The FDA recently approved the first TAVI device for aortic stenosis. Currently the device is only eligible for patients who are unable to withstand surgery. But who will end up making that determination? The cardiologist who will be implanting the device? At present – the company manufacturing the Sapien aortic device is recommending that patients be evaluated by a heart surgeon – but if this follows the typical course, I am sure that this recommendation will be abandoned as a matter of course.
Hopefully, the industry (interventional cardiology) will proceed cautiously, after being ‘omce bitten, twice shy” in light of the epidemic overstenting catastrophies.
For more on Aortic stenosis, TAVI and the overstenting controversies – look under the cardiology and cardiac surgery tab.