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.
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 (TAVR).
The transcatheter valve procedures take about 90 minutes, compared with four to six hours for open-heart surgery. In open-heart surgery, the surgeon cuts through the breastbone, stops the heart, removes the valve and replaces it. Open-heart surgery can require a two- to three-month recovery period, compared to only a few days for the transcatheter approach.
The next generation Edwards SAPIEN XT valve in The PARTNER II trial was engineered to provide a better valve patterned after surgical heart valves and potentially decrease treatment complications.
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 syste
|Contact: Deb Song|
Rush University Medical Center