Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial.

BACKGROUND: Blood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery. METHODS: The study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%. RESULTS: Between January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2-Q3: 10-19) days in the CC group vs. 13 (10-21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6-7.45) vs. 5 (2.6-7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2-Q3: 18.73-41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55). CONCLUSIONS: Custodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017.

Risk Factors for Post-cardiac Surgery Infections.

Background Cardiac surgery infection is a life-threatening complication associated with high morbidity and mortality. One of the main types of these infections, surgical site infections (SSIs), also called postoperative wound infections basically delayed the post-surgical recovery in many patients. These infections rarely happen within 30 days after surgery due to different risk factors. Objectives The purpose of this study is to determine the risk factors that are involved in causing post-cardiac surgical infections. Methods This study was a retrospective study. The data of postoperative cardiac patients was obtained from the Cardiology and Cardiac Surgery Center in King Fahad Armed Force Hospital, Jeddah. Data on the patients were collected from 2016 to 2021. Eligible patients were those of age 18 and greater. These patients were evaluated on basis of the pre and postoperative risk factors and were analyzed for 30 days after discharge and those that developed SSIs were identified. Results Out of the total number of 2366 patients, 151 patients (6.4%) were identified with post-surgery infections out of which 107 (4.5%) had developed superficial wound infections (SSWIs) and 44 (1.9%) had developed deep wound infections (DSWIs). Infection mainly occurs in the male population (n=88, 58.3%). Major risk factors that were the main cause of post-cardiac surgery infections were diabetes (61.5%), hypertension (56.9%), smoking (38.4%), renal failure (27.1%), and re-do operation (25.1%). Conclusion Our study has demonstrated major risk factors that are involved in the occurrence of post-cardiac surgery infections like smoking, diabetes mellitus, sex, more than one operation during a single stay, etc. In the future, the contribution of various other factors involved in the occurrence of surgical site infections and best practices and methods should be studied and implemented to prevent the occurrence of post-cardiac surgery infections. Various simple techniques can still be utilized to prevent these sorts of infections, which will decrease the mortality rate.

Evolution of the Norwood operation outcomes in patients with late presentation.

OBJECTIVES: We present the evolution of Norwood operation outcomes and practice pattern changes over 15 years from a single institution in Saudi Arabia. We intended to identify time trends in patient selection, procedural details, and outcome predictors over time. METHODS: Patients who underwent a Norwood operation (n = 145) between 2003 and 2018 with the use of a Blalock-Taussig shunt (BT group; n = 72), right ventricle to pulmonary artery shunt (Sano group; n = 66), or a primary cavopulmonary shunt (CPS group; n = 7) were included. The study outcomes were operative mortality, long-term survival, and multistate transition to CPS, Fontan, and death. RESULTS: Median age was 29 days. Predictors of operative mortality were lower weight (P = .026), and longer bypass time (P = .014), whereas age, and type of shunt were not. Predictors of improved long-term survival were greater weight at operation (P = .0016), later era (P = .006), and shorter bypass time (P = .001). The multistate model revealed that patients with lower weight were more likely to undergo Sano versus BT (P < .001), and if BT was chosen in such patients, they were more likely to die (P = .027). The likelihood of receiving Sano shunt was 3-fold greater in the recent era (P = .003). CONCLUSIONS: Improved outcomes of the Norwood operation are evident in the recent era and with Sano shunt, especially in patients of smaller weight. Late presentation or older age is not a contraindication to Norwood operation. The incorporation of a primary CPS at stage one operation is feasible in selected patients.