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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Valvular Heart Disease: Edoxaban vs Warfarin in the ENGAGE AF-TIMI 48 Trial

MedicalResearch.com Interview with:
Raffaele De Caterina MD, PhD

Professor of Cardiology and Director of the University Cardiology Division
‘G d’Annunzio’ University in Chieti

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

Response: The widely used term “valvular atrial fibrillation” encompasses a variety of conditions in which atrial fibrillation and valvular heart disease coexist. Since most trials of the non-vitamin K antagonist oral anticoagulants (NOACs) have variably excluded “valvular atrial fibrillation”, in more or less restrictive terms, there has been uncertainty whether NOACs can be used in such varied conditions. While atrial fibrillation in the presence of a mechanical valve or rheumatic mitral stenosis has to be a true contraindication (unfavorable data with one NOAC in the former setting; no data in the latter setting), patients with valvular diseases such as mitral insufficiency, aortic stenosis, aortic insufficiency, or with the presence of a bioprosthesis, have been variably included in the phase III trials of NOACs, but had not been extensively and conclusively studied before.

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TAVR for Bicuspid Vs. Tricuspid Aortic Valve Stenosis

MedicalResearch.com Interview with:
Sung-Han Yoon MD
Clinical Trials, Cardiology, Developmental Biology
Cedars-Sinai Medical Center, Los Angeles

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

Response: Transcatheter aortic valve replacement (TAVR) has become the standard treatment in inoperable patients in high surgical risk patients with symptomatic severe aortic stenosis (AS). However, major randomized trials excluded congenital bicuspid AS due to its unique morphological features. The indication of TAVR is expanding into a younger population, in which the frequency of bicuspid AS is higher. Therefore, we will encounter TAVR for bicuspid AS more frequently. However, the experience of TAVR in bicuspid AS is limited to small series. Therefore, we aim to evaluate the clinical outcomes of TAVR in bicuspid AS and compare them to tricuspid AS.

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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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Cardiovascular Procedures That Push the Line: High-Risk or Futility of Care?

MedicalResearch.com Interview with:

Adam Skolnick, MD Cardiologist Associate professor of medicine NYU Langone Medical Center

Dr. Adam Skolnick

Adam Skolnick, MD
Cardiologist
Associate professor of medicine
NYU Langone Medical Center  

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

Response: I am privileged to serve on the ACC Program Planning Committee and helped to design this important session that seeks to determine the line between when a cardiovascular procedure is high risk and when it is futile.    I am co-chairing the session with the incoming chair of the section on Geriatric Cardiology for the ACC, Dr. Karen Alexander from Duke.

We are practicing medicine at one of the most extraordinary times when there are so many devices and procedures to prolong and improve quality of life.    It is critical to assess a patient’s goals of care for a given intervention.   In some patients, particularly those who are multiple degenerative chronic conditions, are frail and/or have cognitive impairment it is difficult to know when a given procedure multiple medical conditions will achieve a patient’s goals.   When is a procedure high risk, and when is it simply futile?    This is the fine line upon which many cardiologists often find themselves.

The speakers present case examples of high risk patients considering TAVI, high risk PCI or CABG and mechanical support devices and with interaction from the audience work through when each procedure is high risk and when it is unlikely to achieve a patient’s goals of care.   We also have a dedicated talk on high risk procedures in patients with cognitive impairment, such as advanced dementia.

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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