By Rick Rouan
THE COLUMBUS DISPATCH
Sunday, March 30, 2014
Fewer patients with diseased aortic valves might have to face
A new study, published online yesterday in The New England
Journal of Medicine, found that the risk of death among severe
aortic stenosis patients one year after treatment was lower in
those who received a prosthetic valve inserted through a catheter
than in those who had the valve replaced during surgery.
The catheter is inserted through an incision in the groin and
threaded through an artery to the aorta. A stent and the
prosthetic valve open when the catheter is unsheathed.
"This will be available for more patients to have a
less-invasive option to replace the aortic valve," said Dr. StevenYakubov, a co-author of the study and system chief of structural heart disease at OhioHealth.
"It will absolutely change the way patients are treated."
The U.S. Food and Drug Administration approved the device for
extreme-risk patients - those who are too sick for open-heart
surgery - in January. The study Yakubov helped to lead could pave
the way for FDA approval for patients who are eligible for surgery
but are at high risk of dying.
FDA approval could come in the next six months, he said.
Each year, aortic steno-sis is diagnosed in about 100,000
people. It's a narrowing of a valve that chokes off the heart's
ability to pump blood to the rest of the body. About one-third
of patients are high-risk.
Patients either must live with shortness of breath and chest
pain or undergo surgery to correct the problem. Stenosis can lead
to heart failure.
A total of 795 people were enrolled in the study at 45 centers
nationwide. Eligible patients were randomly assigned to surgical
aortic-valve replacement or the catheter-valve procedure.
According to the study, 14.2 percent of patients who received
the valve through a catheter died after one year, compared with
19.1 percent of those who had surgery.
Complications, including stroke and death, are inherent in both
the transcatheter treatment and open-heart surgery, but the risk
appears to be lower with the less-invasive treatment, Yakubov
Surgery candidates tend to be older, and in many cases have
other health problems, such as kidney or lung disease, that put
them at high risk, said Dr. Daniel Simon, director of the
Harrington Heart & Vascular Institute at University Hospitals
Case Medical Center in Cleveland. "This (new procedure) really
meets an unmet need," Simon said.
The catheter-inserted replacement valve is made of cow tissue
and represents the second generation of transcatheter aortic-valve
replacements. The original technology required a balloon to open
the valve. The new replacement expands on its own.
Medtronic CoreValve makes the valve and sponsored the study.
Simon said trials are underway to use the treatment for
intermediate-risk patients, and he expects it to be used in
one-third to half of all aortic-valve replacements within five
Older patients who undergo open-heart surgery to receive a
replacement valve typically are hospitalized for about a week and
spend months recovering, he said. Patients who undergo the new
procedure can be conscious, which reduces risks associated with
anesthesia, and they can leave the hospital in about three