Cost-Effectiveness Analysis of the Use of a Prophylactic Antibiotic for Patients Undergoing Lower Limb Amputation due to Diabetes or Vascular Illness in Colombia.

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.

Policy evaluation in diabetes prevention and treatment using a population-based macro simulation model: the MICADO model.

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.

Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease.

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.

Evaluating preventable adverse safety events after elective lower extremity procedures.

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.

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Health-related quality of life outcomes, resource utilization, and cost-effectiveness analysis.

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.

The next 10 years in the management of peripheral artery disease: perspectives from the 'PAD 2009' Conference.

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.

Clinical outcomes and medical care costs among medicare beneficiaries receiving therapy for peripheral arterial disease.

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.

Lower extremity angioplasty: impact of practitioner specialty and volume on practice patterns and healthcare resource utilization.

OBJECTIVES: Lower extremity percutaneous transluminal angioplasty (LE PTA) is currently performed by a variety of endovascular specialists. We hypothesized that cardiologists (CRD) and vascular surgeons (VAS) may have different practice patterns, indications for intervention, and hospital resource utilization. METHODS: Using the State Inpatient Databases for New Jersey (2003-2007), patients with elective admission undergoing PTA procedures with indications of claudication, rest pain, and gangrene/ulceration were examined. Physician specialty was determined based on all procedures performed. We contrasted by specialty, the indication for LE PTA for the procedure, volume, and hospital resource utilization. RESULTS: Of the 1887 cases of LE PTA, VAS performed 866 (45.9%) and CRD 1021 (54.1%) procedures. The mean patient age was 68.0 years (CRD) vs 70.7 years (VAS), P = .0163. Indications for intervention were compared for CRD vs VAS: claudication 80.7% vs 60.7%, (P < .002); rest pain 6.2% vs 16.0%, (P < .002); gangrene/ulceration 13.1% vs 23.3%, (P < .002). Stents (64.8% of cases) were utilized similarly among physicians (P = .18), and mean hospital length of stay were similar (2.38 days vs 2.41 days, P = .85). Hospital charges by indication varied between CRD vs VAS (all procedures: $49,748 vs $42,158 [P < .0001]). Revenue center charges were different between CRD vs VAS: medical surgical supply $19,128 vs $12,737, (P < .0001); pharmacy $1,959 vs $1,115, (P < .0001). Only 10.7% of CRD were high volume practitioners, compared with 36.8% among VAS (P < .05). High volume practitioners had significantly lower hospital charges ($41,730 vs $51,014, P < .001). CONCLUSIONS: Cardiologists performing lower extremity angioplasty were more likely to treat patients with claudication than those with rest pain or gangrene/ulceration. Despite treating younger patients with less severe peripheral vascular disease, cardiologists used significantly greater hospital resources. High practitioner volume, regardless of specialty, was associated with lower hospital resource utilization. Reducing variations in indication and practitioner volume may offer substantial cost savings for lower extremity endovascular interventions.

Cost impact of diagnostic imaging for lower extremity peripheral vascular occlusive disease.

OBJECTIVE: The evaluation of peripheral vascular disease in the primary care setting is routinely performed by contrast-enhanced magnetic resonance angiography (CE-MRA) and digital subtraction angiography (DSA). However, limited data are available on the relative costs and clinical outcomes following these diagnostic procedures. The objective of this study is to assess and compare costs associated with diagnostic imaging in peripheral vascular occlusive disease (PAOD). METHODS: US veterans (n = 19,209) with CE-MRA or DSA for the assessment of PAOD from fiscal year (FY) 1999 to FY 2004. Main outcome measure(s) using the Department of Veterans Affairs' (VA) costing algorithms, cost, and log-cost of interventions (e.g., revascularization, stent, angioplasty), amputations or mortality rates within 30/90 days and 1 year of DSA or CE-MRA were compared, and adjusted for patient characteristics and disease severity using multivariate regression. Imaging modality selection bias was evaluated with propensity score, instrumental variables, and Heckman methods using untransformed costs and log-costs with smearing retransformation. RESULTS: Initial CE-MRA imaging was significantly more likely among patients with prior renal disease or bypass surgery [odds ratio (OR) > 2; P < 0.001], and less likely among patients with prior amputation, peripheral vascular disease (PVD), claudication, or other cardiovascular disease (OR < 0.7; P < 0.001). After adjusting for endogenous choice of initial imaging modality, 30-day treatment costs were US$3500-$4300 lower (P < 0.001) for patients with initial CE-MRA. Eighty-two percent of DSA imaging patients had no additional procedures or events within 30 days, and 65% at 90 days. Less than 3.2% (3.6%) of patients had any repeat imaging within 30 (90) days of initial imaging. CONCLUSIONS: Relative to DSA, CE-MRA imaging was associated with substantial treatment episode savings, beyond the US$950 direct savings in imaging cost per procedure. Substituting CE-MRA for DSA among those not planning or requiring any follow-up procedures within 30 days, could have reduced outpatient imaging costs by up to 55%, and reduced VA system costs by US$13.2 million over the six-year period.

Cost per day of patency: understanding the impact of patency and reintervention in a sustainable model of healthcare.

BACKGROUND: Healthcare resource utilization is an understudied aspect of vascular surgery. Initial cost of a given procedure is not an accurate reflection of resource utilization because it does not account for procedural durability and efficacy. Herein we describe an amortized cost model that accounts for procedural costs, durability, and re-intervention costs. METHODS: A cost model was developed using patency data endpoints and total hospital costs (direct and indirect) associated with an inital revascularization and subsequent re-interventions. This model was applied to a retrospective database of femoropopliteal reconstructions. One hundred and eighty-three open cases were compared with 198 endovascular cases; and the endpoints of initial cost, amortized cost at 12 months, and assisted patency were examined. RESULTS: The open and endovascular cases were not statistically different with respect to indication, patient co-morbid profiles, or post-procedural pharmacotherapy. Primary assisted patency was better in the open revascularization group at 12 months (78% versus 66%, P < .01). There was a statistically significant higher initial cost for open reconstruction when compared with endovascular ($12,389 +/- $408 versus $6,739 +/- $206, P < .001). However, at 12 months post-procedure, the initial cost benefit was lost for endovascular patients ($229 +/- $106 versus $185 +/- $124, P = .71). There was, however, a trend for endovascular cost savings in claudicants, though this did not reach significance ($259 +/- $189 versus $86 +/- $52, P = .31). For patients with critical limb ischemia, renal dysfunction, and end stage renal disease, the trend favored open surgery. CONCLUSIONS: An amortized cost model provides insight into the healthcare resource utilization associated with a particular revascularization and assistive procedures. The initial cost savings of endovascular therapies are not sustained over time. Cost-savings trends were noted, however, longer follow-up is required to see if these will reach statistical significance.

Treatment for peripheral arterial obstructive disease: An appraisal of the economic outcome of complications.

OBJECTIVE: This study determined the average estimated total costs after treatment for peripheral arterial occlusive disease (PAOD) and evaluated the effect of postoperative complications and their consequences for the total costs. METHODS: Cost data on all admissions involving treatment for PAOD from January 2007 until July 2007 were collected. A prospective analysis was made using the patient-related risk factor and comorbidity (Society for Vascular Surgery/International Society of Cardiovascular Surgeons) classification, primary and secondary treatment, and prospectively registered complications. At admission, patients without complications were placed in group A, and those with complications were in group B. Prospectively registered complications were divided into patient management (I), surgical technique (II), patient's disease (III), and outside surgical department (IV). The consequences of these were divided into minor complication, no long-term consequence (1A), additional medication or transfusion (1B), surgical reoperation (2A), prolonged hospital stay (2B), irreversible physical damage (3), and death (4). The main outcome measures were total costs of patients and costs per patient (PP), with or without the presence of complications, cost of complications and costs per complication (PC), and the costs of their consequences calculated in euros (euro). RESULTS: Ninety patients (mean age, 71.4 years; 59% men) were included. Group B patients had a significantly higher American Society of Anesthesiologists (4) and Fontaine (3) classification and more secondary procedures. Total costs were euro 1,716,852: group A, euro 512,811 (PP euro 12,820); and group B, euro 1,204,042 (PP euro 24,081). The costs of the 115 complications were euro 568,500 (PC euro 4943). Split by the cause of the complication, costs were I, euro 95,924 (PC euro 2998); II, euro 163,137 (PC euro 8157); III, euro 289,578 (PC euro 5171); and IV, euro 19,861 (PC euro 2837). The increase of costs in group B was mainly caused by additional medication or transfusion (1B) euro 348,293 (61.3%), a surgical reoperation (2A) euro 118,054 (20.8%), or prolonged hospital stay (2B) euro 60,451 (10.6%). Patients who died caused 23% of the total costs. CONCLUSION: Complications cause an increase of the average estimated total costs in the treatment for peripheral arterial occlusive disease and are responsible for 33% of these total costs. The most expensive complications were errors in surgical technique and patient's disease, resulting in surgical reoperation or additional medication, or both, or transfusion, the two most expensive consequences.

Atherosclerotic cardiovascular diseases in Belgium: a cost-of-illness analysis.

PURPOSE: This study aims to quantify costs of atherosclerotic cardiovascular diseases in Belgium in 2004. METHODS: Costs were estimated using data on prevalence, healthcare resource utilization and unit costs. Healthcare costs included expenditure on ambulatory care, hospital inpatient care, emergency care, and medications. Costs of prevention campaigns and costs of productivity loss were also included. RESULTS: Costs amounted to 3.5 billion euros in Belgium in 2004. Total costs consisted of 80 million euros related to prevention and screening, 1.3 billion euros related to pre-clinical disease, and 2.2 billion euros related to established disease. These costs were incurred by the Belgian third-party payer (58% of costs), patients (10%) and third parties (i.e. employers and supplementary health insurance) (32%). CONCLUSIONS: Atherosclerotic cardiovascular diseases impose a significant economic burden on Belgian society.

Prescribing practice of general practitioners in Northern Ireland for peripheral arterial disease.

Peripheral arterial disease is prevalent and reflects overall cardiovascular disease state. Best medical treatment is the cornerstone of management to reduce peripheral arterial disease symptoms and to minimize vascular morbidity and mortality. The aim of this study was to assess the prescription practice of general practitioners in Northern Ireland for patients with peripheral arterial disease. All general practitioners were from the Northern Ireland Professional Medical Directory, and a questionnaire was used to determine the prescribing patterns for peripheral arterial disease. In all, 468 general practitioners responded; 94% prescribed aspirin to nondiabetic patients, and 44.9% prescribed statin, with similar results for diabetic patients. Angiotensin-converting enzyme inhibitors, multivitamins, and beta-blockers were not often prescribed. Statin was prescribed to patients with diabetic peripheral arterial disease at a lower cholesterol concentration. In all, 52% would consider statin and fibrate together. Budgetary consideration influenced 6%. Northern Ireland general practitioners are reluctant to prescribe medication that is effective in the secondary prevention of vascular morbidity and mortality in high-risk patients.

A systematic review of duplex ultrasound, magnetic resonance angiography and computed tomography angiography for the diagnosis and assessment of symptomatic, lower limb peripheral arterial disease.

OBJECTIVES: To determine the diagnostic accuracy and cost-effectiveness of duplex ultrasound (DUS), magnetic resonance angiography (MRA), and computed tomography angiography (CTA), as alternatives to contrast angiography (CA), for the assessment of lower limb peripheral arterial disease (PAD). DATA SOURCES: Ten electronic databases were searched in April 2004, with an update in May 2005. Six key journals and bibliographies of included studies were also searched and experts in the field were consulted. REVIEW METHODS: Data extraction and quality assessment were performed in duplicate. Data were analysed according to test type and diagnostic threshold. For the economic analysis, a decision tree was developed and a probabilistic sensitivity analysis performed to incorporate statistical uncertainty into the cost-effectiveness analysis. RESULTS: A total of 113 studies met the inclusion criteria (including six economic evaluations). For the detection of stenosis greater than 50% in the whole leg, contrast-enhanced (CE) MRA (14 studies) had the highest diagnostic accuracy, with sensitivity ranging from 92 to 99.5% and specificity from 64 to 99%. Two-dimensional (2D) time-of-flight (TOF) MRA (11 studies) was less accurate, with sensitivity ranging from 79 to 94% and specificity from 74 to 92%. 2D phase-contrast (PC) MRA (one study) had a sensitivity of 98% and specificity of 74%. CTA (seven studies) also appeared slightly inferior to CE MRA, with a sensitivity ranging from 89 to 99% and specificity from 83 to 97%, but better than DUS (28 studies), which had a sensitivity ranging from 80 to 98% and specificity from 89 to 99%. There was some indication that CE MRA and DUS were more accurate for detecting stenoses/occlusions above the knee than below the knee or in the pedal artery. The four studies of patient attitudes strongly suggested that patients preferred CE MRA to CA. CA was considered the most uncomfortable test, followed by CE MRA, with CTA being the least uncomfortable. Half of the patients (from a sample who did not suffer from claustrophobia and had no metallic implants) expressed no preference between undergoing TOF MRA or DUS; most of those who did express a preference favoured TOF MRA. In the 55 studies identified for adverse events, MRA was associated with the highest reported proportion. However, the most severe adverse events were more common in patients undergoing CA; although these were rare for both tests. The economic evaluation showed DUS dominated the other alternatives when the whole leg was assessed, by presenting higher effectiveness at a lower cost per quality-adjusted life-year (QALY; i.e. 13,646 pounds per QALY). When the assessment was limited to a section of the leg, either above the knee or below the knee, 2D TOF MRA was the most cost-effective preoperative diagnostic strategy. The incremental cost per QALY for below-the-knee comparisons was equal to 37,024 pounds when 2D TOF MRA was compared with DUS. For above-the-knee comparisons, 2D TOF MRA presented the lowest cost and slightly lower effectiveness compared with CE MRA, with a cost per QALY equal to 13,442 pounds. CONCLUSIONS: The results of the review suggest that CE MRA has a better overall diagnostic accuracy than CTA or DUS, and that CE MRA is generally preferred by patients over CA. Where available, CE MRA may be a viable alternative to CA. The only controlled trial suggested that the results of DUS were comparable to those of CA, in terms of surgical planning and outcome. This finding conflicts with the results of diagnostic accuracy studies, which reported poor estimates of accuracy for DUS in comparison with CA. There was insufficient evidence to evaluate the usefulness of CTA for the assessment of PAD, particularly newer techniques. The results of the economic modelling suggest that for PAD patients for whom the whole leg is evaluated by a preoperative diagnostic test, DUS dominates the other alternatives by presenting higher effectiveness at a lower cost per QALY. However, when the analysis of stenosis is limited to a section of the leg, either above the knee or below the knee, 2D TOF MRA appears to be the most cost-effective preoperative diagnostic strategy. Further research is needed into a number of areas including the relative clinical effectiveness of the available imaging tests, in terms of surgical planning and postoperative outcome.

[Impact of the choice of an antiplatelet therapy for peripheral arterial disease: cost-effectiveness ratio and health economics assessment]. / Impact du choix d'un antiagrégant plaquettaire dans l'artériopathie oblitérante des membres inférieurs sur les pertes de chances et sur les coûts médicaux.

OBJECTIVES: To evaluate in peripheral arterial disease two strategies of antiplatelet therapy (clopidogrel and aspirin) in terms of number of ischemic stroke and hemorrhagic events, to estimate the losses of chances after no-choice of the most favorable strategy and the impact of these losses of chances in terms of days of hospitalizations, to estimate the cost-effectiveness ratio of the most effective and best tolerated strategy. METHOD: The number of patients to be treated to avoid one critical event (ischemic and hemorrhagic events) was calculated from the results of the annual rates established by the CAPRIE trial conducted in a population of French patients with peripheral arterial disease. This number of patients to treat was then extrapolated to the entire French population of peripheral arterial disease patients. The absolute numbers of critical events avoided with clopidogrel in France defined the losses of chances in the case of no-choice of this drug. Estimates in terms of days of hospitalization and cost-effectiveness ratio (in euro per life year gained) were based on data from the French Medical Information System. RESULTS: The number of patients to treat to avoid one ischemic event was 87 and the number of patients to treat to avoid one major hemorrhagic event was 149. In the peripheral arterial disease population, the numbers of ischemic and hemorrhagic events generated by non-treatment with clopidogrel was estimated at 3761 and 2191, respectively i.e. a total of 5952 events per year. These events included: 2025 myocardial infarctions, 1157 ischemic strokes, 579 deaths of vascular origin and 2191 digestive hemorrhages, requiring 60,394 hospitalization days. The cost-effectiveness ratio of clopidogrel was 10,393 euro per life year gained, and was much lower than commonly accepted cost-effective thresholds in Europe, which are around 30,000 euro per life year gained. CONCLUSION: The choice of clopidogrel in patients with peripheral arterial disease improves the prevention of subsequent events (ischemic and hemorrhagic events) with a cost-effectiveness ratio 2 to 3 times lower than the European thresholds accepted by the World Health Organization and avoids 1 day of hospitalization for 5.4 treated patients.

[Markers predicting progression of disease in PAD: Which of them are both relevant to clinical practice and economically justifiable?]. / Prädiktive Marker der Krankheitsprogression bei pAVK. Welche sind praxisrelevant und ökonomisch vertretbar?

The high cardiovascular morbidity and mortality on peripheral arterial disease (PAD) are attributable to the pronounced tendency to generalization of the atherosclerotic process, the systemic progression of atherosclerosis. The crucial objective in management of a PAD consists in preventing systemic progression. The prognosis can be improved by early diagnosis and early prediction of individual risk with subsequent risk-adapted prevention and causal therapy. Early diagnosis and risk prediction are measures that are already part of the repertory of the general practitioner. Practicable and economically justifiable parameters that nevertheless have a high predictive value are therefore required to stratify individual risk. The vascular indicators ankle-arm index and the localization of the PAD as well as the classical cardiovascular risk factors including homocysteine are suitable. Weighting of these parameters in a multivariable risk score enable the population with the highest risk of early generalization of atherosclerosis to be identified in PAD.

Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I).

OBJECTIVES: In-hospital peripheral vascular complications of balloon angioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes. BACKGROUND: The incidence, costs and outcomes of peripheral vascular complications after coronary intervention have not been fully characterized as a function of randomly assigned therapy. METHODS: At 35 sites in the United States and Europe, 1,012 patients were randomized. Peripheral vascular complications were defined as the composite of pulse loss, pseudoaneurysm, hematoma > 4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these complications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes. RESULTS: Sixty-seven patients (6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, and 2 (3.0%) died. Both in-hospital deaths occurred in patients with peripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to angioplasty or atherectomy. Greater age, female gender, postprocedural heparin and intraaortic balloon counterpulsation were predictive of increased risk. In a representative 60% subset, mean hospital costs increased from $9,583 in patients without to $18,350 in those with peripheral vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications identified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction. CONCLUSIONS: Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, greater age, postprocedural heparin and intraaortic balloon counterpulsation were predictive of higher risk. The twofold increase in cost and sevenfold increase in long-term deaths highlight the need to prevent these periprocedural events and monitor patients closely.