OBJECTIVE: Celsior is a crystalloid solution specifically designed for solid-organ transplantation. Due to its advanced combination of solutes, we wanted to evaluate its safety, efficacy, and possible benefits when used as blood cardioplegia in elective cardiac surgery in a single-center, randomized, controlled clinical trial, comparing its performance with a well-established cardioplegic solution. METHODS:Patients programmed for aortic valve replacement were randomized to receive either St. Thomas No. 2 or Celsior as blood cardioplegia with the same administration protocol. Intraoperative and postoperative variables concerning myocardial protection were registered and compared. RESULTS: A total of 60 patients were enrolled and randomized (Celsior, 30; St. Thomas, 30). There were no significant differences in baseline and preoperative variables. Volume of cardioplegic solution, number of administrations needed and the amount of potassium added were similar in both groups. Patients in the Celsior group showed a higher incidence of spontaneous sinus rhythm after myocardial ischemia (77% vs 40%, p=0.004) and fewer patients required defibrillation (17% vs 43%, p=0.024) for ventricular reperfusion arrhythmias. Postoperatively, there were no significant differences in troponin I release, inotropic and vasopressor drug support, ICU stay, and postoperative evolution. There were no deaths in the study. CONCLUSIONS:Celsior solution used as blood cardioplegia is effective and seems to be safe in elective aortic valve replacement when compared in this pilot study with a standard cardioplegic solution used worldwide. Fast return to sinus rhythm and lower incidence of reperfusion arrhythmias in the Celsior group may reflect a better myocardial protection during cardioplegic arrest. More investigation is needed to elucidate its performance in elective surgery.
RCT Entities:
OBJECTIVE: Celsior is a crystalloid solution specifically designed for solid-organ transplantation. Due to its advanced combination of solutes, we wanted to evaluate its safety, efficacy, and possible benefits when used as blood cardioplegia in elective cardiac surgery in a single-center, randomized, controlled clinical trial, comparing its performance with a well-established cardioplegic solution. METHODS:Patients programmed for aortic valve replacement were randomized to receive either St. Thomas No. 2 or Celsior as blood cardioplegia with the same administration protocol. Intraoperative and postoperative variables concerning myocardial protection were registered and compared. RESULTS: A total of 60 patients were enrolled and randomized (Celsior, 30; St. Thomas, 30). There were no significant differences in baseline and preoperative variables. Volume of cardioplegic solution, number of administrations needed and the amount of potassium added were similar in both groups. Patients in the Celsior group showed a higher incidence of spontaneous sinus rhythm after myocardial ischemia (77% vs 40%, p=0.004) and fewer patients required defibrillation (17% vs 43%, p=0.024) for ventricular reperfusion arrhythmias. Postoperatively, there were no significant differences in troponin I release, inotropic and vasopressor drug support, ICU stay, and postoperative evolution. There were no deaths in the study. CONCLUSIONS: Celsior solution used as blood cardioplegia is effective and seems to be safe in elective aortic valve replacement when compared in this pilot study with a standard cardioplegic solution used worldwide. Fast return to sinus rhythm and lower incidence of reperfusion arrhythmias in the Celsior group may reflect a better myocardial protection during cardioplegic arrest. More investigation is needed to elucidate its performance in elective surgery.