Analysis of a Medically Certified, Wrist-Worn Sensor for the Assessment of Heart Rate and Energy Expenditure During Daily Activities in Patients With Chronic Heart Failure or Coronary Artery Disease and Recreational Athletes: Validation Study.

Abstract

Background: Exercise capacity and lifestyle have proven to be important prognostic factors for cardiovascular patients. Both can be ameliorated through different preventive interventions. Cardiac rehabilitation and remote patient monitoring have been proven to reduce cardiac events and cardiovascular mortality. One of the most important goals of cardiac rehabilitation and remote patient monitoring is improving physical fitness and monitoring of cardiovascular parameters, which could predict cardiac deterioration. In order to monitor cardiac patients successfully, reliable and nonobtrusive devices to assess physical activity and cardiovascular parameters need to be available.

Objective: This validation study aims to determine the accuracy of the Philips Health Band (PHB), a noninvasive, wrist-worn, medically certified device, for the assessment of heart rate (HR) and energy expenditure (EE) in patients with chronic cardiovascular diseases and recreational athletes (RAs).

Methods: The assessment of HR and EE by the PHB was compared with indirect calorimetry (Oxycon Mobile [OM; CareFusion GmbH]) during an activity protocol consisting of daily activities. Three groups were assessed: patients with heart failure with reduced ejection fraction (HFrEF), patients with stable coronary artery disease (CAD) with preserved left ventricular ejection fraction, and RAs.

Results: A total of 57 patients were included: 19 with CAD, 19 with HFrEF, and 19 RAs. HR assessment in the HFrEF and CAD groups was significantly underestimated over the entire protocol by the PHB as compared to the OM, with poor and fair reliability, respectively. No significant difference in HR was found between the PHB and OM over the entire protocol for the RA group, with good reliability (HFrEF: mean difference 3.0; P<.001; intraclass correlation coefficient [ICC] 0.36; CAD: mean difference 2.7; P<.001; ICC 0.55; RA: mean difference 0.8; ICC 0.60). Assessment of EE showed an underestimation over the entire protocol for the RA and CAD group, with poor and fair reliability, respectively. The HFrEF group showed no significant difference in EE assessment over the entire protocol, with poor reliability (HFrEF: mean difference 0.09; ICC 0.32; CAD: mean difference 0.29; P<.001; ICC 0.46; RA: mean difference 0.79; P<.001; ICC 0.26). The responsiveness to detect within-patient changes in activity intensity of the PHB was moderate for the HFrEF and CAD groups and acceptable for the RA group.

Conclusions: HR and EE assessment of a medically certified noninvasive sensor using a photoplethysmogram and accelerometer showed poor accuracy and moderate responsiveness during an activity protocol reflecting daily living activities in patients with stable CAD and chronic HFrEF. Accuracy of HR in RAs was good and the responsiveness for both HR and EE was acceptable. This research confirms previous research and stresses the need for better patient-specific algorithms in noninvasive sensors, taking cardiovascular pathology and medication usage into account, for assessing HR and EE prior to their implemention in patient care.