Physicians at The Christ Hospital are first to bring pioneering technology to Greater Cincinnati that may provide a treatment option for patients with a common heart valve disorder who do not qualify for surgery. The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital (Lindner Research Center) is one of 23 sites in the United States to participate in an investigational research trial using a novel therapy to treat severe aortic stenosis (AS), a condition that affects nearly 1.5 million Americans.
The PARTNER (Placement of AoRTic traNscathetER valves) II Trial will evaluate transcatheter aortic valve replacement (TAVR), using the Edwards SAPIEN XT valve, in patients who are considered high risk or inoperable for traditional valve replacement using open-heart surgery. The Christ Hospital is the only PARTNER II study site between Cleveland, Ohio and Atlanta, Ga.
Severe AS results from hardening or thickening of the aortic valve leaflets, which limits leaflet motion and obstructs oxygen-rich blood flow from the heart to the rest of the body. Patients with severe AS may have symptoms of chest pain, fatigue, shortness of breath, lightheadedness or fainting. Although AS typically progresses slowly without symptoms, once symptoms occur, treatment is required. The prognosis of patients with symptomatic AS is guarded, and previous studies indicate that up to 50 percent of patients may not survive beyond one to three years.
Traditionally, patients with symptomatic AS undergo aortic valve replacement during an open-heart surgery, which can alleviate symptoms, improve survival rates and improve quality of life. However, many patients who are at very high risk for surgery, such as elderly and frail individuals with multiple health concerns, are considered inoperable.
“Elderly patients with multiple medical problems may not survive surgery,” says Dean Kereiakes, M.D., principal investigator in Cincinnati for the PARTNER II trial and medical director at the Lindner Research Center and The Christ Hospital Heart and Vascular Center. “Our goal in joining The PARTNER II Trial was to provide a new treatment option and hope for these individuals. Through this leading edge research, we strive to improve survival and quality of life.”
During the minimally-invasive clinical trial procedure, the Edwards Lifesciences NovaFlex delivery system catheter is used to first deliver a balloon to the site of the original aortic valve via the femoral artery in the thigh. The balloon is expanded at the valve site to break up the calcification. Then, the Edwards SAPIEN XT valve is delivered and deployed at the site of the original valve. It is designed to function like a normal, healthy valve and allow proper blood flow.
Results from The PARTNER Trial showed that the rate of death from any cause at one year was 50.7 percent in the patients who received standard therapy, as compared to 30.7 percent of patients treated with transcatheter aortic valve replacement (TAVR). The next generation, lower profile Edwards SAPIEN XT valve in The PARTNER II Trial was engineered to provide a better valve patterned after surgical heart valves and potentially decrease treatment complications.
“The primary objective of the trial is to reduce death, major stroke and repeat hospitalization in these patients,” says Ian Sarembock, M.D., associate medical director at The Christ Hospital Heart and Vascular Center. “Additionally, we hope to improve quality-of-life indicators. Following the success of The PARTNER Trial, we are energized to bring this technology to Cincinnati."
For more information about The PARTNER II Trial at The Christ Hospital, contact the Lindner Research Center at 866-293-0566.
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About The Lindner Research Center: For the past 25 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has provided leading-edge medicines and medical technology research covering a broad spectrum of conditions from obesity, diabetes, coronary disease, hypertension and hyperlipidemia to new vascular interventional devices, adult stem cell therapies, structural heart disease, cardiovascular surgery, heart failure and electrophysiology. Physicians at the Lindner Research Center have conducted more than 1,200 clinical trials including multiple first-in-man and first-in-the-U.S procedures, which have contributed to best practice standards for the care of patients.
For information on current trials, please call 513-585-1777.