The U.S. Food and Drug Administration (FDA) has approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with severe symptomatic aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery.
These devices were previously approved only in patients at high or greater risk for death or complications during surgery. Morton Plant Hospital has been participating in the FDA trial for intermediate risk patients since 2012.
"Our patients who have been participating in the trial for intermediate risk Transcatheter Aortic Valve Replacement (TAVR) have been able to experience the benefit of this minimally invasive procedure since 2012.
“Now, with the latest FDA approval, we will be able to offer TAVR to any intermediate risk patients with severe symptomatic aortic stenosis," said Joshua Rovin, MD, FACS, cardiovascular surgeon and medical director, for the Center for Advanced Valve and Structural Heart Care at Morton Plant Hospital.
TAVR is the minimally invasive heart valve replacement procedure for patients with severe symptomatic aortic stenosis who were previously not candidates for open heart aortic valve replacement surgery.
"Previously, unless patients qualified for the intermediate risk TAVR study, TAVR treatment was only available to patients considered at high risk for open heart surgery," said Dr. Rovin. A patient's surgical risk is calculated by the multidisciplinary heart team at the Center for Advanced Valve and Structural Heart Care at Morton Plant Hospital and takes into account patients factors such as age, previous heart surgery, heart function, medical comorbidities and frailty.
Aortic stenosis is a disease process that affects the aortic valve. In late stages of the disease, the valve does not open and close properly. This causes the heart to work harder to push blood through the calcified aortic valve.
Eventually the heart's muscles weaken, increasing the patient's risk of heart failure. The disease is debilitating for patients to the point that it interferes with everyday activities and can lead to premature death.
In the clinical study to evaluate safety and effectiveness that Morton Plant Hospital participated in, 1,011 aortic stenosis patients at intermediate risk for standard aortic valve replacement with open heart surgery were randomly selected to have the TAVR procedure using the Sapien XT valve and 1,021 were randomly selected to have a traditional aortic valve replacement with a surgical tissue valve utilizing open-heart surgery.
In a second study, that Morton Plant Hospital participated in, 1,078 intermediate risk patients were implanted with the Sapien 3 valve; and outcomes in these patients were compared to the same group of 1,021 surgical control patients in the first study.
The two studies demonstrated a reasonable assurance of safety and effectiveness of the Sapien XT and Sapien 3 devices in intermediate risk patients.
As part of the approval of these devices, the FDA is requiring the manufacturer to conduct a post-approval study to follow the patients treated with either device in the first and second clinical studies for 10 years to further monitor safety and effectiveness. The Sapien XT and Sapien 3 valves are manufactured by Edwards Lifesciences, LLC, Irvine, California.
The Morton Plant Center for Advanced Valve and Structural Heart Care is a multi-disciplinary team including cardiovascular surgeons, cardiologists, and cardiac anesthesiologists focused on working together to determine the best medical or surgical options for each patient.
The team was the first in the Tampa Bay area to perform the TAVR procedure in February 2012 and has performed more than 600 TAVRs and 85 MitraClip (minimally invasive mitral valve replacement) procedures to date.
