Hi, I'm Dr. Selzman. I'm a cardiac electrophysiologist and the chief of cardiology at the Salt Lake City VA Hospital in Salt Lake City, Utah, and I want to thank the Quality Summit organizers for inviting me to give a talk today. I'm going to be talking about the NCDR ICD registry update or version 2.3. Just to give a little background on the NCDR ICD registry, I just want to talk a few minutes about CMS and the history behind the NCDR ICD registry. So CMS or the Center for Medicare and Medicaid Services can make a determination or a national coverage determination for certain devices or services, and what this means is that it's a national policy for coverage for that particular device or medication as opposed to local or regional coverage. And ICDs or defibrillators have actually been under a national coverage determination way back to 1986. So the national coverage determination was mainly for secondary prevention of sudden cardiac death for many years, but then in 2003, a really important randomized controlled trial called MADET-2, which I'm sure many of you have heard of, was a study looking at the primary prevention for patients who are status post MI with an ischemic cardiomyopathy and a reduced ejection fraction. And this did show a mortality benefit in those patients. And then just a few years later, in 2005, SCUDHEFT came along, and this was also a primary prevention defibrillator trial, but it included both ischemic and non-ischemic patients and again showed a mortality benefit. So the national coverage determination was updated in 2005. So the national coverage determination was updated in 2005, and it was to incorporate the indication for primary prevention defibrillators. And it mandated that the beneficiary receiving the defibrillator was either enrolled in an FDA defibrillator trial or investigational device exemption trial or a qualifying data collection system, including a registry. And so the NCDR-ICD registry fit that need for having to enroll your CMS patients in a registry, and this was implemented in 2005 as well. So from 2005 to 2018, the registry answered a lot of really important questions, and it was a really important tool for outcomes research in terms of not only primary prevention patients but defibrillator patients in general. And then just recently, CMS updated the national coverage determination in 2018. And some of the key changes or updates to the document was that it added additional patient criteria, it added exceptions to the waiting period, and it added a shared decision-making requirement, which we'll talk about in some subsequent slides. And also importantly, it removed the NCDR-ICD registry requirement for CMS reimbursement. So going forward from 2018, the NCDR-ICD registry can certainly continue to be used, I think, as an important tool for outcomes research. Sites can also use it as an important quality improvement tool, and I think it's really important to demonstrate how it's going to maintain its relevancy to users now that it's no longer required by CMS. And I think, again, this is quality improvement and research are the key uses going forward. There's currently 900 sites and 2 million individual patient entries in this registry. So it's a really important registry with a tremendous wealth of data in terms of a national registry and one of the largest registries that we have. So the question is, well, why bother update the data collection form now? So one of them is, as I mentioned, CMS has now made it a requirement for reimbursement to include shared decision-making and to document that. So let's just talk about shared decision-making for a few minutes. So first of all, shared decision-making is a tool that not only, it's basically instead of just consent, which is a little bit different, I think of shared decision-making as kind of part and parcel of the overall informed consent process. So informed consent is where the physician or the provider can explain to the patient the benefits and the risks of the procedure or the device that they're about to receive. But shared decision-making specifically takes into account the patient's values, the patient's goals in terms of their health and what their health, what their preferences are in terms of their health. So this is the 2017 AHA, ACC, HRS guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden death. And I just wanted to highlight that shared decision-making is a class one recommendation in these guidelines. And it basically goes on to say that patients who have had ventricular arrhythmias or are felt to be at increased risk for sudden cardiac death should adopt a shared decision-making approach when discussing defibrillator implantation with their patients. And actually it also is a class one to not only talk to patients in a shared decision-making fashion for new implantations, but even those undergoing generator changes. So in other words, patients who have already had a defibrillator and have been living with their defibrillator for some time. These are the guidelines for the 2018 ACC, HA, HRS guidelines on bradycardia. And so again, I just wanted to highlight not only is it in the sudden cardiac death guidelines, but it's also in the bradycardia guidelines. And again, it's a class one indication that patients with symptomatic bradycardia who clinically qualify for a pacemaker should also undergo a shared decision-making approach to basically incorporate, again, the patient's goals of care, what their preferences are, and what their values are in terms of their health. And again, similar to what I just showed you for the sudden cardiac death guidelines, this is not only patients who will be receiving a new implantation, but patients who have already had pacemaker and now are undergoing a generator change or perhaps a lead revision. So again, when you consent the patient for that additional procedure, whether it be a generator change or lead revision, that it also incorporates shared decision-making. And then on the bottom there, you see it's a class three or no benefit if a patient is clinically indicated for a pacemaker, but it does not match up with their goals of care. So a pacemaker should not be implanted in that scenario. And this is the National Coverage Determination memo. I just highlighted the part speaking to the shared decision-making aspect of it. And it basically states that a formal shared decision-making encounter must occur between a patient and a physician or a qualified non-physician practitioner using evidence-based decision tools on ICDs prior to initial ICD implantation. And again, I'll show, I'll go through some of the decision tools, but they are not only wanting you to just state that you did a shared decision-making, have a shared decision-making encounter with the patient, but actually that you used an evidence-based tool. So this is, I think, one of the more commonly used tools. It's from the folks at University of Colorado at their patient-centered decision-making program. And as you can see at the top here, it's a decision aid for ICD implantation. And it's a nice document that goes through what is an ICD, why has my doctor asked me to consider getting an ICD? And again, this is more specifically geared to those who are primary prevention. So they've never had a prior cardiac arrest or ventricular arrhythmia. And even for patients who are, who have other insurance other than CMS, it's actually a nice tool to use for patients who are having maybe some difficulty and struggling with the decision to get a defibrillator. It's really geared for patients and nicely done. So aside from shared decision-making, another reason, important reason to update the data collection form now is to kind of expand and include patients with pacemakers. So the goal was to not necessarily include every single pacemaker patient, but to focus on kind of the newer technologies. So CRTP has certainly been around for a while. But a lot of our patients with reduced ejection fraction tend to get CRTDs or defibrillators. But the use of CRTP has been going up for various reasons, to avoid RV-only pacing. And also, again, perhaps the shared decision-making process where they want the resynchronization benefit, but not the defibrillator. So we wanted to include CRTPs as their use is going up, and there's not quite as much real world evidence on them as there are with the defibrillators. Leadless pacemakers, which is a relatively new technology, as well as HIS or slash left bundle pacing, where the goal is to avoid RV apical pacing and pace higher on the septum where you're capturing either the HIS or the left bundle, depending on exactly where you place the lead. And I just want to point out that for sites that are currently using the NCDR registry, this is optional to include your pacemaker patients. So it's certainly not mandatory. But if you were interested for QI purposes, research purposes, to include these patients, now the option is available. And on the right-hand side of the screen, you see this is a CRTP, just to illustrate, and it has one lead going in the right atrial appendage, one lead going in the RV apex, and then the third lead for the resynchronization benefit is the LV lead going through the coronary sinus into an epicardial vein. So just to talk a minute about HIS bundle pacing slash LV pacing, I'm just going to focus here on numbers one and three in this schematic. So this is the AV node here, and here's the HIS bundle, and then it goes into the HIS Purkinje system, where it branches into the right bundle, and on the left side, you have the anterior and posterior fascicles. So with HIS bundle pacing, instead of putting the RV lead down here in the RV apex, it's placed quite high on the septum to catch, to capture the HIS. And so because it's higher up in the HIS Purkinje system, it's what I would say more physiologic, because you're able to hook into the HIS Purkinje system rather than pacing the RV myocardium. And then for number three, this is LV septal pacing. So again, it's a transvenous lead implanted just the way you would do a HIS bundle lead or even an RV apical lead, but the lead is placed lower on the septum compared to the HIS bundle lead, and it's much deeper into the septum to reach the left bundle. So these are ways that we can pace, pace the ventricle without pacing the RV apex. I mentioned one of the newer technologies that we want to capture is the leadless pacemaker. Here you can see it where the yellow arrow is pointing to a micro device planted in the RV apex. So this one does go into the apex, but as you can see, there's no device in the chest. There are no leads, transvenous leads, and it is placed with a femoral approach. And this is just another schematic just to show again the lead deployed into the RV apex. So I think the third timely reason to update the data collection for now is to incorporate newer technology, as I was just showing you with HIS bundle pacing. There's also been a few new medications that are really important for our HFREF patient population, and then just some additional elements, additions, kind of updates from the last version. So in terms of defibrillator leads, it's not new, but it was missing on the prior form is that sometimes the defibrillator lead might be placed in the azagus vein, and the blue arrow is kind of pointing to the bottom of the lead there. And as you can see, it's very posterior, this vein, and so it almost acts to kind of, it's like a heart sandwich to get better defibrillation thresholds. And so the more you can encompass the ventricle in a patient with very high defibrillation thresholds, this could be a way to ensure that you're going to be successful when you need to defibrillate the patient. So that's been added. The other thing is that they're still under investigation, so they're not FDA approved as of yet, but in the near future, I think we're going to be seeing more different types of non-transvenous defibrillator leads. So you're probably all familiar with the sub-q defibrillator, which has a defibrillator attached to a non-transvenous lead, but now there are additional ones that are being studied. This is a schematic from the ASD2 study publication, and just to show you, you know, the lead is basically substernal. So we wanted to, you know, it's not the NCDR data collection form, it's certainly not a live document, but we do want to update it and keep it timely with what's going on in modern-day clinical EP practice. So these are just some of the additional options that we added to the lead location section of the data collection form. So there's epicardial options added for the right atrium, right ventricle, and left ventricle, and then we added the his bundle and left bundle positions, as well as the substernal defibrillator lead and azegis lead, as I was showing you. This is what options all together would look like. In terms of medications, there's two important heart failure medications that are indicated in, again, heart failure reduced ejection fraction patients. So a large overlap with the patients indicated for defibrillator therapy. One of these is the angiotensin receptor neprilysin inhibitor, or ARNI for short, and the one that we have used in the US right now is Secubitril-Valsartan, also called Entresto. And so Valsartan, as you know, is an ARB, and the neprilysin inhibitor is also mechanistically different, but basically kind of adds to vasodilation. And so this is a class one indication and part of the armamentarium, I would say, under the guideline directed medical therapy for heart failure. So it's a class one indication to be used instead of, so the patient can take an ACE inhibitor or an ARB or an ARNI as part of their guideline directed medical therapy. And then for sinus node channel inhibitors, it's a funny channel inhibitor. And so this is also indicated for heart failure reduced EF patients. It's meant for patients who are already on guideline directed medical therapy, including maximally tolerated doses of beta blocker. This medication called, again, in the US we use ivabradine. So ivabradine can slow the heart rate. So it's meant for patients who are already on maximally tolerated doses of beta blocker and still have a heart rate of 70 or above. And so this would be added to their other medications. So those are now added to the list of medications on the form. So just to go real quickly through the process, here's the list of working group members. It was a great group of folks. And obviously the ACC staff behind the scenes really made things happen and did the bulk of the work. But it was a really, it was really fun to be part of this working group, I have to say. And we were tasked with basically updating it from version 2.2 to version 2.3. So I showed you a little bit some of the changes. This is just going through the form itself and just showing you how it looks on the form. One addition is that we added ventricular fibrillation at its own element. So here, as you see, the patient may have had ventricular tachycardia or ventricular fibrillation. so not a drastic change, but an update from the prior version. Another important addition that I didn't mention previously is if the patient has had a prior aortic valve procedure, and we use the word procedures because we really want to include both surgical AVR as well as TAVR procedures. And again, it has the aortic valve procedure date to know basically the timeline from that aortic procedure to when they're getting their pacemaker or defibrillator and whether it was elective or not. So that's an addition to the medical surgical history. This is the section where we added the shared decision-making part. We tried to keep it as brief and least cumbersome as possible. So it just asks, was shared decision-making done? Yes or no. If it was done, was a shared decision-making tool used like the one from University of Colorado that I showed you? Yes or no. And if a tool was used, what's the name? And you'll be able to click on a dropdown menu and just select the one that the physician or the other provider used. This is a little bit different from the prior form. So I just wanted to show you primary tachycardia indication present is really just another way of saying, is the primary indication for the device therapy, do they have a primary indication for a defibrillator to treat tachyarrhythmias? So yes or no. If the patient is indicated for a defibrillator, is indicated for a defibrillator, do they also have a bradycardia indication? In other words, maybe they don't need just a single chamber defibrillator, but they need a dual chamber or a bivy defibrillator. And then it has, you can select the pacing mode and I'll talk about this on the next slide. So this is where we have the primary bradycardia indications. And again, this is if the patient is to receive a device primarily for bradycardia indications and they do not have an ICD indication, then you would click yes here. So is the primary reason for the device bradycardia. So if they're getting a pacemaker for a bradycardia indication, you would click yes, and then you would put what type of bradycardia dysrhythmia do they have. And then to talk about the pacing mode, this is something new. So RVPP is not a programmable mode. You can't go to the device programmer and click on RVPP. This is a term that as the working group we created and it stands for RV pacing prevention algorithm. And that's because all device manufacturers have some sort of RV pacing prevention algorithm to pace the RV apex as least as possible. So if you have a bivy, you wanna pace as much as possible. If you have a HISS bundle system, then you're not worried about causing an RV paced cardiomyopathy. But if you do have the lead in the RV apex and you don't have an LV lead, then there is a potential risk of RV pacing induced cardiomyopathy. And so all the device manufacturers for pacemakers and defibrillators have some sort of algorithm. So rather than list them all out specifically, we kind of put them all under this term of RV pacing prevention algorithm. And then you can see here, you can put if the patient had a CS lead implanted or at least attempted, or whether they had a HISS left bundle lead attempted or successfully implanted. And in this case, the left bundle lead is the schematic where I showed you where it's implanted into the septum. So as opposed to through the coronary sinus, if it was through the coronary sinus, you would mark the CS slash LV lead. And then at the bottom here, we have device type with the important addition of the HISS slash left bundle pacemaker. So I just wanted to go through a couple of examples just to hopefully show you how we tried to make it as easy as possible to fill out this form. So the first example I have here is a patient with a non ischemic cardiomyopathy, an ejection fraction of 35% and six sinus syndrome. So they have a reduced EF and a cardiomyopathy. So they are indicated for a primary prevention defibrillator. So to answer the question, is there a primary tachycardia indication present? Again, that's kind of saying, is there a primary indication for an ICD? The answer is yes. And then if you answered yes, was there also a bradycardia indication present? In this case, the patient has six sinus syndrome. And so they do have a pacing indication. So you would mark yes. And then because they have six sinus syndrome, you would mark the six sinus syndrome box. And chances are they're gonna be paced in a DDDR mode. Another example is a patient with non ischemic cardiomyopathy. Oh, sorry. Oh, device implanted. So they have a dual chamber defibrillator. And so you have the atrial lead for the bradycardia and then the defibrillator lead. Sorry, here's our next example. A patient with an ejection fraction of 60% and two to one AV block. So is there a primary tachycardia indication present? No, the patient has a normal ejection fraction and they have no prior history of sudden cardiac death. I didn't put that in the example. And so they have no indication for a defibrillator. So you would put no here. And once you put no, that basically skips you through the rest of that page. And it brings you to the primary bradycardia indications. So in this case, again, they have a ejection fraction of 60% and two to one AV block. So yes, they have a primary bradycardia indication present. In terms of what they have, you would mark two to one AV block. And just to work through the rest of this, you would put them in a pacing mode of DDDR. In this particular case, if you have two to one AV block, you can anticipate that you're gonna RV pace quite a bit, certainly more than 40% of the time. And I would argue you're probably gonna pace 80, 90, virtually 100% of the time. So this is a patient that we might be worried about, a pacing induced cardiomyopathy. So in this example, we're gonna do a HISS bundle pacemaker. So a lead in the right atrium, as well as a lead in the HISS position rather than RV apex. So we would mark not attempted for the CS lead, but we've put successfully implanted for the HISS slash left bundle lead. And then in terms of device implanted, instead of marking, so there's no option here for dual chamber pacemaker and you would mark HISS left bundle pacemaker. So just in summary, the NCDR ICD registry 2.3 update, we updated it to incorporate the shared decision-making process. Also the pacing indications for ICDs, as well as to include novel pacemakers, specifically the CRTPs, the leadless pacemakers and the HISS or left bundle pacemakers where the lead is placed along the septum, as well as incorporate the newer device technology and medications that are coming along. The timeline is roughly version 2.3 will come out in spring of 2021 and be able to continue to use elements and this registry to, again, for quality improvement purposes, identify areas for improvement, documenting that you are doing a shared decision-making process for those primary prevention ICD patients. And I just wanna mention that the registry name will change from ICD registry to the EP device implant registry just to acknowledge that it's expanding from not just defibrillators only, but to EP devices more in general. I hope this presentation was helpful in telling you what's coming down the pike with version 2.3. If you have any questions, please enter the questions into the webinar portal, into the question box, or you can feel free to email me directly at Kimberly.Selzman at va.gov. Thanks so much. Thank you, Dr. Selzman. That was a very informative presentation. We have received some questions. And so let's get started through our Q&A period. Sure. So the first question is, is all pacemaker procedural data being captured in version 2.3? So that's an important question. So the quick answer is no. We're really just wanting to capture the newer technology pacemakers, as well as CRTPs, which are not necessarily new, but are being utilized more and more than they were, let's say, 10, 15 years ago. So the focus is really on CRTP. So resynchronization pacemakers with an LV lead, HIS bundle or LV, left bundle pacing systems and leadless pacing systems. Thank you. Another question that came in was, in version 2.2, only bradycardic reasons were listed for pacemaker indication. Can you please review again, what is primary tachycardia? Sure. So in the new version, 2.3, primary tachycardia indication is really the, basically what I would say, the indication for the defibrillator. And there is also a primary bradycardia indication section for if the patient is, the primary reason for device implantation is bradycardia and they're getting a pacemaker. But specifically to answer your question, primary tachycardia is really, I would say the indication for the defibrillator device implant. Nice. Thank you. Are we required to submit pacemaker data? A really important question. I do know that during the open comment period where folks could submit comments on the new version, there were some comments raising concern about the increased burden of the patient raising concern about the increased burden of inputting all their pacemaker data into this registry. So first of all, as I already mentioned, as you already asked, the registry doesn't allow for all pacemakers to be put in. So we're really not, there's no option to put in for a single or dual chamber transvenous device. So the focus is on CRTP, bleedless and the HISS bundle. And again, this is just purely optional if the site wants to input that data to use it for either QI or research, but certainly it's not required. Okay. Here's another question. I noticed that anticipated requirement of greater than 40% RV pacing location was moved under the bradycardia indication area. Why? Sure. So we do know from prior studies that, and I've touched on this a little bit, that we know that frequent RV pacing can be deleterious. It can cause basically a pacing-induced left bundle branch block, which can lead to a pacing-induced cardiomyopathy. The number 40%, that's the number that's in the 2018 bradycardia guidelines. And it's not a perfect number. In other words, there are patients who pace 100% of the time and don't develop a cardiomyopathy. There are patients who develop, who pace only 25 or 30% of the time and they do develop a cardiomyopathy. But this 40% number comes from certain studies. And so it's, so, and because it's in the guidelines, that's why that number is being used in the data collection form. So if you're trying to prevent a pacing-induced cardiomyopathy and you anticipate that the patient's gonna pace at least 40% of the time, you may be thinking about a CRTP, you may be thinking about his bundle pacing. So it really is in terms of your indication for the type of pacemaker that you're thinking of putting in. Okay. All right. Well, next question. We noticed that V-fib is its own standalone element now. Shouldn't V-fib reversible cause be included with the new element to correlate mapping to the indication? How will it be captured in the new version? So my understanding is that the new element for V-fib will be just for V-fib that is not due to a reversible cause. So you should only be entering in that VTVF section, you should only be marking VF if it's not due to a reversible cause. And I believe there's gonna be instructions, you know, more about that in the data dictionary that will come with the new version. Okay. All right. Next question. Next question. Why is information on prior aortic valve procedure being captured? So that's a timely question. So as use particularly of TAVR and TAVR procedures going up, we know that surgical AVRs, there always was a risk of heart block, but it was probably in the two to three to 5% range. Now with TAVR, depending on the patient, their underlying, if they have underlying conduction disease and other risk factors, as well as the type of valve they receive, the incidence of developing some type of AV block that will require pacemaker therapy is probably in the range of 15 to 25%, depending on the data that you look at. So pretty high incidence in terms of, so I think it's an emerging kind of important indication for pacemaker therapy going forward. Okay. And along the lines of the same type of question, why is it important to capture that the aortic valve procedure is elective or not elective? Sure. So I think this can be helpful to the individual sites to see if perhaps there's a higher incidence of pacemaker implantation in the more urgent procedures, or if there's an increase in other complications if we wanted to look at that data. Okay. And again, for clarification, can you please explain the difference between the DDDR-AAR and the RVPP pacing mode? Sure. That's a good question. I didn't really talk too much about the DDDR-AAR. That is also an RV pacing prevention algorithm. So, but the group felt and our chair also agreed that so many people are familiar with that specific algorithm. The DDDR-AAR. So in other words, you program the device and that's how it comes up. And when you print out the program parameters, that's what it'll say. So even though it really does fall under the umbrella of RVPP, we left it as a standalone just because we thought it would be easier for people that are already very familiar with that term. Okay. And here's a question about shared decision-making tools. Will we be able to submit the name of our own facilities form? Yes. So I showed the University of Colorado shared decision-making tool. That's the one I'm most familiar with and it's readily accessible on the web, but there certainly are other tools out there. And if a facility wants to use their own tool, you can just reach out to ACC, the NCDR folks and it will be added to the dropdown menu. So you can select it there. Okay. And the last question, when is selective sinus node IF channel inhibitor used? So again, the one that we have in the U.S. is called Avabradine and this is indicated for stable heart failure patients and it's part of the kind of the guideline directed medical therapy, but because it does lower the heart rate, the patient should already be on maximally tolerated beta blocker therapy and still have a heart rate of 70 or above. So again, it's not, I think, not as well known as certainly ACE inhibitors, ARBs and beta blockers, but it is FDA approved for heart failure folks. And so we thought it was, because of the overlap between HFREF patients and defibrillator patients, we thought it was important to add. Okay, very nice. That concludes the questions. And I would like to say, thank you very, very much. It was a great presentation. Thank you so much.

NCDR ICD registry

national coverage determination

CMS

primary prevention ICDs

registry

outcomes research

shared decision-making requirements