Morton Plant Hospital One of Two Sites in Florida for Phase II TAVR Trial for Patients with Severe Aortic Stenosis
CLEARWATER, Fla., (Nov. 29, 2012) - Morton Plant Hospital has been invited to participate in the second phase of a research study using a minimally invasive procedure to treat patients with severe aortic heart valve stenosis. Called the PARTNER II Trial, the trial is studying transcatheter aortic valve replacement, or TAVR, where a metal valve is fed through a catheter inserted through an incision made either in the groin, between the ribs, or in the chest wall to replace the diseased aortic valve.
The PARTNER II trial is the follow-up trial to the PARTNER Trial, which demonstrated the safety and effectiveness of the Edwards SAPIEN valve in inoperable patients with severe symptomatic aortic stenosis. The PARTNER trial was the pivotal study that led to the FDA approval of the Edwards SAPIEN valve for inoperable patients in November 2011 and for high-risk patients in October 2012. Since the FDA approval of the SAPIEN valve, Morton Plant Hospital has completed more than 50 TAVR procedures. The PARTNER II trial is designed to study the second generation valve (SAPIEN XT) and delivery system (NovaFlex).
The SAPIEN XT has a smaller profile than the SAPIEN valve. The smaller profile may allow patients who were previously ineligible for the transfemoral approach to now be candidates for TAVR. In the PARTNER II trial, the second generation valve (SAPIEN XT) and delivery system (NovaFlex) are being compared to standard aortic valve replacement for intermediate-risk surgical patients. The Edwards SAPIEN valve is FDA approved for non-operative and/or high-risk surgical patients only.
To qualify for this study, patients must be diagnosed with severe, symptomatic aortic stenosis and must be considered intermediate risk or contraindicated for open heart surgery. For more information, please contact the Morton Plant Hospital Valve Clinic at (855) 448-2583.
The Morton Plant Hospital Valve Clinic Team is a multi-disciplinary team of cardiovascular surgeons, cardiologists, and cardiac anesthesiologists focused on working together to determine the best medical or surgical options for each patient. The team will serve on the trial committee and will oversee this multicenter investigational study.
Morton Plant’s TAVR program is evaluating patients with severe aortic stenosis for consideration of medical, surgical, and transcatheter approaches for therapy. The Morton Plant Hospital Valve Clinic Team has evaluated more than 150 patients. The team includes: Michael Barry, MD; Gregory Girgenti, MD; Todd Kovach, MD; Lang Lin, MD; John Ofenloch, MD; Joshua Rovin, MD; and Douglas Spriggs, MD.
Morton Plant Hospital continued its legacy as a leader in heart care by performing the first transcatheter aortic valve replacement surgery (TAVR) in the Tampa Bay area. A treatment for severe aortic stenosis, the TAVR procedure is used for patients who were previously considered inoperable or high-risk surgical candidates.
The first two TAVR procedures were performed at Morton Plant Hospital on February 2, 2012. Since then, Morton Plant has completed more than 50 TAVR procedures. Morton Plant also was the first hospital in the Tampa Bay area to offer TAVR by the transapical approach, in which a small incision is made between the ribs of the left lower chest. The replacement valve is then inserted directly into the heart and across the diseased aortic valve.
For TAVR and other specialized heart procedures, Morton Plant constructed a new hybrid operative suite, along with opening a Valve Clinic for the treatment of complex heart valve disorders such as aortic stenosis. Patients receive their surgery and recover in Morton Plant’s Morgan Heart Hospital.
For more information about the Morton Plant Hospital’s Valve Clinic, call (855) 448-2583 or log on to www.MPMHealth.com/ValveClinic to learn more about TAVR procedure outcomes.
About Aortic Stenosis
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 and eventually the heart’s muscles weaken, increasing the patient’s risk of heart failure.
About Morton Plant Hospital
Established in 1916, Morton Plant Hospital is a 687-bed facility that has built a national reputation for heart care. For three years, the Society of Thoracic Surgeons (STS) has awarded Morton Plant Hospital's heart surgery program its prestigious overall three-star rating, the highest designation given to hospitals by STS.
Morton Plant is one of only approximately 13 percent of more than 1,000 hospitals with a cardiac surgery program to receive a three-star rating. Morton Plant Hospital is located at 300 Pinellas Street, Clearwater, Fla.
About BayCare Health System
BayCare Health System is a leading community-based health system in the Tampa Bay area. Composed of a network of 10 not-for-profit hospitals, outpatient facilities and services such as imaging, lab, behavioral health and home health care, BayCare provides expert medical care throughout a patient’s lifetime. With more than 200 access points conveniently located throughout Tampa Bay, BayCare connects patients to a complete range of preventive, diagnostic, and treatment services for any health care need.
BayCare’s family of hospitals are: Mease Countryside, Mease Dunedin, Morton Plant, Morton Plant North Bay, St. Anthony’s, St. Joseph’s, St. Joseph’s Children’s, St. Joseph’s Hospital-North, St. Joseph’s Women’s, and South Florida Baptist. For more information, visit BayCare on the Web at www.BayCare.org.