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.

Costos directos en el tratamiento del pie diabético Unidad de Pie Diabético. Hospital de Clínicas. Universidad de la República / Direct costs of diabetic foot treatment Diabetic Foot Department Clínicas Hospital UDELAR / Custos diretos no tratamento do Pé Diabético Unidad de Pie Diabético. Hospital de Clínicas. UDELAR

En el mundo un paciente diabético gasta entre dos y tres veces más que el no diabético. El pie diabético disminuye la calidad de vida, aumenta la morbimortalidad y la carga económica del sistema de salud. Objetivo: comunicar la investigación realizada sobre costos directos en el tratamiento de la úlcera del pie diabético. Material y método: estudio observacional, descriptivo, retrospectivo de pacientes asistidos en la Unidad de Pie del Hospital de Clínicas, Universidad de la República, entre octubre de 2014 y septiembre de 2016. Se estimaron gastos directos del tratamiento ambulatorio e internación a través de información de la historia clínica. El horizonte de tratamiento fue de tres meses. Se calcularon los gastos en unidades reajustables (UR), pesos y dólares. Los gastos se actualizaron a octubre del 2022 utilizando el índice de precios al consumo (IPC), ajustado a la tasa de inflación acumulada. Resultados: incluimos 49 pacientes, 11 mujeres y 38 hombres, edad promedio 61,5 años. El gasto general fue mayor a 400.000 dólares, con el mayor costo en gastos de internación. El gasto total promedio por paciente fue de 8.799 dólares. El tratamiento convencional fue 3.707,93 dólares, la amputación mayor 32.003,61 dólares y amputación menor 12.385,34 dólares. El gasto en internación fue muy superior al del paciente ambulatorio. En emergencia, 28 pacientes gastaron 4.396 dólares. El incremento de costos al año 2022 fue de 37,45%, suponiendo un gasto general de 16.682.993,4 pesos o 410.830,2 dólares. Conclusión: primera evaluación en nuestro país de estimación de gastos en pie diabético. El costo de la úlcera genera una carga económica notoria y en aumento. La gravedad inicial de la úlcera determina ingresos con elevados costes. Los gastos de internación y amputaciones representan la mayor erogación económica.

On a global scale, a diabetic patient incurs healthcare expenses that are 2 to 3 times higher than those of a non-diabetic individual. Diabetic foot syndrome reduces the quality of life, increases morbidity and mortality, and places an economic burden on the healthcare system. Objective: Communicating the research conducted on direct costs in the treatment of diabetic foot ulcers. Method: Observational, descriptive, retrospective study of patients treated at the Foot Unit of the Hospital de Clínicas (UDELAR) between October 2014 and September 2016. Direct treatment costs for outpatient care and hospitalization were estimated using information from the medical records. The treatment horizon extended over a period of 3 months. Expenses were calculated in readjustable units, Uruguayan pesos (UYU), and United States dollars (USD). Expenses were updated to October 2022 using the Consumer Price Index (IPC) adjusted for the cumulative inflation rate. Results: 49 patients were included in the study: 11 women and 38 men, average age was 61.5 years old. The overall expenditure exceeded 400,000 USD, with the highest cost attributed to hospitalization expenses. The average total expenditure per patient amounted to 8,799 USD. The cost of conventional treatment was 3,707.93 USD, major amputation represented USD 32,003.61, and minor amputation USD 12,385.34. Hospitalization expenses significantly exceeded those of outpatient care. In the emergency department, 28 patients spent USD 4,396. The increase in costs by the year 2022 amounted to 37.45%, resulting in a total expenditure of UYU 16,682,993.4 (Uruguayan pesos) or USD 410,830.2. Conclusions: It was the first assessment in our country to estimate diabetic foot costs. The cost of ulcer management imposes a significant and increasing economic burden. The initial severity of the ulcer results in hospitalization which implies high associated costs. Hospitalization and amputation costs constitute the most substantial economic expenditure.

Em todo o mundo, um paciente diabético gasta entre 2 e 3 vezes mais do que um paciente não diabético. O pé diabético reduz a qualidade de vida, aumenta a morbimortalidade e a carga económica no sistema de saúde. Objetivos: Comunicar os resultados da pesquisa realizada sobre os custos diretos no tratamento das úlceras do pé diabético. Materiais e métodos: Estudo observacional, descritivo e retrospectivo de pacientes atendidos na Unidade de Pie do Hospital de Clínicas (UDELAR), entre outubro de 2014 e setembro de 2016. Foram estimados gastos diretos com tratamento ambulatorial e internação, por meio de informações do prontuário do paciente. O período de tratamento estudado foi de 3 meses. As despesas foram calculadas em Unidades Ajustáveis, em pesos uruguaios (UYU) e em dólares norte-americanos (USD). As despesas foram atualizadas para outubro de 2022 pelo Índice de Preços ao Consumidor (IPC) ajustado à inflação acumulada. Resultados: Foram incluídos 49 pacientes: 11 mulheres e 38 homens com idade média de 61,5 anos. A despesa global foi superior a US$ 400.000, com o maior custo em despesas de hospitalização. A despesa total média por paciente foi de US$ 8.799. Os custos por tratamento foram: Tratamento convencional US$ 3.707,93 USD, amputação maior US$ 32.003,61 e amputação menor US$ 12.385,34. O gasto com internação foi muito superior ao do ambulatório. No atendimento de emergência 28 pacientes gastaram US$ 4.396. O aumento dos custos até 2022 foi de 37,45%, assumindo uma despesa geral de UY$ 16.682.993,4 ou US$ 410.830,2 USD. Conclusão: Esta é a primeira avaliação de estimativa de gastos com pé diabético realizada no Uruguai. O custo das úlceras gera uma carga económica notável e crescente. A gravidade inicial da úlcera determina internações com custos elevados. As despesas com hospitalização e amputação representam o maior gasto financeiro.

Procedural and 12-month in-hospital costs of primary infra-popliteal bypass surgery, infrapopliteal best endovascular treatment, and major lower limb amputation for chronic limb threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. METHODS: We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study. RESULTS: Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis). CONCLUSIONS: Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis.

Geographical Variation in the Management of Peripheral Arterial Occlusive Disease: A Nationwide Danish Cohort Study.

OBJECTIVE: Equal access for equal needs is a key goal for many healthcare systems but geographical variation research has shown that this is often not the case in areas other than vascular surgery. This study assessed the variation across specialised vascular centres of an entire healthcare system in the costs and outcomes for patients having first time revascularisation for peripheral arterial occlusive disease. METHODS: This was a national study of all first time revascularisations performed in the Danish healthcare system between 2009 and 2014. Episodes were identified in the Danish Vascular Registry (n = 10 300) and data on one year follow up in terms of the costs of specialised healthcare (€) and amputation status were acquired from national registers. Generalised gamma and logit regressions were used to predict margins between centres while adjusting for population heterogeneity (age, sex, education, smoking, hypertension, diabetes, use of prophylactic pharmacological therapy, indication and type of revascularisation). Cost effectiveness frontiers were used to identify efficient providers and to illustrate the cost of reducing the system level risk of amputation. RESULTS: For each of the indications of chronic limb threatening and acute limb ischaemia, the one year amputation risks varied from 11% to 16% across centres (p = .003, p = .006) whereas for intermittent claudication there was no significant difference across centres. The corresponding costs of care varied across centres for all indications (p = .027, p = .028, p = .030). Linking costs and outcomes, three of seven centres were observed to provide poorer quality at higher costs. Exponentially increasing costs to obtain the maximum reduction of the amputation risk were observed. CONCLUSION: The results suggest that there is substantial variation in the clinical management of peripheral arterial occlusive disease across the Danish healthcare system and that this results in very different levels of efficiency - on top of potentially unequal treatment for equal needs. Further research is warranted.

Cost-Effectiveness of Lower Extremity Nerve Decompression Surgery in the Prevention of Ulcers and Amputations: A Markov Analysis.

BACKGROUND: The costs and health effects associated with lower extremity complications in diabetes mellitus are an increasing burden to society. In selected patients, lower extremity nerve decompression is able to reduce symptoms of neuropathy and the concomitant risks of diabetic foot ulcers and amputations. To estimate the health and economic effects of this type of surgery, the cost-effectiveness of this intervention compared to current nonsurgical care was studied. METHODS: To estimate the incremental cost-effectiveness of lower extremity nerve decompression over a 10-year period, a Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with diabetes and neuropathy who underwent lower extremity nerve decompression surgery, compared to a group undergoing current nonsurgical care. Mean survival time, health-related quality of life, presence or risk of lower extremity complications, and in-hospital costs were the outcome measures assessed. Data from the Rotterdam Diabetic Foot Study were used as current care, complemented with information from international studies on the epidemiology of diabetic foot disease, resource use, and costs, to feed the model. RESULTS: Lower extremity nerve decompression surgery resulted in improved life expectancy (88,369.5 life-years versus 86,513.6 life-years), gain of quality-adjusted life-years (67,652.5 versus 64,082.3), and reduced incidence of foot complications compared to current care (490 versus 1087). The incremental cost-effectiveness analysis was -€59,279.6 per quality-adjusted life-year gained, which is below the Dutch critical threshold of less than €80,000 per quality-adjusted life-year. CONCLUSIONS: Decompression surgery of lower extremity nerves improves survival, reduces diabetic foot complications, and is cost saving and cost-effective compared with current care, suggesting considerable socioeconomic benefit for society.

Socioeconomic factors associated with limb salvage versus amputation for adult extremity bone sarcomas in patients with insurance coverage.

BACKGROUND: Limb salvage (LS) has become the preferred treatment for adult patients with bone sarcoma of the extremities. The decision to perform LS versus an amputation is often dictated by tumor characteristics, however there may be socioeconomic factors associated with LS. Previously this has been linked to insurance status, however currently there is a paucity of data examining socioeconomic factors in patients with medical insurance at the time of sarcoma diagnosis. Therefore, the purpose of the current study was to examine socioeconomic factors which could be associated with the decision to perform LS versus amputation for adult bone sarcoma patients. METHODS: Data from Optum Labs Data Warehouse, a national administrative claims database, was analyzed to identify patients with extremity bone sarcomas from 2006 to 2017. Bivariate regression was used to identify factors associated with LS versus amputation. RESULTS: Of 1,390 (743 males, 647 female) patients, 252 (18%) under amputation while 1,138 (82%) underwent LS. Lower extremity tumors (OR 4.72, p < 0.001), income <$75,000 (OR 1.85, p = 0.03), being treated a public hospital (OR 1.41, p = 0.04) and a hospital with <200 beds (OR 1.90, p = 0.006) were associated with amputation. Income ≥$125,000 (OR 0.62, 0.04) were associated with LS. CONCLUSION: In adult patients with medical insurance at the time of diagnosis, socioeconomic and hospital factors were associated with an amputation for bone sarcoma, with poorer patients, and those treated at smaller, and public hospitals more likely to undergo amputation.

Association of antidiabetic therapies with lower extremity amputation, mortality and healthcare cost from a nationwide retrospective cohort study in Taiwan.

We compared risks of clinical outcomes, mortality and healthcare costs among new users of different classes of anti-diabetic medications. This is a population-based, retrospective, new-user design cohort study using the Taiwan National Health Insurance Database between May 2, 2015 and September 30, 2017. An individual was assigned to a medication group based on the first anti-diabetic prescription on or after May 1, 2016: SGLT-2 inhibitors, DPP-4 inhibitors, GLP-1 agonists or older agents (metformin, etc.). Clinical outcomes included lower extremity amputation, peripheral vascular disease, critical limb ischemia, osteomyelitis, and ulcer. We built three Cox proportional hazards models for clinical outcomes and mortality, and three regression models with a log-link function and gamma distribution for healthcare costs, all with propensity-score weighting and covariates. We identified 1,222,436 eligible individuals. After adjustment, new users of SGLT-2 inhibitors were associated with 73% lower mortality compared to those of DPP-4 inhibitors or users of older agents, while 36% lower total costs against those of GLP-1 agonists. However, there was no statistically significant difference in the risk of lower extremity amputation across medication groups. Our study suggested that SGLT-2 inhibitors is associated with lower mortality compared to DPP 4 inhibitors and lower costs compared to GLP-1 agonists.

Health service organisation impact on lower extremity amputations in people with type 2 diabetes with foot ulcers: systematic review and meta-analysis.

AIMS: Despite the evidence available on the epidemiology of diabetic foot ulcers and associated complications, it is not clear how specific organizational aspects of health care systems can positively affect their clinical trajectory. We aim to evaluate the impact of organizational aspects of care on lower extremity amputation rates among people with type 2 diabetes affected by foot ulcers. METHODS: We conducted a systematic review of the scientific literature published between 1999 and 2019, using the following key terms as search criteria: people with type 2 diabetes, diagnosed with diabetic foot ulcer, treated with specific processes and care pathways, and LEA as primary outcome. Overall results were reported as pooled odds ratios and 95% confidence intervals obtained using fixed and random effects models. RESULTS: A total of 57 studies were found eligible, highlighting the following arrangements: dedicated teams, care pathways and protocols, multidisciplinary teams, and combined interventions. Among them, seven studies qualified for a meta-analysis. According to the random effects model, interventions including any of the four arrangements were associated with a 29% reduced risk of any type of lower extremity amputation (OR = 0.71; 95% CI 0.52-0.96). The effect was larger when focusing on major LEAs alone, leading to a 48% risk reduction (OR = 0.52; 95% CI 0.30-0.91). CONCLUSIONS: Specific organizational arrangements including multidisciplinary teams and care pathways can prevent half of the amputations in people with diabetes and foot ulcers. Further studies using standardized criteria are needed to investigate the cost-effectiveness to facilitate wider implementation of improved organizational arrangements. Similarly, research should identify specific roadblocks to translating evidence into action. These may be structures and processes at the health system level, e.g. availability of professionals with the right skillset, reimbursement mechanisms, and clear organizational intervention implementation guidelines.

Impacto del nivel socioeconómico sobre el perfil del paciente amputado de miembro inferior por causa no traumática / Impact of socioeconomic status on the clinical profile of patients with non-traumatic lower-limb amputation

INTRODUCCIÓN: Analizar la influencia del nivel socioeconómico (NSE) sobre el perfil clínico del paciente amputado de miembro inferior por causa no traumática. MÉTODOS: Estudio retrospectivo con 697 pacientes amputados de miembro inferior, en un Servicio de Angiología y Cirugía Vascular, durante un periodo de 5 años. Los pacientes fueron divididos según NSE (bajo, medio y alto). Se analizaron variables demográficas (edad y género) y clínicas (causa, comorbilidad, factores de riesgo cardiovascular y nivel de amputación). RESULTADOS: La edad media fue 70,5 ± DE 11,9 años y la mediana 72 años. El NSE bajo presentó mayor frecuencia de hombres amputados. Todos los factores de riesgo cardiovascular fueron más frecuentes en este nivel, aunque solo fue estadísticamente significativo en diabetes (85,8% bajo, 69,3% medio, 65% alto; p < 0,01) y obesidad (31,4% bajo, 22,6% medio, 12,5% alto, p < 0,01). La retinopatía diabética fue la única comorbilidad que mostró asociación significativa con el NSE bajo (21,1% bajo, 15,3% medio, 12,5% alto, p < 0,03). No existió diferencia entre los NSE respecto de la causa de amputación. Se observó mayor frecuencia de amputación mayor en el NSE bajo, siendo esta diferencia estadísticamente significativa (63,6% bajo, 41,2% medio, 55% alto, p < 0,04) y una mayor predisposición a este nivel de amputación. CONCLUSIONES: El NSE bajo determina un perfil de riesgo vascular más desfavorable en los pacientes amputados de miembro inferior por causa no traumático y una mayor predisposición a sufrir amputación mayor. Este NSE muestra una influencia negativa sobre diabetes, obesidad y retinopatía diabética en estos pacientes

INTRODUCTION: To analyse the influence of socioeconomic status on the clinical profile of patients undergoing non-traumatic lower-limb amputation. METHODS: Retrospective study of 697 lower-limb amputee patients in an Angiology and Vascular Surgery Department during a 5-year period. Patients were classified according to their socioeconomic status (low, medium and high). We analysed demographic (age and gender) and clinical variables (cause of amputation, comorbidity, cardiovascular risk factors and amputation level). RESULTS: Mean age was 70.5 ± 11.9 years, and the median was 72 years. The low socioeconomic status group presented a higher frequency of amputations in men. Cardiovascular risks factors were more frequent in this socioeconomic group, and the difference was statistically significant for diabetes (85.8% low, 69.3% medium, 65% high; P < .01) and obesity (31.4% low, 22.6% medium, 12.5% high, P < .01). Diabetic retinopathy was the only comorbidity with a significant association with low socioeconomic status (21.1% low, 15.3% medium, 12.5% high, P < .03). Regarding the cause for amputation, there was no difference in terms of socioeconomic status. The low socioeconomic level showed a higher frequency of major amputation, which was a significant difference (63.6% low, 41.2% medium, 55% high, P < .04) and a higher predisposition for this amputation level. CONCLUSIONS: The low socioeconomic status has been shown to determine an unfavourable vascular risk profile in lower-limb non-traumatic amputees and a higher predisposition of a major amputation. This socioeconomic level demonstrates a negative influence on these patients' diabetes, obesity and diabetic retinopathy

Technology-enabled remote management of diabetes foot disease and potential for reduction in associated health costs: a pilot study.

Diabetes-related foot disease, particularly when associated with amputation, affects quality of life and has a significant impact on health care costs. A pilot study using enhanced technology to facilitate remote access and video conferencing from rural locations to the diabetes MDT through a new service pathway confirmed high levels of patient satisfaction with 89% of foot ulcers improved or stable and only two minor amputations. A health economic analysis suggested potential for significant cost savings if this was scaled up regionally. Further evaluation of an integrated pathway, impact on lower limb amputation rates and full health economic assessment is recommended.

A Systematic Review of the Incidence, Prevalence, Costs, and Activity and Work Limitations of Amputation, Osteoarthritis, Rheumatoid Arthritis, Back Pain, Multiple Sclerosis, Spinal Cord Injury, Stroke, and Traumatic Brain Injury in the United States: A 2019 Update.

OBJECTIVES: To present recent evidence on the prevalence, incidence, costs, activity limitations, and work limitations of common conditions requiring rehabilitation. DATA SOURCES: Medline (PubMed), SCOPUS, Web of Science, and the gray literature were searched for relevant articles about amputation, osteoarthritis, rheumatoid arthritis, back pain, multiple sclerosis, spinal cord injury, stroke, and traumatic brain injury. STUDY SELECTION: Relevant articles (N=106) were included. DATA EXTRACTION: Two investigators independently reviewed articles and selected relevant articles for inclusion. Quality grading was performed using the Methodological Evaluation of Observational Research Checklist and Newcastle-Ottawa Quality Assessment Form. DATA SYNTHESIS: The prevalence of back pain in the past 3 months was 33.9% among community-dwelling adults, and patients with back pain contribute $365 billion in all-cause medical costs. Osteoarthritis is the next most prevalent condition (approximately 10.4%), and patients with this condition contribute $460 billion in all-cause medical costs. These 2 conditions are the most prevalent and costly (medically) of the illnesses explored in this study. Stroke follows these conditions in both prevalence (2.5%-3.7%) and medical costs ($28 billion). Other conditions may have a lower prevalence but are associated with relatively higher per capita effects. CONCLUSIONS: Consistent with previous findings, back pain and osteoarthritis are the most prevalent conditions with high aggregate medical costs. By contrast, other conditions have a lower prevalence or cost but relatively higher per capita costs and effects on activity and work. The data are extremely heterogeneous, which makes anything beyond broad comparisons challenging. Additional information is needed to determine the relative impact of each condition.

The Neuro-Vascular Consequence of Diabetes: Foot Amputation and Evaluation of its Risk Factors and Health-Related Economic Impact.

BACKGROUND: The rising prevalence of type 2 diabetes mellitus (T2DM) with the huge burden of diabetic foot amputation is a challenge to the health economy of Pakistan and other countries. Identification of various risk factors for amputation, along with its financial burden, is needed to address this problem. OBJECTIVES: This study aimed to determine the financial burden and risk factors associated with T2DMrelated foot amputation. METHODS: Retrospective hospital-based study from January 2017 to December 2018. Patients with T2DM with and without amputation were enrolled. The direct medical costs of amputation along with various risk factors, were determined. Risk factors were evaluated by logistic regression analysis. RESULTS: A total of 1460 patients with T2DM were included; 484 (33%) patients had an amputation. The mean total cost of below knee, fingers and toe amputation was 886.63±23.91, 263.35 ±19.58 and 166.68 ± 8.47 US$, respectively. This difference among groups was significant (p<0.0001). Male gender (odds ratio, OR: 1.29, 1.01-1.63, p=0.037), peripheral artery disease (OR: 1.93, 1.52-2.46, p=0.000), peripheral neuropathy (OR: 1.31, 1.40-1.63, p=0.000), prior diabetic foot ulcer (OR: 2.02, 1.56- 2.56, p=0.000) and raised glycated haemoglobin (HbA1c) (OR: 3.50, 2.75-4.4, p=0.000) were risk factors for amputation. CONCLUSION: The health-related financial impact of amputations is high. Peripheral artery disease, peripheral neuropathy, prior diabetic foot ulcer and raised HbA1c were risk factors for amputation.

Clinical Negligence Claims Against Vascular Surgery in the United Kingdom: An Observational Study.

BACKGROUND: Claims for clinical negligence awarded to patients and their families are on the increase. The annual "cost of harm" is approximately £7-9 billion in the United Kingdom. In 2017, the National Health Service (NHS) resolution service reported that they mediated more claims than in their entire history. Vascular surgery is a specialty with a disproportionately higher number of claims for clinical negligence. The aim of this observational study was to review the trends of clinical negligence claims in vascular surgery within the United Kingdom. The costs and the primary cause for the complaint were evaluated. METHODS: A retrospective observational study was performed. Clinical negligence claims in vascular surgery between the financial years of April 2005/2006 to April 2018/2019 were requested from NHS resolution under the Freedom of Information Act. Data were provided on November 8, 2019. All data were anonymized, and any categories containing fewer than five claims were removed to protect the identity of claimants. RESULTS: Over the 13-year period, 1,189 claims in vascular surgery were identified, with the annual mean (range) being 91 (20-134) claims per year. Of 1,189 claims, 875 (74%) are closed with payments made to the claimants. The mean annual total payment was £10,015,373. Delay in treatment was the most common cause for litigation claims in vascular surgery with 157 closed claims costing £33,255,248 over the 13-year period. Lower limb amputation was the most common primary injury claim with 140 closed cases but had a larger financial cost at £64,155,969. CONCLUSIONS: Clinical negligence claims in vascular surgery within the United Kingdom have been increasing steadily over the last 13 years and with a changing claims culture is expected to continue. The most common cause for claims with damages paid was delay in treatment, and lower limb amputation was the most common injury suffered. Improved consent, better communication with patients, and a higher surgical skill level could significantly reduce the number of future claims.

Impact of Frailty on Clinical and Financial Outcomes Following Minor Lower Extremity Amputation: A Nationwide Analysis.

Frailty has been shown to portend worse outcomes in surgical patients. Our goal was to identify the impact of frailty on outcomes and resource utilization among patients undergoing minor lower extremity amputation in the United States. Using the Nationwide Readmission Database, we identified all adults undergoing a minor amputation between 2010 and 2015, and assessed 90-day outcomes, including readmission, reamputation, mortality, and cumulative hospitalization costs. Frailty was defined by International Classification of Diseases codes consistent with the ten frailty clusters as defined by the Johns Hopkins Adjusted Clinical Group System. Multivariable regression models were developed for risk adjustment. An estimated 302 798 patients (mean age = 61.8 years) were identified, of which 15.2% were categorized as Frail. Before adjustment, frailty was associated with increased rates of readmission (44% vs. 36%, P < .001) and in-hospital mortality (4% vs. 2%, P < .001). Frailty was also associated with increased cumulative costs of care ($39 417 vs. $27 244, P < .001). After risk adjustment, frailty remained an independent predictor of readmission (Adjusted odds ratio [AOR] 1.18, CI 1.14-1.23), in-hospital mortality (AOR 1.48, CI 1.34-1.65), and incremental costs (+$7 646, CI $6927-$8365). Frailty is an independent marker of worse outcomes following minor foot amputation, and may be utilized to direct quality improvement efforts.

Impact of Time to Receipt of Prosthesis on Total Healthcare Costs 12 Months Postamputation.

OBJECTIVE: The objective was to assess the impact of a prosthesis and the timing of prosthesis receipt on total direct healthcare costs in the 12-mo postamputation period. DESIGN: Data on patients with lower limb amputation (n = 510) were obtained from a commercial claims database for retrospective cohort analysis. Generalized linear multivariate modeling was used to determine differences in cost between groups according to timing of prosthesis receipt compared with a control group with no prosthesis. RESULTS: Receipt of a prosthesis between 0 and 3 mos post lower limb amputation yielded a reduced total cost by approximately 0.23 in log scale within 12 mos after amputation when compared with the no-prosthesis group. Despite the included costs of a prosthesis, individuals who received a prosthesis either at 4-6 mos postamputation or 7-9 mos postamputation incurred costs similar to the no-prosthesis group. CONCLUSION: Earlier receipt of a prosthesis is associated with reduced spending in the 12 mos postamputation of approximately $25,000 compared with not receiving a prosthesis. The results of this study suggest that not providing or delaying the provision of a prosthesis increases costs by about 25%.

National and State-Level Trends in Nontraumatic Lower-Extremity Amputation Among U.S. Medicare Beneficiaries With Diabetes, 2000-2017.

OBJECTIVE: Diabetes is a leading cause of nontraumatic lower-extremity amputation (NLEA) in the U.S. After a period of decline, some national U.S. data have shown that diabetes-related NLEAs have recently increased, particularly among young and middle-aged adults. However, the trend for older adults is less clear. RESEARCH DESIGN AND METHODS: To examine NLEA trends among older adults with diabetes (≥67 years), we used 100% Medicare claims for beneficiaries enrolled in Parts A and B, also known as fee for service (FFS). NLEA was defined as the highest-level amputation per patient per calendar year. Annual NLEA rates were estimated from 2000 to 2017 and stratified by age-group, sex, race/ethnicity, NLEA level (toe, foot, below-the-knee amputation [BKA], or above-the-knee amputation [AKA]), and state. All rates were age and sex standardized to the 2000 Medicare population. Trends over time were assessed using Joinpoint regression and annual percent change (APC) reported. RESULTS: NLEA rates (per 1,000 people with diabetes) decreased by half from 8.5 in 2000 to 4.4 in 2009 (APC -7.9, P < 0.001). However, from 2009 onward, NLEA rates increased to 4.8 (APC 1.2, P < 0.01). Trends were similar across most age, sex, and race/ethnic groups, but absolute rates were highest in the oldest age-groups, Blacks, and men. By NLEA type, overall increases were driven by increases in rates of toe and foot NLEAs, while BKA and AKA continued to decline. The majority of U.S. states showed recent increases in NLEA, similar to national estimates. CONCLUSIONS: This study of the U.S. Medicare FFS population shows that recent increases in diabetes-related NLEAs are also occurring in older populations but at a less severe rate than among younger adults (<65 years) in the general population. Preventive foot care has been shown to reduce rates of NLEA among adults with diabetes, and the findings of the study suggest that those with diabetes-across the age spectrum-could benefit from increased attention to this strategy.

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.

Health Care Costs Associated With Macrovascular, Microvascular, and Metabolic Complications of Type 2 Diabetes Across Time: Estimates From a Population-Based Cohort of More Than 0.8 Million Individuals With Up to 15 Years of Follow-up.

OBJECTIVE: Developing country-specific unit-cost catalogs is a key area for advancing economic research to improve medical and policy decisions. However, little is known about how health care costs vary by type 2 diabetes (T2D) complications across time in Asian countries. We sought to quantify the economic burden of various T2D complications in Taiwan. RESEARCH DESIGN AND METHODS: A nationwide, population-based, longitudinal study was conducted to analyze 802,429 adults with newly diagnosed T2D identified during 1999-2010 and followed up until death or 31 December 2013. Annual health care costs associated with T2D complications were estimated, with multivariable generalized estimating equation models adjusted for individual characteristics. RESULTS: The mean annual health care cost was $281 and $298 (2017 U.S. dollars) for a male and female, respectively, diagnosed with T2D at age <50 years, with diabetes duration of <5 years, and without comorbidities, antidiabetic treatments, and complications. Depression was the costliest comorbidity, increasing costs by 64-82%. Antidiabetic treatments increased costs by 72-126%. For nonfatal complications, costs increased from 36% (retinopathy) to 202% (stroke) in the event year and from 13% (retinopathy or neuropathy) to 49% (heart failure) in subsequent years. Costs for the five leading costly nonfatal subtype complications increased by 201-599% (end-stage renal disease with dialysis), 37-376% (hemorrhagic/ischemic stroke), and 13-279% (upper-/lower-extremity amputation). For fatal complications, costs increased by 1,784-2,001% and 1,285-1,584% for cardiovascular and other-cause deaths, respectively. CONCLUSIONS: The cost estimates from this study are crucial for parameterizing diabetes economic simulation models to quantify the economic impact of clinical outcomes and determine cost-effective interventions.

Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer.

BACKGROUND: In 2007, we reported a summary of data comparing diabetic foot complications to cancer. The purpose of this brief report was to refresh this with the best available data as they currently exist. Since that time, more reports have emerged both on cancer mortality and mortality associated with diabetic foot ulcer (DFU), Charcot arthropathy, and diabetes-associated lower extremity amputation. METHODS: We collected data reporting 5-year mortality from studies published following 2007 and calculated a pooled mean. We evaluated data from DFU, Charcot arthropathy and lower extremity amputation. We dichotomized high and low amputation as proximal and distal to the ankle, respectively. This was compared with cancer mortality as reported by the American Cancer Society and the National Cancer Institute. RESULTS: Five year mortality for Charcot, DFU, minor and major amputations were 29.0, 30.5, 46.2 and 56.6%, respectively. This is compared to 9.0% for breast cancer and 80.0% for lung cancer. 5 year pooled mortality for all reported cancer was 31.0%. Direct costs of care for diabetes in general was $237 billion in 2017. This is compared to $80 billion for cancer in 2015. As up to one-third of the direct costs of care for diabetes may be attributed to the lower extremity, these are also readily comparable. CONCLUSION: Diabetic lower extremity complications remain enormously burdensome. Most notably, DFU and LEA appear to be more than just a marker of poor health. They are independent risk factors associated with premature death. While advances continue to improve outcomes of care for people with DFU and amputation, efforts should be directed at primary prevention as well as those for patients in diabetic foot ulcer remission to maximize ulcer-free, hospital-free and activity-rich days.

Comparative Effectiveness Analysis of Complex Lower Extremity Reconstruction: Outcomes and Costs for Biologically Based, Local Tissue Rearrangement, and Free Flap Reconstruction.

BACKGROUND: Various surgical techniques exist for lower extremity reconstruction, but limited high-quality data exist to inform treatment strategies. Using multi-institutional data and rigorous matching, the authors evaluated the effectiveness and cost of three common surgical reconstructive modalities. METHODS: All adult subjects with lower extremity wounds who received bilayer wound matrix, local tissue rearrangement, or free flap reconstruction were retrospectively reviewed (from 2010 to 2017). Cohorts' comorbidities and wound characteristics were balanced. Graft success at 180 days was the primary outcome; readmissions, reoperations, and costs were secondary outcomes. RESULTS: Five hundred one subjects (166 matrix, 190 rearrangement, and 145 free flap patients) were evaluated. Matched subjects (n = 312; 104/group) were analyzed. Reconstruction success at 180 days for matrix, local tissue rearrangement, and free flaps was 69.2 percent, 91.3 percent, and 93.3 percent (p < 0.001), and total costs per subject were $34,877, $35,220, and $53,492 (p < 0.001), respectively. Median length of stay was at least 2 days longer for free flaps (p < 0.0001). Readmissions and reoperations were greater for free flaps. Local tissue rearrangement, if achievable, provided success at low cost. Free flaps were effective with large, traumatic wounds but at higher costs and longer length of stay. Matrices successfully treated older, obese patients without exposed bone. CONCLUSIONS: Lower extremity reconstruction can be performed effectively using multiple modalities with varying degrees of success and costs. Local tissue rearrangement and free flaps demonstrate success rates greater than 90 percent. Bilayer wound matrix-based reconstruction effectively treats a distinct patient population. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.