Cost-effectiveness of breech version by acupuncture-type interventions on BL 67, including moxibustion, for women with a breech foetus at 33 weeks gestation: a modelling approach.

OBJECTIVES: To assess, using a modelling approach, the effectiveness and costs of breech version with acupuncture-type interventions on BL67 (BVA-T), including moxibustion, compared to expectant management for women with a foetal breech presentation at 33 weeks gestation. DESIGN: A decision tree was developed to predict the number of caesarean sections prevented by BVA-T compared to expectant management to rectify breech presentation. The model accounted for external cephalic versions (ECV), treatment compliance, and costs for 10,000 simulated breech presentations at 33 weeks gestational age. Event rates were taken from Dutch population data and the international literature, and the relative effectiveness of BVA-T was based on a specific meta-analysis. Sensitivity analyses were conducted to evaluate the robustness of the results. MAIN OUTCOME MEASURES: We calculated percentages of breech presentations at term, caesarean sections, and costs from the third-party payer perspective. Odds ratios (OR) and cost differences of BVA-T versus expectant management were calculated. (Probabilistic) sensitivity analysis and expected value of perfect information analysis were performed. RESULTS: The simulated outcomes demonstrated 32% breech presentations after BVA-T versus 53% with expectant management (OR 0.61, 95% CI 0.43, 0.83). The percentage caesarean section was 37% after BVA-T versus 50% with expectant management (OR 0.73, 95% CI 0.59, 0.88). The mean cost-savings per woman was euro 451 (95% CI euro 109, euro 775; p=0.005) using moxibustion. Sensitivity analysis showed that if 16% or more of women offered moxibustion complied, it was more effective and less costly than expectant management. To prevent one caesarean section, 7 women had to use BVA-T. The expected value of perfect information from further research was euro0.32 per woman. CONCLUSIONS: The results suggest that offering BVA-T to women with a breech foetus at 33 weeks gestation reduces the number of breech presentations at term, thus reducing the number of caesarean sections, and is cost-effective compared to expectant management, including external cephalic version.

Hepatocellular adenoma: cost-effectiveness of different treatment strategies.

PURPOSE: To determine the effectiveness, costs, and cost-effectiveness of strategies for the management of hepatocellular adenoma (HA) in women who are otherwise healthy. MATERIALS AND METHODS: A Markov model was developed to estimate the quality-adjusted life expectancy (in quality-adjusted life-years [QALYs]), lifetime costs (in 2007 U.S. dollars), and net health benefits (QALY equivalent) of surgery, transarterial embolization (TAE), radiofrequency ablation (RFA), and watchful waiting. Model parameters and their distributions were derived from the literature and the hospital database. RESULTS: In patients with HA tumors suitable for RFA, RFA had the highest effectiveness (23.89 QALYs) and lowest costs ($2965). The treatment decision was sensitive to RFA-related mortality. In patients with tumors unsuitable for RFA, watchful waiting combined with TAE in cases of hemorrhage had the highest effectiveness (23.83 QALYs) and lowest costs ($8493). The treatment decision was sensitive to probability of tumor growth, probability of hemorrhage, and hemorrhage-related mortality. CONCLUSION: According to the model results, the most favorable treatment strategy for patients with small HAs was RFA. In patients with HA unsuitable for RFA, watchful waiting was the optimal strategy.

Prediction of 30-day mortality after endovascular repair or open surgery in patients with ruptured abdominal aortic aneurysms.

OBJECTIVE: To validate the Glasgow Aneurysm Score (GAS) in patients with ruptured abdominal aortic aneurysms (AAAs) treated with endovascular repair or open surgery and to update the GAS so that it predicts 30-day mortality for patients with ruptured AAA treated with endovascular repair or open surgery. METHODS: In a multicenter prospective observational study, 233 consecutive patients with ruptured AAAs were evaluated; 32 patients did not survive to repair and statistical analysis was performed using collected data on 201 patients. All patients who were treated with endovascular repair (n = 58) or open surgery (n = 143) were included. The GAS was calculated for each patient. The area under the receiver operating characteristics curve (AUC) was used to indicate discriminative ability. We tested for interactions between risk factors and the procedure performed. The GAS was updated to predict 30-day mortality after endovascular repair or open surgery in patients with ruptured AAAs using logistic regression analysis. RESULTS: Thirty-day mortality was 15/58 (26%) for patients treated with endovascular repair and 57/143 (40%) for patients treated with open surgery (P = .06). The AUC for GAS was 0.69. No relevant interactions were found. The updated prediction rule (AUC = 0.70) can be calculated with the following formula: + 7 for open surgery + age in years + 17 for shock + 7 for myocardial disease + 10 for cerebrovascular disease + 14 for renal insufficiency. CONCLUSION: We showed limited discriminative ability of the GAS and therefore updated the GAS by adding the type of procedure performed. This updated prediction rule predicts 30-day mortality for patients with ruptured AAAs treated with endovascular repair or open surgery.

Invasive treatment of claudication is indicated for patients unable to adequately ambulate during cardiac rehabilitation.

BACKGROUND: Cardiac rehabilitation (CR) is of proven benefit for patients with coronary artery disease. Patients who successfully complete CR have a statistically significant reduction in the risk of fatal myocardial infarction (MI) and all-cause mortality. Peripheral arterial disease (PAD) is common in patients with coronary artery disease. OBJECTIVES: We investigated whether PAD prevents the successful completion of CR and cardiac risk reduction and whether invasive treatment of claudicant patients who cannot walk sufficiently to successfully complete CR is indicated. METHODS: The records of 230 consecutive CR patients were reviewed for attendance, target heart rate, and Walking Impairment Questionnaire (WIQ) values to compare PAD among successes and failures. Failure of CR was defined as inability to walk sufficiently to achieve target heart rate. Markov decision analysis using published data for endovascular and open intervention for claudication was used to compare outcomes of treatment strategies in which PAD is untreated (current standard), PAD is treated only if it interfered with CR, and treatment of PAD in all patients before initiating CR. RESULTS: Of 230 patients, 126 had complete records for analysis. Ankle-brachial indices (ABIs) were documented for 39 patients. Overall, 40% of patients failed CR. Failure was significantly more common in patients with claudication (76%) than in those without (26%; odds ratio [OR], 8.9; 95% confidence interval [CI], 3.7-21.7; P < .001). The presence of PAD, determined by the WIQ walking distance score, was significantly higher in the failure group (34%) vs the success group (17%; OR, 2.5; 95% CI, 1.1-6.0; P = .03). The presence of PAD, determined by ABI, was higher in the failure group (39%) vs the success group (14%; OR, 3.8; 95% CI, 0.8-17.9; P = .08). Logistic regression analysis when CR failure was adjusted for age and gender was significantly associated with presence of PAD based on WIQ walking distance score (OR, 2.8; 95% CI 1.1-7.1; P = .03). A strategy of invasive therapy only if PAD interfered with the successful completion of CR would save an additional 54 lives per 10,000 patients compared with no intervention. CONCLUSIONS: PAD is a significant cause of CR failure, preventing patients from successfully completing the program and achieving a reduction in risk of fatal cardiac events. Invasive treatment of PAD in patients who fail CR is indicated, with an expected lifesaving outcome.

Cost-effectiveness of new cardiac and vascular rehabilitation strategies for patients with coronary artery disease.

OBJECTIVE: Peripheral arterial disease (PAD) often hinders the cardiac rehabilitation program. The aim of this study was evaluating the relative cost-effectiveness of new rehabilitation strategies which include the diagnosis and treatment of PAD in patients with coronary artery disease (CAD) undergoing cardiac rehabilitation. DATA SOURCES: Best-available evidence was retrieved from literature and combined with primary data from 231 patients. METHODS: We developed a markov decision model to compare the following treatment strategies: 1. cardiac rehabilitation only; 2. ankle-brachial index (ABI) if cardiac rehabilitation fails followed by diagnostic work-up and revascularization for PAD if needed; 3. ABI prior to cardiac rehabilitation followed by diagnostic work-up and revascularization for PAD if needed. Quality-adjusted-life years (QALYs), life-time costs (US $), incremental cost-effectiveness ratios (ICER), and gain in net health benefits (NHB) in QALY equivalents were calculated. A threshold willingness-to-pay of $75,000 was used. RESULTS: ABI if cardiac rehabilitation fails was the most favorable strategy with an ICER of $44,251 per QALY gained and an incremental NHB compared to cardiac rehabilitation only of 0.03 QALYs (95% CI: -0.17, 0.29) at a threshold willingness-to-pay of $75,000/QALY. After sensitivity analysis, a combined cardiac and vascular rehabilitation program increased the success rate and would dominate the other two strategies with total lifetime costs of $30,246 a quality-adjusted life expectancy of 3.84 years, and an incremental NHB of 0.06 QALYs (95%CI:-0.24, 0.46) compared to current practice. The results were robust for other different input parameters. CONCLUSION: ABI measurement if cardiac rehabilitation fails followed by a diagnostic work-up and revascularization for PAD if needed are potentially cost-effective compared to cardiac rehabilitation only.

Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: a randomized controlled trial.

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.

Impact of claudication and its treatment on quality of life.

Improvement in quality of life is the ultimate goal of healthcare for the treatment of intermittent claudication. Until recently, the measures of success after therapy were those derived from the vascular laboratory, including ankle-brachial indices and ankle and toe pressures. There are now several validated and reliable survey tools that can assess patient-reported quality of life in a generic or disease-specific manner. Major survey instruments are reviewed. The information gathered through these quality-of-life assessment tools is important to all those involved in the care of patients with peripheral arterial disease. Although claudication is neither life- nor limb-threatening, it has a significant negative impact on quality of life, as measured by these instruments. Patients so afflicted report more bodily pain, worse physical function, and worse perceived health, in addition to limited walking ability. These measures of quality of life do not correlate with standard parameters of ankle-brachial index or ankle pressures. Treatment of the claudicant with exercise therapy and percutaneous or open revascularization also impacts quality of life. Each of these modalities is capable of improving quality of life, but some are associated with decline over time. The major benefits and risks to quality of life of these specific forms of treatment for the claudicant are reviewed. This data demonstrates that patients suffering from symptoms of intermittent claudication are best served by therapies that address their major self-reported impediments to quality of life.

Cost-effectiveness of the unrestricted use of sirolimus-eluting stents vs. bare metal stents at 1 and 2-year follow-up: results from the RESEARCH Registry.

AIMS: To assess the cost-effectiveness of sirolimus-eluting stents (SESs) compared with bare metal stents (BMSs) as the default strategy in unselected patients treated in the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) Registry at 1 and 2-years following the procedure. METHODS AND RESULTS: A total of 508 consecutive patients with de novo lesions exclusively treated with SES were compared with 450 patients treated with BMS from the immediate preceding period. Resource use and costs of the index procedure, and clinical outcomes were prospectively recorded over a 2-year follow-up period. Follow-up costs were measured as unit costs per patient based on the incidence of clinically driven target vessel revascularization (TVR), to obtain cumulative costs at 1 and 2-years. Cost-effectiveness was measured as the incremental cost-effectiveness ratio (ICER) per TVR avoided. The use of SES cost euro 3,036 more per patient at the index procedure, driven by the price of SES. Follow-up costs after 1-year were euro 1,089 less with SES when compared with BMS, due to less TVR, resulting in a net excess cost of euro 1,968 per patient in the SES group, and reduced by a further euro 100 per patient in the second year. The incidence of death or myocardial infarction between groups was similar at 1 and 2 years. Rates of TVR in the SES and BMS groups were 3.7% vs. 10.4%, P<0.01 at 1 year, respectively; and 6.4% vs. 14.7%, P<0.001 at 2 years. The ICER per TVR avoided was euro 29,373 at 1 year, and euro 22,267 at 2 years. CONCLUSION: The use of SES, while significantly beneficial in reducing the need for repeat revascularization, was more expensive and not cost-effective in the RESEARCH registry at either 1 or 2-years when compared with BMS. On the basis of these results, in an unselected population with 1 year of follow-up, the unit price of SES would have to be euro 1,023 in order to be cost-neutral.

Acute abdominal aortic aneurysms: cost analysis of endovascular repair and open surgery in hemodynamically stable patients with 1-year follow-up.

PURPOSE: To retrospectively assess the in-hospital and 1-year follow-up costs of endovascular aneurysm repair and conventional open surgery in patients with acute infrarenal abdominal aortic aneurysm (AAA) by using a resource-use approach. MATERIALS AND METHODS: Institutional Review Board approval was obtained, and informed consent was waived. In-hospital costs for all consecutive patients (61 men, six women; mean age, 72.0 years) who underwent endovascular repair (n = 32) or open surgery (n = 35) for acute infrarenal AAA from January 1, 2001, to December 31, 2004, were assessed by using a resource-use approach. Patients who did not undergo computed tomography before the procedure were excluded from analysis. One-year follow-up costs were complete for 30 patients who underwent endovascular repair and for 34 patients who underwent open surgery. Costs were assessed from a health care perspective. Mean costs were calculated for each treatment group and were compared by using the Mann-Whitney U test (alpha = .05). The influence of clinical variables on the total in-hospital cost was investigated by using univariate and multivariate analyses. Costs were expressed in euros for the year 2003. RESULTS: Sex, age, and comorbidity did not differ between treatment groups (P > .05). The mean total in-hospital costs were lower for patients who underwent endovascular repair than for those who underwent open surgery (euro20 767 vs euro35 470, respectively; P = .004). The total costs, including those for 1-year follow-up, were euro23 588 for patients who underwent endovascular repair and euro36 448 for those who underwent open surgery (P = .05). The results of multivariate analysis indicated that complications had a significant influence on total in-hospital cost; patients who had complications incurred total in-hospital costs that were 2.27 times higher than those for patients who had no complications. CONCLUSION: Total in-hospital costs and total overall costs, which included 1-year follow-up costs, were lower in patients with acute AAA who underwent endovascular repair than in those who underwent open surgery.

A cost-effectiveness analysis of a hypothetical catheter-based strategy for the detection and treatment of vulnerable coronary plaques with drug-eluting stents.

AIM: Extensive efforts are underway to develop methods for the detection and treatment of vulnerable/high-risk coronary artery plaques. We utilized decision analysis to evaluate the hypothetical clinical benefits and cost-effectiveness of a catheter-based strategy. METHODS AND RESULTS: Currently, stenotic coronary plaques are treated without regard to vulnerability. In a new strategy, vulnerable coronary plaques are detected with a catheter-based test and treated with a drug-eluting stent, regardless of degree of stenosis. A Markov-decision model was developed to compare the new strategy with current practice. Monte Carlo simulations were performed from a societal perspective, costs were converted to year 2003 U.S. dollars, and future costs and outcomes were discounted at 3%. Sensitivity analyses were performed to evaluate the effect of assumptions on variables such as the prevalence of vulnerable plaques and treatment effect. In 60-year-old male patients with coronary stenoses the new strategy would be less expensive and more effective than current practice (37,045 dollars vs 38,257 dollars and 10.23 vs 9.86 quality-adjusted life years (QALYs), respectively). The benefits of the new strategy were robust in sensitivity analyses (e.g., if the prevalence of vulnerable plaques in this patient group was 50% or more and the sensitivity and specificity of the new test were at least 0.80). CONCLUSION: In selected patients with coronary artery stenosis, the detection of vulnerable plaques with a catheter-based test followed by their treatment with a drug-eluting stent could be a less expensive and more effective strategy than current practice. If applied to 1 million such patients in the United States undergoing catheterization, the new strategy would add 370,000 QALYs and save 1.2 billion dollars per year.

Cost-effectiveness of uterine artery embolization and hysterectomy for uterine fibroids.

PURPOSE: To compare the cost-effectiveness of uterine artery embolization (UAE) with that of hysterectomy for women with symptomatic uterine fibroids. MATERIALS AND METHODS: The authors developed a decision model to compare the costs and effectiveness of UAE and hysterectomy. In the model, a cohort of women aged 40 years with a diagnosis of uterine fibroids and no desire for future pregnancy was followed up until menopause. The analysis was performed from a societal perspective, including all costs and effects, regardless of who incurs them. Transition probability and quality-of-life estimates were obtained from the literature and a gynecologist, whereas costs (in 1999 U.S. dollars) were estimated by using rates of Medicare reimbursement for hospital costs and physician fees. Sensitivity analyses of key estimates were performed. Results were expressed in costs per quality-adjusted life-year (QALY). RESULTS: UAE was more effective (8.29 vs 8.18 QALYs) and less expensive (US dollars 6916 vs US dollars 7847) than hysterectomy. Cost-effectiveness results, with the exception of quality-of-life data, were robust to changes in most model assumptions. When the quality-of-life adjustment was eliminated, the two procedures were equally effective. CONCLUSION: UAE is a cost-effective alternative to hysterectomy across a wide range of assumptions about the costs and effectiveness of the two procedures. However, the study results were sensitive to changes in quality-of-life values.

Abdominal aortic aneurysms: cost-effectiveness of elective endovascular and open surgical repair.

PURPOSE: To evaluate the cost-effectiveness of elective endovascular and open surgical repair of infrarenal abdominal aortic aneurysms (AAAs) by taking into account short- and long-term outcomes. MATERIALS AND METHODS: A Markov decision model was developed to evaluate quality-adjusted life-years (QALYs) and lifetime costs of endovascular and open surgical repair. The incremental cost-effectiveness ratio (CER) was calculated for endovascular repair relative to open surgery in a cohort of 70-year-old men with an AAA between 5 and 6 cm in diameter. Clinically effectiveness data were derived from the literature. Cost data were derived from Medicare reimbursement rates, the hospital database, and the literature. One- and multiple-way sensitivity analyses were performed on uncertain model parameters. Costs were converted to year 2000 U.S. dollars; future costs and outcomes were discounted at 3%. RESULTS: The incremental CER of endovascular repair was 9,905 dollars per QALY. QALYs and lifetime costs were higher for endovascular repair than for open surgery (6.74 vs 6.52 and 39,785 dollars vs 37,606 dollars, respectively). In sensitivity analyses, the incremental CER was insensitive to immediate conversion rate and procedure mortality rate. The incremental CER was sensitive (ie, more than 75,000 dollars per QALY or endovascular repair was ruled out by dominance) to systemic-remote complications, long-term failures, and ruptures. CONCLUSION: The results suggest that endovascular repair is a cost-effective alternative compared with open surgery for the elective repair of AAA. The benefits and cost-effectiveness are highly dependent on uncertain outcomes, however, particularly long-term failure and rupture rates.

Hospital costs of uterine artery embolization and hysterectomy for uterine fibroid tumors.

RATIONALE AND OBJECTIVES: The purpose of this study was to compare the total actual hospital costs of uterine artery embolization (UAE) and hysterectomy for treatment of uterine fibroid tumors and to evaluate factors that might influence cost. MATERIALS AND METHODS: Total actual hospital costs were collected from the institution's cost accounting system on patients who underwent UAE (n = 57) or hysterectomy (n = 300) for uterine fibroids between 1998 and 2001. Electronic medical records were reviewed to collect clinical information. Standard statistical techniques were used to determine which factors influenced hospital costs. RESULTS: The mean total actual hospital costs of UAE were significantly higher than hysterectomy ($8,223 vs $6,046, P < .0001), but the mean length of stay was shorter (0.95 vs 2.6 days, P < .0001). In linear regression analyses, complications were predictive of increased costs of UAE; length of stay, complications, and laparoscopic hysterectomy were predictive of increased costs of hysterectomy. CONCLUSION: Hospital costs of UAE were higher than hysterectomy for the treatment of uterine fibroids, but the hospital stays were shorter.

Comparison of preference-based utilities of the Short-Form 36 Health Survey and Health Utilities Index before and after treatment of patients with intermittent claudication.

The authors compared SF-36 utilities with Health Utilities Index (HUI) utilities (HUI2 and HUI3) assessed in patients with intermittent claudication. A total of 87 patients with intermittent claudication completed the SF-36 and HUI before and 1, 3, and 12 months after revascularization. Utilities were estimated using SF-36 and HUI published algorithms (i.e., both algorithms were based on standard-gamble utilities assessed in random samples of the general population). The utilities were compared using repeated-measures multivariate analysis of variance, paired t tests, and univariate linear regression analyses. Before treatment, the mean SF-36 and HUI3 utilities were the same (0.66 vs. 0.66, P = 0.92) and less than the mean HUI2 utility (0.70, P = 0.02). After treatment, all utilities showed improvement from before treatment (P < 0.05); the gain in utilities from treatment was lowest when using the SF-36 (e.g., 0.74, 0.80, 0.77 at 3 months for the SF-36, HUI2, and HUI3, respectively). The correlations of changes over time of the SF-36 with HUI2 utilities and of the SF-36 with HUI3 utilities were 0.39 and 0.49, respectively. The relationships between the SF-36 and HUI2 or HUI3 utilities were moderate to good (i.e., range-adjusted R2 = 31% to 72%). The results suggest that SF-36 data can be transformed to preference-based utilities and be used for economic evaluation in health care. The gain in utilities from treatment, however, was less for SF-36 utilities than for HUI utilities.