After the release of the European Society of Cardiology (ESC) 2021 Heart Failure Guidelines, the US cardiology community waited with anticipation for the forthcoming guidelines for US-based organizations. That moment arrived in April 2022, with the release of the joint guidelines from the American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA).
Although the addition of SGLT2 inhibitors as guideline-directed medical therapy for symptomatic heart failure across the spectrum of ejection fraction was the main highlight in media coverage of the release and among many cardiologists, the guidelines also included multiple other updates of note, including in the realm of device therapy in people with heart failure.
Devices and interventional therapies for heart failure with reduced ejection fraction (HFrEF) received a dedicated section within the document, where the writing committee provided perspective on 15 specific situations. This included 3 Class 1 recommendations, 6 Class 2A recommendations, a pair of Class 2B recommendations, 3 Class 3 recommendations, and a pair of value statements. At the HFSA 2022 annual scientific meeting, Practical Cardiology sat down with Andrew Sauer, MD, cardiologist at St. Luke’s Mid America Heart Institute, for his perspective on the latest in heart failure and part of that conversation centered around his reaction to the latest guideline recommendations in the realm of device therapy.
Practical Cardiology: When discussing the most recent heart failure guidelines, how did you feel the recommendations reflected recent data related to device therapies?
Sauer: When we look at some of the important devices, the guidelines did speak to them—in particular with LVAD. We saw a strong endorsement, a class 1 recommendation, based on a significant compounding of evidence that we've seen over the years in clinical trials looking at durable mechanical circulatory support devices. Probably, of note, the most recent being the MOMENTUM 3 study, which now has 5 years’ worth of follow up data and continued access and showed a 5-year survival of nearly 60% for the arm randomized to the HeartMate 3 compared to the HeartMate 2. I think, based on this accumulation of data, it's nice to see a strong endorsement. This applies to patients with advanced heart failure or stage D heart failure, where they are thought to be dependent on inotropes or intra-aortic balloon pump. These are the patients in the ICU who have NYHA Class 4 symptoms of heart failure, and I think it's important to remember that we probably are not getting all the patients that we need to therapy, we need to work on earlier referral so that patients are not coming in more critically ill because we know that the most critically ill patients still don't do as well as patients who come in stable on inotropes. So, we need to, I think, do a better job in organizing in our communities to recognize who these patients are, referring them in a timely fashion, and getting them safely to the operating room—especially if they're not a candidate for transplant or maybe they need a durable LVAD for bridge to transplant.
Practical Cardiology: There has been a greater push in cardiology in recent years of pushing to begin treatments proactively before the heart accumulates too much damage. Is this being seen with device therapies in heart failure?
Sauer: I think a lot of us would like to go there and there's been efforts to go there. We look at the ROADMAP data, which was kind of a venture into ultimately implanting patients sooner when they're not necessarily in cardiogenic shock, and we're kind of equivocating after looking at that data because it looks like it's probably safe to watch those patients very carefully and implant them as they progress. On the other hand, what we haven't fully explored is the role for earlier intervention as a better way to recover sick left ventricles, because when the ventricle becomes severely dilated in patients who had already been on medications and they end up with durable LVAD, the likelihood of a more meaningful recovery to the point of being explanted is really, really low—less than 3%.
So, I think there's a good hypothesis out there, where if we can have less invasive devices, with less surgical risk, and less adverse events, there is justification for intervening before patients are dependent on inotropes. We were already doing that to some extent with INTERMACS 4-7, but they still remain a minorityof the overall population that's being followed in the Society of Thoracic Surgeons Intermacs Database. So, I think we'd like to see the field move that direction, but we have got to be careful because the options for patients who don't have dependence on inotropes or balloon pump, are still good options, like medications and adjunct therapies such as cardiac contractility modulation, Barostim to improve functional capacity, and alike.
Practical Cardiology: At HFSA 2022, there has been a considerable effort into emphasizing the impact of clinical inertia on outcomes. How does the concept of clinical inertia in device therapy differ from that seen with contemporary pharmacologic agents?
Sauer: I think it's a bit of a complex question. I think that some of it has to do with time and awareness. There are some arguments that to be made that, for example, with durable LVAD and heart transplantation referrals, I think there's still some struggle in the community with knowing when to refer and I think there's some reticence to refer too early. There's some discomfort with sending a patient out of their own home or their own community. As a result,transfers to coronary centers can be difficult. In my region, transfers from Wichita to Kansas City can become somewhat complex.
So, there is a component of that, especially if the care teams in these communities don't have the durable therapies. They may not necessarily know what a patient should look like that might need one of these therapies. When you look at some other therapies like MitraClip, for example, I think there's a pretty good pathway for referral, although we could certainly do better, but I think the incentives and the organization around the heart team is pretty well aligned with getting patients to the intervention. It is also a great adjunct to GDMT or cardiac resynchronization therapy. So, these are really complementary therapies that help with left ventricular reverse remodeling and help reduce severity of mitral regurgitation. There are some other device therapies that are a little bit more emerging like cardiac contractility modulation, Barostim, and, to some extent, we can toss in remote PA pressure monitoring as a sort of device therapy. We still have a lot of opportunity to help more patients that would qualify based on the FDA label based on the indications.
Editor’s note: This transcript has been edited for length and clarity.