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Meta-Analysis of Implantable Hemodynamic Monitors for HFrEF
Quick Takes
- In a pooled analysis of clinical trials of implantable hemodynamic monitoring devices, hemodynamic-guided management in patients with HFrEF was associated with a 25% reduction in overall mortality.
- This analysis also confirmed prior observations that this approach leads to reductions in HF hospitalizations, with a notable 36% reduction in this analysis.
Study Questions:
Does using implantable hemodynamic monitors (IHMs) reduce mortality and heart failure hospitalizations (HFHs) in patients with heart failure and reduced ejection fraction (HFrEF)?
Methods:
This was a meta-analysis of three randomized clinical trials (GUIDE-HF, CHAMPION, and LAPTOP-HF) of IHMs (measuring either pulmonary artery or left atrial pressures) in the management of patients with HF with a recent HFH or elevated natriuretic peptide levels. For this meta-analysis, patient-level data were used and only participants with HFrEF were included. Follow-up data through 24 months (CHAMPION, LAPTOP-HF) or prior to the COVID-19 pandemic (GUIDE-HF) were used. Overall mortality and HFHs were the outcomes examined.
Results:
This pooled analysis included 1,350 patients with HFrEF. Median follow-up was 12.2 months (interquartile range, 7.8-21.8 months). Overall, 25% of patients were women and 25% were Black persons. Most patients exhibited New York Heart Association (NYHA) class III symptoms. In terms of medications, 78% of patients were on an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor (ARNI), 95% on a beta-blocker, and 52% on a mineralocorticoid antagonist. For the outcomes of interest, IHM-guided management was associated with a 25% reduction in overall mortality (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.57-0.99; p = 0.043) and a 36% reduction in HFH (HR, 0.64; 95% CI, 0.55-0.76; p < 0.0001).
Conclusions:
The authors conclude that in patients with HFrEF, IHM-guided management is associated with reductions in overall mortality and HFH compared to standard care.
Perspective:
It has been well-established that congestion in HF negatively impacts quality of life and prognosis. However, monitoring for congestion is challenging. IHMs offer a potential solution by providing more precise assessments of intracardiac pressures in ambulatory patients. Studies of these types of devices have in general demonstrated benefit via reductions in HFH but not overall mortality. Some point to the small trial sizes, shorter duration of follow-up, and inclusion of a broad range of HF as limiting factors for detecting changes in mortality. The authors of this study try to address this by performing a pooled meta-analysis with patient-level and long-term follow-up data and limiting analysis to patients with HFrEF. The results both confirm the previously observed benefit with respect to HFH, but also show a reduction in overall mortality. While there are limitations to this analysis (variable trial design and blinding, early trial stoppage, low use of ARNI and SGLT2 inhibitor medications, etc.), it appears that for selected patients with HF, IHM seems to provide tangible benefits.
Clinical Topics: Cardiovascular Care Team, Heart Failure and Cardiomyopathies
Keywords: Heart Failure, Reduced Ejection Fraction, Hemodynamic Monitoring
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