Benefits of hemodynamic-guided HF management may extend to broader range of patients
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The GUIDE-HF trial of hemodynamic-guided management of HF did not meet its primary endpoint, but analyses limited to the period before the COVID-19 pandemic showed benefit in a broader range of patients than previously demonstrated.
Presented at the European Society of Cardiology Congress, the trial evaluated whether hemodynamic-guided management with the implantable CardioMEMS device (Abbott) reduces HF events and mortality in patients with NYHA class II, III and IV HF and a previous HF hospitalization or elevated natriuretic peptides.
In the overall analysis, hemodynamic-guided management was safe but did not reduce the primary composite endpoint of mortality and total HF events. In a pre-COVID-19 impact analysis limited to data before March 13, 2020, researchers reported a benefit of hemodynamic-guided management on the primary endpoint, which was driven by a decrease in HF hospitalizations.
“The benefits of hemodynamic-guided management in reducing HF hospitalizations extend to patients with less severe HF (NYHA class II) and to those with NYHA II and III symptoms and elevated natriuretic peptides but no previous hospitalization,” Cardiology Today Editorial Board Member JoAnn Lindenfeld, MD, FHFSA, professor of medicine at Vanderbilt University Medical Center, said during a press conference.
Moreover, the results underscore that the COVID-19 pandemic “had an important impact” on the GUIDE-HF trial, the researchers wrote in the Lancet simultaneous publication.
Primary results
The GUIDE-HF trial enrolled 1,000 patients with NYHA class II, III and IV HF and either an HF hospitalization within the prior year or elevated natriuretic peptide levels within the month before consent to participate. The patients’ mean age was 70 years, nearly two-thirds were men and more than 80% were white. Enrollment took place at 118 centers in the United States and Canada from March 2018 through December 2019. Follow-up was completed in January 2021.
All patients underwent implantation of a CardioMEMS device and then were randomly assigned to hemodynamic-guided management using transmitted pulmonary artery pressure data or to control management, for which pulmonary artery pressures were not made available. The CardioMEMS device is a wireless, battery-free sensor that is implanted into the pulmonary artery via a right heart catheterization. It transmits data that are used to titrate HF medications. CardioMEMS is approved in the U.S. and in Europe to reduce HF hospitalizations in patients with class III HF and a HF hospitalization in the previous year.
The primary endpoint was a composite of all-cause mortality and total HF events, including HF hospitalizations and urgent HF hospital visits, at 12 months.
A prespecified statistical analysis plan to account for the effects of the COVID-19 pandemic was approved several months prior to the end of the trial, Lindenfeld said during the press conference. Twenty-six percent of all primary endpoint events occurred after the U.S. National COVID-19 Emergency Declaration on March 13, 2020.
“GUIDE-HF started well before the COVID-19 pandemic. But when we all realized the effect on HF hospitalizations, one of our main endpoints, we did a statistical analysis ... to account for the possible effects of COVID-19. ... There was an interaction of COVID-19 with the outcome of the study,” Lindenfeld said.
In the overall analysis, the primary endpoint was reduced by 12% in the hemodynamic-guided group, but did not meet statistical significance (HR = 0.88; 95% CI, 0.74-1.05; P = .16). In the pre-COVID-19 analysis, there was a 19% reduction in primary endpoint events in the hemodynamic-guided group (HR = 0.81; 95% CI, 0.66-1; P = .0489).
HF hospitalizations were reduced by 17% in the hemodynamic-guided group in the overall analysis, but did not meet statistical significance (HR = 0.83; 95% CI, 0.68-1.01; P = .064). In the pre-COVID-19 analysis, HF hospitalizations were reduced by 28% (HR = 0.72; 95% CI, 0.57-0.92; P = .0072).
Results were inconsistent in patients with severe class IV HF. The trial enrolled only 54 patients with class IV HF. There was not a benefit of hemodynamic-guided management in this group, but the small patient cohort makes it difficult to draw conclusions, Lindenfeld said during the press conference.
Results were consistent across subgroups, including left ventricular ejection fraction, sex, age and race.
Driven by HF hospitalizations
Lindenfeld noted that “the benefit of hemodynamic-guided management was primarily due to the 28% reduction in HF hospitalizations consistent with that previously reported in CHAMPION.”
In the CHAMPION trial, as previously reported by Healio, remote pulmonary artery pressure monitoring was associated with approximately 50% fewer HF hospitalizations vs. usual care in patients with NYHA class III HF.
With the new GUIDE-HF data, “reductions in HF hospitalizations already shown in NYHA class III patients with a previous HF hospitalization extend to patients with NYHA class II symptoms with a prior HF hospitalization or natriuretic peptides; NYHA class III symptoms with elevated natriuretic peptides but without a prior HF hospitalization; and also apply to patients with all ejection fractions,” Lindenfeld said.
The results presented at ESC Congress are from the randomized arm of GUIDE-HF. The trial also includes a single-arm, observational study that is ongoing.
The researchers also highlighted the impact of clinical trial conduct during a pandemic, noting that “[c]linical trials during the COVID-19 pandemic should plan for sensitivity analyses regarding the effect of COVID-19,” they wrote in Lancet.
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Perspective
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Anu Lala, MD
It’s an exciting day in cardiology, particularly in the field of HF. Knowing the results of GUIDE-HF is a very exciting, in that it included half patients with preserved EF and half with reduced EF. It showed that there was a reduction in HF hospitalizations in the pre-COVID-19 era and I am convinced by these data. I am a proponent of pulmonary artery pressure monitoring because, while we attempt to do a good job in decongesting our patients with HF, we can do better. It is about appreciating hemodynamic congestion can precede clinical congestion by days to weeks, and this technology allows us to assess hemodynamic congestion before it turns into clinical congestion, thereby preventing urgent visits and HF hospitalizations, which we know are associated with poor prognosis.
I hope these data will help to expand the indications for implantation of this device and make it available for more patients. It has been challenging in the outpatient setting to obtain insurance coverage for some patients.
From a research perspective, this study shows the influence of COVID-19 on clinical trials, research and practice, and how we need to be prepared to innovate in the way research is conducted as the pandemic continues.
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Lindenfeld J, et al. Hot Line: GUIDE-HF. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).
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