Cardiology & Heart Surgery

sick child in palliative care hospital bed

New study compares first and second wave of MIS-C

sick child in palliative care hospital bed

When comparing the first and second wave of patients diagnosed with multi-system inflammatory syndrome in children (MIS-C), the second wave patients had more severe illness, according to a new prospective cohort study at Children’s National Hospital in Washington, D.C.

When comparing the first and second wave of patients diagnosed with multi-system inflammatory syndrome in children (MIS-C), the second wave patients had more severe illness, according to a new prospective cohort study of 106 patients at Children’s National Hospital in Washington, D.C. The results, published in The Pediatric Infectious Disease Journal, show that despite increased severity in the second wave cohort, both cohorts had similarities in cardiac outcomes and length of stay. Researchers are still working to better understand the exact immunologic mechanisms that trigger MIS-C and the specific factors accounting for its rare occurrence.

“We’ve now seen three distinct waves of MIS-C since the beginning of the pandemic, each wave following national spikes in cases,” said Roberta DeBiasi, M.D., chief of the Division of Pediatric Infectious Diseases at Children’s National and co-author of the study. “Kids in the second wave cohort had potentially experienced intermittent and/or repeated exposures to the virus circulating in their communities. In turn, this may have served as repeated triggers for their immune system which created the more severe inflammatory response.”

In this new study, key demographic features Children’s National researchers previously identified held true across both waves – including the fact that Black and Latino children are significantly more affected than white children.  Of the 106 patients, 54% were Black and 39% were Hispanic. The authors also noted that 75% of the patients were otherwise healthy children with no underlying medical conditions.

“While we believe the most recent third wave associated with the delta variant surge is tapering off, the findings from the first two waves provide important baseline information and are highly relevant for clinicians across the country that are evaluating and treating kids with MIS-C,” said Dr. DeBiasi.

Children’s National has cared for more than 4,200 symptomatic patients with SAR-CoV-2 infection and more than 185 MIS-C patients since the pandemic began. The first wave of MIS-C patients were hospitalized between March 2020 and October 2020. Second wave patients were hospitalized between November 2020 and April 2021. Each wave came 4-6 weeks following periods of COVID-19 surges in the community.

In the study, researchers compared patient demographics, clinical features, laboratory results, radiographic images, therapies and outcomes. The second wave cohort had a higher proportion of children 15 years of age or older. Patients also presented more frequently with shortness of breath and required more advanced respiratory and inotropic support. Researchers also found that patients in the second wave were less likely to test positive for SARS-CoV-2 on a PCR test.

Dr. DeBiasi and her team hope to unlock even more insights as they now analyze data from the third wave associated with the delta variant, which currently appears to have affected less children than the previous two. Children’s National is also working in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to study the long-term effects of MIS-C and COVID-19 on the pediatric population after recovery. This is among the largest and longest studies being conducted, and researchers are hopeful the findings will help improve treatment of COVID-19 and MIS-C in the pediatric population both nationally and around the world.

“Our timely established multidisciplinary MIS-C task force here at Children’s National allowed us to reduce the learning curve,” said Ashraf S. Harahsheh, M.D., F.A.A.P., F.A.C.C., director of Quality Outcomes in Cardiology and co-first author of the study. “Experience from other centers showed that immunotherapy was utilized more frequently in recent MIS-C cohorts leading to reduction in percentage of cardiac complications. On the other hand, and despite having increased illness severity in the second cohort, our approach with prompt immunotherapy helped stabilize the rate of cardiac complications.”

brain network illustration

Cardiopulmonary bypass may cause significant changes to developing brain and nerve cells

brain network illustration

Cardiopulmonary bypass, more commonly known as heart-and-lung bypass, has some unique impacts on the creation and growth of brain cells in the area of a child’s brain called the subventricular zone (SVZ), according to a study in the Annals of Neurology. The SVZ is a critical area for the growth and migration of neurons and nerve cells called neuroblasts, both of which ultimately contribute to the proper development of key brain structures and functions during the early years of life.

The findings, from a study conducted in the Cardiac Surgery Research Laboratory at Children’s National Hospital, provide new insight into the cellular impacts of the cardiopulmonary bypass machine on brain growth and development for newborn infants with congenital heart disease. They will have an important role in the refinement of strategies to help protect the fragile brains of children who require lifesaving cardiac surgery with cardiopulmonary bypass immediately after birth.

Specifically, the research team found that during cardiopulmonary bypass:

  • Creation of neurons (neurogenesis) in the neonatal and infant subventricular zone is altered.
  • Migration of nerve cells, called neuroblasts, to the frontal lobe is potentially disrupted.
  • Changes to the growth and movement of neurons in the SVZ are prolonged.
  • Cortical development and expansion is impaired.
  • Specific types of neurons found only in the brain and spinal cord, called interneurons, are also affected.

The study uses an innovative pre-clinical model of the developing brain that is more anatomically and physiologically similar to human neonates and infants than those used in prior studies and in most neurological laboratory-based research.

Cardiopulmonary bypass is one of several key factors thought to cause children with congenital heart disease to sometimes demonstrate delays in the development of cognitive and motor skills. These disabilities often persist into adolescence and adulthood and can ultimately represent long-term neurocognitive disabilities. It is also believed that genetic factors, abnormal blood flow to the brain while in utero or low cardiac output after surgical procedures on the heart may contribute to these challenges.

“Unraveling cellular and molecular events during surgery using this preclinical model will allow us to design therapeutic approaches that can be restorative or reparative to the neurogenic potential of the neuronal stem precursor cells found in the subventricular zone of the neonatal or infant brain,” says Nobuyuki Ishibashi. M.D., Foglia-Hills Professor of Pediatric Cardiac Research, director of the Cardiac Surgery Research Laboratory at Children’s National and senior author on the study. “In particular, previous studies in our laboratory have shown improvement in the neurogenic activities of these precursor cells when they are treated with mesenchymal stromal cells (MSCs).”

The findings from this study further support the work already underway in the NIH-funded MeDCaP clinical trial for neonates and infants undergoing cardiac surgery using the cardiopulmonary bypass machine. That trial uses the heart and lung machine itself to deliver MSCs directly into the main arteries that carry blood to the brain.

Drs. Wernovsky and Martin

Cardiac care leaders recognized for mentorship and innovation at AAP

Two Children’s National Hospital cardiac care leaders received prestigious recognition awards from the American Academy of Pediatrics (AAP) during that organization’s virtual National Conference and Exhibition in October 2021.

  • Gil Wernovsky, M.D., cardiac critical care specialist at Children’s National Hospital, received the 2021 Maria Serratto Master Educator Award from AAP Section on Pediatric Cardiology and Cardiac Surgery, celebrating his 30-plus-years as a clinician, educator, mentor and leader in the field.
  • Gerard Martin, M.D., FAAP, FACC, FAHA, C. Richard Beyda Professor of Cardiology, Children’s National Hospital, received the AAP Section on Advances in Therapeutics and Technology (SOATT) Achievement Award, in recognition of his work to establish the use of pulse oximetry to screen newborn infants for critical congenital heart disease in the first 24 hours of life.

Dr. Wernovsky: 2021 Maria Serratto Master Educator Award, AAP Section on Pediatric Cardiology and Cardiac Surgery

Gil Wernovsky

Gil Wernovsky, M.D., received the 2021 Maria Serratto Master Educator Award from AAP Section on Pediatric Cardiology and Cardiac Surgery.

The Master Educator Award is presented each year to a pediatric cardiologist or cardiothoracic surgeon who exemplifies excellence as an educator, mentor and/or leader in the field.

A practicing cardiac critical care specialist with more than 30 years’ experience in pediatric cardiology, Dr. Wernovsky trained and mentored more than 300 fellows in pediatric cardiology, cardiac surgery, neonatology, critical care medicine and cardiac anesthesia, in addition to countless residents and fellows. He also organizes national and international symposia to share expertise around the world. During the COVID-19 public health emergency, for example, he co-founded the Congenital Heart Academy (CHA). The CHA provides content from an international faculty of cardiac care to more than 26,000 practitioners in 112 countries and includes a thriving YouTube channel.

Dr. Wernovsky is also a founding member of several international societies focused on bringing together clinicians, researchers and students across sub-specialties of pediatric cardiology and cardiac surgery for knowledge exchange and best practice sharing. These include: the Pediatric Cardiac Intensive Care Society, World Society for Pediatric and Congenital Heart Surgery, the International Society of Pediatric Mechanical Circulatory Support and the Cardiac Neurodevelopmental Outcome Collaborative.

Dr. Wernovsky received the award on October 10 at the virtual Scientific Sessions of the 2021 American Academy of Pediatrics National Conference and Exhibition.

Dr. Martin: AAP Section on Advances in Therapeutics and Technology (SOATT) Achievement Award

Gerard Martin

Gerard Martin, M.D., FAAP, FACC, FAHA, C. Richard Beyda Professor of Cardiology, Children’s National Hospital, received the AAP Section on Advances in Therapeutics and Technology (SOATT) Achievement Award.

The Section on Advances in Therapeutics and Technology (SOATT) educates physicians, stimulates research and development and consults on therapeutics and technology-related matters for the AAP. The Achievement Award recognizes someone who has shown leadership in applying innovative approaches to solve pressing problems.

Dr. Martin is the C. Richard Beyda Professor of Cardiology and has cared for children at Children’s National for more than 30 years. As an advocate for congenital heart disease efforts nationally and internationally, he played an integral role in the development of an innovative use of existing hospital technology—the pulse oximeter—to detect critical congenital heart disease in newborn babies.

Today, Dr. Martin and colleagues across the United States and around the world have worked to make this screening method a standard of care for newborns everywhere. It is a part of the Health Resources and Services Administration (HRSA) Recommended Uniform Screening Panel and has become law in every state. They continue to conduct research to refine the recommendations and hone-in on the most effective ways to harness these tools.

Dr. Martin was selected for this award in 2020. He accepted it and offered remarks during the 2021 virtual AAP National Conference and Exhibition on Monday, October 11, 2021.

cardiology timeline

History of cardiac care for children in Washington, D.C.

An article published in the journal Cardiology in the Young provides a comprehensive timeline mapping the growth trajectory of cardiology and cardiac surgery at one of the nation’s oldest children’s hospitals — Children’s National Hospital in Washington, D.C.

Cardiology and cardiac surgery at Children’s National have grown exponentially in the nearly 80 years since the first heart-related surgery was recorded in 1942. Today, aligned with the growth trajectory of the hospital as it has evolved to become one of the top-ranked pediatric institutions in the country, the Children’s National Heart Institute has also evolved. In the last year, this included welcoming new Cardiac Surgery Chief, Yves d’Udekem, M.D., Ph.D.

The authors, Gerard Martin, M.D., M.A.C.C., C.R. Beyda Professor of Cardiology, and Richard Jonas, M.D., emeritus chief of Cardiac Surgery, both from Children’s National Hospital, note that this history of care has laid the groundwork for the Heart Institute to continue growing and caring for more neonates, infants, children and adults with congenital heart disease in the entire mid-Atlantic region and around the world.

cara timeline mapping the growth of cardiac care for neonates, children and adults at Children’s National Hospital

The article features a timeline mapping the growth of cardiac care for neonates, children and adults at Children’s National Hospital.

flow chart of pulse ox study

Newborn screening for critical congenital heart disease serves as vital safety net

One of the nation’s longest-running newborn screening programs for critical congenital heart disease (CCHD) finds that screening continues to serve as a necessary tool to help identify every child with CCHD — even in states where the majority of babies are diagnosed before birth.

The screening program study findings were published in Pediatrics. The data is some of the first to provide long-term evidence for using pulse oximetry to screen newborns for critical congenital heart disease 24 hours after birth. This screening test was added to the Department of Health and Human Services Recommended Uniform Screening Panel in 2011 and is now required in all 50 states.

“This study reinforces why pulse oximetry screening for CCHD is an important tool in our arsenal to identify and treat critical congenital heart disease, and other conditions that affect the flow of oxygen throughout the body, as soon as possible,” says Bryanna Schwarz, M.D., a cardiology fellow at Children’s National Hospital and lead author. “We know that prompt, early detection and swift intervention is crucial to positive long-term outcomes for these kids.”

The team looked at the data and outcomes for all babies born throughout eight years at Holy Cross Hospital in suburban Maryland, one of the first community birthing hospitals in the country to routinely perform the screening. Over the eight-year period, 64,780 newborns were screened at the site. Of those:

  • Thirty-one failed the screening, and every baby who failed was found to have congenital heart disease or another important medical condition.
  • Twelve of the failures (38.7%) were babies with critical congenital heart disease who were not previously identified by prenatal detection.
  • Nine others (29%) had a non-critical congenital heart condition.
  • Ten additional babies (32%) had a non-cardiac condition.

The authors note that the 12 newborns with CCHD identified through pulse oximetry screening are noteworthy because they represent critical congenital heart disease cases that are not found before birth in the state of Maryland, where rates of prenatal diagnosis are relatively high. The finding indicates that screening after birth continues to play a critical role in ensuring every baby with critical congenital heart disease is identified and treated as quickly as possible.

“Holy Cross Health and Children’s National have had a decades-long relationship, as we mutually care for women and infants throughout the region. With Children’s National having the U.S. News & World Report #1 ranking Neonatology service in the nation and Holy Cross Hospital being among the top 10 hospitals for the number of babies delivered each year, we are honored to be leading together the great work that is being done to serve our health care community,” says Ann Burke, M.D., vice president of Medical Affairs at Holy Cross Hospital. “We are committed to continuing to do our part to care for women and infants, as well as contribute to the national landscape for neonatal care. We are delighted in the outcomes we have seen and look forward to continued advancement.”

In this study, infants who did not have critical congenital heart disease were considered “false positives” for CCHD. Still, every one of them was found to have another underlying condition, including non-critical congenital heart disease or non-cardiac conditions (such as sepsis and pneumonia) that would also require monitoring and treatment.

The researchers also ran a projection of recently recommended updates to the screening protocol, which include removing a second re-screen after a newborn fails the initial test, to look at whether removing the second rescreen to verify results would decrease accuracy. While the false positive rate did increase slightly from .03% to .04%, eliminating a second re-screen allowed the newborns who were identified to receive crucial care sooner without having to wait an additional hour for one more test to verify their condition.

“It’s time to stop asking if pulse oximetry is a necessary tool to detect critical heart disease in babies,” says Gerard Martin, M.D., M.A.C.C., senior author of the study and C.R. Beyda Professor of Cardiology at Children’s National Hospital. “Our focus now should be on making evidence-based refinements to the screening protocol based on collected data to ensure the process is simple, can be performed consistently and provides as accurate results as possible.”

Ugandan boy in hospital bed

Acute rheumatic fever often goes undiagnosed in sub-Saharan Africa

Ugandan boy in hospital bed

Despite low numbers of documented acute rheumatic fever cases in sub-Saharan Africa, the region continues to show some of the highest numbers of people with, and dying from, rheumatic heart disease, the serious heart damage caused by repeat instances of rheumatic fever.

Despite low numbers of documented acute rheumatic fever cases in sub-Saharan Africa, the region continues to show some of the highest numbers of people with, and dying from, rheumatic heart disease, the serious heart damage caused by repeat instances of rheumatic fever. A population-based study in the Lancet Global Health collected evidence of acute rheumatic fever in two areas of Uganda, providing the first quantifiable evidence in decades that the disease continues to take a deadly toll on the region’s people.

“These findings matter. Access to life-saving heart surgery is only available to a very small fraction of the hundreds of thousands of patients in Africa who have irreversible heart damage from rheumatic heart disease,” says Craig Sable, M.D., associate chief of Cardiology at Children’s National Hospital and one of the senior authors of the study. “It’s time to focus upstream on capturing these conditions sooner, even in low-resource settings, so we can implement life-sustaining and cost-saving preventive treatments that can prevent further heart damage.”

The authors, who hail from Uganda and several institutions around the United States, including Children’s National and Cincinnati Children’s Hospital Medical Center, note this is the first study to use an active case-finding strategy for diagnosing acute rheumatic fever. They also note that raising awareness in the community and among its healthcare workers while also finding new ways to overcome some of the diagnostic challenges in these low-resource settings greatly improved diagnosis and treatment of the condition.

The study also described clinical characteristics of children ages 5 to 14 presenting with both definitive and possible acute rheumatic fever, providing further clinical data points to help healthcare workers in these communities differentiate between this common infection and some of the other frequently diagnosed conditions in the region.

“With this study, we can now confidently dismiss the myth that acute rheumatic fever is rare in Africa,” the authors write. “It exists at elevated rates in low-resource settings such as Uganda, even though routine diagnosis remains uncommon. While these incidence data have likely underestimated the cases of acute rheumatic fever in two districts in Uganda, they show that opportunity exists to improve community sensitization and healthcare worker training to increase awareness of acute rheumatic fever. Ultimately this leads to diagnosing more children with the condition before they develop rheumatic heart disease, so that they can be offered secondary prophylaxis with penicillin.”

Children with suspected acute rheumatic fever participated in this population-based study. Data was collected over 12 months in Lira district (January 2018 to December 2018) and over nine months (June 2019 to February 2020) in Mbarara district.

Follow-up of children diagnosed in this study will provide more data on the outcomes of acute rheumatic fever, including a better understanding of the risk for a child to develop rheumatic heart disease.

This work was funded by the American Heart Association Children’s Strategically Focused Research Network Grant #17SFRN33670607 and by DEL‐15‐011 to THRiVE‐2 and General Electric.

Learn more about the challenges of rheumatic heart disease in sub-Saharan Africa and other developing parts of the world through the Rheumatic Heart Disease microdocumentary series:


coronavirus

One-half of MIS-C patients at a single center experienced heart complications

coronavirus

A single center study of patients with multisystem inflammatory disease in children (MIS-C) found that half of children diagnosed with MIS-C had a heart complication as part of the disease. The study collected and analyzed data from 39 cases of MIS-C at Children’s National Hospital in 2020. MIS-C is a pediatric disease that has been linked to SARS-CoV-2, the virus that causes COVID-19.

The study’s findings appear in the journal Cardiology of the Young. The authors aimed to describe the type and frequency of cardiac complications in children with MIS-C while also outlining the disease’s short-term progression. They also hoped to better understand the demographics, clinical and laboratory findings, as well as the therapeutic successes for children with cardiac complications from MIS-C.

“While half of all children at our hospital diagnosed with MIS-C did experience a cardiac complication, it’s important to note that almost all of them (84%) also fully recovered from that cardiac complication within 50 days of diagnosis,” says Ashraf Harahsheh, M.D., director of Quality Outcomes in Cardiology at Children’s National Hospital, who led the study. “We were also able to identify a few common factors among those with cardiac complications that, with further research, may help us identify earlier the children with MIS-C who are at greater risk for heart problems.”

The study found that children with cardiac complications had higher levels of natriuretic peptides, which appear in greater numbers when the heart isn’t pumping enough blood to the rest of the body. Additionally, children who developed heart complications also had higher initial white blood cell counts. MIS-C cardiac complications ranged from mild systolic dysfunction to coronary artery abnormalities and/or artery dilation.

This was a retrospective, observational study of 39 patients admitted to Children’s National Hospital from March 2020 to September 2020 who met the Centers for Disease Control and Prevention MIS-C case definition. Patient demographics, clinical features, laboratory values, diagnostic investigations, including echocardiograms, and therapies were extracted from the electronic medical records.

“This syndrome has some similarities to Kawasaki disease, another inflammatory syndrome that is known to cause cardiac complications,” says Dr. Harahsheh. “Thankfully what we’ve learned from studying and treating Kawasaki disease in children has helped us collaborate with partners around the world to find treatments for MIS-C that seem to minimize the impact of these complications, at least in the short term.”

Charles Berul receives award

Charles Berul, M.D., named Pioneer in Cardiac Pacing and Electrophysiology by Heart Rhythm Society

Charles Berul receives award

Dr. Berul receives the Pioneer in Cardiac Pacing and Electrophysiology from the Heart Rhythm Society at their 2021 meeting.

The Heart Rhythm Society has awarded its 2021 Pioneer in Cardiac Pacing and Electrophysiology Award to Charles Berul, M.D., chief of Cardiology and co-director of the Children’s National Heart Institute at Children’s National Hospital.

The award recognizes an individual who has been active in cardiac pacing and/or cardiac electrophysiology for many years and has made significant contributions to the field. It is typically given to electrophysiologists who treat adults. Dr. Berul is the second pediatric specialist to receive it. Dr. Berul accepted his award at Heart Rhythm 2021, the society’s annual meeting.

“It is wonderful news that Dr. Berul is receiving this award in recognition of his major contributions to this field and to improve the lives of children with heart rhythm challenges,” says David Wessel, M.D., executive vice president, chief medical officer and physician-in-chief at Children’s National Hospital. “We are proud of all he has achieved so far, and are so thankful that he shares his expertise, leadership, mentorship and friendship with us at Children’s National every day. Congratulations to him on this tremendous honor.”

The Heart Rhythm Society notes that Dr. Berul has mentored dozens of trainees who have gone on to successful careers and particularly advocates for young investigators and clinician-scientists. He is known for his collaborative style and promotion of faculty physicians in academic medicine. His scientific work began with cellular electrophysiology and clinical genetics of inherited arrhythmia disorders.

He is known for his development of innovative electrophysiologic studies for phenotypic evaluations of genetically manipulated pre-clinical models. Over the past two decades, his research focus and passion have been to develop novel minimally invasive approaches to the heart and improving methods for pediatric pacing and defibrillation.

Dr. Berul is an active member of the Heart Rhythm Society. He has served on multiple society committees, task forces, and writing groups, and is currently an associate editor for the society’s journal, Heart Rhythm. He is also actively involved in other key organizations such as Mended Little Hearts and the Pediatric and Congenital Electrophysiology Society (PACES).

He has more than 300 publications and is an invited speaker nationally and internationally in the areas of pediatric cardiac electrophysiology and miniaturized device development.

bisphenol A

Alternative synthetic compound might offer safer solution to children’s health

bisphenol A

Not only is bisphenol A (BPA) added to medical equipment used to treat patients, it can also be found in 60% of neonatal intensive care unit (NICU) supplies, such as bandages and items for feeding, suggesting that occupational and clinical environments have a higher exposure to this synthetic compound.

Researchers at Children’s National Hospital found that a commonly used plastic, known as bisphenol S (BPS), was the least disruptive to cardiac electrophysiology and may serve as a safer chemical alternative for plastic medical devices used to treat vulnerable populations compared to other compounds, according to a new preclinical study published in Toxicological Sciences.

For decades, the medical device industry has used bisphenol chemicals known to antagonize ion channels, impair electrical conduction and trigger arrhythmias that affect the overall cardiovascular health in children. Not only is bisphenol A (BPA) added to medical equipment used to treat patients, it can also be found in 60% of neonatal intensive care unit (NICU) supplies, such as bandages and items for feeding, suggesting that occupational and clinical environments have a higher exposure to this synthetic compound.

Yet, very little is known about the downstream impact of BPA, BPS or bisphenol F (BPF) exposure on cardiac physiology.

To shed light on the safety profile of BPA and its alternatives BPS and BPF in plastic medical devices, Children’s National researchers present the first study that compares the acute effects of these three chemicals on cardiac electrophysiology in a preclinical model.

According to the researchers, children should continue receiving medical care to treat their condition.

“It is important to investigate iatrogenic plastic chemical exposures in young patients, as biomonitoring studies have reported elevated chemical exposures in NICU and pediatric intensive care unit patients,” said Devon Guerrelli, M.S., a Ph.D. candidate at Children’s National. “Our lab is actively working with cardiac surgeons to investigate patient exposure to both BPA and phthalate plasticizer chemicals. Patients and their parents can rest assured that our team’s priority is safety and advancement of the field.”

Future studies are needed to fully understand the chemicals’ safety on cardiac electrical and mechanical function due to notable biological differences between humans and preclinical models. The researchers call for the scientific community to explore the impact of these compounds on other organ systems by comprehensively assessing intracellular targets, genomic and proteomic expression profiles.

While health concerns remain, there is no consensus among the scientific community on the potential use of safer compound alternatives in pediatric plastic medical devices.

“First, a variety of preclinical models have been used by the scientific community to assess BPA toxicity. But, there is considerable variability between these different models, including differences in ion channel expression, which may produce conflicting results and limit extrapolation of the data to humans,” said Nikki Posnack, Ph.D., principal investigator at Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and senior author. “Accordingly, in the presented study, we tested the effects of bisphenol chemicals using three different preclinical models. Second, studies assessing the safety profile of new structural analogs to BPA are limited.”

The researchers compared the cardiac safety profile of BPA, BPS and BPF by using a whole-cell voltage clamping recording on cell lines to study voltage-gated channels Nav1.5, Cav 1.2 and hERG, allowing the measurements of the cell’s electrical properties and total current through all the channels on a membrane in non-human subjects and cardiomyocytes human cell lines. Results of the study found that BPA was the most potent inhibitor of sodium, calcium and potassium channel currents compared to the alternatives BPS and BPF. BPA and BPF exposure also slowed atrioventricular conduction and increased atrioventricular nodal refractoriness.

“Based on our findings, acute exposure to high concentrations of BPA could lead to changes in cardiac electrophysiology,” said Tomas Prudencio, M.S., a research technician at Children’s National and lead author. “This includes slowing of electrical conduction from the atria to the ventricles, which would present as a prolongation of the PR interval in an electrocardiogram.”

coronavirus

Children’s National Hospital and NIAID launch large study on long-term impacts of COVID-19 and MIS-C on kids

coronavirus

Up to 2,000 children and young adults will be enrolled in a study from Children’s National Hospital in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) that will examine the long-term effects of COVID-19 and multisystem inflammatory syndrome in children (MIS-C) after these patients have recovered from a COVID-19 infection.

This $40 million multi-year study will provide important information about quality of life and social impact, in addition to a better understanding of the long-term physical impact of the virus, including effects on the heart and lung. The researchers hope to detail the role of genetics and the immune response to COVID-19, so-called “long COVID” and MIS-C, including the duration of immune responses from SARS-CoV-2, the virus that causes COVID-19. It is fully funded by a subcontract with the NIH-funded Frederick National Laboratory for Cancer Research operated by Leidos Biomedical Research, Inc.

“We don’t know the unique long-term impact of COVID-19 or MIS-C on children so this study will provide us with a critical missing piece of the puzzle,” says Roberta DeBiasi, M.D., M.S., chief of the Division of Pediatric Infectious Diseases at Children’s National and lead researcher for this study. “I am hopeful that the insights from this enormous effort will help us improve treatment of both COVID-19 and MIS-C in the pediatric population both nationally and around the world.”

Over the past year, more than 3.6 million children have tested positive for SARS-CoV-2 and over 2,800 cases of MIS-C have been reported throughout the U.S. While the vast majority of children with primary SARS-CoV-2 infection may have mild or no symptoms, some develop severe illness and may require hospitalization, including life support measures. In rare cases, some children who have previously been infected or exposed to someone with SARS-CoV-2 have developed MIS-C, a serious condition that may be associated with the virus. MIS-C symptoms can include fever, abdominal pain, bloodshot eyes, trouble breathing, rash, vomiting, diarrhea and neck pain, and can progress to shock with low blood pressure and insufficient cardiac function. Long COVID is a wide range of symptoms that can last or appear weeks or even months after being infected with the virus that causes COVID-19.

The study is designed to enroll at least 1,000 children and young adults under 21 years of age who have a confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection or MIS-C. Participants who enroll within 12 weeks of an acute infection will attend study visits every three months for the first six months and then every six months for three years. Participants who enroll more than 12 weeks after acute infection will attend study visits every six months for three years. The study will also enroll up to 1,000 household contacts to serve as a control group, and up to 2,000 parents or guardians (one parent per participant) will complete targeted questionnaires.

“The large number of patients who will be enrolled in this study should provide us with a truly comprehensive understanding of how the virus may continue to impact some patients long after the infection has subsided,” says Dr. DeBiasi.

The study primarily aims to determine incidence and prevalence of, and risk factors for, certain long-term medical conditions among children who have MIS-C or a previous SARS-CoV-2 infection. The study will also evaluate the health-related quality of life and social impacts for participants and establish a biorepository that can be used to study the roles of host genetics, immune response and other possible factors influencing long-term outcomes.

Children’s National was one of the first U.S. institutions to report that children can become very ill from SARS-CoV-2 infection, despite early reports that children were not seriously impacted. In studies published in the Journal of Pediatrics in May of 2020 and June of 2021, Children’s National researchers found that about 25% of symptomatic COVID patients who sought care at our institution required hospitalization. Of those hospitalized, about 25% required life support measures, and the remaining 75% required standard hospitalization. Of patients with MIS-C, 52% were critically ill.

Study sites include Children’s National Hospital inpatient and outpatient clinics in the Washington, D.C. area, and the NIH Clinical Center in Bethesda, Maryland.

Those interested in participating should submit this form. You will then be contacted by a study team member to review the study details and determine whether you are eligible to participate.

You can find more information about the study here.

Crowded makeshift buildings of a shantytown

Calling greater attention to sub-Saharan Africa’s pressing challenges in pediatric cardiac care

Crowded makeshift buildings of a shantytown

Sub-Saharan Africa has only 0.19 pediatric cardiac surgeons per million children — nowhere near enough surgeons to care for all the pediatric congenital heart disease and acquired heart disease present in the people who live there.

A literature review in the journal Current Opinion in Cardiology draws further attention to the pressing needs for better pediatric cardiac care in regions of the world where the population continues to grow, but the development of specialty care for children continues to lag. The article focuses specifically on sub-Saharan Africa.

“If 40% of live births occur in Africa by 2050 as the projections suggest, congenital heart disease may well become the most important contributor to infant mortality rate in sub-Saharan Africa in the next three decades,” stated the authors, including Annette Ansong, M.D., who recently joined Children’s National Hospital as medical director of outpatient cardiology.

As highlighted previously by other authors within the Global Health Initiative at Children’s National and through the work of the American Heart Association, the region’s needs are already significant in  tackling the impacts of existing congenital heart disease and rheumatic heart disease. Rheumatic heart disease is a devastating long-term outcome of rheumatic fever caused by untreated streptococcus infections.

Annette Ansong

“If 40% of live births occur in Africa by 2050 as the projections suggest, congenital heart disease may well become the most important contributor to infant mortality rate in sub-Saharan Africa in the next three decades,” stated the authors, including Annette Ansong, M.D., who recently joined Children’s National Hospital as medical director of outpatient cardiology.

Dr. Ansong and colleagues reiterate the point that today, “whereas one cardiac center caters to approximately 120,000 people in North America, 33 million people in sub-Saharan Africa must depend on one center for care.” They also note that this region of Africa has only 0.19 pediatric cardiac surgeons per million children compared with more than 58 times as many in North America.

Changing the trajectory of pediatric cardiac care in sub-Saharan Africa will take motivation on several fronts, the authors write. Dedication to early detection and intervention (medical or surgical), an emphasis on building an in-country pipeline of human resources and skills’ sets are needed to tackle the increasing numbers of children requiring this specialty care. Political will and better financial resources can also support the training and development of centers that specialize in these capabilities.

little boy at doctor

Demographic, clinical and biomarker features of MIS-C

little boy at doctor

In a new observational study, researchers provide insight into key features distinguishing MIS-C patients to provide a more realistic picture of the burden of disease in the pediatric population and aid with the early detection of disease and treatment for optimal outcomes.

Multisystem Inflammatory Syndrome in Children (MIS-C) significantly affected more Black and Latino children than white children, with Black children at the highest risk, according to a new observational study of 124 pediatric patients treated at Children’s National Hospital in Washington, D.C. Researchers also found cardiac complications, including systolic myocardial dysfunction and valvular regurgitation, were more common in MIS-C patients who were critically ill. Of the 124 patients, 63 were ultimately diagnosed with MIS-C and were compared with 61 patients deemed controls who presented with similar symptoms but ultimately had an alternative diagnosis.

In the study, published in The Journal of Pediatrics, researchers provide insight into key features distinguishing MIS-C patients to provide a more realistic picture of the burden of disease in the pediatric population and aid with the early detection of disease and treatment for optimal outcomes. The COVID-linked syndrome has affected nearly 4,000 children in the United States in the past year. Early reports showed severe illness, substantial variation in treatment and mortality associated with MIS-C. However, this study demonstrated that with early recognition and standardized treatment, short-term mortality can be nearly eliminated.

“Data like this will be critical for the development of clinical trials around the long-term implications of MIS-C,” says Dr. Roberta DeBiasi, M.D., lead author and chief of the Division of Pediatric Infectious Diseases at Children’s National. “Our study sheds light on the demographic, clinical and biomarker features of this disease, as well as viral load and viral sequencing.”

Of the 63 children with MIS-C, 52% were critically ill, and additional subtypes of MIS-C were identified including those with and without still detectable virus, those with and without features meeting criteria for Kawasaki Disease, and those with and without detectable cardiac abnormalities. While median age (7.25 years) and sex were similar between the MIS-C cohort and control group, Black (46%) and Latino (35%) children were overrepresented in the MIS-C group, especially those who required critical care. Heart complications were also more frequent in children who became critically ill with MIS-C (55% vs. 28%). Findings also showed MIS-C patients demonstrated a distinct cytokine signature, with significantly higher levels of certain cytokines than those of controls. This may help in the understanding of what drives the disease and which potential treatments may be most effective.

In reviewing viral load and antibody biomarkers, researchers found MIS-C cases with detectable virus had a lower viral load than in primary SARS-CoV-2 infection cases, but similar to MIS-C controls who had alternative diagnoses, but who also had detectable virus. A larger proportion of patients with MIS-C had detectable SARS-CoV-2 antibodies than controls. This is consistent with current thinking that MIS-C occurs a few weeks after a primary COVID-19 infection as part of an overzealous immune response.

Viral sequencing was also performed in the MIS-C cohort and compared to cases of primary COVID-19 infection in the Children’s National geographic population. 88% of the samples analyzed fell into the GH clade consistent with the high frequency of the GH clade circulating earlier in the pandemic in the U.S. and Canada, and first observed in France.

“The fact that there were no notable sequencing differences between our MIS-C and primary COVID cohorts suggests that variations in host genetics and/or immune response are more likely primary determinants of how MIS-C presents itself, rather than virus-specific factors,” says Dr. DeBiasi. “As we’ve seen new variants continue to emerge, it will be important to study their effect on the frequency and severity of MIS-C.”

Researchers are still looking for consensus on the most efficacious treatments for MIS-C. In a recent editorial in the New England Journal of Medicine, Dr. DeBiasi calls for well-characterized large prospective cohort studies at single centers, and systematic and long-term follow-up for cardiac and non-cardiac outcomes in children with MIS-C. Data from these studies will be a crucial determinant of the best set of treatment guidelines for immunotherapies to treat MIS-C.

boy in hospital bed

Long-term, controlled studies needed to chart optimal MIS-C immunotherapy

boy in hospital bed

Roberta L. DeBiasi, M.D., chief of the Division of Pediatric Infectious Diseases at Children’s National Hospital, cautions that two new studies in the New England Journal of Medicine present seemingly conflicting findings about which treatments for MIS-C are optimal.

Multisystem inflammatory disease in children (MIS-C) has affected nearly 4,000 children in the United States in the last year. Two major studies appearing in the June edition of the New England Journal of Medicine seek to better define which immunotherapy treatments or combinations of treatments — intravenous immune globulin (IVIG), glucocorticoids or biologics — do the best job of combating the syndrome’s effects.

But Roberta L. DeBiasi, M.D., chief of the Division of Pediatric Infectious Diseases at Children’s National Hospital, cautions that though these two studies present seemingly conflicting findings about which treatments are optimal, neither study can provide a complete picture of efficacy, in part due to their retrospective and observational study design and population made up of patients from many different centers. True consensus will likely be found, she writes in an editorial that accompanies the studies in the journal, through single-center prospective cohort studies with standardized treatment approaches and long-term follow-up on outcomes.

“While there is a diagnostic criterion and an agreed upon need to induce a rapid therapy for MIS-C, the scientific community has not been able to agree on specific and optimal forms of immunomodulatory therapy,” she writes.

Despite efforts by the study authors to use statistical methods and modeling to control for variations in treatment applications from center to center, the study data is limited by the fact that the therapies have already been administered, in various combinations, based on conditions at each center where a  child was treated and not on a common set of treatment criteria.

Another challenge for generalizing from the findings of these studies is a mismatch in time. The data collected from the two published studies have two different time frames: before and after variants emerged or at various points during different waves of COVID-19 circulation in the U.S.

“Depending on the strain of initial infection and/or subsequent exposure, the dysregulated hyperimmune response of MIS-C could change,” Dr. DeBiasi says. And along with it, how patients respond to a particular treatment or combination of treatments.

Also, she notes it is too soon for any consortia to assess the impact of these therapies on longer-term outcomes, “specifically, comparative efficacy for progression or resolution of coronary abnormalities and prolonged or permanent cardiac dysfunction or scarring.”

Dr. DeBiasi concludes her editorial with a call for well-characterized large prospective cohort studies at single centers, and systematic and long-term follow-up for cardiac and non-cardiac outcomes in children with MIS-C. Data from these studies will be a crucial determinant of the best set of treatment guidelines for immunotherapies to treat MIS-C. Without findings from these types of studies, the selection of the most efficacious treatments is still unknown.

Read the full editorial in the New England Journal of Medicine: Immunotherapy for MIS-C: IVIG, Glucocorticoids, and Biologics

US News badges

For fifth year in a row, Children’s National Hospital nationally ranked a top 10 children’s hospital

US News badges

Children’s National Hospital in Washington, D.C., was ranked in the top 10 nationally in the U.S. News & World Report 2021-22 Best Children’s Hospitals annual rankings. This marks the fifth straight year Children’s National has made the Honor Roll list, which ranks the top 10 children’s hospitals nationwide. In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children’s hospitals for the fifth year in a row.

For the eleventh straight year, Children’s National also ranked in all 10 specialty services, with seven specialties ranked in the top 10.

“It is always spectacular to be named one of the nation’s best children’s hospitals, but this year more than ever,” says Kurt Newman, M.D., president and CEO of Children’s National. “Every member of our organization helped us achieve this level of excellence, and they did it while sacrificing so much in order to help our country respond to and recover from the COVID-19 pandemic.”

“When choosing a hospital for a sick child, many parents want specialized expertise, convenience and caring medical professionals,” said Ben Harder, chief of health analysis and managing editor at U.S. News. “The Best Children’s Hospitals rankings have always highlighted hospitals that excel in specialized care. As the pandemic continues to affect travel, finding high-quality care close to home has never been more important.”

The annual rankings are the most comprehensive source of quality-related information on U.S. pediatric hospitals. The rankings recognize the nation’s top 50 pediatric hospitals based on a scoring system developed by U.S. News. The top 10 scorers are awarded a distinction called the Honor Roll.

The bulk of the score for each specialty service is based on quality and outcomes data. The process includes a survey of relevant specialists across the country, who are asked to list hospitals they believe provide the best care for patients with the most complex conditions.

Below are links to the seven Children’s National specialty services that U.S. News ranked in the top 10 nationally:

The other three specialties ranked among the top 50 were cardiology and heart surgery, gastroenterology and gastro-intestinal surgery, and urology.

doctor listening to girl's heart

Decision support tool for chest pain reduces unnecessary cardiology referrals

doctor listening to girl's heart

A new study in the journal Medical Decision Making reports how well a new decision-support tool assisted pediatricians to apply validated criteria and reduce referrals to cardiology for children with chest pain.

In 2017, cardiologists from Children’s National Hospital and other centers published criteria to reliably detect risk for cardiac disease in children presenting with chest pain. However, despite the validated criteria published more than three years ago, as many as half of the children with chest pain who are referred to cardiology from a primary care doctor continue not to meet these criteria.

In response, the cardiology and Children’s National Pediatricians & Associates (CNP&A) team developed a decision support tool based on the validated criteria that was then incorporated into the CNP&A electronic medical record. A study, Promoting Judicious Primary Care Referral of Patients with Chest Pain to Cardiology: A Quality Improvement Initiative, in the journal Medical Decision Making reports how well the tool assisted pediatricians to apply the criteria and reduced referrals to cardiology for children who do not meet criteria for consultation by a pediatric cardiac specialist.

“As stated by the Institute for Healthcare Improvement, improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations and reducing per capita costs of health care. Known as the Triple Aim, such improvement includes reducing referrals to specialists for conditions that could be managed in primary care. Fewer unnecessary referrals can reduce costs by decreasing unnecessary testing and specialist time and also has the potential to improve the patient experience by providing care in the medical home,” the authors note.

The study highlights the results of a focused healthcare improvement initiative that engaged pediatricians, nurses, trainees and nurse practitioners at primary care practices to implement the new decision support tool. With the tool in place, the team saw a 71% reduction (from 17% referred to 5% referred) in cardiology referrals for children presenting to cardiology who did not meet the criteria for a referral. At almost one year of follow up, the reduction in referrals based on the criteria did not lead to any missed detections of potential life-threatening events, either.

“This study shows that patients presenting with chest pain who do not meet clinical criteria for referral can be safely and confidently managed at their medical home by their primary care provider,” says Ashraf Harahsheh, M.D., director of Quality Outcomes in Cardiology at Children’s National Heart Institute, who led the study with colleagues. “Avoiding unnecessary referrals to cardiology may help prevent missed work and school days for families and children and will also make sure that the children who truly need a cardiology evaluation can be evaluated quickly.”

This collaboration between our specialty colleagues and primary care clinicians improves care for our patients by bringing an evidence-based approach to managing a condition in a manner that reduces the burden of anxiety for families by addressing their concerns in their medical home,” adds Ellen Hamburger, M.D., study co-author and medical director of the Pediatric Health Network.

After the success of the project at Children’s National Hospital in partnership with the CNP&A, the team is now in talks with UPMC Children’s Hospital of Pittsburgh and Phoenix Children’s Care Network to expand the quality improvement initiative to their primary care networks as well.

Ashraf S Harahsheh, Ellen K Hamburger, Lena Saleh, Lexi M Crawford, Edward Sepe, Ariel Dubelman, Lena Baram, Kathleen M Kadow, Christina Driskill, Kathy Prestidge, James E Bost, Deena Berkowitz. Promoting Judicious Primary Care Referral of Patients with Chest Pain to Cardiology: A Quality Improvement Initiative. Med Decis Making. 2021 Mar 3;272989X21991445. Online ahead of print. DOI: 10.1177/0272989X21991445

video still of Dr. Yves d'Udekem

A conversation with Yves d’Udekem, M.D., Ph.D.

Dr. Yves d’Udekem discusses his background, the history of pediatric cardiovascular surgery and his vision for the future.

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PeriTorq, a catheter grip tool for use during pediatric cardiac interventional procedures

Five finalists selected in prestigious pediatric medical device pitch competition

Electrophysiology device innovators gain access to pediatric accelerator and will compete in September 2021 final showcase.

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pregnant hispanic woman

Significant health disparities in detection of critical congenital heart disease

pregnant hispanic woman

Mothers who are Hispanic or who come from rural or low socioeconomic status neighborhoods are less likely to have their child’s critical heart condition diagnosed before birth, according to a new study in the journal Circulation.

Mothers who are Hispanic or who come from rural or low socioeconomic status neighborhoods are less likely to have their child’s critical heart condition diagnosed before birth, according to a new study in the journal Circulation.

This is the largest and most geographically diverse study of these challenges to date. The study compared patient data of more than 1,800 children from the United State and Canada diagnosed with two of the most common, and the most serious, critical congenital heart defects: hypoplastic left heart syndrome (HLHS), when the left side of the heart is not developed completely, and transposition of the great arteries (TGA), when the two main arteries that carry blood away from the heart are reversed.

“The earlier we diagnose a heart defect, especially a serious one such as HLHS or TGA, the sooner we can make a plan for how to safely deliver the infant and reduce the impacts of that heart defect on the rest of the body,” says Anita Krishnan, M.D., first author and cardiologist at Children’s National Hospital. “Early detection and diagnosis of these conditions is crucial to ensuring the best possible outcome for the child, especially in protecting the brain.”

Even when infants’ heart defects were detected before birth, babies from neighborhoods with lower socioeconomic status were detected later in gestation than others.

“The COVID-19 pandemic has brought the idea of significant disparities in health care to the forefront of our national attention,” says Dr. Krishnan. “Even though many health care providers have seen these inequities firsthand in their own clinical experience, it was still surprising to see the strength of the association between socioeconomic position and the care available to mothers.”

In both the United States and Canada, expectant mothers are first screened as part of routine prenatal care in the first trimester for early signs of congenital heart defects and other genetic disorders via blood screen and ultrasound. In the second trimester, a comprehensive ultrasound evaluation for structural anomalies is routine. If any issues are detected, the mother is referred for a fetal echocardiogram and counseling.

The authors suggest that decreased linkages between neighborhoods and people identified in the study and subspecialists could contribute to the disparities found in the study.

“Prenatal detection rates may improve if we are able to leverage outreach and telehealth to strengthen the relationships between these specialties and the groups we identified in the study,” Dr. Krishnan says.

The study included a total of 1,862 patients, including 1,171 patients with HLHS (91.8% prenatally diagnosed) and 691 with TGA (58% prenatally diagnosed). The study group included prenatally diagnosed fetuses with HLHS or TGA and postnatally diagnosed infants less than two months old with HLHS or TGA. Data was collected from institutions participating in the Fetal Heart Society, a non-profit 501(c) multicenter research collaborative with a mission to advance the field of fetal cardiovascular care and science. Mary Donofrio, M.D., director of Prenatal Cardiology at Children’s National, is society president and served as a senior author on this study.

Read the AHA’s press release: Prenatal detection of heart defects lower in rural, poor areas and among Hispanic women.

little girl at the dentist

Limit antibiotic use before dental procedures to high-risk heart patients, says AHA

little girl at the dentist

A new scientific statement from the American Heart Association (AHA) says that good oral hygiene and regular dental care are the most important ways to reduce the risk of a heart infection called infective endocarditis (IE) caused by bacteria in the mouth.

A new scientific statement from the American Heart Association (AHA) says that good oral hygiene and regular dental care are the most important ways to reduce the risk of a heart infection called infective endocarditis (IE) caused by bacteria in the mouth. The statement was published in Circulation, the AHA’s flagship journal.

This statement addresses the impact of the major changes made in the 2007 AHA infective endocarditis (IE) guidelines that limited antibiotic prophylaxis (AP) prior to dental procedures to cardiac conditions at highest risk of complications from endocarditis by focusing on the following:

  • What was the acceptance of and compliance with the 2007 recommendations?
  • Was there an increased incidence of viridians group streptococci (VGS) infective endocarditis (IE)?
  • Were the recommendations from the guideline valid and should they be revised?

While the statement speaks to all types of heart disease, one area of particular interest in congenital heart disease was highlighted by statement co-author Craig Sable, M.D., F.A.H.A., associate division chief of Cardiology at Children’s National Hospital.

He noted that the statement specifies that children and adult congenital heart patients undergoing pulmonary valve replacement can be at higher risk for IE. The most significant risk factor for IE is the material the valve is made from, regardless of whether it is placed by surgery or catheterization.

Read more about this statement from the AHA

Watch AHA’s video explaining the statement, which features Dr. Sable.

chest x-ray showing pacemaker

Medical device pitch competition focuses on pediatric electrophysiology devices for CHD

chest x-ray showing pacemaker

While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period.

Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. each year and is often complicated by arrhythmias, a condition where the heart beats too rapidly, too slowly or irregularly due to a misfiring of the body’s electrical impulses. While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period. As a result, pediatric specialists are often using off-label or improvised devices to treat pediatric arrhythmias, including the smallest newborns.

Recognizing this unmet need, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is accepting applications through April 12, 2021, for its annual “Make Your Medical Device Pitch for Kids!” competition. This year’s competition focuses on innovations in pediatric devices that treat CHD, with an emphasis on electrophysiology devices such as pacemaker systems, ablation catheters, wearable monitoring devices and related technologies that address arrhythmias in children.

“NCC-PDI was created, with the support of the Food and Drug Administration (FDA), to seek out and address significant unmet needs in pediatric medical devices,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “We have learned from the experts that pediatric-specific technologies for treating arrhythmias would be a game changer in the care of their patients, so we are focusing our competition and grant awards on this opportunity.”

Kolaleh-Eskandanian

“We have learned from the experts that pediatric-specific technologies for treating arrhythmias would be a game changer in the care of their patients, so we are focusing our competition and grant awards on this opportunity,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI.

Using a virtual format, semi-finalists chosen from all submissions will make their first pitch on May 12, 2021. Up to 10 finalists selected from this event earn participation in a special pediatric-focused track of the MedTech Innovator accelerator program, the largest medtech accelerator in the world, beginning in June 2021. These innovators then participate in the pediatric competition finals in September 2021 where judges will award up to $150,000 in FDA-sponsored grants to the devices selected as most impactful and commercially viable.

How significant is the need for pediatric devices to address arrhythmias? In a recent survey of members conducted by the Pediatric and Congenital Electrophysiology Society (PACES), the vast majority (96%) said they believe there is a deficiency in devices available to serve the needs of pediatric patients. Conducted with the U.S.FDA, the survey also asked respondents to identify the biggest unmet need, which physicians identified as cardiovascular implantable electronic devices that are smaller, have better battery life and have pediatric-specific algorithms. Specifically, a leadless pacemaker designed for pediatric care was consistently on the most-wanted list.

NCC-PDI is one of five members in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children, which lags significantly behind the advancement of adult medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland with support from partners MedTech Innovator, BioHealth Innovation and design firm Archimedic.

Eskandanian says that enhancing access to resources for pediatric innovators is also one of the aims of the Children’s National Research & Innovation Campus, a first-of-its-kind focused on pediatric health care innovation, with the first phase currently open on the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on-site incubator Johnson and Johnson Innovation – JLABS, the campus provides a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.