Bacillamide D produced by Bacillus cereus from the mouse intestinal bacterial collection (miBC) is a potent cytotoxin in vitro.

The gut microbiota influences human health and the development of chronic diseases. However, our understanding of potentially protective or harmful microbe-host interactions at the molecular level is still in its infancy. To gain further insights into the hidden gut metabolome and its impact, we identified a cryptic non-ribosomal peptide BGC in the genome of Bacillus cereus DSM 28590 from the mouse intestine ( www.dsmz.de/miBC ), which was predicted to encode a thiazol(in)e substructure. Cloning and heterologous expression of this BGC revealed that it produces bacillamide D. In-depth functional evaluation showed potent cytotoxicity and inhibition of cell migration using the human cell lines HCT116 and HEK293, which was validated using primary mouse organoids. This work establishes the bacillamides as selective cytotoxins from a bacterial gut isolate that affect mammalian cells. Our targeted structure-function-predictive approach is demonstrated to be a streamlined method to discover deleterious gut microbial metabolites with potential effects on human health.

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.

Intermittent claudication: clinical effectiveness of endovascular revascularization versus supervised hospital-based exercise training--randomized controlled trial.

PURPOSE: To compare clinical success, functional capacity, and quality of life during 12 months after revascularization or supervised exercise training in patients with intermittent claudication. MATERIALS AND METHODS: This study had institutional review board approval, and all patients gave written informed consent. Between September 2002 and September 2005, 151 consecutive patients who presented with symptoms of intermittent claudication were randomly assigned to undergo either endovascular revascularization (angioplasty-first approach) (n = 76) or hospital-based supervised exercise (n = 75). The outcome measures were clinical success, functional capacity, and quality of life after 6 and 12 months. Clinical success was defined as improvement in at least one category in the Rutherford scale above the pretreatment level. Significance of differences between the groups was assessed with the unpaired t test, chi(2) test, or Mann-Whitney U test. To adjust outcomes for imbalances of baseline values, multivariable regression analysis was performed. RESULTS: Immediately after the start of treatment, patients who underwent revascularization improved more than patients who performed exercise in terms of clinical success (adjusted odds ratio [OR], 39; 99% confidence interval [CI]: 11, 131; P < .001), but this advantage was lost after 6 (adjusted OR, 0.9; 99% CI: 0.3, 2.3; P = .70) and 12 (adjusted OR, 1.1; 99% CI: 0.5, 2.8; P = .73) months. After revascularization, fewer patients showed signs of ipsilateral symptoms at 6 months compared with patients in the exercise group (adjusted OR, 0.4; 99% CI: 0.2, 0.9; P < .001), but no significant differences were demonstrated at 12 months. After both treatments, functional capacity and quality of life scores increased after 6 and 12 months, but no significant differences between the groups were demonstrated. CONCLUSION: After 6 and 12 months, patients with intermittent claudication benefited equally from either endovascular revascularization or supervised exercise. Improvement was, however, more immediate after revascularization.

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.

Effectiveness of acupuncture-type interventions versus expectant management to correct breech presentation: a systematic review.

OBJECTIVE: A systematic review of studies assessing the effectiveness of acupuncture-type interventions (moxibustion, acupuncture, or electro-acupuncture) on acupuncture point BL 67 to correct breech presentation compared to expectant management, based on controlled trials. DATA SOURCES: Articles published from 1980 to May 2007 in databases of Medline, EMBASE, the Cochrane Central Register of Controlled Trials, AMED, NCCAM, Midirs and reference lists. STUDY SELECTION: Studies included were original articles; randomised controlled trials (RCT) or controlled cohort studies; acupuncture-type intervention on BL 67 compared with expectant management; ultrasound confirmed breech presentation and position of the fetus after treatment confirmed with ultrasound, position at delivery, and/or the proportion of caesarean sections reported. DATA EXTRACTION: Three reviewers independently extracted data. Disagreements were resolved by consensus. DATA SYNTHESIS: Of 65 retrieved citations, six RCT's and three cohort studies fulfilled the inclusion criteria. Data were pooled using random-effects models. In the RCT's the pooled proportion of breech presentations was 34% (95% CI: 20-49%) following treatment versus 66% (95% CI: 55-77%) in the control group (OR 0.25 95% CI: 0.11-0.58). The pooled proportion in the cohort studies was 15% (95% CI: 1-28%) versus 36% (95% CI: 14-58%), (OR 0.29, 95% CI: 0.19-0.43). Including all studies the pooled proportion was 28% (95% CI: 16-40%) versus 56% (95% CI: 43-70%) (OR 0.27, 95% CI: 0.15-0.46). CONCLUSIONS: Our results suggest that acupuncture-type interventions on BL 67 are effective in correcting breech presentation compared to expectant management. Some studies were of inferior quality to others and further RCT's of improved quality are necessary to adequately answer the research question.

Preference-based quality of life of patients on renal replacement therapy: a systematic review and meta-analysis.

OBJECTIVES: Various utility measures have been used to assess preference-based quality of life of patients with end-stage renal disease (ESRD). The purposes of this study were to summarize the literature on utilities of hemodialysis (HD), peritoneal dialysis (PD), and renal transplantation (RTx) patients, to compare utilities between these patient groups, and to obtain estimates for quality-of-life adjustment in economic analyses. METHODS: We searched the English literature for studies that reported visual analog scale (VAS), time trade-off (TTO), standard gamble (SG), EuroQol-5D (EQ-5D), and health utilities index (HUI) values of ESRD patients. We extracted patient characteristics and utilities and calculated mean utilities and 95% confidence intervals (CIs) for categories defined by utility measure and treatment modality using random-effects models. RESULTS: We identified 27 articles that met the inclusion criteria. VAS articles were too heterogeneous to summarize quantitatively and we found only one study reporting HUI values. Thus, we summarized utilities from TTO, SG, and EQ-5D studies. Mean TTO and EQ-5D-index values were lower for dialysis compared to RTx patients, though not statistically significant for TTO values (TTO values: HD 0.61, 95% CI 0.54-0.68; PD 0.73, 95% CI 0.61-0.85; RTx 0.78, 95% CI 0.63-0.93; EQ-5D-index values: HD 0.56, 95% CI 0.49-0.62; PD 0.58, 95% CI 0.50-0.67; RTx 0.81, 95% CI 0.72-0.90). Mean HD versus PD associated TTO, EQ-5D-index and EQ-VAS values were not statistically significantly different. CONCLUSION: RTx patients tended to have a higher utility than dialysis patients. Among HD and PD patients, there were no statistically significant differences in utility.

Ruptured abdominal aortic aneurysms: endovascular repair versus open surgery--systematic review.

PURPOSE: To perform a systematic review of studies in which endovascular repair was compared with open surgery in the treatment of patients with a ruptured abdominal aortic aneurysm (AAA). MATERIALS AND METHODS: A search of the English-language literature from January 1994 until March 2006 was performed. Inclusion criteria for studies were that they were about a comparison between patients who underwent endovascular repair and patients who underwent open surgery, that each treatment group included at least five patients, that information about patients' hemodynamic condition at presentation was reported, and that 30-day mortality was reported for each treatment group. Two reviewers independently extracted the data, and discrepancies were resolved by an arbiter. Random-effects models and meta-regression analysis were used to calculate crude and adjusted odds ratios (ORs) for endovascular repair versus open surgery. RESULTS: Ten studies, in which the results of 478 procedures (n=148 for endovascular repair, n=330 for open surgery) were reported, met the inclusion criteria. All studies were observational; no randomized controlled trials were found. The pooled 30-day mortality was 22% (95% confidence interval [CI]: 16%, 29%) for endovascular repair and 38% (95% CI: 32%, 45%) for open surgery. The pooled rate for total systemic complications was 28% (95% CI: 17%, 48%) for endovascular repair and 56% (95% CI: 37%, 85%) for open surgery. The crude OR for 30-day mortality for endovascular repair compared with open surgery was 0.45 (95% CI: 0.28, 0.72). After adjustment for patients' hemodynamic condition, the OR was 0.67 (95% CI: 0.31, 1.44). CONCLUSION: In this systematic review, after adjustment for patients' hemodynamic condition at presentation, a benefit in 30-day mortality for endovascular repair compared with open surgery for patients with a ruptured AAA was observed, but it was not statistically significant.

Quality of life assessed with the Medical Outcomes Study Short Form 36-Item Health Survey of patients on renal replacement therapy: a systematic review and meta-analysis.

OBJECTIVES: The Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) is the most widely used generic instrument to estimate quality of life of patients on renal replacement therapy. Purpose of this study was to summarize and compare the published literature on quality of life of hemodialysis (HD), peritoneal dialysis (PD), and renal transplant (RTx) patients. METHODS: We used random-effects regression analyses to compare the SF-36 scores across treatment groups and adjusted this comparison for age and prevalence of diabetes using random-effects meta-regression analyses. RESULTS: We found 52 articles that met the inclusion criteria, reporting quality of life of 36,582 patients. The unadjusted scores of all SF-36 health dimensions were not significantly different between HD and PD patients, but the scores of RTx patients were higher than those of dialysis patients, except for the dimensions Mental Health and Bodily Pain. Point differences between dialysis and RTx patients varied from 2 to 32. With adjustment for age and diabetes, the differences became smaller (point difference 2-22). The significance of the differences of both dialysis groups compared with RTx recipients disappeared for the dimensions Vitality and Social Functioning. The significance of the differences between HD and RTx patients disappeared on the dimensions Physical Functioning, Role Physical, and Bodily Pain. CONCLUSION: We conclude that dialysis patients have a lower quality of life than RTx patients, but this difference can partly be explained by differences in age and prevalence of diabetes.

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.

Endovascular repair versus open surgery in patients with ruptured abdominal aortic aneurysms: clinical outcomes with 1-year follow-up.

OBJECTIVE: To compare the clinical outcomes of treatment after endovascular repair and open surgery in patients with ruptured infrarenal abdominal aortic aneurysms (AAAs), including 1-year follow-up. METHODS: All consecutive conscious patients with ruptured infrarenal AAAs who presented to our tertiary care teaching hospital between January 1, 2001, and December 31, 2005, were included in this study (n = 55). Twenty-six patients underwent endovascular repair, and 29 patients underwent open surgery. Patients who were hemodynamically too unstable to undergo a computed tomography angiography scan were excluded. Outcomes evaluated were intraoperative mortality, 30-day mortality, systemic complications, complications necessitating surgical intervention, and mortality and complications during 1-year follow-up. The statistical tests we used were the Student t test, chi2 test, Fisher exact test, and Mann-Whitney U test (two sided; alpha = .05). RESULTS: Thirty-day mortality was 8 (31%) of 26 patients who underwent endovascular repair and 9 (31%) of 29 patients who underwent open surgery (P = .98). Systemic complications and complications necessitating surgical intervention during the initial hospital stay were similar in both treatment groups (8/26 [31%] and 5/26 [19%] for endovascular repair, respectively, and 9/29 [31%] and 8/29 [28%] for open surgery, respectively; P > .40). During 1-year follow-up, two patients initially treated with endovascular repair died as a result of non-aneurysm-related causes; no death occurred in the open surgery group. Complications during 1-year follow-up were 1 (5%) of 20 for endovascular repair and 4 (16%) of 25 for open surgery (P = .36). CONCLUSIONS: On the basis of our study with a highly selected population, the mortality and complication rates after endovascular repair may be similar compared with those after open surgery in patients treated for ruptured infrarenal AAAs.

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.

Embolic protection filters for carotid stenting: differences in flow obstruction depending on filter construction.

PURPOSE: To investigate the pressure gradient and degree of flow reduction associated with embolus protection filters for carotid stenting in an in vitro experiment. METHODS: Three filter devices with a perforated membrane design and one wire mesh type filter were tested. At a pressure of 70 mmHg, the flow reduction and pressure gradient were measured in a 5-mm tube using blood-mimicking fluid. RESULTS: The pressure gradient in the wire mesh filter was 1.65+/-0.49 mmHg (95% CI 1.32 to 1.86). The mean pressure gradient in the perforated membrane filters was 6.88+/-2.62 mmHg (95% CI 6.22 to 7.55, p<0.0001). There was also a significant correlation between pressure gradient and flow reduction (r=-0.77, p<0.01). CONCLUSION: Embolic protection filters cause a pressure gradient and obstruct blood flow. This effect is marked in perforated membrane filters and almost absent in the wire mesh filter.

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.

Reporting success rate at 12 months after percutaneous treatment for peripheral arterial disease: the impact of outcome criteria.

OBJECTIVE: The objectives of our study were to assess the influence of varying outcome criteria on the success rate at 12 months after percutaneous intervention for peripheral arterial disease and to suggest a reporting method that can be used in studies that report results of interventions as measured by parameters of daily clinical practice. MATERIALS AND METHODS: The outcomes of 1,411 consecutive procedures in 1,583 limbs recorded in a multicenter registry involving six hospitals were analyzed. Six sets of outcome criteria were evaluated: one based on symptomatic change, three based on ankle-brachial index (ABI) measurements, and two based on combining the symptomatic and ABI outcome measures. Agreement among the outcome measures was compared using the kappa statistic. RESULTS: The ABI outcome measures alone showed good agreement (kappa = 0.74-0.94). The symptomatic outcome measures yielded a substantially higher 12-month success rate than the ABI outcome measures (difference, 18-24%) and the agreement was only fair (kappa = 0.52-0.60). The agreement between symptomatic outcome and ABI outcome measures was poor in patients with a pretreatment ABI measurement at rest of more than 0.90 (kappa = 0.20). Combining symptomatic outcome and the ABI outcome measures with the logical operator "OR" showed good agreement with the symptomatic outcome measures alone (kappa = 0.97) and using "AND" showed good agreement with the ABI outcome measures alone (kappa = 0.87). CONCLUSION: In patients with a pretreatment ABI measurement at rest of more than 0.90, classifying procedures using a criterion based on improvement in ABI measurements with more than 0.10 is inaccurate and underestimates the actual success rate at 12 months after percutaneous intervention. Furthermore, combining subjective improvement in symptoms and improvement in ABI measurements does not yield more information than reporting these outcome measures separately. Therefore, we suggest that improvement in symptoms and improvement in ABI measurements should be reported separately to indicate the 12-month success rate of percutaneous interventions for peripheral arterial disease.

Intermittent claudication: functional capacity and quality of life after exercise training or percutaneous transluminal angioplasty--systematic review.

PURPOSE: To systematically review published data about the short- and long-term effects of exercise training and angioplasty on functional capacity and quality of life of patients with intermittent claudication. MATERIALS AND METHODS: Articles published between January 1980 and February 2003 were included if patients had intermittent claudication treated with exercise training or angioplasty and if both functional capacity and quality-of-life scores from Medical Outcomes Study 36-Item Short Form health survey were reported for at least 3 months of follow-up. Data were pooled by using a random effects model and weighted means. Pooled results were compared between the treatment groups by using the chi2 test and the Student t test (alpha = .05, two sided). RESULTS: In the analyses, five studies (202 patients) were included in the exercise group, and three studies (470 patients), in the angioplasty group. At 3 months of follow-up, the ankle-brachial index was significantly improved in the angioplasty group (mean change, 0.18; P < .01) but not in the exercise group (mean change, 0.01; P = .29). At 3 months, quality of life was significantly improved with regard to ratings of physical functioning and bodily pain in the exercise group (mean change, 18 and 10, respectively; P < .01) and physical role functioning in the angioplasty group (mean change, 30; P = .03). Mean change in ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months (P < .01); mean change in quality-of-life scores did not. CONCLUSION: Improvement in quality of life was demonstrated after both exercise training and angioplasty, whereas functional capacity showed significant improvement after angioplasty. The ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months, whereas the quality-of-life scores did not.