Insights on the 2025 Appropriate Use Criteria for Cardiac Implantable Devices

Interview With Andrea M Russo, MD, FACC, FHRS, FAHA

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EP LAB DIGEST. 2025;25(6):14-15.

Interview by Jodie Elrod

In this episode of The EP Edit podcast, we are joined by Dr Andrea Russo to discuss the 2025 Appropriate Use Criteria for ICDs, CRT, and Pacing. Dr Russo shares key updates, clinical implications, and what these recommendations mean for real-world EP practice. 

What are the most significant updates in the 2025 appropriate use criteria (AUC)¹ compared to the 2013 guidelines? Could you highlight key differences in implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT), and pacing indications? How has the inclusion of new technologies like conduction system pacing and leadless pacing also influenced these updates?

Let me start by saying that I think we do not always recognize, and I certainly did not recognize until we started to put these documents together, how complex the decision is to implant an ICD. All the things we think about every day were not necessarily things that were studied in randomized trials to great detail for the variety of patients who receive an implanted device. The 2013 AUC included ICDs, CRT, generator replacements, and comorbidities. But in this document, we extended that to include the totally subcutaneous ICD, which had just been approved by the United States Food and Drug Administration, as well as conduction system pacing and leadless pacing. 

We really expanded well beyond the initial document and each of these types of scenarios may be modified by things like ejection fraction, duration of heart failure, heart failure class, type of heart disease, etc. So, there is a lot of detail in each of the scenarios that are covered. There are actually 335 scenarios, but there are many more than that, because each of the scenarios has things that are modified by other factors. 

The new aspects of the document are related to the new technology. It is amazing how much new technology we have seen in just over 10 years. With leadless pacing, even though that has been approved for a number of years now, we still do not have guidelines. So, the purpose of the 2025 AUC is to help bridge the gaps in the guidelines and talk about the kind of things that people see every day in their practice. 

Now, they are different than guidelines and guideline recommendations. Guidelines are developed out of the evidence, so they are developed out of our clinical trials. It may be large observational studies and meta-analysis. The AUC is a little different. These are real-life scenarios. The writing group creates these real-world scenarios and then those go out to a review panel, who looks at the scenarios and makes recommendations. It then goes to a rating panel, who grades the recommendations from a 1 to a 9, with 1 to 3 being rarely appropriate, the middle numbers being maybe appropriate, and 7 through 9 being considered appropriate. They may certainly align with the guidelines, but there are many other scenarios that are not included in the guidelines. 

The things that have changed the most are truly the recommendations for the new types of devices, such as conduction system pacing and leadless pacing. There was minimal change elsewhere because there has not really been a lot of new evidence in primary or secondary prevention ICDs. This includes the indications for CRT using biventricular pacing—that updated guideline was already published in 2012, and there was not a lot of new evidence in that realm either. Therefore, the newer aspects of the 2025 AUC are related to the newer sections, for the most part. 

The 2025 AUC reflect advancements in guideline-directed medical therapy (GDMT) and new clinical evidence. Why was an update needed at this time?

It is amazing, and I do not think we realize how much the field of electrophysiology (EP) has changed so rapidly over a period of 10 or more years. Even at the time of the prior document, the totally subcutaneous device was not included because that was just approved. It was mid-2012 and the document was already written by that point. There has been a lot of new technology. I think leadless pacemakers were not approved until 2016. In conduction system pacing, we started to rapidly utilize that much after the time that this document was published. So, we needed an update, not as much for the ICD indications for secondary primary prevention, but more so for these newer technologies where we have a lot more evidence. In fact, I think what we really need in EP, which is such a rapidly changing field, is a continuous document that updates much more frequently. 

How do these changes align with the latest heart failure and EP guidelines? How does the AUC help fill gaps where clinical trials may not provide clear recommendations?

These AUC align well with the guideline documents, but they cover well beyond that. They cover many clinical scenarios that are not included in the guidelines. This includes things that either were not studied or had lower levels of evidence, for example, if there was not enough to give a class I or II recommendation in the guidelines. So, it covers many more scenarios. These scenarios help guide clinicians in their decision-making process when there is a question about whether this a reasonable thing to do if there is not a huge body of evidence. That is not the primary purpose, but sometimes there are gray areas and you might want to gain support from payers. The purpose of the document is not for payment but can be utilized to get support for reimbursement purposes in areas that are not on the list of things that different payers may reimburse for. 

With an expanded scope, how does the 2025 AUC ensure real-world applicability? How does the AUC incorporate shared decision-making and patient-centered care?

The AUC helps to fill the gaps in the guidelines and is very much aligned with real-world scenarios. The writing group did not vote or rate. We wrote the different scenarios and then went to the reviewers to make sure we did not miss anything. The scenarios are typical examples seen in day-to-day practice, so this is the real world. There are some areas where there is a lot of evidence and randomized trials in the document, but the purpose is to design some guidance for those areas where there are gaps in the guidelines, such as small groups that are not going to have large, randomized studies. So, they really do align well with patient-centered care because these are not rules. This is something that would be appropriate to do if you think it is appropriate for that particular patient depending on their comorbidities. It does not mean it has to be done; it means it is okay to offer that therapy. It is up to the physician and their own shared decision-making with the patient as to whether that is appropriate for that particular patient in that setting. 

Given the expanded criteria, what are the key “do’s and don’ts” for ICD implantation in primary and secondary prevention? What should clinicians prioritize when considering an ICD for their patients?

We did re-look at all the ICD scenarios for both primary and secondary prevention, but overall, most of the scenarios had minimal or no change in terms of how they were written, and even how they were rated, because there was not really a lot of new evidence. All the primary and secondary prevention ICD trials came out before this, except for a Danish trial that came out in the interim in 2016. That was looking for patients with non-ischemic cardiomyopathy and whether an ICD should be implanted, and the rating panel still rated it pretty much the same as in 2013. This would be consistent with our guidelines as well, to implant ICDs in that particular cohort of patients. We also looked at things like duration of GDMT, and still things came out appropriate for non-ischemic cardiomyopathy—at least 3 months of GDMT in most scenarios, particularly for a narrow QRS. But again, with the CRT indications, the update was already made after the large trials for CRT. There was not a huge amount of change because there was not a lot of new evidence that would change people's minds for primary and secondary prevention ICDs. 

How will the 2025 AUC impact clinical practice, and how should electrophysiologists integrate it into their decision-making?

I think that clinicians can really use this as a guide or supplement to what they already know from guidelines in clinical trials, and it can be particularly useful in places where there are gaps in the guidelines. There are gray areas in medicine all the time, and again, your own clinical judgment in medicine is what you need to fall back on, along with the patients, their values and preferences, and shared decision-making. But hopefully, they can provide some kind of framework to support their decisions and perhaps even support decisions from payers as they look at this. It can also identify gaps where we need more study. In 2013, right at the time that we were writing this document, the Department of Justice investigation was taking place regarding ICDs in Medicare patients who were getting devices that were supposedly not in the guidelines. So, they came to us as the chairs of the writing group to see what we were doing and realizing how complex this decision-making process was for deciding whether a patient needs an ICD. It is not always black and white. Some of the scenarios that they looked at were also in our document, for example, utilizing ICDs after revascularization and where that falls into our decision-making process. 

The transcripts were edited for clarity and length.

Reference

1.     Russo AM, Desai MY, Do MM, et al. ACC/AHA/ASE/HFSA/HRS/SCAI/SCCT/SCMR 2025 Appropriate Use Criteria for Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy, and Pacing. J Am Coll Cardiol. 2025;85(11):1213-1285. doi:10.1016/j.jacc.2024.11.023