MedicalResearch.com Interview with: Dr Christopher Michael Cook MBBS Bsc(Hons) MRCP MRC Clinical Research Fellow NHLI, Cardiovascular Medicine, Imperial College London MedicalResearch.com: What is the background for this...
Dr. Gulani[/caption]
Vikas Gulani, MD, PhD
Director, MRI, UH Cleveland Medical Center
Associate Professor, Radiology, CWRU School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We wanted to learn if performing MR before prostate biopsy, followed by MR guided strategies for biopsy, are cost effective for the diagnosis of prostate cancer in men who have not previously undergone a biopsy and who have a suspicion of prostate cancer.
The most significant findings are as follows:
We found that all three MR guided strategies for lesion targeting (cognitive targeting, MR-ultrasound fusion targeting, and in-gantry targeting) are cost effective, as the increase in net health benefits as measured by addition of quality adjusted life years (QALY), outweigh the additional costs according to commonly accepted willingness to pay thresholds in the United States.
Cognitive targeting was the most cost effective. In-gantry biopsy added the most health benefit, and this additional benefit was cost-effective as well.
Pr. Schwitter[/caption]
Pr. Juerg Schwitter MD
Médecin Chef Cardiologie
Directeur du Centre de la RM Cardiaque du CHUV
Centre Hospitalier Universitaire Vaudois - CHUV
Suisse
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Coronary artery disease (CAD) is still one of the leading causes of death in the industrialized world and as such, it is also an important cost driver in the health care systems of most countries. For the European Union, the estimated costs for CAD management were 60 billion Euros in 2009, of which approximately 20 billion Euros were attributed to direct health care costs (1). In 2015, the total costs of CAD management in the United States were estimated to be 47 billion dollars (2).
Substantial progress has been achieved regarding the treatment of CAD including drug treatment but also revascularizations procedures. There exists a large body of evidence demonstrating myocardial ischemia as one of the most important factors determining the patient’s prognosis and reduction of ischemia has been shown to improve outcome.
On the other hand, techniques to detect CAD, i.e. relevant myocardial ischemia, were insufficient in the past. Evaluation of myocardial perfusion by first-pass perfusion cardiac magnetic resonance (CMR) is now closing this gap (3) and CMR is recommended by most international guidelines for the work-up of known or suspected CAD (4,5).
Still, a major issue was not clarified until now, i.e. “how much ischemia is required to trigger revascularization procedures”. Thus, this large study was undertaken to assess at which level of ischemia burden, patients can be safely deferred from revascularization and can be managed by risk factor treatment only. Of note, this crucial question was addressed in both, patients with suspected CAD but also in patients with known (and sometimes already advanced) CAD, thereby answering this question in the setting of daily clinical practice.
Dr. Matthias Götberg[/caption]
Matthias Götberg, MD, PhD
Director Cardiac Cath Lab
Department of Coronary Heart Disease
Skane University Hospital- Lund
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.
Dr. Davies[/caption]
Dr. Justin Davies PhD
Senior Reserch Fellow and Hononary Consultant Cardiologist
National Heart and Lung Institute,
Imperial College London
MedicalResearch.com: What is the background for this study?
Response: We know from the FAME study that compared to angiography alone, FFR guided revascularization improves long-term clinical outcomes for our patients. Despite this, adoption of FFR into everyday clinical practice remains stubbornly low. One major factor for this is the need for adenosine (or other potent vasodilator medications) in order to perform an FFR measurement. Adenosine is expensive, unpleasant for the patient, time consuming and even potentially harmful.
iFR is a newer coronary physiology index that does not require adenosine for its measurement. In the prospective, multi center, blinded DEFINE FLAIR study, 2492 patients were randomly assigned to either FFR guided revascularisation or iFR guided revascularization and followed up for a period of 1 year.
Dr. Marco Valgimigli[/caption]
MedicalResearch.com Interview with:
Dr. Marco Valgimigli, MD, PhD
Interventional Cardiology
Sandro Pertini Hospital, ASL RM2, Rome, Italy
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Every year millions of people with coronary artery disease are treated worldwide with percutaneous coronary intervention (PCI). Radial access as compared to femoral access reduces bleeding and mortality in patients with acute coronary syndrome (ACS) undergoing invasive management. However, prior studies have raised concerns over the increased risk of radiation exposure for both patients and operators with radial instead of femoral access and it remains still unclear whether radial access increases the risk of operator or patient radiation exposure in contemporary practice when performed by expert operators.
The MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial is the largest randomized trial comparing radial versus femoral access in ACS patients undergoing invasive management. In this radiation sub-study (RAD-MATRIX), we collected fluoroscopy time and dose area product (DAP) and equipped radial operators consenting to participate with dedicated dosimeters, each wearing a thorax (primary endpoint), wrist and head (secondary endpoints) lithium fluoride thermo luminescent dosimeter, during study conduct to establish non-inferiority of radial versus femoral access.
Among eighteen operators, performing 777 procedures in 767 patients, the non-inferiority primary endpoint was not achieved. Operator equivalent dose at the thorax was significantly higher with radial than femoral access. After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ in the right radial compared to the left radial access. In the overall MATRIX population, fluoroscopy time and DAP were higher with radial as compared to femoral access.
Dr. Matthias Götberg[/caption]
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. MedicalResearch.com Interview with: [caption id="attachment_32943" align="alignleft" width="180"] Dr. Boessen[/caption] Lars Boesen MD PhD Department of Urology Herlev Gentofte University Hospital Herlev MedicalResearch.com: What is the background...
Dr. Won Young Kim[/caption]
Won Young Kim, MD
Department of Emergency Medicine
Ulsan University College of Medicine
Asan Medical Center
Seoul, Korea
MedicalResearch.com: What is the background for this study?
Response: The current advanced cardiac life support guidelines recommended emergent percutaneous intervention for out-of-hospital cardiac arrest (OHCA) survivors with ST-segment elevation and suspected cardiac origin without ST-segment elevation. However, spontaneous subarachnoid hemorrhage (SAH) is a well-known cause of cardiac arrest, and its electrocardiogram may mimic myocardial infarction or ischemia. The need and timing for brain computed tomography in non-traumatic OHCA remain controversial.
The present study aimed at determining the role of the post-resuscitation ECG in patients with significant ST-segment changes on initial ECG to investigate the difference in post-resuscitation ECG characteristics between OHCA patients with SAH and those with suspected cardiac origin of OHCA.
Dr. Robert Russo[/caption]
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.
Mammogram showing small lesion
Dr. Ahmedin Jemal[/caption]
Ahmedin Jemal, DVM, PHD
Vice President, Surveillance and Health Services Research
American Cancer Society, Inc.
250 Williams St.
Atlanta, GA 30303
MedicalResearch.com: What is the background for this study?
Response: In December 2013, the United States Preventive Services Task Force (USPSTF) recommended annual screening for lung cancer with low dose computed tomography (LDCT) for current or former heavy smokers who quit within the past 15 years.
A previous study estimated that only 2-4% of heavy smokers received LDCT for lung cancer screening in 2010 in the United States. We sought to determine whether lung cancer screening among high risk smokers increased in 2015, following the USPSTF recommendation in 2013.
Dr. Linda Kinsinger[/caption]
Linda Kinsinger, MD, MPH
National Center for Health Promotion and Disease Prevention
U.S. Department of Veterans Affairs
NW Washington DC 20420
MedicalResearch.com: What is the background for this study?
Response: The U.S. Preventive Services Task Force recommends annual lung cancer screening with low-dose computed tomography (LDCT) for current and former heavy smokers ages 55 to 80.
However, clinicians have questioned the practical aspects of implementing lung cancer screening. VA provides care for 6.7 million Veterans each year, mostly older men – many of whom are current or former smokers – thus the implementation of a lung cancer screening program for VA patients would require substantial resources. In order to understand the feasibility and implications of this for patients and clinical staff, VA implemented a three-year Lung Cancer Screening Demonstration Project (LCSDP) in eight geographically-diverse VA hospitals. Investigators identified 93,033 primary care patients at eight sites who were assessed on screening criteria, of whom 2,106 patients were screened between July 2013 and June 2015.
Dr. Adam Sharp[/caption]
Adam L. Sharp MD MS
Research Scientist/Emergency Physician
Kaiser Permanente Southern California
Kaiser Permanente Research
Department of Research & Evaluation
Pasadena, CA 91101
MedicalResearch.com: What is the background for this study?
Response: Millions of head computed tomography (CT) scans are ordered annually in U.S. emergency Departments (EDs), but the extent of avoidable imaging is poorly defined. Ensuring appropriate use is important to ensure patient outcomes and limited resources are optimized. A large number of stake holders have highlighted the need to reduce “unnecessary” CT scanning as part of their recommendations for the Choosing Wisely campaign. However, despite calls for improved stewardship, the extent of avoidable CT use among adults with minor trauma in community EDs is not known.
The Canadian CT Head Rule (CCHR) is perhaps the most studied of many validated decision instruments designed to assist providers in evaluating patients with minor head trauma. This study aims to describe the scope of overuse of CT imaging by ED providers in cases where application of the CCHR could have avoided imaging.
Secondarily, we sought to describe the extent to which avoidable CTs, if averted, would have resulted in “missed” intracranial hemorrhages requiring a neurosurgical intervention.
Dr Ahmed Tawakol[/caption]
Dr Ahmed Tawakol MD
Co-Director, Cardiac MR PET CT Program
Massachusetts General Hospital and
Harvard Medical School
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: While the link between stress and heart disease has long been established, the mechanism mediating that risk hasn’t been clearly understood. Animal studies showed that stress activates bone marrow to produce white blood cells, leading to arterial inflammation. This study suggests an analogous path exists in humans. Moreover, this study identifies, for the first time in animal models or humans, the region of the brain (the amygdala) that links stress to the risk of heart attack and stroke.
The paper reports on two complementary studies.
The first analyzed imaging and medical records data from almost 300 individuals who had PET/CT brain imaging, primarily for cancer screening, using a radiopharmaceutical called FDG that both measures the activity of areas within the brain and reflects inflammation within arteries. All participants in that study had no active cancer or cardiovascular disease at the time of imaging and each had information in their medical records on at least three additional clinical visits after imaging.
The second study enrolled 13 individuals with a history of post-traumatic stress disorder, who were evaluated for their current levels of perceived stress and received FDG-PET scanning to measure both amygdala activity and arterial inflammation.
Dr. Gregory Cooper[/caption]
Dr. Gregory Cooper, MD
Program Director, Gastroenterology
UH Cleveland Medical Center
Co-Program Leader for Cancer Prevention and Control, UH Cleveland Medical Center
Professor, Medicine, CWRU School of Medicine
Co-Program Leader for Cancer Prevention and Control
UH Seidman Cancer Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Affordable Care Act, among other features, removed out of pocket expenses for approved preventive services, and this may have served as a barrier to cancer screening in socioeconomically disadvantaged individuals. If so, then the gap in screening between socioeconomic groups should narrow following the ACA.
The main findings of the study were that although in the pre-ACA era, there were disparities in screening, they narrowed only for mammography and not colonoscopy.
Dr. Henry M. Kuerer[/caption]
Henry M. Kuerer, MD, PhD, FACS
Executive Director, Breast Network Programs
MD Anderson Cancer Network
PH and Fay Etta Robinson Distinguished Professor in Research
Department of Breast Surgical Oncology
Director, Breast Surgical Oncology Training Program
MedicalResearch.com: What is the background for this study?
Response: Worldwide, triple negative and HER2 positive breast cancers, combined, account for about 370,000 women diagnosed annually. With recent advances in neoadjuvant systemic therapy (NST, chemotherapy and targeted therapy given before surgery) for both subsets, the pCR (pathologic complete response- when no residual cancer is found) rates found at the time of surgery in these populations can be as high as 60 percent. This high rate of pCR naturally raises the question of whether surgery is required for all patients, particularly those who will receive adjuvant radiation.
We believe surgery may potentially be redundant – at least for these two subtypes of breast cancer – because of such a high chance for no evidence of disease at the time of pathological review. If there’s no cancer left after the patient has received chemotherapy and the patient is going to receive local radiation therapy, is surgery actually needed?
The challenge has been that standard breast imaging methods cannot accurately predict residual disease after NST. However, by doing the same image-guided percutaneous needle biopsies after neoadjuvant systemic therapy that we do at time of diagnosis, our preliminary research reveals that we may be able to accurately predict which women will have cancer or not.
Dr. Catherine Limperopoulos[/caption]
Catherine Limperopoulos, PhD
Director, Developing Brain Research Laboratory
Co-Director of Research, Division of Neonatology
Diagnostic Imaging and Radiology
Children’s National Health System
Washington, DC
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Premature birth is a major public health concern in the United States affecting 1 in 10 infants each year. Prematurity-related brain injury is very common and associated with a high prevalence of brain injury and accompanying lifelong neurodevelopmental morbidities.
Early disturbances in systemic and cerebral hemodynamics are thought to mediate prematurity-related brain injury. The extent to which cerebral blood flow (CBF) is disturbed in preterm birth is poorly understood, in large part because of the lack of monitoring techniques that can directly and non-invasively measure cerebral blood flow.
We report for the first time early disturbances in global and regional cerebral blood flow in preterm infants following brain injury on conventional magnetic resonance imaging (MRI) over the third trimester of ex-uterine life using arterial spin labelling images. In terms of regional differences, we saw a marked decrease in blood flow to the thalamus and the pons, regions known to be metabolically active during this time.
Dr. Jeffrey S. Anderson[/caption]
Jeffrey S. Anderson, MD, PhD
Director the fMRI Neurosurgical Mapping Service
Principal Investigator for the Utah Functional Neuroimaging Laboratory
University of Utah
MedicalResearch.com: What is your study about?
Response: Billions of people find meaning in life and make choices based on religious and spiritual experiences. These experiences range from epiphanies that change the lives of celebrated mystics to subtle feelings of peace and joy in the lives of neighbors, friends, or family members that are interpreted as spiritual, divine, or transcendent.
Astonishingly, with all we understand about the brain, we still know very little about how the brain participates in these experiences. We set out to answer what brain networks are involved in representing spiritual feelings in one group of people, devout Mormons.
Close-up of fetus at 26 weeks[/caption]
MedicalResearch.com Interview with:
Dr. Heron Werner Junior
Clínica de Diagnóstico por Imagem – CDPI
Rio de Janeiro - Brazil
MedicalResearch.com: What is the background for this study?
Response: A growing number of technological advancements in obtaining and viewing images through noninvasive techniques have brought major breakthroughs in fetal medicine.
In general, two main technologies are used to obtain images within the uterus during pregnancy i.e. ultrasound (US) and magnetic resonance imaging (MRI).
Dr. Maryam Kavousi[/caption]
Maryam Kavousi MD, PhD, FESC
Assistant Professor
Department of Epidemiology
Erasmus University Medical Center
Rotterdam The Netherlands
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The most recent American College of Cardiology/American Heart Association (ACC/AHA) cardiovascular disease (CVD) prevention guidelines recommend statins for a larger proportion of populations.
Notably, a large group of women are categorized as low CVD risk by the guidelines and would therefore not typically qualify for intensive management of their standard risk factors. Coronary artery calcium (CAC) scanning allows for the detection of subclinical coronary atherosclerosis and is viewed as the vessel’s memory of lifetime exposure to risk factors. We therefore aimed to address the utility of CAC as a potential tool for refining CVD risk assessment in asymptomatic women at low CVD risk based on the new guidelines.
This study involved data on 6,739 low-risk women from 5 population-based cohort studies across the United States and Europe. We found that CAC was present in 36% of low-risk women and was associated with increased risk of CVD.
Dr. Devon A. Klein[/caption]
Devon A. Klein, MD, MPH
Asst. Professor of Radiology and Orthopaedics
Hofstra Northwell School of Medicine
Associate Chairman, Radiology
Lenox Hill Hospital
New York, NY 10075
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: As our Emergency Department continued to grow our Radiology Department was challenged to accommodate the resultant increased volume with fixed resources (i.e. CT Scanners) and maintain CT scan throughput. Uncoordinated insular efforts within the Department of Radiology failed to resolve the problem. A collaborative approach utilizing Six Sigma lean and involving stakeholders from the Departments of Radiology, Emergency, Medicine, and Patient Transportation was able to better illustrate the “bottlenecks” and devise solutions.