Dr. George W. Vetrovec Discusses Completeness of Revascularization
Data is emerging to support the notion that leaving patients behind with un-revascularized territories may be a risk to be discussed with patients. The key challenge is to completely revascularize patients. Dr. George Vetrovec, Professor Emeritus of the Virginia Commonwealth University, shares his thoughts with ProtectedPCI.com's Dr. Seth Bilazarian in the podcast below covering completeness of revascularization.
Seth: Hi, I'm Seth Bilazarian on ProtectedPCI.com. I have the good fortune of having Dr. George Vetrovec, Professor Emeritus of the Virginia Commonwealth University joining me to give his thoughts about completeness of revascularization. George was very kind to review the literature and give us some thoughts about this topic, and I'm very excited to hear his presentation. So George, share with our audience what you have to say.
George: Well Seth, I appreciate this opportunity. There's been a lot of debate over the years. How important is it really to totally revascularize patients who have Ischemic disease, and I'm going to try to provide, very quickly, just a couple of scientific pieces of data to try to give some insight into that.
We're talking about optimal revascularization, strategies. Here are my disclosures. And I'll ask the first question which is: Optimal Revascularization, Why Should We Care? The answer is because it provides better outcomes for our patients. And let me just give a couple points of data that might support that.
We have a changing set of patient population. Patients are older, they're sicker, their risk factors are higher. There are many surgical turndown patients with no other options, really. Patients with much worse left ventricular function than I think we've seen in the past. There's just a huge opportunity for clinical impact if we can do something for this population. I think the really critical thing here is making that opportunity happen by better completeness of revascularization.
Here's some data from the NY State Database, they've looked at this issue many times. Most recently, they looked at it in the drug-eluting stent era to see in this large database whether patients did better or not if they had complete revascularization.
In the past it's always been that complete revascularization won, but they thought maybe in the drug-eluting stent era that would be different. And this curve shows clearly that the patients have greater survival, the A curve, than the B curve which has incomplete revascularization in this database.
And furthermore, if you look at a breakdown of heart attack and future heart attack, it's the same if you look at the risk of, in various degrees of incomplete revascularization, it's all the same. So I think the more complete the revascularization, overall the better the outcome.
One other interesting piece of data is, we've all heard about The STICH Trial, and the STICH Trial was obviously aimed at seeing whether with surgical revascularization there was better outcome with revascularization and medical therapy. And the Trial was negative, there were many complications with it. Like so many of those trials, there's a lot of crossover data.
This particular publication looked at just the outcome for patients based on what they got in terms of revascularization. So when you compare the patients who got bypass surgery versus the patients that got continued medical therapy, it was a significant difference favoring revascularization. So again, important to get revascularization.
The whole issue about CTOs just continues to be an evolving issue. What I've got here is some data from a large UK database that looks at mortality for patients based on whether they had successful or failed CTO attempts. Then furthermore, whether they had totally complete revascularization or not. Again, it highly favors complete revascularization and the totally occlusion is important to be revascularized.
I think the data is more and more clear that this is the thing to do. The issue that comes up for operators is what's the likelihood that you can safely do this? And that leads me to make a couple of comments about the importance of Hemodynamic Support, because some of these patients have very poor L.V. function. And if you're going to get complete revascularization it takes more time, particularly to do it well where you implant the stents optimally and so forth, and you don't want to be rushing. Too many people I think have tried to do sort of a hit-and-run intervention.
If you look at hemodynamic support with the Impella device which is FDA approved for high-risk coronary intervention, which what we're talking about is a major form of revascularization for many of these no-option patients. Frequently this is done with a 2.5 Impella catheter providing significant improvements in arterial pressure, both systolic and diastolic, and particularly mean pressure. When the coronary arteries, particularly the last remaining conduit or a left main are intervened upon and there's no flow, the pulse pressure may drop substantially, but the mean pressure is maintained with the Impella device.
If you look at the outcome in the PROTECT II trial, which is shown here, if you look at the intra-aortic balloon pump versus the Impella catheter there's a highly, statistically significant difference in late MACCE, and that's with two Cs, both coronary and cerebral, favoring the use of Impella over the intra-aortic balloon pump, a total of 29% reduction in the event rate.
I think the question of hemodynamic support is important. Particularly using the Impella over the intra-aortic balloon pump is going to give much better outcomes.
To summarize what's been sort of a very superficial, quick overview, I think in terms of the strategies for optimal revascularization, the first thing is always to evaluate the patient. That includes the clinical characteristics of the patients, the patients' heart function and the patients' coronary anatomy. You really need to decide then, "What's the best way to treat this patient?" And that's when you sit down with your heart surgeon and you go over this and you decide, "Is this something that surgery can be done safely and with good revascularization?" And if that's the case, the patient needs to go to surgery.
If it's one of these cases where the distal vessels are not ideal, the patient has severe overall problems, then maybe it's better that this be a high-risk coronary intervention. And if they go to coronary intervention, again, you need to evaluate the anatomy and figure out the best approach. This is where there's no shame for getting help. We discuss things among ourselves and figure out how to best do it. If somebody has to help someone else, that's fine, but the goal is to get complete, technically high-quality revascularization.
In selected high-risk patients, particularly who have poor L.V. function, last remaining artery, the use of hemodynamic support may significantly increase the safety and optimize the time to get really excellent and optimal revascularization, which in the long run will make a difference in how these patients do.
That's been a sort of quick run as to what we're talking about, and I hope that's given a little insight into what you're talking about and asking about.
Seth: Yes. Well George, thank you very much, for me and for our audience, for giving a really helpful overview, in my mind. I think that largely a lot of the literature and generally the talk in our specialty and medicine at large is to do less. Less is more. There's a section of JAMA Internal Medicine, increasingly, everything should be done less and minimized. Of course, in some areas that is appropriate, we don't want to over-treat patients.
But I think the data is really emerging to really support this notion that leaving patients behind with un-revascularized territories is something we have to at least acknowledge as a risk and discuss it with the patients, but ideally not leave them incompletely revascularized. That's often a challenge and I think you did a beautiful job summarizing it. So thanks very much for me and for the audience, George.
George: Thank you.
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The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi.