Association Between Diagnosis-to-Limb Revascularization Time and Clinical Outcomes in Outpatients With Chronic Limb-Threatening Ischemia: Insights From the CLIPPER Cohort.

BACKGROUND: The extent and consequences of ischemia in patients with chronic limb-threatening ischemia (CLTI) may change rapidly, and delays from diagnosis to revascularization may worsen outcomes. We sought to describe the association between time from diagnosis to endovascular lower extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI. METHODS AND RESULTS: In the CLIPPER cohort, comprising patients between 66 and 86 years old diagnosed with CLTI betweeen 2010 and 2019, we used Medicare claims data to identify patients who underwent outpatient endovascular revascularization within 180 days of diagnosis. We described the risk-adjusted association between D2L time and clinical outcomes. Among 1 130 065 patients aged between 66 and 86 years with CLTI, 99 221 (8.8%) underwent outpatient endovascular lower extremity revascularization within 180 days of their CLTI diagnosis. Among patients with D2L time <30 days, there was no association between D2L time and all-cause death or major lower extremity amputation. However, among patients with D2L time >30 days, each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (hazard ratio, 1.025 [95% CI, 1.014-1.036]). There was no association between D2L time and all-cause death. CONCLUSIONS: A delay of >30 days from CLTI diagnosis to lower extremity endovascular revascularization was associated with an increased risk of major lower extremity amputation among patients undergoing outpatient endovascular revascularization. Improving systems of care to reduce D2L time could reduce amputations.

Hepatitis C virus antibody seropositivity is associated with albuminuria but not peripheral artery disease in patients with type 2 diabetes.

Hepatitis C virus (HCV) infection is prevalent in patients with type 2 diabetes mellitus (DM). We aimed to investigate whether HCV antibody (Ab) seropositivity is associated with diabetic micro- and macro-vascular diseases. In this hospital-based cross-sectional study, we retrospectively collected data from patients who participated in the diabetes pay-for-performance program and underwent HCV Ab screening in the annual comprehensive assessment between January 2021 and March 2022. We examined the relationships of HCV Ab seropositivity with the spot urinary albumin-to-creatinine ratio (UACR) and ankle-brachial index (ABI) in patients aged ≥ 50 years with type 2 DM. A total of 1758 patients were enrolled, and 85 (4.83%) of the enrolled patients had HCV Ab seropositivity. Multivariable regression analyses revealed that albuminuria showed a dose-dependent association with HCV Ab seropositivity (UACR [30-299 mg/g]: odds ratio [OR] = 1.463, 95% confidence interval [CI] 0.872‒2.456); UACR [≥ 300 mg/g]: OR = 2.300, 95% CI 1.160‒4.562; P for trend = 0.015) when compared with normal albuminuria (UACR < 30 mg/g). However, the proportion of patients with peripheral arterial disease, defined as an ABI ≤ 0.9, was not significantly different between the groups with and without HCV Ab seropositivity (3.5% vs. 3.9%, P = 0.999). In conclusion, severely increased albuminuria, but not the ABI, showed a significant association with HCV Ab seropositivity in patients aged ≥ 50 years with type 2 DM.

Assessment of clinical and economic impact of rivaroxaban plus aspirin vs. aspirin alone as a secondary prophylaxis in patients with chronic and symptomatic peripheral arterial disease in the United States.

AIM: The objective in this study was to assess the clinical and economic implications of the inclusion of rivaroxaban as a secondary prophylaxis in patients with chronic or symptomatic peripheral artery disease (PAD) in the United States (US). METHODS: A cost-consequence model was adapted to evaluate the economic impact of rivaroxaban plus aspirin in a hypothetical 1-million-member health plan. The model inputs were taken from multiple sources: efficacy and safety of rivaroxaban + aspirin vs. aspirin alone were abstracted from COMPASS and VOYAGER randomized clinical trials; the prevalence of chronic and symptomatic PAD and incidence rates of clinical events (major adverse cardiac events [MACE], major adverse limb events [MALE], and major bleeding), were abstracted from the analysis of claims data; healthcare costs of clinical events and wholesale acquisition costs for rivaroxaban were abstracted from the literature and Red Book, respectively (2022 USD). One-way sensitivity analyses and subgroup analyses were also conducted. RESULTS: Over one year, with a 5% uptake of rivaroxaban, the model estimated rivaroxaban + aspirin to reduce 21 MACE/MALE events in the PAD patient population. The reduction in these clinical events offsets the increased risk of major bleeding (16 additional events), demonstrating a positive health benefit of the rivaroxaban addition. These benefits led to a $0.27 incremental cost per member per month (PMPM) to a US plan. The major driver of the incremental cost was the cost of rivaroxaban. In a subgroup of patients with the presence of any high-risk factor (heart failure, diabetes, renal insufficiency, or history of vascular disease affecting two or more vascular beds), the incremental PMPM cost was $0.13. CONCLUSIONS: Rivaroxaban + aspirin was found to provide positive net clinical benefit on the annual number of MACE/MALE avoided, with a modest increase in the PMPM cost.

Obesity prevalence and variability in management practices for patients with symptomatic peripheral artery disease.

Obesity has been associated with poor disease outcomes in patients with lower extremity peripheral arterial disease (PAD). Given evolving treatments for obesity, evaluating its prevalence and treatment practices are key to develop a holistic management of PAD. We aimed to examine prevalence of obesity and variability of management strategies in symptomatic PAD patients enrolled in the international multicenter PORTRAIT registry from 2011 to 2015. Obesity management strategies studied included weight and/or dietary counseling and prescription of weight loss medications (orlistat, lorcaserin, phentermine-topiramate, naltrexone-buproprion, and liraglutide). Use frequency of obesity management strategies were calculated by country and compared across centers using adjusted median odds ratios (MOR). Of 1002 patients included, 36 % had obesity. No patients received weight loss medications. Weight and/or dietary counseling was prescribed in only 20 % of patients with obesity with significant variability in practices between centers (range 0.0-39.7 %; MOR 3.6, 95 % CI 2.04-9.95, p = < 0.001). In conclusion, obesity is a prevalent modifiable comorbidity in PAD that is hardly addressed during PAD management, with significant variability across practices. As obesity prevalence rates are growing, along with treatment modalities to treat it, especially in those with PAD, building systems to integrate systematic evidence-based weight and dietary management strategies in PAD are essential to close this gap in care.

Impact of cardiovascular disease on health care economic burden and resource utilization: a retrospective cohort study in adults in the United States with type 2 diabetes with or without stroke, myocardial infarction, and peripheral arterial disease.

OBJECTIVES: To evaluate incidence of stroke, myocardial infarction (MI), and peripheral artery disease (PAD) in patients with type 2 diabetes mellitus (T2DM) and assess associated health care resource utilization (HCRU) and costs in the United States. METHODS: Patients ≥18 years of age with a T2DM diagnosis, with or without incident stroke/MI/PAD, were indexed between 1 January 2012 and 31 December 2020, from the deidentified Optum Clinformatics Data Mart claims database. Incidence of stroke, MI, and PAD was evaluated in the year following T2DM. HCRU and costs were measured in the 12 months following study entry in patients with T2DM + stroke, T2DM + MI, and T2DM + PAD (experimental cohorts) and compared to HCRU and costs in patients with T2DM alone (control cohorts). RESULTS: Incidence of stroke, MI, and PAD in patients with T2DM was 0.9% (n = 16,034), 0.7% (n = 13,681), and 4.1% (n = 68,479), respectively. Compared to matched patients with T2DM alone, patients with T2DM + stroke/MI/PAD had significantly higher total healthcare costs in the year post-index date (T2DM + stroke: +$5962 per patient per month [PPPM]; T2DM + MI: +$7932 PPPM; T2DM + PAD: +$2652 PPPM; p < .05). Patients with T2DM + stroke/MI/PAD had significantly higher mean HCRU than patients without stroke/MI/PAD in all categories measured. CONCLUSION: Having stroke, MI, or PAD was associated with increases in HCRU and costs in patients with T2DM. Although PAD was associated with smaller per patient increases in total healthcare costs than patients with T2DM + stroke/MI, the higher frequency of incident PAD may make it more costly than MI or stroke in a large population of patients with T2DM.

Compared to patients without type 2 diabetes (T2D), patients with T2D have a greater chance of having a stroke, heart attack, and narrowing of blood vessels in the arms and legs (peripheral artery disease [PAD]). A stroke, heart attack, or PAD may lead to hospitalization or death. We sought to understand healthcare usage (hospital visits, emergency room visits, office visits, etc.) and costs associated with stroke, heart attack, and PAD in patients with T2D in the United States. Healthcare resource usage and costs were estimated by using data from health insurance claims to compare healthcare usage and costs among patients with T2D, some of whom had a stroke, heart attack, or PAD, and some who did not. Compared to patients with T2D without stroke/heart attack/PAD, patients with T2D and stroke/heart attack/PAD had more overnight hospital visits, doctors' office visits, and emergency room visits. Patients with T2D and stroke/heart attack/PAD also had longer hospital stays. Patients with T2D and stroke/heart attack/PAD all had higher total healthcare costs in the year following their diagnoses, compared to patients with T2D without stroke/heart attack/PAD. By highlighting the greater costs and use of healthcare associated with stroke, heart attack, and PAD in patients with T2D, we hope to encourage more preventative management of stroke, heart attack, and PAD in patients with T2D.

The assessment of lower extremity peripheral artery disease impact on body mass center disorders.

BACKGROUND: Lower extremity peripheral artery disease is a problem of contemporary medicine and along with the ischemic heart disease it is considered to be a civilization disease. The risk of the disease increases significantly within a group of people reaching the age of 55 years and is closely related to co-occurring hazardous factors, such as diabetes, hyperlipidemia, hypertension or tobacco smoking. The first symptom reported by patients is intermittent claudication. Such symptoms may indicate that lower extremity peripheral artery disease does have an impact on posture disorders and motor skills. METHODS: The study covered four stages. The first stage involved medical interviews to obtain information regarding anthropometry, age, motor organ surgery, concomitant diseases and the lifestyle. In the following stage the value of the ankle brachial index for both lower limbs were calculated. In case of symptomatic patients, additionally, the location of artery stenosis/aortoiliac section, was verified. The third stage involved using a dynamometric platform for determination of the body mass center position for both studied groups. In the fourth stage a treadmill walk test was used to assess the participants for intermittent claudication. FINDINGS: Based on the obtained results, an attempt was taken to observe the relationship between the clinical characteristics of the disease and the body mass center position deviations. INTERPRETATION: The attempt was undertaken to assess whether the measurement of body mass center position might be a diagnostic parameter to evaluate the patient's condition and thus an indication for taking a decision for surgical treatment or rehabilitation.

Outcomes Associated With Peripheral Artery Disease in Myocardial Infarction With Cardiogenic Shock.

BACKGROUND: Mortality rates for patients presenting with acute myocardial infarction (AMI) and cardiogenic shock (CS) remain high despite advances in revascularization strategies and mechanical circulatory support (MCS) devices. OBJECTIVES: This study sought to elucidate the association between comorbid lower extremity peripheral artery disease (PAD) and outcomes in CS and AMI. METHODS: PAD status was defined in Medicare beneficiaries hospitalized with CS and AMI from October 1, 2015 to June 30, 2018. Primary outcomes ascertained through December 31, 2018 included in- and out-of-hospital mortality. Secondary outcomes included bleeding, amputation, stroke, and lower extremity revascularization. Multivariable regression models with adjustment for confounders were used to estimate risk. Subgroup analyses included patients treated with MCS and those who underwent coronary revascularization. RESULTS: Among 71,690 patients, 5.9% (N = 4,259) had PAD. Mean age was 77.8 ± 7.9 years, 58.7% were male, and 84.3% were White. Cumulative in-hospital mortality was 47.2%, with greater risk among those with PAD (56.3% vs 46.6% without PAD; adjusted OR: 1.50; 95% CI: 1.40-1.59). PAD patients also had greater risk of in-hospital amputation (1.6% vs 0.2%; adjusted OR: 7.0; 95% CI: 5.26-9.37) and out-of-hospital mortality (67.9% vs 40.7%; adjusted HR: 1.78; 95% CI: 1.67-1.90). MCS was less frequently utilized in PAD patients (21.5% vs 38.6% without PAD; P < 0.001) and was associated with higher mortality, need for lower extremity revascularization, and amputation risk. Findings were consistent in patients who underwent coronary revascularization. CONCLUSIONS: Among patients presenting with AMI and CS, PAD was associated with worse limb outcomes and survival. In addition to lower MCS utilization rates, those with PAD who received MCS had increased mortality, lower extremity revascularization, and amputation rates.

Peripheral Arterial Disease Located in the Feet of Patients With Diabetes and Foot Ulceration Demands a New Approach to the Assessment of Ischemia.

Peripheral arterial disease (PAD) is common below the knee in diabetes but arteries in the foot are controversially said to be spared of occlusive disease. This is relevant to the convenient site of vascular assessment that is recommended in guidelines. Should assessment be distal at toe/forefoot to detect foot disease or only proximal to detect disease at ankle level? The objective was to determine frequency of PAD at foot and ankle level. This was a cross-sectional observational study, evaluating arterial disease proximally by palpation of pedal pulses and Ankle Brachial Index (ABI), and distally by Toe Brachial Index (TBI), and forefoot transcutaneous oxygen tension (tcpO2), in consecutive patients presenting with foot ulceration. We assessed 301 limbs in 154 patients: 59% of limbs were ulcerated. PAD in the foot was detected in 70% and 74% of limbs by TBI and forefoot tcpO2, respectively, but PAD at ankle level only in 51% and 34% by pulse palpation and ABI, respectively. In limbs with "normal" ABI, PAD was present in the foot in 70% as indicated by low TBI, and in 73% by low tcpO2, with 70% to 64% having associated ulceration, respectively. When compared with arterial waveforms, as a measure of PAD, TBI gave an excellent AUC (area under the curve of the receiver operating characteristic curve) of 0.81 (95% confidence interval: 0.73-0.89), but ABI gave a poor AUC of 0.65 (95% confidence interval: 0.55-0.76). In conclusion, arterial disease is important in the foot and can be detected by TBI, which should be performed even when ABI is normal. Guidelines that recommend TBI only if ABI is artificially raised need updating.

Diabetic foot ulcer, the effect of resource-poor environments on healing time and direct cost: A cohort study during Syrian crisis.

Diabetic foot ulcer (DFU) is one of the slowest healing wounds that hurt the human body. Many studies from developed countries are concerned about materials, procedures, and equipment that accelerate the healing time. In Sweden, the diabetic foot management costs around 24965$/patient. In this review, we would evaluate the healing time of DFUs during what is considered one of the worst humanitarian crisis of the 21st century. 1747 DFUs were studied from the main diabetic foot clinic in Damascus (2014-2019). We predicted many variables that could prolong the healing time. The cost according to these variables was also reported. The SINBAD Classification was performed to grade the severity of ulcers. We noticed that the median healing time for DFUs was 8 weeks. Almost half of these ulcers healed between 3 and 12 weeks. The time of healing for men was significantly longer than that for women. While the presence of infection doubled the median time of healing, the presence of peripheral artery disease doubled the mean of the direct health care cost. The location of the ulcer acted as another independent risk factor. In conclusion, DFUs face many barriers to heal during a crisis.The environment with resource-poor settings should be added to the traditional risk factors that delay the healing of DFUs for months or even years. More studies from disaster are as are needed to evaluate low-cost materials that could be cost effective in applying standard care of the diabetic foot.

Trends in Use of Cardioprotective Medication in Peripheral Artery Disease: A Nationwide Study.

Background Guideline-based cardioprotective medical therapy is intended to reduce the burden of adverse cardiovascular and limb outcomes in patients with peripheral artery disease (PAD). However, contemporary data describing trends in use of medication remains limited. The present study, therefore, aims to investigate changes in use of cardioprotective medication in PAD. Methods and Results By using Danish national healthcare registries, we identified all patients with first-time diagnosis of PAD (1997-2016) and classified them into two groups: (1) PAD+ that includes all patients with PAD with a history of cardiovascular disease, ie, myocardial infarction, atrial fibrillation, and stroke (n=162 627); and (2) PAD (n=87 935) that comprise patients without a history of cardiovascular disease. We determined the use of medication in the first 12 months after the incident diagnosis of PAD and estimated age standardized 1-year mortality rates. Our results showed increase in use of cardioprotective medication throughout the study period in both groups. However, PAD+ had a higher use of medication (acetylsalicylic acid, 3.5%-48.4%; Clopidogrel, 0%-17.6%; vitamin K antagonists, 0.9%-7.8%; new oral anticoagulants, 0.0%-10.1%; Statins, 1.9%-58.1%; angiotensin-converting enzyme inhibitors, 1.2%-20.6%), compared with PAD (acetylsalicylic acid, 2.9%-54.4%; Clopidogrel, 0%-11.9%; vitamin K antagonists, 0.9%-2.4%; new oral anticoagulants, 0.0%-3.4%; Statins, 1.5%-56.9%; angiotensin-converting enzyme, 0.9%-17.2%), respectively. Furthermore, 1-year mortality rates in PAD declined with increased use of medications during study. Conclusions In this nationwide study, use of cardioprotective medication increased considerably with time, but compared to patients with other atherosclerotic diseases, there remains an underuse of guideline-based medical therapy in patients with PAD.

Long Term Survival and Limb Salvage in Patients With Non-Revascularisable Chronic Limb Threatening Ischaemia.

OBJECTIVE: The aim of this study was to provide long term survival and limb salvage rates for patients with non-revascularisable (NR) chronic limb threatening ischaemia (CLTI). METHODS: This was a retrospective review of prospectively collected data, derived from a randomised controlled trial (JUVENTAS) investigating the use of a regenerative cell therapy. Survival and limb salvage of the index limb in CLTI patients without viable options for revascularisation at inclusion were analysed retrospectively. The primary outcome was amputation free survival, a composite of survival and limb salvage, at five years after inclusion in the original trial. RESULTS: In 150 patients with NR-CLTI, amputation free survival was 43% five years after inclusion. This outcome was driven by an equal rate of all cause mortality (35%) and amputation (33%). Amputation occurred predominantly in the first year. Furthermore, 33% of those with amputation subsequently died within the investigated period, with a median interval of 291 days. CONCLUSION: Five years after the initial need for revascularisation, about half of the CLTI patients who were deemed non-revascularisable survived with salvage of the index limb. Although the prospects for these high risk patients are still poor, under optimal medical care, amputation free survival seems comparable with that of revascularisable CLTI patients, while the major amputation rate within one year, especially among NR-CLTI patients with ischaemic tissue loss, is very high.

The association of healthcare disparities and patient-specific factors on clinical outcomes in peripheral artery disease.

BACKGROUND: PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known. METHODS: Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation. RESULTS: Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation. CONCLUSIONS: Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD.

How Does SARS-CoV-2 Infection Affect Survival of Emergency Cardiovascular Patients? A Cohort Study From a German Insurance Claims Database.

OBJECTIVE: A previous study revealed a preliminary trend towards higher in hospital mortality in patients admitted as an emergency with acute stroke during the COVID-19 pandemic in Germany. The current study aimed to further examine the possible impact of a confirmed SARS-CoV-2 infection on in hospital mortality. METHODS: This was a retrospective analysis of health insurance claims data from the second largest insurance fund in Germany, BARMER. Patients hospitalised for ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, acute limb ischaemia (ALI), aortic rupture, acute stroke, or transient ischaemic attack (TIA) between 1 January 2017, and 31 October 2020, were included. Admission rates per 10 000 insured and mortality were compared between March - June 2017 - 2019 (pre-COVID) and March - June 2020 (COVID). Mortality rates were determined by the occurrence of a confirmed SARS-CoV-2 infection. RESULTS: A total of 316 718 hospitalisations were included (48.7% female, mean 72.5 years), and 21 191 (6.7%, 95% CI 6.6% - 6.8%) deaths occurred. In hospital mortality increased during the COVID-19 pandemic when compared with the three previous years for patients with acute stroke from 8.3% (95% CI 8.0 - 8.5) to 9.6% (95% CI 9.1 - 10.2), while no statistically significant changes were observed for STEMI, NSTEMI, ALI, aortic rupture, and TIA. When comparing patients with confirmed SARS-CoV-2 infection (2.4%, 95% CI 2.3 - 2.5) vs. non-infected patients, a higher in hospital mortality was observed for acute stroke (12.4% vs. 9.0%), ALI (14.3% vs. 5.0%), and TIA (2.7% vs. 0.3%), while no statistically significant differences were observed for STEMI, NSTEMI, and aortic rupture. CONCLUSION: This retrospective analysis of claims data has provided hints of an association between the COVID-19 pandemic and increased in hospital mortality in patients with acute stroke. Furthermore, confirmed SARS-CoV-2 infection was associated with increased mortality in patients with stroke, TIA, and ALI. Future studies are urgently needed to better understand the underlying mechanism and relationship between the new coronavirus and acute stroke.

Clinical and Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients With Coronary Artery Disease and/or Peripheral Artery Disease.

To address literature gaps on treatment with real-world evidence, this study compared effectiveness, safety, and cost outcomes in NVAF patients with coronary or peripheral artery disease (CAD, PAD) prescribed apixaban versus other oral anticoagulants. NVAF patients aged ≥65 years co-diagnosed with CAD/PAD initiating warfarin, apixaban, dabigatran, or rivaroxaban were selected from the US Medicare population (January 1, 2013 to September 30, 2015). Propensity score matching was used to match apixaban versus warfarin, dabigatran, and rivaroxaban cohorts. Cox models were used to evaluate the risk of stroke/systemic embolism (SE), major bleeding (MB), all-cause mortality, and a composite of stroke/myocardial infarction/all-cause mortality. Generalized linear and two-part models were used to compare stroke/SE, MB, and all-cause costs between cohorts. A total of 33,269 warfarin-apixaban, 9,335 dabigatran-apixaban, and 33,633 rivaroxaban-apixaban pairs were identified after matching. Compared with apixaban, stroke/SE risk was higher in warfarin (hazard ratio [HR]: 1.93; 95% confidence interval [CI]: 1.61 to 2.31), dabigatran (HR: 1.69; 95% CI: 1.18 to 2.43), and rivaroxaban (HR: 1.24; 95% CI: 1.01 to 1.51) patients. MB risk was higher in warfarin (HR: 1.67; 95% CI: 1.52 to 1.83), dabigatran (HR: 1.37; 95% CI: 1.13 to 1.68), and rivaroxaban (HR: 1.87; 95% CI: 1.71 to 2.05) patients vs apixaban. Stroke/SE- and MB-related medical costs per-patient per-month were higher in warfarin, dabigatran, and rivaroxaban patients versus apixaban. Total all-cause health care costs were higher in warfarin and rivaroxaban patients compared with apixaban patients. In conclusion, compared with apixaban, patients on dabigatran, rivaroxaban, or warfarin had a higher risk of stroke/SE, MB, and event-related costs.

Association between ankle-brachial index and cognitive function in participants in the PREDIMED-Plus study: cross-sectional assessment.

INTRODUCTION AND OBJECTIVES: The ankle-brachial index (ABI) is an indicator of peripheral artery disease (PAD). The aim of this study was to assess the association between PAD, measured with the ABI, and cognitive function in persons with overweight or obesity and metabolic syndrome. METHODS: Cross-sectional study conducted with baseline data from the PREDIMED-Plus study, which included 4898 participants (after exclusion of those without ABI measurements) aged between 55 and 75 years, and with overweight or obesity and metabolic syndrome. At the baseline assessment, we measured the ABI with a standardized protocol and assessed the presence of other cardiovascular risk factors (eg, diabetes, dyslipidemia, hypertension). Cognitive function was evaluated using several tests validated for the Spanish population (mini-mental state examination [MMSE], phonological and semantic verbal fluency test, WAIS-III working memory index [WMI], parts A and B of the trail making test (TMT), and clock drawing test). Generalized linear models were used to assess the association between the ABI and cognitive function. RESULTS: Among the participants, 3.4% had PAD defined as ABI ≤ 0.9, and 3.3% had arterial calcification defined as ABI ≥ 1.4. PAD was associated with age, systolic blood pressure and obesity indicators, while arterial calcification was also associated with obesity and diabetes. No significant associations were observed between cognitive function and ABI or PAD. CONCLUSIONS: In our sample, the presence of PAD increased with age, blood pressure, and obesity. No significant association was observed between ABI, PAD, or cognitive function.

Diagnostic accuracy of non-contrast quiescent-interval slice-selective (QISS) MRA combined with MRI-based vascular calcification visualization for the assessment of arterial stenosis in patients with lower extremity peripheral artery disease.

OBJECTIVES: The proton density-weighted, in-phase stack-of-stars (PDIP-SOS) MRI technique provides calcification visualization in peripheral artery disease (PAD). This study sought to investigate the diagnostic accuracy of a combined non-contrast quiescent-interval slice-selective (QISS) MRA and PDIP-SOS MRI protocol for the detection of PAD, in comparison with CTA and digital subtraction angiography (DSA). METHODS: Twenty-six prospectively enrolled PAD patients (70 ± 8 years) underwent lower extremity CTA and 1.5-T or 3-T PDIP-SOS/QISS MRI prior to DSA. Two readers rated image quality and graded stenosis (≥ 50%) on QISS MRA without/with calcification visualization. Sensitivity, specificity, and area under the curve (AUC) were calculated against DSA. Calcification was quantified and compared between MRI and non-contrast CT (NCCT) using paired t test, Pearson's correlation, and Bland-Altman analysis. RESULTS: Image quality ratings were significantly higher for CTA compared to those for MRA (4.0 [3.0-4.0] and 3.0 [3.0-4.0]; p = 0.0369). The sensitivity and specificity of QISS MRA, QISS MRA with PDIP-SOS, and CTA for ≥ 50% stenosis detection were 85.4%, 92.2%, and 90.2%, and 90.3%, 93.2%, and 94.2%, respectively, while AUCs were 0.879, 0.928, and 0.923, respectively. A significant increase in AUC was observed when PDIP-SOS was added to the MRA protocol (p = 0.0266). Quantification of calcification showed significant differences between PDIP-SOS and NCCT (80.6 ± 31.2 mm3 vs. 88.0 ± 29.8 mm3; p = 0.0002) with high correlation (r = 0.77, p < 0.0001) and moderate mean of differences (- 7.4 mm3). CONCLUSION: QISS MRA combined with PDIP-SOS MRI provides improved, CTA equivalent, accuracy for the detection of PAD, although its image quality remains inferior to CTA. KEY POINTS: • Agreement in stenosis detection rate using non-contrast quiescent-interval slice-selective MRA compared to DSA improved when calcification visualization was provided to the readers. • An increase was observed in both sensitivity and specificity for the detection of ≥ 50% stenosis when MRI-based calcification assessment was added to the protocol, resulting in a diagnostic accuracy more comparable to CTA. • Quantification of calcification showed statistical difference between MRI and non-contrast CT; however, a high correlation was observed between the techniques.

Racial and ethnic disparities in lower extremity amputation: Assessing the role of frailty in older adults.

BACKGROUND: Frailty is a state of decreased physiologic reserve contributing to functional decline and is associated with adverse surgical outcomes, particularly in the elderly. Racial disparities have been reported previously both in frail individuals and in limb-salvage patients. Our goal was to assess whether race and ethnicity are disproportionately linked to frailty status in geriatric patients undergoing lower-limb amputation, leading to an increased risk of complications. METHODS: A 3-year analysis was conducted of the National Surgical Quality Improvement Program database and included all geriatric (age ≥65 years) patients who underwent amputation of the lower limb. The frailty index was calculated using the 11-factor modified frailty index with a cutoff limit of 0.27 defined for frail status. Outcomes were 30-day complications, mortality, and readmissions. Multivariate regression analysis was performed. RESULTS: A total of 4,218 geriatric patients underwent surgical amputation of a lower extremity (above knee: 41%; below knee: 59%). Of these patients, 29% were frail, 26% were African American, and 9% were Hispanic. Being African American (odds ratio: 1.6 [1.3-1.9]) and Hispanic (odds ratio: 1.1 [1.05-2.5]) was independently associated with frail status. Frail African Americans had a higher likelihood of 30-day complications (odds ratio: 3.2 [1.9-4.4]) and 30-day readmissions (odds ratio: 2.9 [1.8-3.6]) when compared with nonfrail individuals. Similarly, frail Hispanics had higher 30-day complications (odds ratio: 2.6 [1.9-3.1]) and 30-day readmissions (odds ratio: 1.4 [1.1-2.7]) compared with nonfrail Hispanics/Latinos. CONCLUSION: African American and Hispanic geriatric patients undergoing lower-limb amputation are at increased risk for frailty status and, as a result, increased associated operative complications. These disparities exist regardless of age, sex, comorbid conditions, and location of amputation. Further studies are needed to highlight disparities by race and ethnicity to identify potentially modifiable risk factors, decrease frailty, and improve outcomes.

Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease.

Peripheral artery disease (PAD) stems from atherosclerosis of lower extremity arteries with resultant arterial narrowing or occlusion. The most severe form of PAD is termed chronic limb-threatening ischemia and carries a significant risk of limb loss and cardiovascular mortality. Diabetes mellitus is known to increase the incidence of PAD, accelerate disease progression, and increase disease severity. Patients with concomitant diabetes mellitus and PAD are at high risk for major complications, such as amputation. Despite a decrease in the overall number of amputations performed annually in the United States, amputation rates among those with both diabetes mellitus and PAD have remained stable or even increased in high-risk subgroups. Within this cohort, there is significant regional, racial/ethnic, and socioeconomic variation in amputation risk. Specifically, residents of rural areas, African-American and Native American patients, and those of low socioeconomic status carry the highest risk of amputation. The burden of amputation is severe, with 5-year mortality rates exceeding those of many malignancies. Furthermore, caring for patients with PAD and diabetes mellitus imposes a significant cost to the healthcare system-estimated to range from $84 billion to $380 billion annually. Efforts to improve the quality of care for those with PAD and diabetes mellitus must focus on the subgroups at high risk for amputation and the disparities they face in the receipt of both preventive and interventional cardiovascular care. Better understanding of these social, economic, and structural barriers will prove to be crucial for cardiovascular physicians striving to better care for patients facing this challenging combination of chronic diseases.

Accuracy of non-contrast quiescent-interval single-shot and quiescent-interval single-shot arterial spin-labelled magnetic resonance angiography in assessment of peripheral arterial disease in a diabetic population.

INTRODUCTION: Diabetic patients with peripheral arterial disease (PAD) are challenging to assess. Non-contrast magnetic resonance angiography (MRA) offers a safe alternative in patients with renal impairment. The study objective is to evaluate accuracy of lower limb quiescent-interval single-shot (QISS) MRA and pedal QISS-arterial spin-labelled (ASL) MRA for detection of significant stenosis in diabetic patients with PAD. METHODS: Combined QISS and QISS-ASL MRA was performed in 32 diabetic PAD patients (20 male, 12 female; mean 69 years; 8 with critical ischaemia). Two readers assessed haemodynamically significant (>50%) stenosis and diagnostic confidence on MRA, against digital subtraction angiography (DSA) as the reference standard, with subgroup analysis of patients with severe renal impairment (n = 7). Inter-reader agreement of stenosis and diagnostic confidence were evaluated. Test-retest reproducibility was evaluated in 10 subjects who underwent repeat MRA on a different day. RESULTS: At DSA, 262/645 segments (40.6%) had haemodynamically significant stenoses. MRA accuracy was 78.1% (478/612) and 75.6% (464/614), sensitivity 64.7% (161/249) and 77.5% (193/249), and specificity 87.3% (317/363) and 74.2% (271/365) for 2 readers. MRA accuracy was 80.9% and 80.7% for readers 1 and 2, respectively, in patients with severe renal impairment. QISS MRA but not pedal QISS-ASL MRA was considered of diagnostic image quality. Inter-reader agreement was moderate for stenosis (ĸ = 0.60) and diagnostic confidence (ĸ = 0.41). Test-retest reproducibility was high (ĸ = 0.87) and moderate (ĸ = 0.54) for individual readers. CONCLUSIONS: Quiescent-interval single-shot MRA has reasonable accuracy in a diabetic PAD population with high burden of disease, providing a non-contrast option in patients with renal impairment. QISS-ASL MRA requires further optimisation to be clinically feasible.

Cost-effective analysis of clopidogrel versus aspirin for high risk patients with established peripheral arterial disease in China.

Objective: To assess the cost-effectiveness of clopidogrel versus aspirin for high risk patients (pre-existing symptomatic atherosclerosis or multi-vascular territory involvement) with established peripheral arterial disease (PAD) for secondary prevention of atherothrombotic events in a Chinese setting.Methods: A Markov model with a lifetime horizon was developed from the perspective of the national healthcare system in China. The primary outputs are quality adjusted life years (QALYs), direct medical costs, and the incremental cost-effectiveness ratios (ICERs). Clinical efficacy data were obtained from the CAPRIE trial. Drug acquisition cost, other direct medical costs, and utilities were from pricing records and the literature. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were conducted to test the robustness of the model on all parameters.Results: In patients with pre-existing atherosclerosis, 2 years of treatment with clopidogrel and aspirin would yield total QALYs of 8.776 and 8.576 at associated costs of ¥18,777 ($2,838) and ¥12,302 ($1,859), respectively, resulting in an ICER of ¥32,382 ($4,893) per QALY gained. In patients with PVD, secondary prevention with the same drugs would expect to lead to total QALYs of 8.836 and 8.632 at associated costs of ¥18,518 ($2,798) and ¥12,041 ($1,820), respectively, resulting in a corresponding ICER of ¥31,743 ($4,797) per QALY gained. The results were most sensitive to the discount rate for future outcomes and costs. The PSA indicated that the probability of clopidogrel being cost-effective was 100% at the willingness-to-pay threshold of 3-times GDP.Conclusions: Secondary prevention with clopidogrel is an attractive cost-effective option compared with aspirin for high risk patients with established PAD from the perspective of the national healthcare system in Chinese settings.