In June, Saint Thomas Heart became one of 27 cardiac programs nationwide to offer an investigational “sutureless” prosthesis for patients in need of an aortic valve replacement. Participants are still being recruited for the TRANSFORM™ trial, a cardiac surgery for aortic stenosis that is expected to decrease surgery times and improve patient outcomes by using a next generation surgical aortic valve.
“The surgery utilizes three small sutures to place the valve, which traditionally takes 15-18 sutures around the valve,” said Evelio Rodriguez, MD, principle investigator for the trial’s Saint Thomas site. A balloon is then used to dilate the valve.
The TRANSFORM Trial is the first U.S. clinical trial of a rapid deployment system for surgical aortic valve replacement (AVR) procedures. The EDWARDS INTUITY valve system, which consists of a bovine pericardial heart valve and novel balloon-expandable frame, is designed to facilitate small incision surgery and rapid valve deployment with the goal of enabling faster procedures.
“As we move through smaller incisions, we can perform an aortic valve replacement in a less invasive manner,” Rodriguez said. “It saves time, which means the heart is stopped for less time, and the patient spends less time on the bypass machine.”
The multi-center trial by Edwards Lifesciences is expected to enroll between 500 and 700 participants nationwide. In addition to Saint Thomas Health in Nashville, Baptist Memorial Hospital in Memphis is currently the only other participating trial site in Tennessee. For information on patient eligibility, exclusion criteria and other trial specifics, call Saint Thomas Hospital at (615) 222-3083 or visit clinicaltrials.gov.
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