Prospective assessment of dynamic changes in frailty and its impact on early clinical outcomes following physician-modified fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

INTRODUCTION: Frailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. METHODS: Consecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. RESULTS: Seventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: -96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). CONCLUSIONS: Preoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.

Understanding the Impact of Enhanced Recovery Programs on Social Vulnerability, Race, and Colorectal Surgery Outcomes.

BACKGROUND: Increasing social vulnerability, measured by the Social Vulnerability Index, has been associated with worse surgical outcomes. However, less is known about the impact of social vulnerability on patients who underwent colorectal surgery under enhanced recovery programs. OBJECTIVE: We hypothesized that increasing social vulnerability is associated with worse outcomes before enhanced recovery implementation, but that after implementation, disparities in outcomes would be reduced. DESIGN: Retrospective cohort study using multivariable logistic regression to identify associations of social vulnerability and enhanced recovery with outcomes. SETTINGS: Institutional American College of Surgeons National Surgical Quality Improvement Program database. PATIENTS: Patients undergoing elective colorectal surgery (2010-2020). Enhanced recovery programs were implemented in 2015. Those adhering to 70% or more of enhanced recovery program components were defined as enhanced recovery and all others as nonenhanced recovery. OUTCOMES: Length of stay, complications, and readmissions. RESULTS: Of 1523 patients, 589 (38.7%) were in the enhanced recovery group, with 625 patients (41%) in the lowest third of the Social Vulnerability Index, 411 (27%) in the highest third. There were no differences in Social Vulnerability Index distribution by the enhanced recovery group. On multivariable modeling, social vulnerability was not associated with increased length of stay, complications, or readmissions in the enhanced recovery group. Black race was associated with increased length of stay in both the nonenhanced recovery (OR 1.2; 95% CI, 1.1-1.3) and enhanced recovery groups (OR 1.2; 95% CI, 1.1-1.4). Enhanced recovery adherence was associated with reductions in racial disparities in complications as the Black race was associated with increased odds of complications in the nonenhanced recovery group (OR 1.9; 95% CI, 1.2-3.0) but not in the enhanced recovery group (OR 0.8; 95% CI, 0.4-1.6). LIMITATIONS: Details of potential factors affecting enhanced recovery program adherence were not assessed and are the subject of current work by this team. CONCLUSION: High social vulnerability was not associated with worse outcomes among both enhanced recovery and nonenhanced recovery colorectal patients. Enhanced recovery program adherence was associated with reductions in racial disparities in complication rates. However, disparities in length of stay remain, and work is needed to understand the underlying mechanisms driving these disparities. See Video Abstract . COMPRENDIENDO EL IMPACTO DE LOS PROGRAMAS DE RECUPERACIN MEJORADA EN LA VULNERABILIDAD SOCIAL, LA RAZA Y LOS RESULTADOS DE LA CIRUGA COLORRECTAL: ANTECEDENTES:El aumento de la vulnerabilidad social medida por el índice de vulnerabilidad social se ha asociado con peores resultados quirúrgicos. Sin embargo, se sabe menos sobre el impacto de la vulnerabilidad social en los pacientes de cirugía colorrectal bajo programas de recuperación mejorados.OBJETIVO:Planteamos la hipótesis de que el aumento de la vulnerabilidad social se asocia con peores resultados antes de la implementación de la recuperación mejorada, pero después de la implementación, las disparidades en los resultados se reducirían.DISEÑO:Estudio de cohorte retrospectivo que utilizó regresión logística multivariable para identificar asociaciones de vulnerabilidad social y recuperación mejorada con los resultados.ESCENARIO:Base de datos institucional del Programa de Mejora Nacional de la Calidad de la Cirugía del American College of Surgeons.PACIENTES:Pacientes sometidos a cirugía colorrectal electiva (2010-2020). Programas de recuperación mejorada implementados en 2015. Aquellos que se adhieren a ≥70% de los componentes del programa de recuperación mejorada definidos como recuperación mejorada y todos los demás como recuperación no mejorada.MEDIDAS DE RESULTADO:Duración de la estancia hospitalaria, complicaciones y reingresos.RESULTADOS:De 1.523 pacientes, 589 (38,7%) estaban en el grupo de recuperación mejorada, con 732 (40,3%) pacientes en el tercio más bajo del índice de vulnerabilidad social, 498 (27,4%) en el tercio más alto, y no hubo diferencias en la distribución del índice vulnerabilidad social por grupo de recuperación mejorada. En el modelo multivariable, la vulnerabilidad social no se asoció con una mayor duración de la estancia hospitalaria, complicaciones o reingresos en ninguno de los grupos de recuperación mejorada. La raza negra se asoció con una mayor duración de la estadía tanto en el grupo de recuperación no mejorada (OR1,2, IC95% 1,1-1,3) como en el grupo de recuperación mejorada (OR1,2, IC95% 1,1-1,4). La adherencia a la recuperación mejorada se asoció con reducciones en las disparidades raciales en las complicaciones, ya que la raza negra se asoció con mayores probabilidades de complicaciones en el grupo de recuperación no mejorada (OR1,9, IC95% 1,2-3,0), pero no en el grupo de recuperación mejorada (OR0,8, IC95% 0,4-1,6).LIMITACIONES:No se evaluaron los detalles de los factores potenciales que afectan la adherencia al programa de recuperación mejorada y son el tema del trabajo actual de este equipo.CONCLUSIÓN:La alta vulnerabilidad social no se asoció con peores resultados entre los pacientes colorrectales con recuperación mejorada y sin recuperación mejorada. Una mayor adherencia al programa de recuperación se asoció con reducciones en las disparidades raciales en las tasas de complicaciones. Sin embargo, persisten disparidades en la duración de la estadía y es necesario trabajar para comprender los mecanismos subyacentes que impulsan estas disparidades. (Traducción-Dr. Felipe Bellolio ).

Racial and Ethnic Underserved Populations Prescription Analgesic Use Before and After Lower Extremity Amputation in US Medicare.

BACKGROUND: Racial disparities exist in access to health care and management of multiple health conditions including chronic pain; however, racial disparities in pre- and postoperative pain management in lower extremity amputation are not well-studied. Our objective was to examine the association between different racial and ethnic groups and prescription opioid and other analgesics use before and after lower extremity amputation. We hypothesize prescription opioid and other analgesic use among Black, Hispanic, and Native American US Medicare beneficiaries undergoing lower extremity amputations will be lower compared to White US Medicare beneficiaries. METHODS: This retrospective cohort study included a 5% national sample of all Medicare beneficiaries from 2011 to 2015 and 15% national sample of fee-for-service Medicare beneficiaries from 2016 to 2018 undergoing nontraumatic, lower extremity amputations. The exposure of interest was racial and ethnic group membership (ie, Black, Hispanic, Native American, White, and others-with others being the combination of the categories Asian and other) as provided in Medicare claims data. Using multivariable generalized estimating equations with a logistic link to account for repeated measurements over time, we estimated the odds of prescription opioid use within 6 months before and after lower extremity amputation across different racial and ethnic groups separately, adjusting for sociodemographic and health status factors (eg, Elixhauser index). Adjusted odds ratios (aORs) and 95% confidence intervals (95% CI) were reported. RESULTS: Among 16,068 eligible beneficiaries who underwent major and minor amputations (mean age = 65.1 ± 12.7 years; female = 36.1%), 10,107 (62.9%) were White, 3462 (21.5%) were Black, 1959 (12.2%) were Hispanic, 247 (1.5%) were Native American, and 151 (2.9%) were beneficiaries of other races. During the 6 months before lower extremity amputation, Hispanic beneficiaries (aOR, 0.71, 95% CI, 0.65-0.78) and beneficiaries of other races (aOR, 0.60, 95% CI, 0.47-0.76) had significantly lower odds of using prescription opioids compared to White beneficiaries. Similarly, Hispanic beneficiaries (aOR, 0.78, 95% CI, 0.71-0.84) and beneficiaries of other races (aOR, 0.63, 95% CI, 0.51-0.78) were associated with lower odds of opioid use in the 6 months after amputation compared to White beneficiaries. CONCLUSIONS: Among fee-for-service Medicare beneficiaries, Hispanic and other (eg, Asian) fee-for-service Medicare beneficiaries had lower odds of prescription opioid use than their White counterparts before and after nontraumatic, lower extremity amputations. Efforts to determine the underlying reasons are needed to ensure equitable health care access.

The Impact of Mental Health on Patient Outcomes in Peripheral Arterial Disease and Critical Limb Threatening Ischemia and Potential Avenues to Treatment.

The physical consequences of peripheral artery disease (PAD) are well established; however, the impact of comorbid mental health disorders such as depression and anxiety are not well understood. The impact of psychological stress is not only associated with worse perioperative morbidity and mortality but also with a physiologic cascade that accelerates plaque formation. Increasing screening to identify and subsequently treat comorbid mental health disorders is an integral next step in improving outcomes in PAD management. Failure to adequately address social and psychological impact on PAD patients will further widen the gap in disparities faced by high-risk and disenfranchised populations. Integration of mental health professionals, addiction specialists, and community navigators into multidisciplinary care teams can bolster support for PAD patients and improve outcomes.

Impact of COVID-19 on patients undergoing scheduled procedures for chronic venous disease.

OBJECTIVE: The COVID-19 pandemic has drastically altered the medical landscape. Various strategies have been employed to preserve hospital beds, personal protective equipment, and other resources to accommodate the surges of COVID-19 positive patients, hospital overcapacities, and staffing shortages. This has had a dramatic effect on vascular surgical practice. The objective of this study is to analyze the impact of the COVID-19 pandemic on surgical delays and adverse outcomes for patients with chronic venous disease scheduled to undergo elective operations. METHODS: The Vascular Surgery COVID-19 Collaborative (VASCC) was founded in March 2020 to evaluate the outcomes of patients with vascular disease whose operations were delayed. Modules were developed by vascular surgeon working groups and tested before implementation. A data analysis of outcomes of patients with chronic venous disease whose surgeries were postponed during the COVID-19 pandemic from March 2020 through February 2021 was performed for this study. RESULTS: A total of 150 patients from 12 institutions in the United States were included in the study. Indications for venous intervention were: 85.3% varicose veins, 10.7% varicose veins with venous ulceration, and 4.0% lipodermatosclerosis. One hundred two surgeries had successfully been completed at the time of data entry. The average length of the delay was 91 days, with a median of 78 days. Delays for venous ulceration procedures ranged from 38 to 208 days. No patients required an emergent intervention due to their venous disease, and no patients experienced major adverse events following their delayed surgeries. CONCLUSIONS: Interventions may be safely delayed for patients with venous disease requiring elective surgical intervention during the COVID-19 pandemic. This finding supports the American College of Surgeons' recommendations for the management of elective vascular surgical procedures. Office-based labs may be safe locations for continued treatment when resources are limited. Although the interventions can be safely postponed, the negative impact on quality of life warrants further investigation.

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

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

WIfI Classification Based Analysis of Risk Factors for Outcomes in Patients with Chronic Limb Threatening Ischaemia after Endovascular Revascularisation Therapy.

OBJECTIVE: The evaluation of limb status with the Wound, Ischaemia, and foot Infection (WIfI) classification and the assessment of patient risks combined with systemic factors, are recommended in patients with chronic limb threatening ischaemia (CLTI). However, there is little evidence of the application of the WIfI classification in the Chinese population. This study aimed to verify the use of the WIfI classification in a Chinese patient population, and to further identify local and systemic independent predictors of adverse CLTI outcomes. METHODS: A total of 474 patients who underwent endovascular therapy (EVT) for CLTI in a tertiary hospital between July 2017 and September 2020 were included in this retrospective study. The outcomes included one year major adverse limb events (MALEs), one year all cause mortality, and one year amputation free survival (AFS). Cox regression was used to analyse the association between risk factors and adverse outcomes. RESULTS: In total, 104 (21.9%) all cause deaths were recorded. The rate of MALEs was 17.5%, while the AFS was 71.9%. Multivariable analysis revealed that a body mass index (BMI) < 18.5 kg/m2 (p = .002), a left ventricular ejection fraction (LVEF) < 50% (p < .001), and WIfI wound grade (p < .001) were independent risk factors for MALEs, while age ≥ 77 years (p = .031), BMI < 18.5 kg/m2 (p < .001), coronary heart disease (p = .040), and WIfI clinical stages (p = .021) were independent risk factors for death in patients with CLTI. Age ≥ 77 years (p = .003), BMI < 18.5 kg/m2 (p < .001), coronary heart disease (p = .012), LVEF < 50% (p < .001), WIfI wound grade (p = .004), and WIfI clinical stages (p = .044) were independently associated with a decreased AFS rate. CONCLUSIONS: This study has confirmed the predictive ability of the WIfI classification for Chinese patients with CLTI who underwent EVT. Wound grade was the most sensitive and important risk factor of the three components of WIfI. In addition, systemic factors should be considered to ensure a more accurate prognosis prediction and appropriate clinical decision making in patients with CLTI.

Examining health care access disparities in Hispanic populations with peripheral artery disease and diabetes.

INTRODUCTION: This study investigated disparities in health care access for Hispanic adults with diabetes and peripheral artery disease (PAD) who are at risk of lower-extremity amputation and other cardiovascular morbidities and mortalities. METHODS: We utilized the health care access survey data from the All of Us research program to examine adults (⩾ 18 years) with either diabetes and/or PAD. The primary associations evaluated were: could not afford medical care and delayed getting medical care in the past 12 months. Multivariable logistic regression models were used to assess the association of Hispanic ethnicity and survey responses, adjusting for age, sex, income, health insurance, and employment status. RESULTS: Among 24,104 participants, the mean age was 54.9 years and 67% were women. Of these, 8.2% were Hispanic adults. In multivariable analysis, Hispanic adults were more likely to be unable to afford seeing a health care provider, and receiving emergency care, follow-up care, and prescription medications (p < 0.05) than non-Hispanic adults. Furthermore, Hispanic adults were more likely to report being unable to afford medical care due to cost (odds ratios [OR] 1.72, 95% CI 1.50-1.99), more likely to purchase prescription drugs from another country (OR 2.20, 95% CI 1.69-2.86), and more likely to delay getting medical care due to work (OR 1.46, 95% CI 1.22-1.74) and child care (OR 1.80, 95% CI 1.35-2.39) issues than non-Hispanic White adults. CONCLUSION: The Hispanic population with diabetes and PAD faces substantial barriers in health care access, including a higher likelihood of delaying medical care and being unable to afford it.

Interruption of Insurance Coverage and the Risk of Amputation in Patients with Pre-Existing Commercial Health Insurance and Peripheral Artery Disease.

BACKGROUND: Peripheral artery disease (PAD) is linked with an increased risk of lower extremity amputation and multiple socioeconomic factors attenuate this risk. Prior studies have demonstrated increased rates of amputation in PAD patients with suboptimal or no insurance coverage. However, the impact of insurance loss in PAD patients with pre-existing commercial insurance coverage is unclear. In this study, we evaluated the outcomes of PAD patients who lose commercial insurance coverage. METHODS: The Pearl Diver all-payor insurance claims database was used to identify adult patients (>18 years) with a PAD diagnosis from 2010 to 2019. The study cohort included patients with pre-existing commercial insurance and at least 3 years continuous enrollment after diagnosis of PAD. Patients were stratified based on whether they had an interruption of commercial insurance coverage over time. Patients who transitioned from commercial insurance to Medicare and other government-sponsored insurance during follow up were excluded. Adjusted comparison (1:1 ratio) was performed using propensity matching for age, gender, the Charlson Comorbidity Index (CCI), and relevant comorbidities. The main outcomes were major amputation and minor amputation. Cox proportional hazards ratios and Kaplan-Meier estimate were used to examine the association between loss of insurance and outcomes. RESULTS: Among the 214,386 patients included, 43.3% (n = 92,772) had continuous commercial insurance coverage and 56.7% (n = 121,614) had interruption of coverage (transition to uninsured or Medicaid coverage) during follow up. In the crude cohort and matched cohort, interruption of coverage was associated with lower major amputation-free survival on Kaplan Meier estimate (P < 0.001). In the crude cohort, interruption of coverage was associated with 77% increased risk of major amputation (OR 1.77, 95% CI 1.49-2.12) and a 41% high risk of minor amputation (OR 1.41, 95% CI 1.31-1.53). In the matched cohort, interruption of coverage was associated with 87% increased risk of major amputation (OR 1.87, 95% CI 1.57-2.25) and a 104% increased risk of minor amputation (OR 1.47, 95% CI 1.36-1.60). CONCLUSIONS: Interruption of insurance coverage in PAD patients with pre-existing commercial health insurance was associated with increased risks of lower extremity amputation.

Taking a Load Off: User Perceptions of Smart Offloading Walkers for Diabetic Foot Ulcers Using the Technology Acceptance Model.

People with diabetic foot ulcers (DFUs) are commonly prescribed offloading walkers, but inadequate adherence to prescribed use can be a barrier to ulcer healing. This study examined user perspectives of offloading walkers to provide insight on ways to help promote adherence. Participants were randomized to wear: (1) irremovable, (2) removable, or (3) smart removable walkers (smart boot) that provided feedback on adherence and daily walking. Participants completed a 15-item questionnaire based on the Technology Acceptance Model (TAM). Spearman correlations assessed associations between TAM ratings with participant characteristics. Chi-squared tests compared TAM ratings between ethnicities, as well as 12-month retrospective fall status. A total of 21 adults with DFU (age 61.5 ± 11.8 years) participated. Smart boot users reported that learning how to use the boot was easy (ρ =-0.82, p≤ 0.001). Regardless of group, people who identified as Hispanic or Latino, compared to those who did not, reported they liked using the smart boot (p = 0.05) and would use it in the future (p = 0.04). Non-fallers, compared to fallers, reported the design of the smart boot made them want to wear it longer (p = 0.04) and it was easy to take on and off (p = 0.04). Our findings can help inform considerations for patient education and design of offloading walkers for DFUs.

Diabetic Foot Ulcers: A Review.

Importance: Approximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. These ulcers precede 80% of lower extremity amputations among people diagnosed with diabetes and are associated with an increased risk of death. Observations: Neurological, vascular, and biomechanical factors contribute to diabetic foot ulceration. Approximately 50% to 60% of ulcers become infected, and about 20% of moderate to severe infections lead to lower extremity amputations. The 5-year mortality rate for individuals with a diabetic foot ulcer is approximately 30%, exceeding 70% for those with a major amputation. The mortality rate for people with diabetic foot ulcers is 231 deaths per 1000 person-years, compared with 182 deaths per 1000 person-years in people with diabetes without foot ulcers. People who are Black, Hispanic, or Native American and people with low socioeconomic status have higher rates of diabetic foot ulcer and subsequent amputation compared with White people. Classifying ulcers based on the degree of tissue loss, ischemia, and infection can help identify risk of limb-threatening disease. Several interventions reduce risk of ulcers compared with usual care, such as pressure-relieving footwear (13.3% vs 25.4%; relative risk, 0.49; 95% CI, 0.28-0.84), foot skin measurements with off-loading when hot spots (ie, greater than 2 °C difference between the affected foot and the unaffected foot) are found (18.7% vs 30.8%; relative risk, 0.51; 95% CI, 0.31-0.84), and treatment of preulcer signs. Surgical debridement, reducing pressure from weight bearing on the ulcer, and treating lower extremity ischemia and foot infection are first-line therapies for diabetic foot ulcers. Randomized clinical trials support treatments to accelerate wound healing and culture-directed oral antibiotics for localized osteomyelitis. Multidisciplinary care, typically consisting of podiatrists, infectious disease specialists, and vascular surgeons, in close collaboration with primary care clinicians, is associated with lower major amputation rates relative to usual care (3.2% vs 4.4%; odds ratio, 0.40; 95% CI, 0.32-0.51). Approximately 30% to 40% of diabetic foot ulcers heal at 12 weeks, and recurrence after healing is estimated to be 42% at 1 year and 65% at 5 years. Conclusions and Relevance: Diabetic foot ulcers affect approximately 18.6 million people worldwide each year and are associated with increased rates of amputation and death. Surgical debridement, reducing pressure from weight bearing, treating lower extremity ischemia and foot infection, and early referral for multidisciplinary care are first-line therapies for diabetic foot ulcers.

Economic value of podiatry service in limb salvage alliance.

OBJECTIVE/BACKGROUND: Over the past decade, multidisciplinary "toe and flow" programs have gained great popularity, with proven benefits in limb salvage. Many vascular surgeons have incorporated podiatrists into their practices. The viability of this practice model requires close partnership, hospital support, and financial sustainability. We intend to examine the economic values of podiatrists in a busy safety-net hospital in the Southwest United States. METHODS: An administrative database that captured monthly operating room (OR) cases, clinic encounters, in-patient volume, and total work relative value units (wRVUs) in an established limb salvage program in a tertiary referral center were examined. The practice has a diverse patient population with >30% of minority patients. During a period of 3 years, there was a significant change in the number of podiatrists (from 1 to 4) within the program, whereas the clinical full-time employees for vascular surgeons remained relatively stable. RESULTS: The limb salvage program experienced >100% of growth in total OR volumes, clinic encounters, and total wRVUs over a period of 4 years. A total of 35,591 patients were evaluated in a multidisciplinary limb salvage clinic, and 5535 procedures were performed. The initial growth of clinic volume and operative volume (P < .01) were attributed by the addition of vascular surgeons in year one. However, recruitment of podiatrists to the program significantly increased clinic and OR volume by an additional 60% and >40%, respectively (P < .01) in the past 3 years. With equal number of surgeons, podiatry contributed 40% of total wRVUs generated by the entire program in 2019. Despite the fact that that most of the foot and ankle procedures that were regularly performed by vascular surgeons were shifted to the podiatrists, vascular surgeons continued to experience an incremental increase in operative volume and >10% of increase in wRVUs. CONCLUSIONS: This study shows that the value of close collaboration between podiatry and vascular in a limb salvage program extends beyond a patient's clinical outcome. A financial advantage of including podiatrists in a vascular surgery practice is clearly demonstrated.

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

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

The patient's perspective of diabetic foot ulceration: A phenomenological exploration of causes, detection and care seeking.

AIMS: Diabetic foot ulceration can contribute to lowered life expectancy and quality of life for people with diabetes, and yet, scant attention has been given to improving preventive and educational measures. This article uses a phenomenological approach to explore individuals' lived experiences of diabetic foot ulcerations to explore factors that can be harnessed to achieve improved outcomes. DESIGN: This was a qualitative study using semi-structured interviews grounded in a phenomenological framework to explore how patients perceive and understand their foot problems. METHODS: Study participants were recruited from February 2020 to February 2021 from a tertiary referral centre that treats foot problems in persons with diabetes. A total of 15 Hispanic, Native American and White patients participated in the study. We conducted in-depth semi-structured interviews which were audio recorded with the participant's consent. Interview data were transcribed and analysed with Dedoose data management software. RESULTS: Analysis revealed findings in two primary domains: (1) how patients perceive foot ulceration, with themes around limited understandings of foot ulceration, close sensory observation of foot problems and barriers to ulcer perception and (2) how patients experience the timing of foot ulceration, with themes on how time perceptions shifted as foot problems became more serious, which correlated closely to how patients responded to their foot problems. CONCLUSION: Despite the close sensory observation of their feet, people with diabetes face an array of barriers to recognizing and understanding the implications of diabetic foot ulceration, which can lead to delayed care seeking. Nurses can play a critical role in promoting patient education and improving patient self-management of foot ulcers. IMPACT: This phenomenological study offers important lessons to guide nurses and other providers in enhancing patient self-management of DFUs and improving care outcomes by expanding an understanding of DFU early warning signs, the imperative to seek medical care quickly, and addressing possible barriers.

The impact of hemoglobin A1c on outcomes after lower extremity bypass.

OBJECTIVE: Diabetes has been shown to be associated with increased risk of postoperative complications after lower extremity bypass (LEB), although it is unclear whether medium-term glucose control affects outcomes. This study aimed to assess the association of perioperative hemoglobin A1c (HbA1c) level on perioperative outcomes after LEB. METHODS: We examined consecutive infrainguinal LEBs for chronic limb-threatening ischemia (CLTI) using the Vascular Quality Initiative database (2007-2018). Perioperative HbA1c levels were stratified into <5.7%, 5.7% to 6.5%, and >6.5%. Propensity score matching on demographics, medical history, and procedural characteristics was used to select comparable patients across HbA1c groups. The primary outcome was postoperative wound infection. Multivariable analyses were performed for matched and unmatched groups using Cox proportional hazards models for survival outcomes and logistic regression for binary outcomes with association expressed by adjusted hazard ratio (aHR) or adjusted odds ratio (aOR) and corresponding 95% confidence intervals (CIs). RESULTS: The CLTI cohort included 8171 infrainguinal LEBs: 631 (7.7%) had HbA1c <5.7%; 1691 (20.6%), 5.7% to 6.5%; and 5849 (71.6%), >6.5%. There was no difference in rates of wound infection in the CLTI cohort (HbA1c ≤5.7%, 3.8%; HbA1c 5.7%-6.5%, 3.7%; HbA1c >6.5%, 3.2%; P = .53) or matched cohort (4.3%, 4.5%, 3.4%; P = .62). There were no differences in perioperative mortality in the CLTI cohort (2.5%, 1.7%, 1.5%; P = .16) or the matched cohort (2.7%, 2.3%, 2.2%; P = .84). In multivariable analysis, there was no significant association between HbA1c and wound infection in the CLTI cohort (HbA1c 5.7%-6.5% vs <5.7%: aOR, 0.91 [95% CI, 0.56-1.50; P = .72]; HbA1c >6.5% vs <5.7%: aOR, 0.81 [95% CI, 0.52-1.26; P = .35]). There was, however, a significant association between decreased HbA1c and mortality (HbA1c 5.7%-6.5% vs <5.7%: aHR, 0.77 [95% CI, 0.61-0.97; P = .03]; HbA1c >6.5% vs <5.7%: aHR, 0.75 [95% CI, 0.61-0.93; P = .01]). CONCLUSIONS: Our study suggests no significant association of increased HbA1c level and perioperative complications. Additional investigation is required to further evaluate the impact of short-term glycemic control and long-term outcomes of patients undergoing LEB.

Association of state tobacco control policies with active smoking at the time of intervention for intermittent claudication.

OBJECTIVE: Active smoking among patients undergoing interventions for intermittent claudication (IC) is associated with poor outcomes. Notwithstanding, current levels of active smoking in these patients are high. State-level tobacco control policies have been shown to reduce smoking in the general US population. We evaluated whether state cigarette taxes and 100% smoke-free workplace legislation are associated with active smoking among patients undergoing interventions for IC. METHODS: We queried the Vascular Quality Initiative database for peripheral endovascular interventions, infrainguinal bypasses, and suprainguinal bypasses for IC. Active smoking at the time of intervention was defined as smoking within one month of intervention. We implemented difference-in-differences analysis to isolate changes in active smoking owing to cigarette taxes (adjusted for inflation) and implementation of smoke-free workplace legislation. The difference-in-differences models estimated the causal effects of tobacco policies by adjusting for concurrent temporal trends in active smoking unrelated to cigarette taxes or smoke-free workplace legislation. The models controlled for age, sex, race/ethnicity, insurance type, diabetes, chronic obstructive pulmonary disease, state, and year. We tested interactions of taxes with age and insurance. RESULTS: Data were available for 59,847 patients undergoing interventions for IC in 25 states from 2011 to 2019. Across the study period, active smoking at the time of intervention decreased from 48% to 40%. Every $1.00 cigarette tax increase was associated with a 6-percentage point decrease in active smoking (95% confidence interval, -10 to -1 percentage points; P = .02), representing an 11% decrease relative to the baseline proportion of patients actively smoking. The effect of cigarettes taxes was greater in older patients and those on Medicare. Among patients aged 60 to 69 and 70 to 79 years, every $1.00 tax increase resulted in 14% and 21% reductions in active smoking relative to baseline subgroup prevalences of 53% and 29%, respectively (P < .05 for both); however, younger age groups were not affected by tax increases. Among insurance groups, only patients on Medicare exhibited a significant change in active smoking with every $1.00 tax increase (an 18% decrease relative to a 33% baseline prevalence; P = .01). The number of states implementing smoke-free workplace legislation increased from 9 to 14 by 2019; however, this policy was not significantly associated with active smoking prevalence. At follow-up (median, 12.9 months), $1.00 tax increases were still associated with decreased smoking prevalence (a 25% decrease relative to a 33% baseline prevalence; P < .001). CONCLUSIONS: Cigarette tax increases seem to be an effective strategy to decrease active smoking among patients undergoing interventions for IC. Older patients and Medicare recipients are the most responsive to tax increases.

Intravenous drug use history is not associated with poorer outcomes after arteriovenous access creation.

OBJECTIVE: Rising intravenous drug use (IVDU) paralleled with an increasing dialysis-dependent end-stage renal disease population may pose a challenge for creating and maintaining arteriovenous (AV) access for hemodialysis. We aimed to elucidate baseline characteristics and outcomes of AV access creation in the IVDU population. METHODS: The Vascular Quality Initiative (2011-2018) was queried for patients undergoing AV access placement. Univariable and multivariable analyses comparing outcomes of patients with and without IVDU history were performed. RESULTS: Of 33,404 patients undergoing AV access creation, 601 (1.8%) had IVDU history (21.8% current and 78.2% past users). IVDU patients receiving AV access were more often younger, male, nonwhite, smokers, homeless, Medicaid recipients, and hospitalized at the time of surgery (P < .001 for all). They exhibited higher rates of congestive heart failure, chronic obstructive pulmonary disease, and human immunodeficiency virus/acquired immunodeficiency syndrome (P < .05 for all). They more frequently had tunneled catheters at the time of access creation (53.6% vs 42%; P < .001) and had a previous AV access (25.3% vs 21.7%; P = .002). IVDU patients more often received prosthetic AV grafts (28.6% vs 18%; P < .001) and more often had anastomoses created to basilic veins (33.1% vs 23.2%; P < .001) but less often to cephalic veins (36.8% vs 57.7%; P < .001). IVDU patients had longer postoperative length of stay (2 ± 6 days vs 0.9 ± 5 days; P < .001) but no significant difference in 30-day mortality (1.7% vs 1.2%; P = .3). Comparing IVDU vs no IVDU cohorts, 1-year access infection-free survival (85.4% vs 86.6%; P = .382), primary patency loss-free survival (39.5% vs 37.9%; P = .335), endovascular/open reintervention-free survival (58% vs 57%; P = .705), and overall survival (89.7% vs 88.9%; P = .635) were similar. On multivariable analysis, IVDU was independently associated with postoperative length of stay (odds ratio, 1.64; 95% confidence interval, 1.35-2; P < .001) but not with 30-day mortality or 1-year infection-free survival, primary patency loss-free survival, reintervention-free survival, and all-cause mortality. The null results were confirmed in a propensity score-matched cohort. CONCLUSIONS: IVDU history was uncommon among patients undergoing AV access creation at Vascular Quality Initiative centers and was not independently associated with major morbidity or mortality postoperatively. IVDU patients more often received grafts or autogenous access with anastomoses to basilic veins. Although these patients frequently have more comorbidities, IVDU should not deter AV access creation.

Frailty Syndrome in Patients With Lower Extremity Amputation: Simplifying How We Calculate Frailty.

BACKGROUND: Frailty syndrome is an established predictor of adverse outcomes after surgical procedures. Our study aimed to compare the simplified National Surgical Quality Improvement Program 5-factor-modified frailty index (mFI-5) to its prior 11-factor-modified frailty index (mFI-11) with respect to the predictive ability for mortality, postoperative complications, and unplanned 30-d readmission in patients undergoing lower limb amputation. METHODS: The National Surgical Quality Improvement Program (2005-2012) databank was queried for all geriatric patients (>65 y) who underwent above-knee and below-knee amputations. We calculated each mFI by dividing the number of factors present for a patient by the total number of available factors. To assess the correlation between the mFI-5 and mFI-11, we used Spearman's rho rank coefficient. We then compared the two indices for each outcome (30-d complication, 30-d mortality, and 30-d readmission) and C-Statistic using predictive models. RESULTS: A total of 8681 patients were included with mean age of 76 ± 9 y, complication rate 35.8%, mortality rate 10.2%, and readmission rate 15.9%. There was no difference in type of amputation in frail and nonfrail. Correlation between the mFI-5 and mFI-11 was above 0.9 for all outcome measures. Both mFI-5 and mFI-11 indexes had strong predictive ability for mortality, postoperative complications, and 30-d readmissions. CONCLUSIONS: In patients undergoing major lower limb amputation, we found mFI-5 and the mFI-11 were equally effective in predicting postoperative outcomes. Frailty remained a strong predictor of postoperative complications, mortality, and 30-d readmission.

Upper Arm Arteriovenous Grafts are Superior over Forearm Arteriovenous Grafts in Upper Extremity Dialysis Access.

BACKGROUND: In this study, we compared the outcomes of forearm arteriovenous grafts (AVGs) and upper arm AVGs in a large, prospectively collected data set, which represents real-world experience with upper extremity prosthetic dialysis access, to determine if there are clinically significant differences in the upper arm and forearm positions. METHODS: We identified 2,063 patients who received upper extremity AVGs within the Vascular Quality Initiative data set (2010-2018). Axillary to axillary upper arm AVGs were excluded (n = 394) from the analysis. The main outcome measures were primary and secondary patency rates at 12 months. Other outcomes were 6-month wound infection, steal syndrome, and arm swelling. The log-rank test was used to evaluate patency loss using a Kaplan-Meier analysis. Cox proportional hazards models were used to examine adjusted association between locations (forearm and upper arm) and outcomes. RESULTS: There were 1,160 forearm AVGs and 509 upper arm brachial artery AVGs in the study cohort. Patients with forearm AVGs were more likely to have a body mass index > 30 (45% vs. 38%, P = 0.013), no history of previous access (73% vs. 63%, P < 0.001), and underwent local-regional anesthesia (56% vs. 43%, P < 0.001). The 12-month primary patency (51.5% vs. 62.9%, P < 0.001) and secondary patency (76.4% vs. 89.1%, P < 0.001) were significantly lower for forearm AVGs. Wound infection, steal syndrome, and arm swelling were similar between forearm AVGs and upper arm AVGs at the 6-month follow-up. In multivariable analysis, the primary patency loss (adjusted hazard ratio (aHR) 1.66, 95% confidence interval (CI) 1.33-2.01, P < 0.001) and 12-month secondary patency loss (aHR 2.71, 95% CI 1.84-3.98, P < 0.001) were significantly higher for forearm AVGs at 12 months. CONCLUSIONS: From this observational study of the Vascular Quality Initiative data set, the primary and secondary patency rates were superior for upper arm brachial artery AVGs compared with forearm AVGs.

Association of Medicaid Expansion with Tunneled Dialysis Catheter Use at the Time of First Arteriovenous Access Creation.

BACKGROUND: In the United States, many low-income patients initiating hemodialysis are uninsured before qualifying for Medicare. Inadequate access to predialysis care may delay their arteriovenous (AV) access creation and increase tunneled dialysis catheter (TDC) use. The 2014 Affordable Care Act expanded eligibility for Medicaid among low-income adults, but not every state adopted this measure. We evaluated whether Medicaid expansion was associated with decreased TDC use for hemodialysis initiation. METHODS: We queried the United States Vascular Quality Initiative state-level database for non-Medicare patients undergoing initial AV access creation from 2011 to 2018. We evaluated associations of receiving initial AV access in states that expanded Medicaid with concurrent TDC use, survival, and insurance coverage. RESULTS: Data were available for patients in 31 states: 19 states expanded Medicaid from January 2014 to February 2015. Among 8462 patients in the postexpansion period from March 2015 to December 2018, 58% were in Medicaid expansion states. Patients in Medicaid expansion states less often had concurrent TDCs (40% vs. 48%, P < 0.001). In multivariable analysis, Medicaid expansion was independently associated with fewer TDCs (OR 0.7, 95% CI 0.6-0.8, P < 0.001). Three-year survival was similar between patients in Medicaid expansion and nonexpansion states (84.7% vs. 85.2%, P = 0.053). Multivariable cox-regression confirmed the finding (HR 0.95, 95% CI 0.82-1.1, P = 0.482). In difference-in-differences analysis, Medicaid expansion was associated with a 9.2-percentage point increase in Medicaid coverage (95% CI 2.7-15.8, P = 0.009). Hispanic patients exhibited a 30.1-percentage point increase in any insurance coverage (95% CI 0.3-59.9, P = 0.048). CONCLUSIONS: Patients in Medicaid expansion states were less likely to have TDCs during initial AV access creation, suggesting earlier predialysis care. Hispanic patients benefited from increased insurance coverage. Expanding insurance options for the underserved may improve quality metrics and cost-savings for hemodialysis patients.