An Upfront RotaTripsy Strategy for the Treatment of De Novo and In-Stent Restenosis Cases

In this video, Dr Deepak Bhatt, JIC Editor-in-Chief interviews Dr Samin Sharma about his recent paper in JIC describing the “RotaTripsy” technique.

Dr Deepak Bhatt: Hello. This is Dr. Deepak Bhatt, editor-in-chief of Journal of Invasive Cardiology, here for the Journal of Invasive Cardiology podcast. Thanks for listening.

I'm here today with my good friend, Dr. Samin Sharma, one of the world's most noted interventional cardiologists, and he has just served as senior author for a paper in Journal of Invasive Cardiology entitled, “Efficacy and Safety of an Upfront RotaTripsy Strategy in the Treatment of De Novo and In-Stent Restenosis Cases.”

I thought it was a fascinating paper. And you can certainly read all the details in JIC, but I was hoping to hear from Dr. Sharma directly what his study shows.

Samin, perhaps you can just tell our audience what the study was, and then exactly what it showed.

Dr Sarmin Sharma: Dr. Bhatt, thank you.

Basically, as we know, when calcified lesions are becoming more challenging, and particularly, we are also having many devices, we used to have rotational atherectomy, and orbital atherectomy in severely calcified lesions.

The laser has some role, and now the IVL which has come up. All are good for severely calcified lesions. One of the issues has been with the IVL, which everybody wants to use, which has very little technical requirement, it’s easy to learn, is that it doesn’t go everywhere, in the tortuous anatomy because it's a bulky balloon and it does not go in all cases. Our second point is, the rotational atherectomy is good. But if you use a bigger burr, the large size is associated with more complications, of slow flow and chest pain, and also, subsequent restenosis, which was shown by the ESTRATAS trial.

Since IVL and rotational atherectomy, both are here, we do about 25% of our cases using atherectomy. We felt that, what if we use a smaller burr even in a large vessel, and combine it with IVL? That was the whole concept of the RotaTripsy. There have been some publications in the literature and then we said, "Let's do methodically, in a large vessel." Which we define more than 3.5 millimeter vessel. Because small vessel, I think just alone, rotational atherectomy and balloon angioplasty will be good enough. But in the large vessel, use a smaller burr, around 0.4 burr to artery ratio means 1.75 or 1.5 ... and then combine with IVL.

That was the whole concept. And look into it, that does it increase more vascular complication, more procedural complications, slow flow, and so.

And what we found in these 21 patients, where we use 12 in the de novo, and 9 in the in-stent restenosis cases, this device's strategy, with a lower burr size, and IVL one-to-one burr/artery ratio was very effective.

One patient did have a bad outcome. And maybe I'll just talk about that little later, why, what that particular case was. But overall, it actually kind of become now, in our lab ... In the past, in very calcified lesions, about 15%, we used to use two burrs.

Now, second burr is almost none. Because instead of second burr, now we use IVL. This combination, whether RotaTripsy, the name we gave ... There's some publication, they call it RotaShock, because the Shockwave. But we thought that RotaTripsy, it looks better. Name RotaShock doesn't look good.

So, RotaTripsy has been commonly, I would say frequently, used strategy in large vessel, and with a tight lesion. In a less tight lesion, 70% large vessel calcified, I think that case can be done with IVL. 2.53 millimeter vessel, calcified lesion. Rota alone is good enough. But in the 3.54 millimeter vessel, combining these two strategies, in my opinion, synergistic. And that, our study showed of these 21 patients.

Dr Deepak Bhatt: I like the name RotaTripsy, I think it’s really catchy. But beyond the name, this is a really clever approach for folks that have used a shockwave. It's a wonderful technology. I'll say a transformative technology in interventional cardiology.

But as you said, the reality is it just doesn’t get everywhere. And even if you do get it into a really tight, tortuous vessel, once you've inflated, it might not be so easy repositioning it sometimes.

It could be a little bit tricky, and you can't always leave it where it is. Let’s say you're doing something very proximal. Oftentimes, a patient might get ischemic, if you've inflated and deflated the balloon. But then if you've withdrawn it, it might be hard getting it back there. Even if you can pass it initially, sometimes the subsequent passes, it can get tough.

So this technique of atherectomy beforehand, I think, could be really useful, and simplify ... in some cases, even shorten the procedure, versus just using intravascular lithotripsy alone. Really, I think, a clever technique.

Dr Sarmin Sharma: Yeah. Means synergistic. Question is, as you just mentioned, the people then give the example, Disrupt CAD. They did the cases, no rotational atherectomy was done. I said, "No. There was protocol."

BVA protocol indication means that the trial inclusion was that, if you think you'll need rotational atherectomy, those patients were not enrolled in the Disrupt CAD III. They clearly said no rotablation.

But if you think it's such a long and calcified lesion, angulated very tight lesion, that you are going to need rotablation, those patients were not enrolled in Disrupt CAD III. There were some cases done in Disrupt CAD II, with atherectomy.

So, what they did is, only in those tight cases, 54%, they did a pre-dilatation with a high-pressure balloon, and then did the IVL. So, with the Disrupt CAD III, really didn't give us any idea about this combined strategy. Because as the protocol, the rotational atherectomy was excluded.

Dr Deepak Bhatt: Yeah. No, that's really a terrific point about that study, which was a great study. But of course, in terms of applying it in real life, many times we encounter situations that may not have exactly been in trial.

A question that might be asked is, in terms of the RotaTripsy strategy, what is the atherectomy choice that an operator can use? Does it have to be rotational atherectomy? Can it be using orbital atherectomy?

And I'll just mention to the audience parenthetically, just this past weekend, I was lucky to see India's first use of the orbital atherectomy by Dr. Sharma at his hospital, at Eternal Heart Care. Really remarkable that you brought this technology to India.

But for our audience, does RotaTripsy have to be rota? Could it be orbital atherectomy? How would you decide between the two?

Dr Sarmin Sharma: Yeah, so very good point. I would say that it is the same, both rota or orbit. Only question is, many of these cases are very tortuous. There, we are concerned with the orbital. We have done cases with the orbital atherectomy.

Only problem, what I want to say, that orbital device is so effective because does such deep cuts. Very rarely, you'll need the adjunct device. In the rota with a 3.5 millimeter vessel, if 1.5, or 1.75 millimeter burr, high pressure balloon, probably 20% will not open the lesion. And then you have to use IVL.

In orbital atherectomy, maybe in 5% of cases, will not open the lesion because it just causes such deep cuts the vessel opens up, even at 80,000 rpm. We rarely use 220,000 rpm. So that orbital, same way, I would say large left main.

I think using orbital with a shockwave IVL is a good combination in a left main type situation. So that you open some lumen with the orbital, and then you're following with the short ... Of course, you have to do pulses, ten second pulses. But maybe you can do just three pulses rather than doing eight pulses, which can cause more ischemia in the left main.

So, we personally have done three cases of orbital with IVL, but all three were left main.

Dr Deepak Bhatt: Yeah. Very, very interesting. And any considerations about cost, lumping together different strategies, that is, rota plus IVL, or orbital atherectomy plus IVL?

Dr Sarmin Sharma: Yeah. We actually are still looking into the final payments for the devices. Only problem is once you get the DRG, you get the ... For the atherectomy and the device, it added device cost. So question is, second burr, which is about $1,700 versus this $4,000 IVL ... That’s the issue, definitely.

But, it will pay off by decreasing the complication. What complication is, we all know. IVL, chances of perforation is almost nil. All the trials have shown, most of them happen just balloon, and after stenting, and so on.

Case which we have, very interesting. 4.5 millimeter large vessel, right coronary artery. Elective patient, 80-plus year old patient, and which we described in this particular case. We did a 2.0 burr, dilated with a 4.0 balloon, did not completely open.

Then did 4.0 IVL. IVL opened it little bit, but still there was residual because it was a 4.5-plus millimeter vessel.

I still put a 4.5 millimeter Synergy stent. And then we post-dilated to the 4.5 at 18 atmosphere.

We came out. Sometimes you say that maybe enemy is to make perfect. We still have that, millimeter stent. Then back. The 4.5 millimeter balloon, we went 22 atmosphere, we saw it opening. And opening means the vessel gave up.

And with a frank perforation, went through all the issues with putting the Papyrus stent and the patient developed shock, and later that night died. So that, I would not blame it in IVL. I would not blame it on even Rota directly. It was just such a calcified nature of the case.

But besides that, what we found it, almost no slow flow and other complications. So that is the biggest advantage using a small burr in a large vessel, and combining IVL, and, get away from the perforation.

So this one was, I would say that if I had to use 4.5, since we are no device, nor rota, nor IVL of 4.5 millimeter available, maybe this is not the right case for this. But we have done few cases of that large size combining two. So that was a little anomaly.

But otherwise, this a strategy which we are doing now. We have done it in live cases, few of them. Showed it month before, our CCC live in December. Was the same as a RotaTripsy. We had advertised that way. It was LAD/diagonal bifurcation. And we did both vessels ... rota, LAD and diagonal, as well as the IVL of that particular case.

So key is that this strategy, which to me ... And we are also looking into this aspect, that since use of IVL started, which is in about August of 2021 at Mount Sinai, and we trying to see rotational…, are there complication before or after?

That basically means that by using IVL, are you decreasing your complication? Less, less slow flow. Knowing that we agreed our international database ... perforation pre-IVL, post-IVL rotational atherectomy.

Rotational atherectomy still is about 21%, pre and post. Two, three percent is orbital for us, and about 1% or 0.5% is laser. IVL alone is done small, but most of the time it is combined with atherectomy for us.

Dr Deepak Bhatt: Yeah. My guess is use of IVL will ultimately lead to a decrease in complications in cath labs. I think many times, avoiding the really high-pressure inflations, in particular perhaps with an oversized balloon. I know in the case described here, the balloon wasn't oversized. But I'm just saying in general, a lot of times people see the residual, they go in with a larger balloon, high pressure, and then the perf occurs. I think Shockwave is going to really reduce the risk of that particular type of complication.

Dr Sarmin Sharma: Absolutely so, I think. True synergy. Not only for the lumen gain and lumen. Except that one patient, of course, that was not counted.

I cannot say about the lumen, because that, we put multiple stents in there. But everyone has a good stent expansion with this strategy, with minimal complication.

Dr Deepak Bhatt: Yeah. That's a thing, really related to your paper. But when, let's say doing a distal left main bifurcation, or I suppose any major bifurcation, even an LAD large diag, some operators ... Well, I think historically, operators just put the wire down the initial vessel and do atherectomy.

More recently, there have been some operators, that say for distal left main, are wiring the one vessel, but then that they're going to do atherectomy on. But then actually wire the other vessel, and then protect that wire with a GuideLiner. Obviously, you have to use a large guide to have it all fit in there. Is that something you ever do?

Dr Sarmin Sharma: Yeah. Very good point. Which actually, I would say three times that question in last two years have been asked in our live cases. And I told everyone that, one, we have never done it. And secondly, we never needed to do it. Never needed.

Question is why. We have some cases like very, 80% calcified LAD. But there’s a 90% diagonal, 95%. You worry about. We would know that after atherectomy, unlikely that you'll close the vessel. But you are a little concerned.

In that concern, put a wire in the diagonal, open up with a 2.0 balloon, very small. Make a little lumen, don't go high pressure, and nothing will happen. Now, you complete the rotablation of the LAD. And then, before dilating the LAD post-rota or orbital, just put a wire in the side branch and open it up.

So key is that, yes, that is one of the crazy approach, I call it. Where you need a 8 French Guide. Or you need a ... not 7, 8 French Guide is needed to have your 1.5 burr and the GuideLiner.

You have to bring the GuideLiner or Guidezilla into the side branch, protect that, and then you have to go almost across the ostium. If you're going across the ostium, that means you're going with the GuideLiner, which is a lumen of 1.9 French. So, it's probably not that tight.

But yes, that had been described. If you're very much concerned keeping the side branch. And IVL comes handy in that way, that you can leave the side branch. And if you can open, IVL can go. I can tell you that I have few cases, 70% left main, not even 80, 90 ... 70%.

I said I'm going to put a IVL. And about 5% to 7% of the time, IVL would not even go, in the 70% left main. Then IVL, the cutting balloon 3.5, and then put IVL. Then it goes.

So, IVL is, they're making a lot of changes in the future. The more flexibility, maybe higher the total cycles. Right now, cycles 80 seconds. They’re making those changes.

But until that time, biggest limitation of IVL is, while as good as it is, but the bulkiness is a big issue on that case.

Dr Deepak Bhatt: Yeah, I agree. And as I mentioned before, even for left main where it might be easy or relatively easy to deliver the first time, once it's a bit winged, obviously you can't just leave it parked there in the left main; sometimes people get ischemic. You pull it back, and then it's hard to re-advance it if you haven't debulked initially.

So, the final question I'll ask is just about within stents. You, in this very nice paper, had described cases of instent restenosis also treated with this RotaTripsy methodology. Any particular concerns, or tips or tricks you want to share with the audience on that one?

Dr Sarmin Sharma: Yeah. Basically, what happened is, the instent restenosis, a lot of people are concerned using rotational atherectomy. But we have been ... published paper first time of hundred cases back in 1996 by JACC article. And so, quite experienced.

And particularly, it works quite well in the unexpanded stent. And geographically or IVUS-wise, you see OCT unexpanded stent works quite by generating the heat. The concept, basically, here was that these patients with instent restenosis is the same. That your debulk or modified little bit of a plaque, and now instead of just going high pressure, or never able to completely expand, use the IVL.

And what we did is, is our policy, that if there is two layers of stent, actually a couple of them even failed with the brachytherapy. So, two layers of stent. Just did a rota and IVL. Did not put a third layer. Of the nine cases, two had first time ISR.

So that case, we did a rota IVL and put another stent. So we, in our lab, that third stent is almost no-no. And in most cases, actually. Of the seven, I know that we counted about five already have IVBT in the past. So, they have failed IVBT, but not additional stent.

So key, the question comes, it’s actually even better. They’re using a smaller burr in a ISR or maybe an expanded stent, and will cause less burr entrapment. We have no case of burr entrapment of those nine cases.

But it will, again, the concept will still remain the same, that there is a lot of controversy about. That, should you use rotational atherectomy in a stent or ISR, or an unexpanded stent.

We know the laser is the first treatment, which we understand. And we use it as needed. But we are very comfortable. We are published multiple times, use of rotational atherectomy for ISR.

And this is where we combine the same principle, what needed to be done for the native vessel. That is small burr. And hopefully, got the better lumen. And there was no complication on those cases.

Dr Deepak Bhatt: I recall Pat Whitlow was actually a big believer in rotational atherectomy for instent restenosis. Though, of course, with careful technique and caution, and trying one’s best to avoid burr entrapment.

Well, this has been incredibly insightful. Any final comments for the audience?

Dr Sarmin Sharma: Yeah. I would just say that our paper in JIC is in series of a few other small level, small patient publications, that this device strategy is a good one, and everybody should use it.

And in my opinion, my suggestion is never ... There is almost no situation that, since August of 2021 at Mount Sinai, that we are used more than 2.0. Even 2.0 is small. But none, not 2.1, 2.25, 2.30 ... zero. None.

So key is, avoid the large burr, and this in even large vessel, this device is strategy. But key is that you just go slow. And even if cases in left main, don’t do your all six, eight cycles. Do two, come back, let it re-perfuse, and complete the process.

Dr Deepak Bhatt: Really great advice. Lots of pearls of wisdom there from Dr. Sharma. Hopefully, the audience enjoyed it. Thank you so much. I certainly learned a lot, as I always do speaking to you. This is Dr. Deepak Bhatt for Journal of Invasive Cardiology.

Dr Sarmin Sharma: Thank you, thank you.

Dr Deepak Bhatt: Thank you.

Related Reading:

Efficacy and Safety of an Upfront RotaTripsy Strategy in the Treatment of De novo and In-Stent Restenosis Cases

https://www.hmpgloballearningnetwork.com/site/jic/original-contribution/efficacy-and-safety-upfront-rotatripsy-strategy-treatment-de-novo

Rotatripsy: A Hybrid “Drill and Disrupt” Approach for Treating Heavily Calcified Coronary Lesions   

https://www.invasivecardiology.com/articles/rotatripsy-hybrid-drill-and-disrupt-approach-treating-heavily-calcified-coronary-lesions
 

Synergistic Coronary Artery Calcium Modification With Combined Atherectomy and Intravascular Lithotripsy 

https://www.hmpgloballearningnetwork.com/site/jic/original-contribution/synergistic-coronary-artery-calcium-modification-combined