Introduction: Decompensation of heart failure may manifest as pulmonary congestion or edema – an acute increase in extravascular lung fluid. No direct, reliable, simple and non-invasive method is available for accurate assessment of thoracic fluids. KYMA developed a miniature external patch device, monitoring thoracic fluid content by analyzing electromagnetic ("radar") signals, propagated through tissue layers. Following Positive pre-clinical animal studies we now compared KYMA's non-invasively measured Lung water index (KLWI) with Picco device invasive thermodilution based assessment of extravascular lung water in ICU patients
Methods: AS PiCCO is extremely invasive thus not generally used in acute CHF patients. We recruited patients in a respiratory ICU where invasive monitoring of lung water content was clinically indicated. KYMA lung water index were compared to invasive PICCO thermodilution based extravascular lung volume water (EVLW) as the reference gold standard.
Results: data for 12 patients is available, 50% male age 65 ± 16. Between 4 and 12 data points per patient (total 125 measurement points), each data point include PiCCO lung water reading and concurrent, simultaneous, KYMA patch reading. The KYMA patch performed well, no side effects or interference to ICU monitors/workflow.
A consistent linear correlation between measurements of invasive EVLW and non-invasive Kyma KLWI was found (Figure).
KYMA's system lung water accuracy was in range of 60-70cc while the change in fluid content between normal and congested lung ranges between 250cc and 500cc
Conclusions– KYMA's external, miniature patch device yielded a lung water fluid index with excellent correlation to invasive measurement in a clinical ICU setting. The demonstrated accuracy of the Kyma technology supports its use for high resolution precise thoracic fluid monitoring. Such a device may improve in-hospital management, and potentially reduce Re-hospitalizations For ambulatory CHF patients. Ambulatory clinical trials with the Kyma patch are on-going
