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Michelle M. Kittleson, MD, PhD: Welcome to Medscape's InDiscussion series on heart failure. I'm your host, Dr Michelle Kittleson. This is episode three of our 12-part series, in which we first look at the six core challenges and issues affecting patient care, and then tackle special concerns in the final six episodes. Today we'll be discussing device management of heart failure with reduced ejection fraction (HFrEF), implantable cardioverter defibrillators, and cardiac resynchronization therapy — ICDs and CRT. What are the ins and outs of device placement? And how does current research inform us about what type of device to use for which patients? For expert guidance on these questions, we've invited Dr Sana Al-Khatib. She is professor of medicine at Duke University and an expert in cardiac arrhythmias. She's also director of the fellowship program at the Duke Clinical Research Institute. Welcome, Sana. We are so lucky to have you.
Sana Al-Khatib, MD, MHS: Thank you very much. It's a pleasure to be with you, Michelle.
Kittleson: Let's start this discussion with a little bit about you. How did you know you wanted to be an electrophysiologist, and what keeps you engaged?
Al-Khatib: My journey has been straightforward because I always know what I love, and I listen to my heart. I was a second-year medical student learning about the physiology and pathophysiology of the heart when I fell in love with cardiology and decided I wanted to become a cardiologist. I came to Duke, where I did my internship and residency, and I was an intern on the electrophysiology service when I fell in love with electrophysiology. I absolutely felt that it was my calling — mostly because I felt very attracted to running to codes. We had to carry that code pager. I remember vividly that we had the resident on the team, and it was me wanting to take the code pager every day and run to codes. I would get there even as an intern and try to take over in terms of running codes. I found that very rewarding — when you see that you are indeed saving lives. So, that's when I felt this passion for sudden cardiac arrest and sudden cardiac death and learning how to prevent that outcome not just with medications but also through devices.
Kittleson: That's amazing. I love to hear the origin stories. How lucky are we that you found this affinity? The rest is history. So, in a way, ICDs for primary prevention of sudden cardiac death in patients with HFrEF is old news, as is cardiac resynchronization therapy for HFrEF if you have a wide QRS left bundle morphology. But there are subtleties to the who, what, and when of ICDs and CRTs in heart failure, and for that, we're lucky to have you here. Because when to place them is often clear, we're going to focus our discussion on who might not benefit because, in medicine, sometimes it's easier to know when to say yes than when to say no. So, my first question for you: Are there situations in which a patient with HFrEF should perhaps not have an ICD placed for primary prevention of sudden cardiac death?
Al-Khatib: Thank you for raising these important questions, Michelle. I had the pleasure and privilege of chairing the AHA/ACC/HRS (American Heart Association/American College of Cardiology/Heart Rhythm Society) guideline for the prevention of sudden cardiac death. This guideline came out in 2017. Not only did I have the chance to work with an amazing group, but I also was able to contribute to the guideline in terms of the research I had done. Of course, that was co-leading the effort and then really seeing an immediate impact on policy — because as we were working on the guidelines, CMS [Centers for Medicare & Medicaid Services] reopened their decision about reimbursement for ICDs. I would say that our guideline had a major impact on their decision to continue to reimburse for those ICD implants.
It is important to keep in mind that even in some patients who may exactly and squarely fall into some buckets, there are always exceptions. We as clinicians should use our clinical judgment. We should always empower patients to make the best decisions for themselves by giving them information in terms of benefits, risks, etc., to try and answer their questions. We need to really engage in shared decision-making, which was emphasized in our guideline and, as you know, is now a mandate from CMS for Medicare patients.
Certainly, patients who don't want an ICD should not be getting one. But, of course, make sure that you tell these patients about all the potential benefits and risks of getting an ICD, living with an ICD, the ability to deactivate the ICD once they are older — maybe they have end-stage heart failure or things such as that. I think this is important to include in the discussion. It is important also to have a thoughtful approach when you are taking care of patients who are older and have multiple comorbidities. I say this because these patients may have several competing risks of death. Sudden death may not be their number-one concern or their number-one threat, so to speak. Of course, it is important to keep in mind the distinction between an ICD vs a biventricular device because with a biventricular device, as we all know, there is the potential to improve quality of life. For a lot of these patients, quality of life matters more than quantity of life. I am so thrilled to see the major advances that have been made in the technology with regard not just to the devices themselves but also on how to deliver a left ventricular lead. For example, now the success rate of placing a good left ventricular lead a patient would likely benefit from is significantly higher than it was when we first started implanting biventricular devices. Our ability to program these devices in an intelligent way has improved which patients are indeed getting effective biventricular pacing most of the time, which maximizes their chances of benefiting from this device. Major improvements in technology have had a major impact on patients.
Kittleson: No question — I think that's incredibly important. I love your focus on the shared decision-making. I like to tell patients, "I'm your medical consultant, but you're the boss of your body." When it comes to that, what about those patients for whom, even medically, you're not sure if a defibrillator is right for them? Perhaps they're on dialysis with HFrEF. Perhaps they have noncardiac conditions with a life expectancy of less than 1 year. How do you approach those patients?
Al-Khatib: That's an excellent question, especially when it comes to patients with end-stage renal disease because not only are you having to be mindful of the competing causes of death in those patients, but we all know about the increased risk for infection. We all know about the venous access issues in a lot of those patients. Obviously, as I mentioned, the technology continues to evolve, and now we can implant subcutaneous defibrillators that might be ideal for patients with end-stage renal disease. So, not only is it important for us to talk about "Do you implant, do you not?" in those patients and not only is it important to talk about the potential risks but it is also important to talk about the different types of defibrillators available for these patients — the transvenous defibrillator, the subcutaneous defibrillator, and so on.
Your point is very well taken because if you look at the data and the literature, Michelle, we know that the risk for sudden death is high in patients with end-stage renal disease on dialysis. But what we also know — at least based on the data so far — is that defibrillators may not be beneficial in these patients. We have seen a couple of trials — observational studies — telling us that defibrillators may not work. Again, I go back to my point that I started with, which is that we are clinicians, and we must take care of patients, and each patient is different. I think it is an important discussion to have with a given patient — especially patients with a secondary prevention indication for the device. So, maybe they have heart failure, but they also had a VT [ventricular tachycardia] episode — sustained monomorphic VT — or they had VF [ventricular fibrillation]. I would be very compelled to consider implanting an ICD in these patients unless I knew their life expectancy was very limited and maybe they didn't want a device.
Kittleson: This brings up so many good lessons, as you note, about the patient-clinician relationship. I think the first is that, as the clinician, you can't know everything. It's great to have consultants — your expert electrophysiologists to collaborate with. The two rules I always try to keep in mind when I send a patient to the consultant is, number one, I don't make the consultant decisions for them. I might say to the patient, "I'm not sure if a defibrillator is the right thing for you. Let's send you to the expert to help make a decision." You don't pigeonhole the consultant into being a technician but in having their own clinical expertise and judgment. So, the second rule I'd like to have is for the consultant not to be pigeonholed into that technologist role. I think that's so important. The electrophysiologist is not there to send the patient for a defibrillator. The electrophysiologist is there to have that discussion of the subtleties — that is, if a defibrillator is right for the patient. That approach is so important.
Al-Khatib: Michelle, your approach resonates with me. One thing to highlight here, as I mentioned earlier, is that CMS now mandates that you use shared decision-making with patients when you're counseling them about an ICD. That applies for Medicare patients, but I think it's helpful to use it with all patients. What was really wonderful about that decision is that it allowed the electrophysiology team to be the ones engaging in this discussion with the patient — unlike, for example, with left atrial appendage occlusion, where they said, "No, the procedural team should not be having that discussion." I feel strongly that the procedural team should be having that discussion because we are fully aware not of just the potential benefits for a given patient but also the potential risks — procedural and beyond.
Kittleson: One hundred percent. Make your consultants work for you. Use every member of your team; let them operate at the highest point of their game. One analogy I love to give patients, too, is that a defibrillator is like an insurance policy. If you have it, you don't feel any better because you have the insurance policy, but it's there if you need it. So, your day-to-day life might not change, but if a catastrophe occurs, it's there to save you. I think that's important because patients need to understand what a given device is going to do.
Al-Khatib: That's an excellent point, Michelle. The only thing I would add to that is that sometimes you have patients who are really worried about sudden cardiac death. That's where an ICD might even improve their quality of life because it gives them some assurance, hopefully, that they're going to be fine if they have an event. If they're really spending some time worrying about the risk for sudden cardiac death, the defibrillator can give them peace of mind. By doing so, it can, in fact, improve their quality of life. We are all aware of some temporary situations in which a defibrillator or any device should not be implanted — for example, if a patient has an active infection. Also, if a patient has newly diagnosed heart failure and they're not on excellent guideline-directed medical therapy, you need to take time to optimize their medications. I'm a big fan of making sure patients are on beta blockers, ARNIs [angiotensin receptor-neprilysin inhibitors], aldosterone antagonists, and now the more recent SGLT2 [sodium glucose cotransporter 2] inhibitors. I do want to emphasize the importance of optimizing medical therapy. And then, finally, when patients are going through those periods of just having had an MI [myocardial infarction]; they just had revascularization. Now, of course, you need to wait for 40 days after an MI or 3 months after revascularization to talk about implanting a defibrillator. The one good thing about the final CMS ruling is that now if you are waiting for 40 days or 90 days but you have an indication for pacing, you can proceed with implanting a defibrillator from the beginning. This is a huge victory for our patients because, as you know, if you're stuck with a pacemaker, then you upgrade to a defibrillator in 40 days or 90 days, there is a high risk for infection.
Kittleson: You have led me perfectly into the next question, before we take a detour to CRT, which is about wearable defibrillators. Is there any evidence of benefit? Who are the right patients and who might not be the right patients?
Al-Khatib: This is a question that always comes up, Michelle, so I'm not surprised you're raising it. It is a very valid question, and here's what I would say: If you are talking about patients with a secondary prevention indication for a defibrillator — these are people who survived a VT/VF cardiac arrest, who had sustained VT, who are not able to undergo an implantable device procedure — then a life vest or a wearable defibrillator would actually be beneficial. In fact, in our guideline that I alluded to earlier, we gave that a class 2a recommendation — meaning that in many patients, you may consider doing it.
What about patients who do not have a secondary prevention indication? These are people who have heart failure, an EF [ejection fraction] of 25%, and they are on good medical therapy. Either they are waiting for their medications to be optimized, or they're waiting for the 40 days or 90 days after an MI. Do you put them on a vest defibrillator? The answer there is not clear. The VEST trial showed no improvement in the primary outcome. However, if you have a patient, for example, with a massive heart attack, and now they're having a significant burden of nonsustained VT and you're optimizing their medications, they are still candidates for a wearable ICD. Or, maybe they're nervous about their risk. Sending them out with a wearable defibrillator is reasonable. Again, having that discussion with the patient is important. If a patient has a dilated left ventricle with an EF of less than 15% — especially if I see some nonsustained VT despite optimizing their medical therapy — I would certainly consider a wearable defibrillator.
Compliance with a wearable defibrillator is a major issue. We know that in the VEST trial, for example, that was a major issue. Yes, compliance with the device was high at the beginning of the trial, but by the end of the trial, I think only 40% or 45% of the patients were using the device a good portion of the time. If you don't use it, you're not going to get any benefit. So, that's where the focus should be. How do we improve compliance with the wearable defibrillator?
Kittleson: There were so many pearls in that response that I want to emphasize them. The first one is shared decision-making — the art of medicine — which is why we all went into this. You must feel out the patient, and their goals, values, and preferences when you talk about devices that might not have clear evidence. The second important point you mentioned is that we always think about the sound bite from the clinical trial — the VEST trial was negative — but you have to look at the fine print. Exactly as you said, if there was 100% adherence to wearing the device 24/7, would it have been different? So, there are beautiful subtleties to highlight for the audience.
Now, because everyone's on the edge of their seats anxious to hear your opinion about CRT, let's close with that. We know, of course, with an EF of 35% or less, normal sinus rhythm, wide left bundle branch block, and a QRS of 150 milliseconds or more, we can implant that CRT. But earlier you alluded to the amazing advances in technology that now make a pacing lead and resynchronization more effective, so is it still always worth a try? How do you handle the nonideal patient for CRT? Do you still just give it a go?
Al-Khatib: I think it depends on the answer to the question, "What is a nonideal patient?" If they're not ideal, then in what way? They may be nonideal because of a higher risk for complications. They may be nonideal because they're noncompliant. What if patients don't fit into that bucket where the evidence is so clear that if they have left bundle branch block — a typical left bundle branch block where the QRS is 150 milliseconds or greater — and they are on medical therapy but they still have class II/III or ambulatory class IV heart failure symptoms. Of course, we're going to do everything we can to convince them to proceed with the biventricular device and optimize implantation and programming.
But what about patients, for example, who have right bundle branch block or maybe patients who have IVCD [intraventricular conduction delay]? It's not typical left bundle branch block — maybe the QRS is 135 or 140 milliseconds. What do you do with those patients? If they have non–left bundle branch block morphology and the QRS is 150 milliseconds or greater, I proceed — except for patients with right bundle branch block. For typical right bundle branch block, I order a special type of echocardiogram to look for dyssynchrony. If I see evidence of significant dyssnchrony, then I proceed with implanting a biventricular device. For patients who have atypical left bundle branch block where the QRS is less than 150 milliseconds but greater than or equal to 130 milliseconds, I proceed. If the QRS is less than 130 milliseconds, I do not proceed. There is room if the patient has heart block and you need to implant a pacemaker to now implant a left bundle branch pacing lead. So, there's a lot we are learning about now in relation to conduction system pacing, and I feel very excited and optimistic about the future of that, especially with the left bundle pacing. I wouldn't have said that a few years ago when we were just doing His bundle pacing, but now, with the advent of left bundle branch pacing, I'm very optimistic that this is going to benefit a lot of patients.
Kittleson: Incredible. We are so grateful that your interest was sparked as a medical student. You ran to all those codes as an intern. Now we have this amazing guidance on how to manage sudden cardiac death in our patients. I'd say what we've learned today more than anything else from Dr Al-Khatib is to follow the expertly written guidelines, look at the fine print of the evidence, and, most importantly, talk to your patients and use your consultants for their expertise. I'd like to thank you so much for being here today. It's been a pleasure.
Al-Khatib: It's been my pleasure as well. Thank you so much, Michelle, for having me.
Kittleson: Thanks for joining our discussion with Dr Sana Al-Khatib. There's much more ahead in the coming episodes, so be sure to check out the Medscape Mobile App, and share, save, and subscribe if you enjoyed this episode. I'm Dr Michelle Kittleson for Medscape InDiscussion.
Resources
Implantable Cardioverter Defibrillator Deactivation and Advance Care Planning: A Focus Group Study
Optimal CRT Implantation — Where and How to Place the Left-Ventricular Lead?
Wearable Cardioverter-Defibrillator After Myocardial Infarction
Knowledge and Insights Vested in Us by the VEST
Pathophysiology and Current Evidence for Detection of Dyssynchrony
His Bundle Pacing: A New Strategy for Physiological Ventricular Activation
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Cite this: For Patients With HFrEF, Who Really Benefits From a Device? - Medscape - Feb 09, 2023.
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