Good morning everyone. Thank you for coming. My name is Patty Larkin. I'm the product manager for the E.P. device implant registry. So I'd like to introduce our speaker today. Dr. Amir Youssef is a board certified interventional cardiac electrophysiologist and cardiologist. He completed medical school at the University of Missouri in Kansas City and his internal medicine residency cardiac fellowship and cardiac electrophysiology fellowship at Johns Hopkins Hospital. He was inducted into the prestigious Alpha Omega Alpha Medical Honor Society and the Gold Humanism Honor Society. He is also a Castle Connelly top doctor. He practices at Carrient Heart and Vascular Inova Heart and Vascular Institute and University of Virginia Health Systems in northern Virginia. Prior to New Orlean, Virginia, he was at the Mid-America Heart Institute in Kansas City, Missouri, and an assistant professor of medicine at the University of Missouri in Kansas City. He has previously spent time as a clinical research scholar at the National Institutes of Health and at the FDA. And he specializes in management of all heart rhythm disorders and has expertise in performing complex catheter ablations for atrial and ventricular arrhythmias. Dr. Youssef is a nationally recognized leader in cardiac electrophysiology, serving on several national committees for American College of Cardiology and the Heart Rhythm Society. He's published numerous papers in leading cardiovascular journals and has well been a co-investigator in several leading clinical trials. Welcome, Dr. Youssef. Great. Thank you, Patty. And thank you to the ACC for this kind invitation. So today I'd like to share with you the value of the EP device registry data and how it can impact care delivery with data and metrics. And so the goals of the presentation today is what is the role of the ACC EP device registry? What are the updated data elements in the EP device registry? What are appropriate use criteria and how are they interpreted? What is the appropriateness of ICD implants in the United States and how are AUCs incorporated in the EP device registry? And how can device and these data metrics impact patient care? So this is some history on the EP device registry. Many of you may know that this got implemented back in 2005 when CMS issued a national coverage determination for primary prevention ICDs and at that time they required that organizations develop a registry for reimbursements for patients that enrolled in clinical trials or post clinical trials, a registry that would support understanding of outcomes. And that led to the inception of initially what was called the NCDR ICD registry and as of last year it's now the EP device registry. And so over 1,800 hospitals participate in this. In 2017 it was revised and actually CMS no longer requires data collection as part of an implant procedure. However most hospitals continue to participate in this. There is a new shared decision making requirement that is now captured by the registry which is a requirement by CMS and most hospitals find a lot of value in this. Data collection is performed on all ICDs regardless of indication and irrespective of pair. And it's a very rich and comprehensive source of data. Over 2 million ICD implants are recorded. There's been over 80 peer reviewed scientific publications as a result of this registry that has led to our understanding of outcomes and significantly impacted the advancement on device selection outcomes effectiveness safety equity as well as efficiency. Efficiency of care and it's really become the bedrock for quality and safety improvement. It supports FDA post market requirements CMS coverage decisions and it's been a model for other cardiovascular procedures that have followed the the ICD implants such as the transcatheter valve registry and a fib ablation as well as left atrial appendage closure devices and it translates clinical trial knowledge and guidelines into contemporary clinical practice and really gets at the bottom of you know what are people doing on a day to day basis and how does that compare with how these trials were initially conducted. And it's a model for professional transparency self accountability and platform to advance science. And so you know the the device registry has really been along with other registries has been the bedrock behind the accreditation that many institutions can receive and showcase and the AP accreditation is one such accreditation which links process improvement to patient outcomes and promotes consistent processes across the care continuum from pre procedural peri procedural as well as post procedural care delivery and it supports quality metrics and clinical decision making and requires participation in one of the following of these registries. And so if an institution wishes to apply for this and they have they participate in the registry can significantly allow them to bolster their sort of initiatives and endeavors and improving the quality of life and improving outcomes for patients. And so in last year the device and city or device registry got renamed to the MPP device implant registry and there was an update in the data collection form and I want to highlight some of these. Some of these are more minuscule and others are more significant. One such addition was the addition of ventricular fibrillation as part as part of the new data collection form. Previously there was a data element for ventricular fibrillation as part of cardiac arrest but not separately and so patients have incurred a non sustained ventricular fibrillation or a VF event that has not resulted in cardiac arrest. This would be a place that it may be captured. There's also now data elements on capturing prior aortic valve procedures. A number of our patients now undergo device implants post aortic valve replacements and so we this allows us to get a better understanding of what happens to those patients and more importantly the shared decision making which is a mandate from CMS is now an element on the new form and so it allows us to capture whether shared decision making was performed and which tool was used and perhaps the most significant change has been addition of several novel pacemakers including CRT pacemakers leadless pacemakers and conduction system pacing with his and left bundle leads. And so traditionally the device registry has been really focused on ICD implants and I think this is an initiative by the ACC to really try to capture outcomes in a large population in newer implants that are being performed beyond the ICD and you can see that conduction system pacing has really been at the forefront over the last few years and this registry will allow us to capture those implants and get a better understanding on outcomes in those patients over over the years and these are reflected not only in the in the main component of the collection form but also in other elements where coding occurs for lead location and similarly there's been some newer drugs that have been available over the last few years such as Arnie as well as running inhibitors that are now available to code as guilty to inhibitors are still not here but I imagine on the next update that should hopefully make it. And there's been some updates on the lead dislodgement section again accommodating some of the newer leads that are being implanted. This is an example of a template that we use at our institution. This is a dot phrase that we type in for all ICD implants and it really captures a lot of these data elements which makes it really easy for our colleagues nurses staff that input a lot of this data in the registry. And so this is just an example of this and this takes just a few minutes but it's been really helpful in trying to capture all this data and similarly we've now added a shared decision making element to be able to reflect that component. Of the requirement. And since the recent update in the collection form we've also added a pacemaker component. And so anyone who is undergoing a CRT pacemaker or conduction system paper pacemaker or leadless implant there will be several elements that are all again captured from the data collection form in order to ensure that it is accurate and thorough. I want to switch gears a little bit and talk about appropriate use criteria and at what are they and how do we apply them in care delivery. So when we think about procedural utilization you know the NCDR registry really captures misuse right which is applying treatment to the right patient in a manner that results in harm. It can capture that element if that is occurring. But then there's other elements such as overuse which is applying treatment to patients in whom the risk may outweigh the benefit or identifying areas of uncertainties and indication as well as under use of therapy. And this falls in you know whether an implant is considered appropriate. The appropriate use criteria cannot identify under use of therapy but it does help identify overuse of therapy and identifying areas where indications may be uncertain to get a better understanding on why implants occur in certain patients. So when we look at processes of care you know generally this is the standard processes of care that we're used to. We have a patient who's offered a potential treatment which is either performed or not performed and ultimately the goal is to assess an outcome and hopefully the outcome is one that we desire to be positive including looking at whether it's survival readmission cost health status guidelines are aimed at identifying evidence based review of what can be done right to as a potential treatment. And when we look at performance measures there are a subset of guidelines that must be done to achieve the desired outcome and appropriate use criteria is extends beyond the guidelines and is an evidence based review of what should be done. And so it really is an extension beyond just guidelines and I'll highlight more on this in the upcoming slides. This is a conceptual model of cost quality and metrics when we think about quality you know we have guidelines performance measures appropriate use criteria as well as efficiency measures and they're all aimed at improving quality as we as we go across the continuum from guidelines all the way to efficiency measures. Certainly the emphasis on quality does decline whereas guidelines are directly aimed at having the most emphasis on delivering high quality efficiency measures have the least emphasis and cost is inversely related where efficiency measures have a much greater emphasis on cost than guidelines do. But the question is you know can we find some intersection between these two competing entities to achieve the best care delivery model and that's where appropriate use criteria really fits in well. And so you know there's three categories in defining appropriateness appropriate is intended for an for an implant or procedure where the benefit outweighs the risk maybe appropriate is one where we don't have sufficient data regarding risk and benefit ratio doesn't mean it's inappropriate. It's maybe appropriate. More research may be needed. There may be clinical equipoise and clinical judgment is needed but it should still be reimbursed and we should still be performing many of these procedures rarely appropriate are procedures where alternative therapies are likely to be better. And so this is an article from 2011 that was published in the JAMA and it got a lot of attention and press at the time. And it looked at the NCDR registry data and identified a substantial number of patients that were being implanted that were deemed to be non evidence based. And so if we dig deep into this you know they concluded that over 22 percent of patients did not meet evidence based criteria for ICD implants and they strictly used clinical trial inclusion criteria to come to this conclusion and that included whether an implant was performed within three months of a diagnosis of heart failure or within 40 days of a prior M.I. New York Heart Association class four symptoms or coronary revascularization within 90 days prior to implants of if patients had an implant and were in those categories they were deemed to have been a non evidence based implant strictly using you know guidelines strictly using clinical trial inclusion criteria and nothing else. And this got a lot of press and it really hurt our specialty for a bit. And you know when we looked at the variability they looked at the variability across different institutions there was enormous variability. So this is you know anywhere ranging from 1 to 5 percent all the way up to 55 percent of of non evidence based implants. But there's a substantial number of patients that are being implanted at some sites at that time that and you know this was very very concerning. And so since then in 2013 the ACC published an appropriate use criteria document which is a very comprehensive document. And and I want to highlight some of the some of the things from this document. But the definition of appropriate appropriateness is you know when the expected value in terms of survival or health benefit exceed the potential adverse health consequences related to the acute procedural risk and the long term consequence of living with an implant device. It doesn't mean that this person absolutely should get an implant but rather it infers that it is very clinically reasonable. And the A.U.C.'s goal is to evaluate overall patterns of care rather than adjudicating specific cases. Maybe appropriate is a case where an individual physician judgment and understanding of the patient is necessary. And again it's important to highlight that this should not exclude the use of these devices for such patients. But perhaps there's clinical equipoise and it's not quite clear and the data is is is not as ambiguous in this area. And it's important to note that limitations in these methodologies will make mistakes. Ultimately you know we should all have some rarely appropriate hopefully few and and more maybe appropriate devices because there is clinical judgment required and every single scenario cannot be captured. And if you look at this document it is quite comprehensive. There's two hundred and thirty five diverse clinical scenarios with over three nearly three hundred sixty nine indications. One hundred and six are aimed at primary prevention. Seventy one are aimed for secondary prevention. Forty are distinct to CRT and 18 of them are for generator changes. And you know this is based upon all sorts of different criteria including look looking at New York Heart Association class ejection fraction the temporal relationship to my revascularization duration of guideline directed therapy and many more. There's also a distinct pacing indications that are incorporated in the AUC document. So one hundred and fifty of them are aimed at the ICD component of therapy which are directly aimed at identifying risk of sudden cardiac death and who should receive ICD therapy. But there are distinct pacing indications for dual chamber devices aimed at determining appropriateness of the atrial lead and likewise for CRT devices aimed at determining appropriateness for the LV lead or the coronary sinus lead. And so when we looked at we actually mapped a lot of the data elements to the appropriate use document so that we can provide these metrics to individual physicians as well as hospitals. And you know over the course of three years there were nearly three hundred and ten thousand implants and about 80 percent of them we were able to map to the appropriate use criterias from from that document. And what we learned is that we're doing a pretty darn good job when we look at very distinct clinical serious scenarios beyond just inclusion criterias from historical clinical trials, nearly 95% of implants implanted are appropriate. About three and a half percent are considered maybe appropriate, and a very small number are considered rarely appropriate, less than 2%. And majority of implants are primary prevention implants, nearly 78% of them. And the distribution between single, dual, and CRT is variable between primary and secondary prevention, but there are a greater number of primary prevention CRT implants than secondary prevention. And so how are these AUCs incorporated in the EP Device Registry, and what does it mean for you as an individual provider and as an institution? Well there are performance reports that you receive if you participate in the NCDR EP Device Registry. There's a professional-level dashboard that allows you to view individual data to gauge performance and quality and outcomes, as well as appropriate use metrics. And this allows benchmarking of one's own outcomes against their peers, both within their own institution as well as nationally. And there's quarterly risk-adjusted benchmark reports with performance measures and quality metrics. And so it allows institutions to measure their performance as well compared to other institutions nationally. This is an example of one. This is one of mine from a couple years ago. And so this is, the first one here is just looking at proportion of implants that fulfill Class 1, 2A, or 2B guideline indications. And this is a rolling sort of performance measure over the course of each quarter. And the second example here is below, which looks at, this is specifically looking at CRT implants that are classified as appropriate. And similarly, there will be maybe appropriate and rarely appropriate if you have those. And you get this metric summary, and this is just like an individual sort of report card to see how individuals are doing. But then beyond that, you can see how your hospital is doing as compared to other hospitals in the country. And so these are not just for you as an individual, but how your hospital ranks compared to what the 50th percentile rate is of appropriateness as well as the 90th percentile. And so this is, the first one was for appropriate. This is for maybe appropriate, and there's a similar metric that's provided for rarely appropriate implants. And so how does this impact patient care? Well, one, it tries to, the question is to identify patterns of care and to see if there's been any changes in patterns of care, either over a course period of time or whether there's outliers, right, between individual operators. And also, it allows us to look at what are the reasons for why patients may be getting rarely appropriate procedures or may be appropriate. And it highlights certain areas that are maybe poised for more research and investigation. So when we looked at the primary prevention implants and most common indications for rarely appropriate implants, we see that over half of them received an implant because of having class four heart failure and not being a candidate for advanced therapies such as transplant or VAD. About 20% of them received an implant within 40 days of an acute MI, but did not have coronary anatomy that was amenable to revascularization, and a small number of them were due to newly diagnosed cardiomyopathy within three months of treatment. And similarly, for secondary prevention, there is about a third of the patients received an implant during an acute MI, within 48 hours of an acute MI, and another third that received an implant within 48 hours of an acute MI who had undergone revascularization. But you can see that patients don't follow these simple rubrics always, right? I mean, there's a lot more that goes into each individual patient. And so there are things that may fall under these rarely appropriate categories that are beyond what is able to be captured even in an appropriate use document, which tries to add very nuanced level of information to try to get as much information as possible. But even then, we will miss some. And when we look at dual-chamber devices, so specifically, why was an atrial lead implanted? And the most common reason for a rarely appropriate dual-chamber implant was, in fact, in all patients, it was due to having long-standing persistent or permanent atrial fibrillation. And when we look at CRT pacing, so this is why was an LV lead added? So you'll get metrics based on the appropriateness of the ICD therapy, but also the appropriateness of the pacing component of that therapy, right? So someone may have an appropriate indication for an ICD implant, but did they have an appropriate indication for CRT therapy, for instance? And so when we look at rarely appropriate implants, we see that there's patients who have an EF greater than 35%. That is considered a rarely appropriate implant. That's against guideline indications. There are several other indications where the QRS duration is less than 120 milliseconds, and we know CRT is not beneficial in those individuals. And then there's non-left bundle branch block with mild heart failure, and we know that CRT may not be as effective in those individuals. And in fact, several of these have been labeled as being a class three indications, which is that they should not be implanted. But you can see that there are several other indications beyond just guideline classes that are captured in the AUC document. This is a sample AUC ICD scoring grid, just to kind of show you how nuanced it can be. So based on their heart failure class, their diagnosis of their cardiomyopathy, what their rejection fraction is, they get a rating of appropriate or maybe appropriate or rarely appropriate. When we look at hospital variation, actually it's very nice to see that overall, the green is showing appropriate number of implants across the spectrum of hospitals, and majority of hospitals are performing appropriate implants. There's far and few maybe appropriate and rarely appropriate implants. And specifically, if we look at the hospital variation of rarely appropriate ICD implants, we see that over 90% of institutions have a very low rate of rarely appropriate implants of less than 4%. And the institutions which have a very high rate of rarely appropriate implants, the 10 to 20 or greater than 20%, are really a fraction of the overall number of implants. And what about hospital volume? What's the relationship of that to rarely appropriate ICD implants? As we would guess, there is a correlation, so the rate of rarely appropriate implants are higher in hospitals with lower volume implants. And so AUC is much more than guidelines. If we go back to the initial study that was published in the JAMA that identified a high number of non-evidence-based implants, if we look at one specific indication from the clinical trials, which was coronary revascularization within 90 days prior to implant, the AUC actually rates that as a maybe appropriate indication. And if they had pre-existing cardiomyopathy and underwent revascularization within 90 days, that's actually considered appropriate. Near-heart class 4 symptoms, well, if they have a VAD, it may be appropriate to consider an ICD implant. If they're a candidate for transplant or CRT, then it is appropriate. But these things were not captured when using strict clinical trial-based criteria. And what about if they're on an inotrope while awaiting a transplant? This is not captured even in the AUCs. But you can see that there's a lot more that goes into these than strict inclusion trial-based criteria. And if we look at MI within 40 days of implant, if they had a pre-existing cardiomyopathy, that would be considered an appropriate implant. And there's always sort of a concern, how do our indications and clinical judgment match up with reimbursements? We all ultimately want to get paid. Hospitals want to get paid for the procedure. And CMS has very strict criteria in terms of what they deem as part of their coverage determination that is reimbursable. And AUCs may have an impact here on, hopefully, some changes in CMS coverage determination. If we look at these are specific indications that are deemed either appropriate or maybe appropriate but are not covered under a CMS coverage determination. So if you have a non-ischemic cardiomyopathy, having been on therapy, guideline-directed medical therapy of over three months with an EF of 35%, but have Class 1 heart failure, CMS, this would be against reimbursement from a coverage determination. But it is considered an appropriate indication based on the AUCs. Similarly, if we look at ischemic cardiomyopathy with a pre-existing cardiomyopathy and having had recent revascularization within 90 days, it's considered appropriate. And in the same scenario, pre-existing cardiomyopathy but MI within the last 40 days, it would be considered appropriate. So we'll see how things evolve. But I think it is very interesting to see how there's a push from our professional societies to highlight things that go in beyond just a strict criteria that were initially used and on which coverage determinations has been based. And over the years, there's been an improvement in ICD outcomes since the inception of the NCDR Registry. The adverse event rate, this is going back a decade now, but has declined when looked at it from 2007 to 2010. Similarly, the number of CRT implants amongst eligible patients have increased. And the prevalence of using more optimal medical therapy has also gone up. And so AUC has an impact on quality. We know that. It can examine and reduce practice patterns that deviate significantly from standard norms of care. It can serve as a guide that applies clinical trial evidence and recommendations of practice guidelines to commonly encountered clinical scenarios. And it's an important metric for health systems and providers to understand how they perform as benchmarked against national standards as well as within their own institution. And it provides a unique insight into patient selection. And it's likely to be incorporated by payers to encourage high-value care delivery, ultimately aimed at lowering cost. And the AUCs rank procedures by the expected benefit, exceeding the risks and cost of the procedure. They're intended to serve as a guide but not as a mandate. And the ICD AUCs are a new step forward in improving the value of EP procedures. And again, as I noted before, if you practice good evidence-based care, we should all have a lot of appropriate implants. But we should also have some maybe appropriate and few rarely appropriate implants because not every patient fits into these rubrics and clinical judgment is critical. And so I think a lot of this information and the participating in these registries really allows patients and families to assess each hospital's profile and learn about the initiatives that institutions are pursuing to improve quality measurement efforts. And so this is highlighted in ACC's CardioSmarts website. And this program really provides unique opportunities to publicly showcase institutions' commitment to continuous quality improvement. I want to thank some of my colleagues at St. Luke's, Mid-America Heart Institute, my colleague Dr. Spertus, and certainly the ACC. I think there's been no other professional organization in medicine that's really poured in the resources to improve care delivery. And we should all be really grateful for ACC's efforts. Thank you. Happy to take any questions. Thank you, Dr. Yusuf. We encourage any questions to come forth. We've had some already. And I'd like to provide that question, one of those questions to you. When will the update to the 2013 AUC paper going to be published? Yeah. So I don't know the exact timeline, but there is a draft that's been circulating for a few months now. And so I think that's something we're all looking forward to. And it'll be interesting. And I've had an opportunity to provide some feedback on it based on our review of mapping the AUC document and how it fits in with the registry data elements to be able to capture more elements in the actual AUC document. So hopefully that will be out soon, and we all look forward to that. And that kind of leads into the next question you may have already answered, in part. Will it address those patients who need a CRT who are in AFib and have a wide QRS duration? Yeah. So I don't know. There's so many nuanced indications, and I don't know on the top of my head whether that particular indication's in there. But I think these are the things that we deal with every day, right? So just because someone has AFib, does that mean they should not get an atrial lead? Well, is it paroxysmal? Is it persistent? And there's been increasing data that suggests that we should be more aggressive at pursuing rhythm control efforts. And so oftentimes, patients get an atrial lead for those reasons, because even though they may have longstanding persistent AFib, there may still be efforts at trying to pursue rhythm control. And similarly, for CRT, whether an atrial lead is beneficial or not, again, it depends on a lot more nuanced clinical judgment as to what the intended goal and treatment strategy is for the patient's atrial fibrillation. But I'm hopeful that many of these data elements will be captured. Great. Thank you. One thing I wanted to clarify for everyone is that the new AUC metrics, the 20 that are on the dashboard, will be forthcoming on the professional level dashboard, as it takes a little time for our IT department to upload all of those. And we test them to make sure that it works well. So that is in progress. I know you had mentioned that it was on the PLD, and they were the first round of AUC metrics were, and we're working on them now. Great. Thank you. Another question that's come in is, we like the dot phrase that you shared. Do you use EPIC? Is that in the EPIC system? Yes, that is in EPIC. And it's really nice, because it's got sort of a scroll down menu for each indication, and you can just kind of click through. And our, frankly, I have to give a lot of credit to our NCDR registry nurse who does all this work. She will hunt you down and make you do it if it did not get done in a pre-procedural sort of note. But now it's just become very habit and habitual, and it's pretty easy to use, and I'm happy to share the elements of that for anyone that's interested in order to incorporate that into their own workflow. Great. Thank you. I believe those are the questions that we've received, and what I'd like to do is thank you, Dr. Youssef, for a wonderful presentation, very informative, and we've all gained some knowledge on the appropriate use measures. I'd like to remind the audience that tomorrow you can complete the evaluation. It will open up in your app, and then you're able to claim your credits. Again, you need to look for the claim your credits tile on the virtual platform or the mobile app. And thank you so much for coming. We appreciate your attendance, and please enjoy the rest of the day. Thank you.

EP device registry

data

care delivery

ICD implants

outcomes

device selection

appropriate use criteria