MultiSENSE Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE Study)
Status: Completed in 2015
Heart failure (HF) involves costly hospitalizations with adverse impact on patient outcomes. The aim of this study was to develop and validate a device-based diagnostic algorithm and alert (HeartLogic™) to predict heart failure events (HFE).
- Sensitivity of 70% (95% confidence interval: 55.4% to 82.1%)
- Unexplained alert rate of 1.47 per patient-year (95% confidence interval: 1.32 to 1.65)
- The median lead time prior to HFE was 34.0 days (interquartile range: 19.0 to 66.3 days)
- International, multicenter, nonrandomized
- 900+ patients were followed for up to 1 year
- Heart Failure Events (HFE) were independently adjudicated to include events where primary cause was worsening HF and patient admission included an overnight stay or intravenous medications.
- Sensor data included heart rate, accelerometer-based heart sounds, respiration rate, relative tidal volume, activity, and intrathoracic impedance.
- Algorithm development combined key feature trends into a composite index and associated alert using HFE and sensor data from 500 patients in Development Set.
- Performance was evaluated against HFE and sensor data in sequestered Test Set patients. Two co-primary endpoints included:
- Sensitivity to detect HFE >40%
- Unexplained alert rate <2.0 per patient-year
- Age 18 or above
- Currently implanted with a COGNIS CRT-D system
- NYHA Class II, III, IV within the last 6 months
Sleep Incline Abstract presented at European Journal of Heart Failure 2017
Sleep incline is the angle between the patient’s torso and the horizontal plane during the night. Sleep sensor provides a posture-based physiological indication for heart failure decompensation. To know more about the latest publications regarding the results of early worsening of heart failure using this sensor, please consult this abstract
Respiratory Rate Abstract presented at Heart Rhythm Society 2017
The Respiratory Sensor uses transthoracic impedance measurements to collect respiration-related data, specifically respiration rate and tidal volume. Worsening heart failure may be associated with a variability in respiration rate. To know more about the latest publications regarding the results of early worsening of heart failure using this sensor, please consult this abstract