Sythnetic Valve Works Better Than Open-Heart Surgery
A minimally invasive synthetic valve has proved more effective at replacing diseased aortic heat valves than open heart surgery, resulting in a notably higher survival rate among patients, according to the results of a Phase III trial.
The results were presented at the American College of Cardiology (ACC) 63rd Annual Scientific Session and Exposition In Washington D.C. this weekend.
According to Dr. David Adams, a co-principal investigator involved in the trial, the success of the implantation of a synthetic valve, called the CoreValve system, was nothing less than "outstanding."
Adams explained during the presentation that the CoreValve system was designed as a minimally invasive alternative to open heart surgery for patients deemed too delicate to heave their chests cracked open.
Using the CoreValve system, doctors use a transcatheter aortic calve replacement (TAVAR) system to implant a synthetic heart valve where a damaged or diseased valve once functioned. This means that doctors can put a new valve in place though a catheter that has been threaded through a major artery and to the heart, rather than simply opening up the chest of a patient to perform surgery.
Adams said that it had been the hope that the TAVAR delivery system of the CoreValve would be nearly as safe as open heart surgery, making it a good alternative.
However, results from the Phase III trial indicate that not only is the CoreValve TAVAR system as safe as open heart surgery, but it may actually be safer.
According to Adams's report, one year after undergoing a CoreValve system procedure, only 14.2 percent of patients died. This is significantly better than the death rate among open-heart surgery patients of an equal health demographic, who died nearly 20 percent of the time during or following surgery.
CoreValve, produced by Medtronic Inc., was approved for use in the U.S. just last January, to treat extreme risk patients who required heart valve repair, but were too frail to risk surgery.
Currently, synthetic heart valves are considered the best option for patients suffering from heart damage, but other approaches to repairing damaged and diseased heart valves have been proposed that involve the use of stem cells to recreate valves or even create entirely new mini-hearts to help pump blood.
The results of CoreValve's Phase III trials was reported at the ACC's 63rd Annual Scientific Session and Exposition In Washington D.C. this weekend.
As these results have yet to be published in a peer-reviewed scientific journal, it is suggested that they be viewed as preliminary findings until the time of official publication.
Mar 29, 2014 03:59 PM EDT