Updated estimates for the burden of chronic limb-threatening ischemia in the Medicare population.

OBJECTIVE: Estimates of chronic limb-threatening ischemia (CLTI) based on diagnosis codes of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) suggest a prevalence of 0.23%-0.32% and incidence of 0.20%-0.26% among Medicare patients. ICD-10-CM includes 144 CLTI diagnosis codes, allowing improved specificity in identifying affected patients. We sought to use ICD-10-CM diagnosis codes to determine the prevalence of CLTI among Medicare patients and describe the patient cohort affected by this condition. METHODS: Using two years of data from Centers for Medicare and Medicaid Services, we identified all patients that had at least one CLTI diagnosis code to determine prevalence and incidence rates. Sensitivity analyses were performed to compare our methodology to prior publications and quantify the extent of missed diagnoses. The number and type of vascular procedures that occurred after diagnosis were tabulated. A cohort of patients with two or more CLTI diagnosis codes were then identified for further descriptive analysis. Associations between patient demographics and survival were analyzed using Cox proportional hazards models. RESULTS: Over 65 million patients were enrolled in Medicare in 2017 to 2018. Of these, 480,227 had diagnosis of CLTI, with a corresponding to a 1-year incidence of 0.33% and a 2-year prevalence of 0.74%. Patients underwent an average of 43.6 vascular procedures per 100 person-years. Sensitivity analyses identified 89,805 additional patients that had a diagnosis code of peripheral arterial disease who underwent revascularization or amputation. Patients with CLTI were predominantly male (56.2%), white (76.4%), and qualified for Medicare due to age (64.0%). Thirty-seven percent were dual-eligible. One-year survival was 77.7%, significantly lower than estimated actuarial survival adjusted for age, sex, and race (95.1%; P < .001). Cox proportional hazards models demonstrate significantly increased mortality for men vs women (hazard ratio, 1.07; 95% confidence interval, 1.04-1.10; P < .001), but no association between race and overall survival (hazard ratio, 0.99; 95% confidence interval, 0.98-1.01; P = .83). CONCLUSIONS: Using ICD-10-CM diagnosis codes, we demonstrated slightly higher incidence and prevalence of CLTI than in published literature, reflecting our more complete methodology. Sensitivity analyses suggest that increased complexity of the highly specific ICD-10-CM coding may diminish capture of CLTI. Inclusion of patients with non-CLTI peripheral arterial disease diagnoses produces moderate increases in incidence and prevalence at the cost of decreased specificity in identifying patients with CLTI. Medicare patients with CLTI are older, and more commonly male, black, and dual eligible compared with the general Medicare population. Observed mid-term survival for patients with CLTI is significantly lower than actuarial estimates, confirming the importance of focused efforts on identifying and aligning goals of care in this complex patient population.

A systematic review and meta-analysis of gender differences in long-term mortality and cardiovascular events in peripheral artery disease.

OBJECTIVE: Individual studies of peripheral artery disease (PAD) have indicated that gender discrepancies exist in the symptoms, functional status, and treatment usage. It remains uncertain whether these discrepancies result in different long-term outcomes. We examined the potential gender differences in mortality and major adverse cardiovascular events (MACE) in patients with symptomatic PAD. METHODS: The PubMed and Embase databases were searched for studies from 2000 to January 2019. After a review of 13,582 citations, 14 articles were analyzed. The reported age-adjusted hazard ratios (HRs) for gender differences in mortality and MACE were included in the meta-analysis. The mortality outcomes were stratified according to the clinical presentation and study context. RESULTS: Male gender was associated with a greater risk of all-cause mortality (HR, 1.13; 95% confidence interval [CI], 1.10-1.16; P < .001) and MACE (HR, 1.10; 95% CI, 1.06-1.14; P < .001). In a stratified analysis, male gender was associated with a higher mortality risk for patients presenting with either critical limb ischemia (HR, 1.08; 95% CI, 1.05-1.10; P < .001) or mixed clinical presentations (HR, 1.16; 95% CI, 1.11-1.21; P < .001) but not for those with intermittent claudication (HR, 1.13; 95% CI, 0.98-1.30; P = .09). Elevated mortality risk was evident after revascularization (HR, 1.11; 95% CI, 1.04-1.19; P = .003), hospitalization (HR, 1.15; 95% CI, 1.08-1.22; P < .001), and amputation (HR, 1.09; 95% CI, 1.08-1.10; P < .001), although not in outpatient clinics (HR, 1.13; 95% CI, 0.97-1.32; P = .13), in men compared with women. CONCLUSIONS: Greater mortality and MACE rates in men with PAD occurred despite other accepted gender disparities. The mechanisms underlying these gender differences in the outcomes for PAD patients require further investigation.

Trends and perioperative outcomes of patients with human immunodeficiency virus (HIV) undergoing lower extremity revascularization.

The development of highly active antiretroviral therapy (HAART) has significantly improved the life expectancy of patients with human immunodeficiency virus (HIV), but has led to the rise of chronic conditions including peripheral artery disease (PAD). However, trends and outcomes among patients with HIV undergoing lower extremity revascularization are poorly characterized. The aim of this study was to investigate the trends and perioperative outcomes of lower extremity revascularization among patients with HIV and PAD in a national database. The National Inpatient Sample (NIS) was reviewed between 2003 and 2014. All hospital admissions with a diagnosis of PAD undergoing lower extremity revascularization were stratified based on HIV status. Outcomes were assessed using propensity score matching and multivariable regression. Among all patients undergoing lower extremity revascularization for PAD, there was a significant increase in the proportion of patients with HIV from 0.21% in 2003 to 0.52% in 2014 (p < 0.01). Patients with HIV were more likely to be younger, male, and have fewer comorbidities, including coronary artery disease and diabetes, at the time of intervention compared to patients without HIV. With propensity score matching and multivariable regression, HIV status was associated with increased total hospital costs, but not length of stay, major amputation, or mortality. Patients with HIV with PAD who undergo revascularization are younger with fewer comorbidities, but have increased hospital costs compared to those without HIV. Lower extremity revascularization for PAD is safe for patients with HIV without increased risk of in-hospital major amputation or mortality, and continues to increase each year.

Contemporary Treatment of Popliteal Artery Aneurysms in 14 Countries: A Vascunet Report.

OBJECTIVE: Popliteal artery aneurysm (PAA) is the second most common arterial aneurysm. Vascunet is an international collaboration of vascular registries. The aim was to study treatment and outcomes. METHODS: This was a retrospective analysis of prospectively registered population based data. Fourteen countries contributed data (Australia, Denmark, Finland, France, Hungary, Iceland, Italy, Malta, New Zealand, Norway, Portugal, Serbia, Sweden, and Switzerland). RESULTS: During 2012-2018, data from 10 764 PAA repairs were included. Mean values with between countries ranges in parenthesis are given. The incidence was 10.4 cases/million inhabitants/year (2.4-19.3). The mean age was 71.3 years (66.8-75.3). Most patients, 93.3%, were men and 40.0% were active smokers. The operations were elective in 73.2% (60.0%-85.7%). The mean pre-operative PAA diameter was 32.1 mm (27.3-38.3 mm). Open surgery dominated in both elective (79.5%) and acute (83.2%) cases. A medial surgical approach was used in 77.7%, and posterior in 22.3%. Vein grafts were used in 63.8%. Of the emergency procedures, 91% (n = 2 169, 20.2% of all) were for acute thrombosis and 9% for rupture (n = 236, 2.2% of all). Thrombosis patients had larger aneurysms, mean diameter 35.5 mm, and 46.3% were active smokers. Early amputation and death were higher after acute presentation than after elective surgery (5.0% vs. 0.7%; 1.9% vs. 0.5%). This pattern remained one year after surgery (8.5% vs. 1.0%; 6.1% vs. 1.4%). Elective open compared with endovascular surgery had similar one year amputation rates (1.2% vs. 0.2%; p = .095) but superior patency (84.0% vs. 78.4%; p = .005). Veins had higher patency and lower amputation rates, at one year compared with synthetic grafts (86.8% vs. 72.3%; 1.8% vs. 5.2%; both p < .001). The posterior open approach had a lower amputation rate (0.0% vs. 1.6%, p = .009) than the medial approach. CONCLUSION: Patients presenting with acute ischaemia had high risk of amputation. The frequent use of endovascular repair and prosthetic grafts should be reconsidered based on these results.

Economic burden of coronary artery disease or peripheral artery disease in patients at high risk of ischemic events in the French setting: a claims database analysis.

Aims: Estimate the direct costs of high-risk patients presenting with coronary artery disease (CAD) or peripheral artery disease (PAD) in France.Materials and methods: This retrospective cohort study used a representative claims database, the "Echantillon Généraliste de Bénéficiaires" (EGB), to identify patients presenting with CAD or PAD between 2011 and 2016. Among those, patients meeting the COMPASS trial selection criteria were selected, as well as controls matched on age and sex. Direct costs (Euros 2016) were estimated in a societal perspective by comparing case and controls.Results: The adult population presenting with CAD or PAD in the EGB in 2016 was estimated at 29,888 individuals, representing a crude prevalence rate of 5.44%. After using the documented selection criteria of the COMPASS study, this population (COMPASS-like) was estimated at 17,369 individuals (58.1% of the CAD and/or PAD total population). Among them, a proportion of 11.5% presented with CAD + PAD. Compared with the original COMPASS population, patients were older (76.5 vs 68.2 years) and with a lower male predominance (60.0% vs 78.2% males). Compared with controls, the COMPASS-like population was characterized by a higher annual mortality (5.9% vs 3.5%) and the presence of more comorbidities on top of CAD and/or PAD. The annual per capita extra direct cost of the COMPASS-like population was estimated at €4,284, with a main contribution from inpatient care (58.9%). This extra cost was higher in the PAD ± CAD sub-group (€5,552) and the CAD + PAD sub-group (€8,067).Limitations: The EGB had limitations about several clinical features defining high-risk patients that may lead to bias in our estimates.Conclusions: Due to the high prevalence of CAD and/or PAD and the associated high unit costs, this population generates a significant economic burden, which is higher among patients with PAD and in those presenting simultaneously with both conditions.

Perfusion Assessment in Critical Limb Ischemia: Principles for Understanding and the Development of Evidence and Evaluation of Devices: A Scientific Statement From the American Heart Association.

There are >12 million patients with peripheral artery disease in the United States. The most severe form of peripheral artery disease is critical limb ischemia (CLI). The diagnosis and management of CLI is often challenging. Ethnic differences in comorbidities and presentation of CLI exist. Compared with white patients, black and Hispanic patients have higher prevalence rates of diabetes mellitus and chronic renal disease and are more likely to present with gangrene, whereas white patients are more likely to present with ulcers and rest pain. A thorough evaluation of limb perfusion is important in the diagnosis of CLI because it can not only enable timely diagnosis but also reduce unnecessary invasive procedures in patients with adequate blood flow or among those with other causes for ulcers, including venous, neuropathic, or pressure changes. This scientific statement discusses the current tests and technologies for noninvasive assessment of limb perfusion, including the ankle-brachial index, toe-brachial index, and other perfusion technologies. In addition, limitations of the current technologies along with opportunities for improvement, research, and reducing disparities in health care for patients with CLI are discussed.

The burden of critical limb ischemia: a review of recent literature.

Peripheral arterial disease is a chronic vascular disease characterized by impaired circulation to the lower extremities. Its most severe stage, known as critical limb ischemia (CLI), puts patients at an increased risk of cardiovascular events, amputation, and death. The objective of this literature review is to describe the burden of disease across a comprehensive set of domains-epidemiologic, clinical, humanistic, and economic-focusing on key studies published in the last decade. CLI prevalence in the United States is estimated to be approximately 2 million and is likely to rise in the coming years given trends in important risk factors such as age, diabetes, and smoking. Hospitalization for CLI patients is common and up to 60% are readmitted within 6 months. Amputation rates are unacceptably high with a disproportionate risk for certain demographic and socioeconomic groups. In addition to limb loss, CLI patients also have reduced life expectancy with mortality typically exceeding 50% by 5 years. Given the poor clinical prognosis, it is unsurprising that the quality of life burden associated with CLI is significant. Studies assessing quality of life in CLI patients have used a variety of generic and disease-specific measures and all document a substantial impact of the disease on the patient's physical, social, and emotional health status compared to population norms. Finally, the poor clinical outcomes and increased medical resource use lead to a considerable economic burden for national health care systems. However, published cost studies are not comprehensive and, therefore, likely underestimate the true economic impact of CLI. Our summary documents a sobering assessment of CLI burden-a poor clinical prognosis translating into diminished quality of life and high costs for millions of patients. Continued prevention efforts and improved treatment strategies are the key to ameliorating the substantial morbidity and mortality associated with this disease.

Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia.

GUIDELINE SUMMARY: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

A national economic and clinical model for ischemic stroke care development in Saudi Arabia: A call for change.

BACKGROUND: Stroke is a significant burden in Saudi Arabia and the Saudi Ministry of Health's stroke committee has identified an urgent need to improve care. AIM: The purpose of this study was to undertake a health-economic analysis to quantify the impact of developing stroke care in the country. METHODS: An economic model was developed to assess the costs and clinical outcomes associated with an ischemic stroke care development program compared with current stroke care. Based on Saudi epidemiological data, cohorts of ischemic stroke patients enter the model each year for the first 10 years based on increasing incidence. Four treatment options were modeled including reperfusion and non-reperfusion treatments. The development scenario estimates the impact of gradually increasing uptake of more effective treatments over 10 years. Changes in the stroke care organization are considered along with resources required to increase capacity, allowing more patients to be admitted to stroke hospitals and access effective treatments. RESULTS: The stroke care development program is associated with an increase in functionally independent patients and a decrease in disabling strokes compared with current stroke care. Additionally, the development program is associated with estimated cost savings of $602 million over 15 years ($255 million direct costs, $348 million indirect costs). CONCLUSIONS: The model predicts that the stroke care development program is associated with improved patient outcomes and lower overall costs compared with the current stroke care program.

Sex differences in stroke metrics among Southeast Asian countries: Results from the Global Burden of Disease Study 2015.

BACKGROUND: Sex differences in cardiovascular diseases generally disadvantage women, particularly within developing regions. AIMS: This study aims to examine sex-related differences in stroke metrics across Southeast Asia in 2015. Furthermore, relative changes between sexes are compared from 1990 to 2015. METHODS: Data were sourced from the Global Burden of Disease Study. Incidence and mortality from ischemic and hemorrhagic strokes were explored with the following statistics derived: (1) women-to-men incidence/mortality ratio and (2) relative percentage change in rate. RESULTS: Women had lower incidence and mortality from stroke compared to men. Notable findings include higher ischemic stroke incidence for women at 30-34 years in high-income countries (women-to-men ratio: 1.3, 95% CI: 0.1, 16.2 in Brunei and 1.3, 95% CI: 0.5, 3.2 in Singapore) and the largest difference between sexes for ischemic stroke mortality in Vietnam and Myanmar across most ages. Within the last 25 years, greater reductions for ischemic stroke metrics were observed among women compared to men. Nevertheless, women below 40 years in some countries showed an increase in ischemic stroke incidence between 0.5% and 11.4%, whereas in men, a decline from -4.2% to -44.2%. Indonesia reported the largest difference between sexes for ischemic stroke mortality; a reduction for women whereas an increase in men. For hemorrhagic stroke, findings were similar: higher incidence among young women in high-income countries and greater reductions for stroke metrics in women than men over the last 25 years. CONCLUSIONS: Distinct sex-specific differences observed across Southeast Asia should be accounted in future stroke preventive guidelines.

Impact of atrial fibrillation on inpatient cost for ischemic stroke in the USA.

BACKGROUND: Atrial fibrillation is a significant risk factor for ischemic stroke and increases cost of treatment. AIMS: To estimate the incremental inpatient cost and length of stay due to atrial fibrillation among adults hospitalized with a primary diagnosis of ischemic stroke after controlling for sociodemographic, clinical, and hospital characteristics in a nationally representative discharge record of US population. METHODS: Hospital discharge records with a primary diagnosis of ischemic stroke were identified from the National Inpatient Sample data for the years 2010-2013. Generalized linear model with log link and least-square means were utilized to estimate the incremental inpatient cost and length of stay in ischemic stroke due to atrial fibrillation after controlling for sociodemographic, clinical, and hospital characteristics. RESULTS: Among 434,544 hospital discharge records with a primary diagnosis of ischemic stroke, 90,190 (20.76%) discharge records had a secondary diagnosis of atrial fibrillation. The average inpatient cost for all discharge records with a primary diagnosis of ischemic stroke was (mean = $13,072, median = $9270.87) significantly (p < 0.0001) higher compared to all discharge records without ischemic stroke (mean = $12,543.07, median = $7517.13). The mean length of stay for all records was 4.55 days (95% CI = 4.53-4.56). Among those identified with ischemic stroke, adjusted mean inpatient cost was higher by $2829 (95% CI = $2708-$2949) and mean length of stay was greater by 0.85 (95% CI = 0.81-0.89) for those with atrial fibrillation compared to those without. CONCLUSIONS: The presence of atrial fibrillation was associated with increased inpatient cost and length of stay among patients diagnosed with ischemic stroke. Increased inpatient cost and length of stay call for a more comprehensive patient care approach including targeted interventions among adults diagnosed with ischemic stroke and atrial fibrillation, which could potentially reduce the overall cost in this population.

Comparison of the flexible parametric survival model and Cox model in estimating Markov transition probabilities using real-world data.

BACKGROUND AND OBJECTIVE: Markov micro-simulation models are being increasingly used in health economic evaluations. An important feature of the Markov micro-simulation model is its ability to consider transition probabilities of heterogeneous subgroups with different risk profiles. A survival analysis is generally performed to accurately estimate the transition probabilities associated with the risk profiles. This study aimed to apply a flexible parametric survival model (FPSM) to estimate individual transition probabilities. MATERIALS AND METHODS: The data were obtained from a cohort study investigating ischemic stroke outcomes in Western China. In total, 585 subjects were included in the analysis. To explore the goodness of fit of the FPSM, we compared the estimated hazard ratios and baseline cumulative hazards, both of which are necessary to the calculate individual transition probabilities, and the Markov micro-simulation models constructed using the FPSM and Cox model to determine the validity of the two Markov micro-simulation models and cost-effectiveness results. RESULTS: The flexible parametric proportional hazards model produced hazard ratio and baseline cumulative hazard estimates that were similar to those obtained using the Cox proportional hazards model. The simulated cumulative incidence of recurrent ischemic stroke and 5-years cost-effectiveness of Incremental cost-effectiveness Ratios (ICERs) were also similar using the two approaches. A discrepancy in the results was evident between the 5-years cost-effectiveness and the 10-years cost-effectiveness of ICERs, which were approximately 0.9 million (China Yuan) and 0.5 million (China Yuan), respectively. CONCLUSIONS: The flexible parametric survival model represents a good approach for estimating individual transition probabilities for a Markov micro-simulation model.

Epidemiology, treatment, and outcomes of acute limb ischemia in the pediatric population.

OBJECTIVE: Acute limb ischemia (ALI) in a pediatric patient is a rare condition but may result in lifelong disability. A paucity of evidence exists to derive treatment guidelines; some surgeons advocate conservative management over invasive measures. The purpose of this study was to evaluate the role of surgical revascularization in the pediatric population and outcomes of conservative vs surgical management. METHODS: The Healthcare Cost and Utilization Project State Inpatient Database (California, Iowa, and New York) between 2007 and 2013 was queried using International Classification of Diseases, Ninth Revision codes. Patients were stratified into two cohorts: conservative management and surgical management. Each group was further subdivided into three age groups: infant (<24 months), child (<12 years), and adolescent (<18 years). Outcome variables included mortality, amputation status, length of hospital stay, and hospital charge. RESULTS: A total of 1576 pediatric patients with ALI were identified among 6,122,535 pediatric admissions (26 per 100,000 admissions). Average age was 9.9 ± 7.1 years. There were 263 patients who underwent surgical revascularization. The conservative management group was younger (5.8 ± 6.2 vs 9.2 ± 6.1 years; P < .01). Otherwise, baseline characteristics were similar between the two groups. Overall, the amputation rate was low (<2%; n = 28), especially in the upper extremities (<0.2%). Outcomes of conservative management and surgical revascularization were similar for mortality (5.0% vs 3.4%; P = .34), amputation (1.9% vs 1.1%; P = .46), length of hospital stay (15.4 vs 12.9 days; P = .07), and hospital charge ($281,794 vs $288,507; P = .28). In subgroup analysis, infants had less concomitant orthopedic injury than other age groups. Children demonstrated a higher likelihood of associated upper extremity injury and operative revascularization (P < .01) than infants or adolescents. In infants, mortality was higher and surgical intervention was associated with longer hospital stay (29.5 ± 34.4 days vs 45.6 ± 31.6 days; P = .02) and larger health care expenditure ($467,885 ± $638,653 vs $1,099,343 ± $695,872; P < .01). CONCLUSIONS: Pediatric ALI is a rare entity and is associated with low amputation and mortality rates. Among the pediatric age cohorts, infants with ALI are at higher risk of in-hospital mortality than older age groups are. Surgical intervention is not associated with improved limb salvage or mortality. Nonoperative management may be considered an initial treatment modality, but further research is needed to elucidate which important subset of pediatric patients benefit from open or endovascular operative intervention.

The relationship between medical expenses and the severity of peripheral arterial disease in Japan.

The main objective is to examine whether the severity of peripheral arterial disease (PAD) affects the expenses and hospital stay of the patients who undergo bypass surgery below the inguinal ligament for PAD. Eighty consecutive patients who underwent infrainguinal bypass surgery for PAD between January 2012 and December 2014 were included in the study. Patients were divided into groups according to their critical limb ischemia (CLI) symptoms and the Wound, Ischemia, and Foot Infection (WIfI) classification. As endpoints, we assessed the duration of postoperative hospital stay and expenses during hospitalization. CLI was a significant factor for longer hospital stay and increased medical expenses (p = 0.009 and p = 0.001). In the patients with CLI, significant factors for longer hospital stay and increased medical expenses were (1) history of distal bypass (p = 0.33 and p = 0.003, respectively) and stage 4 local lower limb status in WIfI classification (p = 0.0007 and p = 0.053). PAD severity was associated with prolonged postoperative hospital stay and increased medical expenses. The presence or absence of CLI and its severity according to the WIfI classification correlated with medical expenses and hospital stay duration between the milder and severe groups.

Prevalence and impact of critical limb ischaemia on in-hospital outcome in transcatheter aortic valve implantation in Germany.

AIMS: Peripheral artery disease (PAD) is common in patients with aortic valve stenosis (AS). This study sought to assess the prevalence of critical limb ischaemia (CLI) and its impact on in-hospital outcome in patients undergoing transcatheter aortic valve implantation (TAVI) for severe AS. METHODS AND RESULTS: All isolated TAVI procedures for AS in Germany between 2007 and 2013 were analysed regarding the stage-specific prevalence of PAD, comorbidities, in-hospital complications and mortality using diagnostic and procedural codes. Among 32,044 patients with TAVI, 3,375 (10.5%) had PAD and 654 (2.0%) CLI. TAVI patients with PAD, particularly those with CLI, had a higher incidence of periprocedural stroke, bleeding and acute kidney injury (p<0.001). The overall in-hospital mortality among TAVI without PAD, non-CLI PAD and CLI was 6.1%, 8.4% and 14.7%, respectively (p<0.001). In a multivariate logistic regression analysis, CLI was an independent predictor of in-hospital mortality (odds ratio 1.96, 95% confidence interval 1.56-2.47; p<0.001). CONCLUSIONS: In patients undergoing TAVI, the presence of PAD is associated with an increased risk of periprocedural complications, while only CLI independently predicts increased in-hospital mortality. Whether CLI represents a marker of general poor health status resulting in poor outcome or is a modifiable risk factor whose treatment prior to TAVI can improve the outcome requires prospective studies.

Burden of Readmissions Among Patients With Critical Limb Ischemia.

BACKGROUND: Readmissions constitute a major health care burden among critical limb ischemia (CLI) patients. OBJECTIVES: This study aimed to determine the incidence of readmission and factors affecting readmission in CLI patients. METHODS: All adult hospitalizations with a diagnosis code for CLI were included from State Inpatient Databases from Florida (2009 to 2013), New York (2010 to 2013), and California (2009 to 2011). Data were merged with the directory available from the American Hospital Association to obtain detailed information on hospital-related characteristics. Geographic and routing analysis was performed to evaluate the effect of travel time to the hospital on readmission rate. RESULTS: Overall, 695,782 admissions from 212,241 patients were analyzed. Of these, 284,189 were admissions with a principal diagnosis of CLI (primary CLI admissions). All-cause readmission rates at 30 days and 6 months were 27.1% and 56.6%, respectively. The majority of these were unplanned readmissions. Unplanned readmission rates at 30 days and 6 months were 23.6% and 47.7%, respectively. The major predictors of 6-month unplanned readmissions included age, female sex, black/Hispanic race, prior amputation, Charlson comorbidity index, and need for home health care or rehabilitation facility upon discharge. Patients covered by private insurance were least likely to have a readmission compared with Medicaid/no insurance and Medicare populations. Travel time to the hospital was inversely associated with 6-month unplanned readmission rates. There was a significant interaction between travel time and major amputation as well as travel time and revascularization strategy; however, the inverse association between travel time and unplanned readmission rate was evident in all subgroups. Furthermore, length of stay during index hospitalization was directly associated with the likelihood of 6-month unplanned readmission (odds ratio for log-transformed length of stay: 2.39 [99% confidence interval: 2.31 to 2.47]). CONCLUSIONS: Readmission among patients with CLI is high, the majority of them being unplanned readmissions. Several demographic, clinical, and socioeconomic factors play important roles in predicting readmissions.

The Impact of Chronic Kidney Disease on Hospitalized Patients With Peripheral Arterial Disease and Critical Limb Ischemia.

Peripheral arterial disease (PAD) and chronic kidney disease (CKD) are major public health problems worldwide. Evaluations of large-scale data on morbidity, outcome, and costs in patients having PAD with CKD are essential. Cross-sectional nationwide population-based analysis of all hospitalizations for PAD during 2009 in Germany focused on the stage-related impact of CKD on morbidity, in-hospital mortality, amputations, length of hospital stay, and health-related expenditure. The total number of hospitalizations was 483 961. Of those, 132 993 (27.5%) had CKD. Chronic kidney disease caused 1.8-fold higher amputation rate ( P < .001) with a stepwise increasing rate with higher CKD stage. Chronic kidney disease doubled in-hospital mortality of patients with PAD (7.8%; n = 10 421) versus 4.0% (n = 14 174, P < .001) with a stepwise increasing risk with higher CKD stage ( P < .001). The highest in-hospital mortality occurred in patients with coprevalence of CKD stage 4 and Fontaine stage IV (16.4%, n = 1176, P < .001). Chronic kidney disease caused 15% higher costs and 21% increased length of stay compared to the whole PAD cohort. This analysis demonstrates the stage-related influence of CKD on morbidity, in-hospital mortality, amputations, length of hospital stay, and reimbursement costs of hospitalized patients with PAD.

A multicentre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and health-care resource use following cardiac surgery (TITRe2).

BACKGROUND: Uncertainty about optimal red blood cell transfusion thresholds in cardiac surgery is reflected in widely varying transfusion rates between surgeons and cardiac centres. OBJECTIVE: To test the hypothesis that a restrictive compared with a liberal threshold for red blood cell transfusion after cardiac surgery reduces post-operative morbidity and health-care costs. DESIGN: Multicentre, parallel randomised controlled trial and within-trial cost-utility analysis from a UK NHS and Personal Social Services perspective. We could not blind health-care staff but tried to blind participants. Random allocations were generated by computer and minimised by centre and operation. SETTING: Seventeen specialist cardiac surgery centres in UK NHS hospitals. PARTICIPANTS: Patients aged > 16 years undergoing non-emergency cardiac surgery with post-operative haemoglobin < 9 g/dl. Exclusion criteria were: unwilling to have transfusion owing to beliefs; platelet, red blood cell or clotting disorder; ongoing or recurrent sepsis; and critical limb ischaemia. INTERVENTIONS: Participants in the liberal group were eligible for transfusion immediately after randomisation (post-operative haemoglobin < 9 g/dl); participants in the restrictive group were eligible for transfusion if their post-operative haemoglobin fell to < 7.5 g/dl during the index hospital stay. MAIN OUTCOME MEASURES: The primary outcome was a composite outcome of any serious infectious (sepsis or wound infection) or ischaemic event (permanent stroke, myocardial infarction, gut infarction or acute kidney injury) during the 3 months after randomisation. Events were verified or adjudicated by blinded personnel. Secondary outcomes included blood products transfused; infectious events; ischaemic events; quality of life (European Quality of Life-5 Dimensions); duration of intensive care or high-dependency unit stay; duration of hospital stay; significant pulmonary morbidity; all-cause mortality; resource use, costs and cost-effectiveness. RESULTS: We randomised 2007 participants between 15 July 2009 and 18 February 2013; four withdrew, leaving 1000 and 1003 in the restrictive and liberal groups, respectively. Transfusion rates after randomisation were 53.4% (534/1000) and 92.2% (925/1003). The primary outcome occurred in 35.1% (331/944) and 33.0% (317/962) of participants in the restrictive and liberal groups [odds ratio (OR) 1.11, 95% confidence interval (CI) 0.91 to 1.34; p = 0.30], respectively. There were no subgroup effects for the primary outcome, although some sensitivity analyses substantially altered the estimated OR. There were no differences for secondary clinical outcomes except for mortality, with more deaths in the restrictive group (4.2%, 42/1000 vs. 2.6%, 26/1003; hazard ratio 1.64, 95% CI 1.00 to 2.67; p = 0.045). Serious post-operative complications excluding primary outcome events occurred in 35.7% (354/991) and 34.2% (339/991) of participants in the restrictive and liberal groups, respectively. The total cost per participant from surgery to 3 months postoperatively differed little by group, just £182 less (standard error £488) in the restrictive group, largely owing to the difference in red blood cells cost. In the base-case cost-effectiveness results, the point estimate suggested that the restrictive threshold was cost-effective; however, this result was very uncertain partly owing to the negligible difference in quality-adjusted life-years gained. CONCLUSIONS: A restrictive transfusion threshold is not superior to a liberal threshold after cardiac surgery. This finding supports restrictive transfusion due to reduced consumption and costs of red blood cells. However, secondary findings create uncertainty about recommending restrictive transfusion and prompt a new hypothesis that liberal transfusion may be superior after cardiac surgery. Reanalyses of existing trial datasets, excluding all participants who did not breach the liberal threshold, followed by a meta-analysis of the reanalysed results are the most obvious research steps to address the new hypothesis about the possible harm of red blood cell transfusion. TRIAL REGISTRATION: Current Controlled Trials ISRCTN70923932. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 60. See the NIHR Journals Library website for further project information.

Epidemiology of Peripheral Arterial Disease and Critical Limb Ischemia.

With a rise in the aging popluation, the prevalence of peripheral arterial disease (PAD) is markedly increasing. The overall disease prevalence of PAD is in the range of 3%-10%, which increases to 15%-20% in persons older than 70 years of age. Given this upward trend in disease prevalence, the economic and societal burden of PAD would be considerable. The subgroup of patients who develop critical limb ischemia (CLI) represents the most challenging population to manage medically, surgically, and endovascularly. Patients with symptomatic PAD and CLI have an increased risk for death and cardiovascular events, especially in those with CLI who carry with them a substantial risk of limb loss. Advances in medical, surgical, and endovascular techniques have shown excellent outcomes in the treatment of these patients, however the optimal management paradigm has not been elucidated. This article reviews the classification and epidemiology, risk factors, natural history, and health care costs associated with PAD and CLI.

[Cost and cost-effectiveness in the treatment of peripheral arterial occlusion disease - what is proven?]. / Kosten und Kosteneffizienz bei der Behandlung der peripheren arteriellen Verschlusskrankheit - was ist gesichert?

BACKGROUND: This overview comments on the health-care relevance of peripheral arterial occlusive disease (PAOD) in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). We evaluated different treatment modalities in terms of cost-effectiveness. METHOD: For the literature review, the Medline database (PubMed) was searched under the key words "critical limb ischemia AND cost", "critical limb ischemia AND economy", "peripheral arterial disease AND cost", "peripheral arterial disease AND economy". RESULTS: In the years 2005 to 2009, the hospitalisations of patients with PAOD rose disproportionately in Germany by 20 %, to 483,961 hospital admissions. By comparison, hospital admissions altogether increased by only 8 %. The average in-patient costs were estimated to be approximately € 5000 per PAOD-patient - a rather conservative estimate. For the patient with IC the economic data position is clear, supervised exercise training is by far the most cost-effective treatment option, followed by percutaneous transluminal angioplasty (PTA) and finally the peripheral bypass. In accordance with the guidelines of the UK, the latter is therefore indicated only if PTA fails or is technically not possible. In patients with CLI, the situation is not obvious. Indeed, a short-term economic advantage can be calculated for the PTA, the long-term comparison of both methods, however, is impossible due to insufficient data. In addition, the risk factors for the patient have to be included in the calculation. This was indeed demonstrated in the short-term, but could not be analysed in the long-term follow-up. CONCLUSION: The issue of greater cost-effectiveness of open or endovascular treatment in patients with CLI is uncertain, the studies and patient populations are too heterogeneous. Further studies are urgently needed to structure the sequence of the various treatment options in guidelines and clinical pathways.