Crystalloid hypothermic and blood normothermic cardioplegia

Blood normothermic cardioplegia demonstrates advantages over crystalloid cold cardioplegia. The crystalloid solution Custodiol and the innovative Normacor blood normothermic solution were compared.
Aim. To evaluate the efficacy and safety of the normothermic blood cardioplegic solution Normacor used in open heart surgery in comparison with the hypothermic crystalloid cardioplegic solution Custodiol.

Material and methods. An open comparative study of the efficacy and safety of Normacor in comparison with Custodiol was conducted. The study included 90 patients who were randomized to the cardioplegia group by Normacor or Custodiol in a 1:1 ratio. Of 90 patients, 85 patients completed the study according to the protocol, 40 patients in the Normacor group and 45 patients in the Custodiol group. For a comparative assessment of efficacy, the results of clinical observations during operations and in the postoperative period, indicators of arterial and venous blood tests, the number, duration and severity of adverse events were compared.

Results. When comparing the performance criteria, the difference between the Normacor and Custodiol groups is shown: cardiac arrest through asystole (not fibrillation) was more often observed in the Normacor drug group (p=0.032), rhythm recovery on its own without defibrillation was more often in the Normacor drug group (p<0.0001), cardiotonic support before the patient was taken to the intensive care unit was required less often in the Normacor drug group (p=0.045). When analyzing the parameters of arterial and venous blood, it was shown that the metabolism when using a cardioplegic solution Normacor is more physiological. In terms of quantity, duration, and severity of adverse events, the groups were comparable. The drug Normacor has shown its good tolerance and safety both in standard situations and in the case of intraoperative complications.

Conclusion. The totality of clinical trial data suggests a better protection of the heart with Normacor compared with Custodiol. Patient groups using Normacor and Custodiol were comparable in the number, duration, and severity of adverse events. In general, in a clinical trial, Normacor demonstrated good safety and tolerability, comparable to the data obtained in the Custodiol group of the drug. The drug Normacor has shown its good tolerance and safety both in standard situations and in the case of intraoperative complications. Normacor should be used not only in standard situations, but also in patients with a high risk of intraoperative complications, both from the cardiovascular system and in the presence of severe concomitant pathology.