"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."
All rights reserved