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In pediatric imaging, sedation is often necessary to obtain diagnostic quality imaging. We aim to quantify patient and imaging-specific factors associated with successful pediatric scans without anesthesia and to evaluate labor cost savings associated with our institutional Scan Without Anesthesia Program (SWAP). Patients who participated in SWAP between 2019-2022 were identified. Chart review was conducted to obtain sociodemographic and clinical information. Radiology database was used to obtain scan duration, modality/body part of examination, and administration of contrast. Mann-Whitney U and Chi-Square tests were used for univariate analysis of factors associated with success. Multivariate logistic regression was used to evaluate independent contributions to success. Associated hospital labor cost savings were estimated using salary information obtained through publicly available resources. Of 731 patients, 698 had successful and 33 had unsuccessful scans (95% success rate). In univariate analysis, older age, female sex, absence of developmental delay, and administration of contrast were significantly associated with successful scans. Multivariate analyses revealed that older age, female sex, and absence of developmental delay were significant independent factors lending toward success. Imaging-related factors were not associated with outcome in multivariate analysis. Estimated labor cost savings were $139,367.80 per year for the medical center. SWAP had an overall success rate of 95%. Older age, absence of developmental delay, and female sex were independently significantly associated with successful outcome. Cost analysis reveals substantial labor cost savings to the institution compared with imaging under anesthesia. [ABSTRACT FROM AUTHOR]

In the past, public stakeholders have indicated strong negative preferences in response to some approaches, such as culling, for managing Chronic wasting disease (CWD). We collect data across Canada from the general public and several stakeholder groups and assess their preferences using a paired comparison approach. The results suggest that the public wants action in managing CWD. Members of the general public seem receptive to a number of different types of management approaches for CWD. Specifically, the public seems to support hunters reducing herd sizes, through increased tags and compensation for submitting positive testing CWD heads, and promoting environmental sampling on private land to detect CWD. In contrast, the public seems to dislike using sharpshooters to cull herds (on public or private land), and a number of options involving landowners, including increasing the number of licenses they may obtain, allowing them to charge hunters for access and providing them with extension services. Another stark result of our study is the remarkable homogeneity of preferences across different segments of society. There are very few cases where we find conflicting positive and negative preferences across groups. • The Canadian public wants action in managing Chronic Wasting Disease. • The Canadian public supports using hunters to control Chronic Wasting Disease. • Preferences for management are similar across segments of Canadian society. [ABSTRACT FROM AUTHOR]

Background: The use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described.Methods: BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure. Multiple logistic regression and time-dependent hazard models were used to identify major bleeding predictors.Results: We analyzed 1,813 patients of whom 895 received bridging and 918 received placebo. Median patient age was 72.6 years, and 73.3% were male. Forty-one major bleeding events occurred at a median time of 7.0 days (interquartile range, 4.0-18.0 days) postprocedure. Bridge therapy was a baseline predictor of major bleeding (odds ratio [OR]=2.4, 95% CI: 1.2-4.8), as were a history of renal disease (OR=2.9, 95% CI: 1.4-6.0), and high-bleeding risk procedures (vs low-bleeding risk procedures) (OR=2.9, 95% CI: 1.4-5.9). Perioperative aspirin use (OR=3.6, 95% CI: 1.1-11.9) and postprocedure international normalized ratio >3.0 (OR=2.1, 95% CI: 1.5-3.1) were time-dependent predictors of major bleeding. Major bleeding was most common in the first 10 days compared with 11-37 days postprocedure (OR=3.5, 95% CI: 1.8-6.9).Conclusions: In addition to bridge therapy, perioperative aspirin use, postprocedure international normalized ratio >3.0, a history of renal failure, and having a high-bleeding risk procedure increase the risk of major bleeding around the time of an elective surgery/procedure requiring warfarin interruption. [ABSTRACT FROM AUTHOR]

A sustainable ventilation method is one of the possible solutions to mitigate climate change and carbon emission. This method shall involve an analysis of the environmental impact, energy performance, and economical cost-effectiveness. There are still few studies concerning the life cycle assessment (LCA) of various alternative ventilation systems incorporating the combined effect of life cycle cost (LCC) and carbon emission in the supply-and-installation phase, as well as energy performances in the operation phase. The supply-and-installation phase of the system materials and components has a significant contribution to the total energy consumption and environmental loads of buildings. This paper covers a systematic approach to estimate their environmental impact, which has been counted in terms of energy demand and CO 2 emission in the two phases. This approach has been applied to an actual typical classroom served by mixing ventilation (MV), displacement ventilation (DV) and stratum ventilation (SV). The results show that SV has the least environmental impact and life cycle cost (LCC). Results of this analysis demonstrated that by adopting DV and SV, it is possible to reduce the CO 2 emission up to 23.25% and 31.71% respectively; and to reduce the LCC up to 15.52% and 23.89% respectively, in comparison with an MV system for 20 service years. This approach may be generally applied to a sustainability analysis of ventilation methods in various scales of air-conditioned spaces. [ABSTRACT FROM AUTHOR]

Background: Younger age as an independent predictor of death or all-cause rehospitalization at 30 days post-randomization for hospitalized heart failure (HF) patients has not been well described.Methods and Results: ASCEND-HF enrolled 7141 hospitalized acute HF patients (categorized by age: <45, 45 to <55, 55 to <65, 65 to <75, and ≥75 years) and followed them for 30 days to assess clinical outcomes, which included death or rehospitalization. Patients 45 to <55 years had the lowest percentages of death (1.4%) and total rehospitalizations (10.7%); percentages increased for younger (3.0% and 12.2%, respectively, for age <45 y) and older (5.8% and 12.5%, respectively, for age ≥75 y) patients. For those rehospitalized, the total HF-induced readmissions were highest in the youngest (68%) and declined with increasing age (P = .03). Although patients ≥55 years of age were more likely to die or be rehospitalized within 30 days of randomization for each additional 10 years of life, those <55 years of age had a significant reduction in death or HF rehospitalization for each 10-year increase in age (similar findings for death and HF rehospitalization).Conclusions: There is a dichotomous relationship between age and risk of death or rehospitalization, and death or HF rehospitalization-risk decreases as age increases up to age 55 years, then increases after age 55 years. [ABSTRACT FROM AUTHOR]

The paper describes an experimental study from forty-eight subjects about the acceptable thermal conditions under three ventilation strategies with six exhaust configurations, including mixing ventilation (MV), displacement ventilation (DV), and four exhaust types of stratum ventilation (ceiling-level-exhausted “SV”, rear-low-level-exhausted “SV-1”, front-low-level-exhausted “SV-2” & rear-middle-level-exhausted “SV-3”) serving a confined 8.8 m × 5.1 m × 2.4 m (h) classroom. Tests were carried out in a specially constructed test chamber designed to represent a typical small-medium sized classroom in Hong Kong. Thermal comfort analyses were carried out under specific supply flow rates, room temperatures, and air speeds in three ventilation strategies with six exhaust configurations. From the collected data, SV at 26 °C & 10 ACH and SV-3 at 28 °C & 15 ACH are achieved 100% of acceptable vote, the highest percentage of 97.3%, scoring neutral (0), are under the SV-3 at 28 °C & 10 ACH. The thermal satisfaction acceptance percentage in stratum ventilation strategies can be improved by increasing the air flow supply from 10 to 15 ACH at the elevated indoor condition of 26.8 °C, 27.3 °C and 26.4 °C by SV, SV-1 and SV-3 respectively, but not under MV, DV and SV-2. It implies that the thermal comfort will be affected no only by the temperature and air supply flow, but also by difference ventilation strategies in this study of three ventilation strategies with six exhaust configurations. This result indicates that SV-3 can satisfy human perception of comfort with least value of energy consumption, due to higher neutral temperature in comparison with the other ventilation strategies. [ABSTRACT FROM AUTHOR]

Background Despite initial in-hospital treatment of acute heart failure (HF), some patients experience worsening HF (WHF). There are limited data about the outcomes and characteristics of patients who experience in-hospital WHF. Methods and Results We assessed the characteristics and outcomes of patients with and without WHF in the ASCEND-HF trial. Worsening HF was defined as at least 1 symptom or sign of new, persistent, or WHF requiring additional intravenous inotropic/vasodilator or mechanical therapy during index hospitalization. We assessed the relationship between WHF and 30-day mortality, 30-day mortality or HF hospitalization, and 180-day mortality. We also assessed whether there was a differential association between early (days 1-3) vs late (day ≥4) WHF and outcomes. Of 7,141 patients with acute HF, 354 (5%) experienced WHF. Patients with WHF were more often male and had a history of atrial fibrillation or diabetes, lower blood pressure, and higher creatinine. After risk adjustment, WHF was associated with increased 30-day mortality (odds ratio 13.37, 95% CI 9.85-18.14), 30-day mortality or HF rehospitalization (odds ratio 6.78, 95% CI 5.25-8.76), and 180-day mortality (hazard ratio 3.90, 95% CI 3.14-4.86) (all P values < .0001). There was no evidence of a difference in outcomes between early and late WHF (all P values for comparison ≥ .2). Conclusions Worsening HF during index hospitalization was associated with worse 30- and 180-day outcomes. Worsening HF may represent an important patient-centered outcome in acute HF and a focus of future treatments. [ABSTRACT FROM AUTHOR]

Background The number of cardiac implantable electronic device (CIED) recalls and advisories has increased over the past 3 decades, yet no consensus exists on how to best manage patients with these CIEDs, partially because rates of complications from prophylactic replacement are unknown. Objective The purpose of this study was to establish rates of complications when recalled CIED generators are replaced prophylactically. Methods We searched MEDLINE and the Cochrane Controlled Trials Register for reports of prophylactic replacement of recalled CIED generators. Studies with <20 subjects were excluded. We then conducted a meta-analysis of qualifying studies to determine the rates of combined major complications, mortality, and reoperation. Results We identified 7 citations that met our inclusion criteria and reported ≥1 end-points of interest. Four were single center, and 3 were multicenter. Six studies collected data retrospectively (n = 1213) and 1 prospectively (n = 222). Using a random effects model to combine data from all included studies, the rate of major complications was 2.5% (95% confidence interval [CI] 1.0%-4.5%). Combining data from 6 studies reporting mortality and reoperation, the rates were 0.5% (95% CI 0.1%–0.9%) and 2.5% (95% CI 0.8%–4.5%), respectively. Conclusion Prophylactic replacement of recalled CIED generators is associated with a low mortality rate but nontrivial rates of other major complications similar to those reported when CIED generators are replaced for other reasons. Thus, when considering replacing a recalled CIED generator, known risks of elective generator replacement likely apply and can be weighed against risks associated with device failure. [ABSTRACT FROM AUTHOR]

Résumé Objectifs L’objectif principal de cette étude était d’estimer la prévalence des conduites à risque et des symptômes dépressifs chez les adolescents consultant au service d’accueil des urgences (SAU) d’un hôpital général. L’objectif secondaire était de comparer cette prévalence en fonction des motifs d’admission. Méthode Étude observationnelle, monocentrique, menée de janvier à septembre 2013, à l’aide d’un questionnaire distribué à tous les adolescents de 12 à 18 ans se présentant au SAU pédiatrique. Les questions s’attachaient à décrire leur environnement, leur mode de vie, les conduites à risque et les symptômes évocateurs de dépression. Les patients ont été répartis entre trois groupes en fonction du motif initial d’admission : médical, traumatologique ou manifestation de souffrance psychique. Résultats Nous avons inclus 379 adolescents, de 15 ans d’âge médian. Ceux du groupe souffrance psychique différaient de façon significative sur les points suivants : vie avec un seul parent ou en foyer, suivi par un professionnel de la santé mentale et/ou par un éducateur, consommation régulière d’alcool, consommation en binge drinking , consommation plus élevée de cannabis et de tabac, fréquence des symptômes tels que douleurs abdominales, céphalées, dorsalgies, vertiges, des difficultés d’endormissement et consommation plus fréquente de médicaments à visée hypnotique et/ou anxiolytique. Ils avaient plus souvent fugué, eu des idées suicidaires et/ou fait des tentatives de suicide et présentaient plus de symptômes évocateurs de dépression. Dans les deux autres groupes, la fréquence de ces symptômes de dépression et/ou de conduites à risque était également très élevée. Conclusion Les SAU sont un endroit privilégié pour le repérage de situations à risque ou de signes de dépression dans la population adolescente, quel que soit le motif d’admission. Summary Objectives The main objective of this study was to estimate the prevalence of social and psychological problems, risk behaviors, and depression symptoms in a population of adolescents consulting in a Pediatric Emergency Department of a general hospital, and compare these according to the reasons for consulting. Methods Observational monocentric study, in the Pediatric Emergency Department of a general hospital in Britany, France, between January and September 2013, using a questionnaire dispensed to 12- to 18-year-old adolescents. The questions covered habits, school, symptoms, risk behaviors, and depression symptoms. Patients were classified into three groups based of the initial aim of the consultation: medical, traumatologic, and acute psychiatric. Results A total of 379 adolescents, median age: 15 years, were included. Adolescents from the “psychiatric” group resided significantly more often with only one of their parents or in a residential home; they were more often followed by an youth worker and/or a mental health professional such as a psychologist or a psychiatrist; consumed alcohol, cannabis, and/or tobacco more often; they complained more often of headache or abdominal and lumbar pain, dizziness, and sleep disorders; they consumed anxiolytic and hypnotic drugs more often; they ran away more often; and had signs of depression and/or suicidal ideation and behaviors. The prevalence of all these psychosocial and behavioral risks was also high in the two other groups. Conclusion The Pediatric Emergency Department is a good place to detect adolescents with behavioral problems and/or depression symptoms, even if this is not the initial purpose of admission. [ABSTRACT FROM AUTHOR]

Introduction Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS + HIPEC) is currently considered the standard of care for pseudomyxoma peritonei, mesothelioma and peritoneal metastases (PM) from colorectal cancer. CRS + HIPEC has also been suggested as a potential treatment option in PM of the much rarer small bowel cancer. Therefore, the current study was undertaken to investigate the results of CRS + HIPEC in all HIPEC centers in The Netherlands. Methods From the 4 tertiary referral centers for peritoneal surface malignancies in The Netherlands, data from all patients with peritoneally metastasized small bowel carcinoma intended to undergo CRS and HIPEC were collected between January 2005 and July 2014. Primary tumor characteristics, operative details, and survival outcomes were collected. Results Sixteen of 19 patients (84.2%) who underwent explorative laparotomy underwent CRS + HIPEC. Of these patients, 81.3% were female, and primary tumors were mainly located in the ileum (50%). A complete macroscopic resection was achieved in 93.8%. Serious adverse events requiring re-intervention occurred in 25%, and no in-hospital mortality was observed. Recurrent disease was observed in 50% of patients and median survival after CRS and HIPEC was 31 months. Conclusion In a select group of patients in whom a complete macroscopic resection can be achieved, survival rates comparable with those in colorectal PM are attainable with acceptable morbidity. The role of adjuvant chemotherapy needs further research. [ABSTRACT FROM AUTHOR]

Résumé Le cancer du testicule est peu fréquent chez l’adolescent mais représente la première cause de cancer solide des sujets de 15–30 ans. Nous rapportons l’observation d’un adolescent de 16 ans qui s’était présenté au service des urgences pédiatriques avec une masse du testicule évoluant depuis plusieurs mois et dont le diagnostic s’est avéré être un cancer testiculaire multi-métastatique. Or la précocité du diagnostic conditionne en grande partie le pronostic de ce cancer. Une revue de la littérature permet de faire le point sur les facteurs pronostiques, les causes de retard diagnostique et les pratiques actuelles concernant le dépistage de la maladie. Il n’existe à l’heure actuelle en France aucune recommandation officielle. Summary Testicular cancer is a rare disease in adolescents but is the leading cause of solid cancer in 15- to 30-year-old men. We report a clinical case of a 16-year-old who presented to the pediatric emergency unit with a testicular mass that had been enlarging for several months and the diagnosis turned out to be multimetastatic testicular cancer. However, early diagnosis largely determines the prognosis of this disease. A literature review enabled us to update the prognostic factors, the reasons for diagnostic delay, and current screening practices for this disease. There are currently no formal guidelines in France. [ABSTRACT FROM AUTHOR]

Introduction Complete tumor extirpation (R0 resection) remains the best possibility for long-term survival in patients with pancreatic adenocarcinoma. Unfortunately, approximately 80% of patients are not amenable to resection at diagnosis either because of metastatic (40%) or locally advanced disease (40%). Recent reports of irreversible electroporation (IRE), a high-voltage, short-pulse, cellular energy ablation device, have shown the modality to be safe and potentially beneficial to prognosis. IRE to augment/accentuate the margin during pancreatic resection for certain locally advanced pancreatic cancers has not been reported. Methods Patients with locally advanced/borderline resectable pancreatic cancer who underwent pancreatectomy with margin accentuation with IRE were followed in a prospective, institutional review board–approved database from July 2010 to January 2013. Data regarding local recurrence, margin status, and survival were evaluated. Results A total of 48 patients with locally advanced pancreatic/borderline cancers underwent pancreatectomy, including pancreatoduodenectomy (58%), subtotal pancreatectomy (35%), distal pancreatectomy (4%), and total pancreatectomy (4%), with IRE margin accentuation of the superior mesenteric artery and/or the anterior margin of the aorta. Most patients had undergone induction therapy with 33 patients (69%) receiving chemoradiation therapy and 18 patients chemotherapy for a median of 6 months (range, 4–13) before resection. A majority (54%) required vascular resection. A total of 9 patients (19%), sustained 21 complications with a median grade of 2 (range, 1–3), with a median duration of stay of 7 days (range, 4–58). With median follow-up of 24 months, 3 (6%) have local recurrence, with a median survival of 22.4 months. Conclusion Simultaneous intraoperative IRE and pancreatectomy can provide an adjunct to resection in patients with locally advanced disease. Long-term follow-up has demonstrated a small local recurrence rate that is lower than expected. Continued optimization in multimodality therapy and consideration of appropriate patients could translate into a larger subset that could be treated effectively. [ABSTRACT FROM AUTHOR]

Background We sought to identify risks for 30-day readmission in patients undergoing colorectal surgery. Methods We reviewed 2011 American College of Surgery National Surgical Quality Improvement Program data to identify patients readmitted after colorectal surgery. We found 3,228 readmissions from 30,412 records. Using statistically suggestive variables from logistic regression ( P < .1), we built conditional inference trees (CTREES) with subsampled records to identify combined risks. Results Logistic regression identified 27 potentially significant variables. Using these in new logistic regression and CTREES, we found classification accuracies of 0.70 and 0.63, respectively. CTREES predicted that the majority of patients who required reoperation during their hospitalization were predicted to require readmission ( n = 496), along with the majority of patients who developed organ space infection ( n = 671). Patients with deep infections discharged ≤10 days from their index operation required readmission in 443 of 459 of records; this approach predicted a >99% risk of readmission in patients with these infections who were discharged ≤5 days (220/222). Additionally, >90% (253/271) of patients who returned to the operating room and were discharged ≤8 days from the first operation are predicted to return. Conclusion Subgroups identified using the CTREES model demonstrate that patients with deep space infections or who return to the operating room have a greater readmission rate if they are discharged early. Modeled patients found to have organ space infections and who returned to the operating room had 30-day readmission risks of >50%, with those discharged a rate of >90%. We show herein that CTREES can be used with retrospective data on surgery populations to bring hidden patterns into relief. [ABSTRACT FROM AUTHOR]

Abstract: This editorial explains how creative prototyping could make both a theoretical and methodological contribution, to the long and established tradition of user-driven forecasting and foresight scholarship. We provide summarized reviews of thirteen articles from emerging prototype researchers. This SI contains a very diverse and exciting crop of papers that could stimulate lively debate and discussion amongst the TFSC readership. [Copyright &y& Elsevier]

Abstract: The climate specific effectiveness of solar DEC-systems and relevant preferable adaptions of the system design have been so far predominantly analysed based on individual simulation for selected sites. In order to systematically deduce design-specific outline data for the application of the solar DEC-technology at climatically different sites a methodological zoning approach was further developed. A subsequent meteorological analysis for 17 sites mapping the world climate creates a transparent understanding on the activity of the specific system components. This results in a comprehension on the site-specific effectiveness of solar DEC-systems and provides insights on principally relevant and efficient system configurations. [Copyright &y& Elsevier]

Highlights: [•] Different policies are used in the Murray-Darling Basin to recover environmental water. [•] We examine irrigator preferences for those policies to compare with existing approaches. [•] Preferences for capital works are lower, and targeted trade higher, than perceived. [•] Increasing capital work cost may be explained by diminishing marginal returns. [•] Reallocation of recovery budget may increase social welfare and water recovery. [Copyright &y& Elsevier]

Objective: Left ventricular systolic dysfunction is associated with increased morbidity and mortality in patients undergoing cardiac surgery. The authors performed a meta-analysis investigating the effects of levosimendan in cardiac surgery patients with and without preoperative systolic dysfunction. Design: Meta-analysis of randomized controlled trials. Setting: Hospital. Participants: The 1,155 patients who participated in 14 randomized controlled trials of perioperative levosimendan were included. Interventions: None. Measurements and Main Results: PubMed, EMBASE, the Cochrane database of clinical trials, and conference proceedings were searched for clinical trials of perioperative levosimendan in patients undergoing cardiac surgery through May 1, 2012. Studies were grouped by mean ejection fraction (EF). Those with a mean EF <40% were designated as low-EF. Pooled results demonstrated a reduction in mortality with levosimendan (risk difference [RD]–4.2%; 95% CI −7.2%, −1.1%; p = 0.008). Subgroup analysis showed that this benefit was confined to the low-EF studies (RD −7.0%; 95% CI −11.0%, −3.1%; p < 0.001). No benefit was observed in the preserved-EF subgroup (RD +1.1%; 95% CI −3.8%, +5.9%; p = 0.66). Significant reductions also were seen in the need for dialysis (RD −4.9%; 95% CI −8.2%, −1.6%; p = 0.003), myocardial injury (RD −5.0%; 95% CI −8.3%, −1.7%; p = 0.003), and postoperative atrial fibrillation (RD −8.1%; 95% CI −13.3%, −3.0%; p = 0.002). Conclusions: Levosimendan was associated with reduced mortality and other adverse outcomes in patients undergoing cardiac surgery, and these benefits were greatest in patients with reduced EF. These data support the need for adequately powered randomized clinical trials to confirm the benefits of levosimendan in patients with reduced EF undergoing cardiac surgery. [Copyright &y& Elsevier]

Abstract: This special issue (SI) explores the use of creative fictional prototyping to motivate and direct research into new high-tech products, environments and lifestyles. Fictional prototyping combines storytelling with science fact to explore a wide variety of possible futures. We define what a prototype is, then outline the design challenges. Commentaries are presented on each fictional prototype. Finally we highlight the significance of this SI by making reference to similar studies published in Futures. [Copyright &y& Elsevier]

Summary: Decisions regarding the end-of-life care of neonates, especially those at the limits of viability, cannot be made on the basis of clinical facts alone. They should take into account the values and beliefs of all concerned. Application of classical moral theories may take insufficient account of the interests of small babies. Due consideration needs to be given to the value and quality of babies'' lives, their best interests, and the interests of their parents in practical decision-making. Life-sustaining treatments can be withheld or withdrawn if they no longer serve the baby''s best interests, but active euthanasia (though an acceptable practice in The Netherlands) remains illegal in the UK. Withdrawal of clinically assisted nutrition and hydration can be ethical but remains controversial. If organ donation in UK neonates is to become established it will need to respond to the changing characteristics of neonatal deaths in ways that are ethically and socially sensitive. [Copyright &y& Elsevier]

Abstract: Background: The benefit of oral anticoagulation therapy with warfarin for stroke prevention in atrial fibrillation (AF) is directly dependent on the quality of anticoagulation (QoA), which in the US is provided predominantly in the community setting. With the emergence of new oral anticoagulation agents, the current QoA needs to be assessed. Objectives: The purpose of our study is to define the QoA with warfarin in patients with nonvalvular AF who are managed exclusively in community practices, and to compare the quality in the community setting with the quality demonstrated in the recent large randomized control trials. In addition, this study will assess the differences in the QoA based on cardiology vs primary care practices. Methods: This is a retrospective, observational, multi-center study of 392 patients with AF in the community who were initiated on anticoagulation with warfarin for stroke prevention. International Normalized Ratio (INR) values were collected over a one-year period and the QoA was expressed as time in therapeutic range (TTR) calculated by the linear interpolation method. Results: One hundred patients from cardiology practices and 292 patients from primary care were studied. During the one-year period, the overall mean TTR was 56.7%. The TTR in the primary care vs cardiology practices was 55.3% vs. 60.8% (p=0.02). Both practices had similar percent of time below therapeutic range, 29.8% vs. 29.2%. However, the primary care practice patients were above the therapeutic range 15% of the time vs. 10% in cardiology (p<0.001). There were one death secondary to intracranial bleed and one major bleed in the primary care group. There were no strokes during the study period in either group. Conclusion: The QoA with warfarin, as assessed by TTR, in the current community setting remains suboptimal, and there has been little to no improvement in current clinical practices. TTR should be considered when assessing the recent comparative studies evaluating novel pharmacologic agents to warfarin for the treatment of AF. Subject Areas: Arrhythmias, preventive cardiology, anticoagulation, thromboembolism, cardiovascular disease risk factors. [Copyright &y& Elsevier]

Abstract: A field study conducted through a series of four field campaigns between 2005 and 2007 investigated the potential for dust emissions around the Salton Sea in California, USA. This paper explores the landform related controls on fugitive PM10 dust emissions from soil surfaces surrounding the Salton Sea by measuring soil properties combined with estimating the in situ PM10 dust emissions using a novel small portable field wind tunnel (PI-SWERL). The locations surrounding the Salton Sea were selected to encompass varying geomorphic landforms, including exposed shoreline areas with playa characteristics, barnacle covered beaches, dry washes, interdunes, and exposures of ancient Lake Cahuilla. The largest variation in potential dust emissions over the sampling period was from the playa-like surfaces that are near the open water and exhibited surface salt crusts, with the highest emissions measured from these surfaces during the winter. However, the largest emitting landform over the entire period were the dry washes that only exhibited a small degree of silt/clay crust, if any and were composed mainly of sand-sized particles. The highest emissions from all surfaces are compared with dust fluxes measured from Owens Lake and are within the same order of magnitude as those also measured with wind tunnels. Salt content did not show any statistically significant correlation with PM10 dust emissions during any sampling period for the soils tested, which is attributed to the complications associating soil salt contents with particular salt crystal habit. [Copyright &y& Elsevier]

Abstract: Fallen timber is widely considered to be a key element of ecosystem structure and function that is critical to maintenance of biodiversity. This concept is closely linked to ideas of wilderness and old growth. ‘Conventional wisdom’ is that fallen timber has been drastically depleted from natural levels by human activity. However natural conditions reflect interactions of Aborigines with their environment, and fallen timber as well as broadcast fire was critically important to Aboriginal economies in the New World and Australia. Quantitative historical data are not available, so it is necessary to use qualitative historical information to describe natural loads and dynamics of fallen timber. A comparison against detailed historical descriptions of woodlands under Aboriginal management in Australia indicates that benchmarks from ‘undisturbed’ examples of the same types of vegetation are generally inflated. The ecological history of grassy woodlands since European settlement shows that proposed ‘restoration’ measures will favour common and widespread biota at the expense of rare and endangered species. No correlation of biodiversity with fallen timber has been demonstrated for grassy eucalypt ecosystems. Globally, conservation strategies that minimize human activity have generally failed because resilience of ecosystems and ancient trees has been reduced and rare species have been lost. The concept of wilderness has little application outside the unpeopled continent of Antarctica. [Copyright &y& Elsevier]

Abstract: The exact nature of the mechanism that triggers initiation of chromosome replication in the best understood of all organisms, Escherichia coli, remains mysterious. Here, I suggest that this mechanism evolved in response to the problems that arise if chromosome replication does not occur. E. coli is now known to be highly structured. This leads me to propose a mechanism for initiation of replication based on the dynamics of large assemblies of molecules and macromolecules termed hyperstructures. In this proposal, hyperstructures and their constituents are put into two classes, non-equilibrium and equilibrium, that spontaneously separate and that are appropriate for life in either good or bad conditions. Maintaining the right ratio(s) of non-equilibrium to equilibrium hyperstructures is therefore a major challenge for cells. I propose that this maintenance entails a major transfer of material from equilibrium to non-equilibrium hyperstructures once per cell and I further propose that this transfer times the cell cycle. More specifically, I speculate that the dialogue between hyperstructures involves the structuring of water and the condensation of cations and that one of the outcomes of ion condensation on ribosomal hyperstructures and decondensation from the origin hyperstructure is the separation of strands at oriC responsible for triggering initiation of replication. The dualism hypothesis that comes out of these speculations may help integrate models for initiation of replication, chromosome segregation and cell division with the ‘prebiotic ecology’ scenario of the origins of life. [Copyright &y& Elsevier]

Historically, oral and maxillofacial surgeons have had considerable autonomy in operating their offices. Oral and maxillofacial surgeons have had a singular history of safety, training, and success in outpatient anesthesia in their offices. However, preventable patient morbidity and mortality in private office-based surgical facilities of a variety of professions have brought increased scrutiny to the office environment. The present report describes the experiences of 3 oral and maxillofacial surgeons with 3 accrediting agencies in obtaining office accreditation and offers recommendations to be considered for the future of our specialty in terms of private office certification. [ABSTRACT FROM AUTHOR]

Background: Several devices have been developed to create an antireflux barrier endoscopically for the treatment of gastroesophageal reflux disease. All have failed to provide long-term symptom relief, were associated with clinically important complications, or were otherwise removed from the market. A new device, the Esophyx (Endogastric Solutions, Redmond, WA), provides the closest approximation experimentally to a standard Belsy fundoplication. This report describes an initial experience with this device. Methods: Patients considered candidates for endoscopic fundoplication include those with symptomatic gastroesophageal reflux disease, a small (<2 cm) hiatal hernia, objective pathologic evidence of gastroesophageal reflux disease, and an absence of other esophageal motility disorders. The procedure was conducted under general anesthesia with a surgeon operating the device and an endoscopist operating the gastroscope. H-fasteners were placed from the esophagus to the gastric cardia with the goal of creating an approximately 270–300° fundoplication approximately 3–4 cm in length. Symptom severity was measured with the GERD-HRQL instrument (best possible score 0, worst possible score 50). The patients were followed-up for complications and symptom improvement. Results: In all, 26 patients underwent an attempted endoscopic fundoplication. Two patients could not be completed because of the inability to pass the device. Of the 24 patients who underwent endoscopic fundoplication, 20 had the typical symptoms of gastroesophageal reflux disease, 4 had symptoms of laryngopharyngeal reflux, and 4 had recurrent symptoms after a Nissen fundoplication. There was 1 major complication of a gastric mucosal tear that led to bleeding and the need for a blood transfusion. Nineteen (79%) patients reported satisfaction with their symptom relief. Of those dissatisfied, 2 had symptoms of laryngopharyngeal reflux, 1 had functional heartburn, 1 had associated gastroparesis, and 1 had clear failure with gastroesophageal reflux disease. The median GERD-HRQL score improved from 25 (interquartile range, 19.5–28.5) to 5 (interquartile range, 3–9; P = .0004). Conclusion: Endoscopic fundoplication with the Esophyx device is feasible with satisfactory initial results. Endoscopic fundoplication seems to be best suited for patients with small hiatal hernias and mild-to-moderate typical symptoms; however, subsequent trials are needed to assess the long-term effectiveness of the technique. [Copyright &y& Elsevier]

Abstract: This paper presents an innovative method for tourist market segmentation-based on dominant movement patterns of tourists; that is, the travel sequences or patterns used by tourists most frequently. There were three steps to achieve this goal. In the first step, general log-linear models were adopted to identify the dominant movement patterns, while the second step was to discover the characteristics of the groups of tourists who travelled with these patterns. The Expectation–Maximisation algorithm was then used to partition tourist segments in terms of socio-demographic and travel behavioural variables. The third step was to select target markets based upon the earlier analysis. These methods were applied to a sample of tourists, over the period of a week, on Phillip Island, Victoria, Australia. A significant outcome of this research is that it will assist tourism organisations to identify tourism market segments and develop better tour packages and more efficient marketing strategies aligned to the characteristics of the tourists. [Copyright &y& Elsevier]

Cell-based, phenotypic screening of small molecules often identifies compounds with provocative biological properties. However, determining the cellular target(s) and/or mechanism of action (MoA) of lead compounds remains an extremely challenging and time-consuming exercise. To provide insights into a compound''s cellular action and greatly reduce the time required for MoA determination, we have developed a screening platform consisting of an extensive series of reporter gene assays (RGAs). A collection of >11,000 compounds of known MoA (e.g., World Drug Index entries) were screened against the entire panel. The output provided evidence that an RGA signature could be ascribed to numerous, biologically diverse MoAs. The reference database generated suggested novel biological activity for particular compounds. For example, the profiling data led to the prediction that the cellular target of the natural product terprenin was dihydroorotate dehydrogenase (DHODH), which was confirmed experimentally. The screening methodology developed for this endeavor renders it amenable to the future examination of compounds with unknown MoA, in an automated, inexpensive, and time-efficient manner. [Copyright &y& Elsevier]

Abstract: On the western rivers and plains of southern New South Wales, relatively small areas of forests remain in a semi-natural condition and conservation reserves are lacking. Severe drought stress in recent decades after two centuries of European management has raised issues about how best to manage these forests and, if necessary, restore them. The region was explored between 1817 and 1836. Settlers, foresters and ecologists described changes as Aboriginal culture was displaced, domestic stock, feral animals and exotic plants were introduced, rabbits were controlled, rivers were regulated, and grazing was reduced. The Aboriginal ecosystems were different to the new red gum (Eucalyptus camaldulensis) and white cypress (Callitris columellaris) forests which lack resilience. Trees, saplings, fallen timber, shrubs and parasitic plants have accumulated in recently ‘undisturbed’ sites and these features are now promoted as benchmarks for conservation. However, human activity including watering, thinning, firewood collection, grazing and/or burning may aid restoration whereas non-intervention may allow continuing degradation. This historical ecology and recent palaeoecology provide insights to conserving grassy woodlands globally. [Copyright &y& Elsevier]

Abstract: A mild, low-temperature analytical approach based on sonication assisted extraction coupled with HPLC electrospray ionization triple quadrupole tandem mass spectrometry has been developed for the simultaneous qualitative and quantitative determination of the four Irgarol-related s-triazine species, namely Irgarol-1051, M1, M2 and M3, in coastal sediments and Green-lipped mussel samples. Mild extraction conditions were necessary for the preservation of the thermally unstable M2. The Multiple Reaction Monitoring (MRM) mode of detection by ESI-MS/MS enabled reliable qualitative identification and sensitive quantitative determination of those s-triazines. This determination method was applied to evaluate the degree of Irgarol-1051 contamination in the sediments and biota of the coastal environment of Hong Kong – one of the busiest maritime ports in the world. All the four s-triazine species were observed in all of the samples. This is the first time that the newly identified M2 and M3 are detected in coastal sediments and biota tissues. [Copyright &y& Elsevier]

Summary: Short chain poly-(R)-3-hydroxybutyrate (cPHB) is a ubiquitous molecule that readily adheres to others, that is covalently added to proteins and that forms, with polyphosphate, ion channels. High levels of cPHB have been implicated in atherosclerosis and in diabetes. Here, we propose a hypothesis in which cPHB adheres to filaments in the extracellular matrix and this raises intraocular pressure. In a corollary, we propose that a positive feedback relationship between cPHB adherence to filaments, raised IOP and filament stretching constitutes a switch. [Copyright &y& Elsevier]

Background: Measurement of circulating natriuretic peptides has been shown to play an important role in diagnosis and prognosis in patients with chronic heart failure. Whether serial natriuretic peptide measurements to aid in the titration of therapy can improve heart failure outcomes remains uncertain. We performed a quantitative meta-analysis of available randomized controlled trials to determine whether titration of therapy based on natriuretic peptide measurements improves mortality in chronic heart failure. Methods: We identified potentially relevant studies through a search of MEDLINE (1996-2009), ISI Web of Knowledge (1996-2009), Cochrane Central Register of Controlled Trials (1996-2009), clinicaltrials.gov, proceedings of major US and European cardiology meetings (2000-2009), and bibliographic review of secondary sources. Search terms were “biomarker,” “natriuretic peptide,” “B-type natriuretic peptide,” “N-terminal B-type natriuretic peptide,” and “heart failure.” Studies were included if they were prospective, randomized controlled trials of patients with chronic heart failure, they randomized patients to a strategy of titrating medical therapy based on the level of a circulating biomarker compared to a parallel control group, and they reported all-cause mortality. Results: Six studies randomizing 1627 patients met criteria for inclusion. Pooled analysis showed a significant mortality advantage for biomarker-guided therapy (hazard ratio was 0.69, 95% CI 0.55-0.86) compared to control. There was no quantitative evidence of heterogeneity between studies (P = .42). Conclusions: Titration of therapy incorporating serial BNP or N-terminal pro-B-type natriuretic peptide levels is associated with a significant reduction in all-cause mortality compared to usual care in patients with chronic heart failure. [Copyright &y& Elsevier]

The kinetics of the photoinduced degradation and transformation of the antifouling booster biocide, Irgarol-1051, in natural coastal seawater was studied. The measured first-order rate constant for the degradation of Irgarol-1051 was 4.02±0.1×10−4 h−1, while the rate constant for the formation of 2-methylthio-4-tert-butylamino-6-amino-s-triazine (M1), the most dominant degradation product of Irgarol-1051, was 4.6±0.1×10−5 h−1. This considerably slower rate suggested that the transformation of Irgarol-1051 to M1 may not be the predominant pathway of the photodegradation process. During the photodegradation study, a new s-triazine species was observed in the degradation mixtures which, together with M1, appeared immediately upon photolysis and continued to accumulate in the degradation mixture throughout the entire study duration. This is in contrast to the behaviour of the recently identified degradation product of Irgarol-1051, 3-[4-tert-butylamino-6-methylthiol-s-triazin-2-ylamino]- propionaldehyde (M2), which was only detected in the degradation mixture after a long induction period. High-resolution tandem mass spectrometric analysis hinted that the new degradation product (M4) may possess a terminal alcohol and is likely to be an N-allylic alcohol derivative of M1. This suggests that M4 may, indeed, be a precursor of M2 via redox transformation at its N-allylic alcohol functionality. [Copyright &y& Elsevier]

Background: Acute decompensated heart failure (ADHF) is a major public health burden with significant mortality and morbidity. Nesiritide is a recombinantly produced intravenous formulation of human B-type natriuretic peptide that promotes vasodilation and increases salt and water excretion, which results in reduced cardiac filling pressures. Prior studies have shown that dyspnea is improved in patients with ADHF 3 hours after nesiritide infusion with significant dose-related reductions in cardiac filling pressures and systemic vascular resistance without significant arrhythmias. However, the effect of nesiritide on dyspnea at 6 or 24 hours is unknown, and no clinical outcome trials have been done to provide a reliable estimate of the effect of nesiritide on morbidity and mortality. Methods: The Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure trial (ASCEND-HF) is a phase III study evaluating the efficacy and safety of nesiritide in patients with ADHF. Patients hospitalized for hear failure will be randomly assigned to receive either intravenous nesiritide or matching placebo for 24 hours to 7 days. The 2 coprimary end points are (1) assessment of acute dyspnea at 6 or 24 hours and (2) death or rehospitalization for hear failure within 30 days. A total of 7,000 patients will be enrolled worldwide between 2007 and 2010. Conclusions: The data from the ASCEND-HF trial will establish whether nesiritide safely improves acute dyspnea as well as morbidity and mortality at 30 days. [Copyright &y& Elsevier]

Abstract: In the Eden area in NSW, Australia, low fertility granitic surface soils were sampled from 156 sites and analysed for pH, organic C, total N, total P, available P, exchangeable bases and exchangeable Al. Fifty eight of these sites were also sampled to a depth of 40cm. Time since fire ranged from 1 to 39 years and was used in the analysis as a surrogate for fire frequency. No information was available on fire intensity. No significant relationships were found between time since fire and P or base cations. However, the quantities of organic matter and total N (kgha−1), and the C/N ratio were significantly related to both time since fire alone and to the combination of time since fire and soil total P. Based on these relationships, it was estimated that there were average net increases of between 11 and 21kgNha−1 year−1 in surface soil, the actual quantity depending on the level of soil total P. There was little change in N in the initial 10 years after fire and there was a peak in N accumulation about 24 years after fire. The C/N ratio and surface soil pH decreased with time since fire. Accumulation of N and reductions in pH and C/N ratio were studied further in a small scale paired plot analysis. The repeatedly burnt plots had lower levels of both litter and understorey and the overstorey trees generally had healthier crowns than in the unburnt plots. The differences between the repeatedly burnt and the unburnt plots matched the models developed from the general survey. There were no significant changes in the C/N ratio, but the unburnt sites had higher levels of extractable mineral N and the relationships between the mineral N and the C/N ratio for burnt and unburnt sites were statistically significant. The quantities of extractable mineral N in the unburnt soils (2.3kgNha−1) were about twice the levels in the burnt soils (1.2kgNha−1). The pH of the surface soil (4.4 in 1:1 water) in the regularly burnt area was higher than in the unburnt area (pH 4.1) and the exchangeable aluminium also differed (0.62cmol−1 in the burnt area and 1.3cmol−1 in the unburnt). The combined data indicate that changes occur in forest soils when there is a long period of exclusion of fire. It is suggested that these changes generally lead to secondary changes, such as in pH and availability of other elements such as aluminium. The study highlights a number of issues including the rates of inputs of N to the system and the question of N saturation and its long term interaction with plant species. It is hypothesised that reduced burning leads to increased N availability and other soil changes which negatively impact on tree health. [Copyright &y& Elsevier]

Background: Coronary artery bypass graft (CABG) surgery is effective in relieving angina and improving survival and quality of life in patients with obstructive coronary artery disease; however, recurrent angina, myocardial infarction, neurological injury, and death can occur in the perioperative and postoperative period. MC-1 (pyridoxal 5′-phosphate) is a novel agent that has shown promise in reducing myocardial necrosis by reducing cellular calcium overload after percutaneous coronary intervention and CABG surgery in high-risk patients undergoing these procedures. Methods: MEND-CABG II is a phase III study evaluating the efficacy and safety of MC-1 in reducing cardiovascular morbidity and mortality after CABG. High-risk patients undergoing CABG surgery will be randomly assigned to receive either MC-1 (250 mg/d) or matching placebo immediately before and continuing for 30 days after the procedure. The primary end point is the occurrence of cardiovascular death or nonfatal myocardial infarction through postoperative day 30. A total of 3023 patients were enrolled at 130 sites in Canada, the United States, and Germany between October 2006 and September 2007, with results anticipated shortly after completion of 90-day follow-up in March 2008. Conclusions: The data from the MEND-CABG II trial will establish whether peri- and postoperative treatment with MC-1 can decrease the short- and intermediate-term morbidity and mortality of high-risk patients undergoing CABG surgery. [Copyright &y& Elsevier]

Background & Aims: Although observational studies have found regular aspirin use to be associated with a reduced risk of colorectal neoplasia, results from randomized trials using aspirin have been inconsistent. Dietary folate intake also has been found to be associated with a reduced risk of colorectal neoplasms in observational studies. Methods: A multicenter, randomized, double-blind trial of aspirin (300 mg/day) and folate supplements (0.5 mg/day) to prevent colorectal adenoma recurrence was performed using a 2 × 2 factorial design. All patients had an adenoma (≥0.5 cm) removed in the 6 months before recruitment and were followed-up at 4-month intervals with a second colonoscopy after approximately 3 years. The primary outcome measure was a colorectal adenoma diagnosed after baseline. Results: A total of 945 patients were recruited into the study, of whom 853 (90.3%) underwent a second colonoscopy. In total, 99 (22.8%) of 434 patients receiving aspirin had a recurrent adenoma compared with 121 (28.9%) of 419 patients receiving placebo (relative risk, 0.79; 95% confidence interval [CI], 0.63–0.99). A total of 104 patients developed an advanced colorectal adenoma; 41 (9.4%) of these were in the aspirin group and 63 (15.0%) were in the placebo group (relative risk, 0.63; 95% CI, 0.43–0.91). Folate supplementation was found to have no effect on adenoma recurrence (relative risk, 1.07; 95% CI, 0.85–1.34). Conclusions: Aspirin (300 mg/day) but not folate (0.5 mg/day) use was found to reduce the risk of colorectal adenoma recurrence, with evidence that aspirin could have a significant role in preventing the development of advanced lesions. [Copyright &y& Elsevier]

Background: Hypertension is common in hemodialysis patients; however, the relationship between interdialytic weight gain (IDWG) and blood pressure (BP) is incompletely characterized. This study seeks to define the relationship between IDWG and BP in prevalent hemodialysis subjects.Study Design, Setting,& Participants: This study used data from 32,295 dialysis sessions in 442 subjects followed up for 6 months in the Crit-Line Intradialytic Monitoring Benefit (CLIMB) Study.Outcomes& Measurements: Mixed linear regression was used to analyze the relationship between percentage of IDWG (IDWG [%] = [current predialysis weight - previous postdialysis weight]/dry weight * 100) as the independent variable and systolic BP (SBP) and predialysis - postdialysis SBP (deltaSBP) as dependent variables.Results: In unadjusted analyses, every 1% increase in percentage of IDWG was associated with a 1.00 mm Hg (95% confidence interval [CI], +/-0.24) increase in predialysis SBP (P < 0.0001), 0.65 mm Hg (95% CI, +/-0.24) decrease in postdialysis SBP (P < 0.0001), and 1.66 mm Hg (95% CI, +/-0.25) increase in deltaSBP (P < 0.0001). After controlling for other significant predictors of SBP, every 1% increase in percentage of IDWG was associated with a 1.00 mm Hg (95% CI, +/-0.24) increase in predialysis SBP (P < 0.0001) and a 1.08 mm Hg (95% CI, +/-0.22) increase in deltaSBP with hemodialysis (P < 0.0001). However, in subjects with diabetes as the cause of end-stage renal disease, subjects with lower creatinine levels, and older subjects, the magnitude of the association between percentage of IDWG and predialysis SBP was less pronounced. The magnitude of percentage of IDWG on deltaSBP was less pronounced in younger subjects and subjects with lower dry weights. Results were similar with diastolic BP.Limitations: Hemodialysis BP measurements are imprecise estimates of BP and true hemodynamic burden in dialysis subjects.Conclusions: In prevalent hemodialysis subjects, increasing percentage of IDWG is associated with increases in predialysis BP and BP changes with hemodialysis; however, the magnitude of the relationship is modest and modified by other clinical factors. Thus, although overall volume status may impact on BP to a greater extent, day-to-day variations in weight gain have a modest role in BP increases in prevalent subjects with end-stage renal disease. [ABSTRACT FROM AUTHOR]

Objective: Coronary artery bypass graft surgery remains associated with significant postoperative cardiovascular morbidity and mortality in high-risk patients. MC-1 (pyridoxal-5′-phosphate monohydrate) inhibits purinergic receptors and intracellular influx of Ca2+, thereby reducing cellular injury during experimental ischemia and reperfusion. The MEND-CABG trial tested the hypothesis that MC-1 reduces cardiovascular morbidity and mortality after coronary artery bypass graft. Methods: In a phase 2, double-blinded, placebo-controlled study, 901 patients scheduled for coronary artery bypass graft surgery with cardiopulmonary bypass and at high risk for subsequent cardiac or neurologic complications were randomly assigned to receive oral MC-1 (250 mg or 750 mg/d once daily) or placebo beginning 3 to 10 hours prior to surgery and continued to postoperative day 30. Results: At 30 days, MC-1 250 mg (compared with placebo) reduced the composite of death, nonfatal cerebral infarction, and nonfatal myocardial infarction by 14.0% (P = .3124) with peak creatinine kinase–myocardial band ≥50 ng/mL (prespecified primary end point); 32.3% (P = .0349) with peak creatinine kinase–myocardial band ≥70 ng/mL; and 37.2% (P = .0283) with peak creatinine kinase–myocardial band ≥100 ng/mL. Myocardial infarctions with peak creatinine kinase–myocardial band≥100 ng/mL were reduced by 47.2% in the MC-1 250-mg group versus placebo (P = .0083). Greater efficacy was demonstrated with 250 mg than with the 750-mg dose of MC-1. Conclusions: In high-risk patients undergoing coronary artery bypass graft, treatment with MC-1 did not significantly affect the prespecified primary end point but was associated with a significant reduction in perioperative myocardial infarction with creatinine kinase–myocardial band ≥100 ng/mL. A larger, well-powered trial is needed to evaluate the cardioprotective effects of MC-1. [Copyright &y& Elsevier]

Background: Randomized clinical trials have demonstrated the superiority of drug-eluting stents (DESs) compared with bare-metal stents in reducing the need for revascularization and major adverse cardiac events (MACEs) in low-risk patients with single-vessel lesions. Rapid DES uptake has necessitated shifting the paradigm to active DES-controlled noninferiority study models with most studies using surrogate angiographic measurements to attain adequate statistical power. No previous prospective trial has specifically compared a new DES with an active-control DES in a high-risk patient population using primary clinical end points. Objective: COSTAR II is designed to compare use of the investigational Costar stent (Conor MedSystems, Palo Alto, CA) with the Taxus (Boston Scientific, Maple Grove, MN) stent in single- and multivessel percutaneous coronary intervention. The primary end point is the clinical composite of MACE at 8 months supported by consistent results in the evaluation of 8-month MACE rates in the single- and multivessel cohorts and of in-segment late loss in a small angiographic substudy at 9 months. Methods: A total of 1700 patients, 50% with single-vessel and 50% with multivessel disease, are randomized in a 3:2 ratio to receive either Costar or Taxus stent(s) in this prospective, multicenter, noninferiority study design. Because no prior data were available to determine control multivessel MACE rates, an imputed placebo statistical analysis plan incorporating a variable delta based on actually observed control DES MACE rates will be implemented. The results of COSTAR II will provide information about a novel coronary stent device as well as unique data regarding both control and test DES use in more complex “real-world” patients. [Copyright &y& Elsevier]