Abstract
Rational and Objectives
Non-invasive cardiac output (CO) measurements are essential during the immediate post-operative course of young, congenital heart repaired patients. The use of the Ultrasonic Cardiac Output Monitor (USCOM) in pediatric intensive care units (PICU) is increasing. The literature on accuracy of USCOM in young, critically ill, mechanically ventilated, hemodynamically supported patients is scarce. We aimed to assess agreement between the USCOM device and echocardiography for measurements of CO in this population.
Materials (Patients) and Methods
A prospective observational study in a pediatric cardiac intensive care unit (PCICU). Paired CO measurements were taken in young, mechanically ventilated, immediate post-operative patients with exclusion of unrepaired or residual intra-cardiac shunt, using USCOM and echocardiography, by two separate senior performers. Agreement between echocardiography and USCOM was assessed by percentage error and Bland-Altman analysis.
Results
One hundred and thirteen comparison scans were performed on 61 patients: mean age 94 ± 111 d, weight 4.7 ± 2.1 kg, vaso-inotropic score 15.3 ± 11, and STAT score 3–4 (46%). Mean USCOM cardiac index (CI) percent difference was −9.6% (45.6) and velocity-time-integral (VTI) 8.9% (34.7). Bland–Altman analyzes demonstrated poor agreement comparing USCOM to echocardiography with regard to CI, stroke volume (SV), VTI and aortic diameter (AO) measurements.
Conclusion
Our study shows that USCOM underestimates CI in comparison with echocardiography; therefore USCOM should be used with great caution as an absolute estimate or surrogate of CI in neonates and infants in the immediate post-operative, congenital heart surgery period.
Introduction
In pediatric patients undergoing cardiac surgery, hemodynamic management is extremely important. Cardiopulmonary bypass induces capillary leakage and inflammatory reaction, thus contributing to postoperative hemodynamic instability. 1 The ability to measure cardiac output (CO) may allow early detection of circulatory impairment, guide therapeutic decisions, and improve outcome in critically-ill infants. 2
The ultrasonic CO monitor (USCOM, Sydney, Australia) is a noninvasive hemodynamic monitoring system using continuous wave Doppler interrogation of blood flow in the ascending aorta. Benefits include portability, safety, dynamic monitoring, and ease of operation, but accuracy and precision in perioperative and critical care settings vary. Chong et al's meta-analysis calculated pooled mean bias, precision, and percentage error in six adult studies, 3 concluding that USCOM achieved good agreement with bolus thermodilution similar to other minimally invasive methods of perioperative CO monitoring, and may be useful. Literature on role and accuracy of USCOM in children is scarce with few studies assessing its utility in different pediatric populations,4‐6 mostly with stable hemodynamics; there are fewer evaluations of mechanically ventilated, inotropic supported, cardiac postoperative pediatric patients.
Our aim was to compare and assess USCOM accuracy and precision in young pediatric patients in the immediate post-operative cardiac surgery period.
Materials and Methods
Study Design and Patients Enrollment
This was a prospective diagnostic study, conducted in a pediatric cardiac intensive care unit (PCICU) of a tertiary level, university-affiliated, pediatric hospital. The study was approved by the local ethics and research committee. Written informed consent was provided by all parents. Inclusion criteria were infants who underwent repair of a congenital heart defect at age <1.5 years; needed postoperative mechanical ventilation with tidal volumes 7–10 cc/kg, positive end expiratory pressure (PEEP) 5–8 cm H2O, and adequate sedation with/without muscle paralysis with no additional breaths; and who had repaired cardiac lesions without residual shunt, and normal aorta and aortic valve anatomy. Exclusion criteria were parental refusal to give consent, delayed sternal closure, tracheostomy (inadequate area for USCOM probe placement), presence of unrepaired or residual intra-cardiac shunt, presence of arrhythmia, and need for high frequency ventilation or extracorporeal membrane oxygenator (ECMO) support. These narrow criteria limits were selected after thorough literature search for possible confounders for CO Doppler measurements and mechanical ventilation interference.
Study Protocol
Patients were enrolled in the first 48 hours post-surgery after obtaining parental consent. The following hemodynamic parameters were recorded at the same time point, in real-time during steady-state, from the bedside monitor (BeneVision N22, Mindray Bio-Medical Electronics, Ltd, Shenzhen, China): arterial line pressures, heart rate, and central venous pressure (CVP). CVP was obtained in supine position, via pressure transducer connected to an internal jugular central line with its tip located at the RA/SVC junction.
Sonographic scanning was performed by two different physicians. USCOM Doppler scans, followed by surface echocardiography, were performed in series, immediately, within minutes. The USCOM sonographer, and echocardiography physician were blinded to the results of each other.
The USCOM 2.2 MHz transducer was placed at the patient's suprasternal notch area with slight leftward and anterior adjustment in order to record the optimal aortic continuous wave Doppler flow pattern. 7 The most accurate Doppler blood flow interrogation was selected. Three consecutive independent tests were performed within a period of 5 min, and the average of the results recorded for the following parameters: Cardiac Index (CI), stroke volume (SV), Stroke Volume Index (SVI), velocity-time-integral (VTI), and aortic diameter (AO). USCOM AO was derived from the provided database using age, height, and weight parameters.
Echocardiography (Z.One PRO, Zonare Medical Systems Inc., NY, USA) was performed using a C10-3 curved phased array probe for neonates, and P4-1c phased array probe for infants and toddlers. The inner diameter of the aortic valve annulus was measured by 2-dimensional echocardiography from parasternal long-axis or substernal view (chose the best imaging) during diastole. From the apical five-chamber view, a pulsed-wave Doppler interrogation of the aortic blood flow above the aortic valve was done. No change in insonantion angle was required. The highest velocity was measured as peak velocity (Vpeak) and the average velocity-time integral (VTI) was calculated by tracing the outer contour of the Doppler envelope over three heart cycles. All echocardiographic assessments were performed by a senior pediatric cardiologist and intensivist (OS), following the previously described standard recommendations.
8
CI was calculated using the following formulas:
Comparisons and Statistical Analysis
The statistical analysis for this paper was generated using SAS Software, Version 9.4 (IBM Corp., Armonk, NY, USA).
Continuous variables were presented as Mean ± Std, and categorical variables as (N, %).
Bland Altman analysis was used to estimate agreement between parameters measured by the two methods.
Results
One hundred and thirteen comparison scans were performed on 61 patients. Demographic and clinical characteristics are presented in Table 1. All patients were mechanically ventilated and properly sedated with no additional breaths. Mean tidal volume was 9 cc/kg (±2), mean PEEP was 5 cmH2O (±0), and all patients had sinus rhythm. No mortality occurred during the study period. Summary of the compared parameters is presented in Table 2. Comparing USCOM to Echocardiography yielded a mean CO difference of −0.24 (±0.95) L/min, mean CI difference of −1.01 (±2.6) L/min/m2, mean SV difference of −1.53 (±5.86) cc, and mean VTI difference of 0.37 (±4.75) cm. Bland–Altman analyzes demonstrated poor agreement comparing USCOM to echocardiography in CI, SV, and VTI measurements (Figures 1–3). Comparison of the aortic valve diameter measured by echocardiography with aortic valve diameter estimated by the USCOM also yielded poor agreement (Figure 4). Mean AO difference was 0.08 (±0.15) cm. In order to rule-out the confounding effect of AO discrepancy on hemodynamic variable calculations, we performed multiple regression analyzes and calculated a correction formula to the USCOM derived AO. We used USCOM VTI and SV measurements in order to calculate “corrected” USCOM CI. The corrected CI was also found to have poor agreement with the echocardiography derived CI (Figure 5).

Bland–Altman analysis comparing USCOM to echocardiography for cardiac index (CI) measurements.

Bland–Altman analysis comparing USCOM to echocardiography for stroke volume (SV) measurements.

Bland–Altman analysis comparing USCOM to echocardiography for velocity-time integral (VTI) measurements.

Bland–Altman analysis comparing USCOM aortic diameter (AO) to echocardiography measurements.

Bland–Altman analysis comparing corrected USCOM cardiac index (USCOM corrected CI) to CI by echocardiography. Using multiple regression analyzes we found a correction formula for the USCOM derived aortic diameter. We used USCOM VTI and SV measurements in order to calculate “corrected” USCOM CI.
Demographic and Clinical Parameters of the Study Cohort.
Abbreviations: TOF, Tatrallogy Of Fallot; TGA, transposition of the great arteries; VSD, Ventriculo-Septal Defect; AVSD, Atrio-Ventricular septal defect; TAPVR, Total Anomalous Pulmonary Venous Return.
Comparison Parameters.
Abbreviations: CO, cardiac output; CI, cardiac index; SV, stroke volume; VTI, velocity time integral.
Left ventricular outflow measurements.
Discussion
This study demonstrated that USCOM underestimated CI in comparison with echocardiography, and had poor agreement of VTI, SV, and AO in the setting of mechanically ventilated, immediate postoperative pediatric cardiac intensive care population. These finding cannot be explained solely by diameter discrepancy, as poor agreement was repeated after AO correction by multiple regression analysis.
Literature on the role and accuracy of USCOM in children is scarce with few studies assessing its utility in different pediatric populations. Studies in the neonatal population found that agreement between the USCOM device and conventional echocardiography is poor. Patel et al 9 found a mean percentage error of 43% for left ventricular output, higher by USCOM. Fraga et al 4 demonstrated overestimation in CO by USCOM, as compared with echocardiography. Both studies concluded that USCOM is not adequate for use as an absolute estimate of CO in healthy neonates. Both studies demonstrated higher VTI as assessed by USCOM, a similar finding to our study. Both studies enrolled healthy neonates aged ∼2 weeks old with a mean weight of 3–3.5 kg. One study had 46% mechanical ventilated patients, and the other no data regarding ventilation status. Chaiyakulsil et al 10 studied 121 children in a critical care setting, mean age of 4.9 years and weight 19.8 kg, stable hemodynamics, and 31.4% of them mechanically ventilated. They found that USCOM underestimated CI compared with echocardiography and electrical velocimetry, with 21% error. SVV had 257.1% error, VTI 12.7% error, and aortic valve diameter was smaller with 9.2% error. They concluded that the three noninvasive methods might be used interchangeably in pediatric critical care settings with stable hemodynamics. Wongsirimetheekul et al 6 compared CO estimation between USCOM and echocardiography in 34 pediatric intensive care unit (PICU) patients with mean age 7.8 years and weight of 27.1 kg. Their study confirmed that CO from the USCOM tended to be overestimated in comparison with surface echocardiography, especially in pediatric septic shock patients. Percentage error of CI and VTI were 42.3% and 32%, respectively. They concluded that the USCOM could not be used as a reliable tool for the absolute value measurement of CO and cardiac index in a pediatric population, especially in patients with septic shock. Beltramo et al 11 studied 31 patients, with mean age of 12 years and weight of 46 kg. Only two patients were mechanically ventilated. They assessed the accuracy of CO measurements obtained by USCOM as compared to pulmonary artery thermodilution in hemodynamically stable children with normal cardiac anatomy. The mean percentage error of CO between techniques was 11%. The authors concluded that USCOM is a reliable tool to assess hemodynamic status in pediatric patients with no intracardiac shunts, and that further studies are needed to validate its usefulness in neonates, patients with congenital heart defects, and pediatric patients with both high and low COs as in shock states. Our study demonstrated similar results with studies conducted on young, hemodynamically unstable, mechanically ventilated pediatric patients. This literature review raises a concern that younger patients, mechanically ventilated and possibly hemodynamically unstable, may cause inaccuracy in USCOM CO measurements.
When inspecting the Bland-Altman plots of VTI, CI and AO diameter, one can interpret that USCOM underestimated AO-diameter in comparison with echocardiography in patients with AO-diameter >1.0 cm and overestimated AO-diameter in patients with AO-diameter less than 0.8 cm and the same pattern with VTI interpretation. In order to rule-out the confounding effect of extreme variables on hemodynamic calculations, and put the analyzes within the daily practical range, we performed the above analyzes on patients with “average physiological” range of CO – 1.5–4.5 L/min, or CI 2–7 L/min/m2. 12 The BA plots of CI were found to have poor agreement with the echocardiography derived CI.
In order to overcome a systematic mistake generated from a predefined table-derived USCOM AO diameter, we used Echo-derived AO-diameter and performed multiple regression analyzes and calculated a correction formula to the USCOM derived AO. We used USCOM VTI and SV measurements in order to calculate “corrected” USCOM CI. The corrected CI was also found to have poor agreement with the echocardiography derived CI (Figure 5).
As the clinical purpose of the USCOM monitor is to analyze the current CI of the critically ill child at the bedside, and the AO diameter, SV and VTI are only the measures, in the practical clinical setting, USCOM had poor agreement with echocardiography.
Possible Mechanisms for Errors
While USCOM uses continuous waved Doppler (CWD) measurements for VTI, echocardiography uses pulse waved Doppler (PWD). CWD will identify and measure the highest VTI along the entire path of the ultrasound beam. Conversely, in PWD the cursor is set to measure the velocity obtained at the valve annulus.
The main contributors to the variability found in CO measurements used to determine the VTI are valve outflow area (diameter) and angle of insonation. 12 Mal-positioning of the Doppler probe and failure to optimize angles of insonation of the Doppler beam may induce errors in VTI assessments. Patients with congenital heart malformation, especially post-surgical repair, may have different left ventricular output tract orientation and axis. Using the “blind” wave shape orientation during USCOM VTI measurements may explain the inaccuracies compared with echocardiography.
Study Limitations
This study has several limitations including the relatively small number of measurements. Power analysis could not be performed accurately due to the lack of normal/expected values of USCOM parameters in young, mechanically ventilated, post-operative cardiac pediatric patients at the time of study commencement. Echocardiography has its own limitations, and is not the gold-standard measurement for CO or VTI. Our goal was to test USCOM in “real life” practical clinical use, in which pulmonary artery catheters are no longer used, and cath-labs have different hemodynamic settings. Some of the cardiac defects studied has a “non-normal” aortic valve (transposition of the great arteries (TGA), Tatrallogy Of Fallot (TOF)), which can lead to inaccuracy in CO calculation. We tried to overcome this limitation by AO diameter correction formula. Furthermore, it is important to learn and study on the “real life” population in PCICU.
Conclusion
Our study shows that USCOM underestimates CI in comparison with echocardiography; therefore USCOM should be used with great caution as an absolute estimate or surrogate of CI in neonates and infants in the immediate post-operative, congenital heart surgery period.
Footnotes
Acknowledgments
We thank Debby Mir for medical language, manuscript review, and editing.
Author Contributions
All authors contributed to the study conception and design. Material preparation, Doppler and echocardiography measurements, data collection and analysis were performed by Eran Shostak, and Ofer Schiller. The first draft of the manuscript was written by Eran Shostak and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Ethical Approval
The study was approved by the local ethics and research committee (RMC 0693-14). Written informed consent was provided by all parents.
Availability of Data and Material
All data and materials comply with field standards.
