Effect of Terminal Warm Blood Cardioplegia (Hotshot) on Vasoactive-Inotropic Score and Postoperative Arrhythmias in Pediatric Congenital Heart Surgery: A Double-Blind Randomized Controlled Trial
-
Mahmood Hosseinzadeh Maleki
,
Motahareh Zakian Galugahi
,
Ali Moradi
,
Mehdi Fathi
,
Nahid Zirak
,
Arezoo Orooji
,
Benyamin Fazli
,
Mohsen Yaghubi
Abstract
Background: Myocardial ischemia-reperfusion injury remains a major cause of morbidity after pediatric cardiac surgery. Terminal warm-blood cardioplegia (Hotshot) has demonstrated myocardial protective effects in adult populations. Nonetheless, its efficacy in congenital heart surgery, particularly regarding arrhythmia control and inotropic requirements, has not been established in randomized trials.
Methods: In this outcome-assessor-blinded, parallel-group randomized controlled trial, 100 pediatric patients (age, 1 month-6 years) with congenital heart defects (RACHS-1 categories 1 through 2) undergoing cardiopulmonary bypass were randomized 1:1 to receive either 2 minutes of antegrade warm-blood Hotshot (37 °C; 10 to 15 mL/kg) immediately before aortic cross-clamp removal (intervention group, n=50) or no intervention (control group, n=50). The primary outcome was the incidence of any postoperative arrhythmia requiring intervention. Secondary outcomes included the vasoactive-inotropic score (VIS) at 24 and 72 hours post-surgery, intensive care unit (ICU) length of stay, and mechanical ventilation duration. Analysis was performed on a per-protocol basis after excluding patients with protocol violations and withdrawal of consent. Statistical analyses were performed using SPSS software (version 24.0, SPSS Inc, Chicago, IL). A P value of less than .05 was considered statistically significant.
Results: A total of 96 patients (49 in the intervention group and 47 in the control group) completed the trial. The primary outcome, incidence of postoperative arrhythmias, showed a nonsignificant trend toward reduction in the Hotshot group (Hotshot, 10/49 [20.4%] vs control, 14/47 [29.8%]; relative risk, 0.68; 95% CI, 0.33 to 1.41; P=.10). However, the study was underpowered to detect the anticipated difference based on adult-derived effect estimates. The Hotshot group had significantly lower VIS at 24 hours (mean [SD] score, 6.8 [2.1] vs 10.4 [2.4]; P<.001) and 72 hours (3.2 [1.4] vs 7.6 [1.9]; P<.001), as well as a shorter ICU stay (4.1 [1.1] vs 6.7 [1.2] days; P=.003). Mechanical ventilation duration (P=.27), cardiopulmonary bypass time (P=.44), and aortic cross-clamp time (P=.56) were similar between groups.
Conclusion: In pediatric congenital heart surgery, terminal warm-blood Hotshot did not significantly reduce postoperative arrhythmias but was associated with lower VIS scores and a shorter ICU stay. The observed reduction in postoperative arrhythmias did not reach statistical significance, but the study was underpowered for this outcome. These findings suggest a potential myocardial protective effect that warrants confirmation in larger, adequately powered multicenter trials with long-term follow-up and biomarker assessment.
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