Instantaneous Wave-Free Ratio To Evaluate Coronary Artery Disease

MedicalResearch.com Interview with:

Matthias Götberg, MD, PhD Director Cardiac Cath Lab Department of Coronary Heart Disease Skane University Hospital- Lund Lund, Sweden

Dr. Matthias Götberg

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.

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iFR Can Assess Need For Coronary Revascularization Without Adenosine

MedicalResearch.com Interview with:

Dr. Justin Davies PhD Senior Reserch Fellow and Hononary Consultant Cardiologist National Heart and Lung Institute, Imperial College Londo

Dr. Davies

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.
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Radiation Exposure and Vascular Access in Acute Coronary Syndromes: The RADMatrix Trial

MedicalResearch.com Interview with: Dr. Marco Valgimigli,

Dr. Marco Valgimigli

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.

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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

Clinical Outcomes Following a Low-Suspicion MRI for Prostate Cancer

MedicalResearch.com Interview with:

Lars Boesen MD PhD Department of Urology Herlev Gentofte University Hospital Herlev

Dr. Boessen

Lars Boesen MD PhD
Department of Urology
Herlev Gentofte University Hospital
Herlev

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

Response: Transrectal ultrasound-guided biopsies (TRUS-bx) traditionally used for detecting prostate cancer (PCa) are prone to sampling errors due to difficulties in target identification. Therefore, concerns about the possibility of missing significant prostate cancer result in men with negative biopsy results frequently undergo repeated biopsies, leading to increased medical costs, patient anxiety and morbidity.

Multiparametric MRI (mp-MRI) has become increasingly important in prostate cancer diagnosis. A suspicious lesion can be targeted by MRI-guided biopsies and improve diagnosis. Conversely, a normal mp-MRI may non-invasively exclude the possibility of an aggressive disease, avoiding the need for further biopsies. However, there are no current guidelines for clinicians whether standard repeated biopsies (TRUS-bx) should be performed in men with either a low-suspicion mp-MRI or benign MRI-targeted biopsies of a suspicious lesion and the clinical outcome and future risk of detecting significant prostate cancer following these findings is unknown.

Therefore, we assessed the risk of being diagnosed with prostate cancer after either a low-suspicion mp-MRI or benign targeted biopsies of a suspicious lesion in men with prior negative TRUS-bx, but a persistent clinical suspicion of missed significant cancer over a follow-up period of at least three years. Our results suggest that a low-suspicion MRI in men with prior negative TRUS-bx can be used non-invasively in ruling out longer term significant cancer and immediate repeated biopsies are of limited clinical value and might be avoided even if prostate-specific-antigen levels are persistently elevated.

MedicalResearch.com: What should readers take away from your report?

Response: A low-suspicion mp-MRI in a man with prior negative TRUS-bx has a high accuracy in ruling out a significant aggressive prostate cancer during follow-up of at least three years. Thus, immediate repeated biopsies rarely find significant disease and could be avoided even if the prostate-specific-antigen level is persistently elevated.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Our results should be verified in larger prospective studies with a longer follow-up period to assess other clinical endpoints that include disease progression, cancer specific mortality and associated costs with an mp-MRI approach.

There are no disclosures or conflicts of interest

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:
J Urol. 2017 Feb 21. pii: S0022-5347(17)30297-5. doi: 10.1016/j.juro.2017.02.073. [Epub ahead of print]
Clinical outcome following a low-suspicion multiparametric prostate MRI or benign MRI-guided biopsy to detect prostate cancer: A follow-up study in men with prior negative transrectal ultrasound-guided biopsies.
Boesen L1, Nørgaard N2, Løgager V3, Thomsen HS4.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Using Post-Resuscitation ECG To Predict Need For Brain CT

MedicalResearch.com Interview with:

Won Young Kim, MD Department of Emergency Medicine Ulsan University College of Medicine Asan Medical Center Seoul, Korea

Dr. Won Young Kim

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.

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Subtle Differences in Brain Volume Detected On MRI In ADHD

MedicalResearch.com Interview with:
M. (Martine) Hoogman PhD.

Postdoc and PI of ENIGMA-ADHD
Radboud universitair medisch centrum
Department of Human Genetics
Nijmegen, The Netherlands

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

Response: There are many neuro-imaging studies aimed at investigating structural brain changes related to ADHD, but the results are often inconclusive.

There are two main reasons for this:

1) the small sample size of the studies and
2) the heterogeneous methods used.

We tried to address these issues by forming an international collaboration to provide a sample size sufficient to detect even small effects in volume differences. And in addition, we analyzed all the raw scans again using homogenized methods. There are data of more than 1700 patients (aged 4-63 years of age) and more than 1500 healthy controls in our dataset, coming from 23 sites around the world. We studied the possible volume differences between cases and controls of 7 subcortical regions and intracranial volume by performing mega- and meta-analysis.

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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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False Positive Mammograms Can Lead Women To Delay or Skip Next Exam

MedicalResearch.com Interview with:

Mammogram showing small lesion - Wikipedia

Mammogram showing small lesion
– Wikipedia

Firas Dabbous, PhD
Manager, Patient Centered Outcomes Research
Russell Institute for Research & Innovation
Advocate Lutheran General Hospital
Park Ridge, IL 

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

Response: When women are told that there is something abnormal on their screening mammogram that can cause stress and worry while undergoing additional testing, even when they are later told that there is nothing wrong. We wanted to know if receiving a false positive screening mammogram would cause women to think twice before getting their next screening mammogram, and maybe delay coming back for their next screen. This is important because patients who have a false positive experience may have higher chance to develop breast cancer at a later point in time. Therefore, it is important to understand their screening patterns to better educate and inform them about the importance of adhering to mammography guidelines and emphasize the importance of returning on schedule for their next screens.

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Annual CT Lung Cancer Screening Among Former Smokers Remains Underutilized

MedicalResearch.com Interview with:

Ahmedin Jemal, DVM, PHD Vice President, Surveillance and Health Services Research American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303

Dr. Ahmedin Jemal

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.

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Comprehensive Lung Cancer Screening Is Complex Task With Many False Positives

MedicalResearch.com Interview with:

Dr-Linda-Kinsinger.jpg

Dr. Linda Kinsinger

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.

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Many CT Scans Can Be Avoided During ER Evaluation of Head Trauma

MedicalResearch.com Interview with:

Adam L. Sharp MD MS Research Scientist/Emergency Physician Kaiser Permanente Southern California Kaiser Permanente Research Department of Research & Evaluation Pasadena, CA 91101

Dr. Adam Sharp

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.

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