Endotronix, a subsidiary of Edwards Lifesciences (NYSE: EW), has announced promising one-year clinical outcomes from its PROACTIVE-HF trial, which evaluated the Cordella Pulmonary Artery (PA) Sensor System for managing heart failure. The findings were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting.
The trial involved 456 patients, with results indicating a significant reduction in heart failure-related hospitalisations and all-cause mortality. The data revealed that patients monitored with the Cordella PA sensor had 36 events per 100 patients, compared to a prespecified 70 events per 100 patients. This marked a 49% reduction in heart failure hospitalisations and deaths.
In addition to reducing hospitalisations and mortality, the study also demonstrated notable improvements in patients’ quality of life and key heart failure biomarkers. According to the findings, patients experienced a 10.5% improvement on the Kansas City Cardiomyopathy Questionnaire (a 5.7-point increase), which measures health-related quality of life specific to heart failure. Further results included a 13.3% improvement in the 6-minute walk test (an increase of 35 metres), a 36.2% improvement in New York Heart Association (NYHA) classification, and a 5.7% reduction in NT-proBNP levels, a biomarker associated with heart failure.
These positive outcomes build on the earlier six-month data, underscoring the long-term efficacy and safety of the Cordella PA sensor in managing heart failure. The system enables continuous remote monitoring of PA pressure and vital signs, allowing for proactive management of the condition.
Dr Liviu Klein, Section Chief of Advanced Heart Failure, Pulmonary Hypertension, and Heart Transplant at the University of California, San Francisco, and the national principal investigator of the PROACTIVE-HF trial, highlighted the significance of the results.
“These data are consistent and compelling, validating that PA pressure-guided therapy improves heart failure outcomes,” Dr Klein stated. “The trial results add to the growing understanding of the impact of comprehensive data, including seated PA pressure and vital signs, in further improving outcomes. This approach allows for remote medical adjustments and actively engages heart failure patients in their own care.”
Dr Klein also emphasised the ability of clinicians to optimise treatment, such as guideline-directed medical therapy (GDMT) and diuretics, to reduce PA pressures and improve heart function. He noted that Cordella’s unique capability of providing patients with access to their health data fosters better engagement and compliance, which is critical for managing a condition as complex as heart failure.
The Cordella PA Sensor System is designed to monitor heart failure patients remotely, allowing clinicians to make timely adjustments to their treatment plans based on real-time data. This reduces the risk of hospitalisation and helps patients maintain a better quality of life.
The PROACTIVE-HF trial’s one-year results provide further evidence of the effectiveness of this innovative system in helping to manage heart failure, offering hope for patients and their healthcare providers alike.
