August 31st, 2011
TAVI—When Will It Come to an Operating Theater Near Me?
Stephen Fleet, MD
At the ESC meeting in Paris, Gerhard Schuler from Leipzig reviewed the current indications for Transcatheter Aortic Valve Implantation (TAVI).
TAVI is considered appropriate for:
- Inoperable patients with severe aortic stenosis with a baseline 1-year mortality risk of 50%.
- Patients with severe aortic stenosis and a surgical risk of greater than 15%.
- Valve-in-valve implantation for degenerated bioprosthetic valves with severe aortic stenosis.
Specific patient types suitable for TAVI include those with porcelain aorta, general frailty, poor pulmonary function from COPD or pulmonary fibrosis, open bypass grafts at risk during re-operation, “hostile” thorax due to prior radiation therapy, and cirrhosis of the liver.
Potential complications include stroke, need for permanent pacemaker, and vascular injury.
The seminal PARTNER trial reported a rate of death from any cause at one year to be 30.7% with TAVI and 50.7% with standard therapy (including balloon aortic valvuloplasty).
As I observed video presentations of elegant transcatheter valve implantations in European patients, I was struck by the fact that Europe is now roughly 5 years ahead of the U.S. with regard to routine TAVI. In fact, Europeans are beginning to explore whether indications should be broadened to patients at less risk.
U.S. clinicians, with no shortage of patients who meet TAVI guidelines, cannot help feeling frustrated by the slow uptake of new technologies in our country. In many ways we in the U.S. have become the old world, hampered by red tape and bureaucracy. In the words of Edward R. Murrow, we need to “remember that we are not descended from fearful men.”
Innovation requires a certain bold spirit. If people want conclusive evidence and randomized trials before using something, we’ll all be safer, I guess, but who will be the Blalock’s and Gruenzig’s of the future? If an American has to go to Europe to learn new techniques, we in the U.S. may have lost the initiative.