Observational study

The use of Normacor and Custodiol in protecting the heart in patients with acute coronary syndrome and coronary heart disease

Benefits of normothermic blood cardioplegia in high-risk patients
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Clinical center
Voronezh Regional Clinical Hospital No. 1
Study design
Comparison of hypothermic cardioplegia (Custodiol, HTK) and normothermic blood cardioplegia (Normacor®)
Sample
613 patients
Normacor group
202 patients
Custodiol group
411 patients

Purpose of the study

Comparison of normothermic blood cardioplegia and cold cardioplegia for myocardial protection in high-risk patients.

1

Spontaneous restoration of heart rhythm was observed more often in patients in the Normacor group

Spontaneous restoration of heart rhythm in the Normacor® group occurred in 95.50% of cases versus 17.80% of cases in the Custodiol group.

Spontaneous restoration of cardiac rhythm
95,50%
Normacor
17,80%
Custodiol
2

The need for cardiotonic support was significantly lower when using Normacor

The need for cardiotonic support was significantly higher among patients in the Custodiol group, requiring it in 100.00% of cases. In the Normacor® group, cardiotonic support was required in 172 patients (15.00% of cases).

Need for cardiotonic support
15,00%
Normacor
100,00%
Custodiol
3

The need for increased doses of Dopamine was less frequent in the Normacor group

After cardioplegia, Normacor required dopamine significantly less (p<0.01). Dopamine dose after CPB: Normacor - 4.94±2.78 mcg/kg/h, Custodiol - 6.89±1.83 mcg/kg/h.

Dopamine after CPB (mcg/kg/h)
4,94±2,78
Normacor
6,89±1,83
Custodiol
4

The volume of postoperative exudate during normothermia (Normacor) was less than during hypothermia (Custodiol)

The volume of exudate discharged through the drains was greater in the Custodiol group—678.13±10.27 ml, versus 563.93±9.48 ml in the Normacor group (p<0.001). This was due to hemodilution and the negative impact of cold on the blood coagulation properties.

Volume of exudate through drainage, ml
563,93±9,48
Normacor
678,13±10,27
Custodiol
5

Cognitive impairment test

In the Normacor group, 78% of patients scored at least 28 on the clock drawing test and MMSE after 24 hours, and 95% returned to their preoperative status. In the Custodiol group, only 44% scored 28 on the clock drawing test after 24 hours, compared to 81% by 48 hours. Cognitive recovery after 24 hours was 4.66 times higher in the Normacor group than in the Custodiol group (p=0.0000044).

Normacor · ≥28 points after 24 h

78%
yes 78%no 22.00%

Normacor · returned to status

95%
yes 95%no 5.00%

Custodiol · ≥28 points after 24 h

44%
yes 44%no 56.00%

Custodiol · returned to status (48 h)

81%
yes 81%no 19.00%

Conclusion

The use of Normacor solution for blood cardioplegia during CABG surgery promotes spontaneous restoration of cardiac contractile function and provides reliable myocardial protection with a low need for cardiotonic support.

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