Newswise — CLEVELAND – University Hospitals Cleveland Medical Center interventional cardiologists and surgeons recently announced participation in a new clinical trial designed to measure the impact of transcatheter aortic valve replacement (TAVR) in low surgical risk patients with severe aortic stenosis (AS).
Guilherme Attizzani, MD, Co-Director, Valve and Structural Heart Disease Center, UH Harrington Heart & Vascular Institute and Alan Markowitz, MD, Chief Surgical Officer, UH Harrington Heart & Vascular Institute, are serving as principal investigators on the two-year trial that includes monitoring for a decade.
In 2011, the TAVR procedure was developed and aimed at patients who are at high risk of mortality or complications from traditional open-heart surgery. It was viewed as a last resort for those patients but its indications progressively expanded and it is currently approved for moderate or higher surgical risk candidates.
“The great outcomes of TAVR for patients with severe AS have led to a progressive expansion in its indications,” said Dr. Attizzani who is also Clinical Assistant Professor, Medicine, Case Western Reserve University School of Medicine. “Initially, this technology was approved only for prohibitive (non-operable) surgical risk patients and currently it is approved for moderate or higher surgical risk patients. This study is extremely important as it is investigating TAVR against surgical aortic valve replacement in low surgical risk patients with severe aortic stenosis and may expand further the indications of this outstanding technology.”
UH was the first to implant the Evolut R self-expandable valve in the US as part of an earlier trial and was the first to enroll a low-risk patient in the study in Northern Ohio. The large trial will include up to 1,300 patients in almost 40 different sites across the country.
The procedure enables patients to reap the benefits of valve replacement without undergoing invasive surgery. In TAVR, cardiologists thread the new valve to the heart via a catheter, or tube, inserted in the patient’s groin. The new valve is steered into the dysfunctional valve, replacing it.
Prior to this procedure, UH interventional cardiologists had performed more than 700 TAVR procedures to reduce the extreme fatigue, shortness of breath, dizziness, chest pain, and the death risk associated with symptomatic AS.
“This is an important trial because this is a commercially approved valve that has already shown great outcomes in thousands of patients,” said Dr. Markowitz, who is also Assistant Clinical Professor, Surgery, at the School of Medicine. “In other words, this study is not investigating a new device but rather utilizing a device very well known for its outstanding performance in lower risk individuals.”
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About University HospitalsFounded in 1866, University Hospitals serves the needs of over 1 million patients per year through an integrated network of 18 hospitals, more than 40 outpatient health centers and 200 physician offices in 15 counties throughout northern Ohio. The system’s flagship academic medical center, University Hospitals Cleveland Medical Center, located on a 35-acre campus in Cleveland’s University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, dermatology, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals – part of The Harrington Project for Discovery & Development. UH is the second largest employer in northern Ohio with 26,000 employees. For more information, go to UHhospitals.org.
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