October 23, 2019
Gainesville, FL - In August 2019, the U.S. Food and Drug Administration (FDA) approved several transcatheter heart valves to treat patients who have severe aortic valve stenosis, and who are low risk candidates for valve replacement. This valve replacement procedure, the Transcatheter Aortic Valve Replacement, also known as TAVR, had previously only been approved for use in intermediate or high risk patients. The cardiovascular surgeons and cardiologists at North Florida Regional Medical Center (NFRMC) are highly-skilled and prolific with the TAVR procedure, and are now thrilled to provide this option to low risk patients under FDA guidelines.
Previously, open-heart surgery has been the standard-of-care for aortic valve replacement in low risk patients. The invasiveness of this procedure has a hindrance on the patient's recovery and comes with some risk of potential serious complications. Currently, surgical valve replacement is still the appropriate choice in some low risk patients, as it can be performed very safely and in a minimally invasive fashion. However, for appropriately selected low risk patients, TAVR is an even more minimally invasive procedure with a much quicker recovery process for the patient. TAVR patients become mobile hours after the procedure, and greater than 90% of patients are discharged home the following morning.
"This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population," said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health. "As the FDA assesses new medical technologies or expanded uses for previously approved products such as these, the agency remains committed to evaluating evidence from clinical trials and real-world clinical data in both the pre-market and post-market settings to ensure patients have access to high-quality, safe, and effective medical devices."
During their research, the FDA completed several clinical studies to measure the safety and effectiveness of both open-heart surgery and TAVR surgery on low risk patients with severe aortic stenosis. When comparing the results of patients who had open-heart surgery and those who had the TAVR procedure, the transcatheter heart valve "achieved comparable results to open heart surgery," further ensuring the success of TAVR's use for low risk patients.
The TAVR team at NFRMC is proud to have top quality metrics of exceptionally low mortality and morbidity, stroke, Acute Kidney Injury (AKI) rates and discharge time that place the program as one of the top across the country.
"We are enthusiastically embracing the newly announced approval of low risk patient profiles for transcatheter heart valve consideration," said Dr. Charles Klodell, a cardiothoracic surgeon at the Florida Heart and Lung Institute. "We look forward to helping guide each patient to the ideal valve therapy for them. We are confident that our unsurpassed, quality TAVR program will continue to deliver both efficient and outstanding care to the valve patients in our region."