The Journal of ExtraCorporeal Technology No 57-2 | Page 56

H. M. da Rocha Coutinho et al.: J Extra Corpor Technol 2025, 57, 105 – 112 107

Figure 1. A: detailed depiction of the valve design; a central plug connected by rods equidistant to an outer circumference sized to equalize the line passage area, resulting in a smaller rod passage area and inlet and outlet connections 3 / 8”. This design, resembling a cartwheel, inspired the piece’ s name. B: SafeCEC Ò drawing showing the housing profile. C: Illustrative image from SafeCEC.

ranges from 0 to 1, with values between 0.10 and 0.29 denoting a small effect, 0.30 to 0.49 a medium effect, and 0.50 or greater indicating a large effect [ 18 ].

All statistical analyses were conducted using IBM SPSS Statistics version 29( IBM Corporation, Armonk, NY, 113 USA) and Jamovi software( The Jamovi Project, 2023). A significance threshold of p < 0.05 was applied throughout [ 19 ]. We did not use the t-test because the hemoglobin data did not have a normal distribution; and with a small sample size, it was even more important to use other tests, in this case, non-parametric tests, which is what we did, using the Mann- Whitney test. Pilot studies do not aim to have high power to detect differences, but rather to assess the feasibility of the research, so that a larger study can be conducted later.

Results

The results of this study showed that the use of SafeCEC Ò in CPB with a centrifugal pump did not have a significant impact on hemolysis, compared to the conventional circuit. The perfusionist routinely uses clamps to close the arterial line when operating the heart-lung machine. With the use of SafeCEC Ò, it was observed that it was not necessary to use clamps, because when the perfusionist reduced the pump rotation and consequently, the blood flow, the valve acted immediately, preventing the occurrence of reflux and without the need to clamp the arterial line. This increases the feeling of safety and eliminates a task for the perfusionist in the CPB operation.

Exploratory data analysis included the descriptive statistics mean and standard deviation. To analyze the behavior of continuous variables, descriptive statistics and the Shapiro- Wilk test for normality assumption were considered. Among the 31 patients recruited, 22 were male( 71 %) and 9 were female( 29 %). The mean age of this study population was 59.9 ± 12.4 years( Table 1). The mean CPB time was 102.8 ± 40.5 min, and the mean aortic clamping time was 80.33 ± 33 min( Table 2).

Table 1. Summary of demographic data for study participants.

Categorical variables are described as numbers( percentages); continuous variables are described as mean ± standard deviation.

The mean baseline plasma free hemoglobin before CPB was 0.02 ± 0.17 mg / dL and after CBP was 0.08 ± 0.48 mg / dL, with a mean variation of 0.06 mg during CPB. However, after 24 h, levels returned to baseline. To compare continuous variables between the two groups, Student’ s t-test was employed for parametric data. In cases where the data lacked homogeneity of variance, Welch’ s correction was used to interpret the results [ 16 ]. Cohen’ s d was used as the effect size, offering a statistical measure to quantify the difference between two groups in terms of standard deviations. Regarding the type of surgery performed, the vast majority of the studied population( 70.9 %) underwent coronary artery bypass grafting surgeries, alone or combined with other procedures. Table 3 shows the categorical variables related to surgery.

Bivariate analysis of demographic and clinical variables by group

According to Table 4, therewasnosignificant difference in hemolysis or plasma free hemoglobin concentration between groups. In group A, Group A( SafeCEC), the mean plasma hemoglobin after CPB was 0.08 ± 0.05 versus 156 0.07 ± 0.05 in group B. Group A had two indications for blood transfusion versus three indications in group B. There was one death in group A, but the cause was unrelated to the use of the SafeCEC Ò valve and plasma hemoglobin data were