Summation
- “These findings represent a notable improvement of the standard of care, which has patients stepping on a weight scale each day to detect worsening heart failure,” said Marat Fudim, MD, MHS, who presented the data and is an advanced heart failure specialist and cardiologist with Duke University Medical Center.
- “This biomarker-based technology also utilizes the familiar patient routine of stepping onto a scale, but the scale's sensors and algorithms have doubled the number of predicted heart failure events, significantly boosting the utility of remote monitoring to head off the kinds of serious complications that can lead to hospitalization.
- The standard weight rule, defined as a weight gain exceeding 3 pounds in a day or 5 pounds in a week, only detected 24 of 69 HFEs (35%), half that of the Congestion Index.
Bodyport Late Breaking News
Bodyport Inc., a virtual care company focused on heart failure, today announced data from a late-breaking presentation showing its FDA-cleared, non-invasive, biomarker-based technology for remote heart failure monitoring detected twice as many heart failure events as compared to the weight-based standard of care. It demonstrated this using the same monitoring routine patients already follow in weighing themselves daily and concurrently minimized false alerts for care teams, generating nearly 40 percent fewer overall alerts.
The data from a preliminary analysis of Bodyport’s SCALE-HF 1 study were presented today during a session highlighting late-breaking research results at the Cardiovascular Research Foundation’s third annual Technology and Heart Failure Therapeutics (THT) conference in Boston (March 4-6, 2024).
Findings
“These findings represent a notable improvement of the standard of care, which has patients stepping on a weight scale each day to detect worsening heart failure,” said Marat Fudim, MD, MHS, who presented the data and is an advanced heart failure specialist and cardiologist with Duke University Medical Center. “This biomarker-based technology also utilizes the familiar patient routine of stepping onto a scale, but the scale’s sensors and algorithms have doubled the number of predicted heart failure events, significantly boosting the utility of remote monitoring to head off the kinds of serious complications that can lead to hospitalization.”
SCALE-HF 1
SCALE-HF 1 was a prospective, observational study conducted among 329 enrolled participants across 8 sites with 238 patient-years of follow-up. Participants took measurements at home by standing barefoot for approximately 20 seconds a day on the Bodyport Cardiac Scale, a non-invasive device with the familiar form factor of a weight scale. The data gathered include congestion-related biomarkers from the FDA-cleared device, which are used as inputs to the company’s algorithm known as the Congestion Index. In this latest study, the Congestion Index has been shown to accurately predict heart failure events (HFEs), defined in the study as unplanned administration of IV diuretics or hospital admissions with a primary diagnosis of heart failure.
Over the course of the study, the Congestion Index correctly predicted 48 of 69 heart failure events (70%), demonstrating significantly higher sensitivity (p<0.01) than the weight-scale standard of care. The standard weight rule, defined as a weight gain exceeding 3 pounds in a day or 5 pounds in a week, only detected 24 of 69 HFEs (35%), half that of the Congestion Index.
In addition to demonstrating greater sensitivity in detecting heart failure events, the Congestion Index did so with a lower alert rate, generating only 2.58 alerts per patient-year compared to the 4.18 produced by the standard of care.
“This should be welcome news for patient care teams because a greater prediction rate with fewer false alerts translates into more effective and efficient care,” said Corey Centen, founder, president, and chief technical officer at Bodyport. “What’s more, use of the Cardiac Scale and the Congestion Index is a seamless transition for clinicians and patients because it enhances, rather than replaces, the existing pathways built around weight monitoring. The lower alert rate should lead to workflow efficiencies because care teams—who are often feeling overly burdened by the large number of notifications and data flowing in—will spend less time responding to false alerts.”
Mean Age of Patients
Among the 329 patients enrolled in the study, the mean age was 64 (+/-14 years), 43 percent were women, and 32 percent were black. Additionally, 56 percent of patients had a left ventricular ejection fraction (LVEF) of </=40%, also known as “reduced EF,” while 36 percent had an LVEF of >/=50% or “preserved EF,” meaning the Congestion Index is applicable across the broad range of heart failure patients.
To learn more about the Congestion Index and the FDA-cleared Cardiac Scale and commercial availability, visit www.bodyport.com.