Economic impact of limb-salvage strategies in chronic limb-threatening ischaemia: modelling and budget impact study based on national registry data.

BACKGROUND: Missed opportunities to reduce numbers of primary major lower-limb amputation and increase limb-salvage procedures when treating chronic limb-threatening ischaemia have previously been identified in the literature. However, the potential economic savings for healthcare providers when salvaging a chronic limb-threatening ischaemia-affected limb have not been well documented. METHODS: A model using National Health Service healthcare usage and cost data for 1.6 million individuals and averaged numbers of primary surgical procedures for chronic limb-threatening ischaemia from England and Wales in 2019-2021 was created to perform a budget impact analysis. Two scenarios were tested: the averaged national rates of major lower-limb amputation (above the ankle joint), angioplasty, open bypass surgery or arterial endarterectomy in the National Vascular Registry (current scenario); and revascularization rates adjusted based on the lowest amputation rate reported by the National Vascular Registry at the time of the study (hypothetical scenario). The primary outcome was the net impact on costs to the National Health Service over 12 months after the index procedure. RESULTS: In the current scenario, the proportions of different index procedures were 10% for lower-limb major amputation, 55% for angioplasty, 25% for open bypass surgery and 10% for arterial endarterectomy. In the hypothetical scenario, the procedure rates were 3% for major lower-limb amputation, 59% for angioplasty, 27% for open bypass surgery and 11% for arterial endarterectomy. For 16 025 index chronic limb-threatening ischaemia procedures, the total care cost in the current scenario was €243 924 927. In the hypothetical scenario, costs would be reduced for index procedures (-€10 013 814), community care (-€633 943) and major cardiovascular events (-€383 407), and increased for primary care (€59 827), outpatient appointments (€120 050) and subsequent chronic limb-threatening ischaemia-related surgery (€1 179 107). The net saving to the National Health Service would be €9 645 259. CONCLUSION: A shift away from primary major lower-limb amputation towards revascularization could lead to substantial savings for the National Health Service without major cost increases later in the care pathway, indicating that care decisions taken in hospitals have wider benefits.

Assessing the influence of rural residence and economic distress on lower extremity risk stratification among diabetic foot ulcer patients utilizing the Wound, Ischemia, and Foot Infection (WIfI) classification system.

OBJECTIVE: Diabetic foot ulcers (DFU) are a major sequela of uncontrolled diabetes with a high risk of adverse outcomes. Poor DFU outcomes disproportionately impact patients living in rural and economically distressed communities with lack of access to consistent, quality care. This study aimed to analyze the risk of geographic and economic disparities, including rural status and county economic distress, on the disease burden of DFU at presentation utilizing the SVS WIfI classification system. METHODS: We conducted a retrospective review of 454 patients diagnosed with a DFU from 2011 to 2020 at a single institution's inpatient and outpatient wound care service. Patients >18 years old, with type II diabetes mellitus, and diabetic foot ulcer were included. RESULTS: ANCOVA analyses showed rural patients had significantly higher WIfI composite scores (F(1,451) = 9.61, p = .002), grades of wound (F(1,439) = 11.03, p = .001), and ischemia (F(1,380) = 12.574, p = .001) compared to the urban patients. Patients that resided in at-risk economic counties had significantly higher overall WIfI composite scores (F(2,448) = 3.31, p = .037) than patients who lived in transitional economic counties, and higher foot infection grading (F(2,440) = 3.02, p = .05) compared to patients who lived in distressed economic counties. DFU patients who resided in distressed economic counties presented with higher individual grades of ischemia (F(2, 377) = 3.14, p = .04) than patients in transitional economic counties. Chi-Square analyses demonstrated patients who resided in urban counties were significantly more likely to present with grade 1 wounds (χ2(3) = 9.86, p = .02) and grade 0 ischemia (χ2(3) = 16.18, p = .001) compared to patients in rural areas. Economically distressed patients presented with significantly less grade 0 ischemia compared to patients in transitional economic counties (χ2(6) = 17.48, p = .008). CONCLUSIONS: Our findings are the first to demonstrate the impact of geographic and economic disparities on the disease burden of DFU at presentation utilizing the SVS WIfI classification system. This may indicate need for improved multidisciplinary primary care prevention strategies with vascular specialists in these communities to mitigate worsening DFU and promote early intervention.

The cost-effectiveness of intensive low-density lipoprotein cholesterol lowering in people with peripheral artery disease.

BACKGROUND: People with peripheral artery disease are at a high risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Randomized controlled trials suggest that intensive lowering of low-density lipoprotein cholesterol (LDL-C) with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors is an effective strategy to prevent these events. This study estimated the potential benefit and cost-effectiveness of administrating PCSK9 inhibitors to a cohort of participants with peripheral artery disease. METHODS: A total of 783 participants with intermittent claudication (IC; n = 582) or chronic limb-threatening ischemia (CLTI; n = 201) were prospectively recruited from three hospitals in Australia. Serum LDL-C was measured at recruitment, and the occurrence of MACE and MALE was recorded over a median (interquartile range) follow-up of 2.2 years (0.3-5.7 years). The potential benefit of administering a PCSK9 inhibitor was estimated by calculating the absolute risk reduction and numbers needed to treat (NNT) based on relative risk reductions reported in published randomized trials. The incremental cost-effectiveness ratio per quality-adjusted life year gained was estimated. RESULTS: Intensive LDL-C lowering was estimated to lead to an absolute risk reduction in MACE of 6.1% (95% confidence interval [CI], 2.0-9.3; NNT, 16) and MALE of 13.7% (95% CI, 4.3-21.5; NNT, 7) in people with CLTI compared with 3.2% (95% CI, 1.1-4.8; NNT, 32) and 5.3% (95% CI, 1.7-8.3; NNT, 19) in people with IC. The estimated incremental cost-effectiveness ratios over a 10-year period were $55,270 USD and $32,800 USD for participants with IC and CLTI, respectively. CONCLUSIONS: This analysis suggests that treatment with a PCSK9 inhibitor is likely to be cost-effective in people with CLTI.

Lower Limb Revascularization for Peripheral Arterial Disease in 10,951 Procedures over 11 years in a Public Health System: A Descriptive Analysis of the Largest Brazilian City.

BACKGROUND: Worldwide, peripheral arterial disease (PAD) is a disease with high morbidity, affecting more than 200 million people. Our objective was to analyze the surgical treatment for PAD performed in the Unified Health System of the city of São Paulo during the last 11 years based on publicly available data. METHODS: The study was conducted with data analysis available on the TabNet platform, belonging to the DATASUS. Public data (government health system) from procedures performed in São Paulo between 2008 and 2018 were extracted. Sex, age, municipality of residence, operative technique, number of surgeries (total and per hospital), mortality during hospitalization, mean length of stay in the intensive care unit and amount paid by the government system were analyzed. RESULTS: A total of 10,951 procedures were analyzed (either for claudicants or critical ischemia-proportion unknown); 55.4% of the procedures were performed on males, and in 50.60%, the patient was older than 65 years. Approximately two-thirds of the patients undergoing these procedures had residential addresses in São Paulo. There were 363 in-hospital deaths (mortality of 3.31%). The hospital with the highest number of surgeries (n = 2,777) had lower in-hospital mortality (1.51%) than the other hospitals. A total of $20,655,272.70 was paid for all revascularizations. CONCLUSIONS: Revascularization for PAD treatment has cost the government system more than $20 million over 11 years. Endovascular surgeries were performed more often than open surgeries and resulted in shorter hospital stays and lower perioperative mortality rates.

Fast-track thrombolysis protocol for acute limb ischemia.

OBJECTIVE: Catheter-directed thrombolysis in the treatment of acute lower extremity arterial occlusions often requires several interventional sessions to generate successful outcomes. It is typically an expensive procedure, necessitating extended hospital length of stay (LOS) that may be associated with an increase in both local and systemic hemorrhagic complications. Five years ago, we created the fast-track thrombolysis protocol for arteries (FTTP-A) to deal with these concerns. The goal of our protocol is to re-establish patency during the first session of thrombolysis, thus decreasing costs and complications associated with prolonged periods of thrombolytic exposure. METHODS: A retrospective study of 42 patients who were treated for acute limb ischemia at our institution by FTTP-A from January 2014 to February 2019 was performed. FTTP-A includes periadventitial lidocaine injection at the arterial puncture site under ultrasound guidance, contrast arteriography of the entire targeted segment, pharmacomechanical rheolytic thrombectomy of the occluded arterial segment, tissue plasminogen activator infusion along the occluded segment, balloon maceration of the thrombus, and (if deemed necessary) placement of a stent in an area of significant (≥30%) stenosis that is refractory to balloon angioplasty and thrombolysis. After the stenosis or thrombus is cleared, patients are prescribed an oral anticoagulant agent. RESULTS: Primary FTTP-A (50 total interventions) was performed in 42 patients. The median age of patients was 67.2 ± 12.2 years (range, 41-98 years), and 54.8% were male; 59.5% of the procedures were performed on the left lower extremity. Initial arterial access was obtained through the common femoral artery in 39 of 42 cases (92.9%); in the remaining 3 cases, it was obtained in a left bypass access site, a right femoral-popliteal graft, and a right femoral-femoral graft. The mean operative time was 148.9 ± 62.9 minutes (range, 83-313 minutes), and the mean volume of tissue plasminogen activator infused was 9.7 ± 4.0 mg (range, 2-20 mg). The median cost including medications and interventional tools was $4673.19 per procedure. The mean postoperative LOS was 3.1 ± 4.5 days (range, 1-25 days). Median postoperative LOS was 1 day. Mean postoperative follow-up was 27 ± 19.2 months (range, 0-62 months). Single-session FTTP-A was successful in 81% (n = 34/42) of patients; the remaining 8 patients (19%) required a single additional session. Of the 42 patients, 34 (81%) required arterial stenting. Periprocedural complications consisted of one patient with hematuria, which resolved, and one patient with thrombocytopenia, which resolved. No patients experienced rethrombosis within 30 days of FTTP-A. During the 5-year study period, there was no significant local or systemic hemorrhage, limb loss, or mortality related to this protocol. CONCLUSIONS: FTTP-A appears to be a safe, efficacious, and cost-effective procedure in the resolution of acute lower extremity arterial occlusions.

"Failure-to-Cross" in Patients Undergoing Percutaneous Peripheral Intervention: The Nonreimbursed Procedure.

BACKGROUND: Percutaneous peripheral intervention (PPI) is often the first mode of therapy for patients with symptomatic arterial occlusive disease. Technical success generally remains high although "failure-to-cross" still complicates 5-20% of cases. Extended efforts to cross long, occlusive lesions can utilize significant hospital and practitioner resources. The hospital is typically reimbursed for this effort as facility fees are charged by the hour and materials are charged per use. However, given the lack of a CPT® code for "failure-to-cross," practitioners are rarely appropriately compensated. The purpose of this study is to analyze the predictors, technical details, outcomes, and costs of "failure-to-cross" during PPI. METHODS: All PPI procedures over a 2-year period at a single institution were retrospectively reviewed. Clinical characteristics, results, costs, and reimbursements obtained from hospital cost accounting were compared among successful therapeutic interventions, crossing failures, and diagnostic angiograms without attempted intervention. RESULTS: A total of 146 consecutive PPIs were identified; the rate of "failure-to-cross" was 11.6% (17 patients). The majority of patients with "failure-to-cross" were male (82%) with single-vessel runoff (53%). Compared to successful interventions, the incidences of chronic limb-threatening ischemia (82% vs. 70%, P = 0.34) and infrapopliteal occlusive disease were similar (47% vs. 31%, P = 0.20). "Failure-to-cross" procedures were just as long as successful procedures; there were no significant differences in fluoroscopy time (27 ± 10 vs. 24 ± 14 min, P = 0.52), in-room time (106 ± 98 vs. 103 ± 44 min, P = 0.84), or contrast dye volume utilization (73 ± 37 vs. 96 ± 54 mL, P = 0.12). As expected, "failure-to-cross" procedures incurred far higher hospital charges and costs compared to noninterventional diagnostic angiograms (charges $13,311 ± 6,067 vs. $7,690 ± 1,942, P < 0.01; costs $5,289 ± 2,099 vs. $2,826 ± 1,198, P < 0.01). Despite the additional time and effort spent attempting to cross difficult lesions, the operators were reimbursed at the same low rate as a purely diagnostic procedure (average fee charge $7,360; average reimbursement $992). After 1 year, the 17 patients in whom lesions could not be crossed were treated with advanced interventional procedures with success (n = 2), surgical bypass grafting (n = 5), extremity amputation (n = 4), or no additional intervention in their salvaged limb (n = 6). CONCLUSIONS: Patients whose lesions cannot be crossed during PPI fare worse than patients undergoing successful interventions. Hospital costs and charges appropriately reflect the high technical difficulty and resource utilization of extended attempts at endovascular therapy. For practitioners, crossing lesions during PPI is truly a "pay-for-performance" procedure in that only successful procedures are reasonably reimbursed.

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.

Medicare reimbursement of lower extremity bypass does not cover cost of care for most patients with critical limb ischemia.

OBJECTIVE: Lower extremity bypass surgery remains an important treatment option for patients with critical limb ischemia (CLI), but is resource intensive. We sought to evaluate the cost and Medicare reimbursement for lower extremity bypass surgery in patients with CLI. METHODS: Hospital cost accounting systems were queried for total technical and professional costs incurred and reimbursement received for patients with CLI undergoing lower extremity bypass at our center between 2011 and 2017. Patients were identified by assignment to Diagnosis-Related Group (DRG) 252, 253, or 254 (other vascular procedure with major complication/comorbidity, with complication/comorbidity, and without complication/comorbidity, respectively). Additional clinical data were incorporated from the Vascular Quality Initiative clinical registry. For non-Medicare patients, reimbursement was indexed to Medicare rates. Contribution margins (reimbursement minus cost) from technical and professional services were analyzed for each patient and summarized by DRG. We compared technical, professional, and total costs; reimbursement; and contribution margins across DRGs using univariate statistics and evaluated factors associated with total contribution margin using median quantile regression. RESULTS: We analyzed 68 patients with hemodynamically confirmed CLI (46% rest pain, 54% tissue loss), of whom 25% received a prosthetic graft. Mean age was 66.1 ± 11.6 years, 69% were male, 49% diabetic, 44% current smokers, and 4% on dialysis. In general, total infrainguinal bypass cost was adequately compensated for patients assigned only the most complex DRG 252 (median, $2490; interquartile range [IQR], -$1,621 to $10,080). In the majority of patients with less complex DRG 253 (median, -$3,100; IQR, -$8499 to $109) and DRG 254 (median, -$4902; IQR, -$9259 to $1059), reimbursement did not cover the cost of care. Both technical costs and professional costs varied significantly with the complexity of DRG. Although reimbursement from technical services increased alongside increasing complexity of DRG, there was insignificant variation in professional reimbursement as DRG complexity increased. On multivariable modeling, longer length of stay (-$2547 per additional day) and preoperative dialysis (-$5555) were significantly associated with negative margins. CONCLUSIONS: For the majority of patients with CLI, current Medicare reimbursement does not adequately cover the cost of providing care after open bypass surgery. As commercial insurers move toward Medicare reimbursement rates, more granular risk stratification profiles are needed to ensure open surgical care for patients with CLI remains financially sustainable.

Endovascular Versus Surgical Revascularization for Acute Limb Ischemia: A Propensity-Score Matched Analysis.

BACKGROUND: The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking. METHODS: We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs. RESULTS: Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; P=0.002), myocardial infarction (1.9% versus 2.7%; P=0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; P<0.001), acute kidney injury (10.5% versus 11.9%; P=0.043), fasciotomy (1.9% versus 8.9%; P<0.001), major bleeding (16.7% versus 21.0%; P<0.001), and transfusion (10.3% versus 18.5%; P<0.001), but higher vascular complications (1.4% versus 0.7%; P=0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; P=0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization. CONCLUSIONS: In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.

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.

Cost-Effectiveness of Drug-Eluting Stents for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: The PADI Trial.

PURPOSE: Drug-eluting stents (DES) improve clinical and morphological long-term results compared to percutaneous transluminal angioplasty (PTA) with bailout bare metal stenting (BMS) in patients with critical limb ischemia (CLI) and infrapopliteal lesions (PADI trial). We performed a cost-effectiveness analysis of DES compared to PTA ± BMS in cooperation with Dutch health insurance company VGZ, using data from the PADI trial. MATERIALS AND METHODS: In the PADI trial, adults with CLI (Rutherford category ≥ 4) and infrapopliteal lesions were randomized to receive DES with paclitaxel or PTA ± BMS. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) with PTA ± BMS. The costs were calculated by using the mean costs per stent multiplied by the mean number of stents used per patient (€750 × 1.8 for DES vs €250 × 0.3 for PTA ± BMS). These costs were compared with the costs of major amputation (€16.000) and rehabilitation (first year €15.750, second year €7.375 and third year €3.600). RESULTS: The 5-year major amputation rate was lower in the DES group (19.3% vs 34.0% for PTA ± BMS; p = 0.091). In addition, the 5-year amputation-free survival and event-free survival were significantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively). After 1 year, the cost difference per patient between DES and PTA ± BMS is €1.679 in favor of DES and €2.694 after 3 years. CONCLUSION: In our analysis, DES are cost-effective due to the higher hospital costs of amputation and rehabilitation in the PTA ± BMS group. LEVEL OF EVIDENCE: Level 1b, analysis based on clinically sensible costs and randomized controlled trial.

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.

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.

Temporal trends and hospital costs associated with an endovascular-first approach for acute limb ischemia.

OBJECTIVE: Recent studies suggest similar perioperative outcomes for endovascular and open surgical management of acute limb ischemia (ALI). We sought to describe temporal trends, patient factors, and hospital costs associated with contemporary ALI management. METHODS: We used the weighted National Inpatient Sample to estimate primary ALI cases requiring open or endovascular intervention (2005-2014). We used multivariable regression models to examine temporal trends, patient factors, and hospital costs associated with endovascular-first vs open-first management. RESULTS: Of 116,451 admissions for ALI during the study period, 35.2% were treated by an endovascular-first approach. The percentage of admissions managed with an endovascular-first approach increased over time (P < .001). Independent predictors of endovascular-first management included younger age, male sex, renal insufficiency, and more recent calendar year of admission (P ≤ .02), whereas patients who underwent fasciotomy, those with Medicaid, and those admitted on a weekend were more likely to undergo open-first management (P ≤ .02). Endovascular-first management had higher mean hospital costs than open-first management ($29,719 vs $26,193; P < .001). After adjustment for patient, hospital, and admission characteristics, there was an increase of $981 in treatment costs per year in the endovascular-first group (95% confidence interval [CI], $571-$1392; P < .001), whereas the costs associated with an open-first approach remained relatively stable over time ($10 per year; 95% CI, -$295 to $315; P = .95; P < .001 for interaction). The risk-adjusted odds of in-hospital major amputation was similar in both groups (adjusted odds ratio, 0.99; 95% CI, 0.85-1.15; P = .88). CONCLUSIONS: Use of an endovascular-first approach for the treatment of ALI has significantly increased over time. Although major amputation rates are similar for both approaches, the costs associated with an endovascular-first approach are increasing over time, whereas the costs of open surgery have remained stable. The cost-effectiveness of modern ALI management warrants further investigation.

Cost-effectiveness of the treatments for critical limb ischemia in the elderly population.

OBJECTIVE: The treatment of critical limb ischemia (CLI), with the intention to prevent limb loss, is often an intensive and expensive therapy. The aim of this study was to examine the cost-effectiveness of endovascular and conservative treatment of elderly CLI patients unsuitable for surgery. METHODS: In this prospective observational cohort study, data were gathered in two Dutch peripheral hospitals. CLI patients aged 70 years or older were included in the outpatient clinic. Exclusion criteria were malignant disease, lack of language skills, and cognitive impairment; 195 patients were included and 192 patients were excluded. After a multidisciplinary vascular conference, patients were divided into three treatment groups (endovascular revascularization, surgical revascularization, or conservative therapy). Subanalyses based on age were made (70-79 years and ≥80 years). The follow-up period was 2 years. Cost-effectiveness of endovascular and conservative treatment was quantified using incremental cost-effectiveness ratios (ICERs) in euros per quality-adjusted life-years (QALYs). RESULTS: At baseline, patients allocated to surgical revascularization had better health states, but the health states of endovascular revascularization and conservative therapy patients were comparable. With an ICER of €38,247.41/QALY (∼$50,869/QALY), endovascular revascularization was cost-effective compared with conservative therapy. This is favorable compared with the Dutch applicable threshold of €80,000/QALY (∼$106,400/QALY). The subanalyses also established that endovascular revascularization is a cost-effective alternative for conservative treatment both in patients aged 70 to 79 years (ICER €29,898.36/QALY; ∼$39,765/QALY) and in octogenarians (ICER €56,810.14/QALY; ∼$75,557/QALY). CONCLUSIONS: Our study has shown that endovascular revascularization is cost-effective compared with conservative treatment of CLI patients older than 70 years and also in octogenarians. Given the small absolute differences in costs and effects, physicians should also consider individual circumstances that can alter the outcome of the intervention. Cost-effectiveness remains one of the aspects to take into consideration in making a clinical decision.

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 Cost of Drug-Eluting Stents versus Bare Metal Stents in the Treatment of Critical Limb Ischemia in the United States.

BACKGROUND: Despite significant technical advancement in the last decade, the durability of endovascular management of critical limb ischemia (CLI) remains highly debatable. Drug-eluting stents (DESs) are being popularized for the management of CLI after its precedent success in coronary intervention. Initial reports on the durability of DES are promising. However, little is known on the additional cost of this relatively newer technology. The aim of this study is to compare the cost of the traditional bare metal stents (BMSs) to the newly introduced DES in a large cohort of CLI patients. METHODS: Using the Premier database (2009-2015), we identified all patients with CLI undergoing DES and BMS. A multivariable generalized linear model was implemented to examine in-hospital cost adjusting for patients' characteristics, comorbidities, and regional characteristics. RESULTS: A total of 20,702 patients with CLI underwent peripheral artery revascularization using BMS (18,924 [91.41%]) or DES (1,778 [8.6%]). Majority of patients were males (53%) and whites (71%). Patients undergoing BMS were slightly younger (median age [interquartile range]: 70 [62-79] versus 71 [63-80]) and were more likely to be smokers (46% vs. 39%) and have a history of cerebrovascular disease (10% vs. 8%) and chronic pulmonary disease (24.5% vs. 20.9%) as compared with those undergoing DES (all P < 0.05). On the other hand, DES patients had a high prevalence of diabetes (4% vs. 3%) and renal disease (25% vs. 22%) (both P < 0.05). There was also a significant increase in the proportion of patients undergoing DES and a corresponding decrease in BMS (P < 0.001) over the study period. Median total in-hospitalization cost (BMS: $13,342 [8,574 to 21,166], DES: $13,243 [8,560-20,232], P = 0.76) was similar for both approaches. After adjusting for potential confounders, DES was associated with $407 higher cost than BMS (adjusted mean difference [95% confidence interval]: 407 [17 to 798], P = 0.04). In addition, the cost was $672 higher in teaching hospitals, $1,153 higher in Rural areas, and increased in all regions compared with the Midwest (adjusted mean difference [95% confidence interval]-South: $293 [31 to 555], Northeast: $2,006 [1,517 to 2,495], West: $3,312 [2,930 to 3,695], all P < 0.05). CONCLUSIONS: In this large cohort of CLI patients, after controlling for potential confounders, we demonstrated that the cost of endovascular revascularization is significantly higher in patients undergoing DES than those undergoing BMS. Regional disparities in cost were also observed. Further studies looking at the long-term durability and costs of DES versus BMS are needed.

Determinants of Long-Term Outcomes and Costs in the Management of Critical Limb Ischemia: A Population-Based Cohort Study.

Background The optimal treatment for critical limb ischemia remains controversial owing to conflicting conclusions from previous studies. Methods and Results We obtained administrative claims on Medicare beneficiaries with initial critical limb ischemia diagnosis in 2011. Clinical outcomes and healthcare costs over 4 years were estimated among all patients and by first treatment (endovascular revascularization, surgical revascularization, or major amputation) in unmatched and propensity-score-matched samples. Among 72 199 patients with initial primary critical limb ischemia diagnosis in 2011, survival was 46% (median survival, 3.5 years) and freedom from major amputation was 87%. Among 9942 propensity-score-matched patients (8% rest pain, 26% ulcer, and 66% gangrene), survival was 38% with endovascular revascularization (median survival, 2.7 years), 40% with surgical revascularization (median survival, 2.9 years), and 23% with major amputation (median survival, 1.3 years; P<0.001 for each revascularization procedure versus major amputation). Corresponding major amputation rates were 6.5%, 9.6%, and 10.6%, respectively ( P<0.001 for all pair-wise comparisons). The cost per patient year during follow-up was $49 700, $49 200, and $55 700, respectively ( P<0.001 for each revascularization procedure versus major amputation). Conclusions Long-term survival and cost in critical limb ischemia management is comparable between revascularization techniques, with lower major amputation rates following endovascular revascularization. Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher healthcare costs versus revascularization. Results from this observational research may be susceptible to bias because of the influence of unmeasured confounders.

Nationally Representative Readmission Factors in Patients with Claudication and Critical Limb Ischemia.

BACKGROUND: Hospital readmissions are associated not only with increased mortality, morbidity, and costs but also, with current health-care reform, tied to significant financial and administrative penalties. Some studies show that patients undergoing vascular surgery may have higher than average readmission rates. The recently released Nationwide Readmission Database (NRD) is the most comprehensive national source of readmission data, gathering discharge information from 22 geographically dispersed states, accounting for 51.2% of the total U.S. resident population and 49.3% of all U.S. hospitalizations. The aim of this study is to use the power of the NRD and obtain nationally representative readmission information for patients admitted with claudication or critical limb ischemia (CLI) who underwent revascularization procedures. METHODS: The NRD was queried for all patients admitted for claudication (International Classification of Diseases Ninth Revision [ICD-9] 440.21) or CLI (ICD-9 440.22-440.24) and who underwent percutaneous transluminal angioplasty, peripheral bypass, or aortofemoral bypass. Patient demographics, comorbidities, length of stay (LOS), mortality, readmission rates, and associated costs were collected. Univariable and multivariable logistic regression analysis was implemented on claudication and CLI groups on all outcomes of interest. The most common readmission diagnosis codes and diagnosis groups were also identified. RESULTS: A total of 92,769 patients were admitted for peripheral vascular disease (33,055 with claudication and 59,714 with CLI). The 30-day readmission/any readmission rate was 8.97%/21.49% and 19.26%/40.36%, for claudication and CLI, respectively. Significant differences were found for claudication and CLI, respectively, on initial cost of admission ($18,548 vs. $29,148, P < 0.001), readmission costs ($14,726 vs. $17,681 P < 0.001), LOS (4 days vs. 9 days, P < 0.001), days to readmission (73 days vs. 59 days, P < 0.001), mortality during initial admission (256 vs. 1,363, P < 0.001), and mortality during any admission (538 vs. 3,838, P < 0.001). Univariate and multivariate logistic regression analysis found that claudication, CLI, angioplasty, peripheral bypass, aortofemoral bypass, female sex, age >65, Charlson Comorbidity Index, LOS, and primary expected payer status were all significant predictors of 30-day and overall readmissions at varying degrees. The 5 most common disease readmission groups found were other vascular procedures (12.6%), amputation of lower limb except toes (6.3%), sepsis (5.4%), heart failure (4.9%) and postoperative or other device infections (4.8%). Of the abovementioned groups, the 4 most common diagnoses included "other postoperative infections," sepsis, atherosclerosis of native arteries with gangrene, and "other complications due to other vascular device, implant, or graft." CONCLUSIONS: Our results demonstrate that there is a significant difference in readmission rates, cost, and morbidity between patients admitted for claudication and CLI. Furthermore, based on regression analysis, there are multiple other clear risk factors associated with worse clinical and economic outcomes. Further study is needed to predict which patients will require increased vigilance during their hospital stay to prevent readmissions and worse outcomes. LEVEL OF EVIDENCE: Care management/epidemiological, level IV.