Pilot study on the utilization of a non-invasive µCor device for monitoring fluid status and cardiac biomarkers during treatment for patients with hematologic malignancies.
Authors: Ali Abdelrahman , Pierce Elizabeth , Song Juhee , Koutroumpakis Efstratios , Palaskas Nicolas , Deswal Anita , Daver Naval Guastad , Kadia Tapan M. , Jain Nitin , Yilmaz Musa , Borthakur Gautam , Hammond Danielle , Iliescu Cezar , Pemmaraju Naveen 
Published: June 2024

e18507

Background: The management of acute leukemia and blastic plasmacytoid dendritic cell neoplasm (BPDCN) poses substantial clinical challenges, notably the risk of volume overload due to capillary leak syndrome (CLS), pneumonia, and hypoalbuminemia-induced third spacing. A non-invasive, real-time fluid status assessment tool, offering significant clinical advantages during the vulnerable induction chemotherapy phase, is of paramount importance. This is the first study to evaluate the tolerability and usability of the µCor device (FDA approved in general patient populations) to predict such clinical events over a six-month period in patients with hematologic malignancies. Methods: In this prospective, single-arm, observational pilot study at a tertiary cancer center, the µCor Device—a non-invasive wearable sensor—employs radiofrequency signals to measure the Thoracic Fluid Index (TFI), detecting fluid accumulation. We evaluated tolerability by recording device-related skin alterations and usability by monitoring the device's wear time. Scatter plots were generated to visually inspect the association between a pair of parameters. SAS 9.4 was used for data analysis. Results: Among the 30 patients initially recruited a subset of 26 provided data that was amenable to analysis. The median age was 62.5 years, with males constituting 53.8% of participants. Cardiovascular risk factors included hypertension (42.3%), diabetes mellitus, and hyperlipidemia (19.2%).Diagnoses included acute myelogenous leukemia (57.5%), acute lymphoblastic leukemia (11.5%), BPDCN (27%), and myelodysplastic syndrome (4%). Most participants received frontline induction therapy (61.5%), with 77% enrolled during inpatient admission. Baseline ejection fraction averaged 57.2% ± 9.6%, with a median NT-proBNP level of 236 pg/ml (35.5-1251 pg/ml). Attrition resulted from skin complications (23%), device maintenance (27%), and technical issues (8%). A statistically significant moderate positive partial correlation was observed between TFI and NT-proBNP (r=0.37, p < 0.0001; r=0.13, p=0.0049 for log-transformed NT-proBNP). Conclusions: This study confirms the µCor device's potential for monitoring fluid-related cardiac stress in hematologic malignancies. The correlation between TFI and NT-proBNP underscores its utility in early cardiac strain identification due to volume overload, infections, and CLS. We ascertained several important patient-related factors that led to decreased usage of this novel device which can be easily mitigated and addressed in future clinical trials. The findings advocate for extended investigations into this non-invasive cardiopulmonary monitoring system in larger patient cohorts within the hematologic malignancy domain.