Stephen Greene, MD, discusses trials, data, and themes to look for at the HFSA 2023 meeting.
Within cardiology, and the medical landscape as a whole, the world of heart failure management has stood out in recent years for the marked advancement in pharmacologic therapies and its fervor for implementation science. There has been no better evidence of the excitement surrounding the field than the Heart Failure Society of America (HFSA) Annual Scientific Meeting.
With attendance growing with each passing year, the meeting has served as a showcase for the latest advancements and hub for discussions, with special sessions and late-breaking data providing insight into clinically impactful news for patients with heart failure and cardiomyopathy.
At HFSA 2022, attendees were given a deep dive into the results of the DELIVER trial after the trial was presented at ESC Congress 2022. At HFSA 2023, which is being held from October 6-9, 2023 in Cleveland, OH, attendees will be given an additional deep dive into the results of a trial presented at the most recent ESC Congress, but this time in the form of a prespecified STEP-HFpEF analysis. Another major talking point for HFSA 2023 is the presentation of REBALANCE-HF, which is a trial assessing the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve in subjects having heart failure with preserved ejection fraction (HFpEF).
With an interest in learning more about this year’s meeting and what experts are looking forward to most, HCPLive Cardiology sat down with editorial advisory board member Stephen Greene, MD, of the Duke Clinical Research Institute and the Division of Cardiology at Duke University School of Medicine. In the conversation, Greene, who also serves as a co-host of Don’t Miss a Beat, Greene offers his perspective on a pair of late breakers from this year’s meeting as well as what he sees as evolving themes at the HFSA’s annual meetings.
HCPLive Cardiology: What study or piece of data are you most looking forward to at this year’s HFSA meeting?
Greene: So one trial that I'm very much looking forward to seeing at HFSA 2023 is the presentation of REBALANCE-HF, which is a small randomized control trial of about 80 patients or so of heart failure patients with an ejection fraction of 50% or more and exercise-induced elevations in wedge pressure. They were randomized to either right, greater splanchnic nerve ablation versus a sham procedure.
Now, as mentioned, this is a small randomized trial, but there has been a lot of work, including by my colleague at Duke, Dr. Marat Fudim, really trying to tease out the potential benefits of splanchnic nerve ablation. In patients with HFpEF, the concept is thinking about volume redistribution and how blocking the sympathetic nervous system with a block of the splanchnic nerve can help redistribute fluid from the chest, the thoracic cavity, back into the splanchnic vascular bed, decrease preload, and, hopefully, and potentially, improve the patient's exercise capacity, quality of life, and maybe other key endpoints.
About a year or so ago, the investigators did present the initial results of a roll-in open-label part of REBALANCE that had about 18 patients or so in it. Again, this was open-label, observational data, but it showed the procedure did seem to be relatively safe and it did seem to be associated with substantial improvements in both patient-reported quality of life in KCCQ and NYHA class as well as decreases in wedge pressure, including the wedge pressure with exercise.
So, I think there's been a lot of build-up to this moment for this part of the field and I'm really interested to see this randomized, sham-controlled study to really put this therapy to the test and see what the next steps are in this field.
HCPLive Cardiology: Are there any other late breakers or anything else that is on your radar is sort of music from the meeting?
Greene: Well, I think another late breaking trial that will be presented will be the results from secondary analysis of STEP-HFpEF trial looking at the effects of semaglutide across the spectrum of ejection fraction within patients from the trial, which enrolled those with a 45% ejection fraction or higher, to see just how effective and safe was semaglutide in these patients. Now, we know the overall results of STEP-HFpEF, were really a blockbuster we had, arguably, the largest quality of life improvement in terms of KCCQ scores ever seen in a heart failure trial. We also had substantial weight loss with semaglutide, but with some of our other heart failure therapies we've seen attenuation of benefit at the very high ejection fractions.
When you think about the GLP-1 receptor agonists. There has been some smaller trials among patients with HFrEF that actually do not show benefit and maybe even a signal of harm. So, I think it will be really interesting to see here on the low end of the ejection fraction spectrum included in STEP-HFpEF, and also the very high ejection fraction patients, just how safe and effective semaglutide seem to be.
My suspicion is that it is going to be consistent across the entire spectrum of ejection fraction included in the trial. I think these effects on quality of life are probably durable across the entire spectrum of ejection fraction and might have more to do with levels of obesity than ejection fraction, per se. But again, this is why we do the trials and we'll have to wait and see what those data show.
I also think it'll be interesting to see these data on ejection fraction setting the stage further for the American Heart Association meeting where we are going to have the SELECT trial presented. That's a 17,000-patient trial with semaglutide not a heart failure trial, but, importantly, about 20 to 25% of those 17,000 patients had underlying heart failure. The primary endpoint in SELECT will be MACE, so really just look mostly looking at atherosclerotic cardiovascular disease and cardiovascular death, but it will also include heart failure endpoints as well.
So, combining what we'll see from STEP-HFpEF with SELECT upcoming that includes patients with established heart failure and also has heart failure as secondary outcomes. Again, it will be really interesting to see where this field goes.
HCPLive Cardiology: Are there any evolving themes that you've noticed at HFSA that you Are expecting to continue on or any themes that you would like to see emerge from this year's meeting?
Greene: I think HFSA really has been a key leader in the implementation efforts for GDMT and across the heart failure space. I mean, they are really yelling from the rooftops about this with their OMT certification class and a lot of other education initiatives. I think after CHAMP-HF was published a few years ago, it really kind of sounded the alarms for the whole field. And credit to the HFSA for standing up and stepping up with the emphasis on implementation, the emphasis on education, and the emphasis on the risks of omission or continuing the status quo with these gaps in GDMT.
So, I suspect a similar theme to continue with this year's HFSA meeting combined with the theme of multidisciplinary care, because I think that is one of the things that HFSA is always talking about: Bringing all the team members together to take best care of our heart failure patients And that encompasses implementation as well. So, I suspect to see similar themes at this year's HSA and really looking forward to it.