HOUSTON--(BUSINESS WIRE)-- The Texas Heart Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) has been conditionally named by the U.S. Food and Drug Administration as one of the national sites for clinical trials of a new nonsurgical method to repair damaged aortic heart valves, a common condition in older people that, left untreated, can lead to life-threatening heart failure.
Doctors said the trials offer new hope for older patients for whom surgery is very high risk or not an option at all. Researchers also have hailed the trials as a milestone in the new era of less-invasive treatment for cardiovascular diseases. This generally means for patients less risk, much shorter recovery times and less costly treatment.
“This can completely change the paradigm,” said Dr. Biswajit Kar, one of the principal investigators on the THI study. “We believe it will be a remarkable innovation and advancement.”
“Our decades of experience on the cutting edge of cardiovascular research and medical advancement, and our location here in one of the nation’s largest cities, make us a prime site for this trial,” added Dr. James T. Willerson, THI’s President and Medical Director. “In particular there is a whole class of high-risk, mostly elderly patients for whom surgery is not an option and who could benefit from this.”
“We are proud to have been chosen and look forward to enrolling patients and moving ahead,” said Dr. Joseph S. Coselli, Chief of Adult Cardiac Surgery for THI at SLEH and another principal investigator on the study. “We believe this will be a milestone step in advancing treatment options for our patients.”
The clinical trials to be conducted over the next five to seven years, will involve the use of a prosthetic device known as a CoreValve, which can be placed into the heart via a catheter inserted through a small incision in the patient’s groin area.
The CoreValve device, manufactured by Medtronic Inc., has been in use in Europe and other parts of the world since 2007 with a high success rate.
The aorta is the main artery leaving the heart, pumping blood to the body. When the blood leaves the heart, it flows outward through the aortic valve in the left ventricle, the lower left chamber of the heart.
A condition known as Severe Aortic Stenosis (SAS) occurs in many older patients when the valve becomes scarred, deformed and encrusted with calcium deposits that obstruct the valve, restricting the blood flow. This can then weaken the heart and, left untreated, it can become a life-threatening condition leading to heart failure and increasing the risk of sudden cardiac death.
This condition often begins to manifest itself around the age of 60 and, with an aging population, the incidence of SAS might be expected to increase.
Symptoms of SAS can include chest pains, fatigue, dizziness, light-headedness, fainting with activity, shortness of breath, heart palpitations and heart murmur.
Studies have shown that replacing the valve is the only effective, life-saving treatment. However, some patients, due to age or other medical conditions, are deemed either very high-risk candidates or ineligible for the traditional valve replacement surgery.
The new clinical trials will randomly select high-risk surgery eligible patients to receive the device via catheter and compare them to patients who have the traditional surgery. Another portion of the study will compare patients who are inoperable due to age or other medical conditions. One group of randomly selected patients will receive established medical treatment and the other will receive the CoreValve.
About St. Luke’s Episcopal Health System
St. Luke’s Episcopal Health System (www.stlukestexas.com) includes St. Luke’s Episcopal Hospital in the Texas Medical Center, founded in 1954 by the Episcopal Diocese of Texas; St. Luke’s The Woodlands Hospital; St. Luke’s Sugar Land Hospital; St. Luke’s Lakeside Hospital; and St. Luke’s Episcopal Health Charities, a charity devoted to assessing and enhancing community health, especially among the underserved. St. Luke’s Episcopal Hospital is home to the Texas Heart® Institute, which was founded in 1962 by Denton A. Cooley, MD, and is consistently ranked among the top 10 cardiology and heart surgery centers in the country by U.S. News & World Report. Affiliated with several nursing schools and three medical schools, St. Luke’s Episcopal Hospital was the first hospital in Texas named a Magnet hospital for nursing excellence, and has been honored four times with the Distinguished Hospital Award for Clinical Excellence™ by HealthGrades, a leading independent company that measures healthcare quality in hospitals. The Health System has been recognized by FORTUNE as among the “100 Best Companies to Work For” and by the Houston Business Journal as a top employer in Houston. St. Luke’s Episcopal Health System also was honored as one of Modern Healthcare magazine’s “100 Best Places to Work.”
About the Texas Heart® Institute
The Texas Heart Institute (www.texasheart.org), founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education and improved patient care. Together with its clinical partner, St. Luke’s Episcopal Hospital, it has been ranked among the top 10 cardiovascular centers in the United States by U.S. News & World Report’s annual guide to “America’s Best Hospitals” for the past 20 years. The Texas Heart Institute is also affiliated with the University of Texas (UT) System, which promotes collaboration in cardiovascular research and education among UT and THI faculty at the Texas Heart Institute and other UT components.
St. Luke’s Episcopal Health System
Frank Michel, 832-355-9510
KEYWORDS: United States North America Texas
INDUSTRY KEYWORDS: Surgery Health Cardiology Clinical Trials Hospitals Medical Devices