SUNDAY, Nov. 4 (HealthDay News) -- Older, high-risk heart patients with narrowed aortas who typically need open-heart surgery might someday have a new, less invasive option -- an implanted, balloon-expandable aortic valve.
The balloon is inserted percutaneously (through the skin), placed across the problem valve and then inflated, experts said. In a new study, the procedure -- not yet approved by the U.S. Food and Drug Administration -- showed real health benefits for up to two years.
The research is to be presented Sunday at the American Heart Association annual meeting in Orlando, Fla.
"The percutaneous balloon expandable aortic valve insertion provides a safe and sustained alternative for high-risk patients with severe aortic stenosis [closure]," said lead researcher Dr. Sanjeevan Pasupati, who was an interventional fellow at St. Paul's Hospital in Vancouver, British Columbia, when the study was conducted.
"In our first 100 high-risk patients, the intra procedural mortality was only 2 percent with minimal morbidity," Pasupati said. "Our long-term survival is promising, with 70 percent and 60 percent at one and two years, respectively. This procedure is here to stay."
Other experts stressed caution, however.
"This is a very exciting frontier for us in terms of being able to potentially fix these with percutaneous approach versus putting patients on a heart-lung machine," said Dr. John P. Erwin III, an associate professor of internal medicine at Texas A&M Health Science Center College of Medicine and a cardiologist with Scott & White Hospital in Temple. However, "this is still considered to be a high-risk procedure that is not quite ready for prime time at this point," he said.
According to the American Heart Association, aortic stenosis involves a blockage of the heart's aortic valve. The aorta is the body's main artery. The aortic valve closes over after each heartbeat to prevent blood from flowing back into the heart's left ventricle.
"Patients who have severe aortic stenosis and who may reach the criteria where they're best suited to have heart surgery often are very elderly and have other significant risk factors, so they're at high risk at the time they have open-heart surgery," Erwin explained. "There's a high prevalence of stroke and, in octogenarians, when we do bypass and place a valve, the combined mortality and major morbidity is about 25 percent."
So, physicians have long looked for an alternative to open-heart surgery.
For this study, balloon expandable aortic valves (BEAVs) were implanted in 100 patients, average age 83, of which slightly more than half were male. The procedure was successful in 91 (91 percent) of patients.
Two percent of the participants died during the procedure. At 30 days after surgery, 15 percent of the participants had died.
There was also "significant improvement" in heart function.
"Currently, this is not an alternative to surgery, and we need to await the results of the FDA-approved randomized PARTNER study," said Pasupati, who is now an interventional cardiologist at Waikato Hospital in Hamilton, New Zealand. "The technology has CE Marked approved [indicating conformity with European health and safety requirements] and is currently available in Europe."
"Definitely, it's going to be something to be watched, but that's only the Canadian trial," added Dr. Carlos Ruiz, director of the division of cardiac intervention for constructive heart disease at Lenox Hill Hospital in New York City. "There are the Canadian trial ongoing, the European trial, as well as the U.S. trial."
Find out more about aortic valve stenosis at the American Heart Association.
SOURCES: Sanjeevan Pasupati, MBChB, FRACP, interventional cardiologist, Waikato Hospital, Hamilton, New Zealand; John P. Erwin III, M.D., associate professor of internal medicine, Texas A&M Health Science Center College of Medicine and cardiologist, Scott & White Hospital, Temple, Texas; Carlos Ruiz, M.D., Ph.D., director, division of cardiac intervention for constructive heart disease, Lenox Hill Hospital, New York City; Nov. 4, 2007, presentation, annual meeting, American Heart Association, Orlando, Fla.