How do you see FDA approval to expand the indications of TAVI to include low risk aortic stenosis? how would this affect the already decreasing volume of cardiac surgery cases?
Patients will clamor to have the TAVI, without realizing that not every case is suitable for TAVI compared to SAVR. High calcification of the annulus, specific Coronary anatomy relationships to the landing area, considerations of conduction disturbances, and many other factors must be weighed. I fear that some will be offered TAVI not because it is the best for them, but, because the patient has such a strong desire to avoid surgery...and the Team relents. It's important to have a total Team approach to this discussion with the patient. It reminds me of a problem I saw decades ago, where I overheard a cardiologist say, "I will never send a patient for CABG before I first try an intervention." I cannot count the number of emergency surgeries we performed to try and salvage a patient after there were problems in the cath lab....including many patients with a chart entry that said, "Successful PTCA to the ________", and we are doing chest compressions, priming the pump, snatching a vein from a large incision in the leg, and trying to save them. We didn't save every one. But, they COULD have had an elective surgery using Internal Thoracic artery, perhaps a radial graft, and if a vein was used, it could have been taken endoscopically with care. We need to look at the whole picture, and most patients are not educated enough to make this decision if they aren't given to opportunity to have an informed discussion of all the options...and that requires a Team approach.
I think expanding the indications to low risk patients is limited to elder patients according to PARTNER trial, which included patients above 70 years old. The longterm outcomes of TAVI is not known, especially the durability of the valve and there are studies suggesting early degeneration of transcatheter prosthesis compared to the biological valves used in SAVR. Future studies are required to compare the outcomes of TAVI and SAVR and expansion of the indications to low risk patients should be interpreted according to the inclusion criteria of the trials.