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Background: Previous cross-sectional studies have identified wide practice pattern variations in the use of peripheral vascular interventions (PVIs) for the treatment of claudication. However, there are limited data on longitudinal practice patterns. We aimed to describe the temporal trends and charges associated with PVI use for claudication over the past 12 years in the United States., Methods and Results: We conducted a retrospective analysis using 100% Medicare fee-for-service claims data to identify all patients who underwent a PVI for claudication between January 2011 and December 2022. We evaluated the trends in utilization and Medicare-allowed charges of PVI according to anatomic level, procedure type, and intervention settings using generalized linear models. Multinomial logistic regressions were used to evaluate factors associated with different levels and types of PVI. We identified 599 197 PVIs performed for claudication. The proportional use of tibial PVI increased 1.0% per year, and atherectomy increased by 1.6% per year over the study period. The proportion of PVIs performed in ambulatory surgical centers/office-based laboratories grew at 4% per year from 12.4% in 2011 to 55.7% in 2022. Total Medicare-allowed charges increased by $11 980 035 USD/year. Multinomial logistic regression identified significant associations between race and ethnicity and treatment setting with use of both atherectomy and tibial PVI., Conclusions: The use of tibial PVI and atherectomy for the treatment of claudication has increased dramatically in in ambulatory surgical center/office-based laboratory settings, non-White patients, and resulting in a significant increase in health care charges. There is a critical need to improve the delivery of value-based care for the treatment of claudication.

Objective: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment., Methods: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits., Results: The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY., Conclusion: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < €50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < £20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication., Methods: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009-2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications., Results: Overall, 7154 patients had undergone elective LEB for claudication during the study period. The median age was 66 years (interquartile range, 59-73 years), 67.5% were male, and 75.3% were white. Two thirds of patients (61.2%) had Medicare insurance, followed by private insurance (26.9%), Medicaid (7.7%), and other insurance (4.2%). In-hospital complications occurred in 8.5% of patients, including acute kidney injury in 3.0%, MALE in 2.8%, wound complications in 2.3%, and MACE in 1.0%. The overall median crude hospital cost was $11,783 (interquartile range, $8911-$15,767) per patient. The incremental increase in cost associated with a postoperative complication was significant, ranging from $6183 (95% confidence interval, $4604-$7762) for MALE to $10,485 (95% confidence interval, $6529-$14,441) for MACE after risk adjustment., Conclusions: Postoperative complications after elective LEB for claudication are not uncommon and increase the in-hospital costs by 46% to 78% depending on the complication. Surgical revascularization for claudication should be used sparingly in carefully selected patients., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: People with peripheral artery disease are at a high risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Randomized controlled trials suggest that intensive lowering of low-density lipoprotein cholesterol (LDL-C) with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors is an effective strategy to prevent these events. This study estimated the potential benefit and cost-effectiveness of administrating PCSK9 inhibitors to a cohort of participants with peripheral artery disease., Methods: A total of 783 participants with intermittent claudication (IC; n = 582) or chronic limb-threatening ischemia (CLTI; n = 201) were prospectively recruited from three hospitals in Australia. Serum LDL-C was measured at recruitment, and the occurrence of MACE and MALE was recorded over a median (interquartile range) follow-up of 2.2 years (0.3-5.7 years). The potential benefit of administering a PCSK9 inhibitor was estimated by calculating the absolute risk reduction and numbers needed to treat (NNT) based on relative risk reductions reported in published randomized trials. The incremental cost-effectiveness ratio per quality-adjusted life year gained was estimated., Results: Intensive LDL-C lowering was estimated to lead to an absolute risk reduction in MACE of 6.1% (95% confidence interval [CI], 2.0-9.3; NNT, 16) and MALE of 13.7% (95% CI, 4.3-21.5; NNT, 7) in people with CLTI compared with 3.2% (95% CI, 1.1-4.8; NNT, 32) and 5.3% (95% CI, 1.7-8.3; NNT, 19) in people with IC. The estimated incremental cost-effectiveness ratios over a 10-year period were $55,270 USD and $32,800 USD for participants with IC and CLTI, respectively., Conclusions: This analysis suggests that treatment with a PCSK9 inhibitor is likely to be cost-effective in people with CLTI., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Worldwide, peripheral arterial disease (PAD) is a disease with high morbidity, affecting more than 200 million people. Our objective was to analyze the surgical treatment for PAD performed in the Unified Health System of the city of São Paulo during the last 11 years based on publicly available data., Methods: The study was conducted with data analysis available on the TabNet platform, belonging to the DATASUS. Public data (government health system) from procedures performed in São Paulo between 2008 and 2018 were extracted. Sex, age, municipality of residence, operative technique, number of surgeries (total and per hospital), mortality during hospitalization, mean length of stay in the intensive care unit and amount paid by the government system were analyzed., Results: A total of 10,951 procedures were analyzed (either for claudicants or critical ischemia-proportion unknown); 55.4% of the procedures were performed on males, and in 50.60%, the patient was older than 65 years. Approximately two-thirds of the patients undergoing these procedures had residential addresses in São Paulo. There were 363 in-hospital deaths (mortality of 3.31%). The hospital with the highest number of surgeries (n = 2,777) had lower in-hospital mortality (1.51%) than the other hospitals. A total of $20,655,272.70 was paid for all revascularizations., Conclusions: Revascularization for PAD treatment has cost the government system more than $20 million over 11 years. Endovascular surgeries were performed more often than open surgeries and resulted in shorter hospital stays and lower perioperative mortality rates., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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

Background: Despite guidelines cautioning against the use of endovascular peripheral vascular interventions (PVI) for claudication, more than 1.3 million PVI procedures are performed annually in the United States. We aimed to describe national rates of PVI for claudication, and identify patient and county-level risk factors associated with a high rate of PVI., Methods: We used the Medicare claims database to identify all Medicare beneficiaries with a new diagnosis of claudication between January 2015 and June 2017. A hierarchical logistic regression model accounting for patient age, sex, comorbidities; county region and setting; and a patient race-county median income interaction was used to assess the associations of race and income with a high PVI rate., Results: We identified 1,201,234 patients with a new diagnosis of claudication for analysis. Of these, 15,227 (1.27%) underwent a PVI. Based on hierarchical logistic regression accounting for patient and county-level factors, black patients residing in low-income counties had a significantly higher odds of undergoing PVI than their white counterparts (odds ratio [OR], 1.30; 95% confidence interval [CI], 1.20-1.40), whereas the odds of PVI for black versus white patients was similar in high-income counties (OR, 1.06; 95% CI, 0.99-1.14). PVI rates were higher for low versus high-income counties in both the black (OR, 1.46; 95% CI, 1.31-1.64) and white (OR, 1.19; 95% CI, 1.12-1.27) groups. There were no significant associations of Hispanic, Asian, North American native, or other races with PVI in either low- or high-income counties after risk adjustment (all P ≥ .09)., Conclusions: In the Medicare population, the mean rate of PVI of 12.7 per 1000 claudication patients varies significantly based on race and income. Our data suggest there are racial and socioeconomic differences in the treatment of claudication across the United States., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach., Methods: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint., Results: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P =0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P =0.02)., Conclusions: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.

Background: The overall use of intensive care units (ICUs) in the United States has been steadily increasing and is associated with tremendous health care costs. We suspect that the burden of ICU utilization after elective infrainguinal lower extremity bypass (LEB) procedures is high, despite relatively low risks of complications in the immediate postoperative period. We sought to identify the burden of ICU utilization after elective LEB in patients with claudication., Methods: We queried the Premier Healthcare Database for all adult patients undergoing first recorded elective infrainguinal LEB for claudication from 2009 to 2015. Baseline characteristics and ICU utilization on postoperative day 0 (POD 0) were identified for each patient using Premier room and board chargemaster codes. A bivariate logistic regression was performed and postestimation concordance statistics were calculated to identify predictors of postoperative ICU vs regular surgical floor admission immediately after surgery., Results: There were 6010 patients who met the selection criteria, of whom 2772 (46.1%) were admitted to the ICU and 3238 (53.9%) to the regular surgical floor on POD 0. Whereas patient-level factors were responsible for minor differences found in postoperative admission to the ICU after elective LEB, hospital characteristics made up the majority of variation in admission practices. Specifically, patients undergoing elective infrainguinal LEB in rural, nonteaching, small hospitals and those in certain geographic regions were more likely to be admitted to the ICU than to the floor (all, P < .001). Patient-level factors were poorly predictive of admission to the ICU immediately postoperatively, with C statistics ranging from 0.50 to 0.53. In contrast, hospital-level factors had higher C statistics ranging from 0.51 to 0.66, with geographic location being the strongest predictor of post-LEB ICU admission. There were no significant differences in the incidence of postoperative wound complications, major adverse limb events, major adverse cardiac events, or in-hospital mortality between groups (all, P ≥ .32). The median total hospital cost was $2340 higher for ICU compared with floor admission ($13,273 [interquartile range, $10,136-$17,883] vs $10,927 [interquartile range, $8342-$14,523]; P < .001)., Conclusions: Nearly half of patients are admitted to an ICU directly after elective infrainguinal LEB for claudication. This practice is associated with significantly higher hospital cost and is predominantly influenced by hospital-level rather than by patient-level factors. Perioperative morbidity and mortality were similar regardless of postoperative disposition. To minimize ICU utilization, postoperative care intensity should be determined by clinical severity of the patient rather than by hospital routine., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Revascularization is a treatment option for patients with intermittent claudication. However, there is a lack of evidence to support its long-term benefits and cost-effectiveness. The aim of this study was to compare the cost-effectiveness of revascularization and best medical therapy (BMT) with that of BMT alone., Methods: Data were used from the IRONIC (Invasive Revascularization Or Not in Intermittent Claudication) RCT where consecutive patients with mild-to-severe intermittent claudication owing to aortoiliac or femoropopliteal disease were allocated to either BMT alone (including a structured, non-supervised exercise programme) or to revascularization together with BMT. Inpatient and outpatient costs were obtained prospectively over 24 months of follow-up. Mean improvement in quality-adjusted life-years (QALYs) was calculated based on responses to the EuroQol Five Dimensions EQ-5D-3 L™ questionnaire. Cost-effectiveness was assessed as the cost per QALY gained., Results: A total of 158 patients were randomized, 79 to each group. The mean cost per patient in the BMT group was €1901, whereas it was €8280 in the group treated with revascularization in addition to BMT, with a cost difference of €6379 (95 per cent c.i. €4229 to 8728) per patient. Revascularization in addition to BMT resulted in a mean gain in QALYs of 0·16 (95 per cent c.i. 0·06 to 0·24) per patient, giving an incremental cost-effectiveness ratio of €42 881 per QALY., Conclusion: The costs associated with revascularization together with BMT in patients with intermittent claudication were about four times higher than those of BMT alone. The incremental cost-effectiveness ratio of revascularization was within the accepted threshold for public willingness to pay according to the Swedish National Guidelines, but exceeded that of the UK National Institute for Health and Care Excellence guidelines., (© 2018 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Background: Hospital readmissions are associated not only with increased mortality, morbidity, and costs but also, with current health-care reform, tied to significant financial and administrative penalties. Some studies show that patients undergoing vascular surgery may have higher than average readmission rates. The recently released Nationwide Readmission Database (NRD) is the most comprehensive national source of readmission data, gathering discharge information from 22 geographically dispersed states, accounting for 51.2% of the total U.S. resident population and 49.3% of all U.S. hospitalizations. The aim of this study is to use the power of the NRD and obtain nationally representative readmission information for patients admitted with claudication or critical limb ischemia (CLI) who underwent revascularization procedures., Methods: The NRD was queried for all patients admitted for claudication (International Classification of Diseases Ninth Revision [ICD-9] 440.21) or CLI (ICD-9 440.22-440.24) and who underwent percutaneous transluminal angioplasty, peripheral bypass, or aortofemoral bypass. Patient demographics, comorbidities, length of stay (LOS), mortality, readmission rates, and associated costs were collected. Univariable and multivariable logistic regression analysis was implemented on claudication and CLI groups on all outcomes of interest. The most common readmission diagnosis codes and diagnosis groups were also identified., Results: A total of 92,769 patients were admitted for peripheral vascular disease (33,055 with claudication and 59,714 with CLI). The 30-day readmission/any readmission rate was 8.97%/21.49% and 19.26%/40.36%, for claudication and CLI, respectively. Significant differences were found for claudication and CLI, respectively, on initial cost of admission ($18,548 vs. $29,148, P < 0.001), readmission costs ($14,726 vs. $17,681 P < 0.001), LOS (4 days vs. 9 days, P < 0.001), days to readmission (73 days vs. 59 days, P < 0.001), mortality during initial admission (256 vs. 1,363, P < 0.001), and mortality during any admission (538 vs. 3,838, P < 0.001). Univariate and multivariate logistic regression analysis found that claudication, CLI, angioplasty, peripheral bypass, aortofemoral bypass, female sex, age >65, Charlson Comorbidity Index, LOS, and primary expected payer status were all significant predictors of 30-day and overall readmissions at varying degrees. The 5 most common disease readmission groups found were other vascular procedures (12.6%), amputation of lower limb except toes (6.3%), sepsis (5.4%), heart failure (4.9%) and postoperative or other device infections (4.8%). Of the abovementioned groups, the 4 most common diagnoses included "other postoperative infections," sepsis, atherosclerosis of native arteries with gangrene, and "other complications due to other vascular device, implant, or graft.", Conclusions: Our results demonstrate that there is a significant difference in readmission rates, cost, and morbidity between patients admitted for claudication and CLI. Furthermore, based on regression analysis, there are multiple other clear risk factors associated with worse clinical and economic outcomes. Further study is needed to predict which patients will require increased vigilance during their hospital stay to prevent readmissions and worse outcomes., Level of Evidence: Care management/epidemiological, level IV., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Despite increased interest in treating common femoral artery (CFA) with endovascular technology, there are little data regarding the long-term outcomes of different endovascular treatment modalities. We report the results after endovascular therapy of symptomatic obstructions of the CFA in a single center., Methods: We retrospectively reviewed the records of consecutive patients with eligible CFA lesions who were treated with endovascular methods between 2011 and 2013. The preoperative demographic operative details and postoperative outcomes were compared and statistically analyzed., Results: Ninety patients with CFA lesions were treated, and 76 (84.4%) completed a follow-up. Claudication was present in 62 of 76 (81.6%) patients, and stenosis was present in 60 of 76 (78.9%) patients. Angioplasty was performed in 45 patients, and atherectomy was performed in 31 patients. There was no significant difference in the preoperative demographic data, procedure time, contrast administration, or length of hospital stay between the 2 groups. In-hospital treatment costs were significantly higher in the atherectomy group (69,822 RenMinBi Yuan vs. 49,078 RenMinBi Yuan; P = 0.043). During the 4-year primary patency, for whole group or bifurcated/claudicant subgroup, all patients within the atherectomy group were significantly better than those in the angioplasty group., Conclusions: Atherectomy may be a better alternative to angioplasty for CFA atherosclerotic obstructions lesions. Compared with angioplasty, atherectomy seems to have better results in bifurcated lesions or claudicant patients. In diabetic patients, no superiority was found on either patency or improvement in walking distance., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to provide an overview of evidence regarding exercise therapies for patients with lower extremity peripheral artery disease (PAD)., Methods: This manuscript summarizes the content of a lecture delivered as part of the 2016 Crawford Critical Issues Symposium., Results: Multiple randomized clinical trials demonstrate that supervised treadmill exercise significantly improves treadmill walking performance in people with PAD and intermittent claudication symptoms. A meta-analysis of 25 randomized trials demonstrated a 180-meter increase in treadmill walking distance in response to supervised exercise interventions compared with a nonexercising control group. Supervised treadmill exercise has been inaccessible to many patients with PAD because of lack of medical insurance coverage. However, in 2017, the Centers for Medicare and Medicaid Services issued a decision memorandum to support health insurance coverage of 12 weeks of supervised treadmill exercise for patients with walking impairment due to PAD. Recent evidence also supports home-based walking exercise to improve walking performance in people with PAD. Effective home-exercise programs incorporate behavioral change interventions such as a remote coach, goal setting, and self-monitoring. Supervised treadmill exercise programs preferentially improve treadmill walking performance, whereas home-based walking exercise programs preferentially improve corridor walking, such as the 6-minute walk test. Clinical trial evidence also supports arm or leg ergometry exercise to improve walking endurance in people with PAD. Treadmill walking exercise appears superior to resistance training alone for improving walking endurance., Conclusions: Supervised treadmill exercise significantly improves treadmill walking performance in people with PAD by approximately 180 meters compared with no exercise. Recent evidence suggests that home-based exercise is also effective and preferentially improves over-ground walking performance, such as the 6-minute walk test., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Advances made in medical management and treatment options in addressing lower extremity claudication and vascular disease have skyrocketed during the last decade. Given the recent advances in treatment options, there is often the perception within the medical community and general community that to get the most "cutting edge" treatment, one must go to an academic center or practitioner. The goal of this portion of the discussion is to explore the question of what differences in treatment options there are between a community practice and an academic practice within those members of the vascular surgery specialty. Are there really any differences in the types of treatments offered or availability of the different modalities, and what drives us as practitioners to one over the other?, (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective/background: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period., Methods: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort., Results: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; +22% [p < .001]) and INT in 44% (2009: 66%; -22% [p < .001]) of the IC population. Additional revascularisation was performed in 19% of patients in the SET group (2009: 6%; +13% [p < .001]) and also in 19% of patients in the INT group (2009: 35%; -16% [p < .001]). Later on, 29% of patients in the INT group were referred for SET (2009: 10%; +19% [p < .001]). Average costs of IC treatment per patient in 2011 were 6% lower than in 2009 (€6885 vs. €7300; p = .020)., Conclusion: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Intermittent claudication (IC) is a manifestation of peripheral arterial disease. IC has a high prevalence in the older population, is closely associated with other expressions of atherosclerotic disease and often co-exists in multimorbid patients. Treatment of IC should address reduction of cardiovascular risk and improvement of functional capacity and health-related quality of life (QoL). As recommended by contemporary international guidelines, the first-line treatment includes supervised exercise therapy (SET). In several randomized controlled trials and systematic reviews, SET is compared with usual care, placebo, walking advice and endovascular revascularization. The evidence supporting the efficacy of SET programs to alleviate claudication symptoms is robust. SET improves walking distance and health-related QoL and appears to be the most cost-effective treatment for IC. Nevertheless, only few of all newly diagnosed IC patients worldwide receive this safe, efficient and structured treatment. Worldwide implementation of structured SET programs is seriously impeded by outdated arguments favoring an invasive intervention, absence of a network of specialized physical therapists providing standardized SET and lack of awareness and/or knowledge of the importance of SET by referring physicians. Besides, misguiding financial incentives and lack of reimbursement hamper actual use of SET programs. In the Netherlands, a national integrated care network (ClaudicatioNet) was launched in 2011 to combat treatment shortcomings and stimulate cohesion and collaboration between stakeholders. This care intervention has resulted in optimized quality of care for all patients with IC.

We compared the effects of an original structured home-based exercise program and revascularization in elderly patients with peripheral arterial disease over a 4-month period. Twenty-seven participants (n = 21; age = 68 ± 7 years) with moderate to severe claudication were randomized into (1) a test in-train out group (Ti-To; n = 18) that performed a home-based walking program prescribed and controlled at the hospital or (2) a revascularization group (Rev; n = 9) that underwent an endovascular and/or surgical procedure. The primary end point was quality of life as evaluated by the physical component summary (PCS) score of the Medical Outcomes Study Short Form 36 questionnaire. Secondary outcome measures included initial claudication distance (ICD) and absolute claudication distance (ACD), 6-minute walk distance (6MWD) and pain-free walk distance (PFWD), ankle-brachial index (ABI), and cost per walking meter gained. The PCS score significantly increased for both treatments at follow-up without a significant intergroup difference, as did ICD, ACD, and PFWD. The 6MWD and ABI significantly improved in the Rev group, and the Ti-To group exhibited a markedly lower cost per meter gained. The comparable effects of the 2 treatments need to be confirmed in a larger, randomized controlled trial., (© The Author(s) 2015.)

Background: The short form 36 (SF36) questionnaire is used for assessment of generic quality of life. Responses to the individual question in SF36 are also used for calculation of the SF6D index score. This score is used for calculation of quality adjusted-life years (QALYs) in economical analyses. As the individual patient questionnaires are not always available for performing systematic reviews and meta-analyses, a new formula has been developed for derivation of SF6D index score from the reported SF36-domain scores. This study aimed to evaluate the validity of this formula for use in patients with intermittent claudication., Methods: A retrospective review of a prospectively collected database of a randomized controlled trial was performed. A total of 178 patients were recruited. Clinical indicators of ischemia were recorded. All patients completed SF36 questionnaires. Response and domain-based SF6D scores (R-SF6D and D-SF6D) and QALYs were calculated. Correlation and agreement analysis were performed., Results: Response rate was 88% (n = 781) over a 1-year follow-up period. Domain-based SF6D score (mean, 0.684; standard deviation [SD] 0.110) was significantly higher (paired t-test, P = 0.001) than the response-based score (mean, 0.627; SD, 0.110) with a mean difference of 0.056 (95% confidence interval, 0.053-0.060). Mean QALY calculated using D-SF6D score (0.503; SD, 0.116) was also significantly higher than the QALY calculated from the R-SF6D score (0.467; SD, 0.121). Bland-Altman comparison showed strong agreement (limit of agreement -0.167 to 0.054) between the 2 methods with equal variances (Pitman's test, P = 0.629). D-SF6D scores showed stronger correlation with clinical indicators of ischemia (r = 0.246-0.602) compared with that of R-SF6D scores (r = 0.233-0.549)., Conclusions: Domain-based estimation of SF6D score is a valid and reliable method with strong agreement to the gold standard response-based scores in claudicants. However, adjustments may be required in studies using a mixture of D-SF6D and R-SF6D scores for QALY calculation., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Peripheral artery disease (PAD) is a significant medical concern that is highly prevalent, costly, and deadly. Additionally, patients with PAD have significant impairments in functional independence and health-related quality of life due to leg symptoms and ambulatory dysfunction. Exercise therapy is a primary treatment for patients with PAD, as ambulatory outcome measures improve following a program of exercise rehabilitation. This review describes the outcomes that improve with exercise, the potential mechanisms for improved leg symptoms, key exercise program considerations for training patients with PAD with walking-based exercise, other exercise modalities that have been utilised, the use of on-site supervised exercise programs, and a major focus on historical and contemporary trials on conducting home-based, minimally supervised exercise program to treat PAD. The review concludes with recommendations for future exercise trials, with particular emphasis on reported greater details of the exercise prescription to more accurately quantify the total exercise dose of the program.

Background: Peripheral arterial disease is common and is associated with significant morbidity and mortality., Methods: We conducted a systematic review to identify randomized trials and systematic reviews of patients with intermittent claudication to evaluate surgery, endovascular therapy, and exercise therapy. Outcomes of interest were death, amputation, walking distance, quality of life, measures of blood flow, and cost., Results: We included eight systematic reviews and 12 trials enrolling 1548 patients. Data on mortality and amputation and on cost-effectiveness were sparse. Compared with medical management, each of the three treatments (surgery, endovascular therapy, and exercise therapy) was associated with improved walking distance, claudication symptoms, and quality of life (high-quality evidence). Evidence supporting superiority of one of the three approaches was limited. However, blood flow parameters improved faster and better with both forms of revascularization compared with exercise or medical management (low- to moderate-quality evidence). Compared with endovascular therapy, open surgery may be associated with longer length of hospital stay and higher complication rate but resulted in more durable patency (moderate-quality evidence)., Conclusions: In patients with claudication, open surgery, endovascular therapy, and exercise therapy were superior to medical management in terms of walking distance and claudication. Choice of therapy should rely on patients' values and preferences, clinical context, and availability of operative expertise., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

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

Background: Both supervised exercise (SE) and stenting (ST) improve functional status, symptoms, and quality of life compared with optimal medical care (OMC) in patients with claudication. The relative cost-effectiveness of these strategies is not well defined., Methods and Results: The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study randomized patients with claudication due to aortoiliac stenosis to a 6-month SE program, to ST, or to OMC. Participants who completed 6-month follow-up (n=98) were included in a health economic analysis through 18 months. Costs were assessed using resource-based methods and hospital billing data. Quality-adjusted life-years were estimated using the EQ-5D. Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life. Through 18 months, mean healthcare costs were $5178, $9804, and $14 590 per patient for OMC, SE, and ST, respectively. Measured quality-adjusted life-years through 18 months were 1.04, 1.16, and 1.20. In our base case analysis, which assumed that observed differences in quality of life would dissipate after 5 years, the incremental cost-effectiveness ratios were $24 070 per quality-adjusted life-year gained for SE versus OMC, $41 376 for ST versus OMC, and $122 600 for ST versus SE. If the treatment effect of ST was assumed to be more durable than that of SE, the incremental cost-effectiveness ratio for ST versus SE became more favorable., Conclusions: Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease. ST is more expensive than SE, with uncertain incremental benefit., Clinical Trial Registration Url: www.clinicaltrials.gov, Unique identifier: NCT00132743., (© 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Objectives: International guidelines recommend supervised exercise therapy (SET) as primary treatment for intermittent claudication (IC). The aim of this study was to calculate treatment costs in patients with IC and to estimate nationwide annual savings if a stepped care model (SCM, primary SET treatment followed by revascularization in case of SET failure) was followed., Methods: Invoice data of all patients with IC in 2009 were obtained from a Dutch health insurance company (3.4 million members). Patients were divided into three groups based on initial treatment after diagnosis (t0). The SET group received SET initiated at any time between 12 months before and up to 3 months after t0. The intervention group (INT) underwent endovascular or open revascularization between t0 and t+3 months. The third group (REST) received neither SET nor any intervention. All peripheral arterial disease related invoices were recorded during 2 years and average costs per patient were calculated. Savings following use of a SCM were calculated for three scenarios., Results: Data on 4954 patients were analyzed. Initial treatment was SET (n = 701, 14.1%), INT (n = 1363, 27.5%), or REST (n = 2890, 58.3%). Within 2 years from t0, invasive revascularization in the SET group was performed in 45 patients (6.4%). Additional interventions (primary at other location and/or re-interventions) were performed in 480 INT patients (35.2%). Some 431 REST patients received additional SET (n = 299, 10.3%) or an intervention (n = 132, 4.5%). Mean total IC related costs per patient were €2,191, €9851 and €824 for SET, INT, and REST, respectively. Based on a hypothetical worst, moderate, and best case scenario, some 3.8, 20.6, or 33.0 million euros would have been saved per annum if SCM was implemented in the Dutch healthcare system., Conclusion: Implementation of a SCM treatment for patients with IC may lead to significant savings of health care resources., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Background: The aim was to compare costs and utilities of percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA + SEP) in patients with intermittent claudication (IC) to establish the most cost-effective treatment., Methods: Patients with IC due to femoropopliteal disease were randomized to receive PTA, SEP or PTA + SEP. Assessments were performed before, and at 1, 3, 6 and 12 months postintervention. Clinical and quality-of-life indicators were recorded. The SF-6D Health Utilities index was calculated from the Short Form 36, plotted, and quality-adjusted life-years (QALYs) were generated by calculating the area under the curve. Costs were calculated using National Health Service 2009-2010 payment-by-results tariffs and the National Institute for Health Research Clinical Research Network Investigation pricing index, and adjusted for reinterventions. Cost per QALY and incremental costs were calculated, and sensitivity analyses performed., Results: A total of 178 patients (PTA, 60; SEP, 60; PTA + SEP, 58) were randomized. All treatments resulted in significant improvement in the SF-6D index (P < 0.001). There was no significant difference between treatments in mean QALYs gained (PTA: 0.620, 95 per cent confidence interval 0.588 to 0.652; SEP: 0.629, 0.597 to 0.660; PTA + SEP: 0.649, 0.622 to 0.675). The adjusted mean cost per procedure was significantly higher for PTA (€7301.74) compared with SEP (€3866.49) and PTA + SEP (€6911.68) (P < 0.001). The cost per QALY was significantly higher for PTA (€11,777.00) compared with SEP (€6147.04) and PTA + SEP (€10,649.74). QALYs were lost when PTA alone was used as first-line treatment in comparison with SEP or PTA + SEP. These results were robust and valid in sensitivity analyses., Conclusion: Supervised exercise is the most cost-effective first-line treatment for IC, and when combined with PTA is more cost-effective than PTA alone., (© 2013 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: The aim was to perform an economic evaluation of the cost-effectiveness of endovascular enhancements to percutaneous transluminal balloon angioplasty (PTA) with bail-out bare metal stents for infrainguinal peripheral arterial disease., Methods: The following interventions were considered: PTA with no bail-out stenting, PTA with bail-out drug-eluting stents, drug-coated balloons, primary bare metal stents, primary drug-eluting stents, endovascular brachytherapy, stent-grafts and cryoplasty. A discrete-event simulation model was developed to assess the relative cost-effectiveness of the interventions from a health service perspective over a lifetime. Populations of patients with intermittent claudication (IC) and critical leg ischaemia (CLI) were modelled separately. Univariable and probabilistic sensitivity analyses were undertaken. Effectiveness was measured by quality-adjusted life-years (QALYs)., Results: For both patient populations, the use of drug-coated balloons dominated all other options by having both lower lifetime costs and greater effectiveness. For willingness-to-pay thresholds between £0 and £100,000 per additional QALY, the probability of drug-coated balloons being cost-effective was at least 58.3 per cent for patients with IC and at least 72.2 per cent for patients with CLI. Sensitivity analyses showed that the results were robust to different assumptions regarding the clinical benefits attributable to the interventions., Conclusion: The use of drug-coated balloons represents a cost-effective alternative to the use of PTA with bail-out bare metal stents., (© 2013 Crown copyright. British Journal of Surgery © 2013 British Journal of Surgery Society Ltd.)

Aim: Intermittent claudication (IC) in peripheral vascular disease is characterized by lower limb pain appearing on effort. Treatment with PGE1 has been successfully used to manage IC patients. This registry has evaluated safety and costs of PGE1 in the management of IC., Methods: In this study a long-term treatment protocol (LTP), a short-term protocol (STP) and an outpatient (OP), "on-demand" treatment have been compared. A treadmill effort test has been used to evaluate walking distance. The follow up for these three protocols was 40 weeks. PGE1 treatment was associated to a risk reduction plan and to an exercise program., Results: The final analysis has included 252 LTP patients, 223 STP patients and 284 OP patients (total 659 valid cases). A group of 171 comparable patients not treated with PGE1 was used for a parallel comparison. Cardiovascular mortality and morbidity has been evaluated in 731 PGE1 patients completing 24 months of follow up. All protocols have been well tolerated. No side effects were observed. The lower cost has been observed for OP patients. In the long term, mortality and morbidity were lower in patients treated with PGE1 in comparison with patients not treated with PGE1., Conclusion: Considering costs and results (increase in walking distance) and improvement in Karnofsky scale the STP plan appears to be better than LTP for IC patients. The OP, "on-demand" treatment offers further improvements. This last treatment plan is simpler; the plan allows better timing for exercise. The treatment can be used even in non-specialized centers.

Introduction: Intermittent claudication (IC) is a manifestation of peripheral arterial occlusive disease (PAOD). Besides cardiovascular risk management, supervised exercise therapy (SET) should be offered to all patients with IC. Outdated guidelines, an insufficient number of specialized physiotherapists (PTs), lack of awareness of the importance of SET by referring physicians, and misguided financial incentives all seriously impede the availability of a structured SET program in The Netherlands., Description of Care Practice: By initiating regional care networks, ClaudicatioNet aims to improve the quality of care for patients with IC. Based on the chronic care model as a conceptual framework, these networks should enhance the access, continuity, and (cost) efficiency of the health care system. With the aid of a national database, health care professionals will be able to benchmark patient results while ClaudicatioNet will be able to monitor quality of care by way of functional and patient reported outcome measures., Discussion: The success of ClaudicatioNet is dependent on several factors. Vascular surgeons, general practitioners and coordinating central caregivers will need to team up and work in close collaboration with specialized PTs. A substantial task in the upcoming years will be to monitor the quality, volume, and distribution of ClaudicatioNet PTs. Finally, misguided financial incentives within the Dutch health care system need to be tackled., Conclusion: With ClaudicatioNet, integrated care pathways are likely to improve in the upcoming years. This should result in the achievement of optimal quality of care for all patients with IC.

Background: Peripheral arterial disease (PAD) is a condition in which there is blockage or narrowing of the arteries that carry blood to the legs and arms. It is estimated to affect around 4.5% of people aged between 55 and 74 years within the UK. The most common symptom of PAD is intermittent claudication (IC), characterised by pain in the legs on walking that is relieved with rest., Objective: To assess the effectiveness and cost-effectiveness of cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate, compared with no vasoactive drugs, for IC due to PAD in adults whose symptoms continue despite a period of conventional management., Data Source: Electronic bibliographic databases were searched during April to June 2010 (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library databases, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Conference Proceedings Citation Index, BIOSIS Previews)., Review Methods: Effectiveness outcomes sought were maximal walking distance (MWD), pain-free walking distance (PFWD), ankle-brachial pressure index, cardiovascular events, mortality, adverse events (AEs) and health-related quality of life (HRQoL). A narrative synthesis was provided for all outcomes and a network meta-analysis was undertaken for the walking distance outcomes. A Markov model was developed to assess the relative cost-effectiveness of the interventions from a NHS perspective over a lifetime. The model has three states: vasoactive drug treatment, no vasoactive drug treatment and death. Each 1-week cycle, patients may continue with the drug, discontinue the drug or die. Regression analysis was undertaken to model the relationship between MWD and utility so that a cost per quality-adjusted life-year (QALY) outcome measure could be presented. Univariate and probabilistic sensitivity analyses were undertaken. All costs and outcomes were discounted at 3.5%., Results: Twenty-six randomised controlled trials were identified that met the inclusion criteria for the clinical effectiveness review. There was evidence that walking distance outcomes were significantly improved by both cilostazol and naftidrofuryl oxalate; the 95% credible intervals for the difference from placebo in the logarithm mean change MWD from baseline were 0.108 to 0.337 and 0.181 to 0.762, respectively. It was not possible to include inositol nicotinate within the meta-analysis of MWD and PFWD owing to the lack of 24-month data; however, the shorter-term data did not suggest a significant effect. AEs were minor for all drugs and included headaches and gastrointestinal difficulties. The incidence of serious adverse events (SAEs), including cardiovascular events and mortality, was not increased by the vasoactive drugs compared with placebo; however, most studies had a relatively short follow-up time to address this outcome. HRQoL data were limited. Two studies of limited quality were identified within the review of cost-effectiveness. The de novo model developed suggests that naftidrofuryl oxalate dominates cilostazol and pentoxifylline and has a cost per QALY gained of around £6070 compared with no vasoactive drug. This result is reasonably robust to changes within the key model assumptions. Inositol nicotinate was not included within the main analysis owing to lack of data. However, it is unlikely to be considered to be cost-effective due to its high acquisition cost (£900 vs £100-500 per year for the other drugs)., Conclusions: Naftidrofuryl oxalate and cilostazol both appear to be effective treatments for this patient population, with minimal SAEs. However, naftidrofuryl oxalate is the only treatment that is likely to be considered cost-effective. The long-term effectiveness is uncertain and hence a trial comparing cilostazol, naftidrofuryl oxalate and placebo beyond 24 weeks would be beneficial. Outcomes associated with naftidrofuryl oxalate could also be compared with those associated with supervised exercise programmes and angioplasty.

Purpose: Debate exists as to the benefit of angioplasty vs bypass graft in the treatment of lower extremity peripheral vascular disease. The associated costs are poorly defined in the literature. We sought to determine national estimates for the costs, utilization, and outcomes of angioplasty and bypass graft for the treatment of both claudication and limb threat., Methods: We searched the Nationwide Inpatient Sample (NIS) database (1999-2007), identifying patients who had an identifiable International Classification of Disease (ICD)-9 diagnosis code of atherosclerotic disease (claudication [440.21] or limb threat [440.22-440.24]). Of these, only patients who underwent intervention of angioplasty ± stent (percutaneous transluminal angioplasty [PTA; 39.50-39.90]), peripheral bypass graft (BPG; 39.29) or aortofemoral bypass (ABF; 39.25) were included. We compared demographics, costs, and comorbidities, as well as multivariable-adjusted outcomes of in-hospital mortality and major amputation. Additionally, we used the New Jersey State Inpatient and Ambulatory databases in order to better understand the influence of outpatient procedures on current volume and trends., Results: There were 563,143 patients identified (PTA: 38%, BPG: 50%, ABF: 6%; 5.1%: multiple procedure codes). Patients who had PTA and BPG were similar in age (70.4 vs 69.5 years) but older than patients who had ABF (61.8 years, P < .01). Patients who underwent PTA were more often women (PTA: 46%, BPG: 42%, ABF: 45.2%; P < .01). Average costs for PTA increased over 60% for claudication between 2001 and 2007 ($8670 to $14,084) and limb threat ($13,903 to $23,196). For BPG, average costs increased 36% for both claudication ($9322 to $12,681) and limb threat ($16,795 to $22,910). In 2007, the average cost per procedure of PTA was higher than BPG for both claudication ($13,903 vs $12,681; P = .02) and limb threat ($23,196 vs $22,910; P = .04). The number of patients per year undergoing PTA increased threefold (15,903 to 46,138) for claudication and limb threat (6752 to 19,468). For BPG, procedures per year decreased approximately 40% for both claudication (13,625 to 9108) and limb threat (25,575 to 13,762). In-hospital mortality was similar for PTA and BPG groups for claudication (0.1% vs 0.2%; P = .04) and limb threat (2.1% vs 2.6%; P < .01). In-hospital amputation rates were significantly higher for patients who had PTA (7%) than BPG (3.9%, odds ratio [OR], 1.67 [1.49-1.85]; P < .01) or patients who underwent ABF (3.0%; OR, 2.32 [1.79, 3.03]; P < .01)., Conclusion: PTA has altered the treatment paradigm for lower limb ischemia with an increase in costs and procedures. It is unclear if this represents an increase in patients or number of treatments per patient. Although mortality is slightly lower with PTA for all indications, amputation rates for limb-threat patients appear higher, as does the average cost. Longitudinal studies are necessary to determine the appropriateness of PTA in both claudication and limb-threat patients. The mortality benefit with PTA may be ultimately lost, and average costs elevated, if multiple interventions are performed on the same patients., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Patients with intermittent claudication (IC) could benefit from low-cost, effective rehabilitative programs. This retrospective study evaluates compliance, impact on Quality of Life (QoL) and cost-effectiveness of a hospital prescribed, at-home performed (Test-in/Train-out) rehabilitative program for patients with IC., Methods and Results: Two-hundred and eighty-nine patients with IC (71 ± 10.1 years, M = 210) were enrolled for a 2-year period. Two daily 10-min home walking sessions at maximal asymptomatic speed were prescribed, with serial check-ups at the hospital. Compliance with the program was assessed by assigning a score of 1 (lowest compliance) to 4 (highest compliance). The SF-36 questionnaire and a constant-load treadmill test were used to evaluate QoL and Initial/Absolute Claudication Distance, respectively. Both direct and indirect costs of the program were considered for cost-effectiveness analysis. Two-hundred and fifty patients (70.5 ± 9.2 years, M = 191), at Fontaine's II-B stage (86%), were included in the study. No adverse events were reported. The average compliance score was 3.1. At discharge, both SF-36 domains and walking performance significantly increased (P < 0.0001). A total of 1,839 in-hospital check-ups (7.36 /patient) were performed. Direct and indirect costs represented 93% and 7% of the total costs, respectively. The average costs of a visit and of a therapy cycle were C68.93 and C507.20, respectively. The cost to walk an additional meter before stopping was C9.22., Conclusions: A Test-in/Train-out program provided favourable patient compliance, QoL impact and cost-effectiveness in patients with IC.

Objectives: The Exercise Therapy in Peripheral Arterial Disease (EXITPAD) study has shown supervised exercise therapy (SET) to be more effective regarding walking distance and quality of life than a 'go home and walk' advice (WA) for patients with intermittent claudication. The present study aims to assess the cost-effectiveness of SET versus WA., Patients and Methods: Data from the EXITPAD study, a 12-month randomised controlled trial in 304 patients with claudication, was used to study the proportion of costs to walking distance and quality of life. Two different incremental cost-effectiveness ratios (ICERs) were calculated for SET versus WA: costs per extra metre on the treadmill test, and costs per quality-adjusted life year (QALY). QALYs were based on utilities derived from the EuroQoL-5 dimensions (EQ-5D)., Results: Mean total costs were higher for SET than for WA (3407 versus 2304 Euros), mainly caused by the costs of exercise therapy. The median walking distance was 620 m for SET and 400 m for WA. QALYs were 0.71 for SET and 0.67 for WA. All differences were statistically significant. The ICER for cost per extra metre on the 12-month treadmill test was € 4.08. For cost per QALY, the ICER was € 28,693., Conclusion: At a willingness-to-pay threshold of € 40,000 per QALY, SET likely is a cost-effective therapeutic option for patients with claudication., (Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Background: Treatment of claudication with endovascular intervention (EVI), a procedure designed to enhance quality of life, is on the rise despite being expensive. We examined clinical outcomes and costs for treatment of claudication with EVI., Methods: Records of all EVI performed at a University Health Center during a single year were reviewed for functional capacity, Trans-Atlantic Inter-Society Council (TASC) classification, procedure, reintervention, and financial data. Sustained clinical success (SCS) (improvement without target extremity revascularization [TER]) and secondary sustained clinical success (SSCS) (improvement with TER) were tracked over 2 years follow-up., Results: There were 77 patients (90 limbs). Mean follow-up was 14.8 +/- 7.7 months (1-30). Procedural success was 94%. Two-year SCS and SSCS were found to be 28 +/- 9% and 49 +/- 11%, respectively. SCS differed significantly from TASC (p = 0.02), whereas SSCS did not (p = 0.33). Mean time to reintervention was 11.7 +/- 6.6 months. Two-year TER-free rate (65 +/- 7%) did not differ significantly by procedure (p = 0.26), the artery treated (p = 0.24), or TASC (p = 0.18). Two-year costs for EVI were $13,886, differing significantly by TASC (p = 0.017) and by the artery treated (p < 0.001). Estimated cost for a 3-month trial of supervised exercise and pharmacotherapy was $1,376, and the maintenance cost over a 2 year follow-up period was $6,602., Conclusions: TER was necessary in more than one-third of limbs to maintain 2-year SSCS in 49% of patients. EVI was twice as expensive as estimated 2-year costs for supervised exercise and pharmacotherapy, and 10 times more costlier than a 3-month trial. Mandating a trial of conservative therapy before EVI merits consideration., (Copyright 2010. Published by Elsevier Inc.)

Objective: The aim of this study is to design the optimal study comparing endovascular revascularization and supervised exercise training for patients with intermittent claudication and to demonstrate value of information (VOI) analysis of patient-level data from an economic randomized controlled trial to guide future research., Methods: We applied a net benefit framework to patient-level data on costs and quality-of-life of a previous randomized controlled trial. VOI analyses were performed using Monte Carlo simulation. We estimated the total expected value of perfect information (total EVPI), the total expected value of sample information (total EVSI), the partial expected value of perfect information (partial EVPI), and the partial expected value of sample information (partial EVSI). These VOI analyses identified the key parameters and the optimal sample size of future study designs. Sensitivity analyses were performed to explore the robustness of our assumptions about the population to benefit, the willingness-to-pay threshold, and the study costs. The VOI analyses are demonstrated in statistical software (R) and a spreadsheet (Excel) allowing other investigators to apply VOI analysis to their patient-level data., Results: The optimal study design for the treatment of intermittent claudication involves a randomized controlled trial collecting data on the quality-adjusted life expectancy and additional admission costs for 525 patients per treatment arm. The optimal sample size remained between 400 and 600 patients for a willingness-to-pay threshold between euro30,000 and euro100,000/quality-adjusted life-years, for even extreme assumptions about the study costs, and for a range of 3 to 7 years that future patients will benefit from the results of the proposed study., Conclusions: 1) The optimal study for patients with intermittent claudication collects data on two key parameters for 525 patients per trial arm; and 2) we have shown that value of information analysis provides an explicit framework to determine the optimal sample size and identify key parameters for the design of future clinical trials.

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.

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.

The Claudication: Exercise vs Endoluminal Revascularization (CLEVER) Study is a prospective multicenter randomized clinical trial designed to compare the relative clinical and cost-effectiveness of invasive revascularization with stents to supervised exercise rehabilitation in a cohort with moderate to severe claudication due to aortoiliac insufficiency. The study is currently enrolling at twenty-eight sites in the US and Canada. Enrollment of 217 participants is planned, with data collected at baseline, six months, and 18 months. The primary study endpoint is maximum walking duration (MWD) on a graded treadmill test; secondary endpoints include community-based walking, markers of cardiovascular disease risk (body mass index, waist circumference, blood pressure, lipid profile, glucose tolerance, and plasma fibrinogen), health-related quality of life, and cost effectiveness. There are currently sixty randomized participants; recruitment is projected to end in July 2010 and final study results reported in June 2012.

Background: The optimal first-line treatment for intermittent claudication is currently unclear., Objective: To compare the cost-effectiveness of endovascular revascularization vs supervised hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period., Design: Randomized controlled trial with patient recruitment between September 2002-September 2006 and a 12-month follow-up per patient., Setting: A large community hospital., Participants: Patients with symptoms of intermittent claudication due to an iliac or femoro-popliteal arterial lesion (293) who fulfilled the inclusion criteria (151) were recruited. Excluded were, for example, patients with lesions unsuitable for revascularization (iliac or femoropopliteal TASC-type D and some TASC type-B/C., Intervention: Participants were randomly assigned to endovascular revascularization (76 patients) or supervised hospital-based exercise (75 patients)., Measurements: Mean improvement of health-related quality-of-life and functional capacity over a 12-month period, cumulative 12-month costs, and incremental costs per quality-adjusted life year (QALY) were assessed from the societal perspective., Results: In the endovascular revascularization group, 73% (55 patients) had iliac disease vs 27% (20 patients) femoral disease. Stents were used in 46/71 iliac lesions (34 patients) and in 20/40 femoral lesions (16 patients). In the supervised hospital-based exercise group, 68% (51 patients) had iliac disease vs 32% (24 patients) with femoral disease. There was a non-significant difference in the adjusted 6- and 12-month EuroQol, rating scale, and SF36-physical functioning values between the treatment groups. The gain in total mean QALYs accumulated during 12 months, adjusted for baseline values, was not statistically different between the groups (mean difference revascularization versus exercise 0.01; 99% CI -0.05, 0.07; P = .73). The total mean cumulative costs per patient was significantly higher in the revascularization group (mean difference euro2318; 99% CI 2130 euros, 2506 euros; P < .001) and the incremental cost per QALY was 231 800 euro/QALY adjusted for the baseline variables. One-way sensitivity analysis demonstrated improved effectiveness after revascularization (mean difference 0.03; CI 0.02, 0.05; P < .001), making the incremental costs 75 208 euro/QALY., Conclusion: In conclusion, there was no significant difference in effectiveness between endovascular revascularization compared to supervised hospital-based exercise during 12-months follow-up, any gains with endovascular revascularization found were non-significant, and endovascular revascularization costs more than the generally accepted threshold willingness-to-pay value, which favors exercise.

Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.

Objectives: To determine claudication patients' risk attitude to invasive treatment and whether this treatment is cost effective., Methods: Quality of life and health state utility status of 50 consecutive patients with severe intermittent claudication was assessed and compared with ankle-brachial pressure index values (ABPI) and results from treadmill tests before and after endovascular or open revascularization. Health utility scores were then calculated and used in a cost-utility analysis., Results: Before surgery, patients were assigned a utility score of 0.51 (EQ-5D index) for their disease, and the standard gamble (SG) and time trade-off (TTO) median scores were 0.88 and 0.70, respectively. Before treatment, a weak correlation (r = 0.43, P < .001) between having a high risk perception of treatment and patients' walking distance were observed, where patients able to walk short distances accepted a higher risk. After treatment, ABI (P = .003) and walking distance (P = .002) improved significantly as well the physical components of the quality of life instruments (P < .001). The surgical treatment generated an improvement in quality of life expressed in QALYs equivalent to 0.17. With an estimated survival of 5 years, it adds up to a value of 0.85, corresponding to a sum of 51,000 US dollars gained., Conclusions: Patients with severe intermittent claudication are risk-seeking when it comes to surgical treatment and their risk attitude is correlated to their walking ability and quality of life. The incremental QALYs gained by treatment are achieved at a reasonable cost and revascularization appears to be cost effective.

Purpose: To identify pretreatment predictors of procedural costs in percutaneous and surgical interventions for intermittent claudication due to aortoiliac and/or femoropopliteal disease., Methods: A retrospective study was conducted in 97 consecutive patients who underwent percutaneous or surgical interventions over 15 months at a tertiary care center. Nineteen clinical predictive variables were collected at baseline. Procedural costs (outcome) were assessed from the perspective of the hospital by direct calculation, not based on ratios of costs-to-charges. A multivariable regression model was built to identify significant cost predictors. Follow-up information was obtained to provide multidimensional assessment of clinical outcome, including technical success (arteriographic score) and clinical result (changes in ankle-brachial pressure index; cumulative patency, mortality, and complication rates)., Results: The linear regression model shows that procedural costs per patient are 25% lower in percutaneous patients (versus surgical), 42% lower for patients without rest pain than for those with, 28% lower if treated lesions are unilateral (versus bilateral), 12% lower if the treated lesion is stenotic rather than occlusive, 34% higher in sedentary patients, and 11% higher in patients with a history of cardiac disease. After a mean clinical follow-up >2 years, between-group differences between percutaneous and surgical patients were small and of limited significance in all dimensions of clinical outcome., Conclusion: Predictors of clinical outcome are different from predictors of costs, and one should include both types of variables in the decision-making process. The choice of percutaneous versus surgical strategy, the presence of rest pain, and the bilaterality of the culprit lesions were the main pretreatment determinants of procedural costs. When possible choices of treatment strategy overlap, percutaneous treatment should provide an acceptable result that is less expensive (although not equal to surgery).

Peripheral arterial disease (PAD) is a growing health problem for many Americans and often occurs along with other cardiovascular risk factors, including diabetes mellitus (DM), low-grade inflammation, hypertension, and lipid disorders. Intermittent claudication (IC), an early manifestation of PAD, commonly leads to reduced quality of life for patients who are limited in their ambulation. While recent wide adoption of percutaneous peripheral interventional (PPI) techniques has increased the number patients being aggressively treated for IC, the overall effectiveness of PPI for the treatment of IC is not well known, especially for DM patients who have both hemodynamic and functional obstacles to treatment success. This review is designed to illustrate how treatment outcomes for IC can be measured by different modalities and how diabetes and inflammation can influence those outcomes. In the setting of greater concern for health care resources and clinical accountability, better understanding of treatment outcomes and efficacy will help us manage these complex challenges.

Objectives: The main aims of treatment in patients with intermittent claudication (IC) are to improve the clinical indicators of lower limb ischaemia and patients' quality of life (QoL). The aims of this study were assess the clinical and cost effectiveness of a supervised exercise programme (SEP) in patients with IC., Design: Non-randomised, controlled trial., Setting: University teaching hospital., Patients and Methods: Two groups of patients with IC were studied. Seventy patients were sequentially recruited before and after the establishment of a Supervised Exercise Programme at our unit. Thirty-seven patients (median age 69 years, 26 men) received conservative medical therapy (CMT) and 33 patients (median age 67 years, 22 men) received CMT plus a 3 month SEP of graduated physical exercise for sixty minutes, three times each week. Patients were assessed prior to and at 6 months following treatment. At each assessment patient reported walking distances (PRWD), treadmill claudication and maximal distances (ICD and MWD), ankle brachial pressure indices (ABPI) pre & post exercise and patient reported QoL using the SF36 questionnaire were assessed., Results: Prior to intervention the two groups were well matched. Following treatment, CMT patients demonstrated no significant change in PRWD or ICD but did record a small but significant improvement in MWD. CMT was also associated with a negative effect size in the SF36 index and in 7 of the 8 SF36 QoL domains, effect size >-0.5 for the domains of Physical Function and Emotional Role. SEP patients demonstrated significant improvement in PRWD, ICD and MWD. SEP was associated with a positive effect size in the SF36 index and in 2 SF36 QoL domains but a negative effect size in a further 2 domains. However, all QoL effect sizes following SEP were < +/-0.5. Intergroup differences in effect sizes were >0.5 for the SF36 domains of Physical Function, Physical Role, Emotion Role and SF36 index. SEP resulted in a 0.027 quality adjusted life year (QALY) gain over CMT in the first year post-treatment thus the cost/QALY gained of SEP is pound1780 at 1 year., Conclusions: Compared to CMT, SEP increases walking distances, improves QoL and is a highly cost-effective treatment for IC.

Background: As the number of endovascular interventions increase and resources become scarce, surgeons need to be aware of cost-effective and efficient practice options. Many surgeons routinely admit their patients for overnight observation after uneventful endovascular interventions. Although this may be appropriate for patients with tissue loss and rest pain, we believe that peripheral angioplasty in patients with claudication can be safely performed as an outpatient procedure with significant cost savings., Methods: All patients with intermittent claudication undergoing peripheral angioplasty by a single vascular surgeon were enrolled prospectively in a same-day discharge protocol. Involved arteries and use of stent and closure device were recorded. Time to mobilization and time to discharge were determined. Patients were observed in an observation unit by a registered nurse, and were examined by the surgeon at the time of ambulation and before discharge. Patients were admitted to the hospital if complications arose during the predetermined observation period. Periprocedural complications and reasons for admission were noted. Patients were evaluated at 1 week, 6 weeks, and 3 to 6 months after the intervention., Results: During 27 months, 112 interventions were performed in 97 patients. The superficial femoral artery was the most frequent site of intervention (47%). Multiple sites had angioplasty in 27 (24%) procedures. Nine (8%) procedures resulted in admission. One patient was admitted for a major puncture site hematoma requiring blood transfusion, two patients for observation of a minor hematoma at the puncture site, one for chest pain, and one for observation of transient bradycardia. The mean time to mobilization was 1.4 +/- 1.3 hours, and the mean time to discharge was 2.8 +/- 1.2 hours. The average postprocedural cost for patients undergoing same-day discharge was $320 per patient, which contrasts with $1800 for routine overnight observation. No deaths or unplanned admissions to the hospital occurred < or =30 days of intervention., Conclusions: Same-day discharge after peripheral angioplasty is safe and cost-effective. Need for admission is evident within 2 hours. Routine admission after peripheral angioplasty for patients with claudication is unnecessary and should no longer be the standard of care.

Exercise rehabilitation is a proven, yet poorly available, treatment for intermittent claudication, the primary symptom of peripheral arterial disease (PAD). Exercise rehabilitation is effective, non-invasive, and associated with minimal cardiovascular risk in appropriate patients. Percutaneous transluminal angioplasty (PTA), especially of the iliac segment, is an alternative effective treatment for claudication. There are, however, minimal data currently available to compare the cost-effectiveness of these two interventions. We compared the cost-effectiveness of 3- and 6-month exercise programs with that of iliac PTA without stenting, using the incremental cost-effectiveness ratio [ICER = (Cost2 - Cost1)/(Effectiveness2 - Effectiveness1)]. The ICER represented the price of an additional meter walked derived from each treatment based on conservative models of success of each procedure and specific care assumptions. PTA and exercise efficacy data were derived from a literature review and exercise costs were modeled per the current CPT code 93668. Effectiveness was defined as absolute claudication distance (ACD) at 3 and 6 months. Three treatment alternatives were assessed: (1) no treatment, (2) PTA, and (3) exercise rehabilitation. At 3 months, PTA was more effective than exercise therapy and resulted in an additional 38 meters at an additional cost of $6719, for an ICER of $177/meter. At 6 months, however, exercise was more effective than PTA, resulting in an additional 137 meters walked, and costs less ($61 less per meter gained). In conclusion, exercise rehabilitation at 6 months is more effective and costs less than PTA, and is therefore cost-saving. The cost-effectiveness and availability of claudication treatments has national implications for future PAD care; however, data to inform these care choices can best be obtained in prospective clinical trials.

Aim: The aim of this study was to provide cost-description and cost-effectiveness of a short-course intensive in-hospital rehabilitation program in patients with intermittent claudication., Methods: Costs per case treated were calculated according to a local standard protocol including diagnostic evaluation of peripheral arterial disease and other related cardiovascular conditions, physical training, and secondary prevention. Three additional less structured scenarios were also evaluated., Results: All 107 enrolled patients (males 91%, mean age 65+/-8 years) completed the program (4-week duration; twice a day walking exercise) and showed significant increases in walking performance, as evaluated by constant treadmill-test. At admission, the mean values of initial claudication distance (ICD) and absolute claudication distance (ACD) were 150+/-111 and 432+/-327 m, respectively. At the end of the program, 12 (11%) patients completed the treadmill test without pain, while 31 (29%) completed the test without stopping due to maximal pain. Among the remaining 64 (60%) patients, the ICD and ACD increased by 137% and 112%, respectively. The cost per case treated ranged from Euro 1733.2 (standard protocol) to Euro 918.9 (physical training only). By adding the cost of hospitalization and indirect costs, the same costs ranged from Euro 4626.2 to Euro 3811.9. The average cost to walk one additional meter without pain as a result of the rehabilitation program was Euro 57.5, while the cost to walk one additional meter before stopping was Euro 27. As showed by sensitivity analysis, the maintenance of the expected level of treatment success was crucial for program's cost-effectiveness., Conclusion: From the societal viewpoint, short-course intensive rehabilitation may be cost-effective in patients with stable intermittent claudication and could be considered in decision models evaluating different therapeutic options.

Purpose: To determine the costs, sensitivity for detection of significant stenoses, and proportion of equivocal multi-detector row computed tomographic (CT) angiography results in the work-up of patients with intermittent claudication that would make this imaging examination cost-effective compared with gadolinium-enhanced magnetic resonance (MR) angiography., Materials and Methods: A decision model was used to compare the societal cost-effectiveness of a new imaging modality with that of gadolinium-enhanced MR angiography. Main outcome measures were quality-adjusted life years (QALYs) and lifetime costs. By using threshold analysis of a given willingness to pay per QALY, target values for costs, sensitivity for detection of significant stenoses, and proportion of cases requiring additional work-up with intraarterial digital subtraction angiography owing to equivocal results of the new modality were determined. The base case evaluated was that of 60-year-old men with severe intermittent claudication and assumed an incremental cost-effectiveness threshold of 100,000 US dollars per QALY., Results: If treatment were limited to angioplasty, a new imaging modality would be cost-effective if the costs were 300 US dollars and the sensitivity was 85%, even if up to 35% of patients needed additional work-up. When both angioplasty and bypass surgery were considered as treatment options, a new imaging modality was cost-effective if the costs were 300 US dollars, the sensitivity was higher than 94%, and 20% of patients required additional work-up., Conclusion: Multi-detector row CT angiography, as compared with currently used imaging modalities such as MR angiography, has the potential to be cost-effective in the evaluation of patients with intermittent claudication.