University Medical Center New Orleans is the first facility in New Orleans to use a minimally invasive device designed to improve blood flow for severely ill patients during complex and high-risk percutaneous coronary intervention (PCI) procedures intended to restore blood flow to the heart. The device, known as the St. Jude Medical HeartMate PHP™ (Percutaneous Heart Pump) System, a cardiac assist device, is currently being evaluated in the SHIELD II (Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device) U.S. IDE Clinical Trial.
LSU Health New Orleans interventional cardiologist Murtuza Ali, MD, led a team that performed the first coronary angioplasty using the investigational HeartMate PHP™ in Louisiana on Tuesday, December 20, 2016, at University Medical Center (University Medical Center) New Orleans.
The procedure was part of the SHIELD II clinical trial to compare St. Jude Medical’s PHP (Percutaneous Heart Pump) Heartmate™ device to Abiomed’s Impella® 2.5 device for mechanical circulatory support in high-risk patients undergoing percutaneous coronary intervention (PCI), also known as coronary angioplasty. According to the National Institutes of Health, doctors perform PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque.
PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack. Some patients who undergo PCI have reduced pumping power, which puts them at higher risk for potential problems, so it is standard care to use a heart assist device to maintain blood flow during the procedure. The two devices being compared in the SHIELD II study are used as heart assistive devices to provide support to the left side of the heart during PCI. The HeartMate PHP cardiac assist device is placed via catheter to temporarily assist circulation by continuously pumping blood during PCI.
Unlike traditional catheter-based support devices, the HeartMate PHP cardiac assist device can generate an average blood flow of four to five liters per minute, which is the normal amount of blood pumped out by the left ventricle. SHIELD II (Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device) U.S. IDE Clinical Trial is a prospective, randomized, multi-center, open-label study. The study will randomize up to 425 patients in centers nationwide.
“To meet criteria for this study, patients have to have severe multi-vessel coronary artery disease, severely depressed left ventricular systolic function, and not be candidates for coronary artery bypass graft surgery. The HeartMate device differs from current on-the-market products in that it aims to provide more cardiac support through the same size incision as smaller devices,” notes principal investigator Murtuza Ali, MD, Associate Professor of Clinical Medicine at LSU Health New Orleans School of Medicine.
“Coronary angioplasty can help improve health and quality of life for high-risk patients,” says co-investigator Frank Smart, MD, Professor and Chief of Cardiology at LSU Health New Orleans School of Medicine. “We are trying to determine the safest, most effective percutaneous support device to help protect them during the procedure.” The HeartMate PHP device is CE Mark approved and commercially available in Europe. Approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark Trial.
For more information about the SHIELD II trial, call Dr. Ali’s office at (504) 568-4631.
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