Fixing a diseased aortic heart valve with an implant set in place using a method much like angioplasty sharply improved survival in patients too sick for surgery, a new study shows.
Doctors say the approach represents another step toward a new era of non-surgical valve replacement for patients unlikely to survive surgery, which is now the most effective treatment.
"The new approach led to a 20% reduction in deaths," says lead investigator Martin Leon of Columbia University Medical Center, who helped develop the valve but says he sold his interest to the study sponsor, Edward Lifesciences, and no longer has a financial stake in it.
Currently, Leon says, about 30% of patients diagnosed with aortic stenosis don't undergo surgery because their odds of surviving an operation are poor.
Without surgery, the study showed, half of patients die within a year of suffering their first symptoms, because damaged valves block blood flow from the heart to the rest of the body.
"It's an unbelievable chunk of lives saved," says Christopher White, director of cardiology at the Ochsner Medical Center in New Orleans, who was not involved in the study and has no financial stake in the device. "Still, a third of these patients expired within a year. That's a significant risk, but it beats 50%, which was the control arm."
The study, out Wednesday in The New England Journal of Medicine, involved more than 358 patients divided into two groups. About half received medication, bolstered in many cases by a procedure to widen their clogged aortic valves. The rest were given an experimental valve, fashioned with treated cow tissue encased in a spring-like stent.
The valves were slipped into the patients' aortic valves through a tube called a catheter.
The death rate among valve recipients was 31%, vs. 51% among those who got standard therapy. About 5% of those who got the valve suffered strokes, compared with 1% of those on standard therapy.
Sixteen percent of valve recipients suffered other complications. Leon says smaller implantation devices may reduce complication rates.
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