AUSTIN, Texas, Aug. 15, 2016 /PRNewswire/ -- On July 20, 2016, Austin Heart—in collaboration with Heart Hospital of Austin—became the first in the United States to enroll a patient in the REALITY Study to evaluate the combined use of directional atherectomy and drug-coated balloons (DCB) in patients with peripheral artery disease (PAD). Roger Gammon, M.D., interventional cardiologist with Austin Heart, treated the first patient enrolled in the study at Heart Hospital of Austin.
PAD is a progressive disease that causes a narrowing of the peripheral arteries to the legs, stomach, arms and head. According to the American Heart Association, approximately 8.5 million Americans suffer from PAD. Left untreated, PAD can lead to painful symptoms or amputation. Patients with PAD also have an increased risk of coronary artery disease, stroke and heart attack.
The severity of PAD can often have an impact on treatment options for patients. Current treatment options vary and may include an atherectomy, a minimally invasive procedure to remove the blockage from the arteries and restore blood flow, and drug-coated balloon therapy. Although these treatments are often successful initially, recurrent blockage occurs in up to 40% of patients in the first year due to scar tissue. Many physicians believe that more durable outcomes are possible if a patient has an atherectomy first, to remove much of the plaque, followed by DCB. This strategy may permit better uptake of Paclitaxel, a medication from the DCB, which has the potential to limit scarring and recurrent blockage.
The REALITY Study is a precise, detailed analysis of patient outcomes with combined use of directional atherectomy devices, such as the Medtronic HawkOne™ or TurboHawk™, along with the Medtronic IN.PACT™ Admiral™ drug-coated balloon. The study includes angiographic and duplex ultrasound core lab adjudication. Primary patency is assessed by duplex ultrasound at 12 months. Patients are followed up to 24 months to determine how often a repeat procedure is necessary for recurrent blockage.
"We know that directional atherectomy and DCB perform well as standalone treatments, and early data suggest that combined therapy may improve patient outcomes in more complex lesions," Dr. Gammon said. "Through the REALITY Study, we hope to answer this critical question with rigorous clinical data and set a new standard for the treatment of patients with PAD."
The study is sponsored and managed by VIVA Physicians, with support from Medtronic, through an external research project grant. The study will enroll up to 250 subjects at up to 15 sites in the United States and Germany.
Heart Hospital of Austin
Heart Hospital of Austin is part of St. David's HealthCare, one of the largest health systems in Texas, which was recognized with a Malcolm Baldrige National Quality Award in 2014. Heart Hospital of Austin—home to one of the largest non-academic cardiovascular research programs in the world—is a 58-bed hospital with a comprehensive 24-hour emergency department, an advanced Executive Wellness Program, five operating rooms (ORs), including two hybrid ORs, three catheterization labs and two electrophysiology labs. It is one of the highest performing cardiovascular facilities in the nation, specializing in the diagnosis and treatment of cardiovascular disease. Healthgrades awarded Heart Hospital of Austin, in conjunction with its parent campus, St. David's Medical Center, the 2016 America's 100 Best Hospitals Award™, 2016 Patient Safety Excellence Award™ and the 2016 Outstanding Patient Experience Award™—a unique trio of awards that only three hospitals in the nation were able to achieve. Heart Hospital of Austin has been named one of the Top 50 Cardiovascular Hospitals in the nation by Truven Health Analytics for nine years and to Truven's list of 100 Top Hospitals for four years, in conjunction with St. David's Medical Center.
Austin Heart is the largest provider of cardiac and vascular services in Central Texas, with 12 full-time office locations, 13 outreach clinics and 42 cardiologists. Austin Heart has been serving the Central Texas area since 1973. Austin Heart's cardiologists sub-specialize in every diagnostic and treatment area of cardiovascular disease, America's No. 1 killer—interventional cardiology, electrophysiology, congestive heart failure, peripheral vascular disease, vein disease, sleep disorders, imaging, women's cardiovascular health and a nationally recognized research department.
Misty Whited or Kristin Marcum
Elizabeth Christian Public Relations
SOURCE Heart Hospital of Austin