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PubMed2006

Effect of everolimus-eluting stents in different vessel sizes (from the pooled FUTURE I and II trials).

The everolimus-eluting stent (EES) has been shown to significantly decrease neointimal proliferation at 6 months compared with the bare metal stent (BMS) in patients with de novo coronary lesions. We report mid-term outcomes based on different vessel sizes in the combined FUTURE I and II trials. In the prospective, randomized, FUTURE I trial (single center) and expanded FUTURE II trial (multicenter), 106 patients (107 lesions) were randomized to EESs (n = 49 lesions) or BMSs (n = 58 lesions). Patients were categorized into 3 groups based on preprocedure reference diameter as assessed by quantitative coronary angiography (small vessel < 2.75 mm, medium vessel 2.75 to 3.25 mm, and large vessel > 3.25 mm). At 6-month follow-up, EESs decreased in-stent late lumen loss (decreased rate range of 78% to 94%), resulting in significantly larger minimum lumen area as assessed by intravascular ultrasound (increased range of 34% to 42%) compared with the BMS across all vessel sizes. There were no cases of in-stent restenosis with EESs at any vessel size but 8 cases with BMSs (5 in small vessels). No stent thrombosis, aneurysm formation, or late stent incomplete apposition was observed in any group. The EES appears to be effective for treatment of de novo coronary lesions in decreasing neointimal proliferation at 6-month follow-up compared with BMSs, regardless of vessel size.

Aged↗

PubMed2006

Effect of body mass index on risk of long-term mortality following coronary artery bypass grafting.

The effect of obesity on long-term mortality after coronary artery bypass grafting (CABG) remains inconclusive, partly due to methodologic issues in previous studies. We examined the effect of obesity on long-term mortality (up to a 6-year follow-up) in adult patients with a body mass index (BMI) > or =18.5 kg/m2 who underwent CABG at Baylor University Medical Center (Dallas, Texas) between January 1998 and August 1999 (n = 1,209). Unadjusted analysis indicated a strong association between BMI and long-term mortality (p = 0.001), with a decreased risk of mortality associated with increasing BMI. After adjusting for factors shown to be confounders of this relation (age, diabetes mellitus, chronic obstructive lung disease, renal failure, ejection fraction, and left main disease), the estimated association was no longer significant (p = 0.425). In conclusion, the apparent survival benefit associated with higher BMI became nonsignificant when the relation between mortality and BMI was adjusted, first for age and then for diabetes mellitus, chronic obstructive lung disease, renal failure, ejection fraction, and left main disease. This relation was masked in the crude analysis primarily by the effect of age. Patients with a high BMI were typically younger than patients with a lower BMI, suggesting that physicians and surgeons may only recommend/perform CABG for patients with a high BMI with an otherwise lower risk profile.

Adult↗

PubMed2004

Effects of sustained audit/feedback on self-reported health status of primary care patients.

PURPOSE: Because limited audit/feedback of health status information has yielded mixed results, we evaluated the effects of a sustained program of audit/feedback on patient health and satisfaction. METHODS: We conducted a group-randomized effectiveness trial in which firms within Veterans Administration general internal medicine clinics served as units of randomization, intervention, and analysis. Respondents to a baseline health inventory were regularly mailed the 36-Item Short Form (SF-36) and, as relevant, questionnaires about six chronic conditions (ischemic heart disease, diabetes, chronic obstructive pulmonary disease, depression, alcohol use, and hypertension) and satisfaction with care. Data were reported to primary providers at individual patient visits and in aggregate during a 2-year period. RESULTS: Baseline forms were mailed to 34,050 patients; of the 22,413 respondents, 15,346 completed and returned follow-up surveys. Over the 2-year study, the difference between intervention and control groups (as measured by difference in average slope) was -0.26 (95% confidence interval [CI]: -0.79 to 0.27; P=0.28) for the SF-36 Physical Component Summary score and -0.53 (95% CI: -1.09 to 0.03; P=0.06) for the SF-36 Mental Component Summary score. No significant differences emerged after adjusting for deaths. There were no significant differences in condition-specific measures or satisfaction between groups after adjustment for provider type, panel size, and number of intervention visits, or after analysis of patients who completed all forms. CONCLUSION: An elaborate, sustained audit/feedback program of general and condition-specific measures of health/satisfaction did not improve outcomes. To be effective, such data probably should be incorporated into a comprehensive chronic disease management program.

Aged↗

PubMed2006

Incidence and risk factors for urinary retention after endoscopic hernia repair.

BACKGROUND: Postoperative urinary retention (PO-UR) frequently complicates the repair of inguinal hernias. The purpose of this study was to determine the incidence of and risk factors for developing PO-UR in patients undergoing endoscopic inguinal hernia repair. METHODS: The incidence of PO-UR was determined by a retrospective review of a prospective patient database for all patients undergoing inguinal hernia repair by 1 surgeon from 2001 to 2003 at a tertiary referral center. A case-control study was used to identify risk factors for the development of PO-UR. RESULTS: Thirty-four (22.2%) out of 153 patients undergoing endoscopic inguinal hernia repair developed PO-UR. The use of narcotic analgesia and the volume of intravenous postoperative fluid administered were significant risk factors (P < .05) for the development of PO-UR. CONCLUSIONS: Postoperative urinary retention is common after totally extraperitoneal and transabdominal preperitoneal inguinal hernia repairs and is associated directly with increased narcotic and postoperative intravenous fluid administration.

Adolescent↗

PubMed2005

Effect of increased ICU capacity on emergency department length of stay and ambulance diversion.

STUDY OBJECTIVE: Lack of inpatient bed availability has been identified as a major contributor to emergency department (ED) crowding. Our objective is to determine the changes in ED length of stay and ambulance diversion occurring in an urban, academic medical center after an increase in adult ICU beds. METHODS: This was a secondary analysis of 2 years of hospital administrative data, capitalizing on a natural experiment in which the number of adult ICU beds in the study hospital increased from 47 to 67 (total beds 411 to 431). We analyzed changes in ED length of stay for adults admitted to ICU, telemetry beds, and ward beds and adults discharged home. We also analyzed changes in hours per day spent on 3 types of ambulance diversion: complete diversion (all ambulances), critical care diversion (ambulances carrying patients requiring ICU beds), and diversion of ambulances carrying trauma patients. RESULTS: The average hours per day on complete ambulance diversion decreased from 3.8 hours to 1.4 hours (66% decrease). Critical care and trauma diversion showed similar decreases. Average ED length of stay for patients admitted to the ICU decreased by 25 minutes (257 to 232 minutes). Average ED length of stay did not significantly decrease for other admitted patients and increased for discharged patients. CONCLUSION: The most notable change after ICU expansion was a decrease in time spent on ambulance diversion. Increasing ICU beds appears to have shortened ED length of stay for ICU patients but has less effect on other admitted patients and apparently no effect on patients discharged home.

Academic Medical Centers↗

PubMed2006

Ambulance diversion and lost hospital revenues.

STUDY OBJECTIVE: We estimate ambulance revenues lost from each hour spent on ambulance diversion at an urban teaching hospital's emergency department (ED) and examine the financial impact of increased ICU capacity, which reduced diversion hours by 63%. METHODS: This was a secondary analysis of administrative data to determine the time and date of ambulance arrivals, as well as the insurance status and revenues from each ED patient arriving by ambulance between January 1, 2002, and December 31, 2003. The primary outcome measure was hourly revenues (ie, payments to the hospital) for ambulance patients. RESULTS: Ten thousand three hundred one adult, non-trauma-system ED patients arrived by ambulance in 2002 and 2003, with average hospital revenues of 4,492 dollars. Each hour spent on diversion was associated with 1,086 dollars (95% confidence interval 611 dollars to 1,461 dollars) in forgone hospital revenues from ambulance patients. In August 2002, the study hospital increased its staffed ICU beds from 47 to 67, and diversion decreased from an average of 307 to 114 hours per month. In association with the reduction in diversion, the hospital received more patients by ambulance, which translated into approximately 175,000 dollars in additional monthly revenues from ambulance patients. However, these gains were relatively small in relation to total ambulance revenues and to their large monthly variance. CONCLUSION: Ambulance patients generated substantial revenues for hospital services. Decreasing diversion time led to improved revenues. The potential for increased revenues may provide some incentive for hospitals to take greater efforts to reduce ambulance diversion.

Adult↗

PubMed2004

Demographic and socioeconomic factors associated with disparity in wheelchair customizability among people with traumatic spinal cord injury.

OBJECTIVES: To determine if a standard of care for wheelchair provision exists within the participating centers and if there is disparity in wheelchair customizability among the study sample. DESIGN: Convenience sample survey. SETTING: Thirteen Model Spinal Cord Injury Systems that provide comprehensive rehabilitation for people with traumatic spinal cord injury (SCI) and that are part of the national database funded through the US Department of Education. PARTICIPANTS: A total of 412 people with SCI who use wheelchairs over 40 hours a week. INTERVENTION: Survey information was obtained from subjects via telephone and in-person interviews and from the national database. Collected information included age, race, education, level of injury, and wheelchair funding source. MAIN OUTCOME MEASURES: Number and type (manual or power) of wheelchairs. Wheelchair customizability as defined by design features (eg, adjustable axle position, programmable controls). RESULTS: Ninety-seven percent of manual wheelchair users and 54% of power wheelchair users had customizable wheelchairs. No power wheelchair user received a wheelchair without programmable controls. Minorities with low socioeconomic backgrounds (low income, Medicaid/Medicare recipients, less educated) were more likely to have standard manual and standard programmable power wheelchairs. Older subjects were also more likely to have standard programmable power wheelchairs. CONCLUSIONS: The standard of care for manual wheelchair users with SCI is a lightweight and customizable wheelchair. The standard of care for power wheelchairs users has programmable controls. Unfortunately, socioeconomically disadvantaged people were less likely to receive customizable wheelchairs.

Activities of Daily Living↗

PubMed2004

Xenograft transplantation.

Interest in xenotransplantation has increased because conventional organ transplantation has been limited by a shortage of human organs. Although xenotransplantation could alleviate the existing and anticipated need for tissues and organs, the application is hindered by various biologic obstacles. This article reviews the basis for the demand for xenotransplantation, the obstacles to clinical application, and potential approaches to overcoming those obstacles.

Anesthesia↗

PubMed2004

Stimulation of porcine bone marrow stromal cells by hyaluronan, dexamethasone and rhBMP-2.

In the interest of optimizing osteogenesis in in vitro, the present study sought to determine how porcine bone marrow stromal cell (BMSc) would respond to different concentrations of hyaluronan (HY) and its different combinations with dexamethasone (Dex) and recombinant human bone morphogenic protein-2 (rhBMP-2). Cellular proliferation was determined by 3H-thymidine incorporation into DNA at both Days 2 and 7 when BMSc was cultivated with HY at concentrations of 0, 0.5, 1.0, 2.0 and 4.0 mg/ml. HY accelerated cellular proliferation when compared with cultures in the absence of HY at both Days 2 and 7. BMSc proliferation under the high HY concentration of 4 mg/ml was significantly higher than under the other, lower HY concentrations of 0.5, 1.0 and 2.0 mg/ml. When BMSc were cultivated under HY at concentrations of 0, 1.0 and 4.0 mg/ml and its 12 combinations with rhBMP-2 at concentrations of 0 and 10 ng/ml and Dex (+, -) at both Days 2 and 7, cellular responses were examined by 3H-thymidine incorporation into DNA, cellular alkaline phosphatase (ALP) activity, and pro-collagen type I C-terminal propeptide production. HY accelerated cellular proliferation irrespective of the presence of Dex and rhBMP-2. HY increased expression of ALP activity at Day 7, whereas had inhibitory effect at Day 2. HY and Dex showed an interaction on expression of ALP acitivity irrespective of the HY dose by Day 7. Collagen synthesis was inhibited by HY irrespective of the presence of other factors at both Days 2 and 7. When BMSc were cultivated with HY of 4.0 mg/ml alone, its combinations with Dex (+) and 10 ng/ml rhBMP-2, and with DMEM/FBS alone, expression of bone-related marker genes was evaluated by real-time reverse transcription-polymerase chain reaction (Real-time RT-PCR) analysis. Osteocalcin was up-regulated under both rhBMP-2 and HY-Dex-rhBMP-2 at Day 2, as also under 4 mg/ml HY, Dex, HY-Dex, Dex-rhBMP-2, and HY-Dex-rhBMP-2 by Day 7. Type 1alpha1 collagen was induced by rhBMP-2 on Day 2, and by Dex-rhBMP-2 on Day 7. Osteonectin and type X collagen was only marginally induced by HY at Day 2. Type 1alpha1 collagen and type X collagen were down-regulated in the presence of 4 mg/ml HY by Day 7. These results suggest that HY stimulates BMSc proliferation, osteocalcin gene expression, and a secretion of enzymes such as that of ALP activity in vitro. More importantly, HY can interact with Dex and rhBMP-2 to generate direct and specific cellular effects, which could be of major importance in bone tissue engineering.

Animals↗

PubMed2006

Mesenchymal stem cell ingrowth and differentiation on coralline hydroxyapatite scaffolds.

Culture of osteogenic cells on a porous scaffold could offer a new solution to bone grafting using autologous human mesenchymal stem cells (hMSC) from the patient. We compared coralline hydroxyapatite scaffolds with pore sizes of 200 and 500 microm for expansion and differentiation of hMSCs. We cultivated the hMSC statically or in spinner flasks for 1, 7, 14 and 21 days and found that the 200-microm pore scaffolds exhibited a faster rate of osteogenic differentiation than did the 500-microm pore scaffolds as shown by an alkaline phosphatase activity assay and real-time reverse transcriptase polymerase chain reaction for 10 osteogenic markers. The 500-microm scaffolds had increased proliferation rates and accommodated a higher number of cells (shown by DNA content, scanning electron microscopy and fluorescence microscopy). Thus the porosity of a 3D microporous biomaterial may be used to steer hMSC in a particular direction. We found that dynamic spinner flask cultivation of hMSC/scaffold constructs resulted in increased proliferation, differentiation and distribution of cells in scaffolds. Therefore, spinner flask cultivation is an easy-to-use inexpensive system for cultivating hMSCs on small to intermediate size 3D scaffolds.

Biocompatible Materials↗

PubMed2005

Cortical gray and white brain tissue volume in adolescents and adults with autism.

BACKGROUND: A number of studies have found brain enlargement in autism, but there is disagreement as to whether this enlargement is limited to early development or continues into adulthood. In this study, cortical gray and white tissue volumes were examined in a sample of adolescents and adults with autism who had demonstrated total brain enlargement in a previous magnetic resonance imaging (MRI) study. METHODS: An automated tissue segmentation program was applied to structural MRI scans to obtain volumes of gray, white, and cerebrospinal fluid (CSF) tissue on a sample of adolescent and adult males ages 13-29 with autism (n = 23) and controls (n = 15). Regional differences for brain lobes and brain hemispheres were also examined. RESULTS: Significant enlargement in gray matter volume was found for the individuals with autism, with a disproportionate increase in left-sided gray matter volume. Lobe volume enlargements were detected for frontal and temporal, but not parietal or occipital lobes, in the subjects with autism. Age and nonverbal IQ effects on tissue volume were also observed. CONCLUSIONS: These findings give evidence for left-lateralized gray tissue enlargement in adolescents and adults with autism, and demonstrate a regional pattern of cortical lobe volumes underlying this effect.

Adolescent↗

PubMed2005

The discovery and preparation of disubstituted novel amino-aryl-piperidine-based renin inhibitors.

Recently, trans-disubstituted oxo-aryl-piperidines have been identified as small molecule nonpeptide renin inhibitors for the modulation of hypertension. Herein, we report on the discovery and preparation of a new class of novel cis-disubstituted amino-aryl-piperidines as a mixture of enantiomers that are potent in vitro renin inhibitors and also, possess in vivo antihypertensive activity in a double transgenic mouse model.

Animals↗

PubMed2005

Discovery of novel non-peptidic ketopiperazine-based renin inhibitors.

Ketopiperazine 2 was designed from a previously published analog. Compound 2 was shown to be a novel, potent inhibitor of renin that, when administered orally, lowered blood pressure in a hypertensive double transgenic (human renin and angiotensinogen) mouse model. Compound 2 was further optimized to sub-nanomolar potency by designing an analog that addressed the S3 sub-pocket of the renin enzyme (16).

Animals↗

PubMed2006

The discovery of glycine and related amino acid-based factor Xa inhibitors.

Herein, we report on the identification of three potent glycine and related amino acid-based series of FXa inhibitors containing a neutral P1 chlorophenyl pharmacophore. A X-ray crystal structure has shown that constrained glycine derivatives with optimized N-substitution can greatly increase hydrophobic interactions in the FXa active site. Also, the substitution of a pyridone ring for a phenylsulfone ring in the P4 sidechain resulted in an inhibitor with enhanced oral bioavailability.

Crystallography, X-Ray↗

PubMed2004

Haloperidol: towards further understanding of the structural contributions of its pharmacophoric elements at D2-like receptors.

An attempt to understand the pharmacophore-relevant position of the alcoholic moiety in haloperidol and the contributions of other pharmacophoric elements led to the re-synthesis of its tropane analogue (compound 2). An analysis of the binding data suggests that haloperidol binds to the DA receptors with the OH group in the axial position and the OH group, while not essential for binding, enhances binding especially at the D2 receptor. It also became clear that shortening the butyrophenone chain not only reduces binding affinity at the DA receptors but eliminates subtype selectivity.

Haloperidol↗

PubMed2005

The discovery of fluoropyridine-based inhibitors of the Factor VIIa/TF complex.

The activated Factor VII/tissue factor complex (FVIIa/TF) plays a key role in the formation of blood clots. Inhibition of this complex may lead to new antithrombotic drugs. An X-ray crystal structure of a fluoropyridine-based FVIIa/TF inhibitor bound in the active site of the enzyme complex suggested that incorporation of substitution at the 5-position of the hydroxybenzoic acid side chain could lead to the formation of more potent inhibitors through interactions with the S1'/S2' pocket.

Binding Sites↗

PubMed2005

The discovery of fluoropyridine-based inhibitors of the factor VIIa/TF complex--Part 2.

The activated factor VII/tissue factor complex (FVIIa/TF) is known to play a key role in the formation of blood clots. Inhibition of this complex may lead to new antithrombotic drugs. A fluoropyridine-based series of FVIIa/TF inhibitors was discovered which utilized a diisopropylamino group for binding in the S2 and S3 binding pockets of the active site of the enzyme complex. In this series, an enhancement in binding affinity was observed by substitution at the 5-position of the hydroxybenzoic acid sidechain. An X-ray crystal structure indicates that amides at this position may increase inhibitor binding affinity through interactions with the S1'/S2' pocket.

Crystallography, X-Ray↗

PubMed2006

Ketopiperazine-based renin inhibitors: optimization of the "C" ring.

A systematic investigation of the S3 sub-pocket activity requirements was conducted. It was observed that linear and sterically small side chain substituents are preferred in the S3 sub-pocket for optimal renin inhibition. Polar groups in the S3-sub-pocket were not well tolerated and caused a reduction in renin inhibitory activity. Further, compounds with clog P's < or = 3 demonstrated a dramatic reduction in CYP3A4 inhibitory activity.

Crystallography, X-Ray↗