BIOTRONIK SE & Co. KG, a worldwide leader in manufacturing cardiac medical devices and pioneer of remote patient management solutions, announced today that results of the Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) clinical study were published in the European Journal of Heart Failure (doi:10.1093/eurjhf/hfr089).
Home-CARE was a prospective, nonrandomized, multicenter, international clinical trial enrolling 515 patients. The objective of this study was to develop an automated multiparameter algorithm that would use daily BIOTRONIK Home Monitoring® data to predict death and hospitalization for cardiovascular reasons dynamically. Seven physiological parameters (e.g., mean heart rate, patient activity, heart rate variability) were selected to better analyze the cardiovascular status of heart failure (HF) patients. The combination of all parameters resulted in 65.4% sensitivity in detecting cardiovascular hospitalizations and deaths with 99.5% specificity.
"We believe that combining several parameters into a single algorithm may improve the overall ability to risk-stratify patients with implanted cardiac devices. This unique, predictive approach was developed by BIOTRONIK to allow for earlier detection of cardiovascular events based on data collected for analysis by BIOTRONIK Home Monitoring®," commented Professor Stefan Sack, MD, Coordinating Clinical Investigator, Schwabing Clinic, Munich, Germany. "The Home-CARE results also show that adding new physiological parameters increase the power of the cardiovascular predictor."
BIOTRONIK Home Monitoring® uniquely offers reliable daily transmissions and real-time remote monitoring of device diagnostic data, which provides several exciting research and development opportunities. These opportunities include the ability to design and progressively optimize increasingly sophisticated multiparameter diagnostic algorithms, including new sensor technologies, and to prospectively evaluate their impact on patient outcomes, clinical administration and health economic burden.
"BIOTRONIK developed an algorithm able to potentially predict cardiovascular events in patients with HF. This achievement represents another example of our commitment to enhancing the quality of clinical evidence in this therapy area," commented Marlou Janssen, Vice President of Global Marketing and Sales at BIOTRONIK. "Plus, this unique concept paves the way for future HF predictor applications and further expands the options of physicians for advanced patient management with BIOTRONIK Home Monitoring®."
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