Banner Good Samaritan offers heart valve replacement procedure without open heart surgery
PHOENIX, AZ (April 7, 2014) – Banner Good Samaritan Medical Center is the only hospital in Arizona to offer the CoreValve® System, a minimally invasive procedure to treat patients with severe aortic stenosis who are too ill or frail to have open heart surgery.
The U.S. Food and Drug Administration (FDA) recently approved the CoreValve® System following its positive clinical performance in a U.S. clinical study. Banner Good Samaritan was one of only 45 medical centers to participate in the pivotal trial. It had low rates of common complications, such as stroke and valve leakage, which have a dramatic impact on a patient’s quality of life.
With age, a heart valve can become narrowed, which prevents it from properly opening and closing. The conditions limit the blood flow between the heart and the rest of the body, causing the heart to weaken and function poorly. This condition is called Aortic Stenosis (AS).
Experts say approximately one-third of patients who suffer from severe AS are not eligible for open-heart surgery because they are deemed at too high risk, but patients have a 50 percent risk of death at one year unless they’re treated.
“The CoreValve System procedure is truly transformational,” said Timothy Byrne, DO, a cardiologist on staff at Banner Good Samaritan and Principal Investigator for CoreValve System trials at the facility. “'There are no effective medical therapies to treat aortic stenosis and many patients are too sick to have open heart surgery. This procedure provides the patient with life and quality.”
The Phoenix nonprofit hospital now offers the CoreValve System as a method of treatment, which is inserted into a patient through an artery in the leg then guided by the physician through the arteries into the heart at the site of the original aortic valve. Once in place, the device takes over the original valve’s function and ensures that oxygen-rich blood flows out of the heart efficiently and circulates throughout the body.
“The CoreValve procedure has been the most gratifying piece of my career” said Dr. Byrne. “We treat the patient's aortic stenosis, but the procedure has had a profound impact on the loved ones of these patients which has been beautiful to be a part of. It has been a miracle to see patients who are so close to death come back to life.”
The advanced design of the new device was developed to address the needs of the transcatheter aortic valve replacement (TAVR) patient population, serving a broad spectrum of severe aortic stenosis patients. The CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered via a small delivery system, making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the CoreValve System enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.
About Banner Good Samaritan Medical Center
Banner Good Samaritan Medical Center in Phoenix is a large teaching hospital that has provided medical care to Arizona and the Southwest since 1911. The hospital, recently ranked Arizona’s best hospital and one of the best in the United States by U.S. News & World Report, specializes in heart care, cancer care, high-risk obstetrics, neurosciences and stroke care, organ transplants and Emergency care including a Level 1 trauma center. Banner Good Samaritan is part of Banner Health, a nonprofit healthcare system with 24 hospitals in seven states. For more information, visit Banner Good Samaritan.
About the CoreValve U.S. Pivotal Trial (Illiofemoral Access)
The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA). At one month, the rate of stroke was
2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the U.S. pivotal Trial, demonstrated even better survival and stroke performance. For more information about the newly FDA-approved Medtronic CoreValve System, visit http://www.corevalve.com/ or call 1-877-526-7890.
To schedule an interview regarding the CoreValve System, please contact Jen Fenter at (602) 747-2072.