Outcomes better with non-surgical valve replacement than standard medical therapy

Taken from the New England Journal of Medicine (NEJM) – by Bruce Sylvester – Aortic stenosis patients who are too ill to undergo open-heart surgery have achieved  better survival rates and an improved quality of life after undergoing catheter-based heart valve replacement compared with patients treated with standard medical therapy, researchers reported online on March 26  in the New England Journal of Medicine (May 3 print edition).

“This study shows that this minimally invasive procedure adds years to life and life to years,” said investigator Raj Makkar, MD, associate director of the Cedars-Sinai Heart Institute in Los Angeles.

The clinical trial,  funded by valve manufacturer Edwards Lifesciences, enrolled 358 patients at 21 medical centers, who were randomized into two cohorts. Subjects in the first cohort underwent percutaneous procedures. Subjects in the second cohort received standard medical treatment, including prescription drugs. The investigators followed all subjects for two years.

After 2 years, the researchers found that 68 percent of patients receiving standard medical therapy had died, compared to 43 percent of patients who underwent a minimally invasive procedure.

They reported that 33 percent of patients who had a procedure were readmitted to the hospital during the two years of follow up, compared to 72 percent of patients who received medical therapy.

Also, subjects who underwent a procedure had a higher risk of stroke, at 14 percent versus 5 percent for standard therapy patients.

Open-heart surgery to repair or replace heart valves remains the “gold standard,” said Eduardo Marbán, director of the Cedars-Sinai Heart Institute. But, he added, “The heart’s valves wear out as you age. And the older you are generally makes you a less attractive candidate for open heart surgery. This new, less-invasive option will become more and more important to patients as the Baby Boom Generation ages.”