Why the study?
Intracardiac and pulmonary artery pressure monitoring can help predict heart failure decompensation before clinical congestion manifests and leads to hospitalisation.
Does the Cordella PA Sensor System reduce HF hospitalisations in patients with symptomatic heart failure?
Cohort (n=33)
No
Does the Cordella PA Sensor System reduce HF hospitalisations in patients with symptomatic heart failure?
Mean Difference: 0.7
p-value: p=<0.0001
The Cordella PA Sensor System safely and significantly reduced HF hospitalisations and improved NYHA class in a single-center cohort of symptomatic HF patients.
Background: Hospitalisation for acute decompensated heart failure (HF) portends a poor prognosis. Fluid retention manifesting in dyspnoea and oedema are important clinical features of decompensated heart failure and drive hospital admissions. Intracardiac and pulmonary artery pressure (PAP) monitoring can help predict heart failure decompensation, as changes in these haemodynamics occur before clinical congestion manifests. Methods: A retrospective single centre analysis of patients who underwent insertion of the Cordella™ PA Sensor System (Endotronix, Inc., Chicago, IL, USA) in University Hospital Galway, Ireland, as part of three separate clinical trials—SIRONA 1, SIRONA 2, PROACTIVE HF, was performed. The primary clinical outcome assessed was the difference between HF hospitalisation pre- and post-sensor implantation. Results: In total, there were 33 patients with symptomatic HF who underwent device insertion between 2018 and 2023. All patients had NYHA class 3 heart failure, and 48.5% (n = 16) of patients had HF with reduced ejection fraction. Only one device-related complication was noted, and no pressure sensor failures occurred. In total, there were 26 admissions for HF decompensation 1-year pre-device insertion and only three admissions post-insertion. The difference in the mean number of HF hospitalisations per patient pre- and post-device insertion was 0.70 (p < 0.0001). The difference in mean NYHA class score pre- and post-insertion was 1.0 (p < 0.001). Conclusions: Data from this single-centre cohort study have shown that the insertion of the Cordella™ PA Sensor System in symptomatic HF patients was safe and resulted in statistically significant improvements in HF hospitalisations and NYHA class.
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Leahy et al. (2025) conducted a cohort in Symptomatic heart failure (n=33). Cordella PA Sensor System vs. Pre-device insertion was evaluated on Difference between HF hospitalisation pre- and post-sensor implantation (MD 0.70, p=<0.0001).
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