GUIDE-HF: Benefit of hemodynamic guided-management in HF similar across EF
Device therapy for pulmonary artery-pressure-guided management of patients with HF was beneficial regardless of ejection fraction, according to new data from the GUIDE-HF trial presented at TCT 2021.
As Healio previously reported, in the main results of GUIDE-HF, hemodynamic-guided management with the CardioMEMS device (Abbott), which is implanted via a right heart catheterization procedure, was associated with reduction of HF hospitalizations in an analysis of events before the COVID-19 pandemic, but not in an analysis of the overall results.
“Elevated or increasing pulmonary artery pressures are associated with higher heart failure hospitalization rates and higher mortality,” Cardiology Today Editorial Board Member JoAnn Lindenfeld, MD, professor of medicine and Samuel S. Riven Director in Cardiology at Vanderbilt University Medical Center, said during a press conference.
The trial included 1,000 patients with NYHA Class II, III or IV HF and elevated natriuretic peptide levels or at least one HF hospitalization in the prior year.
In the pre-COVID-19 analysis, the primary endpoint of mortality and total HF events occurred less often in those who had the CardioMEMS device activated compared with controls regardless of whether they had HF with preserved ejection fraction, defined as 50% or more (HR = 0.7; 95% CI, 0.47-1.03; P = .07) or HF with reduced ejection fraction, defined as less than 50% (HR = 0.85; 95% CI, 0.66-1.09; P = .2), Lindenfeld said at the press conference.
“Neither of these groups were quite statistically significant, but remember, these are subgroups,” she said. “The trial was not powered to create a subgroup difference.”
Total HF events were reduced in the CardioMEMS group compared with the control group regardless of whether patients had HFpEF (HR = 0.72; 95% CI, 0.48-1.07; P = .11) or HFrEF (HR = 0.77; 95% CI, 0.59-1; P = .051), she said, noting that absolute event rates were less in HFpEF than in HFrEF.
She noted patients with HFpEF had improved outcomes in the CardioMEMS group compared with the control group regardless of whether HFpEF was defined as EF 50% or more or EF more than 40%.
“The GUIDE-HF patients were similar to those in previous trials of hemodynamic monitoring. Both primary and heart failure event rates were lower in HFpEF than in HFrEF, as in previous studies, but the relative benefit of hemodynamic-guided management was similar in both, consistent with previous studies,” Lindenfeld said at the press conference. “Hemodynamic-guided management of heart failure is one of a very small number of effective therapies in HFpEF patients. What GUIDE-HF shows us in both groups is that we can apply hemodynamic-guided management earlier in the course of disease: in class II patients and in those patients who have not yet had a hospitalization but just have elevated natriuretic peptides.”
Perspective
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The trial proved what we knew already: If we hemodynamically monitor ambulatory patients with HF, and tailor our strategy by hemodynamic data, it improves outcomes and patients are not admitted with HF as frequently as before. The reduction is quite substantial and translates to better quality of life, which is improved by avoidance of hospitalizations. It may also translate to improved quantity of life, but we do not yet have evidence of this.
The present analysis confirms what was known from the CHAMPION trial, which created the evidence base for utilization of this technology: Hemodynamic monitoring reduces hospitalizations in all HF, regardless of EF. This is important because we traditionally divide HF into reduced and preserved EF. But almost all guideline-directed medical management is for HFrEF and not HFpEF. However, in terms of HF as a disease state, we recognize the role of congestion as a driving force in both HFpEF and HFrEF. The new universal definition of HF published earlier this year underscores congestion as a pathophysiological syndrome playing a leading role in the evolution and progression of HF. Thus, the monitoring of congestion is the key to successful treatment. Currently, there is only one invasive hemodynamic monitor for ambulatory patients, which is CardioMEMS, and it has been proven to work equally well in preserved and reduced EF. The main message from this presentation is that congestion is a common denominator in HF, and hemodynamic monitoring works well to guide the treatment in both subsets.
I hope these data lead to increased use of hemodynamic monitoring in clinical practice. The caveat is that the onset of the COVID-19 pandemic changed the conditions for HF hospitalization nationwide and compromised the data of the trial, so the final overall results showed no statistical benefit. However, the FDA approved the performing of a separate analysis for the pre-COVID-19 era, because the conditions created by the pandemic modified the data to the point that it warranted a separate analysis. Nationwide hospital admissions for HF and all other serious medical conditions decreased during the pandemic; people were afraid to come to the ED for any reason. So, the pre-COVID-19 analysis is justified. I believe CardioMEMS should be used far more widely than it currently is, and I hope people are not too influenced by the overall net neutral outcome of the trial.
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Lindenfeld J, et al. Late-Breaking Clinical Trials Session III, in Collaboration with JACC. Presented at: TCT Scientific Symposium; Nov. 4-6, 2021; Orlando, Florida (hybrid meeting).