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Temple University Hospital Offering New Investigational Treatment for Tricuspid Regurgitation

POSTED ON June 02, 2015

Brian P. O'Neill, MDTemple University Hospital is the only hospital in the nation participating in a Phase 1 clinical trial to evaluate a new treatment method for patients who suffer from severe tricuspid regurgitation, in which an improperly functioning heart valve causes abnormal blood flow which can lead to life-threatening consequences.

The tricuspid valve is one of four valves in the heart that open and close to allow normal forward flow of blood to and from the body and lungs. Tricuspid regurgitation (backwards flow or 'leakiness') occurs when the tricuspid valve does not close properly and it is this abnormal flow that causes excessive blood volume and pressure to be transmitted to the body. The trial will analyze the effectiveness of placing a transcatheter valve in the inferior vena cava, a vessel which carries blood from the lower half of the body to the right upper heart chamber (atrium), to stop the effects of that leaking or backward flow.

"Patients can become very symptomatic from tricuspid regurgitation. They develop swelling in the legs, abdomen, and kidneys and in some cases, can go into renal failure and require dialysis," said Brian P. O'Neill, MD, Assistant Professor of Medicine at Temple University School of Medicine, and the principal investigator for the study. "Tricuspid regurgitation is a valvular disease that is under-treated in the United States right now. About 1.5 million Americans suffer from moderate to severe tricuspid regurgitation and only less than one percent of the patients with the diagnosis get surgery. A majority of the time, these patients are very poor surgical candidates based on other medical conditions."

The HOVER clinical trial (Heterotopic Implantation of the Edwards-Sapien XT® Transcatheter Valve in the Inferior Vena Cava for the Treatment of Severe Tricuspid Regurgitation) is an investigational and experimental trial that will determine if placing the Edwards-Sapien XT® transcatheter aortic valve in the inferior vena cava will be an effective treatment for severe tricuspid regurgitation in patients who are inoperable or have a high surgical risk for open heart surgery.

According to Dr. O'Neill, this procedure has only been performed on a handful of patients in the United States, and he was part of the multi-disciplinary team each time. It’s a minimally invasive procedure, similar to transcatheter aortic valve replacement (TAVR).

"A tube will be inserted in the leg, and through that tube, the transcatheter valve is delivered into the large vein that sits outside the heart," explained Dr. O’Neill. "The transcatheter valve will act as a stopper to prevent backward flow of the blood in to the lower part of the body. We are trying to relieve symptoms of tricuspid regurgitation and improve the quality of life for patients."

The goal of the research study is to determine short term safety and long term efficacy of the procedure. A total of 30 patients, 22-years-of-age and older, diagnosed with severe tricuspid regurgitation, will be enrolled in the trial at Temple University Hospital. Temple is currently screening and enrolling patients. Interested individuals should contact Robin Vogel, Structural Heart Disease Program Manager, at 215-707-2230 for more information.

Editor's Note: Dr. O'Neill does not have any financial interest in Edwards-Sapien, manufacturer of the transcatheter valve. Dr. O’Neill's father, Dr. William O'Neill, is a paid consultant for Edwards-Sapien.