FDA Approves Minimally Invasive Valve Replacement for New Group of Patients

Morton Plant Hospital Participated in FDA Trial 

CLEARWATER, Fla., (August 25, 2016) -- A new group of patients suffering from aortic stenosis is now eligible for a minimally invasive aortic valve replacement. 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.

About the Morton Plant Center for Advanced Valve and Structural Heart Care
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.

To better serve patients and their families in St. Petersburg and south Pinellas County, a satellite Cardiovascular and Thoracic Surgery office has opened at St. Anthony’s Hospital. Staffed by BayCare’s leading board-certified cardiovascular and thoracic surgeons who are part of Morton Plant’s valve center team, the outpatient heart surgery clinic evaluates patients and guides them through the testing process. If surgery is needed, the St. Anthony’s clinic will help patients through that process and surgical procedures will be performed at Morton Plant Hospital.

Additional disorders treated by the center include pulmonary stenosis, mitral stenosis, aortic regurgitation and mitral regurgitation. Depending on the severity of disease and other factors, patient treatment options may include medical management, minimally invasive valve repair, minimally invasive valve replacement such as Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Mitral Valve Repair (TMVR), or open heart surgery. Visit the Center for Advanced Valve and Structural Heart Care at Morton Plant Hospital or call 855-448-2583.

About Morton Plant Hospital’s Cardiovascular Services
The first hospital in Tampa Bay to perform open heart surgery 40 years ago, Morton Plant Hospital is a Level II cardiac surgery program. Along with being recognized 14 times as a Truven Health Analytics Top 50 Hospital for cardiovascular care, Morton Plant has also received the Society of Thoracic Surgeon’s highest level of recognition, a three-star rating.

About Morton Plant Hospital
Since 1916, Morton Plant Hospital has been committed to improving the health of all we serve through community-owned health care services that set the standard for high-quality, compassionate care. Our 687-bed hospital is proud to offer nationally recognized care delivered in more than 50 specialty areas. Morton Plant Hospital offers innovative, accessible, and quality services to provide our community with a lifetime of compassionate, convenient care. Check out information on Morton Plant’s 100th Anniversary at www.MortonPlant100.org. For more information, call (727) 953-6877, or visit us on Facebook or at 300 Pinellas St., Clearwater, Fla.

About BayCare Health System
BayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 14 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. Inpatient and outpatient services include acute care, primary care, imaging, laboratory, behavioral health, home care, and wellness. Our mission is to improve the health of all we serve through community-owned, health care services that set the standard for high-quality, compassionate care. For more information, visit BayCare on the Web at www.BayCare.org.