Mercy Hospital, part of Allina Health, is among the first facilities in the U.S. to use the ILUMIEN™ PCI Optimization System from St. Jude Medical, the first and only integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform.
Using the combined ILUMIEN system, physicians at Mercy Hospital gain advanced physiological and anatomical insights that can improve the diagnosis and treatment of coronary artery disease.
Dr. Jeffrey Chambers, director of the cardiac catheterization lab at the Metropolitan Heart & Vascular Institute, first used the system on a coronary artery patient soon after the device received FDA approval.
“The ILUMIEN technology provides enhanced visualization of the arteries in the heart and allows us to determine which blockages are appropriate for treatment,” Chambers said.
“Additionally, it helps us decide the best way to treat the blocked artery and ensure optimal results.”
“In this particular case, we were able to use the technology to determine that the patient’s blockage was severe, and treat it accordingly.
“The ultimate goal is to make people feel better, and we always want to use the best tools for the job.”
Patients with coronary artery disease experience decreased oxygen delivery to the heart due to plaque or cholesterol build-up inside arteries.
With the integration of these two technologies, Mercy Hospital physicians can identify the precise measurement and dimensions of culprit narrowings responsible for obstructing blood flow to a patient’s heart and causing, as well as determine vessel size and structure.
FFR technology is used to determine the severity of blood flow blockages in coronary arteries allowing physicians to better identify specific narrowing(s).
Meanwhile the OCT technology is used to visualize and measure important vessel characteristics that are used in guiding stent selection and deployment, and also provide post-stenting information to help ensure the procedure was successful.
The ILUMIEN™ PCI Optimization System received U.S. Food and Drug Administration (FDA) and European CE Mark approval in 2011.
Fractional Flow Reserve (FFR) is a measurement that helps physicians identify which coronary artery narrowings are obstructing blood flow to the patient’s heart muscle (called ischemia) and are in danger of causing a coronary artery event, such as a heart attack.
Current data show the readings generated by FFR prior to the placement of a coronary stent helps physicians better optimize clinical outcomes by determining which specific lesion or lesions are responsible for a patient’s ischemia.
In January 2009, St. Jude Medical announced results from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, a randomized, prospective, multi-center study.
The study enrolled 1,005 patients with multivessel coronary artery disease and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography.
The 12-month results, published in the Jan. 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), including death, myocardial infarction or repeat revascularization, were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone.
After two years, patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent risk reduction in death or heart attack.
Optical Coherence Tomography (OCT) utilizes near-infrared light to create images to visualize and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies- such as fluoroscopy and intravascular ultrasound (IVUS).