Q&A
Q.
Do you normally go up to 6 ATMs on the IVL balloon? We have been using 4 ATMs?
A.
That is correct, initial IVL balloon inflation pressure is 4 ATM for 10 sec and then go to 6 ATM for 2 seconds before deflating. We do go upto 6 ATM many times when feel that lesion has not fully yielded.
Q.
Has CO2 accumulation been any problem in any case?
A.
CO2 accumulation has not been problem in any cases.
Q.
IVL appears a particularly good strategy for under expanded stents?
A.
Fully agree that IVL should be the first line treatment for underexpanded stents followed by ELCA and then Rota.
Q.
Could this case have been done with IVL only? Perhaps using a high pressure balloon for preparation?
A.
Yes present case could entirely have been done with IVL after balloon pre dilatation and if needed post dilatation with NC balloon.
Q.
What is your experience with Orbital Atherectomy (OA) in such cases?
A.
We have seen that OA does not work in underexpanded stents; perhaps due to lack of heat generation, which is the predominant mechanism of RA in these cases.
Q.
And with the excimer laser (ELCA)?
A.
Before IVL, ELCA used to be the first line treatment for underexpanded stents and works very well in 95% of cases. If fails, we use RA in conjunction or as the second line therapy.
Q.
As per new ACC recommendations regarding imaging, do you perceive an increase in both IVUS and OCT? Or more with either?
A.
I predict that going forward both IVUS and OCT use will increase (2-3x of current volume). IVUS due to its ease of use, no need for contrast and easy interpretation will have the edge over OCT during PCI. Currently as per ACC-NCDR data, both together are used in 16-18% of PCIs in USA; 2/3rd IVUS and 1/3rd OCT.
Q.
What would be the various implications of Yellow 3? Seems highly promising?
A.
Two most important implications of Yellow-3 are; almost 60% of stable CAD pts have TCFA and about 20% of pts do not have increase in cap thickness or lipid plaque burden despite significant decrease in LDL; Non-responders. We hope that genetic analysis of Yellow-3 will help to identify gene involved in this subset of non-responder pts.
Q.
For the device to get FDA approval for its numerous indications, would a multicenter trial be mandatory?
A.
Yes it is correct that to get any device approved by FDA, a multi-center trial including 109+ pts will be needed; even as the single arm registry (all CTO devices were approved this way).
Q.
How are Apps developed at your institution changing the interventional cardiology landscape?
A.
Our numerous Mount Sinai Apps for interventional medical education have been a great hit being downloaded and used globally; over 0.5M downloads so far.
