Alessandro Vivacqua1, John Robinson2, Amr E Abbas3, Jeffrey M Altshuler3, Francis L Shannon3, Robert H Podolsky4, Marc P Sakwa3. 1. Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich. Electronic address: Alessandro.Vivacqua@beaumont.edu. 2. Wayne State University School of Medicine, Detroit, Mich. 3. Department of Cardiovascular Surgery, Beaumont Hospital, Royal Oak, Mich. 4. Beaumont Research Institute, Royal Oak, Mich.
Abstract
OBJECTIVE: The present prospective noninferiority randomized trial was designed to demonstrate the safety and efficacy of a single dose of Custodiol histidine-tryptophan-ketoglutarate compared with repetitive cold-blood cardioplegia. METHODS:From October 2012 to May 2014, 110 patients were randomly assigned to 1 of 2 groups: Group 1 (55 patients) received repetitive cold-blood cardioplegia, and group 2 (55 patients) received single-dose Custodiol histidine-tryptophan-ketoglutarate. Isolated aortic valve replacement, isolated mitral valve replacement, and multivalve procedures represented the most frequent operations, with 39 cases (71%) in group 1 and 49 cases (89%) in group 2. There was no difference in cardiopulmonary bypass time (102 ± 26 minutes vs 99 ± 19 minutes, P = .70) or aortic crossclamp time (77 ± 19 minutes vs 74 ± 17 minutes, P = .33). All patients underwent preoperative electrocardiogram and determination of creatine kinase-MB, troponin I, left ventricular ejection fraction, and regional wall motion. Postoperative cardiac biomarkers were checked at 7, 24, and 48 hours, and an echocardiogram was obtained to check for left ventricular function abnormalities. RESULTS: There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23). Left ventricular function was similar between groups preoperatively and at 24 hours after surgery. No death or myocardial infarction was observed in either group. There were no differences in intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels. CONCLUSIONS: A single dose of Custodiol histidine-tryptophan-ketoglutarate cardioplegia is not inferior to repeated cold-blood cardioplegia during elective cardiac surgery.
RCT Entities:
OBJECTIVE: The present prospective noninferiority randomized trial was designed to demonstrate the safety and efficacy of a single dose of Custodiol histidine-tryptophan-ketoglutarate compared with repetitive cold-blood cardioplegia. METHODS: From October 2012 to May 2014, 110 patients were randomly assigned to 1 of 2 groups: Group 1 (55 patients) received repetitive cold-blood cardioplegia, and group 2 (55 patients) received single-dose Custodiol histidine-tryptophan-ketoglutarate. Isolated aortic valve replacement, isolated mitral valve replacement, and multivalve procedures represented the most frequent operations, with 39 cases (71%) in group 1 and 49 cases (89%) in group 2. There was no difference in cardiopulmonary bypass time (102 ± 26 minutes vs 99 ± 19 minutes, P = .70) or aortic crossclamp time (77 ± 19 minutes vs 74 ± 17 minutes, P = .33). All patients underwent preoperative electrocardiogram and determination of creatine kinase-MB, troponin I, left ventricular ejection fraction, and regional wall motion. Postoperative cardiac biomarkers were checked at 7, 24, and 48 hours, and an echocardiogram was obtained to check for left ventricular function abnormalities. RESULTS: There was no difference in cardiac biomarkers release between the 2 groups at baseline and 7, 24, and 48 hours postoperatively (creatine kinase, P = .18, troponin P = .23). Left ventricular function was similar between groups preoperatively and at 24 hours after surgery. No death or myocardial infarction was observed in either group. There were no differences in intensive care unit length of stay, incidence of atrial fibrillation, use of inotropes or vasopressors support, time of intubation, or creatinine levels. CONCLUSIONS: A single dose of Custodiol histidine-tryptophan-ketoglutarate cardioplegia is not inferior to repeated cold-blood cardioplegia during elective cardiac surgery.
Authors: Claudiu Ghiragosian; Marius Harpa; Alexandra Stoica; Flămînd Oltean Sânziana; Radu Bălău; Hussam Al Hussein; Ghiragosian-Rusu Simina Elena; Radu Mircea Neagoe; Horațiu Suciu Journal: J Cardiovasc Dev Dis Date: 2022-06-02