Dosing, Monitoring, Blood Product Utilization, and Thromboembolic Complications of Four-Factor Prothrombin Complex Concentrate as Part of an Institutional Protocol in Pediatric Cardiac Surgery: A Retrospective Cohort Study.

Pediatric cardiac surgery patients are predisposed to blood loss. Blood product administration can lead to complications. Prothrombin complex concentrates (PCCs) offer potential advantages of factor composition, small volume, decreased immunogenicity/infectious risks, and accessibility. The objective of this study was to describe dosing, monitoring, blood product utilization, and thromboembolic complications of administering four-factor PCC (4F-PCC) in pediatric cardiac surgery. We performed a retrospective review of patients aged <18 years undergoing cardiac surgery from June 2020 to May 2022 (inclusive) who received 4F-PCC. Outcomes of interest included 4F-PCC dosing (units/kg) and number of doses administered, chest tube output, blood product administration, donor exposure, length of stay, and thromboembolic events. Eighty-six patients met eligibility criteria. The median (range) age and weight were 0.37 (0.01-16.3) years and 5.3 (1.6-98) kg, respectively. Median (range) total 4F-PCC dose per patient was 25 (9.2-50) units/kg, with 6 patients (7%) receiving a total of two doses. Median (range) 24-hour postoperative packed red blood cells, platelet, plasma, and cryoprecipitate administration volumes were 0 (0-2.57) mL/kg/24 h, 0 (0-1.09), 0 (0-2.64), and 0 (0-0.28 mL/kg/24 h), respectively. Median (range) length of stay and 24-hour postoperative chest tube output were 10 (6-26) days and 1.1 (0.1-4.2) mL/kg/h, respectively. Two (2%) patients experienced a thromboembolic event within 30 days of 4F-PCC administration. These retrospective findings suggest no worsening of hemostatic parameters, a mild median improvement in fibrinogen, low blood product utilization, and low thromboembolism rates following 4F-PCC use in pediatric cardiac surgery.

Heart Transplantation for Pediatric and Congenital Cardiac Disease: A Comparison of Two Eras over 23 Years and 188 Transplants at a Single Institution.

BACKGROUND: To assess changes in patterns of practice and outcomes over time, we reviewed all patients who underwent heart transplantation (HTx) at our institution and compared two consecutive eras with significantly different immunosuppressive protocols (cohort 1 [80 HTx, June 1995-June 2006]; cohort 2 [108 HTx, July 2006-September 2018]). METHODS: Retrospective study of 180 patients undergoing 188 HTx (June 1995-September 2018; 176 first time HTx, 10 second HTx, and 2 third HTx). In 2006, we commenced pre-HTx desensitization for highly sensitized patients and started using tacrolimus as our primary postoperative immunosuppressive agent. The primary outcome was mortality. Survival was modeled by the Kaplan-Meier method. Univariable and multivariable Cox proportional hazard models were created to identify prognostic factors for survival. RESULTS: Our 188 HTx included 18 neonates, 85 infants, 83 children, and 2 adults (>18 years). Median age was 260.0 days (range: 5 days-23.8 years). Median weight was 7.5 kg (range: 2.2-113 kg). Patients in cohort 1 were less likely to have been immunosensitized preoperatively (12.5% vs 28.7%, P = .017). Nevertheless, Kaplan-Meier analysis suggested superior survival in cohort 2 (P = .0045). Patients in cohort 2 were more likely to be alive one year, five years, and ten years after HTx. Multivariable analysis identified the earlier era (hazard ratio [HR] [95% confidence interval] for recent era = 0.32 [0.14-0.73]), transplantation after prior Norwood operation (HR = 4.44 [1.46-13.46]), and number of prior cardiac operations (HR = 1.33 [1.03-1.71]) as risk factors for mortality. CONCLUSIONS: Our analysis of 23 years of pediatric and congenital HTx reveals superior survival in the most recent 12-year era, despite the higher proportion of patients with elevated panel reactive antibody in the most recent era. This improvement was temporally associated with changes in our immunosuppressive strategy.

Post-operative blood loss is higher among African American neonates undergoing open-heart surgery with cardiopulmonary bypass for CHD.

BACKGROUND: Neonates are at high risk of bleeding after open-heart surgery. We sought to determine pre-operative and intra-operative risk factors for increased bleeding after neonatal open-heart surgery with cardiopulmonary bypass. METHODS: We conducted a retrospective cohort study of neonates (0-30 days old) who underwent open-heart surgery with cardiopulmonary bypass from January, 2009, to March, 2013. Cardiac diagnosis; demographic and surgical data; and blood products, haemostatic agents, and anti-thrombotic agents administered before, during, and within 24 hours after surgery were abstracted from the electronic health record and anaesthesia records. The outcome of interest was chest tube output (in ml/kg body weight) within 24 hours. Relationships between chest tube output and putative associated factors were evaluated by unadjusted and adjusted linear regression. RESULTS: The cohort consisted of 107 neonates, of whom 79% had a Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) Mortality Category of 4 or 5. Median chest tube output was 37 ml/kg (range 9-655 ml/kg). Age, African-American race, and longer durations of surgery and cardiopulmonary bypass each had statistically significant associations with increased chest tube output in unadjusted analyses. In multivariable analysis, African-American race retained an independent, statistically significant association with increased chest tube output; the geometric mean of chest tube output among African-American neonates was 71% higher than that of Caucasians (95% confidence interval, 29-125%; p = 0.001). CONCLUSION: Among neonates with CHD undergoing open-heart surgery with cardiopulmonary bypass, African-American race is independently associated with greater chest tube output over the first 24 hours post-operatively.

Eighteen years of paediatric extracorporeal membrane oxygenation and ventricular assist devices: insight regarding late outcomes.

BACKGROUND: We reviewed all patients who were supported with extracorporeal membrane oxygenation and/or ventricular assist device at our institution in order to describe diagnostic characteristics and assess mortality. METHODS: A retrospective cohort study was performed including all patients supported with extracorporeal membrane oxygenation and/or ventricular assist device from our first case (8 October, 1998) through 25 July, 2016. The primary outcome of interest was mortality, which was modelled by the Kaplan-Meier method. RESULTS: A total of 223 patients underwent 241 extracorporeal membrane oxygenation runs. Median support time was 4.0 days, ranging from 0.04 to 55.8 days, with a mean of 6.4±7.0 days. Mean (±SD) age at initiation was 727.4 days (±146.9 days). Indications for extracorporeal membrane oxygenation were stratified by primary indication: cardiac extracorporeal membrane oxygenation (n=175; 72.6%) or respiratory extracorporeal membrane oxygenation (n=66; 27.4%). The most frequent diagnosis for cardiac extracorporeal membrane oxygenation patients was hypoplastic left heart syndrome or hypoplastic left heart syndrome-related malformation (n=55 patients with HLHS who underwent 64 extracorporeal membrane oxygenation runs). For respiratory extracorporeal membrane oxygenation, the most frequent diagnosis was congenital diaphragmatic hernia (n=22). A total of 24 patients underwent 26 ventricular assist device runs. Median support time was 7 days, ranging from 0 to 75 days, with a mean of 15.3±18.8 days. Mean age at initiation of ventricular assist device was 2530.8±660.2 days (6.93±1.81 years). Cardiomyopathy/myocarditis was the most frequent indication for ventricular assist device placement (n=14; 53.8%). Survival to discharge was 42.2% for extracorporeal membrane oxygenation patients and 54.2% for ventricular assist device patients. Kaplan-Meier 1-year survival was as follows: all patients, 41.0%; extracorporeal membrane oxygenation patients, 41.0%; and ventricular assist device patients, 43.2%. Kaplan-Meier 5-year survival was as follows: all patients, 39.7%; extracorporeal membrane oxygenation patients, 39.7%; and ventricular assist device patients, 43.2%. CONCLUSIONS: This single-institutional 18-year review documents the differential probability of survival for various sub-groups of patients who require support with extracorporeal membrane oxygenation or ventricular assist device. The indication for mechanical circulatory support, underlying diagnosis, age, and setting in which cannulation occurs may affect survival after extracorporeal membrane oxygenation and ventricular assist device. The Kaplan-Meier analyses in this study demonstrate that patients who survive to hospital discharge have an excellent chance of longer-term survival.

Risk Factors for Survival After Heart Transplantation in Children and Young Adults: A 22-Year Study of 179 Transplants.

BACKGROUND: This article reviews all patients who underwent heart transplantation (HTx) within a single institution (172 patients underwent 179 HTx [167 first-time HTxs, 10 second HTxs, 2 third HTxs]) to describe diagnostic characteristics, management protocols, and risk factors for mortality. METHODS: Descriptive analysis was performed for the entire cohort using mean, standard deviation, median, interquartile range, and overall range, as appropriate. Univariable and multivariable Cox proportional hazards models were performed to identify prognostic factors for outcomes over time. The primary outcome of interest was mortality, which was modeled by Kaplan-Meier analysis. RESULTS: Median age at HTx was 263 days (range, 5 days to 24 years; mean = 4.63 ± 5.95 years; 18 neonates, 79 infants). Median weight at HTx was 7.5 kg (range, 2.2-113 kg; mean = 19.36 ± 23.54). Diagnostic categories were cardiomyopathy (n = 62), primary transplantation for hypoplastic left heart syndrome (HLHS) or HLHS-related malformation (n = 33), transplantation after cardiac surgery for HLHS or HLHS-related malformation (n = 17), non-HLHS congenital heart disease (n = 55), and retransplant (n = 12). Operative mortality was 10.1% (18 patients). Cumulative total follow-up is 1,355 years. Late mortality was 18.4% (33 patients). Overall Kaplan-Meier five-year survival was 76.2%. One hundred twenty-one patients are alive with a mean follow-up of 7.61 ± 6.46 years. No survival differences were seen among the five diagnostic subgroups ( P = .064) or between immunosensitized patients (n = 31) and nonimmunosensitized patients (n = 141; P = .422). CONCLUSIONS: Excellent results are expected for children undergoing HTx with comparable results among diagnostic groups. Pretransplant mechanical circulatory support and posttransplant mechanical circulatory support are risk factors for decreased survival. Survival after transplantation for HLHS or HLHS-related malformation is better with primary HTx in comparison to HTx after prior cardiac surgery.

National Benchmarks for Proportions of Patients Receiving Blood Transfusions During Pediatric and Congenital Heart Surgery: An Analysis of the STS Congenital Heart Surgery Database.

BACKGROUND: To determine national benchmarks and assess variability across centers, The Society of Thoracic Surgeons Congenital Heart Surgery Database was analyzed to document proportions of patients receiving intraoperative transfusion of packed red blood cells (PRBC) during open heart surgery. METHODS: Index cardiopulmonary bypass operations reported in The Society of Thoracic Surgeons Congenital Heart Surgery Database (2014 to 2015) were potentially eligible for inclusion. Data from centers with more than 15% missing data for PRBC transfusion were excluded, as were individual records missing information about PRBC transfusion. The distribution of center-level PRBC transfusion rates in various clinically relevant groups was estimated by fitting a two-level logistic mixed model. RESULTS: The study population included 22,874 index cardiopulmonary bypass operations in 81 centers. Center-level intraoperative PRBC transfusion rates stratified by age group, weight, STAT Mortality Category, and lowest core temperature were documented. For younger patients and patients undergoing higher-complexity operations, median center PRBC transfusion rates consistently approached 100%, with narrow interquartile ranges indicating little center variability. Center PRBC transfusion rates declined with increasing patient age, but with greater variability (wider interquartile ranges) across centers. Intraoperative PRBC transfusion was uncommon (median center transfusion rates <30%) in older patients (teenagers and adults) undergoing lower-complexity (STAT Mortality Category <3) operations. CONCLUSIONS: Most centers transfuse PRBCs routinely in higher-risk, younger, and smaller patients, with little variability across centers. For lower-risk operations in older and larger patients, centers are more likely to forgo intraoperative transfusions. This analysis provides national benchmarks for center-level PRBC transfusion rates during pediatric and congenital heart surgery.

Effect of metoclopramide on gastric fluid volumes in diabetic patients who have fasted before elective surgery.

BACKGROUND: Diabetes-induced gastroparesis is believed to increase fasting gastric fluid volume before elective surgery. Metoclopramide is routinely administered preoperatively to reduce gastric fluid volume in these patients. This study compared nondiabetic controls to non-insulin-dependent and insulin-dependent diabetics to determine the effect of metoclopramide, administered before surgery, on gastric volumes in patients who fasted before surgery. METHODS: Control and diabetic patients fasted preoperatively before receiving either placebo or 10 mg intravenous metoclopramide 20 min before induction of anesthesia. After intubation, a gastric tube was placed, and stomach contents were aspirated with volumes compared among the groups. RESULTS: Both groups of diabetic patients were older than the control group, and insulin-dependent patients had a higher incidence of comorbidities compared with the non-insulin-dependent group. Fasting blood sugar and hemoglobin A1C values were higher in both insulin-dependent and non-insulin-dependent patients. Gastric fluid volumes were similar in control, non-insulin-dependent, and insulin-dependent patients (8.0 +/- 2.6 vs. 9.6 +/- 4.1 vs. 17.7 +/- 2.5 ml, respectively). In insulin-dependent diabetic patients, metoclopramide decreased gastric volume compared with placebo treatment (17.7 +/- 2.5 vs. 7.8 +/- 2.9 ml; P = 0.027). After stratification, a subpopulation of patients with poorly controlled diabetes, regardless of type, were identified to have increased gastric residual volumes. CONCLUSION: In elective surgical patients who have fasted before surgery, gastric volumes are minimal, even in diabetics with severe neuropathic symptoms. Metoclopramide prophylaxis to reduce gastric volumes seems to be unnecessary unless the patient has a prolonged history of poor blood glucose control.

Recombinant factor VIIa to control excessive bleeding following surgery for congenital heart disease in pediatric patients.

The purpose of this article is to evaluate the efficacy of recombinant factor VII (rFVIIa) in the treatment of bleeding following cardiac surgery in a pediatric population. The study included a case series of postcardiac surgical patients with chest tube output of = 4 mL/kg/h for the initial 3 postoperative hours who received rFVIIa. Chest tube output for the 3 hours before and the 3 hours after rFVIIa was compared using a paired t test. In addition, chest tube output for the initial 3 postoperative hours and the 3 hours following rFVIIa was compared to 8 control patients who did not require rFVIIa. Recombinant factor VIIa was administered to 9 children (age = 9 +/- 4 years) following repair of tetralogy of Fallot (6), closure of ventricular septal defect (1), closure of sinus venosus atrial septal defect (1), and mitral valve repair (1). Chest tube output for the initial 3 postoperative hours prior to the administration of rFVIIa was 5.8 +/- 2.8 mL/kg/h and decreased to 2.0 +/- 1.3 mL/kg/h for the 3 hours following the administration of rFVIIa (P =.002). In the patients that did not receive rFVIIa, chest tube output for the first 3 postoperative hours was 1.6 +/- 0.9 mL/kg/h and 1.2 +/- 0.6 mL/kg/h for the next 3 hours (P = nonsignificant when compared to chest tube output for the 3 hours following rFVIIa in patients who received rFVIIa). No adverse effects were noted. Recombinant factor VIIa decreased chest tubing bleeding following cardiac surgery in children. Given its potential therapeutic impact, rFVIIa warrants further investigation in the pediatric cardiac population.