A randomized trial ( GUIDE-HF) of hemodynamic-guided management of heart failure aims to assess the efficacy of hemodynamic-guided heart failure (HF) management based on data from implantable pulmonary artery pressure monitors (CardioMEMS™ HF system) across patients with all ejection fractions and New York Heart Association (NYHA) class II to IV HF symptoms. 

The study is  randomized, single-blinded study which enrolled 1,000 patients across 118 centers from the United States and Canada. The primary endpoint of all-cause mortality, HF hospitalization, or urgent HF visits was reached by 253/497 in the hemodynamic-guided group and 289/502 in the usual care group. The primary composite endpoint was reduced in favor of the hemodynamic-guided group. This difference in primary events decreased during the COVID-19 pandemic. However, there may also be a confounding effect of different ejection fraction (EF) range given the broad inclusion criteria.

The study results are compared with the additional study results with regards to EF stratification.  The primary endpoint for patients with an EF of <50% was HR 0.85, 95% CI 0.66-1.09 and a HR 0.77, 95% CI 0.59-1.00 for HF hospitalizations. Conversely, for those patients with an EF ≥50% the HR for the primary endpoint was 0.70, 95% CI 0.47-1.03 with a HR for HF hospitalization 0.72, 95% CI 0.48-1.07.

Although results were similar for patients with reduced and preserved EF, there was a signal towards improved composite endpoints in the preserved EF group outside of HF hospitalizations. Implantable pulmonary artery pressure monitors remain one of the few HF therapies shown to be of benefit for patients with preserved EF. 

There is no difference in outcomes among patients managed via implantable pulmonary artery catheter or standard clinical practice irrespective of NYHA class profile and ejection fraction range. Conflicting results may be a product of lower event rates seen during the COVID-19 pandemic time period of the study.

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Source

https://www.acc.org/Latest-in-Cardiology/Articles/2022/01/12/17/37/Implantable-Pulmonary-Artery-Catheter-Monitoring-System-Performance

Tags

Disease Condition ,Therapeutic Modality ,Heart Failure,Implantable Devices,Cardioverter-Defibrillators