Heart Valve Replacement Without Opening The Chest Gives New Option For Non-operable Patients

An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered at Rush University Medical Center to patients with severe aortic stenosis who are at high-risk or not suitable candidates for open heart valve replacement surgery. "This breakthrough technology could save the lives of thousands of patients with heart valve disease who have no other therapeutic options," says Dr. Ziyad Hijazi, director of the Rush Center for Congenital and Structural Heart Disease and interventional cardiologist of the Rush Valve Clinic.

The treatment is offered through a multi-center, phase IIB cohort study called the PARTNER II (Placement of AoRTic traNscathetER valves) trial.

Aortic valve stenosis (AS) is a type of valvular heart disease characterized by an abnormal narrowing of the aortic valve opening. It is a condition that affects nearly 1.5 million Americans. It causes hardening or thickening of the aortic valve leaflets, which limits leaflet motion and obstructs oxygen-rich blood flow from the heart to the rest of the body. Patients with severe AS may have symptoms of chest pain, fatigue, shortness of breath, lightheadedness or fainting. Although AS typically progresses slowly without symptoms, once symptoms occur, treatment is required. Fifty percent of patients may not survive beyond one to three years.

Traditionally, patients with symptomatic AS undergo aortic valve replacement during an open-heart surgery to alleviate symptoms, improve survival and improve quality of life. However, many patients who are at very high risk for surgery, such as elderly, frail individuals with multiple health concerns, are considered inoperable.

The PARTNER II trial will compare a pioneering technology called the Edwards SAPIEN XT valve, which is made of bovine pericardial tissue leaflets hand-sewn onto a metal frame, and a new catheter delivery system called the Edwards NovaFlex delivery system, which navigates the heart from a small incision to the femoral artery in a patient's leg or through a small incision between the ribs and snaked up into the left ventricle. The Edwards NovaFlex delivery system positions the catheter inside the patient's original, collapsed valve, using a balloon to deploy the frame, which holds the artificial valve in place in order to restore normal blood flow. Both procedures are performed on a beating heart, without the need for open, cardiopulmonary bypass and its associated risks.

Annually, some 200,000 people in the U.S. need a new heart valve, but nearly half of them do not receive a new valve for a variety of reasons.

"Past study results show conclusively that transcatheter valve replacement is a safe and effective alternative to open surgery, which remains the 'gold standard' for most patients," says Hijazi.