Rahul N. Doshi, MD: Hello, I am Rahul Doshi. I am director of electrophysiology (EP) and associate professor of medicine at the Keck School of Medicine of the University of Southern California in Los Angeles, California. I would like to welcome everyone to this program, titled "Remote Patient Management: Strategies to Protect the Patient After an MI."

Joining me today are Dr James Januzzi, who is the Hutter Family Professor of Medicine at Harvard Medical School and the Roman W. DeSanctis Endowed Clinical Scholar at Massachusetts General Hospital. To his right is Dr Sunil Rao, who is associate professor of medicine at Duke University Medical Center and section chief, Cardiology Cardiac Catheterization Laboratories in the Durham VA Medical Center. Last, but certainly not least, my dear friend, Dr Riki Birgersdotter-Green, who is professor of medicine, director of pacemaker and implantable cardioverter defibrillator (ICD) services at the University of California, San Diego School of Medicine. I would like to welcome everyone. We, obviously, have a distinguished panel representing 3 subsubspecialties within cardiology: EP, interventional cardiology, and heart failure (HF).

The goals of this program are to discuss how to manage and protect patients in the 90-day period after myocardial infarction (MI). We are going to review actionable data from recently published clinical data to consider in that period, based on patient characteristics how to implement these findings into clinical practice.

Let’s start discussing this unique population: post-MI and/or post-revascularization, specifically, patients after revascularization with low ejection fraction (EF), HF, or other traditional risks. Dr Rao, as an interventional cardiologist, you deal with this all the time. Let’s get your thoughts about what to do for these patients.

Sunil D. Rao, MD: We have seen an evolution of the patient population in the catheterization lab. The kinds of patients we see have been influenced by the availability of terrific interventional equipment and potent antithrombotic therapies; thus we are seeing patients who have very complex coronary disease with reduced EFs. Many have hemodynamic support: either a balloon pump or Impella^®.

The interventional mind-set has always been, when you get the artery open and you put the stent in, you get the patient on dual antiplatelet therapy, and your job is done. Our mind-set is starting to change now because of the patient population that we are seeing. Now, it is not just about getting the artery open; it is about making sure that the entire patient risk is reduced over the long term. That includes events beyond stent thrombosis because we are dealing with a patient population that may have a very low EF soon after a large MI. There is a window of time where the patient is at risk for sudden death (SD)

We have to change our mind-set to incorporate all kinds of secondary prevention strategies and engage our colleagues in that process. It is about getting the HF physician on board. It is about collaborating with EP to make sure that the patient does not fall through the cracks, especially if the patient’s EF does not improve with time, such that he or she becomes a candidate for an ICD.

In terms of reducing the risks, things such as wearable cardioverter defibrillators (WCDs) are something that should be on the radar of the interventional cardiologist because we are, oftentimes, the first touch point for these patients. I like to call it a heart team. It is probably not a heart team in the traditional sense that we think about it, but if we can get everybody engaged, then those patients do not fall through the cracks.

There are observational data from the Cleveland Clinic showing that there is an association between using the WCD after revascularization, whether it is percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery, in patients with low EF and reduced mortality compared with not using the WCD.^[1]

Dr Doshi: This does not just fall into the realm of the interventional cardiologist. We should include cardiothoracic surgeons as well. You were talking specifically about patients after revascularization whom you see in the lab with low EF. Whether it is acute stent thrombosis or other mechanical complications, these patients have a high risk of arrhythmic events. In fact, those of us in EP have relied on traditional interventional trials to identify those risks, such as CADILLAC or VALIANT^[2,3] data. Dr Januzzi, do you see this from the HF standpoint, too?

James L. Januzzi, MD: Yes.

Dr Doshi: How do you identify these patients? Who is a candidate for an ICD? What about the waiting periods?

Dr Januzzi: That is the friction point. You have a patient who is at high risk for SD after an MI revascularization procedure.

Data from VALIANT show that the steepest event rates are within the first 30 days^[2]; yet, we are not at a point where we can implant the defibrillator for a number of good reasons, not the least of which is, some patients will recover their EF.

We know from the CADILLAC study that a low EF almost gets you there in terms of being high-risk for SD.^[3] How we can bridge these patients from their time of vulnerability to possible recovery is something that we struggle with all the time.

Obviously, there are things we can do beyond devices. We can optimize medical therapy, which is something that, unfortunately, sometimes does not get done as well as we might wish. We know that by optimizing neurohormonal blockade, beta blockade, and mineralocorticoid receptor antagonism after MI, we can see a substantial degree of reverse remodeling, but this takes time. This time while the patient is still vulnerable is a time when we need to think about how we can protect patients from an arrhythmic event. Certainly, if a person is at risk after revascularization, whether it is PCI or coronary artery bypass graft surgery, is when there is a good opportunity to think about placement of a WCD because getting through that 90-day period may be a viable option for patients to reduce risk for SD.

Dr Doshi: We introduced the idea of collaboration between 2 subspecialties within cardiology. Dr Green, you see it on the arrhythmia side. We have data suggesting that these high-risk patients might have an arrhythmic event, but they do not necessarily benefit from ICDs.

Ulrika Birgersdotter-Green, MD: This problem from interventional cardiology or HF often ultimately goes to the EP as a common final pathway, but often input from the other subspecialties is lacking. This is a challenging patient population. You guys have done a great job with the PCI, or you treated the HF, but the patient is still at risk for SD.

Clinical trials have told us that putting an ICD in right after an MI is not the way to go. IRIS showed that, and DINAMIT showed it is not ideal treatment,^[4] so what do we do? We know that if we check the EF 3 to 6 months later, after optimal medical therapy has been in place and the stent is working fine, but the EF may still be 35% or less, then the ICD is going to be a good treatment option, but we need to get to that point. How do we get this patient through the 3 to 6 months safely?

That is where I think the LifeVest^® is a good option. Teamwork is how we take care of these patients. In EP, we need to know that you guys are aware of the WCD.

Dr Januzzi: Paradoxically, the patients whom we are surprised by an arrhythmic complication in the low EF category are the ones that are typically not congested. An easy mistake to make is with patients with HF who are seemingly fine and are on good medical therapy. We may mistakenly decide to wait out that period. Statistically speaking, the patients more likely to have an arrhythmic complication are the patients who are New York Heart Association Class II rather than Class IV, where pump failure complications are more likely.^[5] It is important for the audience to remember this is a complication that strikes the patient who seems the least vulnerable. This is something that, when I talk to my colleagues at Mass General, we have a patient, for example, who comes in with newly diagnosed ischemic HF, and we feel really good about getting the patient feeling better, getting meds maximized, and getting him or her ready to go home. We need to remember that there is something else we need to put in place and to alert our EP colleagues because in 90 days, this patient very well may require device implantation.

Dr Rao: The use of the WCD identifies a patient who is at high risk. When a patient comes in to another colleague's clinic, it serves as a reminder that this person is somebody who is within that 90-day window of risk, and I need to either schedule another EF evaluation and/or make sure that the patient is on the right medications. When a patient comes in wearing a WCD, it is sort of a warning bell that goes off for clinicians who may have not been initially involved in the patient's care. It tells these clinicians they need to start paying attention to this patient for risk of SD.

Dr Doshi: The mortality benefit that has been demonstrated in use of the WCD is not necessarily all related to protection from arrhythmia. It probably has a lot to do with this collaborative approach and forcing patient follow-up.

Dr Januzzi, there are other populations who may benefit. You mentioned the waiting period for patients with ischemia, but what about patients without ischemia, such as patients with myocarditis, who are at extremely high risk. What do we need to do about these patients?

Dr Januzzi: There is a broad array of patient types. It is a real grab bag of different diagnoses, some of which are about as benign as a bad group of diagnoses can be, and then there are others with much more complicated situations. In general, the audience knows that patients without ischemia are, more often than not, our friends in terms of how they respond to medical therapies, and their propensity for SD may be different than patients with ischemic cardiomyopathy (CMP). Nonetheless, these patients are at risk. We definitely consider the WCD as an option, particularly in patients with an ambiguous likelihood for recovery of their EF.

There are very few patients whom I do not worry about when they present with nonischemic CMP. Probably the ones with the best outlook in the short term are the patients with tachycardia (tachy)-mediated myopathies, where you expect a rapid recovery. Even there, we have used the WCD for patients who have shown ventricular irritability in the context of a low EF after cardioversion out of atrial fibrillation (AF), for example, or flutter, and they have a low EF because one of the problems is we are not sure what came first. Was it the cardiomyopathy that led to the atrial flutter, or was it the other way around? Until you see recovery, it is not clear. That said, patients with nonischemic CMP require a longer period of waiting before we make a decision to implant. In that setting, the WCD is a great option while we are maximizing medical therapy.

Dr Doshi: Your comments about tachy-mediated CMP are very important. I think Dr Green would agree with me that we want to put the right device in the first time and that upgrades are a completely different problem or a more difficult, riskier procedure.

Dr Birgersdotter-Green: There was a recent publication on the use of the WCD in the peripartum CMP population, too.^[6]

Dr Januzzi: It is a fantastic option.

Dr Birgersdotter-Green: And a very appropriate patient population.

Dr Januzzi: Absolutely. When you have a circumstance of high risk that is potentially reversible, it is a really nice option, especially, since every patient with low EF is reasonably vulnerable. There are some patients who are more vulnerable to ventricular irritability or other high-risk features.

Dr Doshi: What I am hearing is that this nonischemic population is a very diverse set of patients. No one is going to argue with the need for an implantable device in giant cell myocarditis, and tachy-mediated myopathy and peripartum might be another extreme, and everything in between. I think that is important because, we now have data from WEARIT-II with the WCD in a wide spectrum of patients trying to protect these patients in this waiting period.

Dr Birgersdotter-Green: I was just talking to the investigators at the University of California, San Francisco, about the VEST study, which is the prospective randomized study of vest or no vest in the post-MI patients with low EF. Their target is 1900 patients, and they are at 1449 patients as of yesterday. They are hoping by the end of the year to reach the target. That should be very interesting data.

Dr Januzzi: We know from the WEARIT-II study that patient compliance is actually quite good. It is sometimes a learning curve for patients as well as physicians.^[7] The compliance goes up with time, which is interesting to see. In the short term, there are some patients who resist wearing it. It is just not convenient for some people. Over time, compliance was reasonably sustained, which is good to see. From personal anecdotal experience, the device itself thankfully works. We have not seen much in the way at all of inappropriate shocks, which is a really important take-home from recent data.

Also important is the ability to remotely monitor patients because it affords a window into that vulnerable period when we are still waiting to implant where we might pick up information on our patients, whether it is arrhythmia, either rapid or slow, that may inform on different decision points for patients during the waiting period. What if you detect a 10- or 20-beat run of very fast ventricular tachycardia (VT)? The patient may have been dizzy. You now have irrefutable evidence of a rapid monomorphic VT in the context of symptoms. That patient crosses over from primary to secondary prevention. We are moving forward very quickly with the ability to remotely monitor and potentially apply even more precise care for patients.

Dr Rao: The detection of other events is key because having a conversation with patients about putting a WCD on can be complicated. In patients whom you deem appropriate for the device, you have to walk a line between making sure that they are not scared to death by what you are telling them. If you can couch the discussion in terms of, "we are able to pick up information that is going to potentially get you through this high-risk period," that is a much better conversation to have than to say to someone who has just had a large MI, who has undergone PCI, who has been told that their heart does not work well, and now you are telling them, "you need to put this device on, or you may go home and drop dead, and it is going to save you."

Dr Doshi: What we are speaking about, of course, is we have a great deal of registry data, some prospective data. We have good data on the population post-revascularization.

We have prospective data in a broad set of patients, much of it from WEARIT-II, where there was a nice collection of patients with ischemic myopathy, nonischemic CMP, and congenital heart disease.

We have patients who improved and thus, with optimal pharmacologic therapy, did not need an ICD, but we are still protecting them in that high-risk period.

You both have brought up this idea of the device not just as a tool for therapy but a tool for diagnosis. That then turns, of course, to the EP arena. What would you see on a device on which you would act? Does it all have to be treated VT/ventricular fibrillation?

Dr Birgersdotter-Green: Absolutely not. Of course, that is the most important thing for which we are looking, but AF is something that is also clinically important that we can pick up, as would nonsustained VT. Those would be the main buckets of arrhythmias for which you would be looking.

Dr Januzzi: From the point of view of the non-EP, something that has really changed over the last few years is the incredibly valuable information we get from remote monitoring of our patients and also the trend toward implantable monitors for patients where AF or ventricular arrhythmias may be potentially present. Some of this comes from retrospective analyses from trials of pacemaker implantation showing how frequently AF occurs in patients with HF as a precipitant for decompensation, which, of course, is then a potential lead-in to the risk for SD. Having remote information can influence the dialogue with your patients in how you manage them from an HF-cardiologist perspective in terms of maximizing or adjusting beta blockade or other agents or even initiating an antiarrhythmic for AF suppression if a patient poorly tolerates the arrhythmia, so it does change things pretty substantially.

Dr Doshi: For an EP, obviously, this is our bread and butter. The associations with HF is the tip of the iceberg in terms of what we are learning in terms of identifying where and when these events occur and what can we subsequently do to protect the patients.

Dr Januzzi: When a patient is hospitalized for decompensated HF, about two-thirds of the time, you can identify a precipitant, and AF is one of the major precipitants for hospitalization. People say, "Well, what is the big deal about a hospitalization? You tune them up. You make them feel better, and they move on."

Well, it turns out that with each hospitalization, the risk for death at 1 year doubles. Prevention of hospitalization is a major effort in HF, not because of being penalized for rehospitalizations or things like that but because what we do when a patient is hospitalized with intensive diuresis, etc, is actually potentially deleterious in the long-run. Tightening up the screws, so to speak, medically speaking, is something that in a patient with HF, if we can be proactive rather than reactive, is really important to improve outcomes.^[8] Again, remote monitoring to detect unstable arrhythmia as a lead-in to hospitalization prevention is valuable.

Dr Doshi: Obviously, AF is associated with a worsened prognosis and increasing mortality in this patient population. What about nonsustained ventricular tachycardia? We have patients, let us say, an ischemic population: What if you see nonsustained VT during this waiting period? Do we follow the MUST protocol? Do we do EP studies on these patients? What do we do?

Dr Birgersdotter-Green: This is, perhaps, an area where there are some discrepancies in the guidelines that we follow in EP regarding when to implant. Then we have something called the Appropriate Use Criteria. There was a recent consensus statement from the Heart Rhythm Society looking at patient populations that do not fit their criteria.^[8] They are all looking at these patients a little bit differently. Take, for instance, a patient who has had a recent revascularization, and you put a WCD on this patient. Ten days later, you see nonsustained VT. I am not going to feel good about that. You are going to get a phone call very quickly. Then we start thinking, 'Is this somebody whom we need to look at the revascularization? Does the patient go back to the lab? Is the patient on the right medications?' Maybe we need to titrate beta blockers. Maybe this is somebody where we need to cut that waiting period short and say, "This patient really should have an ICD."

Dr Rao: I am a knuckle-dragging interventional cardiologist. I see a rhythm that is wide and fast, and I get very nervous, particularly 10 days out from a revascularization. I think you are right. It puts us on a path to reevaluate the entire treatment paradigm. Do we need to take them back to the lab and make sure the stent is open? Almost always, the stent is open because the stents are pretty good now. These patients have an underlying substrate. It seems to me, for this kind of potentially arrhythmic death, our clinical practice oftentimes is well ahead of what the policy is currently. It is important that we do not get caught up in these nuances and instead focus on what the patient's risk is.

Dr Doshi: I love the fact that it is not about finger-pointing or pushing the buck to the next guy, but it is about this collaborative approach that you have all brought up. It seems to be one of the fundamental take-home messages. Is there any way that we can better collaborate as sub-subspecialists within a subspecialty of cardiology so that we can better take care of these patients that have very complex problems?

Dr Rao: I think we are going to have to. From my perspective of an interventional cardiologist, if I do a PCI on a patient, I, ultimately, am responsible for what happens to that patient over the next 30 days, whether they get readmitted, for whatever reason. It is all-cause readmission. It is now in my best interest to make sure that a patient who has a low EF that I have done a PCI on gets the best therapy because I do not want that patient coming back, and the patient does not want to come back in.

For those kinds of very complex patients, it really is about making sure that everybody is on board because what we have learned is that patients get readmitted oftentimes for things that are unrelated to the revascularization. One of the major causes is HF. There are arrhythmias. There is AF. There are all kinds of other things that, traditionally, I have not had to think about, Developing a care pathway for HF is the best way to make sure that those things do not fall through the cracks. In the era of an electronic health record, there is no reason why we cannot do that.

Dr Januzzi: One of the challenges in busy hospitals is that HF tends to be scattered through the hospital. The collaboration between sub-subspecialties is less the concern to me as it is sort of the collaboration in the healthcare system as a whole if a patient who has chronic HF, who is potentially vulnerable to arrhythmia and potentially eligible for a device, is admitted to a service that is not necessarily facile in this specialty. Understanding how we can educate our colleagues to recognize the potential opportunities for therapy, fine-tuning HF care, and recognizing the vulnerability for arrhythmia to then reach out to those of us in sub-subspecialties who manage these patients is really critically important.

We are very lucky in our institutions. We are very lucky in the United States as a whole that patients with HF and low EF are most often managed by cardiologists but not always. In many places around the world, HF is routinely managed by noncardiologists. This is an opportunity for education and care improvement that crosses all specialties.

Dr Doshi: HF has been the prototypical disease entity that has involved a collaborative approach, mainly because it is the most expensive disease-related group there is.

Dr Januzzi: Right, and only getting worse.

Dr Doshi: We are seeing that within our own fields. You are seeing it in structural hearts, whether it is percutaneous valve or in complex interventions. Dr Green and I are seeing it in things like AF or advanced arrhythmia treatment. All of us are stakeholders in this. We need to collaborate across our disciplines because there are a lot of stakeholders. Of course, the most important one is the patient.

With that, I would like to wrap up. I think the audience appreciates the fact that this is a complex set of patients with a lot of risk factors for terrible lethal arrhythmic events. We have good data that in high-risk populations, we have tools such as the WCD that can protect these patients while we are bridging them to more definitive therapy or deciding whether they are actually candidates for this therapy. We have data that go across a variety of disease spectrums. There is no doubt that as we learn more, we figure out that this is more and more complicated, so stay tuned for more to come.

I would like to thank everyone. I would like to thank our panelists for being here, and, of course, thank you to the audience. I would like to mention that you need to click on the Earn CME Credit link to take the CME posttest and evaluation. Thank you very much.