Case and Plan:
58-year-old female presented to OSH with NSTEMI on May 28, 2021. A Cardiac Cath on June 1, 2021 revealed 2V CAD: 80% long LAD lesion and heavily calcified ulcerated 90% mid RCA, SYNTAX Score of 20 and LVEF = 50%. Patient underwent successful PCI of mid LAD and unsuccessful NC balloon/scoring balloon PTCA of the mid RCA due to severe lesion calcification and residual 70% lesion. A follow up stress MPI revealed significant inferior ischemia and normal LVEF. Patient is now planned for ‘Rota-Shock’ PCI of calcified undilatable mid RCA lesion with IVUS guidance.
Q What makes more sense - de novo IVL or synergistic?
A. If reimbursement is not the issue, then IVL as the primary strategy in large vessels (>3mm size) will be appropriate. In small tortuous long lesions, device synergy using small Rota burr or OA followed by IVL using 1:1 balloon size will be appropriate.
Q Is synergistic strategy not too expensive?
A. Actually in complex lesions with APC code 3, currently there is enhanced payment for atherectomy. Hence adding IVL is the added cost without any extra added reimbursement. We expect in few months, there will be an add on code for IVL, which should cover for some or all of the added cost of IVL.
Q And out of the cost range for most countries?
A. IVL is a very useful and simple to use device for calcified lesions, but has not really picked up globally for its inherent high cost of upwards of $4500+. Once IVL cost comes down, it’s use will certainly double or triple. Currently it is used in <0.5% of PCI in USA and used in less then 0.1% in other countries.
Q What improvements are possible with IVL?
A. Currently the most important limitation of the IVL is its rigid balloon and hence lesions have to be predilated in 50-60% of the cases. More flexible ballon will enhance the IVL delivery and cut the procedure time. Increase in pulses times to 120 will also reduce the cost of adding new catheter in long lesions.
Q Does the vessel always need preparation prior to using IVL at the lesion?
A. Yes almost 2 in 3 lesions, need to be prepared before IVL delivery.
Q What is your preferred synergistic modality for IVL?
A. My preferred synergistic modality with IVL is Rotational Atherectomy (‘RotaTripsy’ or ‘RotaShock’). In long severely calcified lesions, passage of a small Rota burr (1.25 or 1.5mm) followed by appropriate size IVL will provide the most optimal plaque modification strategy and best final stent expansion along with lowest complications.
Q How do you see IVL impacting Rotational Ablation, Orbital Atherectomy, Cutting Balloon, ELCA and Angiosculpt?
A. I expect that with the familiarity and increasing use of IVL, whole field of treating calcified lesion sill get a big push with attended increase in the calcific device usage. Currently Atherectomy is being used in 5% of PCIs in USA while severely calcified lesions are encountered in 10-12% of PCIs. Hence this field has lot to grow. IVL use will certainly reduce the need for atherotomy devices such as cutting balloon and AngioScultpt. I predict Rotablator use will stay same around 3-4% but OA use will go down as well the ELCA use too (which is now primarily used in ISR especially under-expanded stents).
Q How many IVL cases are you doing at your institution?
A. Currently we are doing 10-12 IVL cases per month; all after Rota or OA and not stand alone due to lack of IVL device reimbursement code.
Q To make decisions regarding synergistic strategies with IVL, which imaging modality do you prefer?
A. Both IVUS as well as OCT will show the device synergy of Atherectomy plus IVL but OZcT certainly will be more precise to show the micro fracture in the calcified lesions.
Q In your mind, what is the magic number of cases for a good Rotablator operator.
A. In my opinion, 40 cases per year of Rotablator will provide the best operator-volume safety outcomes.