A Team to the Core
Cardiovascular Center trial ‘pivotal’ to minimally-invasive replacement of aortic valves — and the future of health care
It’s a bold statement Stanley Chetcuti, M.D., makes without hesitation: “CoreValve is forcing us to change the way we take care of patients.”
Chetcuti is one of the principal investigators for the University of Michigan Cardiovascular Center’s section of the Medtronic CoreValve U.S. Pivotal Trial, which has been testing the effectiveness of a minimally invasive alternative to open-heart surgery in relieving severe aortic stenosis, a condition where the aortic valve narrows, limiting blood flow from the aorta to the rest of the body.
His observation isn’t only about the device itself. The prognosis for a successful outcome was pretty rosy anyway, given the CVC’s distinguished track record in research and treatment. And both the CoreValve and the Edwards SAPIEN transcatheter heart valve, a similar implant that was approved by the FDA in November, have been used extensively and to good effect worldwide but had not been evaluated in American trials on American patients.
Chetcuti’s comment also refers to more than transcatheter aortic valve implantation, or TAVI, the percutaneous procedure used to place new valves in aged patients with complications that make open-heart surgery too risky — which is the case with about a third of the 100,000 Americans diagnosed with the ailment every year.
Giving them a chance they wouldn’t otherwise have at a better life, if not necessarily a longer one, is undeniably important, but the means by which that chance is achieved is what has global significance for the future of medicine itself. CoreValve, as used above, is shorthand for the entire process.
“It begins to open our minds to how medicine needs to evolve in the next 10 to 15 years,” says Chetcuti, an interventional cardiologist who is the Eric J. Topol Collegiate Professor of Cardiovascular Medicine and associate professor of internal medicine. “That’s the fundamental issue — not taking care of people with stenosis, but how we train our young doctors, how we use technology. The way we do incisions, the way we do surgery, the way we share data are all going to explode in the next five to 10 years.”