Novel stick-on thoracic fluid sensor may improve HF management, reduce readmissions
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Key takeaways :
- A novel stick-on monitor could reduce HF readmissions by 7% vs. controls.
- The number needed to treat to avoid one readmission is 14.3 patients.
- The device may also improve patient quality of life.
NEW ORLEANS — A wearable thoracic fluid monitor may be of utility in managing patients with HF and was associated with reduced risk for HF readmission and improved quality of life, a speaker reported.
The findings of the Benefit of Microcor in Acute Decompensated Heart Failure (BMAD) trial that evaluated the use of a novel stick-on thoracic fluid monitor for HF management (Cor, Zoll Medical) were presented at the American College of Cardiology Scientific Session.
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“Heart failure is a major public health problem afflicting over 26 million people globally, and annually in the United States more than 1 million patients are hospitalized with the primary diagnosis of heart failure, and this is expected to increase. Although significant developments have occurred to advance heart failure medical therapy, heart failure readmissions remain far too common,” John P. Boehmer, MD, professor of medicine and surgery at Pennsylvania State University in State College, said during a presentation. “Strategies and approaches that aim to reduce hospitalization readmissions have the potential to improve patient care, as well as ease the burden on the heart failure system. The purpose of this study is to evaluate the strategy of using data from a novel [radiofrequency] sensor to manage heart failure and compare it to a concurrent control group.”
In this multicenter, multinational, prospective analysis, Boehmer and colleagues tested the use of the fluid monitoring sensor for the management of HF compared with controls.
The wearable device detects ECG and heart rate via two electrodes and respiration rate, activity and posture via tri-axial accelerometer. Lung fluid was estimated via low-power electromagnetic pulses in the radiofrequency wavelength range between 0.5 GHz and 2.5 GHz, according to the presentation.
A total of 249 patients admitted with a primary diagnosis of HF were assigned to the stick-on device for up to 90 days and participated in weekly phone calls, monthly office visits, and 6-month and 1-year follow-up calls (60.2% aged older than 65 years; 58% men; 25% Black). Another 245 patients (52.7% aged older than 65 years; 59% men; 26% Black) were assigned to a control group who wore the device but did not have their data sent to their clinician. Quality of life was assessed via Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score.
The device would provide a data update report when the patient’s thoracic fluid index remained higher than the threshold value for 3 consecutive days or more, at which time an investigator contacted the patient to conduct a structured interview. The results of the interview could lead to a medication, lifestyle or diet change, an office/hospital visit or no change.
Device data were shared with the investigators and patients via secure website.
The primary endpoint was time to first HF hospitalization between the two study arms.
After Kaplan-Meier analysis, the researchers observed that patients assigned to the wearable device had an approximately 38% relative risk reduction in HF hospitalization (HR = 0.62; P = .03); an approximately 7% absolute risk reduction at 90 days; and a number needed to treat to prevent one HF hospitalization of 14.3.
The findings were consistent when the primary endpoint was expanded to a composite of HF hospitalization, ED visit or death (HR = 0.62; P = .02).
Both arms experienced improvement in quality of life; however, the device arm was, on average, 12 KCCQ-12 points higher compared with the control arm (P = .004), with 70% of the device group reporting clinically meaningful quality of life improvement at 90 days compared with 50% of the control arm.
“This study demonstrates the strategy of managing heart failure using a threshold alert in the [HF monitoring system] results in the 38% relative risk reduction in heart failure readmissions following the heart failure hospitalization,” Boehmer said. “The magnitude of benefit ... is clinically meaningful.”
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Boehmer JP, et al. Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).
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