Fewer patients with diseased aortic valves might have to face open-heart surgery.
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. Steven Yakubov, 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 stenosis 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 said.
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 CoreValue 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 years.
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 days.
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