Instantaneous Wave-free Ratio vs Fractional Flow Reserve to Guide PCI

MedicalResearch.com Interview with:

Dr. Matthias Götberg MD PhD Department of Cardiology, Clinical Sciences Lund University, Skåne University Hospital Lund, Sweden

Dr. Matthias Götberg

Dr. Matthias Götberg MD PhD
Department of Cardiology, Clinical Sciences
Lund University, Skåne University Hospital
Lund, Sweden

MedicalResearch.com: What is the background for this study?

Response: Cardiologists encounter patients with narrowing of the coronary arteries on a daily basis. They typically use visual estimation of the severity of narrowing when performing coronary angiography, but it is difficult to accurately assess, based on a visual estimation alone, whether a stent is needed to widen the artery and allow the blood to more freely.

FFR (Fractional Flow Reserve) is more precise tool and results in better outcomes than using angiography alone to assess narrowing of the coronary arteries. With FFR, the doctor threads a thin wire through the coronary artery and measures the loss of blood pressure across the narrowed area. To acquire an accurate measurement, the patient must be given adenosine, which is a drug that dilates the blood vessels during the procedure. This drug causes discomfort; patients describe having difficulty breathing or feeling as if someone is sitting on their chest. The drug also adds to the cost of the procedure and can have other rare but serious side effects.

iFR (Instantaneous Wave-Free Ratio) is also based on coronary blood pressure measurements using a thin wire, but unlike FFR, it uses a mathematical algorithm to measure the pressure in the coronary artery only when the heart is relaxed and the coronary blood flow is high. As a result, a vasodilator drug is not needed.

iFR has been validated in smaller trials and have been found to be equally good as FFR to detect ischemia, but larger randomized outcome trials are lacking.

iFR-Swedeheart is a Scandinavian Registry-based Randomized Clinical Trial (RRCT) in which 2000 patients were randomized between iFR and FFR as strategies for performing assessment of narrowed coronary vessels. The primary composite endpoint at 12 months was all-cause death, non-fatal myocardial infarction, and unplanned revascularization.

RRCT is a new trial design originating from Scandinavia using existing web-based national quality registries for online data entry, randomization and tracking of events. This allows for a very high inclusion rate and low costs to run clinical trials while ensuring robust data quality.  Continue reading

Study Fails To Support Routine Screening For Subclinical Hypothyroidism During Pregnancy

MedicalResearch.com Interview with:

Professor, Brian Casey, M.D. Gillette Professorship of Obstetrics and Gynecology UT Southwestern Medical Center

Dr. Casey

Professor Brian Casey, M.D.
Gillette Professorship of Obstetrics and Gynecology
UT Southwestern Medical Center 

MedicalResearch.com: What is the background for this study?
Response: For several decades now, subclinical thyroid disease, variously defined, has been associated with adverse pregnancy outcomes.  In 1999, two studies are responsible for increasing interest in subclinical thyroid disease during pregnancy because it was associated with impaired neuropsychological development in the fetus.  One study showed that children born to women with the highest TSH levels had lower IQ levels.  The other showed that children of women with isolated low free thyroid hormone levels performed worse on early psychomotor developmental tests. Together, these findings led several experts and professional organizations to recommend routine screening for and treatment of subclinical thyroid disease during pregnancy.

Our study was designed to determine whether screening for either of these two diagnoses and treatment with thyroid hormone replacement during pregnancy actually improved IQ in children at 5 years of age.

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Can Patients With A Pacemaker or Defibrillator Get An MRI?

MedicalResearch.com Interview with:

Robert Russo, MD, PhD, FACC The Scripps Research Institute The La Jolla Cardiovascular Research Institute

Dr. Robert Russo

Robert Russo, MD, PhD, FACC
The Scripps Research Institute
The La Jolla Cardiovascular Research Institute 

MedicalResearch.com: What is the background for this study?

Response: For an estimated 2 million people in the United States and an additional 6 million people worldwide, the presence of a non-MRI-conditional pacemaker or implantable cardioverter defibrillator (ICD) is considered a contraindication to magnetic resonance imaging. This creates a dilemma for at least half of these patients, who are predicted to require an MRI scan during their lifetime after a cardiac device has been implanted. Safety concerns for patients with an implanted cardiac device undergoing MRI are related to the potential for magnetic field-induced cardiac lead heating resulting in myocardial thermal injury, and a detrimental change in pacing properties. As a result, patients with an implanted device have long been denied access to MRI, although it may have been the most appropriate diagnostic imaging modality for their clinical care. Despite the development of MRI-conditional cardiac devices, a strategy for mitigating risks for patients with non MRI-conditional devices and leads will remain an enduring problem for the foreseeable future due to an ever increasing demand for MRI and the large number of previously and currently implanted non-MRI-conditional devices.

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Survival Rates Improving For Very Preterm Infants

MedicalResearch.com Interview with:

Carla M. Bann, Ph.D. Division of Statistical and Data Sciences RTI International Research Triangle Park, NC

Dr. Carla Bann

Carla M. Bann, Ph.D.
Division of Statistical and Data Sciences
RTI International
Research Triangle Park, NC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Several medical advances have been made over the past two decades to improve the care and survival of infants born pre-term. However, approaches to care differ greatly among providers for infants born at the limits of viability (22 to 24 weeks gestation), far earlier than the 40 weeks generally expected for a pregnancy to reach full-term. Little is known about the outcomes of these infants, particularly whether those who survive experience significant neurodevelopmental impairments.

RTI served as the data coordinating center for this research that examined the survival and neurodevelopmental impairment at 18-22 months corrected age of over 4,000 infants born at 22 to 24 weeks gestation during 2000 to 2011 at medical centers participating in a national research network funded by the NIH. In this group of babies, infant survival improved over time from survival rates of 30 percent in 2000-2003 to 36 percent in 2008-2011. The proportion of infants who survived without a neurodevelopmental impairment also increased from 16 percent in 2000-2003 to 20 percent in 2008-2011.

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Persistence of Zika Virus in Body Fluids — Preliminary Report

MedicalResearch.com Interview with:
Gabriela Paz-Bailey MD PhD

Senior Epidemiologist
Centers for Disease Control and Prevention 

MedicalResearch.com: What is the background for this study?

Response: Zika virus is recognized as a cause of microcephaly and other severe birth defects when a woman is infected during pregnancy. Additionally, it has been associated with potentially fatal complications, such as Guillain-Barré syndrome. It is not well understood how often Zika virus particles can be detected in semen and other body fluids and for how long they remain detectable. Existing evidence is based on case reports and cross-sectional observations, primarily from returning travelers. A more comprehensive description of the dynamics of the early stages of Zika virus infection, observed within infected people over time, is needed to inform diagnostic testing as well as prevention recommendations and interventions.
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Therapeutic Hypothermia After In-Hospital Cardiac Arrest in Children

MedicalResearch.com Interview with:

Victoria Pemberton, RNC, MS, CCRC Program Officer Division of Cardiovascular Sciences National Heart, Lung, and Blood Institute, NIH Bethesda, Maryland

Victoria Pemberton

Victoria Pemberton, RNC, MS, CCRC
Program Officer
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute, NIH
Bethesda, Maryland

MedicalResearch.com: What is the background for this study? What are the main findings?

  • Previous studies have examined cardiac arrest when it occurs outside of the hospital in both children and adults, with current guidelines recommending hypothermia (body cooling) or normothermia (maintenance of normal body temperature) after such an arrest.   This trial addresses pediatric cardiac arrest in a hospital setting, for which no previous data existed. Because children who experience an in-hospital cardiac arrest differ significantly from children who arrest outside of the hospital, it is important to test these treatments in this population.
  • The trial found no significant differences in survival and neurobehavioral functioning a year after cardiac arrest between children assigned to the hypothermia arm and those assigned to normothermia.

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Cigarette Smoking Remains A Huge Public Health Problem

MedicalResearch.com Interview with:
Andrew Hyland, PhD

Chair of the Department of Health Behavior at Roswell Park Cancer Institute and
Karin Kasza, MA
Senior Research Specialist in the Department of Health Behavior
Roswell Park Cancer Institute

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The PATH Study is unique because it is a large, nationally representative study of more than 45,000 youth and adults who are interviewed at multiple points over time and asked about their use of a wide array of tobacco products. The data reported in this study are from the baseline wave, and we find that while cigarettes are by far the most commonly used product for both youth and adults, we see a lot of use of non-cigarette products. E-cigarettes trailed only cigarettes in popularity for youth and water pipe smoking was high among 18-24 year olds. However, we see different patterns of use for different products with cigarettes being used much more frequently that other products like e-cigarettes. Another surprising finding was that about 4 in 10 youth and adult tobacco users were currently using two or more tobacco products.

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Cancer Killed While Preserving A Kidney Transplant

MedicalResearch.com Interview with:

Kenar D. Jhaveri, MD Professor of Medicine Division of Kidney Diseases and Hypertension Hofstra Northwell School of Medicine, 100 Community Drive, Great Neck, NY 11021

Dr. Kenar Jhaveri,

Kenar D. Jhaveri, MD
Professor of Medicine
Division of Kidney Diseases and Hypertension
Hofstra Northwell School of Medicine,
100 Community Drive, Great Neck, NY 11021

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The immune check point inhibitors are novel anti cancer agents being used rapidly in various cancers. Many cancers don’t allow our natural immune system to attack the cancer. These immunotherapy agents “activate” the immune system to attack the cancer. These agents have been reported to cause multiple end organ side effects as noted by this recent NYT article. We also recently reported the known renal effects of immunotherapy.

In the kidney transplant patient who is on immunosuppressive agents, the physicians need to keep the immune system suppressed to preserve the kidney. When one of these agents are used for a cancer in a kidney transplant patient, prior reports have suggested severe rejection episodes and loss of the transplanted kidney. Our case in the NEJM is the first report of a preventive strategy used to allow for simultaneous treatment of cancer and preventive rejection of the kidney. We used a regimen of steroids and sirolimus( an anti-proliferative agent that is used to treat cancer and also is an immunosuppresant) along with the immunotherapy. The cancer started regressing and the kidney did not reject.

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Improved Resolution of Disease Phenotypes With Multilocus Genomic Variation

MedicalResearch.com Interview with:
Jennifer E Posey MD, PhD

Assistant Professor
Department of Molecular and Human Genetics
Baylor College of Medicine

Tamar Harel MD, PhD
Clinical Genetics Academic Research Fellow
Department of Molecular and Human Genetics
Baylor College of Medicine

Current affiliation:
Department of Genetic and Metabolic Diseases
Hadassah-Hebrew University Medical Center
Jerusalem, Israel

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: As physician scientists and geneticists, our goal is to understand how genetic variation in each of us can impact health and disease. Physicians are often taught that the simplest explanation for a medical condition is the most correct explanation, and have historically searched for a single unifying diagnosis. However, in our own practice, we have met – and learned from – individuals who have more than one genetic condition affecting their health.

In the past, it was difficult for physicians to diagnose such individuals. Genetic testing required a physician to recognize the potential for more than one genetic diagnosis in an individual. Single-gene and gene panel testing provided an additional barrier to accurate diagnoses, as they are more narrow in scope, and more than one molecular test was often needed to identify all conditions. Targeted testing also required a physician to accurately pre-suppose which combination of genetic conditions was most likely, and choose the correct targeted tests.

The clinical availability of whole exome sequencing (WES) has removed these barriers: WES is a broad-based, unbiased analysis of an individual’s genetic variation that does not pre-suppose a specific genetic cause. If analysis is pursued systematically, WES can identify more than one genetic diagnosis in an individual, even when not suspected.
In our study, we have been able to assess the frequency with which individuals can have more than one genetic diagnosis, and have begun to understand how genetic variation at more than one place in the genome can affect how a condition may present. We found that among 7,374 individuals referred for WES, 2,076 (28%) had a molecular diagnosis. Of these 2,076, 5% had two, three, or four molecular diagnoses. In our analyses of the clinical features that may be observed in an individual with two genetic conditions, we found that pairs of diagnoses with overlapping clinical features may be incompletely diagnosed as having one or the other condition, and pairs of diagnoses with very distinct clinical features may be erroneously diagnosed in the clinic as having an entirely new condition.
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Economic Effects of Medicaid Expansion in Michigan

MedicalResearch.com Interview with:

John Z. Ayanian, MD, MPP</strong> Director of the Institute for Healthcare Policy and Innovation and Alice Hamilton Professor of Medicine University of Michigan

Dr. John Z. Ayanian

John Z. Ayanian, MD, MPP
Director of the Institute for Healthcare Policy and Innovation and
Alice Hamilton Professor of Medicine
University of Michigan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our study assessed the broad economic impact of Medicaid expansion in Michigan – one of several Republican-led states that have chosen to expand Medicaid under the Affordable Care Act. About 600,000 low-income adults in Michigan are covered through the program, known as the Healthy Michigan Plan, which began in April 2014.

Using an economic modeling tool that is also used to advise the state government for fiscal planning, we found that federal funding for the Healthy Michigan Plan is associated with over 30,000 additional jobs, about $2.3 billion in increased personal income in Michigan, and about $150 million in additional state tax revenue annually. One third of the new jobs are in health care, and 85 percent are in the private sector. The state is also saving $235 million annually that it would have spent on other safety net programs if Medicaid had not been expanded.

Thus, the total economic impact of the Healthy Michigan Plan is generating more than enough funds for the state budget to cover the state’s cost of the program from 2017 through 2021. Beginning in 2017, states are required to cover 5 percent of the costs of care for Medicaid expansion enrollees, and the state share of these costs will rise to 10 percent in 2020. The remaining costs are covered by federal funding.

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Fish Oil Fatty Acids in Pregnancy May Reduce Wheeze and Asthma in Offspring

MedicalResearch.com Interview with:

Hans Bisgaard, M.D., D.M.Sc. COPSAC, Herlev and Gentofte Hospital University of Copenhagen Copenhagen, Denmark

Dr. Hans Bisgaard

Hans Bisgaard, M.D., D.M.Sc.
COPSAC, Herlev and Gentofte Hospital
University of Copenhagen
Copenhagen, Denmark

MedicalResearch.com: What is the background for this study?

Response: Asthma and lower respiratory infections are leading causes of morbidity and mortality in pediatric populations. Thus, having low cost, effective, safe options for prevention could have important implications for both clinical practice and public health.

The increased use of vegetable oils in cooking and of grain in the feeding of livestock has resulted in an increase in the intake of n−6 polyunsaturated fatty acids and a decrease in the intake of n−3 polyunsaturated fatty acids, especially the long-chain poly-unsaturated fatty acids (LCPUFAs) — eicosapentaenoic acid (20:5n–3, EPA) and docosahexaenoic acid (22:6n–3, DHA) — found in cold-water fish. N3-LCPUFAs are known to have immune-modulatory effects, and observational studies have suggested an association between a diet that is deficient in n−3 LCPUFA during pregnancy and an increased risk of asthma and wheezing disorders in offspring. Only a few randomized, controlled trials of n−3 LCPUFA supplementation during pregnancy have been performed and these have generally been underpowered and produced ambiguous results.

Therefore, we conducted a double-blind, randomized, controlled trial of n−3 LCPUFA supplementation during the third trimester of pregnancy in a total of 736 Danish women to assess the effect on the risk of persistent wheeze and asthma in offspring.

The clinical follow-up rate among children was 96% (N=664) by the end of the 3 years double-blind period and 93% (N=647) after an additional follow-up to age 5 years.
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Mutliple Sclerosis: Ocrelizumab Lowers Rate of Disease Progression and Disability

MedicalResearch.com Interview with:

Jerry S. Wolinsky, MD Emeritus Professor in Neurology McGovern Medical School part of UTHealth | The University of Texas Health Science Center at Houston Houston’s Health University Department of Neurology Houston, Texas 77030

Dr. Jerry Wolinsky,

Jerry S. Wolinsky, MD
Emeritus Professor in Neurology
McGovern Medical School
The University of Texas Health Science Center at Houston
Houston’s Health University
Department of Neurology
Houston, Texas 77030

MedicalResearch.com: What is the background for this study?

Response: Multiple sclerosis (MS) clinically is a very heterogeneous disease. It presents in considerably different ways and has a very poorly predictable clinical course. In an attempt to better communicate between experts in the field, there have been multiple attempts to categorize “typical” courses of the disease. How we think about the disease is in part driven by these somewhat artificial categories that lump our patients into those with relapsing forms of the disease (relapsing remitting with or without accumulating clinical disability, and secondary progressive with accumulating disability eventually occurring even in the absence of apparent clinical episodes of the disease), and primary progressive MS, where patients are slowly or sometimes rather rapidly accumulating disability in the absence of prior clinical relapses.

However, the distinctions between multiple sclerosis patients are not always as clear as the definitions would suggest, and it is certain that patients with primary progressive multiple sclerosis sometimes have clinical relapses after years of never having had relapses, and show MRI evidence of having accumulated many lesions in the brain over the course of their disease. Until now, none of the drugs that have shown benefit for relapsing disease have been able to convincingly show clinical benefit for patients with primary progressive disease, and for that matter have shown variable results when attempted in patients categorized as having secondary progressive courses. While some of our currently approved drugs have shown hints of benefit when tried in major clinical trials in primary progressive MS, the results were not been robust enough to seek regulatory approval.

The Oratorio study design was based on lessons learned from prior trials in primary progressive and relapsing forms of MS, as well as the recognition that B cells might play an important role in the immunopathogenesis of disease based on a considerable amount of preclinical work and observations in patients with multiple sclerosis.

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