CHICAGO (Reuters) - Edwards LifeSciences Corp’s less-invasive replacement heart valve alleviates symptoms such as fatigue and breathlessness better than standard medical therapy, data released on Monday show.
Researchers evaluated the symptoms in patients from the company’s successful Partner trial, whose key results on mortality were released in September. Those data showed Edwards’ Sapien valve, which is threaded through the arteries to the heart, sharply reduced death rates at one year compared with patients who received only the standard therapy of medicine or an angioplasty procedure.
In the new data released at the American Heart Association’s annual meeting here, researchers conducted follow-up quality-of-life assessments with the 358 patients in the study’s “Cohort B” arm, the majority of whom were over 80 years of age.
“For patients in that age group, they are far more concerned with the quality of life they have than how long they live,” study researcher David Cohen, director of cardiovascular research at St Luke’s Mid America Heart and Vascular Institute in Kansas City, Missouri, said in an interview at the meeting.
Patients in the study were considered too sick to undergo traditional open-heart valve replacement surgery for severe aortic stenosis, a narrowing of the valve.
After the transcatheter valve replacement procedure, however, patients saw a substantial reduction in symptoms such as fatigue and breathlessness that are related to heart failure and a significant improvement in physical abilities at six months and one year, researchers said.
“It’s almost like they were about 10 years younger,” Cohen said.
The Partner study will form the basis of Edwards’ application to the U.S. Food and Drug Administration to sell the Sapien valve in the United States. The company has said it expects to submit the Cohort B data to FDA by the end of the year.
Irvine, California-based Edwards is also studying its Sapien valve in a second group of patients known as Cohort A. Those results, which compare transcatheter valve implantation to conventional surgical aortic valve replacement, are expected to be presented in the second quarter of next year.
Reporting by Susan Kelly; editing by Andre Grenon