TAVR Showed Increased Neurologic Events

"It behooves us to work with a functional heart-valve team to make sure these complementary techniques [transcatheter aortic valve replacement and open valve replacement] are used appropriately. I don't think that open aortic valve replacement is an endangered species."

Deciding which patients should undergo transcatheter aortic valve replacement (TAVR) will require "defining the line between utility and futility," he said. "You don't want to empty every nursing home in California of patients with aortic stenosis, and on the young side, you don't want the percutaneous option used in patients at low surgical risk." Concern about using TAVR on patients who are good open surgery candidates focuses on the unknown long-term durability of TAVR, and the "high price to pay in neurologic events, at least in the current version of TAVR," he said.

"Patients will always flock to the least invasive approach. That's where the heart-valve team will be very important. This will only work well if surgeons and cardiologists work together to decide whether something should be done about aortic stenosis in a patient and, if so, which treatment is best. TAVR and open replacement are complementary, not competitive.

"You can't let this technology go everywhere," Dr. Miller warned. TAVR is "tricky, and the learning curve is steep and unforgiving. We [at Stanford] still insist on having two surgeons and two interventionalists on every case, because when a case goes south it goes in a hurry. We have done 100 cases, and problems still come up and are, to some extent, unpredictable."

The PARTNER trial was sponsored by Edwards Lifesciences. Dr. Miller said that he has been the Stanford Principal Investigator for PARTNER and has served as an unpaid consultant to Edwards. He has also been a consultant to Abbott Vascular, Medtronic Cardiovascular, and St. Jude Medical.