Subject(s)
Centers for Medicare and Medicaid Services, U.S./economics , Endovascular Procedures/economics , Health Care Costs , Ischemia/economics , Ischemia/therapy , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/therapy , Reimbursement Mechanisms/economics , Vascular Surgical Procedures/economics , Endovascular Procedures/classification , Humans , Ischemia/classification , Ischemia/diagnosis , Peripheral Vascular Diseases/classification , Peripheral Vascular Diseases/diagnosis , Time Factors , Treatment Outcome , United States , Vascular Surgical Procedures/classificationSubject(s)
Diabetic Foot/nursing , Diabetic Neuropathies/nursing , Peripheral Vascular Diseases/nursing , Diabetic Angiopathies/economics , Diabetic Angiopathies/nursing , Diabetic Foot/economics , Diabetic Neuropathies/economics , Health Care Costs , Humans , Nursing Assessment , Peripheral Vascular Diseases/economics , Risk Assessment , State Medicine , United KingdomABSTRACT
BACKGROUND: The use of a prophylactic antibiotic in an amputation surgery is a key element for the successful recovery of the patient. We aim to determine, from the perspective of the Colombian health system, the cost-effectiveness of administering a prophylactic antibiotic among patients undergoing lower limb amputation due to diabetes or vascular illness in Colombia. METHODS: A decision tree was constructed to compare the use and nonuse of a prophylactic antibiotic. The probabilities of transition were obtained from studies identified from a systematic review of the clinical literature. The chosen health outcome was reduction in mortality due to prevention of infection. The costs were measured by expert consensus using the standard case methodology, and the resource valuation was carried out using national-level pricing manuals. Deterministic sensitivity, scenarios, and probabilistic analyses were conducted. RESULTS: In the base case, the use of a prophylactic antibiotic compared with nonuse was a dominant strategy. This result was consistent when considering different types of medications and when modifying most of the variables in the model. The use of a prophylactic antibiotic ceases to be dominant when the probability of infection is greater than 48%. CONCLUSIONS: The administration of a prophylactic antibiotic was a dominant strategy, which is a conclusion that holds in most cases examined; therefore, it is unlikely that the uncertainty around the estimation of costs and benefits change the results. We recommend creating policies oriented toward promoting the use of a prophylactic antibiotic during amputation surgery in Colombia.
Subject(s)
Amputation, Surgical/economics , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/economics , Antibiotic Prophylaxis/economics , Diabetic Angiopathies/economics , Diabetic Angiopathies/surgery , Drug Costs , Lower Extremity/blood supply , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/surgery , Surgical Wound Infection/economics , Surgical Wound Infection/prevention & control , Amputation, Surgical/adverse effects , Amputation, Surgical/mortality , Colombia , Cost-Benefit Analysis , Decision Support Techniques , Decision Trees , Diabetic Angiopathies/diagnosis , Diabetic Angiopathies/mortality , Drug Administration Schedule , Humans , Models, Economic , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/mortality , Surgical Wound Infection/microbiology , Treatment OutcomeABSTRACT
AIMS: To test a simulation model, the MICADO model, for estimating the long-term effects of interventions in people with and without diabetes. METHODS: The MICADO model includes micro- and macrovascular diseases in relation to their risk factors. The strengths of this model are its population scope and the possibility to assess parameter uncertainty using probabilistic sensitivity analyses. Outcomes include incidence and prevalence of complications, quality of life, costs and cost-effectiveness. We externally validated MICADO's estimates of micro- and macrovascular complications in a Dutch cohort with diabetes (n = 498,400) by comparing these estimates with national and international empirical data. RESULTS: For the annual number of people undergoing amputations, MICADO's estimate was 592 (95% interquantile range 291-842), which compared well with the registered number of people with diabetes-related amputations in the Netherlands (728). The incidence of end-stage renal disease estimated using the MICADO model was 247 people (95% interquartile range 120-363), which was also similar to the registered incidence in the Netherlands (277 people). MICADO performed well in the validation of macrovascular outcomes of population-based cohorts, while it had more difficulty in reflecting a highly selected trial population. CONCLUSIONS: Validation by comparison with independent empirical data showed that the MICADO model simulates the natural course of diabetes and its micro- and macrovascular complications well. As a population-based model, MICADO can be applied for projections as well as scenario analyses to evaluate the long-term (cost-)effectiveness of population-level interventions targeting diabetes and its complications in the Netherlands or similar countries.
Subject(s)
Diabetes Mellitus, Type 2/therapy , Diabetic Angiopathies/prevention & control , Health Policy , Models, Cardiovascular , Models, Economic , Quality of Life , Vascular Diseases/prevention & control , Amputation, Surgical/adverse effects , Amputation, Surgical/economics , Blindness/complications , Blindness/economics , Blindness/epidemiology , Blindness/therapy , Clinical Trials as Topic , Cohort Studies , Combined Modality Therapy/economics , Computer Simulation , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/economics , Diabetes Mellitus, Type 2/prevention & control , Diabetic Angiopathies/economics , Diabetic Angiopathies/epidemiology , Diabetic Angiopathies/therapy , Diabetic Nephropathies/economics , Diabetic Nephropathies/epidemiology , Diabetic Nephropathies/prevention & control , Diabetic Nephropathies/therapy , Health Care Costs , Humans , Incidence , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/economics , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/therapy , Mortality , Netherlands/epidemiology , Peripheral Vascular Diseases/complications , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/epidemiology , Peripheral Vascular Diseases/therapy , Prevalence , Risk Factors , Vascular Diseases/economics , Vascular Diseases/epidemiology , Vascular Diseases/therapyABSTRACT
OBJECTIVES: Lymphatic complications, lymphocele and lymphorrhea being the leading, are generally encountered after vascular interventions and surgeries. The present study aimed to evaluate the outcomes of vacuum-assisted-closure (VAC) therapy, which we frequently prefer as the first-choice treatment for such complications. MATERIALS AND METHODS: Among patients undergoing peripheral vascular intervention or surgery between January 2008 and February 2012, the medical files of 21 patients who received VAC therapy or other treatment due to symptomatic lymphatic complications were retrospectively analyzed and the results were discussed. RESULTS: Group I consisted of 10 patients (three with lymphocele and seven with lymphorrhea) who underwent VAC therapy as the first-choice treatment, Group II consisted of 11 patients of which 7 patients received various therapies before VAC therapy and 4 patients received other treatments alone. The patients who received VAC therapy as the primary therapy demonstrated more rapid wound healing, early drainage control, and shorter hospital stay. The mean hospital medical cost was 1038 (range, 739-1826) for the patients who primarily underwent VAC therapy; it was calculated to be 2137 (range, 1610-3130) for the other patients (p=0.001). CONCLUSION: In addition to its safety and good clinical outcomes, VAC therapy also has economic advantages and should be the primary method for the treatment of lymphatic complications.
Subject(s)
Endovascular Procedures/adverse effects , Lymphatic Diseases/therapy , Negative-Pressure Wound Therapy , Peripheral Vascular Diseases/therapy , Vascular Surgical Procedures/adverse effects , Adult , Aged , Cost-Benefit Analysis , Drainage , Endovascular Procedures/economics , Female , Hospital Costs , Humans , Length of Stay , Lymphatic Diseases/diagnosis , Lymphatic Diseases/economics , Lymphatic Diseases/etiology , Lymphocele/etiology , Lymphocele/therapy , Male , Middle Aged , Negative-Pressure Wound Therapy/adverse effects , Negative-Pressure Wound Therapy/economics , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/surgery , Retrospective Studies , Time Factors , Treatment Outcome , Vascular Surgical Procedures/economics , Wound HealingABSTRACT
Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease and is associated with a risk of limb loss. This vascular condition is currently treated with limb revascularization by surgery or endovascular intervention performed by a variety of specialists. Because both open vascular bypass and the less invasive endovascular therapy can be performed in selected patients with CLI, there exists significant disagreement as to which therapy should be performed first and which is more successful. The paucity of comparative effectiveness data to guide treatment of CLI has prompted a multidisciplinary effort to organize the Best Endovascular Versus Best Surgical Therapy in Patients With CLI (BEST-CLI) trial. The BEST-CLI trial is a pragmatic, multicenter, open-label, randomized trial that compares best endovascular therapy with best open surgical treatment in patients eligible for both treatments. BEST-CLI aims to provide urgently needed clinical guidance for CLI management by using a pragmatic design comparing the effectiveness of established techniques while allowing for the introduction of newer therapies as they become available; a novel primary endpoint that includes limb amputation rates, repeat intervention, and mortality; a multidisciplinary structure that fosters cooperation among interventional cardiologists, interventional radiologists, vascular surgeons, and vascular medicine specialists; and novel techniques to evaluate the cost-effectiveness and quality-of-life outcomes of the two treatment strategies being tested.
Subject(s)
Blood Vessel Prosthesis Implantation , Endovascular Procedures , Ischemia/therapy , Lower Extremity/blood supply , Patient Care Team , Peripheral Vascular Diseases/therapy , Research Design , Saphenous Vein/transplantation , Amputation, Surgical , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/economics , Clinical Protocols , Cost-Benefit Analysis , Critical Illness , Endovascular Procedures/adverse effects , Endovascular Procedures/economics , Health Care Costs , Humans , Interdisciplinary Communication , Ischemia/diagnosis , Ischemia/economics , Ischemia/surgery , Limb Salvage , North America , Patient Care Team/economics , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/surgery , Prospective Studies , Quality of Life , Time Factors , Treatment OutcomeABSTRACT
PURPOSE: The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. METHODS: A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. RESULTS: The model estimated a net cumulative 5-year budget reduction of
Subject(s)
Arterial Occlusive Diseases/economics , Arterial Occlusive Diseases/therapy , Atherosclerosis/economics , Atherosclerosis/therapy , Budgets , Drug-Eluting Stents/economics , Femoral Artery , Models, Economic , Paclitaxel/economics , Paclitaxel/therapeutic use , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/therapy , Popliteal Artery , France , Health Care Costs , HumansSubject(s)
Cardiac Surgical Procedures/economics , Cardiology/economics , Decision Making , Mitral Valve Insufficiency/economics , Peripheral Vascular Diseases/economics , Cardiac Catheterization/economics , Cardiac Surgical Procedures/ethics , Cardiology/ethics , Decision Making/ethics , France , Heart Valve Prosthesis/economics , Heart Valve Prosthesis Implantation/economics , Humans , Mitral Valve Insufficiency/surgery , Peripheral Vascular Diseases/surgeryABSTRACT
BACKGROUND: Improving patient safety has become a national priority. Patient safety indicators (PSIs) are validated tools to identify potentially preventable adverse events. No studies currently exist for evaluating lower extremity (LE) vascular procedures and the occurrence of PSIs. METHODS: The Nationwide Inpatient Sample (2003-2007) was queried for elective LE angioplasty (endo) and bypass (open). PSIs appropriate to surgery were analyzed by χ(2) and logistic regression analyses. RESULTS: A total of 226,501 LE interventions (104,491 endo; 122,010 open) were evaluated. The rate of developing any PSI was 7.74% (open) and 8.51% (endo), P < .0001. In the latter group, PSI9 (postoperative hemorrhage or hematoma) with the rate 4.74% was a predominant indicator that was associated with an almost three times greater likelihood of death in this group. PSI predictors included advanced age (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.55-1.75 for oldest vs youngest patients), females (OR, 1.18; 95% CI, 1.13-1.22), blacks (OR, 1.10; 95% CI, 1.04-1.17), congestive heart failure (OR, 1.83; 95% CI, 1.72-1.96), diabetes mellitus (OR, 1.20; 95% CI, 1.12-1.28), renal failure (OR, 2.31; 95% CI, 2.14-2.50), hospital teaching status (OR, 1.21; 95% CI, 1.17-1.26), and larger hospitals (OR, 1.11; 95% CI, 1.05-1.17). PSI occurrence was associated with increased cost ($28,387 vs $13,278; P < .0001). CONCLUSIONS: Endovascular procedures were found to have lower mortality rates overall, but were found to have a greater number of safety events occur primarily due to bleeding complications in women and the elderly. PSIs were associated with advanced age, black race, and comorbidities. Adverse events added significant cost, occurred more frequently in teaching and large hospitals, and future organizational analysis may improve safety and reduce cost.
Subject(s)
Angioplasty/adverse effects , Hospitals , Lower Extremity/blood supply , Peripheral Vascular Diseases/therapy , Postoperative Complications/prevention & control , Quality Improvement , Quality Indicators, Health Care , Vascular Surgical Procedures/adverse effects , Adolescent , Adult , Black or African American , Age Factors , Aged , Aged, 80 and over , Angioplasty/economics , Angioplasty/mortality , Chi-Square Distribution , Comorbidity , Databases as Topic , Female , Hematoma/etiology , Hematoma/prevention & control , Hospital Costs , Hospitals/statistics & numerical data , Hospitals, Teaching , Humans , Logistic Models , Male , Middle Aged , Odds Ratio , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/mortality , Peripheral Vascular Diseases/surgery , Postoperative Complications/economics , Postoperative Complications/mortality , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/prevention & control , Quality Improvement/economics , Quality Improvement/statistics & numerical data , Quality Indicators, Health Care/economics , Quality Indicators, Health Care/statistics & numerical data , Risk Assessment , Risk Factors , Sex Factors , Treatment Outcome , United States , Vascular Surgical Procedures/economics , Vascular Surgical Procedures/mortality , Young AdultABSTRACT
OBJECTIVES: Critical limb ischemia (CLI) patients who are unsuitable for intervention face the dire prospect of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. This study assessed the outcome of SCBD in severe CLI patients who otherwise would face an amputation. Primary end points were limb salvage and 30-day mortality. Secondary end points were hemodynamic outcomes (increase in popliteal artery flow and toe pressure), ulcer healing, quality-adjusted time without symptoms of disease or toxicity of treatment (Q-TwiST), and cost-effectiveness. METHODS: From 2004 to 2009, we assessed 4538 patients with peripheral vascular disease (PVD). Of these, 707 had CLI, 518 underwent intervention, and 189 were not suitable for any intervention. A total of 171 patients joined the SCBD program for 3 months. RESULTS: All patients were Rutherford category ≥4. Median follow-up was 13 months. Mean toe pressure increased from 39.9 to 55.42 mm Hg, with a mean difference in toe pressure of 15.49 mm Hg (P = .0001). Mean popliteal flow increased from 35.44 to 55.91 cm/s, with mean difference in popliteal flow of 20.47 cm/s (P < .0001). Mortality at 30 days was 0.6%. Median amputation-free survival was 18 months. Limb salvage at 3.5 years was 94%. Freedom from major adverse clinical events (MACE) at 4.5 years was 62.5%. We treated 171 patients with SCBD at a cost of 681,948, with an estimated median per-patient cost of treatment with SCBD of 3988. CONCLUSION: SCBD therapy is a cost-effective and clinically efficacious solution in CLI patients with no option of revascularization. It provides adequate limb salvage and ameliorated amputation-free survival while providing relief of rest pain without any intervention.
Subject(s)
Intermittent Pneumatic Compression Devices , Ischemia/therapy , Lower Extremity/blood supply , Peripheral Vascular Diseases/therapy , Aged , Aged, 80 and over , Amputation, Surgical , Cost-Benefit Analysis , Critical Illness , Equipment Design , Female , Hemodynamics , Hospital Costs , Humans , Intermittent Pneumatic Compression Devices/adverse effects , Intermittent Pneumatic Compression Devices/economics , Ireland , Ischemia/economics , Ischemia/etiology , Ischemia/mortality , Ischemia/physiopathology , Kaplan-Meier Estimate , Limb Salvage , Male , Peripheral Vascular Diseases/complications , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/mortality , Peripheral Vascular Diseases/physiopathology , Quality-Adjusted Life Years , Severity of Illness Index , Time Factors , Treatment Outcome , Wound HealingABSTRACT
BACKGROUND: Elective peripheral vascular surgery provides quality outcomes that are of great benefit to patients, but have complications that result in severe morbidity and excessive costs. METHODS: We studied elective carotid endarterectomy, aortofemoral bypass/aortic aneurysm repairs, and femoral-distal bypass surgeries among hospitals(N ≥ 20 cases) from 2002 to 2005 from the national Inpatient Sample of the Healthcare Cost and Utilization project. Adverse outcomes, mortality, and cost models were developed. Outlier hospitals were defined for excessive adverse outcomes (P < .005) and excess cost (P < .0005). RESULTS: There were 43,700 carotid endarterectomy patients from 447 hospitals, 9,090 aortofemoral bypass/aortic aneurysm patients from 187 hospitals, and 14,453 femoral-distal bypass patients from 243 hospitals. Approximately 3% of hospitals were quality outliers, and 8% to 24% of hospitals were efficiency outliers by procedure. CONCLUSIONS: Comparative effectiveness and efficiency modeling at the hospital level shows inefficiency and is responsible for 90% of excess costs. Overall reduced complication rates will further enhance cost reductions.
Subject(s)
Hospital Costs , Peripheral Vascular Diseases/surgery , Risk Adjustment , Vascular Surgical Procedures/economics , Adult , Aged , Aortic Aneurysm/surgery , Comparative Effectiveness Research , Cost-Benefit Analysis , Elective Surgical Procedures/economics , Endarterectomy, Carotid/economics , Female , Femoral Artery/surgery , Health Care Costs , Humans , Male , Middle Aged , Peripheral Vascular Diseases/economics , Treatment Outcome , United States , Vascular Grafting/economics , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortalityABSTRACT
BACKGROUND: Limb salvage requires early prevention therapy, knowledgeable use of wound care technology, and active management of peripheral vascular disease. This field has changed considerably over the past decade, with new advanced wound healing products and minimally invasive surgery for peripheral vascular disease. Treatment can be very costly in terms of medical and human resources. Evaluation of the clinical and economic impact of medical care is becoming more important as the population with diabetes and the need to contain the cost of health care simultaneously increase. The aim of this study was to review the economic impact of prevention therapies, wound care, and peripheral vascular disease interventions to prevent major lower extremity amputations. METHODS: The authors reviewed the economic impact of prevention therapy, wound care, and peripheral vascular disease interventions to prevent lower extremity amputations. RESULTS: Length of stay in the hospital and intensive care drive the cost of treatment. Surgical intervention and complications for foot ulcers, amputations, and peripheral vascular disease are significant factors in the cost of limb salvage. CONCLUSIONS: Not surprisingly, prevention and evidenced-based treatments are the most cost-effective way of reducing the use of medical resources and improving and prolonging productive lifestyles. Future prospective studies need to be conducted to more accurately understand the financial impact of limb salvage.
Subject(s)
Diabetic Angiopathies/surgery , Limb Salvage/economics , Peripheral Vascular Diseases/surgery , Wounds and Injuries/surgery , Diabetic Angiopathies/economics , Diabetic Angiopathies/etiology , Diabetic Foot/economics , Humans , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/etiology , Wounds and Injuries/economicsSubject(s)
Diabetic Angiopathies/surgery , Limb Salvage/economics , Peripheral Vascular Diseases/surgery , Wounds and Injuries/surgery , Diabetic Angiopathies/economics , Diabetic Angiopathies/etiology , Diabetic Foot/economics , Humans , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/etiology , Wounds and Injuries/economicsABSTRACT
BACKGROUND: Peripheral arterial disease (PAD) is a common disorder with multiple options for treatment, ranging from medical interventions, surgical revascularization, and endovascular therapy. Despite the explosive advances in endovascular therapy, cost-effective methods of care have not been well defined. We analyze therapeutic strategies, outcomes, and medical cost of treatment among Medicare patients with PAD. METHODS AND RESULTS: Patients who underwent therapy for PAD were identified from a 5% random sample of Medicare beneficiaries from Medicare Standard Analytic Files for the period 1999-2005. Clinical outcomes (death, amputation, new clinical symptoms related to PAD) and direct medical costs were examined by chosen revascularization options (endovascular, surgical, and combinations). One-year PAD prevalence increased steadily from 8.2% in 1999 to 9.5% in 2005. The risk-adjusted time to first post-treatment clinical outcome was lowest in those treated with "percutaneous transluminal angioplasty (PTA) or atherectomy and stents" (HR, 0.829; 95% CI, 0.793-0.865; p < 0.001) and stents only (HR, 0.904; 95% CI, 0.848-0.963; p = 0.002) compared with PTA alone. The lowest per patient risk-adjusted costs during the quarter of the first observed treatment were associated with "PTA and stents" ($15,197), and stents only ($15,867). Risk-adjusted costs for surgical procedures (bypass and endarterectomy) were $27,021 during the same period. Diabetes was present in 61.7% of the PAD population and was associated with higher risks of clinical events and higher medical costs compared with PAD patients without diabetes. CONCLUSION: The clinical and economic burden of PAD in the Medicare population is substantial, and the interventions used to treat PAD are associated with differences in clinical and economic outcomes. Prospective cost-effectiveness analyses should be included in future PAD therapy trials to inform payers and providers of the relative value of available treatment options.
Subject(s)
Angioplasty, Balloon/economics , Health Care Costs , Medicare/economics , Outcome and Process Assessment, Health Care/economics , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/therapy , Vascular Surgical Procedures/economics , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/instrumentation , Cost-Benefit Analysis , Diabetes Mellitus/economics , Diabetes Mellitus/epidemiology , Diabetes Mellitus/therapy , Female , Humans , Insurance Benefits/economics , Male , Peripheral Vascular Diseases/epidemiology , Prevalence , Proportional Hazards Models , Stents/economics , Time Factors , Treatment Outcome , United States/epidemiology , Vascular Surgical Procedures/adverse effectsABSTRACT
OBJECTIVES: To briefly inform on the conclusions from a conference on the next 10 years in the management of peripheral artery disease (PAD). DESIGN OF THE CONFERENCE: International participation, invited presentations and open discussion were based on the following issues: Why is PAD under-recognised? Health economic impact of PAD; funding of PAD research; changes of treatment options? Aspects on clinical trials and regulatory views; and the role of guidelines. RESULTS AND CONCLUSIONS: A relative lack of knowledge about cardiovascular risk and optimal management of PAD patients exists not only among the public, but also in parts of the health-care system. Specialists are required to act for improved information. More specific PAD research is needed for risk management and to apply the best possible evaluation of evidence for treatment strategies. Better strategies for funding are required based on, for example, public/private initiatives. The proportion of endovascular treatments is steadily increasing, more frequently based on observational studies than on randomised controlled trials. The role of guidelines is therefore important to guide the profession in the assessment of most relevant treatment.
Subject(s)
Cardiovascular Diseases/prevention & control , Peripheral Vascular Diseases/therapy , Biomedical Research/economics , Cardiovascular Diseases/economics , Cardiovascular Diseases/etiology , Clinical Trials as Topic , Evidence-Based Medicine , Health Care Costs , Health Knowledge, Attitudes, Practice , Health Policy , Humans , Patient Education as Topic , Peripheral Vascular Diseases/complications , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/economics , Practice Guidelines as Topic , Research Support as Topic , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeSubject(s)
Angioplasty, Balloon , Ischemia/therapy , Lower Extremity/blood supply , Multicenter Studies as Topic , Peripheral Vascular Diseases/therapy , Randomized Controlled Trials as Topic , Vascular Surgical Procedures , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/economics , Angioplasty, Balloon/mortality , Constriction, Pathologic , Cost-Benefit Analysis , Health Care Costs , Humans , Ischemia/diagnostic imaging , Ischemia/economics , Ischemia/mortality , Ischemia/surgery , Peripheral Vascular Diseases/diagnostic imaging , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/mortality , Peripheral Vascular Diseases/surgery , Quality of Life , Radiography , Research Design , Severity of Illness Index , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/economics , Vascular Surgical Procedures/mortalityABSTRACT
BACKGROUND: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that survival in patients with severe lower limb ischemia (rest pain, tissue loss) who survived postintervention for >2 years after initial randomization to bypass surgery (BSX) vs balloon angioplasty (BAP) was associated with an improvement in subsequent amputation-free and overall survival of about 6 and 7 months, respectively. We now compare the effect on hospital costs and health-related quality of life (HRQOL) of the BSX-first and BAP-first revascularization strategies using a within-trial cost-effectiveness analysis. METHODS: We measured HRQOL using the Vascular Quality of Life Questionnaire (VascuQol), the Short Form 36 (SF-36), and the EuroQol (EQ-5D) health outcome measure up to 3 years from randomization. Hospital use was measured and valued using United Kingdom National Health Service hospital costs over 3 years. Analysis was by intention-to-treat. Incremental cost-effectiveness ratios were estimated for cost per quality-adjusted life-year (QALY) gained. Uncertainty was assessed using nonparametric bootstrapping of incremental costs and incremental effects. RESULTS: No significant differences in HRQOL emerged when the two treatment strategies were compared. During the first year from randomization, the mean cost of inpatient hospital treatment in patients allocated to BSX ($34,378) was estimated to be about $8469 (95% confidence interval, $2,417-$14,522) greater than that of patients allocated to BAP ($25,909). Owing to increased costs subsequently incurred by the BAP patients, this difference decreased at the end of follow-up to $5521 ($45,322 for BSX vs $39,801 for BAP) and was no longer significant. The incremental cost-effectiveness ratio of a BSX-first strategy was $184,492 per QALY gained. The probability that BSX was more cost-effective than BAP was relatively low given the similar distributions in HRQOL, survival, and hospital costs. CONCLUSIONS: Adopting a BSX-first strategy for patients with severe limb ischemia does result in a modest increase in hospital costs, with a small positive but insignificant gain in disease-specific and generic HRQOL. However, the real-world choice between BSX-first and BAP-first revascularization strategies for severe limb ischemia due to infrainguinal disease cannot depend on costs alone and will require a more comprehensive consideration of individual patient preferences conditioned by expectations of survival and other health outcomes.
Subject(s)
Angioplasty, Balloon/economics , Health Resources/statistics & numerical data , Hospital Costs , Ischemia/therapy , Lower Extremity/blood supply , Peripheral Vascular Diseases/therapy , Quality of Life , Vascular Surgical Procedures/economics , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/mortality , Blood Vessel Prosthesis Implantation/economics , Constriction, Pathologic , Cost-Benefit Analysis , Female , Health Resources/economics , Humans , Ischemia/diagnostic imaging , Ischemia/economics , Ischemia/mortality , Ischemia/surgery , Length of Stay , Male , Middle Aged , Peripheral Vascular Diseases/diagnostic imaging , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/mortality , Peripheral Vascular Diseases/surgery , Prospective Studies , Quality-Adjusted Life Years , Radiography , Saphenous Vein/transplantation , Severity of Illness Index , Surveys and Questionnaires , Time Factors , Treatment Outcome , United Kingdom , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortalityABSTRACT
BACKGROUND: Screening for abdominal aortic aneurysm (AAA) of men aged 65-74 years reduces the AAA-related mortality and is generally considered cost effective. Despite of this only a few national health care services have implemented permanent programs. Around 10% of men in this group have peripheral arterial disease (PAD) defined by an ankle brachial systolic blood pressure index (ABI) below 0.9 resulting in an increased mortality-rate of 25-30%. In addition well-documented health benefits may be achieved through primary prophylaxis by initiating systematic cholesterol-lowering, smoking cessation, low-dose acetylsalicylic acid (aspirins), exercise, a healthy diet and blood-pressure control altogether reducing the increased risks for cardiovascular disease by at least 20-25%. The benefits of combining screening for AAA and PAD seem evident; yet they remain to be established. The objective of this study is to assess the efficacy and the cost-effectiveness of a combined screening program for AAA, PAD and hypertension. METHODS: The Viborg Vascular (VIVA) screening trial is a randomized, clinically controlled study designed to evaluate the benefits of vascular screening and modern vascular prophylaxis in a population of 50,000 men aged 65-74 years. Enrolment started October 2008 and is expected to stop in October 2010. The primary outcome is all-cause mortality. The secondary outcomes are cardiovascular mortality, AAA-related mortality, hospital services related to cardiovascular conditions, prevalence of AAA, PAD and potentially undiagnosed hypertension, health-related quality of life and cost effectiveness. Data analysis by intention to treat. RESULTS: Major follow-up will be performed at 3, 5 and 10 years and final study result after 15 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT00662480.
Subject(s)
Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Mass Screening/methods , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/mortality , Aged , Aortic Aneurysm, Abdominal/economics , Cost-Benefit Analysis , Denmark/epidemiology , Follow-Up Studies , Humans , Hypertension/diagnosis , Hypertension/economics , Hypertension/mortality , Male , Mass Screening/economics , National Health Programs/economics , Peripheral Vascular Diseases/economics , Prevalence , Surveys and QuestionnairesABSTRACT
BACKGROUND: The management of atherothrombotic disease is responsible for a large proportion of direct medical costs in most countries, imposing a substantial financial burden on health care payers. There is limited knowledge about direct per-person medical costs using a "bottom-up" approach. OBJECTIVE: This study was designed to estimate the per-person direct medical costs incurred by communitybased subjects in Australia who have or are at high risk for atherothrombotic disease. The perspective was a governmental one, at the federal level for pharmaceuticals and at the state level for hospitalizations. METHODS: One-year follow-up data were obtained for Australian participants in the international REACH (Reduction of Atherothrombosis for Continued Health) Registry who were aged >or=45 years and had either established atherothrombotic disease (coronary artery disease, cerebrovascular disease, or peripheral artery disease [PAD]) or >or=3 risk factors for atherothrombotic disease. Information was extracted on the use of cardiovascular medications, hospitalizations, general practice visits, clinical pathology and imaging studies, and use of rehabilitation services. Bottom-up costing was undertaken by assigning unit costs to each health care item, based on Australian government reimbursement data for 2006-2007. Costs were estimated in Australian dollars. RESULTS: Data for 2873 Australian participants in the REACH Registry were included in the analysis. Mean (SD) annual pharmaceutical costs per person were A$1388 (A$645). Mean ambulatory care costs per person were A$704 (A$492), and mean hospitalization costs were A$10,711 (A$10,494). Compared with participants with >or=3 risk factors (adjusted for age and sex), participants with 2 to 3 affected vascular territories incurred A$160 more in mean pharmaceutical costs (95% CI, 78 to 256) and A$181 more in ambulatory care costs (95% CI, 107 to 252). Mean ambulatory care costs were A$132 greater among participants with PAD only relative to those with >or=3 risk factors (95% CI, 19 to 272). Hospital costs were not significantly increased with an increasing number of affected vascular territories. The greatest difference in direct hospital costs (A$943) was between participants with PAD relative to those with >or=3 risk factors (95% CI, -564 to 3545). CONCLUSIONS: From the government perspective, management of atherothrombotic disease in Australia was costly during the period studied, particularly among those with PAD only or disease affecting 2 to 3 vascular territories. Hospitalization accounted for the majority of health care expenditure associated with atherothrombotic disease, although the number of hospitalized participants was relatively small.
Subject(s)
Atherosclerosis/drug therapy , Atherosclerosis/economics , Health Care Costs/statistics & numerical data , Thrombosis/drug therapy , Thrombosis/economics , Aged , Australia , Cerebrovascular Disorders/drug therapy , Cerebrovascular Disorders/economics , Coronary Artery Disease/drug therapy , Coronary Artery Disease/economics , Costs and Cost Analysis , Follow-Up Studies , Hospitalization/economics , Humans , Insurance Claim Review/economics , Male , Middle Aged , Outcome Assessment, Health Care/economics , Peripheral Vascular Diseases/drug therapy , Peripheral Vascular Diseases/economicsABSTRACT
The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.