Clinical Trial of New, Less Invasive Aortic Valve Replacement Procedure

Wake Forest Cardiologist Robert J. Applegate, MD

This article was published originally in the May 2011 edition of Clinical Update.

Wake Forest Baptist Health is one of 40 sites participating in the Medtronic CoreValve® U.S. clinical study evaluating the safety and effectiveness of a new percutaneous technology that enables aortic valve replacement (AVR) without traditional open-heart surgery.

“There is significant need for a new treatment option for patients with aortic stenosis, and it is enormously rewarding that Wake Forest Baptist Health can help evaluate this revolutionary new treatment,” said interventional cardiologist Robert Applegate, MD.

Aortic stenosis is a heart condition that occurs when the aortic valve narrows, preventing it from properly opening and closing, and diminishing blood flow between the heart and the rest of the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. When aortic stenosis becomes severe and symptoms develop, it is life-threatening. As many as 50 percent of aortic stenosis patients with severe symptoms may die within two years without appropriate treatment.

The most common cause of aortic stenosis is excessive wear on the aortic valve. This usually develops with age, but the process may be expedited in patients who are congenitally predisposed to the disease.

The standard treatment for patients with severe aortic stenosis is aortic valve replacement (AVR). Two types of replacement valves, mechanical and biological, can be used in this procedure. Because AVR is an invasive surgical procedure, patients who are at high risk or ineligible for surgery are not appropriate candidates for AVR.

An alternative to AVR, transcatheter aortic valve replacement is approved for use in more than 35 countries worldwide, and is being evaluated in clinical trials for use in the U.S. In this investigational procedure, a catheter with a porcine prosthetic valve is channeled to the aorta through the femoral artery to reach the heart. The Core Valve system is designed with self-expanding technology, deploying the new valve inside the diseased aortic valve without open-heart surgery or surgical removal of the native valve.

Many patients with severe aortic stenosis are unable to receive surgical valve therapy. For patients at high-risk for open-heart surgery, this trial will study the efficacy of a less-invasive, percutaneous treatment option.

In order to participate in this clinical trial, potential patients should have the following characteristics:

  • Advanced age (usually greater than 75, but not exclusively)
  • Symptomatic severe aortic stenosis (NYHA Class II or greater)
  • High risk for surgical aortic valve replacement
  • Life expectancy of at least 12 months
  • Left ventricular ejection fraction of >20% by resting echocardiogram 

Learn more about this study.

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