Dr. William Lombardi Discusses Overcoming Impediments in Treating High-Risk Coronary Patients

December 18, 2015

In this podcast, Abiomed's Dr. Seth Bilazarian speaks with Dr. William Lombardi, a long-time expert in complex coronary intervention and complete chronic total occlusion therapies. They discuss overcoming the challenges to getting patients treated for complex, high-risk coronary artery disease.

Transcript:

Seth: This is Seth Bilazarian on the ProtectedPCI.com website for a blog opportunity with Dr. William Lombardi. Dr. Lombardi is the long-time expert in complex coronary intervention and complete chronic total occlusion therapies. I was fortunate about a decade ago to be an attendee at one of his earliest courses, and he is continuing this vigorous effort at education of American physicians, and physicians internationally, in best practices in complex, high-risk indicated PCI. And I want to have a few minutes with him as a leading expert in this area, to talk a little bit about some impediments to getting patients treated and get his expertise.

What I think is unique beyond the fact that he is the director of complex coronary artery disease therapies at University of Washington, is that in his prior life, not too long ago, he was actually on the other side of the great divide between academic and community physicians. He, himself, was a community-based physician. So he is actually, I think, rather unique in this regard and give us perspectives for both sides of that divide. So, to begin, Bill, thanks for joining me.

Bill: It's my pleasure. Thanks for having me, Seth.

Seth: Great, and I'm looking forward to asking you some general questions. In my previous opportunities to hear you speak, you've talked about how there is really been a problem in getting patients even evaluated with coronary angiography after congestive heart failure. You told me, actually you...also in a part of your prior life, you were a heart failure specialist. So tell me a little bit about that issue, and what do you think the impediments are to even undergoing coronary angiography to evaluate patients with heart failure?

Bill: Yeah. So actually, I originally did a heart failure transplant fellowship at the University of Utah, and it's actually where I did my clinical research in, was in heart failure. And it's interesting is, in the United States, about 65% of people with cardiomyopathies, it's due to an ischemic nature. And what we see though, from recent data from the Truven Group, that less than 10% of patients with a heart failure admission will get an angiogram within a year of that admission.

So it seems somewhat of a discord that we know there's a high prevalence of coronary disease in these patients, but a low evaluation, either with stress testing or with angiography in this population with a high pre-test probability. So I think the first challenge is getting people to recognize that, one, we're probably under-diagnosing ischemic cardiomyopathy and, two, it's probably related to the fact that people don't understand the abilities to get these patients treated or the benefit that they have in revascularization. So, I think there's an educational gap in the world right now that we have to work diligently to try to overcome.

Seth: Do you think that many of these patients are well suited to just have diagnostic angiography as a first step than smaller community hospitals even without CHIP capacity? Do you think that that would be effective strategies to just move the ball forward for many of these patients?

Bill: Well, I think it's coming up with a consistent construct of how we treat patients, and I think many patients could undergo angiography. Whether they receive revascularization at that center, or another center, or whether they get it done surgically or percutaneously, I don't think is as important as you first must make the diagnosis of what the patient has. Because without a proper diagnosis, you really can't inform proper treatment or proper consent into the long term outcome for the patient, as ischemic cardiomyopathies have a very different prognosis than non-ischemic cardiomyopathies.

Seth: So once the diagnosis of ischemic cardiomyopathy has been made potentially with angiography and there's some understanding of the potential options, we've also taught that many patients are not then revascularized. They may be referred for revascularization and that they don't subsequently get revascularized, or they're not even referred. Any thoughts on that as a next step in the strategy if we do have success in getting people at least diagnosed?

Bill: Yeah, I think the next piece that you have to get is another large educational gap, is that unfortunately, interventional cardiology has in some ways distanced themselves from the general cardiology community and the HeartFare community for a variety of reasons. And the second piece that comes in, is that the large academic training centers have really taught people how to put a wire down, put a balloon down and put a stent down, which works very well for very simple lesions. But in more complex lesion subsets, highly calcified, small vessels, chronic total occlusions, trifurcations, that there is an under-utilization of revascularization due to inappropriate...probably the wrong word...less than adequate training for people to go out and perform revascularization.

And that would be borne out by almost all of the data of PCI versus surgery, which is, surgery takes on more complex coronary anatomy and they do a better job of complete revascularization in complex coronary anatomy. So it's really the willingness of the interventional community to look in the mirror and understand that we have a gap in our abilities to perform complete revascularization. Once accepting that gap, it's really looking at educational solutions so that we can close that gap to provide the care that our patients really need.

Seth: On a practical level, sometimes these patients may undergo the coronary angiogram, be identified with some level of complex anatomy, maybe some left main involvement or multivessel disease. And I think the bias amongst many clinical cardiologists, or non-interventional cardiologists, may be that for certain subsets, reduced ejection fraction and/or diabetes and/or multivessel, those patients' first option should be to go to coronary bypass surgery. So if those patients are revascularized completely, that is obviously a reasonable option for many patients, but sometimes these patients are turned down and sent back. What do you think would be next steps that we could recommend for clinical cardiologists to recommend for their patients after surgery has been not recommended?

Bill: Well, I think the important thing for people to understand is the reason that surgery's not recommended is not because the surgeons don't feel they'll be benefit, because both the referring and the surgeon feel that there would be benefit. The reason they're turned down is they're felt to be either anatomically grafting may not be approachable for some people with smaller diffusive vessels or under-filled vessels in the setting of CTL. And the other is because of clinical complexity, renal failure, bad LV function, bad lungs, age, previous open heart surgeries and a previously invaded chest. All of those will factor in.

What people really need to understand though, is that those patients can be treated percutaneously. And so the concept of sending a patient for surgery, which means you think the patient would benefit from revascularization, then the patient does not get revascularization and then accepting medical therapy as a treatment option is not an academically consistent construct in regards to revascularization.

And I think from my own perspective, it's been interesting the number of notes that I see from cardiologists, that the patient cannot be revascularized. That's, in this day and age, actually not true. There is very, very few people who cannot be revascularized. It's a question of whether you can do the revascularization that we're talking about. We need to change that paradigm so that people either understand who can, or that they develop the skill set so they can, so that patients actually get the treatment they need.

Seth: So, I think that that one often mentioned problem is that physicians are concerned about not being able to effectively partner with an excellent center like yours. Even if they have gotten the word, even if they've been receptive to the teaching that you're recommending now and they really do believe that this is a strategy, they may be at odds being able to find a program that has an outreach and a partnership that you've developed in your area. Any thoughts about how that ball can be moved forward?

Bill: Well, I think, again, that's a tough one for the community to look itself in the mirror. We jokingly have called this a zone of repugnance, which can be as close as the cath lab next to you or it can be a center a thousand miles away. I think what we have to change is the culture of our specialty to accept that we need to collaborate more, and that in working together, we will all get better and we will help our patients better.

I think the era of competition where it's me versus someone else needs to go away, and that we really need to focus in this community and collaboration to help ourselves get better. So I think part of that is the leadership accepting that it needs to learn to be better, and it needs to be more open and willing to collaborate so that we can break down these barriers of perceived competition and ego.

That's certainly something that we've tried to do at the University of Washington is to open our cath lab, allow any physician who wants to bring a patient to work with us, that they can be privileged to scrub with us so that they still have ownership of the patient, so that they still are involved in that patient's care and that they get the communication with the family. And hopefully, at the same time, they get to learn some new skill sets and work in an environment that may be safer from a medical staff approach for them to learn new things, new techniques and more difficult patients.

Seth: And then the last question I would ask, Bill, is your thoughts on the concept of protected PCI. Obviously, you have a fair amount of renown as an operator who does very complex hybrid revascularization strategies for chronic total occlusions and for high risk procedures. Some number of those patients are hemodynamically impaired and may benefit by protection using the Impella support device. Talk a little bit about your thoughts about how that plays a role in your practice and how you suggest others consider its use.

Bill: Well, I think going through the evolution piece of it, I used to be in a community hospital and I used to talk about how great I was, and I didn't need hemodynamic support because I could get away without it. And what I realized over time, and as I've moved to the university, is what am I trying to get away with? What the patient needs is for me to do a very good job. And so what I look at now is, as we deal with people with increasingly poor ventricular function, potentially hemodynamic statuses that are on the margins, my job is to do complete revascularization, not just get in and get out and get away with it.

So similar to a surgeon who takes a patient in for surgery, the first thing they do is they're going to put the patient on pump. After doing that, they get to relax, do their job, do all the sawing, do everything, and then take them off pump to manage the patient. We have to take a very similar approach in the cath lab which is we need to go in, put the patient on pump, take a breather from the hemodynamic status. That allows us then to go in and do what the job is, which is do effective long-term complete revascularization which is a procedure that requires time, thoughtfulness to make sure that it's done well. Hemodynamic support allows us to do that, and that's borne out by the PROTECT II data.

Seth: What a fantastic review. So thank you for spending time with us today, Dr. Bill Lombardi from University of Washington reviewing the scope of the problem, some potential strategies for us to consider as both a society and as a profession, but also on the local level to pursue more treatment of patients who are really in dire need for a complex revascularization, and for helping us understand the role for protected PCI in the management of these patients. Thanks, Bill, for joining me today.

Bill: Thank you for having me, Seth. It was my pleasure.

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About Impella

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.

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