Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement (TAVR) therapy is a revolutionary new procedure for patients with severe symptomatic native aortic valve stenosis.
What is TAVR Therapy?
This transcatheter procedure enables the placement of a collapsible aortic heart valve into the body via the catheter-based RetroFlex 3 transfemoral delivery system, which allows the Edwards SAPIEN valve to be inserted via the femoral artery in the thigh (see illustration below). The valve is designed to replace a patient’s diseased native aortic valve without traditional open-heart surgery and while the heart continues to beat – obviating the need for cardiopulmonary bypass.
Without an aortic valve replacement (TAVR), 50 percent of patients will not survive more than an average of two years after the onset of symptoms. The predicted survival of inoperable patients with severe aortic stenosis who are treated with standard non-surgical therapy is lower than with certain metatastic cancers--cancers that have spread to other parts of the body.
Eligibility for TAVR Therapy
Eligibility requirements to receive a transcatheter procedure can only be determined by a team of heart specialists. Some of the guidelines physicians might use are the following:
- A patient with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement.
- Any co-existing conditions that may prevent an expected benefit from correction of the aortic stenosis.
Call the Heart Valve Center today to determine if you are a candidate for superior heart valve replacement therapy by calling 865.305.5223
Facts about Transcatheter Aortic Valve Replacement (TAVR)
- The first successful TAVR procedure was performed in France on April 16, 2002, by Alain Cribier, M.D., University Hospital Charles Nicolle in Rouen, France.
- The Edwards SAPIEN transcatheter valve received CE Mark for commercial sale in Europe in 2007.
- To date, more than 25,000 patients have been treated with Edwards' transcatheter valves by multi-disciplinary heart teams worldwide.
- The Edwards SAPIEN valve was approved in November of 2011 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.
- Certain inoperable patients with severe, symptomatic native valve aortic stenosis are not candidates for TAVR due to the presence of other co-existing medical conditions or disease processes that would preclude the expected benefit from correction of the aortic stenosis.
- The Edwards SAPIEN valve is the first and only FDA-approved transcatheter aortic heart valve in the U.S.
- The PARTNER Trial was the world’s first randomized controlled trial of TAVR, and importantly, cardiac surgeons and interventional cardiologists were brought together in a clinical trial to collaborate to evaluate and treat patients.
Procedure of the Edwards SAPIEN Valve
- The flaps of tissue (valve leaflets) that open and close to regulate the flow of blood in one direction are sewn onto a balloon-expandable stainless steel frame. (see picture to the right)
- During the procedure, the valve is crimped down to the approximate diameter of a pencil and then delivered into the body via the RetroFlex 3 transfemoral delivery system.
- The delivery system is designed to allow for controlled placement, to minimize impact to surrounding structures within the heart.
- Once in place, the Edwards SAPIEN Transcatheter Heart Valve is intended to function like a normal, healthy valve with proper blood flow.
Call the Heart Valve Center today for a screening of the Transcatheter Aortic Valve Replacement by calling 865.305.5223.