(RxWiki News) Some patients with aortic heart valve problems have long been considered untreatable. For one reason or another they were poor candidates for invasive surgery that requires opening the chest.
Rush University Medical Center study, however, has revealed it is offering a less invasive method for implanting a new aortic heart valve without open heart surgery for patients deemed unsuitable for the more complicated procedure.
Dr. Ziyad Hijazi, director of the Rush Center for Congenital and Structural Heart Disease and interventional cardiologist of the Rush Valve Clinic, said the innovative technology could save thousands of patients with heart valve disease who have no other options.
"Talk to your doctor if you're not eligible for open heart valve surgery."
The treatment is currently 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 that causes hardness of thickening of the aortic valve leaflets, which limits blood flow. It affects nearly 1.5 million Americans.
Those with severe AS may have symptoms of chest pain, fatigue, shortness of breath, lightheadedness or fainting, and 50 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, but many patients who are at very high risk for surgery, such as elderly or frail individuals with multiple health concerns, are considered inoperable.
The PARTNER II trial will compare a 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.
Each year about 200,000 people in the United States need a new heart valve, but nearly half of them do not receive a new valve for a variety of reasons.
Research has shown that transcatheter valve replacement is a safe and effective alternative to open surgery. Results from the first phase of the PARTNER trial showed that the rate of death from any cause at one year was 50.7 percent in the patients who received standard therapy, as compared to 30.7 percent of patients treated with transcatheter aortic valve replacement.
The PARTNER trial is the world's first randomized, controlled trial of a transcatheter aortic heart valve. In this clinical phase IIb cohort, patients are randomized to receive either the new Edwards Sapien XT valve using the NovaFlex delivery system or the Edwards SAPIEN Transcatheter Heart Valve.