Accuracy of a Novel Handheld Wireless Platform for Detection of Cardiac Dysfunction in Anthracycline-Exposed Survivors of Childhood Cancer

Abstract

Childhood cancer survivors are at risk for anthracycline-related cardiac dysfunction, often developing at a time when they are least engaged in long-term survivorship care. New paradigms in survivorship care and chronic disease screening are needed in this population. We compared the accuracy of a novel handheld mHealth platform (Vivio) as well as echocardiography for assessment of cardiac function [left ventricular ejection fraction (EF)] in childhood cancer survivors with cardiac magnetic resonance (CMR) imaging (reference). Cross-sectional study design was used. Concurrent evaluation of EF was performed using Vivio, two-dimensional (2D) echocardiography, and CMR. Differences in mean EF (2D echocardiography vs. CMR; Vivio vs. CMR) were compared using Bland-Altman plots. Linear regression was used to evaluate proportional bias. A total of 191 consecutive survivors participated [50.7% female; median time from diagnosis: 15.8 years (2-44); median anthracycline dose: 225 mg/m (25-642)]. Echocardiography overestimated mean EF by 4.9% ( < 0.001); linear regression analysis confirmed a proportional bias, when compared with CMR ( = 3.1, < 0.001). There was no difference between mean EF derived from Vivio and from CMR (-0.2%, = 0.68). The detection of cardiac dysfunction via echocardiography was poor when compared with CMR [Echo EF< 45% (sensitivity 14.3%), Echo EF < 50% (sensitivity 28.6%)]. Sensitivity was substantially better for Vivio-based measurements [EF < 45% or EF < 50% (sensitivity 85.7%)]. This accessible technology has the potential to change the day-to-day practice of clinicians caring for the large number of patients diagnosed with cardiac dysfunction and heart failure each year, allowing real-time monitoring and management of their disease without the lag-time between imaging and interpretation of results. .

Proof-of-concept for a non-invasive, portable, and wireless device for cardiovascular monitoring in pediatric patients

“…A one-way ANOVA comparison of ω 1 across the pediatric and adult cohorts demonstrated a significant difference (F = 7.3, Prob>F = 0.0001). Post-hoc analysis revealed a significant difference between the adult cohort (ω 1 = 99 +/-5 bpm) and both the 0-4 year old (ω 1 = 111 +/-2 bpm; p = 0.0006) and [15][16][17][18][19] year old (ω 1 = 105 +/-5 bpm; p = 0.02) cohorts ( Fig 4A). A one-way ANOVA comparison of ω 2 across all pediatric and adult cohorts showed a significant difference (F = 4.8, Prob>F = 0.003).…”

“…To better understand the effect of Vivio head geometry on the quality on carotid pulse waveforms collected in a pediatric population, three different head geometries were tested. The standard head size (inner diameter (ID) = 25 mm, outer diameter (OD) 30 mm) was the same as the adult version of the device used in previous studies [18]. Since the Vivio is a membrane-based tonometer there are two options to facilitate Vivio measurements in a pediatric population.…”

“…Previous clinical studies have shown that the IF method can be used to estimate LVEF from non-invasive arterial waveforms measured by an iPhone [17]. Recently, a wireless handheld prototype device (Vivio) capable of simultaneous collection of arterial pulse waveform and phonocardiogram data from the carotid artery was proven to accurately estimate LVEF using the IF method in a large study of adult patients with anthracycline exposure secondary to treatment of childhood cancer [18]. The Vivio requires little time as well as minimal training for use and was shown to measure LVEF more accurately than echocardiogram, with results comparable to the gold standard of cardiac MRI [18].…”

“…Recently, a wireless handheld prototype device (Vivio) capable of simultaneous collection of arterial pulse waveform and phonocardiogram data from the carotid artery was proven to accurately estimate LVEF using the IF method in a large study of adult patients with anthracycline exposure secondary to treatment of childhood cancer [18]. The Vivio requires little time as well as minimal training for use and was shown to measure LVEF more accurately than echocardiogram, with results comparable to the gold standard of cardiac MRI [18]. Given the range of neck sizes within the pediatric population, the Vivio was modified in this study to create both a smaller device head to fit more easily in small necks as well as a larger but more sensitive device to help reduce the amount of hand pressure required to collect a pulse signal.…”

“…This study explores whether the Vivio can be utilized in collecting carotid pressure waveforms and computing IFs in a pediatric population. The objectives of this study are to 1) evaluate whether the Vivio can be used to collect carotid artery waveforms required for IF calculations in patients ages 0 to 19 years; 2) compare the performance of two different sensor head geometries, one larger and one smaller, in a pediatric population to the standard sensor head size [18]; and 3) compare the range of intrinsic frequencies derived from the Vivio between different pediatric age groups and between children and adults with normal LV function.…”