However, a pre-COVID-19 impact analysis did find a benefit of hemodynamic-guided management, which was largely driven by a lower rate of HF hospitalization.
The findings were published in The Lancet and presented at the European Society of Cardiology (ESC) 2021 conference by Dr. JoAnn Lindenfeld of Vanderbilt Heart and Vascular Institute, in Nashville, Tennessee.
Hemodynamic-guided HF management has been previously shown to reduce HF hospitalizations in patients with moderately symptomatic (NYHA class III) HF and a hospital admission in the past year.
Yet, it's been unclear if these benefits extend to patients with mild (NYHA class II) or severe (NYHA class IV) HF or to those with elevated natriuretic peptides without recent HF hospital stay.
The GUIDE-HF clinical trial sought to address these questions, by assessing the benefits of the Abbott CardioMEMS HF System in people living with NYHA class II, III and IV HF.
A total of 1,000 patients were implanted with the Abbott CardioMEMS HF System. Patients were then randomly allocated to either a treatment group, managed with provider remote access to the hemodynamic data, or a control group, managed without provider access to these data.
Overall, 30% of patients were in NYHA class II, 65% in NYHA class III, and 5% in NYHA class IV.
Overall, the trial was neutral for the composite primary endpoint of HF hospitalizations, urgent HF visits or all-cause mortality at 12 months.
In the overall analysis, during a median follow up of 11.7 months, "the primary endpoint was reduced by 12% but did not meet statistical significance," Dr. Lindenfeld reported in her presentation. There were 253 primary endpoint events in the treatment group and 289 events in the usual-care group (hazard ratio, 0.88; 95% confidence interval, 0.74 to 1.05; P=0.16).
However, a prespecified COVID-19 sensitivity analysis suggested an effect of COVID-19 on primary endpoint events, which led to an analysis of all endpoints before March 13, 2020, when the U.S. declared a national COVID emergency.
In this pre-COVID-19 impact analysis, "there was a statistically significant 19% reduction" in the primary endpoint (177 events in the treatment group vs. 224 events in the control group; HR, 0.81, 95% CI, 0.66 to 1.00; P=0.049), Dr. Lindenfeld reported.
In the overall analysis, HF hospitalizations were reduced by 17% "just missing statistical significance," she noted. "The pre-COVID impact analysis demonstrated a highly significant 28% reduction in heart failure hospitalizations."
As has been seen with other trials, the COVID-19 pandemic clearly affected the outcomes of GUIDE-HF, she noted.
"These results suggest that the benefits of hemodynamic monitoring already shown New York Heart Association class III patients with a previous hospitalization extend to patients with New York Heart Association class II, and to New Yorkers Association class II and III patients with either elevated natriuretic peptides or previous heart failure hospitalization, or both and to patients with all ejection factions," Dr. Lindenfeld concluded.
The authors of a linked comment in The Lancet say the GUIDE-HF team "should be congratulated on attempting to master congestion, a key driver of symptoms, signs, and progression of heart failure."
The trial was "simple in concept but complex to implement," write Dr. John Cleland and Dr. Pierpaolo Pellicori with Glasgow Royal Infirmary, in Glasgow, U.K.
"The GUIDE-HF trial did not enroll an ideal group of patients for showing the efficacy of pulmonary artery pressure monitoring, since many had baseline pressures in the target range with little possibility of short-term gain, follow-up was too short, and interventions did not substantially change pulmonary artery pressure," they note.
"Monitoring alone cannot improve outcome, but consequent actions might. The GUIDE-HF results are encouraging but inconclusive, and should inform further research, possibly a large, simple, open-label trial to investigate a system of care rather than a single technology," Dr. Cleland and Dr. Pellicori conclude.
The trial was funded by Abbott. Several authors have disclosed financial relationships with the company. Five authors are employees of the company.
SOURCE: https://bit.ly/3mG5zFQ and https://bit.ly/3DqHw3N The Lancet, online August 27, 2021.
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