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Ralph Brindis, MD, MPH, FACC
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Ralph Brindis, MD, MPH, FACC is the Immediate Past President of the American College of Cardiology, senior advisor for cardiovascular disease for Northern California Kaiser, clinical professor of medicine at the University of California, San Francisco, and an affiliated faculty member of the UCSF Philip R. Lee Institute for Health Policy Studies.

Dr. Brindis is a practicing invasive cardiologist with an active practice of consultative cardiology. His major interest in process measures and outcomes assessment in cardiovascular disease has led him to assist in the creation and implementation of various cardiovascular guidelines for Northern California Kaiser. Dr. Brindis was Chief Medical Officer and Chair of the National Cardiovascular Data Registry (NCDRŪ) Management Board and also chaired the ACC Appropriateness Oversight Task Force developing Appropriate Use Criteria for non-invasive testing and coronary revascularization procedures. Dr. Brindis has over 100 publications in national peer-reviewed cardiovascular journals.

    Ralph Brindis, MD, MPH, FACC
Ralph Brindis, MD, MPH, FACC

Q: The data used by the study on PCI Appropriateness1 that was published this week in JAMA was drawn entirely from the National Cardiovascular Data Registry (NCDR) – an effort that was started in 1997 by the American College of Cardiology. You’ve been at the helm of this effort since it began. How representative of the total U.S. interventional cardiology community is the Registry?
Dr. Brindis: I think our penetration now is pretty damn high. We now have over 1,400 hospitals submitting data and this study really represents the last 500,000 angioplasties that have been reported to the NCDR. It's fairly recent data, so I'm pretty excited about its importance.

This Registry is supported in terms of the expertise by both the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions (SCAI) and I view that this is a fantastic example of how two professional societies appreciate the need for measurement, appreciate the need for quality, have shown professionalism and the concept of self-regulation, in the desire to improve patient care and patient outcomes and, in this case, with appropriateness, to be better stewards of our healthcare dollars, so that we make sure we do the right procedure for the right patient at the right time.

The amount of pride I have over this particular effort, which costs the ACC a substantial amount of money, is great. It's such a huge contribution to the healthcare of the United States of America, particularly as we go forward in healthcare reform and come up with new payment models where we are trying to pay for quality and not for quantity; where we come up with disease-bundling and payment for bundling and episodes of care. I don't have to be a rocket scientist here, but I will predict that the NCDR and the CATH-PCI Registry will have a huge role in the new reimbursement models in terms of differential payment for quality and even figuring out reimbursement for quality and it will incorporate our appropriateness data in doing such.

Q: What is your perspective on the JAMA PCI Appropriateness study?
Dr. Brindis: I'm actually very excited about this study. Interventional cardiologists have been under attack for the last couple of years, ever since the COURAGE trial, about doing inappropriate angioplasties. I think we've been targets because 43% of MEDICARE expenses are cardiovascular in nature. So people are trying to figure out how you decrease costs -- and have been pointing, looking directly with their rifle-sites aimed at the world of cardiology, and in particular the interventional cardiologist.

"Dr. Oz on the Oz Show, just this past November, actually told his viewers that 50% of all angioplasty is unjustified and inappropriate, doing an incredible disservice."     We've had particularly negative press that you're well familiar with. About a year or so ago, Dr. Elliot Fisher went on the Katie Couric six o'clock news, and stated that from his perspective well over 30-40% of all angioplasty is inappropriate, or not necessary. And then Dr. Oz on the Oz Show, just this past November, actually told his viewers that 50% of all angioplasty is unjustified and inappropriate, doing an incredible disservice. And then, of course, increasingly we are hearing reports in different states, related to individual physicians that have been allegedly performing inappropriate angioplasty. I guess the famous one right now is the Maryland case with Dr. Midei with his alleged inappropriate angioplasty, but there are other examples from Louisiana and now other states are looking into it such as Pennsylvania and Iowa. So again, interventional cardiologists are in the cross hairs in terms of excess angioplasty and inappropriate angioplasty.

But let me step back. We view that, as a professional society, we have a privilege of self-regulation. And if we don't do self-regulation in a responsible manner, other people are going to do it to us, and they will use methodologies that a clinician or expert would not agree with. I would say that the American College of Cardiology and the vast majority of the professionals in the ACC appreciate this responsibility of self-regulation. So the American College of Cardiology developed its Appropriate Use Criteria document, which was published in JACC in January 2009, where for the majority of clinical scenarios that we perform coronary revascularization, we have developed criteria for “appropriate”, “inappropriate” or “uncertain” to perform revascularization.

Then the National Cardiovascular Data Registry (NCDR) incorporated new data elements, so that we can accurately assess as to whether clinicians are performing PCI for appropriate means. The way that we do this -- it's related to five domains: how patients present, that is whether they have just stable angina up to a STEMI; what their degree of symptoms is, whether they're asymptomatic, back up to Class IV angina; the amount of ischemia on noninvasive testing, whether there's none or a lot; the amount of medication they’re on, whether none or the kitchen sink; and then, of course, the burden of disease by coronary arteriography, you know, single, double, triple, left main disease. And looking at those domains, related to our clinical patients and also whether they've had previous bypass surgery or angioplasty or whether they're diabetic or LV function, we have a gradient as to whether it's appropriate, inappropriate or uncertain to perform angioplasty.

What's so fascinating about this study is the good news that in general we're pretty appropriate. An important point is that almost 71% of all angioplasty is performed for either STEMI, NSTEMI or for acute coronary syndrome or unstable angina. And that the nation performs PCI for stable angina about 29% of the time So this is actually in contradistinction from the first page of the COURAGE trial in the New England Journal of Medicine which implied that maybe 70% or more of angioplasty is for stable angina in the United States...and that simply is not true! Well over 70% of all angioplasty in the United States is for acute syndromes. And when Paul Chan looked at that, based on our clinical practice guidelines and appropriate use criteria, 99% of the time those patients are getting PCI for appropriate reasons. So that's the good news.     "...the COURAGE trial ...implied that maybe 70% or more of angioplasty is for stable angina in the United States...and that simply is not true! Well over 70% of all angioplasty in the United States is for acute syndromes."

And then when you look at the overall data of the study, the amount of inappropriate angioplasty is actually in the single digits. It's not high compared to what Dr. Oz or Dr. Elliot Fisher said.

Now clearly we have opportunities for improvement. I think one of the important messages from this study, in addition to validating in general what most interventional cardiologists are doing, is that when you look at the stable angina population, clearly we have opportunities for improvement in terms of inappropriate or uncertain patients in that group getting angioplasty.

To me the most telling piece of this study is the graph of the marked variability in our hospitals in terms of the degree of inappropriateness of PCI in this stable angina population which range from as low as 0% to as high as 50-60%. That tells you no matter if an interventionalist says, "Oh, the appropriateness criteria are garbage. You're avoiding these particular situations. Individual patients have different situations," which I totally agree with -- appropriateness criteria guidelines are just a starting place. But the fact that there's such marked variability between hospitals tells you and I that there are opportunities for improvement.

Q: What are some actions, going forward, that can reduce the higher inappropriate figures for some hospitals for stable non-acute indications?
Dr. Brindis: The point here is Peter Drucker's famous line: "If you don't measure it, you can't manage it." So here for the very first time, EVER, somebody has figured out appropriateness criteria. We're now measuring it and, as of last quarter, we're beginning to feed this data back to the hospitals in benchmark form. So prior to this quarter, no on even knew what they were doing. Now they're going to know. Again the right answer isn't to be 100% appropriate. We talked about individual patient-physician relationships -- every patient's different. But if you were a hospital and your appropriateness rate in stable angina patients was 50% and the national average was 90%, you would have to ask yourself, “Should we be looking at how we take care of patients, particularly, appreciating that there's going to be a new payment model, that's going to be ACOs (Accountable Care Organizations)?” And in an ACO model when you start having issues of global payments, or other payments related to an ACO model, people are going to be looking at this. So this affords physicians, hospitals and again new models of care delivery to be able to examine what their practice patterns are and opportunities for improvement.

Q: A very important mission for us at Angioplasty.Org is to communicate to patients the importance of recognizing the symptoms of a heart attack and then getting to a hospital that performs angioplasty ASAP, because a heart attack is no longer a “done deal” – it can be stopped.
Dr. Brindis: This is a continued opportunity for community education by the ACC, AHA to make sure balance and important messages get through to patients. There are lots of reasons for patient delay to seeking care: embarrassment, concern over the cost of ambulance, denial of symptoms, all sorts of reasons, and your comment is on target. And God forbid that this particular issue about concern of inappropriate stenting further complicate all the typical normal human social barriers that we already have in terms of delivering timely angioplasty for patients with acute coronary syndromes.

Q: Finally, there was some mention of Fractional Flow Reserve (FFR) and other measurement modalities of determining appropriateness of PCI – although FFR is something done during the angiogram. Do you think there’s a role for FFR and functional measurement in determining appropriateness?
Dr. Brindis: My own personal feeling and bias is that FFR is an extremely important tool and that it hopefully will increasingly be utilized in terms of appropriate decision-making related to PCI going forward.
And I also predict that, as we come up with different payment models, particularly related to disease-bundling or episodes of care, that it will become even more encouraged at the local hospital level, so that a stent is put in, after a demonstration of ischemia, particularly in intermediate lesions. I will say that within my own institution at Kaiser Permanente, we are finding increasing value in the use of FFR at the time of catheterization for decision-making.

1 Appropriateness of Percutaneous Coronary Intervention ; JAMA. 2011;306(1):53-61.doi:10.1001/jama.2011.916

This interview was conducted in July 2011 by Burt Cohen of Angioplasty.Org.