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Archive for the ‘Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound’ Category

Current Advanced Research Topics in MRI-based Management of Cancer Patients

 Author: Dror Nir, PhD

Step forward towards quantitative and reproducible MRI of cancer patients is the combination of structure and morphology based imaging with expressions of typical bio-chemical processes using imaging contrast materials. The following list brings the latest publications on this subject in Radiology magazine.

 The Effects of Applying Breast Compression in Dynamic Contrast Material–enhanced MR Imaging

Abstract

 Purpose: To evaluate the effects of breast compression on breast cancer masses, contrast material enhancement of glandular tissue, and quality of magnetic resonance (MR) images in the identification and characterization of breast lesions.

Materials and Methods: This was a HIPAA-compliant, institutional review board–approved retrospective study, with waiver of informed consent. Images from 300 MR imaging examinations in 149 women (mean age ± standard deviation, 51.5 years ± 10.9; age range, 22–76 years) were evaluated. The women underwent diagnostic MR imaging (no compression) and MR-guided biopsy (with compression) between June 2008 and February 2013. Breast compression was expressed as a percentage relative to the noncompressed breast. Percentage enhancement difference was calculated between noncompressed- and compressed-breast images obtained in early and delayed contrast-enhanced phases. Breast density, lesion type (mass vs non-masslike enhancement [NMLE]), lesion size, percentage compression, and kinetic curve type were evaluated. Linear regression, receiver operating characteristic (ROC) curve analysis, and κ test were performed.

Conclusion: Breast compression during biopsy affected breast lesion detection, lesion size, and dynamic contrast-enhanced MR imaging interpretation and performance. Limiting the application of breast compression is recommended, except when clinically necessary.

 Localized Prostate Cancer Detection with 18F FACBC PET/CT: Comparison with MR Imaging and Histopathologic Analysis

Abstract

 Purpose: To characterize uptake of 1-amino-3-fluorine 18-fluorocyclobutane-1-carboxylic acid (18F FACBC) in patients with localized prostate cancer, benign prostatic hyperplasia (BPH), and normal prostate tissue and to evaluate its potential utility in delineation of intraprostatic cancers in histopathologically confirmed localized prostate cancer in comparison with magnetic resonance (MR) imaging.

Materials and Methods: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant prospective study. Twenty-one men underwent dynamic and static abdominopelvic 18F FACBC combined positron emission tomography (PET) and computed tomography (CT) and multiparametric (MP) 3-T endorectal MR imaging before robotic-assisted prostatectomy. PET/CT and MR images were coregistered by using pelvic bones as fiducial markers; this was followed by manual adjustments. Whole-mount histopathologic specimens were sliced with an MR-based patient-specific mold. 18F FACBC PET standardized uptake values (SUVs) were compared with those at MR imaging and histopathologic analysis for lesion- and sector-based (20 sectors per patient) analysis. Positive and negative predictive values for each modality were estimated by using generalized estimating equations with logit link function and working independence correlation structure.

Conclusion: 18F FACBC PET/CT shows higher uptake in intraprostatic tumor foci than in normal prostate tissue; however, 18F FACBC uptake in tumors is similar to that in BPH nodules. Thus, it is not specific for prostate cancer. Nevertheless, combined 18F FACBC PET/CT and T2-weighted MR imaging enable more accurate localization of prostate cancer lesions than either modality alone.

Illuminating Radiogenomic Characteristics of Glioblastoma Multiforme through Integration of MR Imaging, Messenger RNA Expression, and DNA Copy Number Variation

 Abstract

Purpose: To perform a multilevel radiogenomics study to elucidate the glioblastoma multiforme (GBM) magnetic resonance (MR) imaging radiogenomic signatures resulting from changes in messenger RNA (mRNA) expression and DNA copy number variation (CNV).

Materials and Methods: Radiogenomic analysis was performed at MR imaging in 23 patients with GBM in this retrospective institutional review board–approved HIPAA-compliant study. Six MR imaging features—contrast enhancement, necrosis, contrast-to-necrosis ratio, infiltrative versus edematous T2 abnormality, mass effect, and subventricular zone (SVZ) involvement—were independently evaluated and correlated with matched genomic profiles (global mRNA expression and DNA copy number profiles) in a significant manner that also accounted for multiple hypothesis testing by using gene set enrichment analysis (GSEA), resampling statistics, and analysis of variance to gain further insight into the radiogenomic signatures in patients with GBM

Conclusion: Construction of an MR imaging, mRNA, and CNV radiogenomic association map has led to identification of MR traits that are associated with some known high-grade glioma biomarkers and association with genomic biomarkers that have been identified for other malignancies but not GBM. Thus, the traits and genes identified on this map highlight new candidate radiogenomic biomarkers for further evaluation in future studies.

PET/MR Imaging: Technical Aspects and Potential Clinical Applications

Abstract

Instruments that combine positron emission tomography (PET) and magnetic resonance (MR) imaging have recently been assembled for use in humans, and may have diagnostic performance superior to that of PET/computed tomography (CT) for particular clinical and research applications. MR imaging has major strengths compared with CT, including superior soft-tissue contrast resolution, multiplanar image acquisition, and functional imaging capability through specialized techniques such as diffusion-tensor imaging, diffusion-weighted (DW) imaging, functional MR imaging, MR elastography, MR spectroscopy, perfusion-weighted imaging, MR imaging with very short echo times, and the availability of some targeted MR imaging contrast agents. Furthermore, the lack of ionizing radiation from MR imaging is highly appealing, particularly when pediatric, young adult, or pregnant patients are to be imaged, and the safety profile of MR imaging contrast agents compares very favorably with iodinated CT contrast agents. MR imaging also can be used to guide PET image reconstruction, partial volume correction, and motion compensation for more accurate disease quantification and can improve anatomic localization of sites of radiotracer uptake, improve diagnostic performance, and provide for comprehensive regional and global structural, functional, and molecular assessment of various clinical disorders. In this review, we discuss the historical development, software-based registration, instrumentation and design, quantification issues, potential clinical applications, potential clinical roles of image segmentation and global disease assessment, and challenges related to PET/MR imaging.

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CVD Prevention and Evaluation of Cardiovascular Imaging Modalities: Coronary Calcium Score by CT Scan Screening to justify or not the Use of Statin

Curator: Aviva Lev-Ari, PhD, RN

Opinion Leader:  Khurram Nasir, M.D., MPH

One of four Symposium Directors

2014 12th Annual Cardiovascular Disease Prevention International Symposium 

Thursday – Sunday, February 6-9, 2014 Fontainebleau Hotel, Miami Beach, Florida

As reported in Time Magazine, March 10, 2014, A Smarter Heart-Health Test Screening for calcium could get millions OFF Statins.

According to Dr. Nasir, 35% of people who have calcium buildup aka plaque in their blood vessels but NO other heart disease risk factors are almost four times as likely to have a heart event in seven years, compared with those who have zero calcium and some risk factors.

Other Heart Health Warning Signs:

  • High levels of C-Reactive Protein (CRP)
  • Differing Blood Pressure in Arms and Ankles
  • Genetically-derived very high LDL

With the new Cholesterol guidelines that have dropped the threshold for starting cholesterol lowering drugs, i.e, Statins – 31 million adults could be prescribed Statin for the remainder life span.

Voices from the Cleveland Clinic: On the New Lipid Guidelines and On the ACC/AHA Risk Calculator

SOLUTION suggested by Dr. Nasir

CVD Prevention and Evaluation of Cardiovascular Imaging Modalities: Coronary Calcium Score by CT Scan Screening to justify or not the Use of Statin

Circ Cardiovasc Imaging. 2014 Feb 18. [Epub ahead of print]

Prognostic Value of Non-Obstructive and Obstructive Coronary Artery Disease Detected by Coronary Computed Tomography Angiography To Identify Cardiovascular Events.

Bittencourt MS1Hulten EGhoshhajra BO’Leary DChristman MPMontana PTruong QASteigner MMurthy VRybicki FJNasir KGowdak LHHainer J,Brady TJDi Carli MFHoffmann UAbbara SBlankstein R.

Author information

  • 11Non-Invasive Cardiovascular Imaging Program, Departments of Medicine and Radiology; Brigham and Women’s Hospital; Harvard Medical School, Boston, MA; Heart Institute – University of São Paulo, São Paulo, Brazil.

Abstract

BACKGROUND:

-The contribution of plaque extent to predict cardiovascular (CV) events among patients with non-obstructive and obstructive coronary artery disease (CAD) is not well defined. Our objective was to evaluate the prognostic value of plaque extent detected by coronary computed tomography (CTA).

METHODS AND RESULTS:

-All consecutive patients without prior CAD referred for coronary CTA to evaluate for CAD were included. Exam findings were classified as normal, non-obstructive (<50% stenosis) or obstructive (≥50%). Based on the number of segments with disease, extent of CAD was classified as non-extensive (≤4 segments) or extensive (>4 segments). The cohort included 3242 patients followed for the primary outcome of cardiovascular (CV) death or myocardial infarction (MI) for a median of 3.6 (2.1 – 5.0) years. In a multivariable analysis, the presence of extensive non-obstructive CAD (HR 3.1, 95% confidence interval (CI):1.5-6.4); non-extensive obstructive (HR 3.0, 95%CI: 1.3-6.9) and extensive obstructive CAD (HR:3.9, 95%CI:2.2-7.2) were associated with an increased rate of events, while non-extensive non-obstructive CAD was not. The addition of plaque extent to a model that included clinical probability as well as the presence and severity of CAD improved risk prediction.

CONCLUSIONS:

Among patients with non-obstructive CAD, those with extensive plaque experienced a higher rate CV death or MI, comparable to those who have non-extensive obstructive disease. Even among patients with obstructive CAD, greater extent of non-obstructive plaque was associated with higher event rate. Our findings suggest that regardless whether obstructive or non-obstructive disease is present, the extent of plaque detected by coronary CTA enhances risk assessment.

KEYWORDS:

computed tomography angiography, coronary artery disease, prognosis, risk assessment

SOURCE
PMID: 24550435
http://www.ncbi.nlm.nih.gov/pubmed/24550435

Related article 

 

Atherosclerosis. 2014 Mar;233(1):190-5. doi: 10.1016/j.atherosclerosis.2013.12.029. Epub 2014 Jan 8.

Incremental prognostic value of coronary artery calcium score versus CT angiography among symptomatic patients without known coronary artery disease.

Hulten E1Bittencourt MS2Ghoshhajra B3O’Leary D4Christman MP4Blaha MJ5Truong Q6Nelson K4Montana P4Steigner M4Rybicki F4Hainer J4,Brady TJ3Hoffmann U3Di Carli MF4Nasir K7Abbara S3Blankstein R8.Author information

Abstract

OBJECTIVE:

To evaluate the prognostic value and test characteristics of coronary artery calcium (CAC) score for the identification of obstructive coronary artery disease (CAD) in comparison with coronary computed tomography angiography (CCTA) among symptomatic patients.

METHODS:

Retrospective cohort study at two large hospitals, including all symptomatic patients without prior CAD who underwent both CCTA and CAC. Accuracy of CAC for the identification of ≥50% and ≥70% stenosis by CCTA was evaluated. Prognostic value of CAC and CCTA were compared for prediction of major adverse cardiovascular events (MACE, defined as non-fatal myocardial infarction, cardiovascular death, late coronary revascularization (>90 days), and unstable angina requiring hospitalization).

RESULTS:

Among 1145 included patients, the mean age was 55 ± 12 years and median follow up 2.4 (IQR: 1.5-3.5) years. Overall, 406 (35%) CCTA were normal, 454 (40%) had <50% stenosis, and 285 (25%) had ≥50% stenosis. The prevalence of ≥70% stenosis was 16%. Among 483 (42%) patients with CAC zero, 395 (82%) had normal CCTA, 81 (17%) <50% stenosis, and 7 (1.5%) ≥ 50% stenosis. 2 (0.4%) patients had ≥70% stenosis. For diagnosis of ≥50% stenosis, CAC had a sensitivity of 98% and specificity of 55%. The negative predictive value (NPV) for CAC was 99% for ≥50% stenosis and 99.6% for ≥70% stenosis by CCTA. There were no adverse events among the 7 patients with zero calcium and ≥50% CAD. For prediction of MACE, the c-statistic for clinical risk factors of 0.62 increased to 0.73 (p < 0.001) with CAC versus 0.77 (p = 0.02) with CCTA.

CONCLUSION:

Among symptomatic patients with CAC zero, a 1-2% prevalence of potentially obstructive CAD occurs, although this finding was not associated with future coronary revascularization or adverse prognosis within 2 years.Published by Elsevier Ireland Ltd.KEYWORDS:Atherosclerosis, Coronary artery calcium score, Coronary computed tomography angiography, Epidemiology

SOURCE

PMID: 24529143 

http://www.ncbi.nlm.nih.gov/pubmed/24529143

Khurram Nasir, M.D., MPH

Research Director, Center for Prevention and Wellness

Director, High-risk Cardiovascular Disease Clinic

Baptist Health South Florida, Miami, Florida
Assistant Professor, Johns Hopkins Ciccarone Center for Preventive Cardiology
Baltimore, Maryland

Bio

Dr. Nasir is considered one of the top international experts in epidemiological outcome research, especially related to CVD prevention and evaluation of cardiovascular imaging modalities.
Dr. Nasir is author of over 200 publications. He has mentored multiple fellows over the last five years, many of whom now hold academic positions in major centers across the country. He was awarded the Young Investigator Award by Johns Hopkins University for his efforts in subclinical atherosclerosis risk associated with a sibling history of premature heart disease.
Most recently, Dr. Nasir was presented with the Young Investigator Award by the Multi-Ethnic Study of Atherosclerosis (MESA) for his contribution to advancing the science. He is an associate editor for the journal Atherosclerosis and serves on the editorial board for the Journal of Cardiac CT. Dr. Nasir lectures frequently and has invited presentations at the American College of Cardiology and has chaired sessions at the American College of Cardiology, American Heart Association and the Society of Cardiac CT. He is currently chair of the prevention council for the Society of Atherosclerosis Imaging and Prevention. He is reviewer for more than 16 journals, including JAMA, Circulation, Journal of American College of Cardiology, Atherosclerosis Thrombosis and Vascular Biology, American Heart Journal and American Journal of Cardiology. He serves as a consultant on various NIH, sponsored studies.

 SOURCE

http://cme.baptisthealth.net/cvdprevention/pages/faculty.aspx

257 Publication of Dr. Khurram Nasir on PubMed

http://www.ncbi.nlm.nih.gov/pubmed/?term=Khurram+Nasir

Other Speakers at the 2014 12th Annual Cardiovascular Disease Prevention International Symposium include the following renown Cardiologists:

2014  Faculty

Michael Ozner, M.D., FACC, FAHA
Symposium Director
Medical Director, Center for Prevention and Wellness
Baptist Health South Florida
Voluntary Assistant Professor of Medicine (Cardiology)
University of Miami Miller School of Medicine
Miami, Florida
Bio

     Dr. Ozner is one of America’s leading advocates for heart disease prevention. He is a Board-certified cardiologist, a Fellow of the American College of Cardiology and of the American Heart Association. Dr. Ozner is a well-known regional and national speaker in the field of preventive cardiology. He has frequently appeared in the print, radio and television media including The New York Times, NPR radio and CBS News. He was the recipient of the 2008 American Heart Association Humanitarian Award and has been elected to Top Cardiologists in America by the Consumer Council of America. Dr. Ozner is also the author of The Miami Mediterranean Diet and The Great American Heart Hoax. His new book, Heart Attack Proof, was released worldwide in April 2012.

Theodore Feldman, M.D., FACC, FACP
Symposium Director 

Medical Director, South Miami Heart Center
Medical Director, Center for Prevention and Wellness
Baptist Health South Florida
Clinical Associate Professor of Medicine
Florida International University Herbert
Wertheim College of Medicine
Miami, Florida
Bio

     Dr. Feldman is Board-certified in internal medicine with a subspecialty in cardiovascular medicine. He received his undergraduate degree from Harvard University and his medical degree from Albert Einstein College of Medicine in New York. He completed his residency at University of Miami/Jackson Memorial Hospital, where he was chief medical resident. He also completed a cardiology fellowship at UM/Jackson.
Dr. Feldman serves on numerous boards, including those of the American Heart Association, Miami-Dade County, HealththeHeart.com, and Liposcience, Inc. He sits on the Private Sector Relations Committee of the American College of Cardiology and is a councilor with the Florida Chapter of the American College of Cardiology.
Dr. Feldman has given numerous lectures on the topic of wellness and prevention of heart disease both locally and internationally, and has served as the principal investigator in research studies on congestive heart failure, hyperlipidemia, hypertension, atrial fibrillation, diabetes and more. His research findings have been widely published in the medical literature.

Arthur Agatston, M.D., FACC
Symposium Director 
Medical Director, Center for Prevention and Wellness
Baptist Health South Florida
Professor, Florida International University Herbert Wertheim College of Medicine
Associate Professor of Medicine, University of Miami Miller School of Medicine
Miami, Florida

Bio

Dr. Arthur Agatston, is a renowned preventive cardiologist. He developed, with Baptist Health’s Warren Janowitz, M.D., a method to quantitate coronary atherosclerosis, named the Agatston Score for coronary calcium, which is used throughout the world and considered one of the best predictors of heart disease. Dr. Agatston is a graduate of New York University School of Medicine. He completed his medical residency at Montefiore Hospital and Medical Center in New York and a cardiology fellowship at New York University. He has published more than 100 scientific articles and abstracts in medical journals. His books, which in addition to The South Beach Diet, include The South Beach Heart Program: The 4-Step Plan that Can Save Your Life, and The South Beach Wake-Up Call.
After founding the nonprofit Agatston Research Foundation, he implemented the Healthier Options for Public School Children (HOPS) initiative. The published work carried out with more than 50,000 school-age children showed that after a dietary intervention, children’s weight, blood pressure and academic test scores improved compared to children without the HOPS process. Dr. Agatston continues to offer new observations and strategies on how to better pinpoint patients who are at high risk for heart attacks.

Khurram Nasir, M.D., MPH
Symposium Director 
Research Director, Center for Prevention and Wellness
Director, High-risk Cardiovascular Disease Clinic
Baptist Health South Florida, Miami, Florida
Assistant Professor, Johns Hopkins Ciccarone Center for Preventive Cardiology
Baltimore, Maryland
Bio

Dr. Nasir is considered one of the top international experts in epidemiological outcome research, especially related to CVD prevention and evaluation of cardiovascular imaging modalities.
Dr. Nasir is author of over 200 publications. He has mentored multiple fellows over the last five years, many of whom now hold academic positions in major centers across the country. He was awarded the Young Investigator Award by Johns Hopkins University for his efforts in subclinical atherosclerosis risk associated with a sibling history of premature heart disease.
Most recently, Dr. Nasir was presented with the Young Investigator Award by the Multi-Ethnic Study of Atherosclerosis (MESA) for his contribution to advancing the science. He is an associate editor for the journal Atherosclerosis and serves on the editorial board for the Journal of Cardiac CT. Dr. Nasir lectures frequently and has invited presentations at the American College of Cardiology and has chaired sessions at the American College of Cardiology, American Heart Association and the Society of Cardiac CT. He is currently chair of the prevention council for the Society of Atherosclerosis Imaging and Prevention. He is reviewer for more than 16 journals, including JAMA, Circulation, Journal of American College of Cardiology, Atherosclerosis Thrombosis and Vascular Biology, American Heart Journal and American Journal of Cardiology. He serves as a consultant on various NIH, sponsored studies.

Roger Blumenthal, M.D. 
Kenneth Jay Pollin, Professor of Medicine
Director, Ciccarone Preventive Cardiology Center
Johns Hopkins Hospital
Baltimore, Maryland
Bio

An experienced writer, Dr. Blumenthal is on the editorial board of Cardiology Today, the American Heart Journal, The Journal of Cardiovascular CT, and Clinical Cardiology. He regularly reviews manuscripts for many of the major cardiology and internal medicine journals. He is a fellow of the American College of Cardiology and the American Heart Association’s Epidemiology and Prevention Council.  He was editor-in-chief of the 2011 textbook Preventive Cardiology – A Companion to Braunwald’s Heart Disease. For many years he has been the medical editor of the annual Johns Hopkins White Paper on Prevention of Heart Attacks.

An expert in noninvasive detection of vascular disease, Dr. Blumenthal was also on the AHA’s official writing group about the utility of cardiac CT and CT angiography. He also was a member of the ACC task force dealing with selection of patients for atherosclerosis imaging techniques such as ultrafast CT scanning and carotid ultrasound. He is now vice-president of the American Society of Preventive Cardiology. In 2010 he was presented with the David Levine Award for Excellence in Mentoring of postdoctoral fellows, residents, and junior faculty in the Johns Hopkins Department of Medicine.

 

Matthew J. Budoff, M.D., FACC, FAHA, FSCCT
Professor of Medicine, David Geffen School of Medicine
University of California Los Angeles
Director of Cardiac CTA
Los Angeles Biomedical Research Center, Harbor-UCLA Medical Center
Torrance, California
Bio
      Dr. Budoff has devoted much of his time over the past 20 years to advancing procedures that can help doctors identify cardiac patients early, and place them on a therapeutic path to prevent a heart attack. Besides his work on early detection of heart disease, Dr. Budoff is pursuing funded research to better understand the second highest cause of death in the U.S., lung disease, and its potential cardiologic correlations. He also participates in research examining the link between diabetes in young adults and heart disease. He recently completed a study looking at the incidence of heart disease among firefighters.

Dr. Budoff works on at least 50 active medical research trials at any given time, and is a frequent lecturer on topics of cardiology at symposia, congresses and annual conferences on every continent. He has authored or co-authored over 400 research papers, six books, and 36 book chapters

Natalie Castro-Romero, M.S., R.D., LDN
Chief, Wellness Advantage Dietitian
Baptist Health South Florida
Miami, Florida
Bio

Ms. Castro-Romero is certified in adult weight management and works passionately on improving the health of both adults and children. Her clinical experience includes working with patients suffering from gastrointestinal disorders and critically ill patients in intensive care, specializing in nutritional support.  In addition, she has conducted research evaluating eating behaviors of overweight and normal-weight children. Her research conducted at the Behavioral Medicine Department at the University at Buffalo has been published in several peer-reviewed medical journals.

Tim Church, M.D., MPH, Ph.D.
Professor of Preventive Medicine
Pennington Biomedical Research Center
Louisiana State University
New Orleans, Louisiana
Bio
Dr. Church has authored over 100 research articles, received numerous awards for preventive health research and co-authored “Move Yourself, The Cooper Clinic Medical Director’s Guide to All Healing Benefits of Exercise.” Frequently used as an expert source for health stories with national media outlets, Dr. Church interviews with NBC, USA Today, Reuters, Wall Street Journal and CNN. He earned his medical degree at Tulane University School of Medicine and is the former vice president of Medical Research at The Cooper Institute.

Tara Dall, M.D.   
Medical Director, Advanced Lipidology Early Detection Center for Heart Disease & Diabetes
President-elect, Midwest Lipid Association
Delafield, Wisconsin
Bio

Dr. Dall has over 10 years’ experience utilizing lipid testing to detect genetic heart disease risk. Dr. Dall graduated in the first class of Diplomates of the American Board of Clinical Lipidology in November 2005, and is one of a handful of U.S. physicians treating pediatric dyslipidemia.
With the support of ProHealth Care’s Women’s Center she helped create the Cholesterol & Lifestyle Center in 2006 with the goal of identifying and reducing a woman’s risk of cardiovascular disease using the latest in medical technologies and aggressive risk factor management The medical practice had a primary focus on preventive cardiology in women and high-risk children, though men made up 50% of her practice, so the clinic was transitioned out of women’s health and into Preventive Cardiology in order to serve men, women and children of all ages.
The National Lipid Association recognizes her clinic as the first fully certified lipid clinic in the United States. In 2007 she was the recipient of Mayo Clinic’s award for “Innovations in preventive cardiology.” In June 2008 she transitioned to private practice and created Advanced Lipidology, Early Detection Center for Heart Disease and Diabetes.
Dr. Dall has a special research interest in advanced lipid testing and B Mode ultrasound technology (CIMT), women’s heart disease, polycystic ovarian syndrome and pediatric obesity.  She is involved in CIMT research in collaboration with UW-Madison. She believes strongly in being an educator and serves as clinical preceptor for Medical College of WI medicine residents.

Valentin Fuster, M.D.
Director, Mount Sinai Heart, Center for Cardiovascular Health
Foundation Professor, Mount Sinai School of Medicine
New York, New York
Bio
     Dr. Fuster is the recipient of two major ongoing NIH grants. He has published more than 800 Pubmed articles on the subjects of coronary artery disease, atherosclerosis and thrombosis, and he has become the lead editor of two major textbooks on cardiology,The Heart (previously edited by Dr. J. Willis Hurst) and Atherothrombosis and Coronary Artery Disease (with Dr. Eric Topol and Dr. Elizabeth Nabel). Dr. Fuster has been appointed editor-in-chief of the Nature journal that focuses on cardiovascular medicine (Nature Reviews, Cardiology, April 2009) and he is the editor of the new AHA Guidelines and Scientific Statements Handbook, which compiles all the latest information.
Dr. Fuster is the only cardiologist to receive the two highest gold medal awards and all four major research awards from the four major cardiovascular organizations: The Distinguished Researcher Award (Interamerican Society of Cardiology, 2005 and 2009), Andreas Gruntzig Scientific Award and Gold Medal Award (European Society of Cardiology, 1992 and 2007 respectively), Gold Medal Award and Distinguished Scientist (American Heart Association, 2001 and 2003 respectively), and the Distinguished Scientist Award (American College of Cardiology, 1993).

Henry N. Ginsberg, M.D.
Irving Professor of Medicine
Columbia University College of Physicians and Surgeons
Director, Irving Institute for Clinical and Translational Research
Columbia University Medical Center
New York, New York
Bio
     Dr. Ginsberg is the principal investigator of one of the first 12 NIH–funded Clinical Translational Science Awards (CTSA). In addition to the CTSA grant, he is principal investigator on two R01 research grants from the NIH, National Heart, Lung, and Blood Institute.  He was also the co-principal investigator at Columbia on the ACCORD Trial and was the lead author on the ACCORD Lipid study published in the NEJM.  His research interests have focused on the regulation of plasma cholesterol and triglyceride blood levels, particularly the metabolism of apolipoprotein B–containing lipoproteins in cells, mice, and humans. Much of his present work focuses on the interaction between insulin resistance, increased secretion of very low-density lipoproteins by the liver, and hepatic steatosis. Very active in clinical research training and education, Dr. Ginsberg was also program director of a T32 Postdoctoral Training Grant in Arteriosclerosis from 1993 until 2008.  The CTSA has a predoctoral T32 program in translational research, a master’s degree program in patient-oriented research, and a junior faculty K12 Clinical Research Scholars Program.
     Dr. Ginsberg is on the editorial boards of the Journal of Lipid Research, Arteriosclerosis, Thrombosis, and Vascular Biology, and the Journal of Metabolism. He has authored or coauthored more than 290 articles, reviews, and chapters related to lipids, diabetes, and heart disease.

Anthony Gonzalez, M.D.
Chief of Surgery and Minimally Invasive and Robotic Surgery, Baptist Hospital
Medical Director, South Miami Hospital’s Weight-loss Surgery Program
General Surgeon, Baptist and South Miami Hospitals
Miami, Florida
Bio
     Dr. Gonzalez, is a member of Baptist Health Medical Group, a network of more than 100 physicians in multiple specialties closely aligned with Baptist Health South Florida. Dr. Gonzalez is a general surgeon with a specialty in laparoscopic and bariatric surgery. He has presented at national and international medical conferences on bariatric surgery, abdominal surgery, colon surgery and robotic surgery. Dr. Gonzalez
is Founding Program Director of Baptist Health MIS/Bariatric Surgery Fellowship.
     He has published in medical journals, including The Official Journal of the American Society for Metabolic & Bariatric Surgery, and Journal of Obesity Surgery. Dr. Gonzalez is a senior member of the American Society for Metabolic & Bariatric Surgery, Society of Laparoendoscopic Surgeons, and Society of American Gastrointestinal and Endoscopic Surgeons. He is a Diplomat of the American Board of Surgery and Fellow of American College of Surgeons. Dr. Gonzalez is a graduate of the University of Miami Miller School of Medicine and completed his residency at University of Miami/Jackson Memorial Hospital. He is Associate Professor of Surgery at Herbert Wertheim College of Medicine at Florida International University and Voluntary Assistant Professor of Surgery at University of Miami Miller School of Medicine. Medicine.                                                                          

Joshua Hare, M.D., FACC, FAHA
Louis Lemberg Professor of Medicine
Chief Sciences Officer
Senior Associate Dean for Experimental & Cellular Therapeutics
Director, Interdisciplinary Stem Cell Institute
University of Miami Miller School of Medicine
Miami, Florida
Bio
     Dr. Hare is an expert in cardiovascular medicine and specializes in heart failure, myocardial infarction, inflammatory diseases of the heart, and heart transplantation. He is an internationally acknowledged pioneer in the field of stem cell therapeutics for human heart disease, currently seeing and evaluating patients from all over the world for this new experimental therapy.
Dr. Hare led the first randomized allogeneic mesenchymal stem cell (MSC) clinical trial for patients with myocardial infarction and is principal investigator of multiple other trials for heart failure and cardiovascular disease. Under his leadership, ISCI now has active programs in cancer biology, cardiology, neonatology, skin diseases, bone diseases, neurologic diseases, ophthalmology, and a program devoted to the ethics of stem cell therapy.
Dr. Hare has published more than 245 original research articles, editorials, and review articles.  He holds five FDA Investigational New Drug applications for cell-based therapy in patients with heart disease, including the first in the United States for idiopathic pulmonary fibrosis.  He is the recipient of four active NIH RO1’s and is the PI of the UM National Heart Lung and Blood Institute Cardiac Cell Therapy Trial Network (CCTRN) center.
Dr. Hare recently completed a term as chair of the Cardiac Contractility and Heart Failure study section of the National Institutes of Health (NIH), chairs the Stem Cell Working Group of the American Heart Association (AHA), and is vice chair of the AHA Basic Cardiovascular Science Council. The NHLBI CCTRN has selected Dr. Hare’s AIRMID trial to be its first new trial addressing heart failure.
Dr. Hare is inventor of eight (two issued) U.S. patents, and his research discoveries have led to the founding of two biotechnology companies, both of which have received initial funding.
He recently released findings on the first human clinical trial testing a stem-cell-based treatment for heart attack patients, which showed the stem-cell-treated patients had lower rates of cardiac arrhythmias, and had significant improvements in heart, lung and symptom status. Dr. Hare is the principal investigator on an NIH Specialized Center for Cell-Therapy (SCCT) funded stem cell study for patients with congestive heart failure.

Sharonne N. Hayes, M.D., FACC, FAHA 
Professor of Medicine and Cardiovascular Diseases
Founder, Women’s Heart Clinic
Director of Diversity and Inclusion
Mayo Clinic, Rochester, Minnesota
Bio
     Dr. Hayes is a nationally recognized educator and speaker on women’s health and cardiovascular issues and has been involved in developing numerous medical educational programs on women’s health topics for both medical professionals and the public.  She co-directed the long-running and award-winning continuing medical education program “Controversies in Women’s Health” and co-produced and hosted “Perspectives in Women’s Health,” Mayo Clinic’s continuing medical education live video-teleconference series from 1998 through 2006. In 2004, Dr. Hayes co-produced the Emmy-nominated PBS show, “Call to Action: Women and Heart Disease.” In 2011 she co-hosted and moderated “In the Prime of Her Life — A Mayo Clinic Media Briefing on Women and Heart Disease” held in February at the Paley Center for Media in New York City.  She has been a guest on the Today Show, Good Morning America, the Charlie Rose Show, CNN Morning Show, Talk of the Nation, and the Dr. Oz Show among others, and has also done live medical reporting for a local ABC affiliate. She serves on the advisory board for Woman’s Day, Diabetic Living, and Women’s Health magazines, and previously wrote a regular column for Better Homes and Gardens’ Heart Healthy Living.


Irwin Klein 

Professor of Medicine

Department of Medicine, Division of Endocrinology

New York School of Medicine

New York City, New York

Bio

Dr. Irwin Klein is professor of Medicine at New York University School of Medicine. He was an NYU Medical School graduate after which he did house staff training at the University of Pennsylvania. He did further work at the NIH and has held positions at the University of Miami, the University of Pittsburgh and North Shore University Hospital before return to NYU. He is on the Editorial Boards of major endocrinology journals including Endocrinology and the Journal of Endocrinology and Metabolism. He has held numerous important positions in the American Thyroid Association and the American Heart Association. His research has spanned basic to clinical investigations in a variety of areas, but mainly on the topic, “Thyroid Disease and the Heart”.

Gervasio Lamas, M.D., FACC, FAHA, FESC
Chairman of Medicine and Chief
Columbia University Division of Cardiology
Professor of Medicine, Columbia University Medical Center
Mount Sinai Medical Center
Miami Beach, Florida
Bio
    Dr. Lamas’ interests include the treatment and prevention of cardiovascular disease. During the last decade, he has enrolled thousands of patients in more than a dozen U.S. and international trials in order to improve cardiac care and prevent death and disability from heart disease. He served as chairman of the Mode Selection Trial in Sinus Node Dysfunction (MOST), a trial that revolutionized cardiac pacemakers. He currently serves as co-chairman for the Occluded Artery Trial (OAT), and study chair for the Trial to Assess Chelation Therapy (TACT), a $30 million trial sponsored by the National Institutes of Health. He has authored over 300 scientific publications, and maintains an active clinical practice in Miami Beach and Key Biscayne.

Robert H. Lustig, M.D.
Professor of Clinical Pediatrics, Division of Endocrinology
Director, UCSF Weight Assessment for Teen and Child Health (WATCH) Program
University of California
San Francisco, California
Bio
     Dr. Lustig is a nationally recognized authority in the field of neuroendocrinology, with a specific emphasis on the regulation of energy balance by the central nervous system. He is currently investigating the contribution of biochemical, neural, hormonal, and genetic influences in the expression of the obesity epidemic both in children and adults. He has defined a syndrome of vagally mediated beta-cell hyperactivity, which leads to insulin hypersecretion and obesity, and which is treatable by insulin suppression. This phenomenon may occur in up to 20% of the obese population. Dr. Lustig is interested in the hypothalamic signal transduction of insulin and leptin, and how these two systems interact. He is studying the cardiovascular morbidity associated with hyperinsulinemia, and developing methods to evaluate and prevent this phenomenon in children. He is also analyzing the contribution of the autonomic nervous system to insulin secretion and insulin resistance in obese children, and the utility of assessing insulin dynamics in targeting obesity therapy. Dr. Lustig has authored over 70 research articles and 35 chapters.

Dariush Mozaffarian, M.D., DrPH, FACC
Associate Professor of Medicine and Epidemiology
Division of Cardiovascular Medicine, Brigham & Women’s Hospital and Harvard Medical School
Department of Epidemiology, Harvard School of Public Health
Boston, Massachusetts
Bio
     Dr. Mozaffarian’s research focuses on effects of lifestyle, particularly diet, on cardiovascular health and disease in the U.S. and globally. He has authored or co-authored nearly 200 scientific publications on lifestyle and cardiovascular health, including on global dietary burdens of disease, fish and omega-3 fats, trans fats, diets and weight gain, and healthy diet patterns. He has served on numerous committees and advisory boards, including for the World Health Organization, United Nations Food and Agriculture Organization, and American Heart Association.

Christopher O’Donnell, M.D.
Associate Director and Scientific Director of the SHARE Project
Framingham Heart Study, National Heart, Lung and Blood Institute
Assistant Professor, Harvard Medical School
Bio
     Dr. O’Donnell joined the Framingham Heart Study as a Medical Officer of the National Heart, Lung and Blood Institute. In 2002, he was appointed associate director of the Framingham Heart Study and co-chair of its Genetic Steering Committee. In 2006, he was named senior advisor to the director of the National Heart, Lung and Blood Institute for Genome Research. In this role, he helps steer the direction of the genetic and genomic research portfolio of NHLBI. In 2006, he was named the scientific director of the Framingham SHARE (SNP Health Association Resource) Study, a whole-genome association study now underway in over 9,000 Framingham Heart Study participants. In 2007, he became a tenured investigator of the Division of Intramural Research of NHLBI. His major research focus is on the epidemiology and genetic epidemiology of clinical and subclinical cardiovascular disease, and he directs numerous large-scale imaging studies using cardiac CT scanning, cardiac magnetic resonance imaging, and other subclinical atherosclerosis modalities. He has published over 160 peer-reviewed articles and chapters in journals including the Journal of the American Medical Association, the American Journal of Medical Genetics, Circulation, and the New England Journal of Medicine.

Michael F. Richman M.D., FACS, FCCP
Cardiothoracic/Vascular Surgeon
The Center for Cholesterol Management
Los Angeles, California
Bio
      Dr. Richman has performed more than 1,000 cardiac bypass procedures throughout his career. He has always maintained a strong interest in the preventive aspect of cardiac care, namely cholesterol (lipid) management. Dr. Richman was the cholesterol expert on WebMD from 2005 to 2012 and is currently on WebMD’s Medical Review Board. He is also the national heart health examiner for The Examiner.com and the medical expert to the nationally syndicated Dennis Prager Show. Dr. Richmond is a published author in the field of lipidology and is on the editorial board of the peer-reviewed being included among Journal of Clinical Lipidology, which is the official journal of the National Lipid Association. He was voted by his peers as a “Southern California Super Doctor” for the Top Thoracic Surgeons in 2012 and Top Thoracic Surgeons and Top Vascular Surgeons in 2013.

Alan Rozanski, M.D.   
Interim Chief, Division of Cardiology
Saint Luke’s Roosevelt Hospital
Professor of Medicine, Columbia University College of Physicians and Surgeons
New York, New York

Bio
     Dr. Rozanski is director of nuclear cardiology and the Cardiology Fellowship Training at St. Luke’s Roosevelt Hospital Center in New York, New York, and professor of medicine at the Columbia University College of Physicians and Surgeons. His interests focus on both the use of cardiac imaging for patient risk stratification and the role of preventive cardiology in patient risk management.
Dr. Rozanski is a former recipient of a two-year sabbatical fellowship from the MacArthur Foundation to study the determinants of health-promoting and health-damaging behaviors. Subsequently, he helped develop the Cardiac Preventive and Rehabilitative Program at Cedars-Sinai Medical Center in Los Angeles and initiated his novel research to study the effects of psychosocial stress and other behavioral factors on atherosclerosis and myocardial ischemia. His ongoing work in this arena has established Dr. Rozanski as an internationally recognized authority in the field of Behavioral Cardiology.

Raul Santos, M.D.
Associate Professor of Cardiology University of Sao Paulo, Brazil
Director Lipid Clinic Heart Institute (InCor) University of Sao Paulo, Brazil
Scientific Advisor Preventive Medicine Center Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Bio
Dr. Santos, research interests include lipid metabolism, severe forms of genetic dyslipidemia, especially familial hypercholesterolemia and HDL deficiency, non-alcoholic fatty liver disease and imaging in atherosclerosis especially detection of vascular calcification. Dr Santos collaborated in research studies with the Ciccarone Preventive Cardiology Center of the Johns Hopkins University in Baltimore, USA, the Lipid Metabolism Laboratory of the Tufts University in Boston, USA and the HJELT Institute, Department of Public Health, University of Helsinki in Finland. He
has published more than 130 papers in peer-review journals like the Lancet, Atherosclerosis, ATVB, Circulation, Cardiovascular Research, The European Heart Journal, JACC, Journal of Lipid Research and Current Opinion of Lipidology among others. Dr. Santos has coordinated and participated in many Brazilian and International guidelines on dyslipidemia and atherosclerosis prevention, metabolic syndrome, obesity, diabetes and coronary heart disease.

Neil Schneiderman, Ph.D.
James L. Knight Professor of Psychology
Professor of Medicine, Psychiatry and Biomedical Engineering
Director, Behavioral Medicine Research Center
Director of the Division of Health Psychology in the Department of Psychology
University of Miami Miller School of Medicine
Miami, Florida
Bio
     Dr. Schneiderman is principal investigator of the Miami Field Center and member of the steering committee and chair of the Ancillary Studies Committee of the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), which is the largest study of Hispanic health ever funded by the NIH.  The HCHS/SOL was launched in 2007 and is funded until 2019.  Professor Schneiderman has published extensively and been the PI on basic science, multi-center epidemiological studies and multi-center clinical trials sponsored by the NIH.  His major area of research interest is in the biobehavioral bases of CVD risk and management.

Wayne M. Sotile, Ph.D., FAACVPR
Special Consultant in Behavioral Health
Carolinas Health System, Sanger Heart and Vascular Institute
Charlotte, North Carolina
Clinical Assistant Professor, Tulane University School of Medicine, Department of Orthopedic Surgery
New Orleans, Louisiana
Bio
     Dr. Sotile is recognized as a pioneer in the fields of cardiac and health psychology. He is the author of nine books, including Thriving with Heart Disease (and, with his wife, Mary, The Resilient Physician (2002), and Letting Go of What’s Holding You Back (2007). He lectures internationally on the keys to resilience and burnout prevention for busy health professionals, and he provides leadership and team-building consultation to medical organizations that are committed to making their workplace a positive interpersonal environment.
A former faculty member of the Wake Forest University School of Medicine, Dr. Sotile served as director of psychological services for the Wake Forest University Cardiac Rehabilitation Program for 25 years. He serves as a special consultant in behavioral health for the Carolinas Health System Sanger Heart and Vascular Institute’s cardiac rehabilitation program, and as a clinical assistant professor at the Tulane University School of Medicine. A Fellow in the American Association of Cardiovascular and Pulmonary Rehabilitation, Dr. Sotile received lifetime career achievement awards from the North Carolina Cardiopulmonary Association and the American Academy of Medical Administrators, and he was the 2004 recipient of AACVPR’s L. Kent Smith Award for Excellence in Clinical Practice.

Neil J. Stone, M.D., MACP, FAHA, FACC
Bonow Professor of Medicine
Feinberg School of Medicine
Northwestern University
Suzanne and Milton Davidson Distinguished Physician and Medical Director
Vascular Center of the Bluhm Cardiovascular Institute of Northwestern Memorial Hospital
Chicago, Illinois

Bio
     Dr. Stone is a cardiologist at Northwestern Memorial Hospital with a special interest in lipid disorders. He is the medical director of the Center for Vascular Disease of the Bluhm Cardiovascular Institute. A seasoned and award-winning lipidologist with more than 30 years of experience in the Chicago area, Dr. Stone opened Northwestern Memorial’s Lipid Clinic in 1974. A pioneer in the field, he has served on numerous expert panels and lectured widely in cardiology and lipidology. A clinical professor at Northwestern University’s Feinberg School of Medicine, Dr. Stone’s research initiatives focus on cardiovascular nutrition, risk factor control and genetic lipid disorders. He has participated in numerous clinical trials, including the first angiographic trial studying the effects of lipid-lowering therapy on angiographic progression and regression. Dr. Stone has co-authored three books on cardiovascular nutrition and lipid disorders and has written more than 100 publications in the field. He was named Northwestern Memorial’s first Jacques Smith Distinguished Physician in Medicine in 1993. Consistently elected to the Best Doctors in America by his peers, Dr. Stone was also awarded the New Jersey Healthcare Foundation Humanism in Medicine Award in 2002 and named Outstanding Volunteer Clinical Teacher in 2001 by the American College of Physicians. Dr. Stone is active in a number of professional societies, serving on boards and expert panels of the American Heart Association, the American College of Physicians, American College of Cardiology, American College of Chest Physicians, and National Lipid Association. He is the current president of the Midwest Lipid Association and an at-large member of the new Council on Nutrition, Physical Activity and Metabolism. He was a member of the first and third National Cholesterol Education Program Adult Treatment Panels. Dr. Stone completed medical school at Northwestern University’s Feinberg School of Medicine, where he graduated in 1968 summa cum laude. He completed his internship and residency at Boston’s Brigham and Women’s Hospital and returned to Northwestern University for his cardiovascular fellowship. He studied lipids and cardiology at the National Heart, Lung and Blood Institute and was the chief medical resident at Northwestern Memorial in 1973-1974. Dr. Stone is board-certified in internal medicine and cardiovascular disease.

Robert Superko, M.D.   
Executive Director
Center for Genomics and Human Health,
Translational Research Institute at St. Joseph’s Hospital
Atlanta, Georgia

Bio

Dr. Superko sits on the editorial boards of several prestigious journals, including the Journal of Cardiovascular Risk and Preventive Cardiology. He has published more than 120 peer-reviewed articles and chapters in the area of lipid metabolism, exercise physiology and cardiac rehabilitation, and he has written a number of books, including, Before the Heart Attacks published in 2003. Dr. Superko currently sits on committees at the American Heart Association, the Transcatheter Therapeutics Scientific Advisory Committee, American Heart Association Atherosclerotic Peripheral Vascular Disease Committee, and the Atlanta American Heart Association Board. He has appeared on many broadcast programs as an expert in the cardiovascular arena, most recently on a CNN health segment on cardiovascular disease.

Ira Tabas, M.D., Ph.D.
Vice-chairman of Research, Department of Medicine, Columbia University
Professor of Medicine and Anatomy & Cell Biology (in Physiology and Cellular Biophysics)
Columbia University College of Physicians and Surgeons
Attending Physician of Medicine
Columbia University Medical Center
New York, New York
Bio
     Dr. Tabas’ research focuses on the molecular-cellular mechanisms of atherosclerosis, with an emphasis on macrophage cell biology, endoplasmic reticulum-induced cell death (apoptosis), mechanisms involved in the generation of clinically dangerous atherosclerotic plaques, translational work in mouse models of atherosclerosis, and mechanistic-based correlative studies on human disease tissue.  His recent activities have expanded into mechanisms of atherosclerosis in diabetes and obesity, including new studies on liver and adipose tissue. He has lectured worldwide and published approximately 175 original research articles and reviews. These papers have been published in Cell, Nature, Nature Cell Biology, Nature Reviews Immunology, Cell Metabolism, Journal of Clinical Investigation, Proceedings of the National Academy of Science USA, Journal of Cell Biology, and Journal of Biological Chemistry. He has served on the editorial board of the Journal of Biological Chemistry, was deputy editor of the Journal of Clinical Investigation in 2002-2007, and is currently on the board of reviewing editors for Science.
Dr. Tabas’ honors include the American Heart Association Established Investigator Award, the Columbia University Doctor Harold and Golden Lamport Research Award, the American Heart Association/ATVB Council Special Recognition Award, the Richard J. Stock Professorship in the Department of Medicine of Columbia University, and the 2011 Alumni Achievement Award from Washington University School of Medicine.  He was elected to both the Society for Clinical Investigation and the Association of American Physicians.

Terry Thomas, R.N., MSN
Board Member, Preventive Cardiovascular Nurses Association
Madison, Wisconsin
Bio
     Terry Thomas has more than 20 years’ experience as a clinician in cardiovascular nursing and preventive cardiology. She is a leader in developing lipid clinics and heart disease prevention programs and developed one of the first women’s heart disease prevention programs in the country at the University of North Carolina at Chapel Hill. Ms. Thomas is active educating and training all levels of healthcare providers in the cardiac prevention field. She is a founding member of the Preventive Cardiovascular Nurses Association and the initial nurse leader on the board of the Southeast Lipid Association.

Peter P. Toth, MD, PhD, FCCP, FAHA, FACC
Director of Preventative Cardiology, CGH Medical Center
Sterling, Illinois
Professor of Clinical Family and Community Medicine, University of Illinois School of Medicine
Peoria, Illinois
Professor of Clinical Medicine, Michigan State University College of Osteopathic Medicine
East Lansing, Michigan
Bio
     Dr. Toth is current president of the National Lipid Association. He has authored and co-authored over 220 publications in medical and scientific journals and textbooks. He is editor-in-chief of the Year in Lipid Disorders (Atlas Publishing, Oxford, UK) and an associate editor for the Yearbook of Endocrinology (Elsevier, New York). He is coeditor with Antonio Gotto of the textbookComprehensive Management of High Risk Cardiovascular Patients (Taylor and Francis, New York) with Michael Davidson of Therapeutic Lipidology (Humana, Philadelphia), with Dominic Sica of Current Controversies in Dyslipidemia Management (Atlas Publishing, Oxford), with Kevin Maki of Practical Lipid Management (Wiley-Blackstone, London), with Christopher Cannon of Comprehensive Cardiovascular Care in the Primary Care Setting (Springer Humana, Philadelphia), Domenic Sica of Clinical Challenges in Hypertension vols I and II (Clinical Publishing, Oxford, UK), Cardiac Lipoglucotoxicity with Vasu Raghavan, and Lipoproteins in Diabetes Mellitus with Alicia Jenkins and Timothy Lyons. He has lectured on many topics in cardiovascular medicine throughout the world.

Robert A. Vogel, M.D., FACC
Clinical Professor of Medicine
University of Colorado Denver
Denver, Colorado
Bio
     Dr. Vogel has investigated heart disease for more than 35 years, pioneering tomographic myocardial perfusion imaging and analysis, and discovering the acute vascular effects of food, physical activity, and media.  He is the author of more than 250 publications.  He was director of cardiology at the University of Maryland for 14 years and served as the president of the Association of University Cardiologists.  Dr. Vogel lectures frequently to practicing physicians on lifestyle and heart disease prevention and has received Good Housekeeping Magazine’s “Best Doctors in America” designation and a Federal Scientist of the Year Award.  Dr. Vogel serves as a consultant to the Pritikin Longevity Institute and co-chair of the National Football League Subcommittee on Cardiovascular Disease.

Michael A. Weber, M.D.
Professor of Medicine
SUNY Downstate Medical Center College of Medicine
Brooklyn, New York
Bio
      Dr. Weber is a professor of medicine and associate dean for research at Downstate. His career has focused primarily on hypertension and preventive cardiology. He has published numerous research articles in the medical literature and has authored and/or edited 10 books. Dr. Weber was one of the founders of The American Society of Hypertension and has served as its president. He is currently chair of the Society’s Hypertension Specialists Program. He is a Fellow of the American College of Physicians, the ACC and the AHA. Dr. Weber has particular expertise and extensive experience in the design and conduct of clinical trials. He has helped design and participated in a large number of national and international clinical outcomes trials. His primary research interests include the role of the renin-angiotensin system in the genesis of hypertension and as a major factor in cardiovascular prognosis. He will contribute to the didactic courses on research design and conduct of clinical trials as well as to the mock study section.

 SOURCE

http://cme.baptisthealth.net/cvdprevention/pages/faculty.aspx

Other Related articles published on this Open Access Online Scientific Journal include the following:

Acute Myocardial Infarction: Curations of Cardiovascular Original Research A Bibliography

Aviva Lev-Ari, PhD, RN and Larry H Bernstein, MD, FCAP

http://pharmaceuticalintelligence.com/2014/01/22/acute-myocardial-infarction-curations-of-cardiovascular-original-research-a-bibliography/

Calcium and Cardiovascular Diseases: A Series of Twelve Articles in Advanced Cardiology

Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2014/01/28/calcium-and-cardiovascular-diseases-a-series-of-twelve-articles-in-advanced-cardiology/

Publications on Heart Failure by Prof. William Gregory Stevenson, M.D., BWH

Read Full Post »

Cardiac Perfusion Exam, Rapid Heart Scanner, CT, MRI and PET imaging – Innovations in Radiology @ Beth Israel Deaconess Medical Center

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/31/2018

VIEW VIDEO

https://www.dicardiology.com/videos/video-state-ct-myocardial-perfusion-imaging?eid=333021707&bid=2191253

A discussion with Gianluca Pontone, M.D., Ph.D., FSCCT, director of cardiovascular MRI, Centro Cardiologico Manzino, Milan, Italy, at the Society of Cardiovascular Computed Tomography (SCCT) 2018 meeting. He said CT can be comparable to the gold-standards of nuclear and MRI perfusion depending on the scanner used to acquire the images.

Read the article “CT Perfusion Imaging Ready for Mainstream.” 

Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better

December 15, 2010 5:20 PM

(credit: Beth Israel Deaconess Medical Center)

(credit: Beth Israel Deaconess Medical Center)

By Michael Lasalandra, Beth Israel Deaconess Medical Center Correspondent

The evolution of imaging technology has resulted in doctors’ being able to more quickly and accurately diagnose many potentially life-threatening disorders, including serious abdominal issues, and coronary artery disease, as well as brain tumors and other cancers, to name a few.

“Current technologic advances in CT, MRI and PET imaging reflect advancements that have evolved over the past 20 years,” said Dr. Max Rosen, Executive Vice Chairman Radiology, Beth Israel Deaconess Medical Center. “They are a leap forward towards more personalized medicine focused on an individual patient’s specific problem. The improvements are leading to more rapid and accurate diagnoses, which potentially can lead to more effective, lifesaving treatments.”

Five examples:

Breast MRI

 

five new imaging tests1 Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better

Breast MRI

MRI (magnetic resonance imaging) machines do not expose patients to radiation. Instead, they use a magnetic field, radio frequency pulses and a computer to obtain images. While mammograms, which use x-ray technology, are the primary method for screening for breast cancer, MRI can be used to work up more subtle cases, or for breast cancers which cannot be seen on a mammogram says Dr. Rosen. Typically, breast MRI is reserved to screen women who are at high risk for developing breast cancer, to determine extent of cancer involvement in newly diagnosed patients,  to problem-solve a suspicious finding on other imaging, or to aid in surgical planning.

Abdominal CT scan

 

five new imaging tests 1 Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better

Abdominal CT Scan

Also known as computed tomography, CT scans combine a series of X-rays taken from a variety of different angles to produce cross-sectional images of the bones and soft tissues inside the body. These are often used in the Emergency Room setting to rapidly and accurately diagnose abdominal pain. “CT can accurately identify the cause of the pain,” says Dr. Rosen. “Common causes would be appendicitis, diverticulitis, kidney stones or inter-abdominal bleeding.” Such scans are also extremely useful for patients who have been in traumatic accidents. Multi-row detector CT scans can rapidly image the entire chest, abdomen and pelvis in less than a minute and can identify life-threatening fractures or other complications, he notes.

Coronary CT Angiogram to evaluate heart arteries

 

five new imaging tests 21 Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better

Coronary CT Angiogram

This test is useful in identifying narrowing in the coronary arteries. “By injecting an IV contrast dye into the vein and using a fast scanner, you can get beautiful images of the coronary arteries,” says Dr. Rosen. “You can see if there is plaque and if it is causing any narrowing.” The test is used for patients who have been having chest pain or for those at high risk for coronary disease with atypical chest pain and can identify those patients who are not having a heart attack, he says. The advantage is that cardiac catheterization – where a balloon-tipped catheter is snaked through the coronary artery – may be avoided. However, if the CTA is abnormal, the catheterization may still need to be performed prior to bypass surgery or to dilate the blocked artery using a balloon catheter or metallic stent.

PET-CT scan for cancer assessment

 

five new imaging tests 31 Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better

PET-CT scan

Positron emission tomography, also called a PET scan, is a type of nuclear medicine imaging. It uses tiny amounts of radioactive material as tracers to diagnose a variety of diseases, including many types of cancer. The scan can visualize metabolic activity in an area of suspected abnormality such as a tumor. Doctors can use PET and CT data and images together for greater diagnostic accuracy than either technique offers alone. PET-CT allows them to see not only the size of the tumors, but also their biological behavior and whether or not they are responding to therapy. This hybrid technology “is the beginning of a new wave of molecular imaging where you can target a specific tumor to help characterize it as well as see if it is growing or metabolizing,” Dr. Rosen says.

fMRI (functional MRI) for evaluation and treatment planning of brain tumors

 

five new imaging tests 61 Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better

fMRI (functional MRI) for evaluation and treatment planning of brain tumors

Functional Magnetic Resonance Imaging (fMRI) is a type of specialized MRI scan. It assesses the change in blood flow related to neural activity in the brain or spinal cord. It is widely used for brain mapping due to its high accuracy and absence of radiation. fMRI is often combined with Diffusion Tensor Imaging (DTI), which measures water diffusion in the brain, for imaging brain tumors. These methods can assist in planning surgery to avoid complications that might occur with less detailed preoperative evaluation. fMRI and DTI are routinely used when the tumor location is such that there is a concern for neurological deficits occurring during surgery. This type of imaging is usually performed shortly before surgery and can be critical in decisions of whether and how to approach the tumor, Dr. Rosen says.

meningioma of olfactory groove 550x415 Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better
fmri550x415 Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better

Above content provided by Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.

More Articles From Beth Israel Deaconess Medical Center:Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better | Airport Security Scanners: Are They Safe? | What Is The Best Breast Cancer Screening Tool? | Cardiac CT Scan An Alternative To Catheterization |Ultrasound Option For Shoulders, Knees | Radiation Reduction | ERCP For Stomach Pain | Five New Imaging Tests Can Help Diagnose A Variety Of Illnesses Better | Airport Security Scanners: Are They Safe? | Women And Sport Injuries – Why It’s A Different Game | Common Sports Injuries – How To Protect Yourself | Repetitive Injuries: Physical Therapy Keeps ‘Wounded Warrior’ On Top Of Game | Skiers, Take Note: ACL Injuries Are Serious, But Not Career Ending |Weekend Warriors: Prevent Injuries | Coming Back From ACL Tear | Athletes & Shoulder Arthritis

SOURCE

http://boston.cbslocal.com/2010/12/15/five-new-imaging-tests-can-help-diagnose-a-variety-of-illnesses-better/

How PET imaging works

 

MIPSMany cancers use more glucose (sugar) than most normal tissues. The Nuclear Medicine physician can take advantage of this by injecting glucose with a small amount of radioactivity attached to the glucose molecule. The PET scanner is then used to obtain images of the distribution of glucose metabolism throughout the body. The amount of glucose used by tissues in the body provides information to help guide further diagnostic and therapeutic options.

What is the purpose of the CT scanner? The CT scanner is needed because the major disadvantage of PET imaging is that the anatomic detail seen in a PET scan is inferior to that of a conventional CT scan. This means that although PET can see the general location of an area of abnormal glucose uptake, the exact localization of the abnormality can be difficult using PET images alone.

Anatomic Information Obtained with CT Scanning

fusion imageCT (Computed Tomography) scanning provides high-resolution images that show anatomy beautifully. But CT does not do a very good job of demonstrating physiology. Therefore, if an abnormality is seen on CT scanning, it is not always obvious if that abnormality is benign or malignant (cancer).

By obtaining both CT and PET images together, and fusing the images, the Nuclear Medicine physician can simultaneously see both anatomic and physiologic changes in the body that provide the most accurate information available today for the imaging diagnosis and localization of cancer.

SOURCE 

http://www.bidmc.org/CentersandDepartments/Departments/Radiology/Exams/NuclearMedicine/Exams/PETCT.aspx#sthash.faab9AeR.dpuf 

Cardiac Perfusion Exam

Overview

An Cardiac Perfusion scan is a test that helps your doctor see if you have coronary artery disease. Coronary artery disease is a narrowing of the blood vessels that supply oxygen to the heart muscle. If the heart muscle doesn’t get enough oxygen, it can cause chest pain or angina. Because angina typically occurs during exercise, we often do this test with you walking on a treadmill.

During this test, a radioactive material is used to take pictures of the heart. The substance is injected into your blood and travels to the heart muscle through the coronary arteries. We then take pictures of your heart, which will help your doctor decide if you have coronary artery disease.

How do I prepare for this test?

Common Foods, Beverages, and Medications Containing Caffeine

Do not take any of these for 12 hours before your nuclear medicine cardiac perfusion test. Please note: Many “decaffeinated” drinks are also not allowed!

Coffee:

Regular or decaffeinated, any variety

Tea

Regular or decaffeinated, any variety

Soft Drinks:

Regular or decaffeinated, any variety
Cola, Dr. Pepper, Mello Yellow, Mountain Dew, Mr. Pibb, Tab

Foods:

Cocoa, Chocolate

Over-the-Counter Medicines:

Anacin, Excedrin, NoDoz

Prescribed Medications:

Cafegot (all forms), Darvon Compound, Fiorinal, Synalog DC, Wigraine (all forms)

  • Do not eat or drink anything containing caffeine for 12 hours before this test. This includes coffee, tea, colas, and chocolate. Other things containing caffeine are listed here.
  • Do not smoke for two hours before this test.
  • Do not eat or drink anything except water for two hours before this test.

May I take my medication?

  • You may be asked to decrease or stop certain medicines for this test. Follow your doctor’s instructions regarding medication. Do not stop your medication unless your doctor tells you to. You should start all your medicines again after the test is over. Please bring a complete listing of all your medicines with you.
  • If you are a diabetic and take insulin or another diabetes medication, please check with your doctor for advice regarding doses before and after this test. Please bring your insulin or oral diabetes medicine to the hospital so you can take the dose recommended by your doctor.

What should I wear?

Please wear comfortable clothes that break at the waist (a shirt or blouse) and flat walking shoes or sneakers. Sneakers are strongly recommended. Electrodes will be placed on your chest so that your heart can be monitored during exercise. Women must remove their bras for the procedure. If you wear an unusually large or small size of clothing, please bring your own T-shirt and pants. You will be working hard during this test. Comfortable clothing will make things easier for you.

What happens during this test?

There are three parts to the test: Taking pictures, exercising, and taking more pictures.

  1. For the first part of the test, we will put an intravenous (IV) line in your arm. This will feel like a pin prick like when you have blood drawn. The radioactive material is then injected through the IV. You will not feel anything from this injection. We will wait 30-45 minutes while the radioactive material circulates in your body. Then, while you are lying down, we will take pictures of your heart with a special camera for about 30 minutes.
  2. For the second part of the test, you will exercise by walking on a treadmill. Your heart will be monitored with an EKG, and we will take your blood pressure many times during this part of the test. A radioactive material will be injected into the IV about 1 minute before you stop exercising. You will not feel anything when the radioactive material is injected. We will again wait a short time while the radioactive material circulates in your bloodstream.
  3. The third part of the test is taking more pictures. You will lie down as before and the camera will take pictures for about 30 minutes.

How long will the test take?

The test takes a total of 3-4 hours.

After The Exam

A doctor from nuclear medicine will provide the results of this test to your doctor. Your doctor will put together the results of this test and your other tests and then will explain the meaning of these results to you.

All the pictures that result from the Cardiac Perfusion exam are catalogued and stored as digital images. These are then displayed on specialized high resolution video monitors and interpreted by the nuclear medicine physician.

In the example images to the left, the physician will note a defect during the exercise phase of the examination which becomes improved during the resting phase.

How safe is this test?

Nuclear medicine procedures are very safe. Your body is able to eliminate the radioactive materials that are used very quickly.

The radiation dose from this test is about 13 mSv.

SOURCE

Rapid Heart Scanner

Introducing… a more advanced way to view the Heart

Beth Israel Deaconess Medical Center is the first in New England to offer patients the Cardius X-ACT Rapid Cardiac Imager. This advanced nuclear imaging system scans for coronary artery disease in half the time of traditional nuclear medicine scans. It’s more comfortable, too. Instead of lying on the stomach with arms stretched above the head, the new upright design allows patients, many with difficult symptoms such as chest pain and pressure, to remain in a seated position during the test.

Cardius X-ACT Rapid Cardiac Imager

  • More Comfort: scan performed in seated position with a shorter imaging time
  • Higher Clarity: state-of-the-art 3D image with motion stabilizer
  • Quicker Results: reports sent directly to ordering physician– same day, in most cases
  • Open Design: accommodates bariatric, claustrophobic and COPD patients

What to Expect:

When the patient arrives, an intravenous (IV) line will be placed in his arm and a small amount of radioactive material will be injected. There are no effects from the injection. After waiting 30-45 min while the material circulates, images will be taken of the heart at rest. The imaging session takes about 10 minutes.

Patient will then undergo a treadmill stress test and a second injection through the IV. After waiting 30-45 minutes a second set of images will be taken to show cardiac blood flow during exercise.

By using the computer to slice and spin the high-resolution 3-D scans taken by the Cardius imager, radiologists can see any part of the heart and the blood flow surrounding it, making diagnosis better and faster than ever before. A radiologist will read the images and provide results to your doctor within 24-hours.

The exam is covered by most medical insurance.

The rapid heart scanner is located in the nuclear medicine department on the first floor of the Rabb building, main entrance, East Campus, 330 Brookline Avenue, Boston. For more information call 617-667-2071.

SOURCE

Other related article published in this Open Access Online Scientific Journal:

Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI – Corus CAD, hs cTn, CCTA

Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2013/03/10/acute-chest-painer-admission-three-emerging-alternatives-to-angiography-and-pci/

Read Full Post »

“Medicine Meets Virtual Reality” – NextMed-MMVR21 Conference 2/19 – 2/22/2014, Manhattan Beach Marriott, Manhattan Beach, CA

Reporter: Aviva Lev-Ari, PhD, RN

 

NEXTMED / MMVR21

Start Date:Wed. February 19, 2014

End Date:Sat. February 22, 2014

Website:http://www.nextmed.com/en/left/welcome/

QUALCOMM VENTURES PARTICIPATION: SPEAKING

“Medicine Meets Virtual Reality” was conceived in 1991 to explore the healthcare utilization of rapidly evolving computing and communications technologies. Physicians, educators, scientists, and engineers gathered to assess how patient care and medical education could be enhanced by increasingly powerful and affordable computers and the expanding Internet. Each specialty brought its own skills and experience. By identifying and nurturing collaborative objectives, they understood that revolutionary tools could be created and existing practices transformed.

Two decades later, the curriculum has expanded beyond virtual reality to encompass a broader range of healthcare topics. The rebranded “NextMed” continues to unite experienced researchers with tomorrow’s leaders while they share current breakthroughs and strategize new directions. Their multidisciplinary expertise generates a unique perspective on what’s now and what’s next in medicine.

SPEAKING – JACK YOUNG, DIRECTOR – QUALCOMM LIFE FUND

Saturday morning (exact time TBD), February 22, 2014

LOCATION
Manhattan Beach Marriott
Manhattan Beach, CA

Conference Program

The program as of February 6 is available for download in PDF:

NextMed-MMVR21_Program

This update describes the Thursday, Friday, and Saturday morning plenary sessions, with their featured presentations. These complement the regular lecture tracks, poster sessions, workshops, panels, and exhibits that provide attendees a wealth of new research in IT-enabled tools and methods for healthcare.

Keep in mind that the Friday evening private tour and reception at USC’s Institute for Creative Technologies will be popular. Space is limited and advance registration necessary.

Note that the program may change in order to accommodate logistical requirements, although we aim to keep it as stable as possible.

Contact us (MMVR21-at-NextMed-dot-com) with any questions about the program.


Program at a Glance

Wednesday Afternoon, February 19

  • 2014 TATRC Military Medical Simulation Public Briefing

Wednesday Evening 

  • Welcome Reception

Thursday Morning, February 20

  • Poster Session: Rehabilitation & Aging; Psychology & Technology; Networking & Telemedicine; Surgical Simulator Systems; Surgical Simulator Design; Surgical Simulator Validation
  • Plenary Session: Cregan, Gallagher, Scott, Debevec
  • Exhibits

Thursday Afternoon

  • Track A: Rehabilitation & Aging; Psychology & Technology; Integrating Intelligent Tutoring Systems in Virtual World Training/Learning
  • Track B: Surgical Simulator Design; Surgical Simulation Metrics; Surgical Simulation Validation; GLSIM: Highly Demanded Full-VR Simulator as an Endoscopic Laser Surgery Curriculum
  • Track C: The Federal Medical Simulation and Training Consortium
  • Track D: Extending Extensible 3D (X3D): from Haptic-based Medical Training to Clinical Applications
  • Track E: Share Your Ideas with the Government

Thursday Evening

  • Networking Social: Innovate NextMed

Friday Morning, February 21

  • Poster Session: Learning & Technology; Simulator Design & Development; Simulator Systems; Information-Guided Therapies; Imaging & Visualization; Robotics; Sensors; Haptics; Modeling
  • Plenary Session: Carmena, Coleman, Palanker, Berger, Mohr, Satava Award
  • Exhibits

Friday Afternoon

  • Track A: Imaging & Visualization; Information-Guided Therapies; Robotics; Interfaces; Haptics
  • Track B: Simulator Validation; Simulator Systems; Simulator Design; Learning & Technology; Fundamentals of Robotic Surgery: Development and Validation of an Online Curriculum and New Psychomotor Testing Device
  • Track C: Novel Approaches to the Study of Medical Skill Decay
  • Track D: Simulation Development

Friday Evening

  • Tour of USC’s Institute for Creative Technologies (Optional)

Saturday Morning, February 22

  • Plenary Session: Satava, Hillman, Patrick, Sanchez, Young

Saturday Afternoon

  • Track A: Modeling
  • Track B: The Wide Area Virtual Environment: Lessons Learned
  • Track C: 3D Printing for Rapid Prototyping
  • Closing Mixer

    Thursday Plenary Presenters

    Patrick C. Cregan FRACS

    University of Sydney, Nepean Clinical School

    “(Un?) Affordable Care”

    Paul Debevec PhD

    Institute for Creative Technologies, University of Southern California

    “Advances in Photoreal Digital Humans in Film and in Real-Time”

    Anthony G. Gallagher PhD DSc

    ASSERT for Health Research Group, University College Cork, Ireland

    “Simulation Fidelity: More Than Experience and Mere Repetition?”

    Stephen H. Scott PhD

    Biomedical and Molecular Sciences, Queen’s University

    “Potential of Robots as Next-Generation Technology for Clinical Assessment of Neurological Disorders”

    Friday Plenary Presenters

    Theodore W. Berger PhD

    Center for Neural Engineering, University of Southern California

    “Human-Computer Interface Technology” (Session Discussant)

    Jose M. Carmena PhD

    Electrical Engineering & Neuroscience, University of California, Berkeley

    “Closed-Loop Design Strategies for Brain-Machine Interfaces”

    Todd P. Coleman PhD

    Bioengineering, University of California, San Diego

    “Wearable Wireless Sensors and Analytics in the Cloud to Advance Human-Computer Interaction”

    Catherine Mohr MD MSME

    Intuitive Surgical 

    “Robotics as a Catalyst for Disruption”

    Daniel Palanker PhD

    Ophthalmology &  Hansen Experimental Physics Laboratory, Stanford University

    “Photovoltaic Restoration of Sight to Patients Blinded by Retinal Degeneration”

    Saturday Plenary Presenters

    Elizabeth M.C. Hillman PhD

    Laboratory for Functional Optical Imaging, Columbia University

    “Hyperspectral and Dynamic Contrast: What your Eyes Can’t See”

    Kevin Patrick MD MS

    Center for Wireless & Population Health Systems, University of California, San Diego

    “Modeling the Exposome: A Whole Health Information Approach to Support Personalized Population Health”

    Justin Sanchez PhD

    Defense Sciences Office, Defense Advanced Research Projects Agency

    “Next-Generation Neurotechnology at the Defense Advanced Research Projects Agency”

    Richard M. Satava MD FACS

    Department of Surgery, University of Washington

    “Directed Energy Surgery: Dawning of the Next Generation of Surgery”

    Jack Young

    Qualcomm Life Fund, Qualcomm Ventures

    “Digital Health Investment”

    SOURCE

Read Full Post »

Fourth Annual QPrize Competition to Fund the World’s Next Groundbreaking Startups by Qualcomm Ventures

Curator: Aviva Lev-Ari, PhD, RN

Qualcomm’s QPrize shows its philosophy on the mobile world

by 

AUG. 31, 2012 – 11:54 AM PST

smartphone users

SUMMARY:MightyText won Qualcomm’s QPrize event yesterday, but the IP texting app and the nine other finalists are also a microcosm of Qualcomm’s views about what mobility can bring to computing and how to design for mobiles.

MightyText, an app that lets you text to any phone from any device, won Qualcomm’s $100,000 QPrize on Thursday evening. And while cool, the app and the other finalists also offer a glimpse into the way Qualcomm thinks about how mobility and connectivity will change our apps, our habits and eventually large portions of our world.

While MightyText is clearly an app that one associates with mobile phones — after all texting originated there — it’s really trying to build connective tissue between all of our platforms with broadband as the mechanism to do so. As many teens could tell you, there’s no difference between a text and an IM unless you consider the device. And thanks to IM applications getting loaded onto phones, there’s really no reason to involve your carrier — something that helped precipitate the changes in mobile data plans by AT&T and Verizon.

Mobile first, and everything else feeds into that.

The lesson here is the mobility isn’t a separate platform, it’s the primary platform for most apps and everything else should be built to tie back into it. This is a fundamental shift in worldview, and some companies like Spotify or MightyText get it, and some companies are struggling, such as Facebook. In an interview a few months back, Nagraj Kashyap, vice president of Qualcomm Ventures, explained how he thinks about mobility and how that influences his investments.

“In general on mobile phones, resources are more expensive and attention spans are less,” Kashyap says. “We like companies that are more creative and come at it without a legacy way of thinking. The app is based around the mobile phone: and we have a growing focus on how to leverage the smartphone and not worry about the PC online business.”

First, he’s focused Qualcomm Ventures more on early stage companies and he’s also broadened the geographic focus for Qualcomm Ventures. There are plenty of places in the world where wireline broadband is a luxury, but millions access the web on their smartphones. Given that, places like Brazil, China and India have a mobile first attitude already giving them an advantage. He’s also broadened the concept of what makes a “mobile company.”

Qualcomm Ventures invests in mobile companies, but some of its investments just like some of the QPrize finalists don’t really seem like a traditional mobile play. For example, Cloudessa, one of the finalists, is a cloud security company. But since many of the potential customers of the Cloudessa software are likely enterprise customers worried about their employees working on corporate apps on unsecured personal phones or tablets, Qualcomm’s interest makes sense.

Another area where Qualcomm is stretching the definition of mobile is in its healthcare investments. For years Qualcomm has been preaching the benefits of linking mobility and wireless devices to medical devices and healthcare in general. Although Ubiqi Health, a QPrize finalist, isn’t a novel medical device that takes advantage of connectivity, it does provide a mobile-first dashboard for managing a chronic condition, tying together two of Qualcomm Venture’s investment theses.

Some other elements of Qualcomm’s worldview and what it aims to invest in through its venture arm are companies that take advantage of the mobility of phones to gather data from users and then turn that data into useful services. Examples of this are Waze, which makes crowd-sourced traffic maps or RootMetrics, which measures wireless signal strengths on phones that run its software and then deliver coverage maps. (Update: To be clear, Qualcomm doesn’t have an investment in RootMetrics.) Kashyap is especially interested in using camera phones and augmented reality along with crowd sourcing to build up a repository of imagery that could help push the envelope on computer vision.

In general Qualcomm’s investments and QPrize finalists exemplify Qualcommm’s mobile-first worldview. And once that worldview is factored in, then the devil is in the details. Remembering that bandwidth is expensive and more limited means designing lightweight apps. Shorter attention spans mean that the lifetime of apps may be short-lived if they are entertainment-focused and that productivity apps will have to balance brevity with a business model (this means advertising that requires extra time and space) may be out.

It’s a new world, and Qualcomm is investing at the forefront of it.

Qualcomm Ventures Launches Fourth Annual QPrize Competition to Fund the World’s Next Groundbreaking Startups

January 15, 2014

Seven Regional Winners Secure US$100,000 each, with an additional US$150,000 Grand Prize

SAN DIEGO – January 15, 2014 – Qualcomm Incorporated (NASDAQ: QCOM), through its venture investment arm, Qualcomm Ventures, today kicked off its QPrize™ 2014 international seed investment competition. The goal of the contest is to identify and fund the industry’s next promising, early-stage technology companies.
The QPrize competition is open to entrepreneurs across China, Europe, India, Israel, Korea, Latin America and North America. One finalist from each region will be awarded US$100,000 in convertible note financing from Qualcomm as seed funding and will be invited to compete against other regional finalists in the QPrize Grand Finals competition.
The Grand Finals winner will receive an additional US$150,000 of convertible note funding to help transform the company’s innovative business plan into reality.“As a leading industry enabler, Qualcomm is committed to fueling innovation and driving cutting-edge technologies into the entire wireless ecosystem,” said Nagraj Kashyap, senior vice president of Qualcomm Ventures. “The QPrize competition allows us to take a look at very early stage companies in key regions throughout the world and fund the next wave of up and coming innovators. Last year’s entrants redefined the capabilities of mobile technology, which was showcased when the Grand Finals winner, iOnRoad, was acquired less than 30 days after the Grand Finals. QPrize acts as an important validation point for many of these startups, and we look forward to fostering the development and leveraging the QPrize brand to further raise awareness of these breakthrough technologies.”

The deadline to submit business plans is April 18, 2014.

From the pool of competing entries, Qualcomm Ventures will select up to eight finalists from each of the seven regions. Finalists will attend a regional competition where each company will be evaluated by a panel of experts based on the merits of the technology innovation, its market potential, the company’s management capabilities and the attainability of the proposal’s financial projections.

The Qualcomm Ventures QPrize competition is now open. To get additional details, including background information on past winners, rules and regulations, submission guidelines, or to submit your business plan go to www.qprize.com.

About Qualcomm
Qualcomm Incorporated (NASDAQ: QCOM) is a world leader in 3G, 4G and next-generation wireless technologies. Qualcomm Incorporated includes Qualcomm’s licensing business, QTL, and the vast majority of its patent portfolio. Qualcomm Technologies, Inc., a wholly-owned subsidiary of Qualcomm Incorporated, operates, along with its subsidiaries, substantially all of Qualcomm’s engineering, research and development functions, and substantially all of its products and services businesses, including its semiconductor business, QCT. For more than 25 years, Qualcomm ideas and inventions have driven the evolution of digital communications, linking people everywhere more closely to information, entertainment and each other. For more information, visit Qualcomm’s website, OnQ blog, Twitter and Facebook pages.

###

Qualcomm is a registered trademark of Qualcomm Incorporated. QPrize is a trademark of Qualcomm Incorporated. All other trademarks are the property of their respective owners.

Source: Qualcomm

VIEW VIDEO

https://qualcommventures.com/media/videos/?channel=qprize

http://bcove.me/7o07nmdr

http://bcove.me/ype9efm7

OVERVIEW

QPrize™ is Qualcomm Venture’s Seed investment competition. It’s designed to provide entrepreneurs their first level of funding so they can launch their idea into a successful start-up business. We are looking for bright, energetic and resourceful entrepreneurs who have a passion for bringing new technologies and services to market. Our goal is to have QPrize act as a catalyst for our winners, providing the initial capital to launch their great ideas and support the company to its first institutional funding round.

View winners from QPrize 2012-2013 Competition

Evolution of QPrize

QPrize Infographic_11.08.13
SOURCE
https://qualcommventures.com/qprize/

UPCOMING EVENTS

NEXTMED / MMVR21

Start Date:Wed. February 19, 2014

End Date:Sat. February 22, 2014

Website:http://www.nextmed.com/en/left/welcome/

QUALCOMM VENTURES PARTICIPATION: SPEAKING

“Medicine Meets Virtual Reality” was conceived in 1991 to explore the healthcare utilization of rapidly evolving computing and communications technologies. Physicians, educators, scientists, and engineers gathered to assess how patient care and medical education could be enhanced by increasingly powerful and affordable computers and the expanding Internet. Each specialty brought its own skills and experience. By identifying and nurturing collaborative objectives, they understood that revolutionary tools could be created and existing practices transformed.

Two decades later, the curriculum has expanded beyond virtual reality to encompass a broader range of healthcare topics. The rebranded “NextMed” continues to unite experienced researchers with tomorrow’s leaders while they share current breakthroughs and strategize new directions. Their multidisciplinary expertise generates a unique perspective on what’s now and what’s next in medicine.

SPEAKING – JACK YOUNG, DIRECTOR – QUALCOMM LIFE FUND

Saturday morning (exact time TBD), February 22, 2014

LOCATION
Manhattan Beach Marriott
Manhattan Beach, CA

Conference Program

The program as of February 6 is available for download in PDF:

NextMed-MMVR21_Program

This update describes the Thursday, Friday, and Saturday morning plenary sessions, with their featured presentations. These complement the regular lecture tracks, poster sessions, workshops, panels, and exhibits that provide attendees a wealth of new research in IT-enabled tools and methods for healthcare.

Keep in mind that the Friday evening private tour and reception at USC’s Institute for Creative Technologies will be popular. Space is limited and advance registration necessary.

Note that the program may change in order to accommodate logistical requirements, although we aim to keep it as stable as possible.

Contact us (MMVR21-at-NextMed-dot-com) with any questions about the program.


Program at a Glance

Wednesday Afternoon, February 19

  • 2014 TATRC Military Medical Simulation Public Briefing

Wednesday Evening 

  • Welcome Reception

Thursday Morning, February 20

  • Poster Session: Rehabilitation & Aging; Psychology & Technology; Networking & Telemedicine; Surgical Simulator Systems; Surgical Simulator Design; Surgical Simulator Validation
  • Plenary Session: Cregan, Gallagher, Scott, Debevec
  • Exhibits

Thursday Afternoon

  • Track A: Rehabilitation & Aging; Psychology & Technology; Integrating Intelligent Tutoring Systems in Virtual World Training/Learning
  • Track B: Surgical Simulator Design; Surgical Simulation Metrics; Surgical Simulation Validation; GLSIM: Highly Demanded Full-VR Simulator as an Endoscopic Laser Surgery Curriculum
  • Track C: The Federal Medical Simulation and Training Consortium
  • Track D: Extending Extensible 3D (X3D): from Haptic-based Medical Training to Clinical Applications
  • Track E: Share Your Ideas with the Government

Thursday Evening

  • Networking Social: Innovate NextMed

Friday Morning, February 21

  • Poster Session: Learning & Technology; Simulator Design & Development; Simulator Systems; Information-Guided Therapies; Imaging & Visualization; Robotics; Sensors; Haptics; Modeling
  • Plenary Session: Carmena, Coleman, Palanker, Berger, Mohr, Satava Award
  • Exhibits

Friday Afternoon

  • Track A: Imaging & Visualization; Information-Guided Therapies; Robotics; Interfaces; Haptics
  • Track B: Simulator Validation; Simulator Systems; Simulator Design; Learning & Technology; Fundamentals of Robotic Surgery: Development and Validation of an Online Curriculum and New Psychomotor Testing Device
  • Track C: Novel Approaches to the Study of Medical Skill Decay
  • Track D: Simulation Development

Friday Evening

  • Tour of USC’s Institute for Creative Technologies (Optional)

Saturday Morning, February 22

  • Plenary Session: Satava, Hillman, Patrick, Sanchez, Young

Saturday Afternoon

  • Track A: Modeling
  • Track B: The Wide Area Virtual Environment: Lessons Learned
  • Track C: 3D Printing for Rapid Prototyping
  • Closing Mixer

    Thursday Plenary Presenters

    Patrick C. Cregan FRACS

    University of Sydney, Nepean Clinical School

    “(Un?) Affordable Care”

    Paul Debevec PhD

    Institute for Creative Technologies, University of Southern California

    “Advances in Photoreal Digital Humans in Film and in Real-Time”

    Anthony G. Gallagher PhD DSc

    ASSERT for Health Research Group, University College Cork, Ireland

    “Simulation Fidelity: More Than Experience and Mere Repetition?”

    Stephen H. Scott PhD

    Biomedical and Molecular Sciences, Queen’s University

    “Potential of Robots as Next-Generation Technology for Clinical Assessment of Neurological Disorders”

    Friday Plenary Presenters

    Theodore W. Berger PhD

    Center for Neural Engineering, University of Southern California

    “Human-Computer Interface Technology” (Session Discussant)

    Jose M. Carmena PhD

    Electrical Engineering & Neuroscience, University of California, Berkeley

    “Closed-Loop Design Strategies for Brain-Machine Interfaces”

    Todd P. Coleman PhD

    Bioengineering, University of California, San Diego

    “Wearable Wireless Sensors and Analytics in the Cloud to Advance Human-Computer Interaction”

    Catherine Mohr MD MSME

    Intuitive Surgical 

    “Robotics as a Catalyst for Disruption”

    Daniel Palanker PhD

    Ophthalmology &  Hansen Experimental Physics Laboratory, Stanford University

    “Photovoltaic Restoration of Sight to Patients Blinded by Retinal Degeneration”

    Saturday Plenary Presenters

    Elizabeth M.C. Hillman PhD

    Laboratory for Functional Optical Imaging, Columbia University

    “Hyperspectral and Dynamic Contrast: What your Eyes Can’t See”

    Kevin Patrick MD MS

    Center for Wireless & Population Health Systems, University of California, San Diego

    “Modeling the Exposome: A Whole Health Information Approach to Support Personalized Population Health”

    Justin Sanchez PhD

    Defense Sciences Office, Defense Advanced Research Projects Agency

    “Next-Generation Neurotechnology at the Defense Advanced Research Projects Agency”

    Richard M. Satava MD FACS

    Department of Surgery, University of Washington

    “Directed Energy Surgery: Dawning of the Next Generation of Surgery”

    Jack Young

    Qualcomm Life Fund, Qualcomm Ventures

    “Digital Health Investment”

    SOURCE

SXSW

Event Date:March 9, 2014

Website:http://panelpicker.sxsw.com/vote/23902

QUALCOMM VENTURES PARTICIPATION: SPEAKING

For the first time in 50 years, the health care industry is facing a major disruption and is moving toward an at-risk/ACO model where opportunities are driven by transition. With the growing aging population and increase in chronic diseases in the U.S., health service providers are focusing on collaborated and coordinated care to create efficiencies, reduce readmissions, and ultimately, lower costs. Innovative medical technologies and big data will play a key role in the continuum of care, providing a real-time and holistic view of the patient’s health history to better inform decisions and help manage care. As health and technology continue to merge, investors have become more interested in funding digital health, giving startups a great opportunity for growth. In this panel session, some of the most prolific investors in digital health will discuss what excites them about the future of health care and why now is the time to reinvent the industry through innovation and collaboration.

SPEAKING – JACK YOUNG, DIRECTOR – QUALCOMM LIFE FUND

TITLE: WHAT HAPPENS WHEN HEALTH AND TECH MEET UP?
DATE: SUNDAY, MARCH 9
MODERATOR: JACK YOUNG QUALCOMM LIFE FUND
PANELISTS:

LOCATION
Startup Village, Hilton Austin Downtown, 4th Floor

Add to calendar

Israel Innovation Conference 2014

Start Date:Tue. May 20, 2014 8:00 am

End Date:Thu. May 22, 2014 5:00 pm

QUALCOMM VENTURES PARTICIPATION: SPEAKING

The first in the world where Biomed and High-tech will join hands in a unique and exciting new international conference format.

SPEAKING – JACK YOUNG, DIRECTOR – QUALCOMM LIFE FUND

LOCATION
Tel Aviv Fairgrounds

SOURCE

Read Full Post »

Positron Emission Tomography (PET) and Near-Infrared Fluorescence Imaging:  Noninvasive Imaging of Cancer Stem Cells (CSCs)  monitoring of AC133+ glioblastoma in subcutaneous and intracerebral xenograft tumors

Reporter: Aviva Lev-Ari, PhD, RN

Noninvasive positron emission tomography and fluorescence imaging of CD133+ tumor stem cells

 

  1. Simone Gaedickea,1,
  2. Friederike Braunb,c,1,
  3. Shruthi Prasada,c,1,
  4. Marcia Macheind,
  5. Elke Firata,
  6. Michael Hetticha,c,
  7. Ravindra Gudihale,
  8. Xuekai Zhua,
  9. Kerstin Klingnerf,
  10. Julia Schülerf,
  11. Christel C. Herold-Mendeg,
  12. Anca-Ligia Grosua,h,
  13. Martin Beheb,i,
  14. Wolfgang Weberb,h,j,
  15. Helmut Mäckeb,h, and
  16. Gabriele Niedermanna,h,2

Author Affiliations

  1. Edited by Owen N. Witte, Howard Hughes Medical Institute, University of California, Los Angeles, CA, and approved December 23, 2013 (received for review August 9, 2013)

 

Significance

Cancer stem cells (CSCs) are thought to be responsible for growth and dissemination of many malignant tumors and for relapse after therapy. Therefore methods for the noninvasive imaging of CSCs could have profound consequences for diagnosis and therapy monitoring in oncology. However, clinically applicable methods for noninvasive CSC imaging are still lacking. The AC133 epitope of CD133 is one of the most intensely investigated CSC markers and is particularly important for aggressive brain tumors. Here we describe the development of clinically relevant tracers that permit high-sensitivity and high-resolution monitoring of AC133+ glioblastoma stem cells in both subcutaneous and intracerebral xenograft tumors using positron emission tomography and near-infrared fluorescence imaging, two clinically highly relevant imaging modalities.

Abstract

A technology that visualizes tumor stem cells with clinically relevant tracers could have a broad impact on cancer diagnosis and treatment. The AC133 epitope of CD133 currently is one of the best-characterized tumor stem cell markers for many intra- and extracranial tumor entities. Here we demonstrate the successful noninvasive detection of AC133+ tumor stem cells by PET and near-infrared fluorescence molecular tomography in subcutaneous and orthotopic glioma xenografts using antibody-based tracers. Particularly, microPET with 64Cu-NOTA-AC133 mAb yielded high-quality images with outstanding tumor-to-background contrast, clearly delineating subcutaneous tumor stem cell-derived xenografts from surrounding tissues. Intracerebral tumors as small as 2–3 mm also were clearly discernible, and the microPET images reflected the invasive growth pattern of orthotopic cancer stem cell-derived tumors with low density of AC133+ cells. These data provide a basis for further preclinical and clinical use of the developed tracers for high-sensitivity and high-resolution monitoring of AC133+ tumor stem cells.

Footnotes

  • Author contributions: F.B., S.P., M.M., M.B., H.M., and G.N. designed research; S.G., F.B., S.P., M.M., M.H., R.G., K.K., and M.B. performed research; M.H., J.S., C.C.H.-M., and A.-L.G. contributed new reagents/analytic tools; S.G., F.B., S.P., M.M., E.F., R.G., X.Z., M.B., W.W., H.M., and G.N. analyzed data; and F.B., S.P., E.F., M.H., W.W., and G.N. wrote the paper.

  • The authors declare no conflict of interest.

  • This article is a PNAS Direct Submission.

  • This article contains supporting information online at www.pnas.org/lookup/suppl/doi:10.1073/pnas.1314189111/-/DCSupplemental.

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Why should Quality Assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)

Why should Quality Assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)

 Reporter: Dror Nir, PhD

Converting life-science innovations into useful products involves allocation of significant resources to handling of regulatory processes. A typical approach that makes the management of these processes difficult and awkward is starting your project and later patching it with a QA system. It then becomes a source of sever headaches to many people who need to live and operate according to such patch.
I hope that the following post by Rina will inspire you all.
It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or one area at a time and making sure you have put in place something to address that requirement. This may easily result in a quality system that feels like a patchwork. Compliant, perhaps, but most certainly awkward and difficult to sustain.
The second most common mistake is to not ask yourself how software tools can help in setting up the quality system. “We already have MS Word, MS Excel, email, and we can always print a document and have it signed.” This is only a solution if you think that the quality system is a one-off activity. In the longer run, the system turns out to be a constant struggle with non-integrated elements that have no cohesion.
A better way to address compliance is to:
  1. Accept the fact that the quality system is a long term commitment and that it is very demanding.
  2. Assume that the right software tools do help.
  3. Think strategically, reviewing the whole standard, and try to identify the different areas, in respect to what type of software would help address those.

Real life example: A company maintains an Excel list of all corrective actions. The date of effectiveness check is filled in manually. A QA engineer needs to review the Excel spreadsheet once a week to identify which effectiveness checks are due. Last audit revealed that in most cases, effectiveness checks were not followed up.
Real life question: Meetings and other events are registered in a calendar and you are reminded when they are due. Wouldn’t it be easier if effectiveness checks due dates were also linked to a calendar? Putting those dates in Excel does not make more sense than putting your meetings in Excel…..

What follows is how we can divide the ISO-13485:2003 in regard to the type of software features which can help us. You do not need to be an IT expert to follow the logic or the explanation – if you know the standard and see my examples hopefully you will get the idea.
In any case, I put here the complete mapping of the ISO into the different categories I describe. I also mention the main Atlassian tools we use to address each area. In future posts we will dive deeper into each of those categories and provide more details on exactly how we achieve easy and sustainable, compliance.
So, as promised, these are the various categories that appear in the ISO 13485:2003:
  1. Document management: These are the various requirements relating to the procedures, manuals, and device related documents you need to have, and how they should be handled within the organization. The ISO elaborates in quite a detailed manner about how the controlled documents needs to be approved, who should access them, etc. Confluence is the key tool we use to handle all these requirements.
  2. Procedures and records are the evidence that the organization lives up to its quality system: The various procedures and work instructions should be followed consistently on a daily basis, forms or other records should be collected as evidence. Some examples (with reference to the standard section):
    • Training( 6.2.2).
    • Customer complaints: (8.5.1).
    • Corrective and preventive actions: (8.5.2, 8.5.3)
    • Subcontractor approvals( 7.4.1)
    • Purchasing forms( 7.4.1).

Those records may be created as electronic or physical paper forms which need to be completed by the authorized person. However, a much better way is to implement an automatic workflow that makes it easier for the team to create, follow, and document all the various tasks they need to do. Such a workflow can automatically schedule tasks, remind and alert, thus triggering better compliance to the quality system and at the same time automatically creating the required records. This is a double win. JIRA® is our tool of choice and it provides a state-of-the-art solution to everything related to forms and workflows.

  1. Design control: Some of the issues covered by section 7 of the ISO 13485 require quite advanced control along several phases of design and development. The risk mitigation measures and the product requirements should be, for example, verified in the product verification stage. This verification, or the test file, could be written as a simple Word or Excel document, but a far better implementation is to create it within JIRA. The advantage of JIRA here is the various reporting that it allows once the data is in and the fact that it can connect directly into the work scheduling of the various team members. JIRA is the principal tool we use for design control. Confluence can be used in some advanced implementations. If the medical device involves software, then the development suite from Atlassian can be implemented to provide a complete software life cycle management suite.
  2. Manufacturing and product traceability: Some requirements relate to your manufacturing setup. Depending on the scale and type of manufacturing, specialized ERP may be the best option. When manufacturing is more basic and does not call for a full blown manufacturing facility, JIRA can handle the requirements of the standard.
  3. Monitoring and improving: A key theme of the standard is the need of the organization to measure and improve (for example, section 8.2.3). The nice thing is that the framework we have put in place to support the other categories, if done correctly, should provide us with the reports, alerts, and statistics we need. Indeed, all the processes we have implemented in JIRA, as well as the various elements we have implemented in Confluence, may easily be collected and displayed in practically endless variations of reports and dashboards.
Requirement (Article) Requirement type
4.Quality management system – 1.General requirements Non specific
4.Quality management system – 2.Documentation requirements – 1.General Document management
4.Quality management system – 2.Documentation requirements – 2.Quality manual Document management
4.Quality management system – 2.Documentation requirements – 3.Control of documents Document management
4.Quality management system – 2.Documentation requirements – 4.Control of records Procedures and records
5.Management responsibility – 1.Management commitment Document management
5.Management responsibility – 2.Customer focus Non specific
5.Management responsibility – 3.Quality policy Monitoring and ongoing improvement
5.Management responsibility – 4.Planning – 1.Quality objectives Monitoring and ongoing improvement
5.Management responsibility – 4.Planning – 2.Quality management system planning Monitoring and ongoing improvement
5.Management responsibility – 5.Responsibility, authority and communication – 1.Responsibility and authority Document management
5.Management responsibility – 5.Responsibility, authority and communication – 2.Management representative Monitoring and ongoing improvement
5.Management responsibility – 5.Responsibility, authority and communication – 3.Internal communication Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 1.General Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 2.Review input Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 3.Review output Monitoring and ongoing improvement
6.Resource management – 1.Provision of resources Non specific
6.Resource management – 2.Human resources – 1.General Procedures and records
6.Resource management – 2.Human resources – 2.Competence, awareness and training Procedures and records
6.Resource management – 3.Infrastructure Manufacturing and product traceability
6.Resource management – 4.Work environment Non specific
7.Product realization – 1.Planning of product realization Design control
7.Product realization – 2.Customer-related processes – 1.Determination of requirements related to the product Design control
7.Product realization – 2.Customer-related processes – 2.Review of requirements related to the product Design control
7.Product realization – 2.Customer-related processes – 3.Customer communication Design control
7.Product realization – 3.Design and development – 1.Design and development planning Design control
7.Product realization – 3.Design and development – 1.Design and development input Design control
7.Product realization – 3.Design and development – 3.Design and development outputs Design control
7.Product realization – 3.Design and development – 4.Design and development review Design control
7.Product realization – 3.Design and development – 5.Design and development verification Design control
7.Product realization – 3.Design and development – 6.Design and development validation Design control
7.Product realization – 3.Design and development – 7.Control of design and development changes Design control
7.Product realization – 4.Purchasing – 1.Purchasing process Procedures and records
7.Product realization – 4.Purchasing – 2.Purchasing information Procedures and records
7.Product realization – 4.Purchasing – 3.Verification of purchased product Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 1.General requirements Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2.Control of production and service provision: Specific requirements – 1.Cleanliness of product and contamination control Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2.Control of production and service provision: Specific requirements – 2.Installation ativities Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2. – 3.Servicing activities Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 3.Particular requirements for sterile medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 2.Validation of processes for production and service provision – 1.General requirements Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 2.Validation of processes for production and service provision – 2.Particular requirements for sterile medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 1.Identification Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 2.Traceability – 1.General Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 2.Particular requirements for active implantable medical devices and implantable medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 3.Status identification Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 4.Customer property Non specific
7.Product realization – 5.Production and service provision – 5.Preservation of product Procedures and records
7.Product realization – 6.Control of monitoring and measuring devices Manufacturing and product traceability
8.Measurement, analysis and improvement – 1.General Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 1.Feedback Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 2.Internal audit Procedures and records
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 3.Monitoring and measurement of processes Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 4.Monitoring and measurement of product – 1. General requirements Design control
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 4.Monitoring and measurement of product – 2.Particular requirement for active implantable medical devices and implantable medical devices Procedures and records
8.Measurement, analysis and improvement – 3.Control of nonconforming product Procedures and records
8.Measurement, analysis and improvement – 4.Aalysis of data Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 5.Improvement – 1.General Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 5.Improvement – 2.Corrective action Procedures and records
8.Measurement, analysis and improvement – 5.Improvement – 3.Preventive action Procedures and records

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Increased Radiation Awareness: CT procedure volume Peaked in 20011 and drops 11% over past 2 years

Reporter: Aviva Lev-Ari, PhD, RN

CT procedure volume drops 11% over past 2 years

By Brian Casey, AuntMinnie.com staff writer

January 16, 2014 — The number of CT procedures being performed in the U.S. has declined at an average annual rate of 5.5% over the past two years, reversing years of steady growth in volume, according to a new report by market research firm IMV Medical Information Division.

The findings appear to dovetail with other studies that have shown an overall slowdown in utilization of advanced imaging technologies throughout the U.S. But while CT use has fallen over the past couple of years, the report indicates that the age of the CT installed based has climbed significantly, generating hope that scanner sales could pick up steam as sites look to replace aging systems and upgrade to new technology.

CT use peaked in 2011

The report is based on a survey that IMV performed in September 2013 of managers of 424 imaging facilities in the U.S. Results were extrapolated to the universe of more than 8,500 CT facilities across the country.

IMV found that CT procedure volume peaked at 85.3 million studies performed in the U.S. in 2011. That number fell 5.5% to 80.6 million studies in 2012, and volume declined another 5.5% to 76 million examinations in 2013.

What is behind the decline? It could be due to several factors, according to Gail Prochaska, IMV vice president of sales:

  • The increased focus on radiation exposure, which has raised awareness among both patients and healthcare providers that CT scans should only be performed when clinically appropriate
  • The rise of scan precertification requirements by insurance payors, giving referring physicians another chance to pause and consider the merits of a CT order
  • A change in how CT procedures are counted, spurred by new Medicare rules on contiguous scans that bundle multiple CT scans performed in a single visit into a single billing code

“We think that has changed how respondents report procedures to us,” Prochaska said in a Google Hangout on the new report (below).

VIEW VIDEO

http://www.auntminnie.com/index.aspx?sec=sup&sub=imc&pag=dis&ItemID=106209&wf=5785

In that vein, the report demonstrates how the mix of CT procedures has changed by anatomical region. While the number of scans performed in most regions changed by only a few percentage points, the number of pelvic and abdominal scans dropped from 31% of the total in 2003 to 24% in 2013 — perhaps due to the new Medicare rules. At the same time, the number of CT angiography studies rose from 4% in 2003 to 10% most recently, reflecting strong interest in this relatively new exam.

The survey also assessed the sentiment of imaging managers, revealing some bright spots. While fewer managers in 2013 felt that procedure volume would increase in the future (49% in 2013, compared with 58% in 2012 and 48% in 2011), more managers felt that their overall revenue would increase, with 35% answering affirmatively in 2013, compared with 31% in 2012 and 25% in 2011.

What explains the difference?

“They are still working hard, patients are coming in through a variety of doors … so there’s a spirit of optimism there,” said Lorna Young, senior director of market research at IMV, in the Hangout.

Future priorities

What are the major priorities of CT managers in the near future? The most cited issues were satisfying the needs of referring physicians and improving their ability to reduce radiation dose to patients, the survey found. At the bottom of the list were managing preauthorization requirements and keeping the department up to date with state-of-the-art technology — although Young pointed out that the latter two issues were still rated highly.

The survey also asked respondents to rate the issues that will affect their future outlook for CT procedures at their facility. Unsurprisingly, reduced Medicare and third-party insurance reimbursement was a top concern, followed immediately by the fact that most managers felt their current CT capacity was sufficient to meet anticipated patient volume over the next two to three years. And, of course, respondents agreed highly with the statement that uncertainty over healthcare reform had prompted them to slow capital equipment spending.

But another silver lining in the new data concerns the average age of the CT installed base. Eight or nine years ago, that average age was about 6.7 years, Young said. Now, it’s closer to 8.9 or 9 years because sites have postponed purchases.

“Because the heyday of purchases was in 2005 and 2006, and you add nine years to that, we’re coming into a time when replacements are starting to be a big factor,” Young said. “It’s not totally doom and gloom; [scanner] replacements and activity is out there.”

Disclosure notice: AuntMinnie.com is a subsidiary of IMV Ltd.

Related Reading

IMV: Cath lab market to grow over next 3 years, October 2, 2013

Report: Radiation therapy market regains stability, July 17, 2013

Good times ahead for MRI? Market conditions favor replacement, September 6, 2012

New PET/CT facilities power utilization growth, August 21, 2012

CT’s growth rate slows, but users remain optimistic, June 5, 2012

SOURCE

http://www.auntminnie.com/index.aspx?sec=sup&sub=imc&pag=dis&ItemID=106209&wf=5785

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The Role of Medical Imaging in Personalized Medicine

Writer & reporter: Dror Nir, PhD

The future of personalized medicine comprise quantifiable diagnosis and tailored treatments; i.e. delivering the right treatment at the right time. To achieve standardized definition of what “right” means, the designated treatment location and lesion size are important factors. This is unrelated to whether the treatment is focused to a location or general. The role of medical imaging is and will continue to be vital in that respect: Patients’ stratification based on imaging biomarkers can help identify individuals suited for preventive intervention and can improve disease staging. In vivo visualization of loco-regional physiological, biochemical and biological processes using molecular imaging can detect diseases in pre-symptomatic phases or facilitate individualized drug delivery. Furthermore, as mentioned in most of my previous posts, imaging is essential to patient-tailored therapy planning, therapy monitoring, quantification of response-to-treatment and follow-up disease progression. Especially with the rise of companion diagnostics/theranostics (therapeutics & diagnostics), imaging and treatment will have to be synchronized in real-time to achieve the best control/guidance of the treatment.

It is worthwhile noting that the new RECIST 1.1 criteria (used in oncological therapy monitoring) have been expanded to include the use of PET (in addition to lymph-node evaluation).

pet

In previous posts I already discussed many examples concerning the use of medical imaging in personalized medicine: e.g. patients’ stratification; Imaging-biomarkers is Imaging-based tissue characterization, the future of imaging-biomarkers in diagnostic; Ultrasound-based Screening for Ovarian Cancer, imaging-based guided therapies; Minimally invasive image-guided therapy for inoperable hepatocellular carcinoma, treatment follow-up; the importance of spatially-localized and quantified image interpretation in cancer management, and imaging-based assessment of response to treatment; Causes and imaging features of false positives and false negatives on 18F-PET/CT in oncologic imaging

Browsing through our collaborative open-source initiative one can find many more articles and discussions on that matter; e.g. Tumor Imaging and Targeting: Predicting Tumor Response to Treatment: Where we stand?, In Search of Clarity on Prostate Cancer Screening, Post-Surgical Followup, and Prediction of Long Term Remission

In this post I would like to highlight the potential contribution of medical imaging to development of companion diagnostics. I do that through the story on co-development of Vintafolide (EC145) and etarfolatide (Endocyte/Merck). Etarfolatide is a folate-targeted molecular radiodiagnostic imaging agent that identifies tumors that overexpress the folate receptor. The folate receptor, a glycosylphosphatidylinositol anchored cell surface receptor, is overexpressed on the vast majority of cancer tissues, while its expression is limited in healthy tissues and organs. Folate receptors are highly expressed in epithelial, ovarian, cervical, breast, lung, kidney, colorectal, and brain tumors. When expressed in normal tissue, folate receptors are restricted to the lungs, kidneys, placenta, and choroid plexus. In these tissues, the receptors are limited to the apical surface of polarized epithelia. Folate, also known as pteroylglutamate, is a non-immunogenic water-soluble B vitamin that is critical to DNA synthesis, methylation, and repair (folate is used to synthesize thymine).

Vintafolide (EC145) delivers a very potent vinca chemotherapy directly to cancer cells by targeting the folate receptor expressed on cancer cells. Approximately 80-90 percent of ovarian and lung cancers express the receptor, as do many other types of cancer. Clinical data have shown that patients with metastases that are all positive for the folate receptor, identified by etarfolatide, benefited the most from the treatment with vintafolide, the corresponding folate-targeted small molecule drug conjugate.

Having both drug and imaging agent rely on folate receptors within the patients body Endocyte’s strategy was to develop the imaging agent and to use it to accelerate R&D and regulation. Endocyte and Merck entered into a partnership for vintafolide in April 2012. Under this partnership Merck was granted an exclusive license to develop, manufacture and commercialize vintafolide. Endocyte is responsible for conducting the PROCEED Phase 3 clinical study in women with platinum resistant ovarian cancer and the Phase 2b second line NSCLC (non-small cell lung cancer) study named TARGET. Merck is responsible for further clinical studies in additional indications. This Co-development of a diagnostic and therapeutic agent, was conducted according to the FDA guidance on personalized medicine and resulted with vintafolide gaining, already in 2012, status of orphan drug in EMA.

 

 The following is an extract from a post by Phillip H. Kuo, MD, PhD, associate professor of medical imaging, medicine, and biomedical engineering; section chief of nuclear medicine; and director of PET/CT at the University of Arizona Cancer Center.

 0213-figure-1

Figure 1 — Targeted Radioimaging Diagnostic and Small Molecule Drug Conjugate

Etarfolatide is comprised of the targeting ligand folic acid (yellow), which has a high folate receptor binding affinity, and a Technetium-99m–based radioimaging agent (turquoise). Etarfolatide identifies metastases that express the folate receptor protein in real time (A). The folic acid-targeting ligand is identical to that found on vintafolide, the corresponding therapeutic small molecule drug conjugate, which also contains a linker system (blue) and a potent chemotherapeutic drug (red) (B).

 

 vinta

Figure 2 — Whole-Body Scan With 111In-DTPA-Folate 

Diagnostic images of whole-body scans obtained following administration of the targeted radioimaging agent 111In-DTPA-folate, which is constructed with the same folic acid ligand as that engineered in etarfolatide. The healthy patient image on the left shows no folate receptor-positive abdominal tumor. Instead, only healthy kidneys (involved in excretion) are revealed. The patient on the right shows folate receptor-positive tumors in the abdomen and pelvis. Patients with metastases, identified with the companion imaging diagnostic etarfolatide as folate receptor-positive are most likely to respond to treatment with the corresponding small molecular drug conjugate vintafolide. Note: Vintafolide currently is being evaluated in a phase 3 clinical trial for platinum-resistant ovarian cancer and a phase 2 trial for non–small-cell lung cancer. Both studies also are using etarfolatide.

0213-figure-3

Figure 3 — Vintafolide’s Mechanism of Action

Folate is required for cell division, and rapidly dividing cancer cells often express folate receptors to capture enough folate to support rapid cell growth. Elevated expression of the folate receptor occurs in many human malignancies, especially when associated with aggressively growing cancers. The folate-targeted small molecule drug conjugate vintafolide binds to the folate receptor (A) and subsequently is internalized by a natural endocytosis process (B). Once inside the cell, vintafolide’s serum-stable linker selectively releases a potent vinca alkaloid compound (C) to arrest cell division and induce cell death.

Epilog

I think that those of you who reached this point in my post deserve a special bonus! So here it is: A medical-imaging initiative that is as ambitious and complex as the initiative to send humans into deep-space.

This is the The European Population Imaging Infrastructure initiative of the Dutch Federation of University Medical Centres (NFU) and the Erasmus University Medical Centre Rotterdam, Department of Radiology, chaired by Professor Gabriel P. Krestin. The NFU has made available initial funding for the development of this initiative.

The European Population Imaging Infrastructure closely cooperates with the European Biomedical Imaging Infrastructure Project EURO-BioImaging which is currently being developed.

The ultimate aim of the infrastructure is to help the development and implementation of strategies to prevent or effectively treat disease. It supports imaging in large, prospective epidemiological studies on the population level. Image specific markers of pre-symptomatic diseases can be used to investigate causes of pathological alterations and for the early identification of people at risk.

More information on this infrastructure and on the role of the European Population Imaging Infrastructure in this can be found in the Netherlands Roadmap for Large-Scale Research Facilities, the applicaton for funding of the Roadmap Large Scale Research Facilities Application form of the Roadmap EuroBioImaging, and on the Euro-BioImaging website.

Certainly, while making progress with this initiative, many lessons will be learned. I recommend to explore this site and Enjoy!

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Summary of Genomics and Medicine: Role in Cardiovascular Diseases

Summary of Genomics and Medicine: Role in Cardiovascular Diseases

Author: Larry H. Bernstein, MD, FCAP

The articles within Chapters and Subchapters you have just read have been organized into four interconnected parts.
  1. Genomics and Medicine
  2. Epigenetics – Modifyable Factors Causing CVD
  3. Determinants of CVD – Genetics, Heredity and Genomics Discoveries
  4. Individualized Medicine Guided by Genetics and Genomics Discoveries
The first part established the
  • rapidly evolving science of genomics
  • aided by analytical and computational tools for the identification of nucleotide substitutions, or combinations of them
that have a significant association with the development of
  • cardiovascular diseases,
  • hypercoagulable state,
  • atherosclerosis,
  • microvascular disease,
  • endothelial disruption, and
  • type-2DM, to name a few.
These may well be associated with increased risk for stroke and/or peripheral vascular disease in some cases,
  • essentially because the involvement of the circulation is systemic in nature.

Part 1

establishes an important connection between RNA and disease expression.  This development has led to
  • the necessity of a patient-centric approach to patient-care.
When I entered medical school, it was eight years after Watson and Crick proposed the double helix.  It was also
  • the height of a series of discoveries elucidating key metabolic pathways.
In the period since then there have been treatments for some of the important well established metabolic diseases of
  • carbohydrate,
  • protein, and
  • lipid metabolism,
such as –  glycogen storage disease, and some are immense challenges, such as
  • Tay Sachs, or
  • Transthyretin-Associated amyloidosis.
But we have crossed a line delineating classical Mendelian genetics to
  • multifactorial non-linear traits of great complexity and
involving combinatorial program analyses to resolve.
The Human Genome Project was completed in 2001, and it has opened the floodgates of genomic discovery.  This resulted in the identification of
genomic alterations in
  • cardiovascular disease,
  • cancer,
  • microbial,
  • plant,
  • prion, and
  • metabolic diseases.
This has also led to
  • the identification of genomic targets
  • that are either involved in transcription or
  • are involved with cellular control mechanisms for targeted pharmaceutical development.
In addition, there is great pressure on the science of laboratory analytics to
  • codevelop with new drugs,
  • biomarkers that are indicators of toxicity or
  • of drug effectiveness.
I have not mentioned the dark matter of the genome. It has been substantially reduced, and has been termed dark because
  • this portion of the genome is not identified in transcription of proteins.
However, it has become a lightning rod to ongoing genomic investigation because of
  • an essential role in the regulation of nuclear and cytoplasmic activities.
Changes in the three dimensional structure of these genes due to
  • changes in Van der Waal forces and internucleotide distances lead to
  • conformational changes that could have an effect on cell activity.

Part 2

is an exploration of epigenetics in cardiovascular diseases.  Epigenetics is
  • the post-genomic modification of genetic expression
  • by the substitution of nucleotides or by the attachment of carbohydrate residues, or
  • by alterations in the hydrophobic forces between sequences that weaken or strengthen their expression.
This could operate in a manner similar to the conformational changes just described.  These changes
  • may be modifiable, and they
  • may be highly influenced by environmental factors, such as
    1. smoking and environmental toxins,
    2. diet,
    3. physical activity, and
    4. neutraceuticals.
While neutraceuticals is a black box industry that evolved from
  • the extraction of ancient herbal remedies of agricultural derivation
    (which could be extended to digitalis and Foxglove; or to coumadin; and to penecillin, and to other drugs that are not neutraceuticals).

The best examples are the importance of

  • n-3 fatty acids, and
  • fiber
  • dietary sulfur (in the source of methionine), folic acid, vitamin B12
  • arginine combined with citrulline to drive eNOS
  • and of iodine, which can’t be understated.
In addition, meat consumption involves the intake of fat that contains

  • the proinflammatory n-6 fatty acid.

The importance of the ratio of n-3/n-6 fatty acids in diet is not seriously discussed when

  • we look at the association of fat intake and disease etiology.
Part 2 then leads into signaling pathways and proteomics. The signaling pathways are
  • critical to understanding the inflammatory process, just as
  • dietary factors tie in with a balance that is maintained by dietary intake,
    • possibly gut bacteria utilization of delivered substrate, and
    • proinflammatory factors in disaease.
These are being explored by microfluidic proteomic and metabolomic technologies that were inconceivable a half century ago.
This portion extended into the diagnosis of cardiovascular disease, and
  • elucidated the relationship between platelet-endothelial interaction in the formation of vascular plaque.
It explored protein, proteomic, and genomic markers
  1. for identifying and classifying types of disease pathobiology, and
  2. for following treatment measures.

Part 3

connected with genetics and genomic discoveries in cardiovascular diseases.

Part 4

is the tie between life style habits and disease etiology, going forward with
  • the pursuit of cardiovascular disease prevention.
The presentation of walking and running, and of bariatric surgery (type 2DM) are fine examples.
It further discussed gene therapy and congenital heart disease.  But the most interesting presentations are
  • in the pharmacogenomics for cardiovascular diseases, with
    1. volyage-gated calcium-channels, and
    2. ApoE in the statin response.

This volume is a splendid example representative of the entire collection on cardiovascular diseases.

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