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Peters N.L.,Denver Veterans Administration Medical Center | Peters N.L.,University of Colorado at Denver | Meiklejohn G.,Denver Veterans Administration Medical Center | Meiklejohn G.,University of Colorado at Denver | Jahnigen D.W.,Cleveland Clinic
Journal of the American Geriatrics Society | Year: 2015

Recent reports have suggested that the antibody response of elderly persons to standard doses of influenza vaccine is depressed. We examined the effect of an additional threefold dose of influenza B vaccine on the antibody response in elderly, ambulatory veterans. One hundred thirty-one male subjects aged 70 years and older were randomized to receive one of three influenza vaccine regimens: Group I received standard trivalent influenza vaccine containing 15 micrograms of B/USSR/100/83 in one arm and placebo in the other; Group II received standard trivalent vaccine in one arm and a supplemental dose of 45 micrograms of B/USSR in the other; Group III received the same dose as group II combined in one arm with a placebo in the other. Antibody levels were measured at baseline, 1 month, and 5 months. Nearly 80% of the participants achieved levels of antibody to B/USSR considered protective; seroconversion rates varied from 40% to 61%. No significant differences in antibody response to B/USSR occurred among the vaccine groups, and there were more side effects at higher doses. The higher dose groups did, however, achieve greater antibody levels to the drifted influenza B virus which circulated during the year of the study. Response to the influenza A components of the vaccine, however, may have been blunted in Group III which received a large dose of A and B antigens all at one site. © 1988 The American Geriatrics Society.


Dattilo P.B.,Aurora University | Tsai T.T.,Denver Veterans Administration Medical Center | Garcia J.A.,Denver Health Medical Center | Allshouse A.,Aurora University | And 2 more authors.
Catheterization and Cardiovascular Interventions | Year: 2012

Objectives: We sought to evaluate the clinical outcomes of a consecutive series of patients treated for iliac artery occlusive disease (IAOD) using contemporary endovascular technology and techniques. Background: As an increasingly complex spectrum of IAOD is treated using endovascular revascularization, there is a need to examine the rates of acute procedural success, complications, and patency to validate the role of an endovascular- first approach to revascularization in contemporary practice. Methods: All patients with IAOD who were treated using endovascular therapy between September 2005 and September 2010 were identified from a prospectively collected database. Baseline patient characteristics, anatomic details, procedural data, and clinical outcomes were assessed retrospectively. Patency and mortality rates were estimated with the Kaplan-Meier method. Results: A total 59 patients underwent 62 procedures. Trans-Atlantic Inter-Society Consensus (TASC) II types B, C, and D disease accounted for 59%, 7%, and 37% of patients, respectively. The procedure was technically successful in 60 of 62 cases (97%) with no procedure-related mortality. Major complications occurred in five procedures (8%). The mean (±standard deviation) duration of follow-up was 2.3 ± 1.4 years. In patients with a successful revascularization, primary and secondary patency rates were 86% and 94% at 1 year, and 77% and 91% at 2 years, respectively. The TASC II classification of disease did not predict the rate of acute technical success or medium-term patency rates. Conclusions: The acute and medium-term clinical outcomes of this series of patients with anatomically complex IAOD support the current paradigm of an endovascular-first approach to revascularization. © 2012 Wiley Periodicals Inc.


Reusch J.,Denver Veterans Administration Medical Center | Stewart M.W.,Glaxosmithkline | Perkins C.M.,PPD Inc | Cirkel D.T.,Glaxosmithkline | And 4 more authors.
Diabetes, Obesity and Metabolism | Year: 2014

Aims: To show that albiglutide, a glucagon-like peptide-1 receptor agonist, is an effective and generally safe treatment to improve glycaemic control in patients with type 2 diabetes mellitus whose hyperglycaemia is inadequately controlled with pioglitazone (with or without metformin). Methods: In this 3-year, randomized, double-blind, placebo-controlled study, 310 adult patients on a regimen of pioglitazone (with or without metformin) were randomly assigned to receive additional treatment with albiglutide [30 mg subcutaneous (s.c.) once weekly, n = 155] or matching placebo (n = 155). The primary efficacy endpoint was change from baseline to week 52 (intention-to-treat) in glycated haemoglobin (HbA1c). Results: The model-adjusted change from baseline in HbA1c at week 52 was significantly better with albiglutide than with placebo (-0.8%, 95% confidence interval -1.0, -0.6; p < 0.0001). Change from baseline fasting plasma glucose was -1.3 mmol/l in the albiglutide group and +0.4 mmol/l in the placebo group (p < 0.0001); a significantly higher percentage of patients reached the HbA1c goals with albiglutide (p < 0.0001), and the rate of hyperglycaemia rescue up to week 52 for albiglutide was 24.4 versus 47.7% for placebo (p < 0.0001). Albiglutide plus pioglitazone had no impact on weight, and severe hypoglycaemia was observed rarely (n = 2). With few exceptions, the results of safety assessments were similar between the groups, and most adverse events (AEs) were mild or moderate. The 52-week incidence rates for gastrointestinal AEs for albiglutide and placebo were: 31.3 and 29.8%, respectively (diarrhoea: 11.3 and 8.6%; nausea: 10.7 and 11.3%; vomiting: 4.0 and 4.0%). Conclusions: Albiglutide 30 mg administered once weekly as an add-on to pioglitazone (with or without metformin) provided effective and durable glucose lowering and was generally well tolerated. © 2014 John Wiley & Sons Ltd.


Dattilo P.B.,Aurora University | Tsai T.T.,Denver Veterans Administration Medical Center | Casserly I.P.,Aurora University | Casserly I.P.,Denver Veterans Administration Medical Center
Catheterization and Cardiovascular Interventions | Year: 2013

Background Common femoral endarterectomy is regarded as the standard revascularization strategy for the treatment of common femoral artery (CFA) disease. The availability of a variety of endovascular tools has resulted in an increased number of patients with CFA disease being treated using an endovascular strategy. We sought to evaluate clinical outcomes in a contemporary series of patients who were treated for CFA disease using an endovascular-first approach. Methods All patients with obstructive CFA disease who were treated using endovascular therapy were retrospectively identified from a peripheral interventional database. Baseline patient characteristics, anatomic details, procedural data, and clinical outcomes were assessed. Kaplan-Meier (KM) curves for mortality, amputation-free survival, and primary and secondary patency were generated. Results Between 2006 and 2011, a total of 30 patients underwent 31 CFA procedures. The primary etiologies of CFA obstruction were atherosclerosis (58%), access-site-related complication (32%), and thromboembolism (10%). Patients presented with severe claudication (60%), critical limb ischemia (13%), or acute limb ischemia (27%). The procedure was technically successful in 90% of cases with major complications in two (7%) patients. There was no procedure-related mortality. The KM estimate of survival and amputation-free survival at 1 year was 96% (±4%) and 96% (±4%), respectively. In those patients who had a successful revascularization, the overall 1-year estimate for primary and secondary patency was 88% (±6) and 92% (±5%), respectively. There was a nonsignificant trend toward lower patency in patients treated for atherosclerotic disease compared to those with access-site-related complications and thromboembolic disease at 2-year follow-up (76 vs. 100%, P = 0.08). Conclusions Endovascular therapy for treatment of obstructive disease of the CFA is associated with a high rate of acute technical success. Primary patency rates in the cohort treated for access-site-related complications and thromboembolic disease are excellent and support an endovascular-first approach for this patient subset. Based on lower patency rates, surgical endarterectomy for the treatment of atherosclerotic disease in the CFA remains the gold standard in patients with normal surgical risk. © 2013 Wiley Periodicals, Inc.


Lillehei K.O.,University of Colorado at Denver | Widdel L.,University of Colorado at Denver | Arias Astete C.A.,University of Colorado at Denver | Wierman M.E.,University of Colorado at Denver | And 3 more authors.
Journal of Neurosurgery | Year: 2011

Object. The aim of this study was to report the results of a large clinical series of patients with symptomatic Rathke cleft cysts (RCCs) who underwent resection by a single neurosurgeon using intraoperative alcohol cauterization, and to review any possible differences in recurrence rates in those treated with this chemically ablative technique. Methods. The authors performed a retrospective database review of 82 patients (age range 10-74 years) with symptomatic RCCs who underwent surgery between 1993 and 2009. Results. Preoperative symptoms of headaches, vision disturbances, and hormone dysfunction were observed in 68%, 35%, and 56% of patients, respectively. All 82 patients underwent treatment by a single surgeon. Surgery consisting of simple cyst drainage followed by cyst wall biopsy without vigorous cyst wall removal was performed. A subset of these patients (62) received intraoperative alcohol instillation. Perioperative complication rates were low: CSF leakage, symptomatic hyponatremia, and permanent diabetes insipidus (DI) in 2%, 5%, and 0% of patients, respectively. Headaches and vision problems improved or resolved in 71% and 83% of patients, respectively. In addition, hyperprolactinemia, hypothyroidism, panhypopituitarism, DI, and adrenal insufficiency improved or resolved in 94%, 90%, 50%, 33%, and 67% of patients, respectively. Recurrence, as defined by enlargement of the cyst as compared with its appearance on baseline 3-month postoperative MR imaging, was noted in 10.7% of the primary surgery group. There was a trend toward increased recurrence rates in the alcohol-treated (12.9%) versus no-alcohol treatment groups (0%), although not statistically significant (p = 0.20). Conclusions. This large, single-surgeon/single-institution series of patients with symptomatic RCCs confirms that significant postoperative improvement in headaches, vision, and pituitary hormone dysfunction can be achieved via a conservative surgical approach, with low complication and recurrence rates. The data also demonstrate a limited role for alcohol cauterization in the treatment of symptomatic RCCs.


Rogers R.K.,University of Colorado at Denver | Dattilo P.B.,University of Colorado at Denver | Garcia J.A.,Denver Health Medical Center | Tsai T.,Denver Veterans Administration Medical Center | Casserly I.P.,University of Colorado at Denver
Catheterization and Cardiovascular Interventions | Year: 2011

A significant proportion (∼20%) of patients with complex tibial artery occlusions cannot be treated using a conventional antegrade approach. We report our experience using the retrograde approach for the treatment of complex tibial artery occlusive disease using retrograde pedal/tibial access in 13 limbs from 12 patients. Retrograde pedal/tibial access was achieved in all cases (facilitated by surgical cutdown in one case), and procedural success was achieved in 11 of 13 limbs (85%). Based on this experience, a discussion of clinical and technical aspects of the retrograde pedal/tibial approach is provided, and a new classification for tibial artery occlusive disease is proposed. © 2011 Wiley-Liss, Inc.


Stoneback J.W.,University of Colorado at Denver | Owens B.D.,U.S. Army | Sykes J.,University of Colorado at Denver | Athwal G.S.,University of Western Ontario | And 2 more authors.
Journal of Bone and Joint Surgery - Series A | Year: 2012

Background: There is minimal published information regarding the epidemiology of simple elbow dislocations. The purpose of this study was to report the estimated incidence of elbow dislocations in the United States, with use of the National Electronic Injury Surveillance System (NEISS) database. Methods: The NEISS database includes 102 hospitals representing a random sampling of all patients presenting to U.S. emergency departments. The database was queried for elbow dislocation events. NEISS data for 2002 through 2006 were used for raw data and weighted injury counts. Incidence rates with 95% confidence intervals (95% CI) were calculated by age group and sex, with use of U.S. census data. Results: One thousand and sixty-six elbow dislocations were identified, representing a weighted estimate of 36,751 acute dislocations nationwide. A calculated incidence of 5.21 dislocations per 100,000 person-years (95% CI, 4.74 to 5.68) was noted. The highest incidence of elbow dislocations (43.5%) occurred in those who were ten to nineteen years old (6.87 per 100,000 person-years; 95% CI, 5.97 to 7.76). The incidence rate ratio for the comparison of dislocations in males with those in females was 1.02 (5.26 per 100,000 for males and 5.16 per 100,000 for females). In patients ten years or older, 474 injuries (44.5% of total dislocations) were sustained in sports. Males dislocated elbows in football, wrestling, and basketball. Females sustained elbow dislocations most frequently in gymnastics and skating activities. Conclusions: The estimated incidence of elbow dislocations in the U.S. population is 5.21 per 100,000 person-years, with use of a national database. Adolescent males are at highest risk for dislocation. Nearly half of acute elbow dislocations occurred in sports, with males at highest risk with football, and females at risk with gymnastics and skating activities. Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2012 by The Journal of Bone and Joint Surgery Incorporated.


Chan P.S.,Saint Lukes Mid America Heart and Vascular Institute | Chan P.S.,University of Missouri - Kansas City | Patel M.R.,Duke Clinical Research Institute | Klein L.W.,University of Illinois at Chicago | And 11 more authors.
JAMA - Journal of the American Medical Association | Year: 2011

Context: Despite the widespread use of percutaneous coronary intervention (PCI), the appropriateness of these procedures in contemporary practice is unknown. Objective: To assess the appropriateness of PCI in the United States. Design, Setting, and Patients: Multicenter, prospective study of patients within the National Cardiovascular Data Registry undergoing PCI between July 1, 2009, and September 30, 2010, at 1091 US hospitals. The appropriateness of PCI was adjudicated using the appropriate use criteria for coronary revascularization. Results were stratified by whether the procedure was performed for an acute (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina with high-risk features) or nonacute indication. Main Outcome Measures: Proportion of acute and nonacute PCIs classified as appropriate, uncertain, or inappropriate; extent of hospital-level variation in inappropriate procedures. Results: Of 500 154 PCIs, 355 417 (71.1%) were for acute indications (ST-segment elevation myocardial infarction, 103 245 [20.6%]; non-ST-segment elevation myocardial infarction, 105 708 [21.1%]; high-risk unstable angina, 146 464 [29.3%]), and 144 737 (28.9%) for nonacute indications. For acute indications, 350 469 PCIs (98.6%) were classified as appropriate, 1055 (0.3%) as uncertain, and 3893 (1.1%) as inappropriate. For nonacute indications, 72 911 PCIs (50.4%) were classified as appropriate, 54 988 (38.0%) as uncertain, and 16 838 (11.6%) as inappropriate. The majority of inappropriate PCIs for nonacute indications were performed in patients with no angina (53.8%), low-risk ischemia on noninvasive stress testing (71.6%), or suboptimal (≤1 medication) antianginal therapy (95.8%). Furthermore, although variation in the proportion of inappropriate PCI across hospitals was minimal for acute procedures, there was substantial hospital variation for nonacute procedures (median hospital rate for inappropriate PCI, 10.8%; interquartile range, 6.0%-16.7%). Conclusions: In this large contemporary US cohort, nearly all acute PCIs were classified as appropriate. For nonacute indications, however, 12% were classified as inappropriate, with substantial variation across hospitals. ©2011 American Medical Association. All rights reserved.


Rogers R.K.,University of Colorado at Denver | Rogers R.K.,Denver Veterans Administration Medical Center | Tsai T.,University of Colorado at Denver | Tsai T.,Denver Veterans Administration Medical Center | And 2 more authors.
Catheterization and Cardiovascular Interventions | Year: 2010

We report the novel application of the Controlled Antegrade and Retrograde subintimal Tracking technique for the endovascular treatment of occlusions of the external iliac artery (EIA). We hypothesized that this technique would limit the extent of subintimal dissection to the length of the EIA occlusion, thus preserving patency of the internal iliac artery proximally and the circumflex iliac artery distally and minimizing the length of stent required to treat the occlusion, including the length of stent placed in the common femoral artery. The technical execution and clinical experience with this technique is reported. © 2009 Wiley-Liss, Inc.


Khandrika L.,University of Colorado at Denver | Koul S.,University of Colorado at Denver | Meacham R.B.,University of Colorado at Denver | Koul H.K.,University of Colorado at Denver | Koul H.K.,Denver Veterans Administration Medical Center
PLoS ONE | Year: 2012

Oxalate is a metabolic end product excreted by the kidney. Mild increases in urinary oxalate are most commonly associated with Nephrolithiasis. Chronically high levels of urinary oxalate, as seen in patients with primary hyperoxaluria, are driving factor for recurrent renal stones, and ultimately lead to renal failure, calcification of soft tissue and premature death. In previous studies others and we have demonstrated that high levels of oxalate promote injury of renal epithelial cells. However, methods to monitor oxalate induced renal injury are limited. In the present study we evaluated changes in expression of Kidney Injury Molecule-1 (KIM-1) in response to oxalate in human renal cells (HK2 cells) in culture and in renal tissue and urine samples in hyperoxaluric animals which mimic in vitro and in vivo models of hyper-oxaluria. Results presented, herein demonstrate that oxalate exposure resulted in increased expression of KIM-1 m RNA as well as protein in HK2 cells. These effects were rapid and concentration dependent. Using in vivo models of hyperoxaluria we observed elevated expression of KIM-1 in renal tissues of hyperoxaluric rats as compared to normal controls. The increase in KIM-1 was both at protein and mRNA level, suggesting transcriptional activation of KIM-1 in response to oxalate exposure. Interestingly, in addition to increased KIM-1 expression, we observed increased levels of the ectodomain of KIM-1 in urine collected from hyperoxaluric rats. To the best of our knowledge our studies are the first direct demonstration of regulation of KIM-1 in response to oxalate exposure in renal epithelial cells in vitro and in vivo. Our results suggest that detection of KIM-1 over-expression and measurement of the ectodomain of KIM-1 in urine may hold promise as a marker to monitor oxalate nephrotoxicity in hyperoxaluria. © 2012 Khandrika et al.

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