The Journal of ExtraCorporeal Technology No 57-2 | Página 58

H. M. da Rocha Coutinho et al.: J Extra Corpor Technol 2025, 57, 105 – 112 109
Table 4. Comparative analyses of clinical variables by group.
Variable
Group
N
Mean ± SD
P-value
Effect size
CPB time
A
15
111.1 ± 44.3
0.439
0.167
B
16
95 ± 36.3
Aortic clamping time
A
14
83.6 ± 33.1
0.506
0.147
B
16
76.9 ± 33.8
Initial hemoglobin level
A
15
10.4 ± 1.8
0.419 *
�0.295
B
16
11.1 ± 3
Final hemoglobin level
A
15
10.8 ± 5.5
0.937
0.021
B
16
9.5 ± 2
Initial hematocrit level
A
15
29.8 ± 7.8
0.293 *
�0.385
B
16
33.1 ± 9.1
Final hematocrit level
A
15
28 ± 2.5
0.443 * W
�0.278
B
16
29.3 ± 6.2
Plasma free hemoglobin before CPB
A
14
0.02 ± 0.01
0.5
0.138
B
16
0.02 ± 0.02
Plasma free hemoglobin after CPB
A
14
0.08 ± 0.05
0.451
0.165
B
16
0.07 ± 0.05
Plasma free hemoglobin 24 h after CPB
A
14
0.03 ± 0.02
0.201
0.263
B
16
0.02 ± 0.01
SD: standard deviation; ES: effect size: Mann-Whitney test( effect size: r biserial point). * Student’ s t-test( Cohen’ s d); w Welch’ s correction; Welch’ s correction was applied due to violation of homogeneity of variances. y
Table 5. Comparative analyses of clinical variables by group.
Variable
Group
N
Mean ± SD
P-value
Effect size
CPB time
A
15
111.1 ± 44.3
0.439
0.167
B
16
95 ± 36.3
Aortic clamping time
A
14
83.6 ± 33.1
0.506
0.147
B
16
76.9 ± 33.8
Initial hemoglobin level
A
15
10.4 ± 1.8
0.419 *
�0.295
B
16
11.1 ± 3
Final hemoglobin level
A
15
10.8 ± 5.5
0.937
0.021
B
16
9.5 ± 2
Initial hematocrit level
A
15
29.8 ± 7.8
0.293 *
�0.385
B
16
33.1 ± 9.1
Final hematocrit level
A
15
28 ± 2.5
0.443 * W
�0.278
B
16
29.3 ± 6.2
Plasma free hemoglobin before CPB
A
14
0.02 ± 0.01
0.5
0.138
B
16
0.02 ± 0.02
Plasma free hemoglobin after CPB
A
14
0.08 ± 0.05
0.451
0.165
B
16
0.07 ± 0.05
Plasma free hemoglobin 24 h after CPB
A
14
0.03 ± 0.02
0.201
0.263
B
16
0.02 ± 0.01
SD: standard deviation; ES: effect size: Mann-Whitney test( effect size: r biserial point). * Student’ s t-test( Cohen’ s d); w Welch’ s correction; Welch’ s correction was applied due to violation of homogeneity of variances. y y
y y
y
y
y
y
y
y
y
y
y natural selection of the spleen, physicochemical imbalance [ 20 ], or by exposing cells to mechanical stress conditions [ 21 ], as observed during artificial blood pumping [ 22 ].
In the case of CPB, hemolysis occurs by mechanical stress, induced either by direct trauma from blood passage through rollers or exposure to different surfaces at different speeds. Centrifugal pumps, favored by Brazilian perfusionists, offer an alternative to roller pumps. Thus, measurement of hemolysis serves as a sensitive means to assess the safety of a medical device added into the arterial line of the CPB circuit.
Evaluation with pre-CPB, post-CPB and 24-hour measurements is an appropriate method for the clinical evaluation of SafeCEC Ò.
According to the article Estatística Cardiovascular – Brasil 2021, published in the journal Arquivos Brasileiros de Cardiologia, in 2019, 79,590 cardiac surgeries were performed in Brazil, with 46,362( 58.2 %) involving CPB and 33,228( 41.8 %) without CPB [ 18 ]. We estimate that 30 – 40 % of surgeries with CPB have used a centrifugal pump, equating to 15,000 – 18,000 surgeries, or possibly even a higher number [ 23 ]. This shows the significant exposure to the risk of blood reflux associated with the use of a centrifugal pump in case of mechanical failure or delay in clamping the arterial line.
The uncertainty surrounding the safety of centrifugal pumps has led organizations such as the American Society of ExtraCorporeal Technology, the Society of Clinical Perfusion