MedicalResearch.com Interview with: Dr Rajeev Kumar Pathak MBBS, FRACP
Cardiologist and Electrophysiology Fellow
Centre for Heart Rhythm Disorders | University of Adelaide
Cardiovascular Investigation Unit | Royal Adelaide Hospital Adelaide Australia
Medical Research: What is the background for this study? What are the main findings?Response: Obesity and atrial fibrillation (AF) are dual epidemics that frequently coexist. Weight-loss reduces atrial fibrillation burden; however, whether this is sustained, has a dose effect or is influenced by weight-fluctuation is not known. In this study we evaluated the long-term impact of weight-loss and weight-fluctuation on rhythm control in obese individuals with atrial fibrillation.
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MedicalResearch.com Interview with:
Donovan Maust, MD, MS
Assistant Professor of Psychiatry
University of Michigan
Research Scientist, Center for Clinical Management Research
VA Ann Arbor Healthcare System
Medical Research: What is the background for this study? What are the main findings?
Dr.Maust: From a recent government report, we known that about 1/3 of older adults with dementia in nursing homes and about 14% of those in the community have been prescribed an antipsychotic. While providers focus on what benefit the treatment they offer, it is important to also be aware of the potential harms, particularly when it is death. Prior estimates came from relatively short studies and showed a 1% increase. This paper finds that, over 180 days, the increased mortality comparing antipsychotic users to matched non-users is about 2 to 5 times higher.
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MedicalResearch.com Interview with:
Sirpa Soini, MHC, researcher
Department of General Practice and Primary Health Care
University of Helsinki
Medical Research: What is the background for this study? Response: Short-term weight loss is often successful, but he obtained results
are difficult to maintain. Therefore, a study focusing on obese people who successfully lost weight, with special emphasis upon methods applied and background factors,
is of major importance. Many people are successful in losing weight by
themselves without taking part in any organized group activity. The
knowledge about their success and the methods applied does not usually
reach the health care personnel and is one reason why it is difficult
to get reliable information about those who are successful in losing
weight.
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MedicalResearch.com Interview with:
Dr. Adil Haider, MD, MPH
Kessler Director of the Center for Surgery and Public Health (CSPH)
at Brigham and Women’s Hospital
Medical Research: What is the background for this study? Response: Disparities in the quality of care received by minority and low-income patients have been reported for years across multiple medical conditions, types of care, and institutions.
To determine whether clinicians’ unconscious race and/or social class biases correlated with a lower quality of care for minority patients and those of lower socioeconomic status, my colleagues and I conducted a web-based survey among 215 physicians at an academic, level one trauma center. Participants were asked to review eight clinical vignettes, and then respond to three questions about management of care after each. Following their response, a test known as an Implicit Association Test (IAT Test) was used to assess any unconscious preferences.
Medical Research: What are the main findings?Response: We found that race and class biases, as measured by response time to a standardized Implicit Association Test, had no relationship to the way that patients were clinically treated.
Whether the lack of association found between implicit bias and decision making in this study represents a true lack of association or the failure of clinical vignettes to capture the nuances of how implicit biases translate into management decisions remains unclear. Existing biases might influence the quality of care received by minority patients and those of lower socioeconomic status in real-life clinical encounters. (more…)
MedicalResearch.com Interview with:
Dr. Pak Kin Wong Ph.D.
Aerospace& Mechanical Engineering Department Biomedical Engineering and Bio5 Institute
The University of Arizona
Medical Research: What is the background for this study? What are the main findings?
Response: Collective cell migration is central to various (patho)physiological processes, such as tissue development, regeneration, and cancer metastasis. At the onset of the process, a subset of cells acquires distinct leader cell phenotypes in the initially homogeneous population and leads the migration. However, how leader cells are initiated among the initial homogeneous population and how leader cell density is regulated during collective migration remain unknown. In this study, we demonstrate the formation of leader cells is regulated dynamically by Dll4 signaling through Notch1 and cellular stress near the leading edge. Our finding provides a molecular basis for the stochastic emergence of leader cells, a process originally considered random.
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MedicalResearch.com Interview with:
Joann G. Elmore M.D., M.P.H.
Professor of Medicine,
Adjunct Professor of Epidemiology,
University of Washington School of Medicine
Harborview Medical Center
Seattle, WA 98104-2499
MedicalResearch: What is the background for this study? What are the main findings?Dr. Elmore: It is estimated that 1.6 million women in the United States each year undergo a breast biopsy. By interpreting these biopsies under the microscope, pathologists provide diagnoses on a spectrum from benign, to atypia, to ductal carcinoma in situ (DCIS), to invasive cancer. Using these diagnostic classifications, clinical doctors work with their patients to decide if they are at increased risk of developing breast cancer in the future, which can lead to additional surveillance, or how to treat them when the diagnosis is invasive breast cancer. As misclassification of breast lesions by pathologists may contribute to overtreatment and undertreatment of breast disease, we decided to study the accuracy of breast pathology diagnoses in the U.S.
In the Breast Pathology (B-Path) Study, we used a set of 240 breast biopsy cases to evaluate the interpretive accuracy of 115 U.S. pathologists who were actively interpreting breast biopsies in their clinical practices. Their diagnoses were compared with reference diagnoses established by a consensus panel of experienced breast pathologists. When the panel members each independently diagnosed the slides pre-consensus, they agreed unanimously on 75 percent of their diagnoses; ninety percent of the panel members’ initial independent diagnoses agreed with the final consensus-derived reference diagnoses.
When comparing participating pathologists’ diagnoses to the reference diagnoses, we found overall agreement for 75 percent of interpretations. The concordance rate for invasive breast cancer was reassuringly high at 96 percent, and fairly high for benign findings without atypia at 87 percent. However, concordance was lower for atypia at 48 percent and for DCIS at 84 percent. This means that nearly one out of five pathologists disagreed on the diagnosis of DCIS. We found disagreement with the reference diagnosis to be statistically more frequent when pathologists had lower weekly case volumes or worked in smaller labs. Disagreement was also statistically significantly more likely when the patient had dense breast tissue on mammogram; however, the absolute difference was small. Our accuracy findings were not altered when we used different methods of defining the reference diagnosis.
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MedicalResearch.com Interview with:
Lona Mody, MBBS, MSc
Associate Division Chief, Clinical and Translational Research
Associate Director, Clinical Programs, VA GRECC
Associate Professor, Internal Medicine
Research Associate Professor, Institute of Gerontology
University of Michigan Geriatrics Ann Arbor, MI
Medical Research: What is the background for this study? What are the main findings?
Response: Over 1.5 million residents live in 15,600 Nursing Homes in the US. The acuity of illness in this population has increased substantially in the last decade, as has the risk of acquiring new infections. Multi-drug resistant organisms, also known as MDROs, are endemic in this setting with prevalence estimates upwards of 35% and surpassing those in the hospitals. Nursing homes historically have had few infection prevention resources, which contributes to these high rates. Patients with indwelling devices such as urinary catheters and feeding tubes present an attractive habitat for these ‘superbugs’ and thus carry the added burden of device-related infections.
The authors examined the effect of a targeted infection program, or TIP, to reduce the prevalence of Multi-drug resistant organisms and new catheter or feeding tube infections among patients with indwelling devices. The TIP intervention was three-fold:
Surveillance for infections and Multi-drug resistant organism colonization with regular feedback to facilities;
Extensive and interactive staff education using adult learning theory about key infection prevention practices and hand hygiene; and
Use of gowns and gown when providing assistance to patients for high-risk activities such as bathing and grooming.
Staff education emphasized precautionary measures against the spread of infection and included mock game shows, songs and dances. Hands were cultured for bacteria before and after hand washing. Outcomes were measured by results of the cultures taken for each patient and monitoring infection rates.
A team of researchers from the University of Michigan and the Veterans Affairs Ann Arbor Health System has demonstrated that simple measures might be all it takes to push back at the spread of Multi-drug resistant organisms or ‘superbugs’ in nursing homes as well as reduce infections. In their study of patients with indwelling devices, MDROs were reduced by 23 percent among 418 residents in six southeast Michigan nursing homes who participated over the course of the three-year study. The numbers of catheter-associated urinary tract infections and MRSA acquisitions also decreased, 46 percent and 22 percent respectively.
The trial examined the relationship between acquisition of antimicrobial resistance among nursing home and assisted living facility residents with the use of devices by adapting new methodological approaches and study designs to study infection prevention interventions including the use of cluster-randomized study design for infection prevention interventions, adopting adult learning practices to engage frontline healthcare personnel and using multi-anatomic site sampling to demonstrate effectiveness of the program.
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MedicalResearch.com Interview with:
Dr.Yecai Liu
Division of Global Migration and Quarantine
Centers for Disease Control and Prevention, Atlanta, Georgia
Medical Research: What is the background for this study? What are the main findings?
Response: Since the early 1900s, immigrants and refugees applying for a visa to come to the United States undergo a medical examination that includes tuberculosis (TB) screening. In 2007, CDC began implementing the new screening guidelines, which require people suspected of having TB to receive a much more sensitive sputum culture test to confirm TB to ensure that those individuals who do have TB receive treatment before they arrive in the United States. These requirements have now been completely rolled out to all countries with U.S.-bound immigrants and refugees.
From 2007 through 2012, half of the 3.2 million arrivals of immigrants and refugees to the United States were screened for TB by the new screening guidelines. Out of more than 4,000 TB cases diagnosed by the new screening guidelines during this period, nearly 2,200 were smear-negative and culture positive. These cases would likely have been missed under the previous screening requirements. The results of this study showed that the updated overseas screening guidelines led to a roughly one-third decrease in the annual number of TB cases among foreign-born persons within their first year in the United States.
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MedicalResearch.com Interview with:
Jeffrey (Jerry) G. Jarvik MD MPH
Professor, Radiology, Neurological Surgery and Health Services
Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine
Director, Comparative Effectiveness, Cost and Outcomes Research Center University of Washington Seattle, WA
Medical Research: What is the background for this study?
Dr. Jarvik: When I arrived at the Univ of WA over 20 years ago, my mentor, Rick Deyo, had just finished leading a project that was responsible for developing one of the first set of guidelines for the diagnosis and treatment of acute low back pain. These guidelines, published in a booklet by AHRQ (then called AHCPR), recommended that patients with acute low back pain not undergo imaging for 4-6 weeks unless a red flag was present. One of the exceptions was that patients older than 50 could get imaged immediately, the rationale being that older adults had a higher prevalence of potentially serious conditions such as cancer, infections, etc, that would justify the early imaging. As a practicing neuroradiologist, it was clear that a potential problem with this strategy is that the prevalence of age-related changes, which may or may not be related to back pain, also increases with age. So earlier imaging of older adults would almost certainly reveal findings, and these could easily start a series of unfortunate events leading to potentially poor outcomes and more healthcare resource use. Thus this policy of early imaging of older adults didn’t entirely make sense.
About 5 years ago, these guidelines hit home when I developed acute low back pain and since I was over 50 (barely) my doctor recommended that I get an imaging study. Being a knowledgeable patient and having a reasonable doctor, we mutually agreed not to get the study. I improved but that wasn’t the end of it. When we had the chance to apply for one of the CHOICE ARRA awards funded by AHRQ, we made answering this question of early imaging in older adults one of our primary goals.
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MedicalResearch.com Interview with:
Stephen W. Waldo, MD
Research Fellow in MedicineMassachusetts General Hospital
MedicalResearch: What is the background for this study? What are the main findings?Dr. Waldo: Public reporting is intended to improve outcomes for our patients. Proponents of public reporting applaud the increased transparency that it offers, allowing both patients and physicians to objectively evaluate health care outcomes for a given institution or individual provider. Previous research has demonstrated, however, that public reporting of procedural outcomes may create disincentives to provide percutaneous coronary intervention for critically ill patients. The present study sought to evaluate the association between public reporting of outcomes with procedural management and clinical outcomes among patients with acute myocardial infarction. As the data demonstrate, public reporting of outcomes is associated with a lower rate of percutaneous revascularization and increased overall in-hospital mortality among patients with an acute myocardial infarction, particularly among those that do not receive percutaneous intervention. This may reflect risk aversion among physicians in states that participate in public reporting, an unintended consequence of this policy.
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MedicalResearch.com Interview with:
Raffaele Bugiardini, M.D.
Professor of Cardiology
University of Bologna
Medical Research: What is the background for this study? What are the main findings?
Dr. Bugiardini: Our analysis differs from previous reports of outcomes following STEMI because prior studies have not looked at sex differences in outcomes adjusted for time from symptom onset to hospital presentation and subsequent utilization of cardiac revascularization procedures, and rates of revascularization are typically significantly lower in women compared with men
Our study is the first to look at the relationship between delays and outcomes. (more…)
MedicalResearch.com Interview with:Marco Valgimigli, MD, PhD
Erasmus MC, Thoraxcenter,
Rotterdam The Netherlands
MedicalResearch: What is the background for this study? What are the main findings?Dr. Valgimigli: Interventional cardiologists can choose between two entry sites in order to perform a diagnostic coronary angiography and or a percutaneous coronary intervention, namely an artery which is in the groin called femoral artery or an artery which is located in the wrist which is called radial artery. The latter is more superficial and has small calibre as compared to the former. Femoral artery is the entry site which is most frequently used in the world especially in US where the use of radial artery is relatively limited.
Our study randomly allocated 8,404 patients to undergo diagnostic coronary angiography and PCI, if clinically indicated, either vie the femoral or the radial artery.
The main results of our study are that radial access reduced the composite of net adverse clinical events driven by a reduction of mortality and of major bleeding, including transfusions and need for surgical repair or the entry site.
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MedicalResearch.com Interview with:
Jagpreet Chhatwal Ph.D.
Assistant Professor, Department of Health Services Research
Division of Cancer Prevention and Population Sciences
The University of Texas MD Anderson Center
Houston, TX
Medical Research: What is the background for this study? What are the main findings?
Dr. Chhatwal: More than two million people in the U.S. are infected with Hepatitis C (HCV), a virus found in the liver. In 2012, the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommended a one-time hepatitis C screening for baby boomers – people born between the years 1946 and 1964. Last year, the Food and Drug Administration approved the medications sofosbuvir and ledipasvir for Hepatitis C treatment. The newly approved oral regimen comes at a staggering price to payers – as much as $1,125 per day. As a result, several payers have questioned if the price is justified.
The study results show that using new therapies is cost-effective in the majority of patients. However, the budget required to treat all eligible patients would be $136 billion over the next five years. Compared with the old drugs, new therapies would cost an additional $65 billion, whereas the cost offsets would be only $16 billion.
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MedicalResearch.com Interview with: Pam R. Taub, MD, FACC
Assistant Professor of Medicine
UC San Diego Health System
Division of Cardiology Encinitas, CA 92024
Medical Research: What is the background for this study?Dr. Taub: Epidemiological studies indicate that the consumption of modest amounts of dark chocolate (DC), which contains the natural cacao flavanol (-)-epicatechin (Epi,) is associated with reductions in the incidence of cardiovascular diseases (CVD). The health benefits of dark chocolate have been attributed to Epi. Clinical studies using cocoa and/or DC in normal volunteers or subjects with CVD have reported improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, insulin resistance, and inflammatory markers. The mechanism underlying these improvements is thought to be due to increased nitric oxide levels and improved endothelial function. We have also shown that capacity of Epi to favorable impact mitochondria under normal and disease states.
We previously conducted pilot study in five patients with heart failure and type II diabetes, and showed that in skeletal muscle (SkM) biopsies there is a severe reduction in mitochondrial volume and cristae, as well as, in structural/functional proteins. After treatment with Epi rich dark chocolate , there was a significant recovery of SkM mitochondrial cristae, structural/functional proteins (e.g. mitofilin), as well as in regulators of mitochondrial biogenesis. However, no studies have examined the capacity of Epi rich dark chocolate to enhance exercise capacity in normal subjects and assess its impact on mitochondrial and oxidative control systems.
Medical Research: What are the main findings?Dr. Taub: Seventeen subjects were randomized to placebo (n=8) or DC groups (n=9) and consumed 2 squares of chocolate (20 g, provided by Hershey) for 3 months.
We showed in the chocolate group subjects had improved levels of HDL cholesterol and enhanced exercise capacity that is linked to the stimulation of SkM metabolic control endpoints which enhance mitochondrial function.
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MedicalResearch.com Interview with:
Jay S. Kaufman, Ph.D
Canada Research Chair in Health Disparities
Department of Epidemiology, Biostatistics, and Occupational Health
McGill University
Montreal, Quebec Canada
Medical Research: What is the background for this study? What are the main findings?
Response: Published scientific articles speculate frequently about genetic predispositions in different racial groups as explanations for observed disease disparities. They infer this from the higher rates observed in racial minorities, even after adjusting for some social and behavioral measures. Taking the example of the racial disparity between blacks and whites in cardiovascular diseases (stroke, heart attack, heart failure, hypertension, etc), ours is the first published study to review all of the existing results from GWAS (genome-wide association studies) to see if they provide any support for this commonly stated position. To date, they do not. We performed an electronic literature search through the PubMed database to identify review articles and meta-analyses related to genetic risk factors for cardiovascular disease in samples that included populations of European and African ancestries. We focused our search on the 7-year period from January 1, 2007 to January 1, 2014, which corresponded to the rapid proliferation of large pooled GWAS activity. This search strategy yielded 197 review articles or meta-analyses. 68 of these articles contained relevant data, but very few reported significant associations in both racial groups, with just 3 variants meeting study-specific significance criteria. For most outcomes, there were too few estimates for quantitative summarization, but when summarization was possible, racial group did not contribute to heterogeneity. Most associations reported from genome-wide searches were small, difficult to replicate, and in no consistent direction that favored one racial group or another.
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MedicalResearch.com Interview with:
Sameer Bansilal, MD, MS
Asst. Prof.- Medicine and Cardiology
Clinical Trials & Global Health Studies
Icahn School of Medicine at Mount Sinai
Medical Research: What is the background for this study? What are the main findings?
Dr. Bansilal: Our group has previously published data from FREEDOM, COURAGE and BARI showing that adherence to recommended therapies are low in diabetic (DM) patients. We have spent the last decade developing a potential solution to this- the Fuster-Ferrer polypill. This study was done to better inform the association between levels of medication adherence and long term major adverse cardiovascular events (MACE) in high risk diabetic patients.
We analyzed a U.S. health insurers’ claims data for 19,962 high risk diabetic subjects. Using proportion of days covered (PDC) for 1 year after first refill, we stratified patients as fully adherent (FA≥80%), partially adherent (PA ≥40- ≤79%) or non-adherent (NA <40%) and examined the associations with a primary cardiovascualr outcome measure of death, myocardial infarction, stroke and coronary revascularization. We found that only 34% participants were fully adherent to therapy. When compared to being non-adherent at 2 yrs follow up,, being fully adherent was associated with a 28% lower rate of MACE; being partially adherent was associated with a 21% lower rate of MACE. Efforts towards improving adherence in diabetic subjects may lead to substantial reductions in MACE.
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MedicalResearch.com Interview with:
Jonathan D. Newman, MD, MPH
Instructor of Medicine
The Leon H Charney Division of Cardiology and
The Center for the Prevention...
MedicalResearch.com Interview with Filippo Calzolari PhD
Institute of Stem Cell Research, ISF-N
Helmholtz Zentrum München
Neuherberg Germany
MedicalResearch: What is the background for this study?...
MedicalResearch.com Interview with: Jaspreet Ahuja, Nutritionist
USDA, Agricultural Research Service
Nutrient Data Laboratory
Beltsville, MD 20705
MedicalResearch: What is the background for this study? What are the main findings? Response: Most sodium in the U.S. diet comes from commercially processed and restaurant foods. Sodium reduction in these foods is key to several recent public health efforts. In this paper, we provide an overview of a program led by Nutrient Data Laboratory, USDA, in partnership with CDC and FDA to monitor sodium contents in commercially processed and restaurant foods in United States.
We track about 125 highly consumed, sodium-contributing foods, termed “Sentinel Foods” annually using information from food manufacturers and periodically by nationwide sampling and laboratory analyses. In addition, we monitor over 1,100 other commercially processed and restaurant food items, termed “Priority-2 Foods,” biennially using information from food manufacturers. These foods serve as indicators for assessing changes in the sodium content of commercially processed and restaurant foods in the U.S. In addition to sodium, we are monitoring related nutrients (potassium, total dietary fiber, total and saturated fat, total sugar) because their levels may change when manufacturers and restaurants reformulate their products to reduce their sodium content.
We sampled all Sentinel Foods nationwide and reviewed all Priority-2 Foods in 2010–2013 to determine baseline sodium concentrations. The results of sodium reduction efforts, based on re-sampling of the Sentinel Foods or re-review of P2Fs, will become available in 2015 on our website. The updated data are also released in USDA food composition databases, National Nutrient Database for Standard Reference and Food and Nutrient Database for Dietary Studies.
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MedicalResearch.com Interview with:
Colleen K. McIlvennan, DNP, ANP
Assistant Professor of Medicine
University of Colorado, Division of Cardiology
Section of Advanced Heart Failure and Transplantation
Medical Research: What is the background for this study?Response: Destination therapy left ventricular assist device (DT LVAD) patients are often older with significant comorbidities that preclude heart transplantation. As such, the decision to get a DT LVAD is arguably more complicated than the decision to receive a temporary LVAD in anticipation of a transplant. Centers offering LVADs often require the identification of a caregiver prior to proceeding with the implant. Caregivers are commonly female spouses of DT LVAD patients, who are also older with co-morbidities. Understanding their perspective in DT LVAD decision making is extremely important as they are at particular risk for experiencing stress and caregiver burden due to the increased demands on caregiving with DT LVAD.
Medical Research: What are the main findings?Response: We performed semi-structured qualitative interviews with 17 caregivers: 10 caregivers of patients living with DT LVAD, 6 caregivers of patients who had died with DT LVAD, and 1 caregiver of a patient who had declined DT LVAD. Throughout the interviews, the overarching theme was that considering a DT LVAD is a complex decision-making process.
Additionally, three dialectical tensions emerged:
1) the stark decision context, with tension between hope and reality;
2) the challenging decision process, with tension between wanting loved ones to live and wanting to respect loved ones’ wishes; and
3) the downstream decision outcome, with tension between gratitude and burden.
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MedicalResearch.com Interview with:
Prof. David Newby
British Heart Foundation Professor of Cardiology
University of Edinburgh
Director of the Wellcome Trust Clinical Research Facility
MedicalResearch: What is the background for this study? What are the main findings?Dr. Newby: The diagnosis of angina (chest pain) due to coronary heart disease can be very challenging and we often get it wrong. We have a wide range of tests that can try and identify patients with angina due to coronary heart disease. However, even with these tests, we fail to identify 1 in 3 patients who go on to have heart attacks. So we need better tests.
The study shows that if you add CTCA to a clinic consultation, you clarify the diagnosis in 1 in 4 patients, alter the investigations in 1 in 6 and change the subsequent treatments in 1 in 4. This did appear not only to increase the use of coronary revascularisation but also reduce the risk of subsequent heart attacks by 38-50%. (more…)
MedicalResearch.com Interview with: Asako Moriya Ph.D
School of Public and Environmental Affairs
Indiana University, Bloomington, IN
Center for Financing, Access and Cost Trends
Agency for Healthcare Research and Quality
Rockville, MD
MedicalResearch:What is the background for this study? What are the main findings?Response: Historically, young adults have had the lowest rate of insurance coverage. They have also frequently sought non-urgent care in emergency departments (EDs). However, ED care, while appropriate for injuries and other true emergencies, is very expensive and inefficient for non-urgent care. The Affordable Care Act (ACA)’s dependent coverage provision requires health plans that offer dependent coverage to allow young adults to stay on their parents’ private health plans until age 26. This insurance expansion had a potential to improve efficiency by reducing inappropriate ED use.
We used data from the Agency for Healthcare Research and Quality and found that the quarterly ED-visit rate decreased by a small, but statistically significant amount (1.6 per 1,000 population) among adults age 19-25 after the implementation of the ACA’s dependent coverage provision. The decrease was concentrated among women, weekday visits, non-urgent conditions, and conditions that could be treated in other settings. We found no effect among visits due to injury, weekend visits, and urgent conditions.
The findings suggest that the ACA’s dependent coverage provision has increased the efficiency of medical care delivery by reducing non-urgent ED use. Having access to their parents’ health insurance appears to be prompting young adults to use medical care more appropriately.
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Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories
Cleveland Clinic Cleveland, OH
For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105).
In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment.
According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement.
“This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says.
Superior survival benefit with TAVR
PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater.
The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83.
The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.
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MedicalResearch.com Interview with:
Ricardo Stein, MD, ScD
Exercise Cardiology Research Group, Cardiology Division
Federal University of Rio Grande do Sul, Hospital de Clinicas de Porto Alegre,
Porto Alegre, RS, Brazil
MedicalResearch:What is the background for this study? Dr. Stein: Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (VO2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal was to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent non complicated MI.
MedicalResearch:What are the main findings?
Dr. Stein: After the 12-week study period, participants in the Tai Chi Chuan group experienced a significant 14% increase in VO2 peak from baseline (21.6 ± 5.2 to 24.6 ± 5.2 mL.Kg-1.min-1), whereas control participants had a non-significant 5% decline in VO2 peak (20.4 ± 5.1 to 19.4 ± 4.4 mL.Kg-1.min-1). There was a significant difference between the two groups (P<0.0001).
As a primary outcome, CPET results for the TCC and control groups at baseline and after the 12-week intervention period leading to a significant difference in peak VO2 (5.2 mL.Kg-1.min-1; 95% CI, 2.8 to 7.7, in favor to TCC group). This difference remained significant after adjustment to baseline measurements, age, gender, diabetes, and smoking (4.1 mL.Kg-1.min-1; 95% CI, 2.6 to 5.6, in favor to TCC group).
Summarizing:
- We observed a significant increase in VO2 peak in TCC group participants.
- Our results provide important information data from a randomized clinical trial of Tai Chi Chuan in patients with a history of recent MI.
- Tai Chi Chuan can be an attractive alternative to cardiac rehabilitation for patients who don't have access to conventional cardiac rehabilitation programs.
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MedicalResearch.com Interview with:
Barnaby C. Reeves, D.Phil.
Professor of Health Services Research, Clinical Trials & Evaluation Unit
School of Clinical Sciences, University of Bristol
Bristol Royal Infirmary Bristol
Medical Research: What is the background for this study?
Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion.
Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).*
Medical Research: What are the main findings?
Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion.
The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant.
We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups.
We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome. (more…)
MedicalResearch.com Interview with:Dr. Ana Ramírez-Boscá, MD
Department of Dermatology and Clinical Research Unit and
Vicente Navarro-López, MD
Clinical Research Unit and Infectious Diseases Unit
Centro Dermatológico Estético, Alicante, Spain
MedicalResearch: What is the background for this study? What are the main findings?Response: Infections have been related with the pathogenesis of guttate psoriasis, however antibiotic treatment does not improve prognosis nor does it affect the evolution of the disease. The association between psoriasis and other infectious diseases has been reported as well, although in these cases there is scarce information on the causative microbial likely involved and the role of these bacteria in the pathogenesis of this skin disease.
MedicalResearch: What are the main findings?Response: Bacterial DNA may be detected in bloodstream of a significant proportion of patients with active plaque psoriasis. Increased levels of pro-inflammatory cytokines in patients with presence of bacterial DNA but not in patients without presence of bacterial genomic fragments suggest a role of bacterial DNA translocation in inducing an inflammatory response.
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MedicalResearch.com Interview with:
Juan Del Coso Garrigós
Profesor CC. de la Act. Física y del Deporte
Responsable del Laboratorio de Fisiología del Ejercicio
UNIVERSIDAD CAMILO JOSÉ CELA
MedicalResearch: What is the background for this study? What are the main findings?Response: From a scientific point of view, it is well known that salt (either in capsules or included in a drink) can improve physical performance and several other physiological factors such as plasma volume maintenance, thermoregulation, etc in endurance activities. These effects are more evident when the amount of salt ingested during exercise matches the amount of salt lost by sweating. By using only sports drinks, it is impossible to replace all the salt lost by sweating because they only contain a relatively small amount of salt in their compositions (between ½ and 1/3 of the amount of salt lost by sweating).
In fact, some of the investigations that determined the effectiveness of ingesting salt in sports have been financed by most popular sport drinks trademarks. However, sports drink companies only include a part of the salt lost by sweating because for them, taste is elemental for their markets! I suppose that, if they include more salt in their commercially available drinks, they would be more effective to prevent dehydration and performance decline, but at the same time, the taste of the drink would diminish the amount of beverage ingested worldwide.
In this case, in the sport drinks market there is a well- established balance between taste and physiological effectiveness.
As an example, most “salted” sport drinks contain 20-25 mM of sodium while it is well known that sweat sodium concentration ranges from 20 to 60 mM (salty sweater can reach 100 mM!!). This is not a regulatory limitation, because UE considers sports drinks to carbohydrate-electrolyte solutions that contain sodium between 20 and 50 mM.
Our main finding is: To ingest salt capsules, in addition to the habitual rehydration routines with sports drinks, improves performance in a triathlon. This ergogenic effect was mediated by better maintenance of body water and electrolytes balances.
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MedicalResearch.com Interview with:
Stella Yi, Ph.D., MPH, Assistant Professor
Department of Population Health
New York University School of Medicine
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Yi: Self-blood pressure monitoring has been shown to be an effective tool for improving blood pressure control, however most studies have only included white race participants. We were interested in assessing whether distribution of self-blood pressure monitors (intervention) would improve blood pressure and hypertension control over usual care (control) in a 9-month period in a predominantly Hispanic, uninsured population. Systolic blood pressure improved over time in both the intervention (n=409) and the control (n=419) arms by 14.7 mm Hg and 14.1 mm Hg, respectively, as did hypertension control; 39% of study participants overall achieved control at the end of follow-up. However there were no statistical differences between the outcomes in the intervention and usual care groups. (more…)
MedicalResearch.com Interview with:
Harold P. Erickson Ph.D.
James B. Duke Professor, Department of Cell Biology
Duke Univ. Med. Center Durham, NC 27710
MedicalResearch: What is the background for this study?Dr. Erickson: In Jan 2012 a paper reported the discovery of irisin, a hormone reportedly lopped off a precursor in muscle and sent through the bloodstream to fat tissue, where it turned white fat into brown fat. Brown fat burns calories, and is what hibernating animals – and even human babies -- use to keep warm. Turning on brown fat had exciting promise for obesity, diabetes, etc. Dozens of labs around the world jumped on the discovery and started trials in animals and humans of how irisin levels in blood were altered by exercise and a variety of metabolic challenges.
MedicalResearch: What are the main findings? Early reports.Dr. Erickson: The follow-up studies from different labs reported a huge range of values for the level of irisin in blood, so they could not all be right. And most of them failed to find any significant effect of exercise. In 2013 two papers criticized the irisin study. A commentary article by Harold Erickson (Adipocyte 2:289-93) reported two substantial flaws in the original study. A research paper by S. Raschke, J. Eckel and colleagues (PloS one 8:e73680) concluded that humans did not make significant amount of irisin. The human gene for irisin has a deleterious mutation in the start codon, and Raschke et al showed that this reduced irisin expression to only 1% the level with the normal start. These two reports may have slowed new labs entering the field, but many groups already invested continued to publish. (more…)
MedicalResearch.com Interview with:
Elizabeth Burns, MPH
Rollins School of Public Health
Emory University
MedicalResearch: What is the background for this study? What are the main findings?Response: Epidemiologic studies suggest that prenatal stress is associated with preterm birth, low birth weight and peripartum anxiety and depressive symptoms. The most recent population-based study on the prevalence of stress among pregnant women, which used data from 1990-1995, reported that 64% of women experience stressful life events (SLEs) in the year before their infant’s birth. More recent estimates of prevalence and trends of prenatal stressful life events are useful for clinicians in order to understand the risk profile of their patients.
The Pregnancy Risk Assessment Monitoring System (PRAMS) collects self-reported information on maternal experiences and behaviors before, during, and after pregnancy among women who delivered a live infant. PRAMS includes 13 questions about maternal SLEs experienced in the year preceding the birth of the child. Based on previous research, SLEs were grouped into four dichotomous constructs:
1) emotional stressors (family member was ill and hospitalized or someone very close died);
2) financial stressors (moved to a new address, lost job, partner lost job, or unable to pay bills);
3) partner-associated stressors (separated/divorced, argued more than usual with partner/husband, or husband/partner said he did not want pregnancy); and
4) traumatic stressors (homeless, involved in a physical fight, partner or self-went to jail, or someone very close had a problem with drinking or drugs).
The prevalence of self-reported stressful life events decreased modestly but significantly during 2000–2010. Despite this, 70.2% of women reported ≥1 SLEs in 2010. Prevalence of stressful life events vary by state and maternal demographic characteristics and are especially prevalent among younger women, women with ≤12 years of education (75.6%), unmarried women (79.6%), and women that were covered by Medicaid for prenatal care or delivery of their child (78.7%).
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MedicalResearch.com Interview with:
Dr Rajeev Kumar Pathak MBBS, FRACP
Cardiologist and Electrophysiology Fellow
Centre for Heart Rhythm Disorders | University of Adelaide
Cardiovascular Investigation Unit | Royal Adelaide Hospital Adelaide Australia
Medical Research: What is the background for this study? What are the main findings?
Response: Obesity and atrial fibrillation (AF) are dual epidemics that frequently coexist. Weight-loss reduces atrial fibrillation burden; however, whether this is sustained, has a dose effect or is influenced by weight-fluctuation is not known. In this study we evaluated the long-term impact of weight-loss and weight-fluctuation on rhythm control in obese individuals with atrial fibrillation.
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