GUIDE-HF: can continuous pulmonary artery pressure monitoring improve heart failure management?
Reported from TCT 2021
The main goal of the randomized GUIDE-HF trial was to assess the ability of continuous PAP monitoring to improve outcomes in patients with heart failure NYHA class II-IV and a HF hospitalization within previous 12 months or elevated BNP/NT-proBNP.
Rationale:
Implantation of a pressure sensor (CardioMEMS; Abbott, Abbott Park, IL, USA) in the pulmonary artery may provide continuous monitoring of the degree of pulmonary congestion and thereby enable its timely management, prior to symptoms onset, and so reducing the need for hospitalizaton.
GUIDE-HF study builds on previous evidence from the CHAMPION trial, which demonstrated that the monitoring of the pulmonary artery pressure (PAP) in patients with NYHA III Class HF was associated with a reduction in the rate of hospitalizations due to HF worsening.
The main goal of the randomized GUIDE-HF trial was to assess the ability of continuous PAP monitoring to improve outcomes in patients with heart failure NYHA class II-IV and an HF hospitalization within previous 12 months or elevated BNP/NT-proBNP.
Methodology:
- After successful implantation of pulmonary artery pressure sensor, 1,000 patients were randomized to either PAP monitoring-guided or standard HF management.
- The primary endpoint was all-cause mortality or worsening of heart failure symptoms requiring hospitalization or emergency department visits or intravenous diuretic therapy.
Main results:
- Primary endpoint tended to be less frequent in the PAP monitoring group (0.56 events per patient-year vs. 0.64 in the control group, p = 0.16).
- Interestingly, there was a significant interaction of the COVID-19 pandemic on the observed outcomes. When considering only the pre-COVID-19 period, the reduction in heart failure events by the hemodynamic-guided strategy reached statistical significance.
Interpretation:
Given the global changes in patient care and health system accessibility during the COVID-19 pandemic, a lower rate of heart failure events, i.e. rehospitalizations or emergency department visits due to worsening HF symptoms in the control group of the GUIDE-HF trial may explain the overall neutral trial results.
However, the significant reduction in HF events achieved by continuous pulmonary artery pressure monitoring in the pre-COVID-19 period is encouraging.
Moreover, these favorable results were documented across a wide range of HF patients, including HF with reduced and preserved ejection fraction, as well as those without prior HF hospitalization but only elevation of BNP/NTproBNP on baseline.
When interpreting these results, the following two issues may need to be additionally considered.
- First, a degree of selection bias cannot be excluded due to the fact that only patients with successful device implantation (pulmonary artery pressure sensor CardioMEMS) were randomized. Of note, in 2 % of the screened patients, optimal device implantation was not achieved.
- Second, the described background therapy does not appear to follow the most recent HF treatment guidelines with angiotensin receptor-neprilysin inhibitor use in < 30 % and SGLT2 inhibitor use in < 1 % of patients.
In summary, the GUIDE-HF study seems to reaffirm the importance of utilizing minimal invasive percutaneous procedures to provide new insights into the hemodynamics of heart failure progression, thus potentially opening the door to tailored medical therapy amid new pharmacological discoveries in this field.
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