Clinical Trial May Help Expand Patient Access to TAVR

Morton Plant Hospital Participating in National Clinical Trial for Low Risk Aortic Stenosis Patients

CLEARWATER, Fla., (October 17, 2016) -- Morton Plant Hospital is participating in a clinical research trial assessing transcatheter aortic valve replacement (TAVR) for low risk aortic stenosis patients who have traditionally been treated with surgical aortic valve replacement. The physician team is currently evaluating low-risk patients for enrollment and possible treatment with TAVR. The minimally invasive procedure is currently available only to intermediate risk and high/extreme risk patients.

“This trial is studying severe symptomatic aortic stenosis patients who are considered low risk for standard open heart surgery, meaning that at this time they are not eligible for the less invasive TAVR procedure under the current FDA-approved guidelines and is considered investigational,” said Joshua Rovin, MD, FACS, cardiovascular surgeon and medical director for the Center for Advanced Valve and Structural Heart Care at Morton Plant Hospital. “Access to TAVR by participating in this FDA-approved study could potentially provide a new treatment option to this patient population.”

The study objective is to demonstrate the safety and effectiveness of TAVR in subjects who have a low predicted risk of operative mortality for surgical aortic valve replacement and that TAVR as measured by rates of all-cause mortality or disabling stroke at two years, is non-inferior to surgical valve replacement in the treatment of severe aortic stenosis. This has previously been demonstrated in patients who are at intermediate and high risk for surgical complications.

Patients with severe aortic stenosis who are at a low surgical mortality risk as determined by Morton Plant’s heart team will be enrolled in the trial. Surgical risk is assessed based on the patient’s overall health status and physical fitness. Morton Plant began enrolling patients in the trial in July.

The catheter valve replaces the diseased aortic heart valve through a minimally invasive procedure, without open-heart surgery/cardiopulmonary bypass and without surgical removal of the native diseased valve. The device is typically inserted via an artery in the leg and then guided through the arteries into the heart. Morton Plant has participated in many FDA TAVR trials for inoperable, high-risk patients and participated in the FDA trial for high-risk, intermediate-risk and now low-risk patients.

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. “Through various FDA trials we have participated in since 2012, our team has been working toward the goal of providing access to TAVR for all patients. With a minimally invasive TAVR procedure patients can have a faster recovery process; in fact 90 percent of our patients are discharged from the hospital the first day after the procedure” said Dr. Rovin.

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.

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 patient’s factors such as age, previous heart surgery, heart function, medical comorbidities and frailty.

More information on the Medtronic TAVR Low-Risk study, can be found at https://clinicaltrials.gov.

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 repair) 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 more than 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.