Hemodynamic monitoring using PA sensors benefits HF patients with no recent hospitalization: GUIDE-HF analysis

The findings were presented at the Heart Failure Society of America (HFSA) 2023 annual scientific meeting.

The findings suggest that hemodynamic monitoring using PA sensors might be warranted in this lower-risk group of patients identified based on NT-proBNP levels alone. PA pressure monitoring provides an early warning system for identifying patients who require drug or device adjustments to evade episodes of decompensation.

The CardioMEMS implantable PA sensor (Abbott) received approval from the US Food and Drug Administration (FDA) in 2014 as a preventive strategy in patients with NYHA class III HF who have had a hospital stay for HF within the prior year based on the CHAMPION trial. The US indication was further extended to those with NYHA class II to IV HF and either a prior admission or elevated NT-proBNP supported by the randomized, sham-controlled, GUIDE-HF trial.

Mandeep Mehra, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, conducted a separate, active-management, single-arm study within GUIDE-HF—run in parallel with the randomized trial to understand whether the differences in outcomes between patients with elevated natriuretic peptides alone and those with a prior hospitalization.

The study enrolled 1,358 patients with NYHA class III symptoms, all of whom underwent PA sensor implantation.

Dr Mehra showed that the reductions in PA pressure were similar in patients with biomarker elevations only and those with prior recent hospitalizations out to 1 year. Additionally, similar percentages of patients in both groups had improved or sustained NHYA class at both 6 months and 1 year. Both groups also had similar improvements in quality of life.

Key findings include:

• Compared with patients who had a prior HF hospitalization, those with elevated NT-proBNP only were older, were less likely to be female or Black, and had a lower body mass index. These patients were also less likely to be diabetic, but they had a greater incidence of atrial fibrillation and lower ejection fractions.
• Guideline-directed medical therapy at baseline was better in those with elevated NT-proBNP, which may reflect that these were patients with a greater prevalence of left ventricular systolic dysfunction.
• At one year, the rate of the primary efficacy endpoint (urgent HF visits, HF hospitalizations, and death) was lower in the elevated NT-proBNP group versus the prior HF hospitalization group (HR 0.51), falling outside the margin for equivalence. Similar trends were seen for the individual components of the primary endpoint.
• For the secondary endpoint of HF hospitalizations at 1 year, there was a 54% reduction in those with a prior HF hospitalization versus a 27% reduction in the group with elevated natriuretic peptides only.
• Between baseline and 1 year, PA pressures fell an average of 2.4 mmHg in the elevated NT-proBNP group and 2.05 mm Hg in the hospitalization-only group, which was significant for both, with a nonsignificant between-group difference.
• At one year, changes in NYHA class were not significantly different between the groups. Looking at quality of life, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score gains from baseline were similar and statistically significant for both.

Further, the study addresses an interesting hypothesis, namely that the strata of heart failure patients identified by natriuretic peptides may respond differently to early detection and treatment than those identified by a prior HF hospitalization.

Reference:

Mehra MR. Primary results of the prospective single-arm trial of hemodynamic-guided management of heart failure (GUIDE-HF). Presented at HFSA 2023. October 9, 2023. Cleveland, OH.