Multicenter Clinical Research in Congenital Heart Disease: Leveraging Research Networks to Investigate Important Unanswered Questions.

Congenital heart disease (CHD) is the most common birth defect in the United States. Neonates with CHD are often cared for by neonatologists in addition to cardiologists. However, there is a paucity of rigorous evidence and limited clinical trials regarding the management of neonates with CHD. In this review, we will describe some of the challenges of research in this field. The Pediatric Heart Network serves as an example of how a research network can effectively overcome barriers to conduct and execute well-designed multicenter studies.

Cardiac Effects of COVID-19 Infection, MIS-C, and the Vaccine in Infants and Children: What Is Known and Future Implications.

The cardiac effects of novel coronavirus disease 2019 (COVID-19) infection on the pediatric heart has become an area of particular interest as elevated cardiac enzymes and abnormalities on echocardiogram and electrocardiogram were seen in a portion of children affected by the virus. In this article, we review the cardiac manifestations of acute COVID-19 infection, multisystem inflammatory syndrome in children, and postvaccine myocarditis. The limited research on the effects of COVID-19 on neonates and infants is also reported. KEY POINTS: · Cardiac involvement from MIS-C is much higher than the risk of COVID-19 vaccine-induced myocarditis.. · Neonates and infants have overall been less affected by COVID-19 than adults and older children.. · At this point in time, there is limited research on the cardiac effects of COVID-19 in neonates..

Rethinking Pulse Oximetry Screening in the Level-IV Neonatal Intensive Care Unit.

OBJECTIVE: This study aimed to evaluate the outcomes of newborn pulse oximetry screening in a level IV, tertiary care neonatal intensive care unit (NICU). STUDY DESIGN: This is a retrospective cohort study of neonates who received newborn pulse oximetry screening after being admitted to a single-center, level-IV NICU between 2014 and 2021. Neonates with known critical congenital heart disease were excluded from the study. RESULTS: Of the 4,493 neonates who had pulse oximetry screening, there were three positive screens (fail rate of 0.067%, 0.67 per 1,000 screened). The average age of screening was 818 hours. There were no positive screens of newborns who were admitted during their initial birth hospitalization and were screened while off oxygen. There were no new diagnoses of critical congenital heart disease (true positives) and there were no known false negatives. CONCLUSION: The results bring into question whether pulse oximetry screening with the current AAP-endorsed algorithm should be re-evaluated for a level-IV NICU at a children's hospital. However, the results may not be generalizable to other NICU's where echocardiography and prenatal echocardiograms are not as readily available. KEY POINTS: · Pulse oximetry has been shown to be effective in decreasing delayed diagnosis of critical congenital heart disease (CCHD); however, there are limited prior studies on newborn pulse oximetry in the NICU.. · In our study of over 4,000 neonates admitted to a level IV tertiary care NICU, there were no true positives (no new diagnoses of CCHD).. · Special considerations may be needed for pulse oximetry screening in the NICU setting..

Lessons Learned from Infants with Late Detection of Critical Congenital Heart Disease.

Late detection of critical congenital heart disease (CCHD) is multifactorial and ill defined. We investigated the results of pulse oximetry screening (POS) and points in the care chain that contribute to delayed detection of CCHD. The medical records of 13 infants with delayed detection at a single pediatric cardiac center between 2013 and 2016 were identified and reviewed. Left heart obstructive lesions were the most common diagnosis (n = 8; 62%) and included coarctation of the aorta (n = 6), interrupted aortic arch with ventricular septal defect (n = 1), and critical aortic stenosis (n = 1). Tetralogy of Fallot (TOF) (n = 2), truncus arteriosus (n = 1), pulmonary atresia with ventricular septal defect (n = 1), and total anomalous pulmonary venous drainage (n = 1) made up the remainder of the conditions. Routine prenatal care was reported in most infants (10/13). Infants with late detection had either a true negative POS (10/13 infants) or no POS performed (3/13 infants). At the time of detection, 5/6 (83%) infants with coarctation had normal pulse oximetry values, whereas 6/7 (86%) infants with other CCHD developed abnormal pulse oximetry values. At diagnosis, 11/13 (85%) infants had significant signs or symptoms of clinical deterioration; only 2 infants were completely asymptomatic. Late detection of CCHD is uncommon and multifactorial. Eliminating late detection is dependent upon improving detection on screening obstetrical ultrasounds, enforcement of universal POS, and attention to the neonatal physical exam.

Newborn Pulse Oximetry Screening at a Community Hospital: An 8-Year Experience.

OBJECTIVES: To evaluate newborn pulse oximetry screening (POS) outcomes at a large community hospital and the impact of the recommended revised POS algorithm. METHODS: A retrospective cohort study was performed to evaluate the results of POS in the well-infant nursery between 2012 and 2020. The POS results were obtained from an electronic platform. Chart review was completed for newborns with failed screens. The recommended revision to POS, no second rescreen, was applied to the data to evaluate screening outcomes. RESULTS: Of the total 65 414 infants admitted to the well-infant nursery during this 8-year period, >99% (n = 64 780) received POS. Thirty-one infants failed POS (4.6 per 10 000 screened). All infants who failed POS were found to have a disorder, with 12 (39%) having critical congenital heart disease (CCHD), 9 (29%) having non-CCHD requiring further follow-up, and 10 (32%) having noncardiac conditions. One false-negative screen result was identified through the Maryland Department of Health Newborn Screening Follow-up Program. The positive predictive value of POS for those screened was 39% for CCHD, with a specificity of 99.97%. Eliminating the second rescreen in the POS algorithm would have resulted in an additional 5 newborns without CCHD failing POS, increasing the false-positive rate from 0.03% to 0.04%. CONCLUSIONS: POS is an effective tool for identifying CCHD and secondary conditions. POS was successfully implemented with few missed screens and was highly specific. Elimination of the second rescreen in the pulse oximetry algorithm would have resulted in a minimal increase in false-positive results and faster evaluation of newborns with CCHD.

Expanding Access to Fetal Telecardiology During the COVID-19 Pandemic.

Background: This study aims to describe one center's experience in expanding a fetal telecardiology program through collaborative work with maternal fetal medicine (MFM) clinics with the goal of safely reaching mothers during the COVID-19 pandemic. We sought to define the extent of fetal telehealth conversion at a large fetal cardiac care center and evaluate the diagnostic accuracy for studies performed. Methods: At our center, fetal telemedicine expanded from one MFM site before the pandemic to four additional sites by May 2020. A retrospective review of fetal telecardiology visits between March 15 and July 15, 2020, was performed. The chart was reviewed for confirmation of diagnosis postnatally. Results: With pandemic onset, there was a large increase in the number of telemedicine visits with a total of 122 mothers seen between five MFM clinics. Fourteen mothers (11.5%) had abnormal fetal echocardiograms requiring additional follow-up, and seven mothers (5.8%) had a fetal echocardiogram suspicious for a critical congenital heart disease (CCHD). All the fetal echocardiograms suspicious for CCHD were confirmed on postnatal echocardiogram. To our knowledge, none of the normal fetal echocardiograms were found to have congenital heart disease postnatally. Conclusions: In response to the COVID-19 pandemic, we rapidly transitioned to fetal telecardiology using a variety of formats. This has reduced potential infectious exposure for pregnant mothers and minimized contact between physicians without compromising diagnostic accuracy. In our experience, the expansion of a telemedicine program requires strong initial infrastructure, prior relationships with MFM providers, and appropriate training among obstetric sonographers.