FFR Factsheet - Updated
OPTIS? INTEGRATED PCI Optimization System Fact SheetWHAT IS CORONARY ARTERY DISEASE?Coronary artery disease (CAD) is the most common type of heart disease, affecting millions of people worldwide. It is caused by a narrowing or blocking of the arteries due to plaque buildup, which restricts blood flow, and reduces the amount of oxygen to the heart.There are several different methods that aid physicians in the diagnosis and treatment of coronary artery disease. One method is cardiac catheterization, which uses a coronary angiogram (X-ray) to identify coronary artery blockages. Other advanced tools that aid physicians in making the best treatment decisions for their patients include a next-generation intravascular imaging technology called optical coherence tomography (OCT) and fractional flow reserve (FFR) measurements, which provide a more detailed, physiological analysis of blood flow blockages in the coronary arteries.Percutaneous coronary intervention, or PCI, is a minimally-invasive option commonly known as coronary angioplasty that is used to treat narrowed coronary arteries of the heart found in coronary artery disease.WHAT IS THE OPTIS? INTEGRATED SYSTEM?The OPTIS Integrated System is the world’s first PCI optimization system to offer OCT and angiography co-registration, which supports procedural decisions by providing high-resolution, 3-D OCT views of coronary anatomy while mapping the exact location of physician’s current view via angiogram. Access to lumen profile information also supports clinical decision-making by providing information that can support stent sizing and implant planning. The OPTIS Integrated system also integrates St. Jude Medical PressureWireTM FFR measurement technology to provide access to critical hemodynamic information during bined, the technology featured in the OPTIS Integrated System enables PCI optimization by helping physicians identify culprit lesions responsible for ischemia (a restriction of blood flow to the heart) and provides more detailed physiological and anatomical analyses of blood flow blockages in the heart. OCT resolution is 100 times better than intravascular ultrasound allowing for enhanced PCI planning and optimization, especially in complex clinical cases.THE VALUE OF ANGIOGRAPHY / OCT CO-REGISTRATIONCo-registration of angiography and OCT imaging is a powerful and differentiated advancement in intravascular imaging. With co-registration, angiography imaging allows physicians to map the exact location and vessel characteristics of corresponding intravascular imaging provided by the side-by-side OCT imaging. The combination eases adoption of the advanced imaging capabilities of OCT among physicians who have historically relied solely on angiography and provides more detailed, on-demand coronary assessment for more accurate PCI guidance.ENVISIONING A MORE INTEGRATED CATH LABOver the last decade, the cardiac catheterization lab – or “cath lab” – has become home to increasingly complex cardiovascular treatments. During these procedures many physicians rely on diagnostic feedback to support clinical decision making. As a result, some procedures will call for multiple cart-based diagnostic tools, creating workflow and space-related issues.The OPTIS Integrated System is a departure from traditional, mobile cart-based diagnostic tools and advances percutaneous coronary intervention (PCI) optimization via direct installation into a hospital’s cardiac catheterization laboratory. The design fully integrates optical coherence tomography (OCT), angiography co-registration and fractional flow reserve (FFR) into PCI workflow.In addition, direct tableside controls allow physicians to directly drive system operations while a new user interface prioritizes image display for increased visibility and operation. Stent planning tools enable enhanced precision in determining optimal stent sizing and placement.WHAT IS OPTICAL COHERENCE TOMOGRAPHY (OCT)?OCT is a medical imaging technique that uses light to provide anatomical images, views of disease morphology and automated measurements. OCT images are of a higher resolution than older coronary imaging technologies such as intravascular ultrasound, offering cardiologists an assessment method with enhanced clarity for their patients with coronary artery disease. During PCI, OCT can provide complimentary anatomical information to the physiological data provided by FFR. With OCT technology, physicians can visualize and measure important vessel characteristics that are otherwise not visible or difficult to assess with the older imaging technology. As a result, OCT can provide automated, highly-accurate measurements that can help guide stent selection and deployment and assess stent placement to help ensure successful procedures. This can potentially minimize the need for repeat revascularization.Three clinical investigations – ILUMIEN I, ILUMIEN II and ILUMIEN III – are currently underway to further develop the body of clinical evidence supporting OCT technology.WHAT IS FRACTIONAL FLOW RESERVE (FFR)?FFR measurements indicate the severity of blood flow blockages in the coronary arteries and allow physicians to identify which specific lesion or lesions (a blockage causing blood flow restriction) are responsible for a patient’s lack of blood flow (called ischemia) and warrant treatment. These measurements of pressure in the coronary arteries help physicians decide when and in which coronary arteries to deliver therapy. The landmark FAME family of trials are sponsored by St. Jude Medical and include the original FAME Trial, the FAME 2 Trial and the FAME 3 Trial. The trials have demonstrated that when PressureWire? measurement technology is used in the treatment of coronary artery disease, patient outcomes are improved and costs may be reduced.THE FAME FAMILY OF STUDIESThe FAME family of studies offer compelling evidence that FFR should be considered the standard of care for treatment of patients with coronary artery disease. The original FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) Trial compared outcomes of patients whose treatment was guided by FFR to those whose treatment was guided by angiography alone. The study found that FFR allows for more accurate identification of narrowed passages most likely to cause a coronary event, reducing rates of death, myocardial infarction (heart attack) and repeat revascularization. Results from this pivotal trial demonstrated improved clinical outcomes and quality of life for patients with stable coronary artery disease.The FAME 2 (FFR Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) Trial analyzed outcomes for patients who received FFR-guided treatment compared to those treated with medicine alone. Trial results published in the New England Journal of Medicine found that FFR-guided treatment is a cost-effective strategy that improves patient outcomes and quality of life compared to medical therapy alone. The FAME 3 Trial was initiated following the positive outcomes of the original FAME and FAME 2 trials. The trial is a comparison of FFR-guided PCI and coronary artery bypass graft surgery in patients with multivessel coronary artery disease (CAD). The study will also evaluate FFR guidance using St. Jude Medical PressureWire guidewires as an important tool to improve treatment outcomes for patients with CAD while reducing treatment costs. An economic analysis of FFR-guided interventions using the St. Jude Medical PressureWire guidewires demonstrated that it can improve health while reducing the economic burden of health care for PCI patients, while also improving quality-adjusted life expectancy. ................
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