. We quantified hazard ratios (HRs) using Cox models across four sex- and race-groups. PAD and CLI were defined by hospitalization discharge codes. RESULTS: The cumulative incidence of PAD-related hospitalization was higher in males than females in Whites (5.1% vs. 2.7%; p

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.

Objective To evaluate the impact of three treatment modalities, superficial truncal vein ablation, perforator vein ablation, and deep venous stenting on venous leg ulcer (VLU) healing, as well as their cumulative effect on ulcer healing, in an attempt to establish the best algorithm for the treatment of chronic and recalcitrant VLUs. Methods Multicenter retrospective cohort study using a standardized database to evaluate patients with chronic venous ulcers treated between January 2013 and December 2017. Results Eight-hundred thirty-two consecutive patients with VLU were identified at 11 centers in the United States. All patients were initially managed with wound care and compression for at least 2 months. Compression and wound care management alone, used in 187 patients, led to ulcer healing in 75% of patients by 36 months. Ulcer recurrence in patients managed without surgery at 6, 12, and 24 months was 3%, 5% and 15%, respectively. Five hundred twenty-eight patients underwent ablation of incompetent superficial veins, and 344 of those also underwent incompetent perforator ablation. Patients who underwent truncal vein ablation alone had an ulcer healing rate of 51% at 36 months. Patients who received both superficial and perforator ablation were significantly younger, and had a 17% improvement in healing at 36 months (68% vs 51%, respectively), but there was no impact of combined superficial and perforator ablations on ulcer recurrence rates. One hundred thirty-four patients had stenosis of one of more lower extremity deep veins and 95 (71%) underwent endovenous stenting. Ulcer healing and recurrence rates for those who underwent stent placement alone was 77% and 27%, respectively, at 36 months. Patients who underwent deep venous stenting and ablation of both incompetent truncal and perforator veins had an ulcer healing rate of 87% at 36 months and ulcer recurrence of 26% at 24 months. Conclusions This study demonstrates that correction of superficial truncal vein reflux, as well as deep vein stenosis, both contribute to healing of VLU. Patients who fail to heal their VLU after superficial and perforator ablation should have the iliocaval system imaged to identify hemodynamically significant stenoses or occlusions amenable to stenting, which facilitates venous ulcer healing even in patients with large ulcers.

Readmissions constitute a major health care burden among peripheral artery disease (PAD) patients. This study aimed to 1) estimate the zip code tabulation area (ZCTA)-level prevalence of readmission among PAD patients and characterize the effect of covariates on readmissions; and (2) identify hotspots of PAD based on estimated prevalence of readmission. Thirty-day readmissions among PAD patients were identified from the South Carolina Revenue and Fiscal Affairs Office All Payers Database (2010–2018). Bayesian spatial hierarchical modeling was conducted to identify areas of high risk, while controlling for confounders. We mapped the estimated readmission rates and identified hotspots using local Getis Ord (G*) statistics. Of the 232,731 individuals admitted to a hospital or outpatient surgery facility with PAD diagnosis, 30,366 (13.1%) experienced an unplanned readmission to a hospital within 30 days. Fitted readmission rates ranged from 35.3 per 1000 patients to 370.7 per 1000 patients and the risk of having a readmission was significantly associated with the percentage of patients who are 65 and older (0.992, 95%CI: 0.985–0.999), have Medicare insurance (1.013, 1.005–1.020), and have hypertension (1.014, 1.005–1.023). Geographic analysis found significant variation in readmission rates across the state and identified priority areas for targeted interventions to reduce readmissions.

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.

Background and aims The ankle-brachial index (ABI) is a diagnostic test for screening and detecting peripheral artery disease (PAD), as well as a risk enhancer in the AHA/ACC guidelines on the primary prevention of atherosclerotic cardiovascular disease (ASCVD). However, our understanding of the association between ABI and cardiovascular risk in contemporary older populations is limited. Additionally, the prognostic value of ABI among individuals with prior ASCVD is not well understood. Methods Among 5,003 older adults at ARIC visit 5 (2011–2013) (4,160 without prior ASCVD [median age 74 years, 38% male], and 843 with ASCVD [median age 76 years, 65% male]), we quantified the association between ABI and the risk of heart failure (HF), and composite coronary heart disease and stroke (CHD/stroke) using multivariable Cox regression models. Results Over a median follow-up of 5.5 years, we observed 400 CHD/stroke events and 338 HF cases (242 and 199 cases in those without prior ASCVD, respectively). In participants without a history of ASCVD, a low ABI ≤0.9 (relative to ABI 1.11–1.20) was associated with both CHD/stroke and HF (adjusted hazard ratios 2.40 [95% CI: 1.55–3.71] and 2.23 [1.40–3.56], respectively). In those with prior ASCVD, low ABI was not significantly associated with CHD/stroke, but was with HF (7.12 [2.47–20.50]). The ABI categories of 0.9–1.2 and > 1.3 were also independently associated with increased HF risk. Beyond traditional risk factors, ABI significantly improved the risk discrimination of CHD/stroke in those without ASCVD and HF, regardless of baseline ASCVD. Conclusions Low ABI was associated with CHD/stroke in those without prior ASCVD and higher risk of HF regardless of baseline ASCVD status. These results support ABI as a risk enhancer for guiding primary cardiovascular prevention and suggest its potential value in HF risk assessment for older adults.

Background Ankle‐brachial index (ABI) is used to identify lower‐extremity peripheral artery disease (PAD). However, its association with severe ischemic leg outcomes (eg, amputation) has not been investigated in the general population. Methods and Results Among 13 735 ARIC (Atherosclerosis Risk in Communities) study participants without clinical manifestations of PAD (mean age, 54 [SD, 5.8] years; 44.4% men; and 73.6% White) at baseline (1987–1989), we quantified the prospective association between ABI and subsequent severe ischemic leg outcomes, critical limb ischemia (PAD with rest pain or tissue loss) and ischemic leg amputation (PAD requiring amputation) according to discharge diagnosis. Over a median follow‐up of ≈28 years, there were 221 and 129 events of critical limb ischemia and ischemic leg amputation, respectively. After adjusting for demographics, ABI ≤0.90 versus 1.11 to 1.20 had a ≈4‐fold higher risk of critical limb ischemia and ischemic leg amputation (hazard ratios, 3.85 [95% CI, 2.09–7.11] and 4.39 [95% CI, 2.08–9.27]). The magnitude of the association was modestly attenuated after multivariable adjustment (hazard ratios, 2.44 [95% CI, 1.29–4.61] and 2.72 [95% CI, 1.25–5.91], respectively). ABI 0.91 to 1.00 and 1.01 to 1.10 were also associated with these severe leg outcomes, with hazard ratios ranging from 1.7 to 2.0 after accounting for potential clinical and demographic confounders. The associations were largely consistent across various subgroups. Conclusions In a middle‐aged community‐based cohort, lower ABI was independently and robustly associated with increased risk of severe ischemic leg outcomes. Our results further support ABI ≤0.90 as a threshold diagnosing PAD and also suggest the importance of recognizing the prognostic value of ABI 0.91 to 1.10 for limb prognosis.

Background Increasing the diversity of research participants is an important focus of clinical trials. However, little is known regarding who enrolls as healthy volunteers in Phase I clinical trials, which test the safety and tolerability of investigational new drugs. Despite the risk, healthy volunteers can derive no medical benefit from their participation, and they are financially compensated for enrolling. Objective This study’s purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials. Methods The HealthyVOICES Project (HVP) is a longitudinal study of healthy individuals who have enrolled in Phase I trials. We describe self-reported sociodemographic information and Phase I trial history from HVP recruitment (May-December 2013) through the project’s end three years later (December 2016). Trial experiences are presented as medians and quartiles. Results The HVP included 178 participants. Nearly three-fourths of participants were male, and two-thirds were classified as racial and ethnic minorities. We found that some groups of participants were more likely to have completed a greater number of clinical trials over a longer timeframe than others. Those groups included participants who were male, Black, Hispanic, 30-39-years-old, unemployed, had received vocational training in a trade, or had annual household incomes of less than $25,000. Additionally, the greater the number of clinical trials participants had completed, the more likely they were to continue screening for new trials over the course of three years. Participants who pursued clinical trials as a full-time job participated in the greatest number of trials and were the most likely to continuing screening over time. Implications Participation as a healthy volunteer in US Phase I trials is driven by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and participate longer than more privileged groups.

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.

Background: To assess racial/ethnic differences in disease severity, hospital outcomes, length of stay and healthcare costs among hospitalized patients with peripheral artery disease (PAD).Methods: This study used data from the National Inpatient Sample (NIS) to explore the racial/ethnic disparities in PAD-related hospitalizations including presence of PAD with chronic limb threatened ischemia (CLI), amputation, in-hospital mortality, length of hospital stays and estimated medical costs. Race-ethnicity groups included non-Hispanic White, Black, Hispanic, Asian or Pacific Islander, Native American, and others (multiple races). Regression analyses adjusted for age, gender, Charlson Comorbidity Index, primary payer, patient location, bed size of the admission hospital, geographic region of the hospital, and rural/urban location of the hospital.Results: A total of 341,480 PAD hospitalizations were identified. Compared with non-Hispanic Whites, Native Americans had the highest odds of PAD with CLI (OR = 1.77, 95% CI: 1.61, 1.95); Black (OR = 1.71, 95% CI: 1.66, 1.76) and Hispanic (OR = 1.36, 95% CI: 1.31,1.41) patients had higher odds of amputation; Asian or Pacific Islanders had a higher mortality (OR = 1.20, 95% CI: 1.01,1.43), whereas Black (OR = 0.81, 95% CI: 0.76, 0.87) patients has a lower mortality; Asian or Pacific Islanders incurred higher overall inpatient costs (Margin = 30093.01, 95% CI: 28827.55, 31358.48) and most prolonged length of stay (IRR = 0.14, 95% CI: 0.09, 0.18).Conclusions: Our study identified elevated odds of amputation among Hispanic patients hospitalized with PAD as well as higher hospital mortality and medical expenses among Asian or Pacific Islander PAD inpatients. These two demographic groups were previously thought to have a lower risk for PAD and represent important populations for further investigation.

Introduction: Ankle-brachial index (ABI) ≤ 0.9 is used to define lower-extremity peripheral artery disease (PAD). However, the association between ABI and severe ischemic leg outcomes in the general population has not been investigated. Hypothesis: Lower ABI is independently associated with risk of severe ischemic leg outcomes. Methods: We studied 13,742 ARIC participants (median age 54 [SD 5.75] years, 45% males) without intermittent claudication or a history of revascularization for PAD at baseline (1987-89). We quantified the association of ABI with risk of severe ischemic leg outcomes using Cox regression. ABI was modeled as a restricted cubic spline allowing for potentially non-linear associations. Severe ischemic leg outcomes were ascertained through ICD codes and included critical limb ischemia (CLI) (defined as PAD with rest pain or tissue loss) and ischemic leg amputation (amputations with PAD diagnosis). Results: Over a median of 28 years of follow-up, there were 221 and 129 events of CLI and ischemic leg amputation, respectively. Lower ABI was linearly associated with both CLI and ischemic leg amputation (Figure). With ABI 1.25 as the reference, adjusted hazard ratios of CLI were 2.48 (95% CI 1.15-5.36) at ABI 0.7, 1.97 (1.30-2.99) at ABI 0.9, and 1.73 (1.18-2.54) at ABI 1.0. The corresponding hazard ratios of ischemic leg amputation were 3.57 (1.44-8.81), 2.63 (1.54-4.48), and 2.23 (1.34-3.70), respectively. The association was largely consistent in demographic and clinical subgroups, although the results were less evident in younger and female participants compared to their counterparts. Conclusions: In middle-aged adults without clinical PAD, lower ABI was independently and linearly associated with higher risk of severe ischemic leg outcomes. Our results support the value of ABI as an indicator for leg vascular condition and also indicate that ABI 0.9-1.1 should not be considered normal for ischemic leg prognosis.

BACKGROUNDWastewater-based epidemiology (WBE) provides an opportunity for near real-time, cost-effective monitoring of community level transmission of SARS-CoV-2, the virus that causes COVID-19. Detection of SARS-CoV-2 RNA in wastewater can identify the presence of COVID-19 in the community, but methods are lacking for estimating the numbers of infected individuals based on wastewater RNA concentrations.METHODSComposite wastewater samples were collected from three sewersheds and tested for SARS-CoV-2 RNA. A Susceptible-Exposed-Infectious-Removed (SEIR) model based on mass rate of SARS-CoV-2 RNA in the wastewater was developed to predict the number of infected individuals. Predictions were compared to confirmed cases identified by the South Carolina Department of Health and Environmental Control for the same time period and geographic area.RESULTSModel predictions for the relationship between mass rate of virus release to the sewersheds and numbers of infected individuals were validated based on estimated prevalence from individual testing. A simplified equation to estimate the number of infected individuals fell within the 95% confidence limits of the model. The unreported rate for COVID-19 estimated by the model was approximately 12 times that of confirmed cases. This aligned well with an independent estimate for the state of South Carolina.CONCLUSIONSThe SEIR model provides a robust method to estimate the total number of infected individuals in a sewershed based on the mass rate of RNA copies released per day. This overcomes some of the limitations associated with individual testing campaigns and thereby provides an additional tool that can be used to better inform policy decisions.

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.

IntroductionRecent outbreaks of COVID-19 in universities across the United States highlight the difficulties in containing the spread of COVID-19 on college campuses. While research has shown that mitigation strategies such as frequent student testing, contact tracing, and isolation of confirmed and suspected cases can detect early outbreaks, such mitigation strategies may have limited effectiveness if large outbreaks occur. A phased reopening is a practical intervention to limit early outbreaks, conserve institutional resources, and ensure proper safety protocols are in place before the return of additional students to campus.MethodsWe develop dynamic compartmental transmission models of SARS-CoV-2 to assess the impact of a phased reopening and pre-arrival testing on minimizing outbreaks (measured by daily infections) and conserving university resources (measured by isolation bed capacity). We assume that one-third of the student population returns to campus each month as part of the phased reopening, and that pre-arrival testing removes 90% of infections at the semester start. We assume an on-campus population of N = 7500, an active COVID-19 prevalence of 2% at baseline, and that 60% of infected students require isolation for an average period of 11 days. We vary the reproductive number (Rt) between 1.25 and 4 to represent the effectiveness of alternative mitigation strategies throughout the semester, where Rt is constant or improving throughout the semester (ranging from 4 to 1.25).ResultsCompared to pre-arrival testing only or neither intervention, phased reopening with pre-arrival testing reduced peak daily infections by 6% and 18% (Rt=1.25), 44% and 48% (Rt=2.5), 63% and 64% (Rt=4), and 72% and 74% (improving Rt), respectively, and reduced the proportion of on-campus beds needed for isolation from 10%-25% to 5%-9% across different values of Rt.ConclusionPhased reopening with pre-arrival testing substantially reduces the peak number of daily infections throughout the semester and conserves university resources compared to strategies involving the simultaneous return of all students to campus. Phased reopenings allow institutions to improve safety protocols, adjust for factors that drive outbreaks, and if needed, preemptively move online before the return of additional students to campus, thus preventing unnecessary harm to students, institutional faculty and staff, and local communities.

Objective: Inflammatory markers, such as hs-CRP (high-sensitivity C-reactive protein), have been reported to be related to peripheral artery disease (PAD). Galectin-3, a biomarker of fibrosis, has been linked to vascular remodeling and atherogenesis. However, its prospective association with incident PAD is unknown; as is the influence of inflammation on the association between galectin-3 and PAD. Approach and Results: In 9851 Atherosclerosis Risk in Communities Study participants free of PAD at baseline (1996–1998), we quantified the association of galactin-3 and hs-CRP with incident PAD (hospitalizations with PAD diagnosis [ International Classification of Diseases - Ninth Revision : 440.2–440.4] or leg revascularization [eg, International Classification of Diseases - Ninth Revision : 38.18]) as well as its severe form, critical limb ischemia (PAD cases with resting pain, ulcer, gangrene, or leg amputation) using Cox models. Over a median follow-up of 17.4 years, there were 316 cases of PAD including 119 critical limb ischemia cases. Log-transformed galectin-3 was associated with incident PAD (adjusted hazard ratio, 1.17 [1.05–1.31] per 1 SD increment) and critical limb ischemia (1.25 [1.05–1.49] per 1 SD increment). The association was slightly attenuated after further adjusting for hs-CRP (1.14 [1.02–1.27] and 1.22 [1.02–1.45], respectively). Log-transformed hs-CRP demonstrated robust associations with PAD and critical limb ischemia even after adjusting for galectin-3 (adjusted hazard ratio per 1 SD increment 1.34 [1.18–1.52] and 1.34 [1.09–1.65], respectively). The addition of galectin-3 and hs-CRP to traditional atherosclerotic predictors (C statistic of the base model 0.843 [0.815–0.871]) improved the risk prediction of PAD (ΔC statistics, 0.011 [0.002–0.020]). Conclusions: Galectin-3 and hs-CRP were independently associated with incident PAD in the general population, supporting the involvement of fibrosis and inflammation in the pathophysiology of PAD.

BackgroundUniversity campuses present an ideal environment for viral spread and are therefore at extreme risk of serving as a hotbed for a COVID-19 outbreak. While active surveillance throughout the semester such as widespread testing, contact tracing, and case isolation, may assist in detecting and preventing early outbreaks, these strategies will not be sufficient should a larger outbreak occur. It is therefore necessary to limit the initial number of active cases at the start of the semester. We examine the impact of pre-semester NAT testing on disease spread in a university setting.MethodsWe implement simple dynamic transmission models of SARS-CoV-2 infection to explore the effects of pre-semester testing strategies on the number of active infections and occupied isolation beds throughout the semester. We assume an infectious period of 3 days and vary R0 to represent the effectiveness of disease mitigation strategies throughout the semester. We assume the prevalence of active cases at the beginning of the semester is 5%. The sensitivity of the NAT test is set at 90%.ResultsIf no pre-semester screening is mandated, the peak number of active infections occurs in under 10 days and the size of the peak is substantial, ranging from 5,000 active infections when effective mitigation strategies (R0 = 1.25) are implemented to over 15,000 active infections for less effective strategies (R0 = 3). When one NAT test is mandated within one week of campus arrival, effective (R0 = 1.25) and less effective (R0 = 3) mitigation strategies delay the onset of the peak to 40 days and 17 days, respectively, and result in peak size ranging from 1,000 to over 15,000 active infections. When two NAT tests are mandated, effective (R0 = 1.25) and less effective (R0 = 3) mitigation strategies delay the onset of the peak through the end of fall semester and 20 days, respectively, and result in peak size ranging from less than 1,000 to over 15,000 active infections. If maximum occupancy of isolation beds is set to 2% of the student population, then isolation beds would only be available for a range of 1 in 2 confirmed cases (R0 = 1.25) to 1 in 40 confirmed cases (R0 = 3) before maximum occupancy is reached.ConclusionEven with highly effective mitigation strategies throughout the semester, inadequate pre-semester testing will lead to early and large surges of the disease and result in universities quickly reaching their isolation bed capacity. We therefore recommend NAT testing within one week of campus return. While this strategy is sufficient for delaying the timing of the outbreak, pre-semester testing would need to be implemented in conjunction with effective mitigation strategies to reduce the outbreak size.

Introduction: Smoking is the strongest risk factor for abdominal aortic aneurysm (AAA), and male ever smokers who are recommended for one-time screening for AAA with ultrasonography at age of 65 to 75 years. However, the proportion of eligible individuals who receive this screening remains small (~1%). Few studies have evaluated the association of key smoking parameters with incident AAA by sex. Methods: In 14,889 ARIC participants free of a history of AAA at baseline (1987-89), we quantified the associations of smoking parameters (pack-years, duration, and intensity [pack/day]) with incident AAA (hospitalizations with AAA diagnosis [ICD code: 441.3, 441.4, 38.44, 39.71] or a death certificate ICD code: 441.3, 441.4, I71.3, I71.4) using Cox models. Years since quitting in former smokers were explored as time-varying variables. Results: Over a median follow-up of 20 years, there were 567 cases of AAA. The incident rate of AAA was 5.98 per 1,000 person-years in male current smokers and 2.65 per 1,000 person-years in female current smokers. Pack-years was significantly associated with incident AAA (HR 7.31 [95% CI 5.48-9.74] for those smoked ≥40 pack-years vs. never smokers) and the association was stronger in women than men (8.53 [5.03-14.45] vs. 5.97 [4.21-8.47], p-for-interaction =0.02). Both smoking duration and intensity showed significant associations with AAA. Smoking cessation demonstrated a graded association with lower risk of AAA in both sexes, but significantly increased risk lasted longer in men (2.16 [1.39-3.36] in 30- Conclusions: All smoking parameters tested consistently show significant associations with incident AAA in both sexes. After cessation, the residual risk lasted at least 40 years in men and 20 years in women. Our results further emphasize the importance of smoking prevention and early cessation for preventing AAA and the potential need of AAA screening in female current smokers and recent quitters.

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.

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.

Background The Effect of Surgery and Compression on Healing and Recurrence (ESCHAR) trial previously reported that patients with venous leg ulcers treated with saphenous stripping experienced a significantly reduced incidence of ulcer recurrence compared with patients treated with compression therapy. Most patients with leg ulcers and saphenous insufficiency are currently treated with endovenous thermal ablation (EVTA), but little information is available on the long-term results after EVTA in Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) clinical class 5 (C5) and class 6 (C6) patients. Methods We retrospectively reviewed all CEAP C5 or C6 patients treated with EVTA to define the incidence of ulcer healing and recurrence. Patients with active ulcers were managed weekly in a comprehensive wound center until healed. After healing, patients were treated with compression stockings and returned at 6-month intervals for follow-up. Time to healing and time to ulcer recurrence were determined by Kaplan-Meier survival analysis. Risk factors were assessed to determine their association with ulcer recurrence. Results EVTA of the great saphenous vein (n = 146), small saphenous vein (n = 20), or both (n = 7) was performed on 173 limbs with active (n = 72) or healed (n = 101) ulcers. Deep venous insufficiency was present in 54 cases (31.2%). Concomitant phlebectomy was performed in 59 limbs (34%). Median follow-up time was 25.2 months after EVTA. Venous ulcers healed after EVTA in 57% of cases at 3 months, 74% at 6 months, and 78% at 12 months. Ulcers recurred in 9% of patients at 1 year after EVTA, 20% at 2 years, and 29% at 3 years of follow-up. Ulcers recurred significantly more often in patients with deep venous insufficiency and in patients who did not undergo phlebectomy of associated varicose veins at the time of EVTA. Conclusions Ulcers recurred in a minority of CEAP clinical C5 and C6 patients after EVTA of the saphenous veins. Ulcer recurrence was less frequent in patients without concomitant deep venous reflux and in those treated with phlebectomy of varicose veins at the time of EVTA. We suggest consideration of phlebectomy at the time of EVTA for patients with C5 and C6 venous insufficiency, particularly in those with isolated superficial venous insufficiency.

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.

Background Whether physical activity is a determinant of peripheral artery disease (PAD) remains unclear. We therefore assessed the association of physical activity (amount and intensity) with subsequent risk of hospitalization with PAD and its severe form, critical limb ischemia, in the ARIC (Atherosclerosis Risk in Communities) study. Methods and Results We included 12 513 participants free of cardiovascular disease at baseline (1987–1989), with a mean age of 53.9 years, 55.3% women, and 25.0% black. Physical activity was assessed using a modified Baecke questionnaire and categorized into poor (no moderate [3 to Conclusions Higher amount and intensity of physical activity were related to lower risks of hospitalization with PAD and critical limb ischemia, further highlighting the importance of engaging in physical activity for vascular health.

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.

Objective Tumor involvement of the inferior vena cava (IVC) can result from primary caval leiomyosarcoma, local invasion by retroperitoneal malignant neoplasm, or metastases. Whereas ligation of the IVC may be well tolerated if collateral circulation can be adequately preserved, collaterals must often be ligated during oncologic resection. Reconstruction of the IVC may be performed by primary repair, patch angioplasty, or interposition graft. The purpose of our study was to describe different strategies of IVC reconstruction and to measure outcomes associated with IVC reconstruction among patients with retroperitoneal malignant disease. Methods All patients undergoing IVC reconstruction at our quaternary care hospital between November 2004 and February 2018 were identified using billing data (Current Procedural Terminology code 34502). Patients who underwent resection of the IVC for tumor involvement were enrolled in our study; data were collected on demographics, operative intervention, type of reconstruction, postoperative course, and 1-year outcomes. Patency rates were assessed by reviewing postoperative imaging including computed tomography, magnetic resonance imaging, ultrasound, and venography. Two-year mortality and patency were calculated using Kaplan-Meier analysis methods. Results We identified 52 (46% female) patients who underwent IVC reconstruction for retroperitoneal malignant disease. The mean age was 53.6 years (range, 23-80 years). Procedures performed included primary repair (n = 17 [33%]), patch angioplasty (n = 18 [35%]), and interposition grafting (n = 17 [33%]). The mean length of stay was 16 days and did not vary significantly by group. Patients undergoing interposition graft were discharged on aspirin 81 mg daily. The 30-day survival rate was 96.2% (95% confidence interval [CI], 90.9-100), 1-year survival rate was 75.1% (95% CI, 62.8-87.4), and 2-year survival rate was 64.7% (95% CI, 50.5-78.9). There were no intraoperative deaths. The 30-day primary patency rate was 96% (95% CI, 90.7-100.0), 1-year primary patency rate was 88.8% (95% CI, 79.4-98.2), and 2-year primary patency rate was 77.5% (95% CI, 63.0-92.0). Seven patients (14%) developed nonocclusive thrombus within the IVC, and 16 patients (30%) developed postoperative symptoms of venous obstruction. Conclusions IVC reconstruction is a safe option for patients requiring IVC resection during oncologic surgery as evidenced by 1-year survival of 75% and 1-year primary patency approaching 90%. The overall rate of postoperative thrombus development was low and similar across all groups. In the management of primary and secondary retroperitoneal malignant disease with IVC infiltration, IVC reconstruction should be considered to achieve appropriate oncologic resection while minimizing possible complications from caval interruption.

Background: The value of detecting PAD using the ankle-brachial index (ABI) among asymptomatic adults is controversial. However, the detection of PAD can help informing cardiovascular preventive therapy (e.g., statin and aspirin) and identifying PAD as a potential cause of reduced leg function which may be improved by exercise therapy. No previous studies have quantified the proportion of community-dwelling older adults who may benefit from PAD detection from these perspectives. Methods: In 4375 ARIC participants aged 66-90 between 2011-2013 without previously diagnosed PAD, we assessed the proportion of participants with newly detected PAD based on ABI who were not taking statin or aspirin and had reduced leg function (defined as the Short Physical Performance Battery score ≤9). Subsequently, we explored factors associated with higher odds of potentially benefitting from the detection of PAD (i.e., not taking statin/aspirin or having reduced leg function despite the presence of PAD) using logistic regression models. ABI ≤0.9 was the primary definition of PAD, but according to recent guidelines we secondarily explored ABI ≤1.0 or >1.4. Results: There were 236 (5.4%) participants with an ABI ≤0.9, among which 119 were not taking statin or aspirin and 151 had reduced leg function (77 having both conditions), leading to 193 (4.4%) participants potentially benefitting from PAD detection with ABI. The corresponding proportion was 12.4% (544) when abnormal ABI was defined as ≤1.0 or >1.4. Older age (per 10 years), black race, and current smoking were strongly associated with higher odds of potentially benefitting from detection of PAD (adjusted odds ratio >2.5). The proportion of benefitting from PAD detection was especially high in current smokers followed by blacks (proportions shown in Figure1). Conclusions: Up to 12.4% of community-dwelling older adults may benefit from PAD detection with ABI. The proportion are especially high among current smokers and black race, with implications on targeted ABI assessment for detecting PAD.

Background Public statements about the effect of smoking on cardiovascular disease are predominantly based on investigations of coronary heart disease (CHD) and stroke, although smoking is recognized as a strong risk factor for peripheral artery disease (PAD). No study has comprehensively compared the long-term association of cigarette smoking and its cessation with the incidence of 3 major atherosclerotic diseases (PAD, CHD, and stroke). Objectives The aim of this study was to quantify the long-term association of cigarette smoking and its cessation with the incidence of the 3 outcomes. Methods A total of 13,355 participants aged 45 to 64 years in the ARIC (Atherosclerosis Risk In Communities) study without PAD, CHD, or stroke at baseline (1987 to 1989) were included. The associations of smoking parameters (pack-years, duration, intensity, and cessation) with incident PAD were quantified and contrasted with CHD and stroke using Cox models. Results Over a median follow-up of 26 years, there were 492 PAD cases, 1,798 CHD cases, and 1,106 stroke cases. A dose-response relationship was identified between pack-years of smoking and 3 outcomes, with the strongest results for PAD. The pattern was consistent when investigating duration and intensity separately. A longer period of smoking cessation was consistently related to lower risk of PAD, CHD, and stroke, but a significantly elevated risk persisted up to 30 years following smoking cessation for PAD and up to 20 years for CHD. Conclusions All smoking measures showed significant associations with 3 major atherosclerotic diseases, with the strongest effect size for incident PAD. The risk due to smoking lasted up to 30 years for PAD and 20 years for CHD. Our results further highlight the importance of smoking prevention and early smoking cessation, and indicate the need for public statements to take PAD into account when acknowledging the impact of smoking on overall cardiovascular health.

Critical limb ischemia (CLI) has been defined as rest pain or tissue loss in patients who have an ankle-brachial index (ABI) ≤0.50, ankle pressure (AP)70 mm Hg, or toe pressure (TP)50 mm Hg. Data suggesting that these patients are at high risk for limb loss without successful revascularization are limited. This study was designed to identify limb loss and mortality rates in patients who did not respond to revascularization or who were not revascularized to determine whether CLI hemodynamic criteria accurately identify patients at high risk for limb loss.Between 2008 and 2010, all patients undergoing lower extremity arterial duplex ultrasound testing at our hospital were identified. Those with ABI0.50, AP70 mm Hg, or TP50 mm Hg were retrospectively reviewed to determine whether they had symptoms of rest pain, ischemic ulceration, or gangrene qualifying them for analysis in the database. Patients who underwent revascularization and subsequently had postrevascularization ABI, AP, or TP greater than the CLI criteria were removed from the cohort. Demographic factors, wound healing, amputation rates, and mortality were obtained and analyzed in relation to the initial APs and TPs. Outcomes were measured by Kaplan-Meier life-table analysis and Cox proportional hazards models.In 381 patients identified in the study, 443 limbs met CLI criteria. After revascularization, 98 limbs with ABI or TP that improved to0.5 and50 mm Hg, respectively, were removed from the study cohort. In 45 limbs, patients did not respond to initial revascularization as their ABI, AP, or TP remained within CLI criteria. These limbs remained in the patient cohort, yielding a final group of 296 patients and 345 limbs. Mean follow-up was 2 years. In the entire patient cohort, limb loss occurred in 24% at 1 year and in 31% at 3 years. Mortality was 32% at 1 year and 56% at 3 years. Amputation-free survival was 54% at 1 year and 28% at 3 years. Lower TPs were associated with a statistically higher incidence of amputation. Among those with an initial TP ≤10 mm Hg (n = 85), limb loss occurred in 46% at 1 year and 60% at 3 years. This limb loss was significantly greater than limb loss among those with a TP of 31 to 50 mm Hg (n = 115; 18% at 3 years; P.001) Amputation-free survival in patients with a TP ≤10 mm Hg was 8% at 3 years.CLI is associated with a high mortality, but not all patients with currently defined hemodynamic criteria for CLI are at high risk of limb loss. Patients with a TP between 31 and 50 mm Hg (41% of the cohort) and not receiving revascularization or not responding hemodynamically to revascularization experienced a low risk of limb loss. We recommend revising the hemodynamic criteria for CLI to better identify patients at high risk for limb loss who require intervention to improve outcomes.