Agreement Between Cardiac Output Estimation with a Wireless, Wearable Pulse Decomposition Analysis Device and Continuous Thermodilution in Post Cardiac Surgery Intensive Care Unit Patients

Purpose: Pulse Decomposition Analysis (PDA) uses integration of the systolic area of a distally transmitted aortic pulse as well as arterial stiffness estimates to compute cardiac output. We sought to assess agreement of cardiac output (CO) estimation between continuous pulmonary artery catheter (PAC) guided thermodilution (CO-CCO) and a wireless, wearable noninvasive device, (Vitalstream, Caretaker Medical, Charlottesville, VA), that utilizes the Pulse Decomposition Analysis (CO-PDA) method in postoperative cardiac surgery patients in the intensive care unit.

Methods: CO-CCO measurements were compared with post processed CO-PDA measurements in prospectively enrolled adult cardiac surgical intensive care unit patients. Uncalibrated CO-PDA values were compared for accuracy with CO-CCO via a Bland-Altman analysis considering repeated measurements and a concordance analysis with a 10% exclusion zone.

Results: 259.7 h of monitoring data from 41 patients matching 15,583 data points were analyzed. Mean CO-CCO was 5.55 L/min, while mean values for the CO-PDA were 5.73 L/min (mean of differences +- SD 0.79 ± 1.11 L/min; limits of agreement - 1.43 to 3.01 L/min), with a percentage error of 37.5%. CO-CCO correlation with CO-PDA was moderate (0.54) and concordance was 0.83.

Conclusion: Compared with the CO-CCO Swan-Ganz, cardiac output measurements obtained using the CO-PDA were not interchangeable when using a 30% threshold. These preliminary results were within the 45% limits for minimally invasive devices, and pending further robust trials, the CO-PDA offers a noninvasive, wireless solution to complement and extend hemodynamic monitoring within and outside the ICU.