The Influence of the Extracorporeal Membrane Oxygenation Circuit and Components on Anticoagulation Management: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference.

OBJECTIVES: To derive systematic-review informed, modified Delphi consensus regarding the influence of extracorporeal membrane oxygenation (ECMO) circuit components on anticoagulation practices for pediatric ECMO for the Pediatric ECMO Anticoagulation CollaborativE. DATA SOURCES: A structured literature search was performed using PubMed, EMBASE, and Cochrane Library (CENTRAL) databases from January 1988 to May 2021. STUDY SELECTION: Management of ECMO anticoagulation in the setting of different ECMO circuit components. DATA EXTRACTION: Two authors reviewed all citations independently, with a third independent reviewer resolving conflicts. Twenty-nine references were used for data extraction and informed recommendations, evidence-based consensus statements, and good practice statements. Evidence tables were constructed using a standardized data extraction form. DATA SYNTHESIS: Risk of bias was assessed using the Quality in Prognosis Studies tool. The evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. Forty-eight experts met over 2 years to develop evidence-based recommendations and, when evidence was lacking, expert-based consensus statements or good practice statements for the influence of ECMO circuit and components on anticoagulation management. A web-based modified Delphi process was used to build consensus via the Research And Development/University of California Appropriateness Method. Consensus was defined as greater than 80% agreement. One good practice statement, 2 weak recommendations, and 2 consensus statements are presented. CONCLUSIONS: The incorporation of new component technologies into clinical practice has outpaced clinical investigations of anticoagulation strategies for pediatric ECMO. Future investigations should leverage academic and industrial collaborations, translational platforms, and modern biostatistical methods to improve patient outcomes.

Executive Summary: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE (PEACE) Consensus Conference.

OBJECTIVES: To present recommendations and consensus statements with supporting literature for the clinical management of neonates and children supported with extracorporeal membrane oxygenation (ECMO) from the Pediatric ECMO Anticoagulation CollaborativE (PEACE) consensus conference. DATA SOURCES: Systematic review was performed using PubMed, Embase, and Cochrane Library (CENTRAL) databases from January 1988 to May 2021, followed by serial meetings of international, interprofessional experts in the management ECMO for critically ill children. STUDY SELECTION: The management of ECMO anticoagulation for critically ill children. DATA EXTRACTION: Within each of eight subgroup, two authors reviewed all citations independently, with a third independent reviewer resolving any conflicts. DATA SYNTHESIS: A systematic review was conducted using MEDLINE, Embase, and Cochrane Library databases, from January 1988 to May 2021. Each panel developed evidence-based and, when evidence was insufficient, expert-based statements for the clinical management of anticoagulation for children supported with ECMO. These statements were reviewed and ratified by 48 PEACE experts. Consensus was obtained using the Research and Development/UCLA Appropriateness Method. Results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method. We developed 23 recommendations, 52 expert consensus statements, and 16 good practice statements covering the management of ECMO anticoagulation in three broad categories: general care and monitoring; perioperative care; and nonprocedural bleeding or thrombosis. Gaps in knowledge and research priorities were identified, along with three research focused good practice statements. CONCLUSIONS: The 91 statements focused on clinical care will form the basis for standardization and future clinical trials.

Extracorporeal cardiopulmonary resuscitation outcomes for children with out-of-hospital and emergency department cardiac arrest.

OBJECTIVE: Data suggest extracorporeal cardiopulmonary resuscitation (ECPR) improves survival in adult patients with refractory cardiac arrest; however, ECPR outcomes in pediatric patients with out-of-hospital cardiac arrest (OHCA) is lacking. The primary aim of this study was to characterize pediatric patients who experience OHCA or cardiac arrest in the ED (EDCA). The secondary aim was to examine associations of cardiac arrest and location of ECPR cannulation with mortality. METHODS: We performed a retrospective analysis of the Extracorporeal Life Support Organization registry. We included pediatric patients (age > 28 days to <18 years) who received ECPR for refractory OHCA or EDCA between 2010 and 2019. Patient, cardiac arrest, and ECPR cannulation characteristics were summarized. We examined associations of location of cardiac arrest and ECPR cannulation with in-hospital mortality using multivariable logistic regression. RESULTS: We analyzed data from 140 pediatric patients. 66 patients (47%) experienced OHCA and 74 patients (53%) experienced EDCA. Overall survival to hospital discharge was 31% (20% OHCA survival vs. 41% EDCA survival, p = 0.008). In adjusted analyses, OHCA was associated with 3.9 times greater odds of mortality (95% confidence interval [CI] 1.61, 9.81) when compared to compared to EDCA. The location of ECPR cannulation was not associated with mortality (odds ratio 1.8, 95% CI 0.75, 4.3). CONCLUSIONS: The use of ECPR for pediatric patients with refractory OHCA is associated with poor survival compared to patients with EDCA. Location of ECPR cannulation does not appear to be associated with mortality.

Waitlist and posttransplant outcomes of critically ill infants awaiting heart transplantation managed without ventricular assist device support.

BACKGROUND: Infants listed for heart transplant are at high risk for waitlist mortality. While waitlist mortality for children has decreased in the current era of increased ventricular assist device use, outcomes for small infants supported by ventricular assist device remain suboptimal. We evaluated morbidity and survival in critically ill infants listed for heart transplant and managed without ventricular assist device support. METHODS: Critically ill infants (requiring ≥1 inotrope and mechanical ventilation or ≥2 inotropes without mechanical ventilation) listed between 2008 and 2019 were included. During the study period, infants were managed primarily medically. Mechanical circulatory support, specifically extracorporeal membrane oxygenation, was utilized as "rescue therapy" for decompensating patients. RESULTS: Thirty-two infants were listed 1A, 66% with congenital heart disease. Median age and weight at listing were 2.2 months and 4.4 kg, with 69% weighing <5 kg. At listing, 97% were mechanically ventilated, 41% on ≥2 inotropes, and 25% under neuromuscular blockade. Five patients were supported by ECMO after listing. A favorable outcome (transplant or recovery) was observed in 84%. One-year posttransplant survival was 92%. Infection was the most common waitlist complication occurring in 75%. Stroke was rare, occurring in one patient who was supported on ECMO. Renal function improved from listing to transplant, death, or recovery (eGFR 70 vs 87 ml/min/1.73m2 , p = .001). CONCLUSION: A strategy incorporating a high threshold for mechanical circulatory support and acceptance of prolonged mechanical ventilation and neuromuscular blockade can achieve good survival and morbidity outcomes for critically ill infants listed for heart transplant.

Conversion From Activated Clotting Time to Anti-Xa Heparin Activity Assay for Heparin Monitoring During Extracorporeal Membrane Oxygenation.

OBJECTIVES: Anticoagulation with unfractionated heparin remains the most common therapy used to prevent circuit thrombosis during extracorporeal membrane oxygenation, but no consensus exists on the optimal method or targets for heparin monitoring. From 2015 to 2018, we switched from monitoring heparin during extracorporeal membrane oxygenation using activated clotting times to anti-Xa heparin activity assays. This study describes the transition from activated clotting time to anti-Xa heparin activity assay monitoring and the associated clinical changes. DESIGN: Retrospective analysis at single institution. SETTING: Referral Children's Hospital. PATIENTS: A total of 145 pediatric patients over 152 extracorporeal membrane oxygenation runs using 206 extracorporeal membrane oxygenation circuits. INTERVENTIONS: Anticoagulation protocol quality improvement. MEASUREMENTS AND MAIN RESULTS: From 2015 to 2018, heparin monitoring during extracorporeal membrane oxygenation changed from hourly activated clotting time to anti-Xa heparin activity assay every 6 hours with an associated 75% reduction in the circuit changes per extracorporeal membrane oxygenation day. Over the 4 years, patients with an average anti-Xa heparin activity assay of at least 0.25 U/mL showed a 59% reduction in circuit changes per extracorporeal membrane oxygenation day compared with less than 0.15 U/mL. In addition to its association with reduced circuit changes, anti-Xa heparin activity assay monitoring was also associated with reduced heparin dose changes per day from 11 ± 4 to 2 ± 1 (p < 0.001), smaller heparin dose changes (less variation in dose), and reduced diagnostic phlebotomy volumes from 41 ± 6 to 25 ± 11 mL/day (p < 0.001). The number of patients with reported bleeding decreased from 69% using activated clotting time to 51% (p = 0.03). Transfusion rates did not change. CONCLUSIONS: Over 4 years, we replaced the activated clotting time assay with the anti-Xa heparin activity assay for heparin monitoring during extracorporeal membrane oxygenation. Minimum anti-Xa heparin activity assay levels of 0.25 U/mL were associated with reduced circuit changes. Further studies are needed to determine the optimum anti-Xa heparin activity assay therapeutic range during extracorporeal membrane oxygenation.

Outcomes After In-Hospital Pediatric Recurrent Cardiac Arrests.

OBJECTIVES: The objective of this study is to determine outcomes of recurrent cardiac arrest events in the general pediatric inpatient population. DESIGN: Retrospective cohort study of inpatients in a single institution. SETTING: A tertiary care free-standing children's hospital. PATIENTS: All patients less than 18 years old at Seattle Children's Hospital with recurrent cardiac arrest events occurring from January 1, 2010, to March 1, 2018, were included. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Overall survival to hospital discharge was 50% and all survivors had a good neurologic outcome, defined as Pediatric Cerebral Performance Category of 3 or less, or unchanged from baseline. Survival among patients who received extracorporeal life support was 43% and among those who received extracorporeal cardiopulmonary resuscitation, 33%. Initial arrest factors associated with survival included initial rhythm of ventricular tachycardia or ventricular fibrillation, shorter duration of cardiopulmonary resuscitation, and absence of multiple organ dysfunction. Additionally, nonsurvivors had more severe metabolic acidosis in the prearrest and postarrest period. CONCLUSIONS: Survival after pediatric in-hospital recurrent cardiac arrest is higher than previously reported. There is also evidence that initial rhythm other than ventricular tachycardia/ventricular fibrillation and longer duration of cardiopulmonary resuscitation as well as multiple organ dysfunction and more severe lactic acidosis in the peri-arrest period are associated with poor outcomes.

The use of extracorporeal membrane oxygenation in human immunodeficiency virus-positive patients: a review of a multicenter database.

AIM: We chose to evaluate the survival of extracorporeal membrane oxygenation among patients with human immunodeficiency virus in a multicenter registry. METHODS: Retrospective case review of the Extracorporeal Life Support Organization Registry respiratory failure of all patients with human immunodeficiency virus supported with extracorporeal membrane oxygenation. RESULTS: A total of 126 patients were included. Survival to discharge was 36%. Eight infants were supported with extracorporeal membrane oxygenation and three (37.5%) survived to discharge. Respiratory extracorporeal membrane oxygenation was the primary indication (78%) with a 39% survival, while cardiac and extracorporeal cardiopulmonary resuscitation indications accounted for 16% and 6% of patients with survivals of 30% and 12.5%, respectively. These differences did not reach significance. There were no significant differences between survivors and non-survivors in demographic data, but non-survivors had significantly more non-human immunodeficiency virus pre-extracorporeal membrane oxygenation infections than survivors. There were no differences in other pre-extracorporeal membrane oxygenation supportive therapies, mechanical ventilator settings, or arterial blood gas results between survivors and non-survivors. The median duration of mechanical ventilation prior to cannulation was 52 (interquartile range: 13-140) hours, while the median duration of the extracorporeal membrane oxygenation exposure was 237 (interquartile range: 125-622) hours. Ventilator settings were significantly lower after 24 hours compared to pre-extracorporeal membrane oxygenation settings. Complications during extracorporeal membrane oxygenation exposure including receipt of renal replacement therapy, inotropic infusions, and cardiopulmonary resuscitation were more common among non-survivors compared to survivors. Central nervous system complications were rare. CONCLUSION: Survival among patients with human immunodeficiency virus infection who receive extracorporeal membrane oxygenation was less than 40%. Infections before extracorporeal membrane oxygenation cannulation occurred more often in non-survivors. The receipt of renal replacement therapy, inotropic infusions, or cardiopulmonary resuscitation during extracorporeal membrane oxygenation was associated with worse outcome.

The Extracorporeal Life Support Organization Maastricht Treaty for Nomenclature in Extracorporeal Life Support. A Position Paper of the Extracorporeal Life Support Organization.

Extracorporeal life support (ECLS) was developed more than 50 years ago, initially with venoarterial and subsequently with venovenous configurations. As the technique of ECLS significantly improved and newer skills developed, complexity in terminology and advances in cannula design led to some misunderstanding of and inconsistency in definitions, both in clinical practice and in scientific research. This document is a consensus of multispecialty international representatives of the Extracorporeal Life Support Organization, including the North America, Latin America, EuroELSO, South West Asia and Africa, and Asia-Pacific chapters, imparting a global perspective on ECLS. The goal is to provide a consistent and unambiguous nomenclature for ECLS and to overcome the inconsistent use of abbreviations for ECLS cannulation. Secondary benefits are ease of multicenter collaboration in research, improved registry data quality, and clear communication among practitioners and researchers in the field.

Assessment of muscle oxygenation in children with congenital heart disease.

BACKGROUND: Adaptive responses to congenital heart disease result in altered muscle perfusion and muscle metabolism. Such changes may be detectable using noninvasive spectroscopic monitors. AIMS: In this study we aimed to determine if resting muscle oxygen saturation (MOx) is lower in children with acyanotic or cyanotic congenital heart disease than in healthy children and to identify differences in muscle oxygen consumption in children with cyanotic and acyanotic congenital heart disease. METHODS: Using a custom fiber optic spectrometer system, optical measurements were obtained from the calf or forearm of 49 patients (17 with acyanotic congenital heart disease, 18 with cyanotic congenital heart disease, and 14 control). Twenty additional control patients were used to develop the analytic model. Spectra were used to determine MOx at baseline, during arterial occlusion, and during reperfusion. The rate of muscle desaturation during arterial occlusion was also evaluated. Two-sample t-tests were used to compare each heart disease group with the controls. RESULTS: Patients with acyanotic and cyanotic congenital heart disease had lower baseline MOx than controls. Baseline MOx was 91.3% (CI 85.9%, 96.7%) for acyanotic patients, 91.1% (CI 86.3%, 95.9%) for cyanotic patients, and 98.9% (CI 96.7%, 101.1%) for controls. Similarly, MOx was lower in the acyanotic and cyanotic groups than the controls after reperfusion (84.6% [CI 74.1%, 95.1%] and 82.1% [CI 74.5%, 89.7%] vs 98.9% [96.5%, 101.3%]). The rate of decline in oxygenation was significantly greater in cyanotic patients versus controls (0.46%/s (CI 0.30%, 0.62%/s) vs 0.17%/s (0.13%, 0.21%/s)). CONCLUSION: This study demonstrates that muscle oxygenation is abnormal in children with both cyanotic and acyanotic congenital heart disease. This suggests that noninvasive monitoring of muscle oxygenation may provide valuable information in situations where children with congenital heart disease may be at risk of hemodynamic compromise.

Comparison of Transplant Waitlist Outcomes for Pediatric Candidates Supported by Ventricular Assist Devices Versus Medical Therapy.

OBJECTIVES: Ventricular assist devices have gained popularity in the management of refractory heart failure in children listed for heart transplantation. Our primary aim was to compare the composite endpoint of all-cause pretransplant mortality and loss of transplant eligibility in children who were treated with a ventricular assist device versus a medically managed cohort. DESIGN: This was a retrospective cohort analysis. SETTINGS: Data were obtained from the Scientific Registry of Transplant Recipients. PATIENTS: The at-risk population (n = 1,380) was less than 18 years old, either on a ventricular assist device (605 cases) or an equivalent-severity, intensively medically treated group (referred to as MED, 775 cases). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The impact of ventricular assist devices was estimated via Cox proportional hazards regression (hazard ratio), dichotomizing 1-year outcomes to "poor" (22%: 193 deaths, 114 too sick) versus all others (940 successful transplants, 41 too healthy, 90 censored), while adjusting for conventional risk factors. Among children 0-12 months old, ventricular assist device was associated with a higher risk of poor outcomes (hazard ratio, 2.1; 95% CI, 1.5-3.0; p < 0.001). By contrast, ventricular assist device was associated with improved outcomes for ages 12-18 (hazard ratio, 0.3; 95% CI, 0.1-0.7; p = 0.003). For candidates 1-5 and 6-11 years old, there were no differences in outcomes between the ventricular assist device and MED groups (hazard ratio, 0.8 and 1.0, p = 0.43 and 0.9). The interaction between ventricular assist devices and age group was strongly significant (p < 0.001). CONCLUSIONS: This is a comparative study of ventricular assist devices versus medical therapy in children. Age is a significant modulator of waitlist outcomes for children with end-stage heart failure supported by ventricular assist device, with the impact of ventricular assist devices being more beneficial in adolescents.

Venovenous extracorporeal life support in patients with HIV infection and Pneumocystis jirovecii pneumonia.

AIM: As experience with extracorporeal life support (ECLS) increases, indications for its use have expanded to diverse patient populations, including those with HIV infection. Pneumocystis jirovecii pneumonia (PJP) is a particularly devastating complication of HIV infections. The objective of this study was to review ECLS use in HIV-positive patients, with particular emphasis on those with concomitant PJP infection. METHODS: All patients were treated by the same ECLS team, consisting of an ECLS specialist intensivist, cardiothoracic surgeon and allied medical professionals at three healthcare institutions. The same ECLS protocol was utilized for all patients during the study period. A retrospective review was performed for all HIV-positive patients placed on ECLS from May 2011 to October 2014. Demographic, clinical, ECLS and complication data were reviewed to identify risk factors for death. RESULTS: A total of 22 HIV-positive patients received ECLS therapy during the study period. All patients were supported with venovenous ECLS and overall survival to hospital discharge was 68%. Survival amongst the PJP positive cohort was 60%. Non-survivors were more likely to require inotropic medications on ECLS (100% non-survivors vs. 46.7% survivors, p=0.022) and had a longer total duration of ECLS (13 days non-survivors vs. 7 days survivors, p=0.011). No difference was observed between PJP-positive and PJP-negative patients with regard to demographic data, complication rates or survival. CONCLUSION: ECLS is a viable treatment option in carefully selected HIV-positive patients, including those with severe disease as manifested by PJP infection.

Shifting Risks and Conflicting Outcomes-ECMO for Neonates with Congenital Diaphragmatic Hernia in the Modern Era.

OBJECTIVES: To update previously described trends for neonates with congenital diaphragmatic hernia (CDH) receiving ECMO with changes in recommendations for care, and to determine how recent advancements in respiratory care have affected this patient population. STUDY DESIGN: This study is a retrospective review of more than 2500 neonates with CDH who received ECMO listed in the Extracorporeal Life Support Organization (ELSO) registry. Cochran-Armitage and multivariate regression analyses were used to analyze changes in the patient population over time and in mortality-related risk factors. RESULTS: Almost one-half (48.1%) of the term neonates survived to discharge, representing a 13.8% decline in survival over the past 25 years (P < .0001). Over the past 10 years, the prevalence of respiratory acidosis more than doubled (P < .0001) and the prevalence of major complications increased (P < .001). During the same period, the number of ECMO courses longer than 1 week increased (P < .001), whereas the prevalence of multiple complications (>4) decreased (P < .0001). Surgeries performed on ECMO were associated with worse outcomes than those performed off ECMO. ECMO duration no longer represents a mortality-related risk factor. CONCLUSIONS: Survival rates for neonates with CDH receiving ECMO have continued to drop in the modern era. Although the safety of ECMO has improved over the last decade, the number of patients experiencing significant respiratory acidosis has more than doubled-increasing the risk of intracranial hemorrhage and overall mortality. The evidence for permissive hypercapnia remains mixed; nonetheless, we believe that the risks outweigh the rewards in this patient population.

Factors Associated With Mortality in Neonates Requiring Extracorporeal Membrane Oxygenation for Cardiac Indications: Analysis of the Extracorporeal Life Support Organization Registry Data.

OBJECTIVES: Survival among neonates supported with extracorporeal membrane oxygenation for cardiac indications is 39%. Previous single-center studies have identified factors associated with mortality, but a comprehensive multivariate analysis is not available for this population. Understanding factors associated with mortality may help design treatment strategies, determine optimal timing for cannulation, and inform patient selection. This study identifies factors associated with mortality in neonates supported with extracorporeal membrane oxygenation for cardiac indications. DESIGN: Retrospective cohort study. SETTING: Two hundred and thirty U.S. and international centers reporting extracorporeal membrane oxygenation data to the Extracorporeal Life Support Organization. SUBJECTS: Four thousand and four seventy one neonates with congenital and acquired cardiac disease supported with extracorporeal membrane oxygenation for cardiac indications during 2001-2011. INTERVENTIONS: None. MEASUREMENTS AND RESULTS: The primary outcome measure was mortality prior to hospital discharge. Overall hospital mortality was 59%. Demographic and preextracorporeal membrane oxygenation factors associated with mortality were evaluated in a multivariable model. Factors associated with death prior to hospital discharge included lower body weight, earlier era, single ventricle physiology, lower preextracorporeal membrane oxygenation arterial pH, and longer time from intubation to extracorporeal membrane oxygenation cannulation. Lower pH was associated with increased mortality regardless of cardiac diagnosis and surgical complexity. The majority of survivors separated from extracorporeal membrane oxygenation less than 8 days after extracorporeal membrane oxygenation deployment. CONCLUSIONS: Mortality for neonates supported with extracorporeal membrane oxygenation for cardiac indications is high. Severity of preextracorporeal membrane oxygenation acidosis was independently associated with increased risk of mortality. Earlier initiation of extracorporeal membrane oxygenation may reduce the degree and duration of acidosis and may improve survival. Further studies are needed to determine optimal timing of cannulation in this population.

Antithrombin concentrates use in children on extracorporeal membrane oxygenation: a retrospective cohort study.

OBJECTIVE: To investigate whether receipt of any antithrombin concentrate improves laboratory and clinical outcomes in children undergoing extracorporeal membrane oxygenation for respiratory failure during their hospitalization compared with those who did not receive antithrombin. DESIGN: Retrospective cohort study. SETTING: Single, tertiary-care pediatric hospital. PATIENTS: Sixty-four neonatal and pediatric patients who underwent extracorporeal membrane oxygenation for respiratory failure between January 2007 and September 2011. INTERVENTION: Exposure to any antithrombin concentrate during their extracorporeal membrane oxygenation course compared with similar children who never received antithrombin concentrate. MEASUREMENTS AND MAIN RESULTS: Thirty patients received at least one dose of antithrombin during their extracorporeal membrane oxygenation course and 34 patients did not receive any. The median age at admission was less than 1-month old. Age, duration of extracorporeal membrane oxygenation, or first antithrombin level did not differ significantly between the two cohorts. The mean plasma antithrombin level in those who never received antithrombin was 42.2% compared with 66% in those who received it. However, few levels reached the targeted antithrombin level of 120% and those who did fell back to deficient levels within an average of 6.8 hours. For those who received antithrombin concentrate, heparin infusion rates decreased by an average of 10.2 U/kg/hr for at least 12 hours following administration. No statistical differences were noted in the number of extracorporeal membrane oxygenation circuit changes, in vivo clots or hemorrhages, transfusion requirements, hospital or ICU length of stay, or in-hospital mortality. CONCLUSIONS: Intermittent, on-demand dosing of antithrombin concentrate in pediatric patients on extracorporeal membrane oxygenation for respiratory failure increased antithrombin levels, but not typically to the targeted level. Patients who received antithrombin concentrate also had decreased heparin requirements for at least 12 hours after dosing. However, no differences were noted in the measured clinical endpoints. A prospective, randomized study of this intervention may require different dosing strategies; such a study is warranted given the unproven efficacy of this costly product.

Safety and Efficacy of Extracorporeal Membrane Oxygenation Heating Units.

BACKGROUND: Patient temperature during extracorporeal membrane oxygenation (ECMO) is commonly managed by dedicated heating units (HUs) that are integrated into ECMO circuitry. Currently, no HU has received approval for ECMO by the FDA in the United States. Older FDA-approved HUs have been implicated in life-threatening patient infections and are no longer manufactured or available for use in the United States. METHODS: We performed laboratory tests to evaluate the safety and efficacy of the Micro-Temp and the HTP-1500 HU systems that are potentially suitable for use in ECMO and describe our initial experience with the HTP-1500 HU after being placed in clinical service. RESULTS: Both units demonstrated similar heating efficacy, with the HTP-1500 achieving steady-state temperature approximately 5 h earlier than the Micro-Temp. Microorganisms were detected in the water compartment of all HUs prior to and after performing the manufacturer's recommended cleaning procedure, and after implementation of the HTP-1500 into clinical use we observed a decrease in the rate of bloodstream infection/ECMO days which did not reach statistical significance. CONCLUSION: Based on the results of this analysis and our institutional experience, we believe that integration of the HTP-1500 HU, an easily replaceable HU, into ECMO systems may reduce the risk of bacterial contamination and thus nosocomial infection when the devices are cleaned and maintained according to manufacturer's guidelines.

Creating Patient-Specific 3D-Printed Airway Models for Slide Tracheoplasty.

This protocol describes the method for creating 3D-printed trachea models for use in high-fidelity simulation-based training and advanced surgical planning for pediatric patients undergoing slide tracheoplasty. The goal is to provide a template and methodology to allow for replicability and more widespread dissemination of these models to improve clinical training and patient care. Laryngoscope, 134:4409-4413, 2024.

Encouraging results of blood conservation in neonatal open-heart surgery.

OBJECTIVE: To report early outcomes of blood conservation in neonatal open-heart surgery. METHODS: Ninety-nine patients undergoing neonatal open-heart surgery during the implementation of a blood conservation program between May 2021 and February 2023 were reviewed. Patients either received traditional blood management (blood prime, n = 43) or received blood conservation strategies (clear prime, n = 56). Baseline characteristics and outcomes were compared between groups. RESULTS: There was no difference in body weight (median, 3.2 kg vs 3.3 kg; P = .83), age at surgery (median, 5 days vs 5 days; P = .37), distribution of The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery Congenital Heart Surgery Mortality Categories categories or duration of cardiopulmonary bypass. Patients in the clear prime group had higher preoperative hematocrit (median, 41% vs 38%; P < .01), shorter postoperative mechanical ventilation time (median, 48 hours vs 92 hours; P = .02) and postoperative intensive care unit length of stay (median, 6 days vs 9 days; P < .01) than patients in the blood prime group. Fourteen patients (25%) in the clear prime group, including 1 Norwood patient, were discharged without any transfusion. Among patients within the clear prime group, hospitalizations without blood exposure were associated with higher preoperative hematocrit (median, 43% vs 40%; P = .02), shorter postoperative mechanical ventilation times (median, 22 hours vs 66 hours; P = .01) and shorter postoperative hospital stays (median, 10 days vs 15 days; P = .02). CONCLUSIONS: Bloodless surgery is possible in a significant proportion of neonates undergoing open-heart surgery, including the Norwood operation, even in the early stages of experience. Early clinical results are favorable but long-term follow-up and continued efforts are warranted to prove safety and reproducibility.

Extracorporeal membrane oxygenation circuitry.

The extracorporeal membrane oxygenation circuit is made of a number of components that have been customized to provide adequate tissue oxygen delivery in patients with severe cardiac and/or respiratory failure for a prolonged period of time (days to weeks). A standard extracorporeal membrane oxygenation circuit consists of a mechanical blood pump, gas-exchange device, and a heat exchanger all connected together with circuit tubing. Extracorporeal membrane oxygenation circuits can vary from simple to complex and may include a variety of blood flow and pressure monitors, continuous oxyhemoglobin saturation monitors, circuit access sites, and a bridge connecting the venous access and arterial infusion limbs of the circuit. Significant technical advancements have been made in the equipment available for short- and long-term extracorporeal membrane oxygenation applications. Contemporary extracorporeal membrane oxygenation circuits have greater biocompatibility and allow for more prolonged cardiopulmonary support time while minimizing the procedure-related complications of bleeding, thrombosis, and other physiologic derangements, which were so common with the early application of extracorporeal membrane oxygenation. Modern era extracorporeal membrane oxygenation circuitry and components are simpler, safer, more compact, and can be used across a wide variety of patient sizes from neonates to adults.

Complete atrioventricular septal defect with absent or diminutive primum component: Incidence, anatomic characteristics, and outcomes.

BACKGROUND: Repair of complete atrioventricular septal defect with absent or diminutive primum defect is challenging because of atrial septal malposition and abnormal anatomy of the left atrioventricular valve. We sought to define the incidence, anatomy, and surgical outcomes of this entity. METHODS: We identified all patients in our institutional database presenting for complete atrioventricular septal defect repair from 2006 to 2018. Operative reports and echocardiograms were reviewed to determine the presence and size of the primum defect, atrioventricular valve anatomy, degree of atrioventricular valve regurgitation, repair method, and complications, including reoperation for atrioventricular valve regurgitation. Functionally univentricular patients and those receiving repair at an outside institution were excluded. RESULTS: Of 183 patients with complete atrioventricular septal defect, absent/diminutive primum defect occurred in 16 patients (8.7%; 10 absent, 6 diminutive). Six patients (38%) had leftward malposition of the atrium septum on the common atrioventricular valve. The rate of reoperation for left atrioventricular valve regurgitation was 31% (3 early, 2 late), for which preoperative predictors included leftward malposition of the atrial septum onto the common atrioventricular valve (4/6 patients with malposition required reoperation, P = .036, Fisher exact test). One patient exhibiting this risk factor died. The overall rate of moderate or greater left atrioventricular valve regurgitation on the most recent postoperative echocardiogram was 13% (2/16 patients; median follow-up, 141 days; range, 3-2236 days). CONCLUSIONS: Complete atrioventricular septal defect with absent or diminutive primum defect is a unique variant of complete atrioventricular septal defect for which the risk of reoperation for left atrioventricular valve regurgitation after complete repair is high and risk factors include leftward malposition of the atrial septum on the common atrioventricular valve.