Transcatheter Heart Valve Replacement

New Trial Examines Less-Invasive Options

For patients with aortic stenosis, surgical replacement of their damaged aortic valve is the standard treatment. However, some higher-risk aortic stenosis patients may not be candidates for this major surgical procedure, which requires cardiopulmonary bypass.

Through the new multicenter PARTNER Trial, physicians at the University of Virginia Health System are examining the safety and effectiveness of a new procedure that implants a replacement aortic valve through a transcatheter technique that uses either a transfemoral or transapical approach.

“It doesn’t require a major chest incision,” says cardiac surgeon Irving Kron, M.D., the co-principal investigator of the trial at UVA with interventional cardiologist Scott Lim, M.D.

“This potentially opens up a new treatment option, especially for elderly patients too frail to undergo a major heart procedure,” Lim adds.

 In the randomized trial, patients who are surgical candidates will either receive a standard aortic valve replacement or transcatheter valve replacement using one of the two transcatheter approaches.

The trial is seeking volunteers with severe aortic stenosis who are high-risk surgical candidates and NYHA Class II or greater. To be eligible for the trial, patients must have a left ventricular ejection fraction of greater than 20 percent and must not have overt renal failure.

To refer a patient to the PARTNER Trial, call UVA Physician Direct at 800.552.3723.

CAUTION: Investigational device. Not available for sale in the U.S. To be used by qualified investigators only. Limited by Federal (USA) Law to investigational use. Edwards SAPIEN is a trademark of Edwards Lifesciences Corp. and is registered in the United States Patent and Trademark Office.