Morton Plant Hospital is the Only Site in Florida for New Heart Study
CLEARWATER, Fla., (Oct. 31, 2013) - Morton Plant Hospital has been invited to be the first hospital in the state – and one of 30 sites in the United States – to participate in the next phase of a research study using transcatheter therapy to treat symptomatic patients with severe aortic heart valve stenosis. This phase of the trial will study the next generation of Edwards transcatheter valves redesigned replacement valve called the SAPIEN 3TM (S3) Transcatheter Heart Valve (THV). The SAPIEN 3 valve can be inserted through the smallest delivery system available and may reduce paravalvular leaks as a result of a newly designed “sealing skirt.”
This study is part of the ongoing Partner II Trial, evaluating transcatheter aortic valve replacement, or TAVR, a procedure in which a stent-based bovine tissue valve is loaded onto a catheter inserted through an incision either in the groin, between the ribs, or in the chest wall to replace the diseased aortic valve.
“The valve clinic team continues to be focused on offering the latest advancements in cardiovascular care to our patients,” said Joshua Rovin, MD, a cardiovascular surgeon and member of the Morton Plant Valve Clinic team. “As a result of the team’s collaboration and outcomes, we have been selected as the first site in Florida to enroll patients in the study offering offer the newly redesigned 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 140 TAVR procedures. The Partner II trial is designed to study the second generation valve (XT) and delivery system (NovaFlex).
“In this next phase of the trial, the Partner II SAPIEN 3 clinical research trial, the valve clinic team will study the redesigned SAPIEN 3 heart valve,” said Douglas Spriggs, MD, an interventional cardiologist and a member of the Morton Plant Hospital Valve Clinic team. “This valve provides new features designed to benefit patients and enhance ease of use, such as a lower profile, a fabric cuff intended to reduce paravalvular leak, and new delivery systems.”
“The TAVR procedure allows for the opportunity of a less invasive procedure, a shorter procedure time, and less anesthesia than in open heart surgery,” said Dr. Rovin. “The hope of this study is that the procedure will provide short- and long-term relief of symptoms, and improve cardiac function for people with severe aortic stenosis who previously had few if any options.”
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.
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 300 patients. The team includes: Michael Barry, MD; Gregory Girgenti, MD; Todd Kovach, MD; Lang Lin, MD; John Ofenloch, MD; Joshua Rovin, MD; Douglas Spriggs, MD and Saul Tuchman, 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 140 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. Our commitment to improving the health of everyone we serve is reflected in our community partnerships and many honors. Morton Plant is the only hospital in the United States to have been awarded Top 100 Hospital designations by the Thomson Reuters 100 Top Hospitals: National Benchmarks for Success for a consecutive 13 years. Other hospital honors include: “Baby-Friendly” hospital status from the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) for its efforts to support mothers’ decision to breast feed and received Florida Hospitals Association’s Innovation of the Year in Patient Care award. Morton Plant Hospital is located at 300 Pinellas St., Clearwater, Fla. For more information about Morton Plant Hospital, call (727) 953-6877.
About BayCare Health System
BayCare Health System is a leading community-based health system in the Tampa Bay area. Composed of a network of 11 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, South Florida Baptist, and Winter Haven. For more information, visit BayCare on the Web at www.BayCare.org.