Surgical Innovation

NCC-PDI Finalists

Pediatric medical device competition names finalists

Five finalists have been named in the prestigious annual “Make Your Medical Device Pitch for Kids!” competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in pediatric technologies that aim to address unmet medical needs for children, these five finalists now have access to a pediatric accelerator program led by MedTech Innovator and will compete for a share of $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) in the final virtual pitch event in October 2022. The pediatric pitch event is part of the 10th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.

“Addressing unmet needs across pediatric populations is critical to advancing children’s health and we are delighted to once again work with pioneering companies that seek to bridge this care gap,” 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. “As an FDA-funded consortium, NCC-PDI serves as a critical device development resource, bringing together individuals and institutions that support viable pediatric innovations and create faster pathways to commercialization. We congratulate this year’s finalists and look forward to seeing the progress made in the coming months as they navigate the accelerator program.”

The following are the five pediatric device innovations that judges selected for the final competition:

  • CorInnova – Houston, TX – Minimally invasive biventricular non-blood contacting cardiac assist device to treat heart failure.
  • Innovation Lab – La Palma, CA – Mechanical elbow brace stabilizes tremors for pediatric ataxic cerebral palsy to improve the performance of Activities of Daily Living (ADLs).
  • Prapela – Biddeford, ME – Prapela’s incubator pad is the first innovation to improve the treatment of apnea of prematurity in over twenty years.
  • Tympanogen – Richmond, VA – Perf-Fix replaces surgical eardrum repair with a nonsurgical clinic procedure
  • Xpan – Concord, Ont. – Xpan’s universal trocar enables safest and most dynamic access and effortless upsizing in conventional/mini/robotic procedures.

Beginning in June 2022, the five finalists will participate in a pediatric-focused track of the MedTech Innovator accelerator, the world’s largest accelerator of medical devices.

NCC-PDI is one of five consortia 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 progress of adult medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National 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.

To date, NCC-PDI has mentored nearly 200 medical device sponsors to help advance their pediatric innovations, with 16 devices having received either their FDA market clearance or CE marking.

The accelerator program is the consortium’s latest addition to a network of resources and experts that it provides in support of pediatric innovators.

Eskandanian adds that supporting the progress of pediatric innovators is a key focus of the new Children’s National Research & Innovation Campus, a one-of-its-kind ecosystem that drives discoveries that save and improve the lives of children. On a nearly 12-acre portion of the former, historic Walter Reed Army Medical Center in Northwest Washington, D.C., Children’s National has combined its strengths with those of public and private partners, including industry, universities, federal agencies, start-up companies and academic medical centers. The campus provides a rich environment of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

NCC-PDI Finalists social card

Everyone Poops Book Cover

2022: Pediatric colorectal and pelvic reconstructive surgery today

Everyone Poops book coverAdapted from Levitt MA. New and exciting advances in pediatric colorectal and pelvic reconstructive surgery – 2021 update. Semin Pediatr Surg. 2020 Dec;29(6):150992.

As demonstrated in the popular children’s book by Taro Gomi, Everyone Poops, the physiology of stooling is a focus of early childhood development and a subject of concern for both parents and children. References to pediatric colorectal problems go back many thousands of years. In fact, the Babylonian Talmud, written in the year 200 CE, recommends that “an infant whose anus is not visible should be rubbed with oil and stood in the sun… and where it shows transparent the area should be torn crosswise with a barley grain.” Surgical techniques to manage such patients have certainly evolved since that time, but the basic principles of care remain the same.

How we got here

The modern story of the care of patients with anorectal malformations (ARMs) began in the 1940s in Melbourne, Australia, when Henry Douglas Stephens worked to define the anatomy of children with ARMs by analyzing the anatomy of twelve deceased patients with these conditions. He continued to focus on this specialty for the rest of his career and published two books on the topic in 1963 and 1971. Prior to his groundbreaking work, the anatomy of such patients was only a concept that existed in surgeons’ minds – without anatomic precision – since no one had actually seen the anatomy. These concepts were depicted in the bible of pediatric surgery in North America, the Gross textbook, which in retrospect was both oversimplified and inaccurate.

During his autopsy dissections, Stephens came to the key anatomic conclusion that the puborectalis muscle (the sphincters) lay behind the urethra. He devised an operation based on this concept: first, the urethra was identified, then a space between it and the puborectalis was dissected, and then the rectosigmoid was pulled through that space. A small incision in the perineum for the pulled-through bowel was made, within which the new anus was created. The perineal dissection was a blind maneuver. During the same time period, William Kiesewetter in Pittsburgh proposed his version of the sacral abdominoperineal pull-through using similar anatomic principles.

Justin Kelly was one of Stephens’ trainees in Australia who learned how to do this operation. At Boston Children’s Hospital in the late 1960’s, he taught what he had learned from Stephens to the surgeons there, including another trainee, Alberto Pena. Pena and his fellow surgical residents benefitted from exposure to Kelly as well as master surgeon Hardy Hendren, who operated on patients across town at Massachusetts General Hospital. Hendren, the pioneer in the care of children with cloacal anomalies, passed away this year at the age of 96.

Pena completed his training in Boston and went to Mexico City in 1972 at the age of 34 to become the head of surgery at the National Pediatric Institute. He tells the story that when he asked his new pediatric surgery faculty to choose an area of specialization, no one chose colorectal, so he decided to take on that group of patients and thus embarked on his revolutionary colorectal career. Pena at first applied the technique he had learned from Kelly to repair anorectal malformations, but he became increasingly frustrated by the procedure. He felt that the maneuvers offered very poor exposure to the anatomy, and over time his incision grew longer and longer. In 1980, Pena’s collaboration with Pieter de Vries – who had come to Mexico City to work on these cases with Pena – culminated in the first posterior sagittal anorectoplasty [Figure 1]. That same year, Pena presented his findings at a meeting of the Pacific Association of Pediatric Surgeons.

imperforate anus repair

Figure 1: Original diagrams of the posterior sagittal approach to repair imperforate anus

This posterior sagittal approach opened a beneficial Pandora’s Box in surgery. It allowed for a true understanding of the pelvic anatomy and led to the care of many conditions that were previously – to use Pena’s words – “too difficult to reach from above (via laparotomy) and too difficult to reach from below (perineally).” This new approach influenced the repair of cloacal malformations, urogenital sinus, pelvic tumors, urethral problems, reoperations for imperforate anus and Hirschsprung disease (HD), a transpubic approach for complex genitourinary problems, and a comprehensive strategy for the management of cloacal exstrophy. In addition to his surgical contributions, Pena also conceived of the intervention that has arguably improved patients’ quality of life the most: a focused approach to the bowel management of fecal incontinence. Thanks to such bowel management programs, now available at many centers across the world, thousands of children are no longer wearing diapers and have said goodbye to their stomas. The impact of bowel management is perhaps comparable to that of intermittent catheterization for patients with urinary incontinence.

My personal journey in this field began in 1992, when I was an eager medical student and signed up for an elective in pediatric surgery with Alberto Pena. This experience changed my career trajectory in a very dramatic and positive way. Medicine was becoming increasingly complex, and fields such as neonatal care, transplantation, and cardiology were benefitting from a collaborative approach. It became clear that the colorectal field needed the same approach. As a comparative example, consider the project of building a bridge. How does such a project start? The cement layers do not show up one day and lay cement prior to the steel team deciding where to place the beams. The project must begin with all parties meeting together to develop a comprehensive plan. Amazingly, however, that type of collaborative planning does not often happen in the care of medically complex patients. It most assuredly needs to.

The value of multi-disciplinary care

Medical complexity requires integrated and collaborative care because all the anatomic structures that need to be managed are located right next to each other and because each has a unique and complex physiology that can affect the other systems. To achieve success, patients with anorectal malformations, Hirschsprung disease, fecal incontinence (related to a variety of conditions), and colonic motility disorders require care from a variety of specialists throughout their lives. These include providers in the fields of colorectal surgery, urology, gynecology, gastroenterology, motility, orthopedics, neurosurgery, anesthesia, pathology, radiology, psychology, social work, nutrition, and many others. Perhaps most important to the achievement of a good functional result, however, is a patient’s connection to superb nursing care. A complex colorectal operation takes about four hours to perform, but to get a good result, it takes an additional 96 hours of work, the vast majority of which involves nursing care. The value of good nursing partners to ensure successful surgery cannot be overemphasized. They have unique skills in identifying and solving problems, a willingness to get down in the weeds, and are always striving to fill the gaps in care.

What parents want and need

Having met many parents with newborns diagnosed with colorectal problems, I have made several observations. First, it seems that no parent has ever imagined that their child could have a problem with stooling – this is a physiologic ability that is taken for granted. When they are told about the problem with their baby, they are uniformly shocked that something like this could happen. Second, when discussing that their child will need surgery to correct their colorectal anatomy, parents don’t focus on the surgical technique and elegance of the reconstruction, as surgeons tend to do. Instead, parents dwell on whether the surgery will create a working reconstructed anatomy that will allow their child to stool without difficulty or embarrassing accidents. As surgeons we need to remember this. We always need to understand what it is that the family and patient wishes us to deliver, and we need to strive to achieve those goals. As proud of our surgical skills as we are, it is the functional outcome that matters most.

Where we are in 2022

In 2022, the advances in the field of pediatric colorectal and pelvic reconstruction are significant. They include new techniques and ideas that over time have made a dramatic and positive impact on the care and quality of life of children who suffer from colorectal problems. Here are a few such advances:

  1. Prenatal diagnosis of anorectal and cloacal malformations has been progressively improving. Perinatologists have learned to look for specific findings, such as a pelvic mass in a female with a single kidney, and consider that it could be a cloaca. Assessment of perineal anatomy, pubic bone integrity, sacral development, abnormalities of the radius bone, as well as cardiac, spinal, and renal anomalies may lead the clinician to consider that a fetus may have an anorectal malformation.
  2. Management of the newborn, particularly in the fields of newborn radiology and neonatal care, has dramatically improved as neonatal techniques have advanced. Specific to the colorectal patient have been advances in radiology such as assessments of hydronephrosis, 3D reconstruction of cloacal anomalies, and ultrasound-guided distal colostography. Further advances include improved techniques in the management of hydrocolpos and stoma care, to name a few.
  3. The treatment of associated urologic anomalies has diminished chronic renal disease, and proactive bladder management is reducing the need for bladder augmentations and renal transplantation.
  4. Understanding the gynecologic collaboration has helped clinicians define the Mullerian anatomy and better plan for menstruation and future obstetric potential.
  5. Prediction of continence, even in the newborn period, requires an understanding of the associated problems with the sacrum and spine. This knowledge has allowed clinicians to have more robust conversations with families about their child’s future.
  6. The decision of whether to do a newborn repair versus a colostomy must be guided by the surgeon’s experience and the clinical circumstances in which they find themselves.
  7. The defining of anatomy allows patients to be compared across medical centers, and for treatment options and outcomes to be uniformly analyzed. Keeping track of one’s outcomes and always striving to improve should be basic tenets of surgical practice.
  8. Recognizing the value of laparoscopy and knowing for which cases this approach should be applied. Morbidities associated with a laparoscopic approach for a rectum in an ARM patient well below the peritoneal reflection have been noted. In HD cases, laparoscopy can limit the stretching of the sphincters which occurs during the transanal rectal dissection.
  9. Development of a treatment algorithm for the management of cloacal malformations which considers the importance of their common channel and urethral lengths.
  10. Recognizing key complications after ARM and Hirschsprung surgery, knowing when and how to do a reoperation, determining the outcomes of such reoperations, and ultimately figuring out how to avoid complications altogether.
  11. Understanding the causes of fecal incontinence, the amount of incontinence that can be anticipated, and the surgical contributors to achieving continence.
  12. Development of bowel management programs in multiple centers and committing to following these patients in the long term.
  13. Learning the pathophysiology of motility disorders and developing treatment protocols, as a result of the vital collaboration between surgery and GI/motility. Medical treatments with laxatives, rectal enemas, botox injection of the anal canal, and surgical adjuncts such as antegrade colonic flush options and sometimes colon resections are key aspects of the treatment armamentarium.
  14. Developing a collaboration between colorectal surgery and urology allows the clinical team to know when the colon can be used for a bladder augment (which not only offers an augment option but also can improve antegrade flushes of the colon) or if the appendix can be shared between Malone and Mitrofanoff. The collaboration with urology to plan the management of both urinary and fecal continence during the same operation is a very valuable trend. This proactive planning has improved the lives of many patients and has reduced the numbers of operations they need as well as their hospital stays.
  15. Sacral Nerve Stimulation (SNS) has shown promise in the management of urinary incontinence and seems to have a role in improving fecal continence and promoting motility, as an adjunct to treatments for constipation.
  16. Development of dedicated colorectal centers that are integrated and collaborative allows a team to tabulate their results and strive for better outcomes. The value of a collaborative model for the care of such patients cannot be overstated, not only for patient convenience, but also for creating an integrated plan for their care. These exist now in many parts of the country and care is available in nearly every region, reducing a family’s need to travel great distances away from their home to access care.
  17. Establishing a transition to adult programs, as with congenital heart disease and cystic fibrosis. Colorectal surgeons are obligated to develop a transition plan for their patients as they enter adulthood.
  18. Using Basic Science to advance the field, including tissue engineering and genetics, will be revolutionary. We should be able to imagine the day when cloacal reconstruction could be based on a previously tissue-engineered segment of vagina, produced by the patient’s own stem cells. In addition, the genetics of anorectal malformations as well as Hirschsprung disease are being vigorously pursued which will impact parental counseling and potential therapies.
  19. Real time data used to follow outcomes is needed to keep track of complications as well. That information can be used to adjust protocols which will improve results.
  20. Development of international consortiums will help patients in a way that is not achievable by a single institution. Consortiums allow ideas to be spread rapidly which will dramatically affect how many patients can be helped and how quickly. The Pediatric Colorectal and Pelvic Learning Consortium, pcplc.org, is well on its way to achieving these goals.
  21. Bringing complex care to all corners of the world because there is a great deficiency in advanced colorectal care in the developing world. The care of colorectal patients in a resource-limited setting has unique challenges, but creative solutions by innovative surgeons in those areas have a led to dramatic improvements in care.
  22. Parent/patient organizations provide education, advocacy, and support for families at all stages of their child’s care. With internet access readily available, colorectal patients and their families can now access the welcoming environment of these organizations, and no longer feel as lost and alone as in previous years.

Why it matters

Given all these wonderful advances, we must continue to reaffirm the key principles stated by Sir Dennis Browne that “the aim of pediatric surgery is to set a standard, not to seek a monopoly.” With an integrated approach to the care of this complex group of patients, great things can be achieved. I am hopeful that the caregivers and parent/patient group organizations who commit to the care of children with colorectal problems and understand the daily struggle of improving a patient’s quality of life will learn the skills and tricks necessary to achieve good results. If they do, they will help many children.

Finally, I will share a humorous piece written by my daughter, Jess Levitt, regarding the value of bringing order to chaos. Its message is particularly relevant to the care of children with colorectal problems in 2022, as we build on our efforts to improve, streamline, and transform the formerly chaotic process through collaboration and education. As we endeavor to advance this field, we need to remember what Dr. Pena often said: “It is not the unanswered questions, but rather the unquestioned answers that one must pursue.”

“A” must come before “B,” which must come before “C,” everybody knows that. But what if the Millercamps of this world did not have to sit next to the Millerchips when it comes to seating arrangements? Can Pat Zawatsky be called before Jack Aaronson when the teacher is taking attendance? Do those 26 letters that make up all the dialogue, signs, thoughts, books, and titles in the English-speaking department of the world need their specific spots in line? Everyone can sing the well-known jingle from A to Z, but not many people can tell you why the alphabet is the way it is.

For almost as long as humans have had the English language, they have had the alphabet. The good ol’ ABCs. However, the alphabet represents the human need for order and stability. I believe that the same thinking that went into the construct of time and even government went into the alphabet. Justifiably, lack of order leads to chaos. Knife-throwing, gun-shooting chaos, in the case of lack of governmental order. Listen to me when I tell you that there is absolutely no reason that the alphabet is arranged the way that it is. Moreover, the alphabet is simply a product of human nature and how it leads people to establish order for things that do not require it.

Now I know this sounds crazy, but bear with me. Only if you really peel away the layers of the alphabet will you find the true weight it carries. People organized the letters of our speech into a specific order simply because there wasn’t already one. Questioning this order will enlighten you on the true meaning of it. Really dig deep into the meaning behind the social construct that is the alphabet. Short and sweet as it may be, the order of the ABCs is much less than meets the eye. There is no reason that “J” should fall before “K”! Understand this. Very important as order is, it is only a result of human nature.

What’s next? X-rays become independent of Xylophones in children’s books of ABCs?

You know what the best part is? Zero chance you even noticed that each sentence in this essay is in alphabetical order.

– Jess Levitt

 

2022 Hackathon logo

Addressing health equity issues through an app innovation competition

Children’s National Hospital launches The Health Equity in Research Hackathon — a team-based collaborative competition that empowers researchers to address health equity issues in the community through innovative apps. A panel of expert judges will select winning app ideas for full development, including finding grant opportunities, access to mentors and collaborators.

The big picture

“This Hackathon is a great chance for our research community to address larger issues related to advancing health equity within translational and clinical research,” said Patrick O’Keefe, administrative director for the Clinical and Translational Science Institute at Children’s National (CTSI-CN). “We are thrilled to see how people collaborate to create solutions for big problems that have traditionally slowed research and contributed to the vast inequities in health we see today.”

Additional details

The 2022 hackathon will be a two-part event. During Part I, slated for June 17, participants will gather in diverse teams to discuss and refine the selected app ideas. They will learn from technical and scientific experts and brainstorm app-based approaches to address health equity.

Each team will pitch their ideas to a panel of judges, and the winning app(s) will advance to Part II of the hackathon planned for Fall 2022, where app developers will build the selected apps.

“We encourage anyone at Children’s or George Washington University to submit an app idea – even if it is not fully formed — as long as they think it would help reduce health disparities through improving the research process,” said Lisa Guay-Woodford, M.D., director for Clinical and Translational Science Institute and Center for Translational Research at Children’s National. “We also hope researchers, staff and students who don’t have app ideas at this time will consider attending anyway to participate in the lively development process of the Hackathon.”

Anyone within the Children’s National and George Washington University research communities can submit an app idea for consideration. No app development experience is necessary to enter.

Why it matters

Health equity also means bringing the community into the research process. Thus, in part II, Children’s National will partner with high schools and universities in the area to incorporate voices who are often under-represented in the science and technology field.

“Our community is home to brilliant young minds at our local high schools and universities,” said Chaya Merrill, Dr.P.H., director for Child Health Data Lab at Children’s National. “We are excited to create an opportunity for them to work alongside experienced app builders – at the intersection of health equity and technology – by engaging in Part II of the Hackathon to build the winning apps!”

The hackathon will take place at Children’s Research and Innovation Campus in partnership with CTSI-CN and the Center for Translational Research.

The app idea submission deadline is on May 20, 2022, by 5pm. You may apply here. If you have questions about completing this submission, please email Patrick O’Keefe at pokeefe@childrensnational.org.

2022 Hackathon logo

parathyroid close-up

A new imaging device with AI may reduce complications during thyroid surgery

parathyroid close-upSurgeons perform approximately 150,000 thyroidectomies in the United States. Post-surgical complications from this procedure frequently occur due to the misidentification or accidental removal of healthy parathyroid glands. On average, 27% of these patients suffer from transient or permanent hypocalcemia, a condition in which the blood has too little calcium, leading to lifelong complications and socioeconomic burden.

To improve parathyroid detection during surgery, Children’s National Hospital experts developed a prototype equipped with a dual-sensor imaging device and a deep learning algorithm that accurately detects parathyroids, according to a new study published in the Journal of Biophotonics.

“What excited us in this study was that even deep-seated tissues were able to be imaged without light loss, and high resolution imaging was possible due to the unique optical design,” said Richard Jaepyeong Cha, Ph.D., council member of the International Society of Innovative Technologies for Endocrine Surgery and principal investigator for the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital. “Moreover, in several cases, parathyroid autofluorescence was detected even before the surgeon dissected the parathyroid gland, and while it was covered by fat and/or fascia.”

What’s unique

This is the first study that uses color RGB/NIR paired imaging-based parathyroid detection by incorporating multi-modal (both RGB light and near-infrared autofluorescence, or NIRAF, ground truth imaging) data into parathyroid identification using a deep learning algorithm.

The patient benefit

“We envision that our technology will open a new door for the digital imaging paradigm of dye-free, temporally unlimited, and precise parathyroid detection and preservation,” said Richard. “Successful translation of this technology will potentially reduce the risk of hypoparathyroidism after common thyroid surgery and improve the clinical outcomes.”

The results support the effectiveness of their novel approach despite the small sample size, which can potentially improve specificity in the identification of parathyroid glands during parathyroid and thyroid surgeries.

The hold-up in the field

It is often difficult for surgeons with naked eyes to identify parathyroid glands from thyroid tissue because of the small size, the variable position, and similar appearance to the surrounding tissues.

Since 2011, surgeons have benefited from using NIRAF, a non-invasive optical method for intraoperative real-time localization of parathyroids.

While the NIRAF technology has gained traction among endocrine surgery community, false negatives can occur with current devices that use the NIRAF technology in secondary hyperparathyroidism cases. According to Kim et al., the technology is still suboptimal, and a significant percentage of parathyroid is being missed.

Children’s National Hospital leads the way

Engineers in Children’s National are leading this field through several innovations:

  • Non-dye injected, label-free use in real-time in comparison to temporally limited ICG angiography. This technology was featured as the cover article in the journal Lasers in Surgery and Medicine 54(3), 2022.).
  • Simultaneous perfusion assessment from four glands at any time during operation.
  • Arterial flow detection from pulsatile information in well-perfused PG vasculature.
  • Quantified parathyroid detection and classification with prediction values using deep learning technique.

You can read the full study “A co-axial excitation, dual-RGB/NIR paired imaging system toward computer-aided detection (CAD) of parathyroid glands in situ and ex vivo” in the Journal of Biophotonics.

overview of parathyroid surgery procedure

Drs. Kane and Petrosyan

POEM procedure is safe and effective for children with esophageal achalasia

Drs. Kane and Petrosyan

Drs. Petrosyan and Kane combined perform more POEM procedures for children than any other pediatric surgeons in the United States.

Peroral endoscopic myotomy (POEM) is a safe and effective procedure to treat pediatric achalasia according to a single-center outcomes study in the Journal of Pediatric Surgery.

Authors Timothy Kane, M.D., chief of General and Thoracic Surgery at Children’s National Hospital, and Mikael Petrosyan, M.D., MBA, associate chief of that division, together perform more of these procedures than any other pediatric surgeons in the United States.

Their experience with POEM shows that it is as safe and effective as the current standard of care for pediatric achalasia, which is a procedure called the laparoscopic Heller myotomy (LHM). Even better, previous research in adults and now in pediatric patients, has shown that those who undergo POEM as an alternative to LHM report less pain and often require shorter hospital stays after surgery.

Why it matters

POEM has been an option for adults with achalasia for many years, but not for children because it requires technical skill and expertise not readily available everywhere. More studies of young patients with successful outcomes following POEM procedures can help make the case for training more pediatric surgeons to learn this approach, and help this alternative method become an additional surgical option for children with achalasia.

The hold-up in the field

Achalasia is a rare condition in adults (1/100,000) and even less common in children, occurring in only 0.1 per 100,000 patients with an estimated prevalence of 10 per 100,000. The rarity of achalasia in children compared with adults makes collecting enough statistically significant evidence about how best to treat them difficult, more so than for other more common pediatric surgical conditions.

Children’s National Hospital leads the way

Children’s National Hospital is one of the only children’s hospitals in the country to offer the option of POEM for treatment of these conditions in children — and Drs. Kane and Petrosyan combined perform more of these procedures than any other pediatric surgeons in the United States.

The surgeons at Children’s National offer POEM as a primary intervention for children with esophageal achalasia and are also applying the same approach for pediatric gastroparesis as well.

Children’s National Hospital is one of only 12 children’s hospitals in the country, and the only hospital in the Washington, D.C., region, to be verified as a Level 1 Children’s Surgery Center by the American College of Surgeons (ACS) Children’s Surgery Verification Quality Improvement Program. This distinction recognizes surgery centers whose quality improvement programs have measurably improved pediatric surgical quality, prevented complications, reduced costs and saved lives.

Bottom line

Given their reported outcomes so far, the authors believe that in the long term this approach may replace the current pediatric standard of care, the LHM. More research is needed to make this case, however, including long-term follow-up studies of the patients who have undergone the procedure so far.

You can read the full study, “Per Oral Endoscopic Myotomy (POEM) for Pediatric Achalasia: Institutional Experience and Outcomes,” in the Journal of Pediatric Surgery.

Ashley Vela Mercedes

Staged surgical hybrid strategy changes outcome for baby born at 28 weeks with HLHS

Ashley Vela MercedesA staged, hybrid cardiac surgical strategy can give fragile infants with hypoplastic left heart syndrome (HLHS) critical time to grow and get stronger. It also gives doctors more time to understand and care for any complicating conditions before necessary open-heart surgery. Doctors at Children’s National Hospital used such a staged approach, called the “hybrid strategy,” to care for Ashley Vela Mercedes, who was born at only 28-weeks-old weighing 1.1 kilos.

Ashley, who is now a smiling and happy 18-month-old, is believed to be the smallest infant born at 28-weeks with HLHS to survive to this age. Though she will need ongoing care and future procedures, her family is grateful for the knowledge and technical expertise of her care team at Children’s National.

The hybrid program at Children’s National is led by Can Yerebakan, M.D., cardiac surgeon, and Joshua Kanter, M.D., director of Interventional Cardiology.

A hypoplastic left heart syndrome miracle

Ashley Vela Mercedes is a happy, smiling 18-month-old. She’s also a true miracle — the smallest baby in the world with HLHS to survive to this age.

Born when her mom was only 28 weeks pregnant, she was 1.1 kilos/2.4 pounds when she arrived — the size of a beanie baby stuffed animal — and her heart was about the size of a grape.

Between her premature birth and her medical issues including her critical HLHS heart condition, her parents, Ana Mercedes and Axel Vela were told that Ashley was unlikely to survive.

The Velas were frustrated, sad and scared. It started to sound like there wasn’t much hope for their tiny baby. They had always dreamed of having a family of their own. Nothing had prepared them for this.

Hope in the hybrid procedure

Their cardiologist, Jennifer Lindsey, M.D., wasn’t ready to give up either. She reached out to the team at Children’s National Hospital to see if Ashley might be considered for a new type of surgery — called a “hybrid procedure.” She hoped that this hybrid procedure might stabilize Ashley’s heart until she could grow strong enough for the open-heart surgeries she would need later.

Hybrid heart procedures blend traditional surgery and a minimally invasive interventional, or catheter-based, procedure. A stent is implanted in the newborn’s ductus arteriosus to hold it open and keep the baby’s blood flowing more efficiently. Usually, the ductus serves as a normal fetal blood vessel that increases blood flow to the mother’s placenta while in utero and closes after the baby is born, when it is not needed.

The hybrid procedure to hold open the ductus isn’t a permanent fix — it just buys the baby extra time to grow and develop before open-heart surgery to start rebuilding the heart in a more sustainable way. They are only considered an option for infants at extremely high risk for open-heart surgery. That’s also why very few congenital heart centers in the world offer them.

The hybrid team at Children’s National is led by Drs. Yerebakan and Kanter have worked together on more hybrid procedures for tiny and fragile infants than most other places. They’ve also worked with the U.S. Food and Drug Administration to safely bring a smaller and more flexible, toothpick-sized stent to the U.S. from Europe that’s made especially for use in the ductus arteriosus of special cases like Ashley.

Record-setting smallest hybrid surgery

Ashley Vela MercedesAccording to Gil Wernovsky, M.D., a cardiac intensive care doctor at Children’s National and Ashley’s Children’s National cardiologist, her birth weight was too low — she weighed 1.1 kilos or 2.4 pounds — for surgery. Her lungs also were not developed enough. She was so small, she lived in the hospital for several more weeks under the care of Dr. Lindsey. Dr. Wernovsky credits the team at Inova Children’s Hospital for providing the support Ashley needed so she could grow and develop to a place where the hybrid procedure was possible.

When she reached 1.7 kilos or 3.7 pounds, she was transported to the Cardiac Intensive Care Unit at Children’s National Hospital for her first procedure, the hybrid. At the time, she was officially the smallest baby to have a hybrid procedure at Children’s National. After the surgery, the Children’s National CICU was Ashley’s home for almost her entire first year of life.

“Landing here at Children’s was a blessing because we thought she was going to die. What has happened here is a miracle,” said Ana Mercedes. “I would like to tell Dr. Yerebakan and Dr. d’Udekem (the chief of Cardiac Surgery at Children’s National) that what they have done with my daughter is incredible, and I will never be able to fully repay them for their efforts.”

Over the next 11 months in the hospital, Ashley had many surgeries and catheterizations, countless other medical procedures and tests, and many, many ups and downs, including some very scary times when she required extracorporeal membrane oxygenation (ECMO) for critical life support.

Celebrating and thriving at home

Ashley Vela MercedesIn July 2021, Ashley went home for the first time in her life. She hasn’t needed to be hospitalized since her discharge. She’s monitored jointly by Dr. Lindsey and the Children’s National single ventricle monitoring program. That program stays in touch with families virtually three times each week. Her care team keeps up with her growth and development through telehealth. Ana Mercedes shares videos and photos of Ashley as part of her routine updates to the clinical team.

She still needs some medical support at home and will likely need additional medical interventions down the road, but for the time being, she is a more independent, happier and thriving little girl.

And she’s a miracle — she is the smallest baby in the world born with HLHS at such a small size and weight to survive to this age.

Ana Mercedes dreams of taking Ashley to the Dominican Republic one day, so they can enjoy the famous beaches and Ashley can be introduced to her heritage since that’s where Ana Mercedes is from.

“We are overall doing well. We have received support from our family and employers,” said Ana Mercedes. “We are extremely grateful to everyone who has given us a hand during this challenging time.”

The last year has been a roller coaster, but Ashley has made incredible progress and exceeded everyone’s expectations. Dr. Wernovsky notes, “Last year at Christmas time, this little girl was on her fourth catheter procedure and had been in intensive care for her entire life. One year later, she’s at home with her family and celebrating — that’s quite the Christmas miracle.”

Diego Preciado

Diego Preciado, M.D., Ph.D., named division chief of Otolaryngology

Diego Preciado

“It is the privilege of a lifetime for me to be able to continue my service to Children’s National in this leadership role,” said Dr. Preciado.

Children’s National Hospital has named Diego Preciado, M.D., Ph.D., as its new chief of the Division of Pediatric Otolaryngology. Dr. Preciado joined Children’s National in 2006 where he has practiced for the past 16 years.

“It is the privilege of a lifetime for me to be able to continue my service to Children’s National in this leadership role,” said Dr. Preciado. “Every otolaryngologist in the world knows of the extraordinary work and tradition of excellence established by my predecessor Dr. George Zalzal. I will work with the surgeon-in-chief to accelerate our mission by engaging our diverse and loyal faculty to become the global leader for complex pediatric otolaryngology care, research, education and advocacy.”

Dr. Preciado is a professor with tenure of Surgery and Pediatrics, Genomics and Precision Medicine at Children’s National and George Washington University. He holds the Joseph E. Robert Endowed Chair in Pediatric Otolaryngology, has served as the vice chief of the Division of Pediatric Otolaryngology for the past seven years, and the program director of the ACGME accredited Pediatric Otolaryngology fellowship since 2009. His clinical practice interests are primarily focused on pediatric airway reconstruction, childhood hearing loss/cochlear implants and velopharyngeal insufficiency.

Dr. Preciado’s translational research lab has been funded over the years through various awards including R01, U01 and R21 National Institutes of Health grants. He has authored over 130 peer-reviewed manuscripts, 20 book chapters, and has been an invited speaker regionally, nationally and internationally. In 2020, he received the Robert Ruben Scientific Achievement Award from the Society for Ear Nose and Throat Advances in Children.

He served as past president of the American Society of Pediatric Otolaryngology (2020-2021) and currently serves as president of the International Society for Otitis Media (2019-2023). He is a senior examiner for the American Board of Otolaryngology – Head and Neck Surgery where he also serves on the Complex Pediatric Otolaryngology Steering Committee.

“Given Dr. Preciado’s superb clinical, research and leadership background, we know the division is well-positioned for continued growth under his guidance,” said Dr. Anthony Sandler, M.D., senior vice president and surgeon-in-chief of the Joseph E. Robert Jr., Center for Surgical Care at Children’s National.

NCC-PDI logo

Pediatric medical device competition takes aim at congenital heart disease

NCC-PDI logo

Consistent with its mission of addressing the most pressing pediatric device needs, this year’s competition focused on innovations in electrophysiology devices that monitor and treat congenital heart disease (CHD) and arrhythmias in pediatric patients.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces five awardees chosen in its prestigious annual “Make Your Medical Device Pitch for Kids!” competition to share $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) to support the advancement of pediatric medical devices. In an unprecedented decision, the competition judges determined that all five finalists were deserving of a grant award and recognition for the potential patient benefit and commercial viability of their innovations.

Consistent with its mission of addressing the most pressing pediatric device needs, this year’s competition, conducted by NCC-PDI partner MedTech Innovator, focused on innovations in electrophysiology devices that monitor and treat congenital heart disease (CHD) and arrhythmias in pediatric patients. The virtual pediatric pitch event was part of the 9th Annual Symposium on Pediatric Device Innovation.

This year’s pediatric device innovation awardees are:

  • PeriCor – The Children’s Hospital at Montefiore – New York, NY, and Children’s National Hospital – PeriTorq, a catheter grip tool for use during pediatric cardiac interventional procedures;
  • Inkspace Imaging – Pleasanton, CA – a pediatric cardiac and vascular MRI coil;
  • Karios Technologies – Charlottesville, VA – Tissue Shield, a technology to prevent scar tissue formation (adhesions) on the heart after surgery;
  • Sibel – Niles, IL – ANNE One, ICU-grade wireless sensors for cardiopulmonary monitoring in neonates with congenital heart defects;
  • Starlight Cardiovascular – San Diego, CA – Project Lifeline, a less-invasive way to maintain sufficient circulation in newborns with ductal-dependent circulation that increases safety, procedural success and ease of use.

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 in the smallest newborns.

“Recognizing this unmet need, NCC-PDI opened the challenge earlier this year to select companies to enter MedTech Innovator’s pediatric accelerator program, made possible by NCC-PDI. The five companies have immensely benefited from the accelerator program and are well-positioned to compete for funding. They have the potential to advance pediatric health and provide a greater standard of care for children living with CHD,” 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. “For too long, the unique needs of children have been overlooked in pediatric device development. Thanks to the support of the FDA, we are able to build our challenge competitions around the direst unmet needs, which are determined through a thorough needs assessment and market analysis conducted to inform each request for proposal. The funding incentivizes pediatric innovation and helps more companies navigate the path to commercialization.”

NCC-PDI is one of five consortia 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 progress 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.

A pediatric accelerator program, powered by MedTech Innovator, is the consortium’s latest addition to a network of resources and experts that NCC-PDI provides in support of pediatric innovators. All five of this year’s competition finalists had an opportunity to participate in the year-long accelerator program.

Eskandanian adds that supporting the progress of pediatric innovators is a key focus of the new Children’s National Research & Innovation Campus, a one-of-its-kind ecosystem that drives discoveries that save and improve the lives of children. On a nearly 12-acre portion of the former, historic Walter Reed Army Medical Center in Northwest Washington, D.C., Children’s National has combined its strengths with those of public and private partners, including industry, universities, federal agencies, start-up companies and academic medical centers, the campus provides a rich environment of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.

scientist using the HoloUS platform

New platform uses augmented reality glasses for ultrasound-guided procedures

Children’s National experts developed a novel visualization platform, called “HoloUS,” for ultrasound-guided procedures using commercially available see-through augmented reality (AR) glasses, according to a pre-clinical study published in the International Journal of Computer Assisted Radiology and Surgery. The finding suggests that the HoloUS application enhanced the user experience and simplified hand-eye coordination.

“By eliminating head-turning and back-and-forth viewing of the patient and the ultrasound screen, our solution could improve the safety, accuracy, intuitiveness, and length of ultrasound-guided procedures, while making them easier to learn and perform,” said Raj Shekhar, M.S., Ph.D., principal investigator for Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and senior author in the study.

Ultrasound-guided procedures demand a high degree of hand-eye coordination to advance a needle with one hand while holding the ultrasound probe with another as they visualize the live ultrasound image. With this application, the practitioner will wear the AR glasses that will allow them to visualize the ultrasound image rendered live in their field of view.

“We are excited about the possibility of improving the accuracy and efficiency from augmented reality visualization because these benefits may translate clinically in the upcoming years after conducting carefully designed clinical studies,” said Trong Nguyen, staff scientist for Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and lead author.

Microsoft’s HoloLense headset, often used for hands-free work and video gaming, set the stage to develop the custom application that would display information from a portable ultrasound machine connected through a wireless network in the form of a hologram. The voice controls on the HoloLense allowed scaling and movement of the ultrasound imaging while displaying in real-time.

Largely driven by video gaming and consumer applications, AR and virtual reality technologies have been growing and are expected to grow at an even faster clip in the coming decade.

“We are a handful of researchers exploring the innovative application of the technology for ultrasound visualization,” said Shekhar. “We are trying to establish ourselves as the leader in the use of AR for pediatric ultrasound procedures.”

To further advance this technology, Shekhar’s team has an IRB protocol pending that will continue to shed light on the benefits through more bench testing and an NIH grant proposal that is also pending. In the meantime, they will adopt second-generation glasses to continue to improve the technology.

two doctors perform surgery

Can complex pediatric surgery interventions be standardized to facilitate telementoring?

two doctors perform surgery

The study’s authors write, “These discussions are particularly relevant to surgeons in small or rural practices who provide much-needed care to underserved populations and have decreased exposure to these index cases. Conversely, in some developing countries where prevalence of rare congenital surgical conditions is higher, there is a shortage of adequately trained pediatric surgeons. Each of these scenarios involves a mismatch in experience and exposure, which can result in poor patient outcomes and inadequate healthcare delivery.”

How does a surgeon-in-training get enough exposure to rare or complex cases to serve the patients who need them? How does a practicing surgeon perform enough cases each year to maintain proficiency at such index cases?

The authors of a study in the Journal of Pediatric Surgery, including Marc Levitt, M.D., chief of the Division of Colorectal and Pelvic Reconstruction at Children’s National Hospital, write that, “These discussions are particularly relevant to surgeons in small or rural practices who provide much-needed care to underserved populations and have decreased exposure to these index cases. Conversely, in some developing countries where prevalence of rare congenital surgical conditions is higher, there is a shortage of adequately trained pediatric surgeons. Each of these scenarios involves a mismatch in experience and exposure, which can result in poor patient outcomes and inadequate healthcare delivery.”

Telementoring is one strategy being explored by the American College of Surgeons’ Telementoring Task Force initiative. Pediatric anorectal malformations (ARM), pediatric colorectal surgical procedure, posterior sagittal anorectoplasty (PSARP) were the “index” areas for the pilot study. Once the expert established the areas of great need, they will test the feasibility of a curriculum and training program using telementoring in pediatric surgery. The ACS Task Force notes that these conditions are relatively rare and require a particular skill level to manage appropriately, making them good candidates for the study.

The Journal of Pediatric Surgery study presents a process for mapping out a standardized curriculum for these procedures. First, the authors sought expert consensus on three interoperative checklists that form a de facto curriculum for teaching, learning and performing ARM and PSARP procedures. Second, a multidisciplinary team of medical educators and pediatric surgery experts drafted the checklists. The authors then sought review and input from pediatric colorectal surgery experts at 10 institutions worldwide, who comprised the study’s colorectal pediatric surgery subject matter expert panel. To be considered “expert,” participants had to meet or exceed several strict inclusion criteria related to years in practice and experience with these case types.

Institutions of the colorectal pediatric surgery subject matter expert panel.

Institutions of the colorectal pediatric surgery subject matter expert panel.

The process led to a successful set of consensus documents. “To our knowledge, this is the first study to establish and standardize key intraoperative objectives using a modified-Delphi method in pediatric surgery,” the authors write. “Although this process can be quite time consuming, it provides an incredible opportunity to standardize intraoperative teaching and expectations of trainees. Future studies will expand these checklists into developing a competency assessment tool involving assessment for validity and reliability in a clinical setting to ultimately improve patient safety through standardization.”

Dr. Levitt says the overarching goal of this work is “to improve the surgical technique everywhere [to] thereby help as many kids as we can, even those we will never meet.”

Drs. Packer and van den Acker at the Pediatric Device Innovators Forum

Pediatric Device Innovators Forum explores state of focused ultrasound

For children living with pediatric tumors, less invasive and less painful treatment with no radiation exposure was not always possible. In recent years, the development of technologies like Magnetic resonance guided high intensity focused ultrasound (MR-HIFU) and Low intensity transcranial focused ultrasound (LIFU) is helping to reverse that trend.

This topic was the focus of the recent Pediatric Device Innovators Forum (PDIF) hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) in partnership with the U.S. Food and Drug Administration’s (FDA) Pediatric Device Consortia (PDC) grant program. A collaboration between Children’s National Hospital and University of Maryland Fischell Institute for Biomedical Devices, NCC-PDI is one of five PDCs funded by the FDA to support pediatric device innovators in bringing more medical devices to market for children.

The discussion, moderated by Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI, explored the use of focused ultrasound’s noninvasive therapeutic technology for two pediatric indications, Osteoid Osteoma (OO) and Diffuse Intrinsic Pontine Glioma (DIPG), and the ways it can increase the quality of life for pediatric patients while also decreasing the cost of care.

The discussion also examined the most common barriers preventing more widespread implementation of focused ultrasound technology, specifically small sample size for evidence generation, lack of funding opportunities and reimbursement issues that can make or break a technology’s chances at reaching the patients that need it.

Karun Sharma, M.D., director of Interventional Radiology at Children’s National, emphasized the potential for focused ultrasound to treat localized pain relief and treat other diseases that, like OO, do not have any other therapeutic alternative

“At Children’s National, we use MR-HIFU to focus an ultrasound beam into lesions, usually tumors of the bone and soft tissues, to heat and destroy the harmful tissue in that region, eliminating the need for incisions,” says Sharma. “In 2015, Children’s National doctors became the first in the U.S. to use MR-HIFU to treat pediatric osteoid osteoma (OO), a painful, but benign, bone tumor that commonly occurs in children and young adults. The trial demonstrated early success in establishing the safety and feasibility of noninvasive MR-HIFU in children as an alternative to current, more invasive approaches to treat these tumors.”

In November 2020, the FDA approved this MR-HIFU system to treat OO in pediatric patients.

Roger Packer, M.D., senior vice president of the Center for Neuroscience and Behavioral Medicine at Children’s National, also discussed how focused ultrasound, specifically LIFU, has also proven to be an attractive modality for its ability to non-invasively, focally and temporarily disrupt the blood brain barrier (BBB) to allow therapies to reach tumors that, until recently, would have been considered unreachable without severe intervention.

“This presents an opportunity in pediatric care to treat conditions like Diffuse Intrinsic Pontine Glioma (DIPG), a highly aggressive brain tumor that typically causes death and morbidity,” says Packer.

Packer is planning a clinical trial protocol to investigate the safety and efficacy of LIFU for this pediatric indication.

The forum also featured insight from Jessica Foley, M.D., chief scientific officer, Focused Ultrasound Foundation; Arjun Desai, M.D., chief strategic innovation officer, Insighttec; Arun Menawat, M.D., chairman and CEO, Profound Medical; Francesca Joseph, M.D., Children’s National; Johannes N. van den Anker, M.D., Ph.D., vice chair of Experimental Therapeutics, Children’s National; Gordon Schatz, president, Schatz Reimbursement Strategies; Mary Daymont, vice president of Revenue Cycle and Care Management, Children’s National; and Michael Anderson, MD, MBA, FAAP, FCCM, FAARC, senior advisor to US Department of Health and Human Services (HHS/ASPR) and Children’s National.

Anthony Sandler, M.D., senior vice president and surgeon-in-chief of the Joseph E. Robert Jr. Center for Surgical Care and director of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital, and Sally Allain, regional head of Johnson & Johnson Innovation, JLABS @ Washington, DC, opened the forum by reinforcing both organizations’ commitment to improving pediatric health.

In September 2020, the Focused Ultrasound Foundation designated Children’s National Hospital as the first global pediatric Center of Excellence for using this technology to help patients with specific types of childhood tumors. As a designated COE, Children’s National has the necessary infrastructure to support the ongoing use of this technology, especially for carrying out future pediatric clinical trials. This infrastructure includes an ethics committee familiar with focused ultrasound, a robust clinical trials research support team, a data review committee for ongoing safety monitoring and annual safety reviews, and a scientific review committee for protocol evaluation.

The Pediatric Device Innovators Forum is a recurring collaborative educational experience designed by the FDA-supported pediatric device consortia to connect and foster synergy among innovators across the technology development ecosystem interested in pediatric medical device development. Each forum is hosted by one of the five consortia. This hybrid event took place at the new Children’s National Research and Innovation Campus, the first-of-its-kind focused on pediatric health care innovation, on the former Walter Reed Army Medical Center campus in Washington, D.C.

To view the latest edition of the forum, visit the NCC-PDI website.

Panelists at the Pediatric Device Innovators Forum

The recent Pediatric Device Innovators Forum (PDIF) exploring the state of focused ultrasound was held at the new Children’s National Research and Innovation Campus, a first-of-its-kind focused on pediatric health care innovation.

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.”

multimodal imaging images

Real-time surgical guidance system enables multimodal tissue monitoring

For the first time, researchers at Children’s National Hospital successfully demonstrated a label-free tissue perfusion imaging in a pre-clinical model, according to a study published in IEEE Transactions on Biomedical Engineering.

Richard Jaepyeong Cha, Ph.D., research faculty associate professor at Children’s National, and colleagues combined visible, near-infrared laser speckle contrast imaging (LSCI) and snapshot hyperspectral (HSI) cameras into a single clinical multimodal imaging device suitable for real-time intraoperative visualization and demonstrated such a device in a surgical model for the first time, to the best knowledge of the authors. This system provides instant microcirculation information about the ischemic regions, normal tissue and transitional ischemic zones with quantitative values that are reproducible.

“Our pre-clinical work demonstrated a novel, dye-free imaging platform for quantitatively assessing bowel perfusion. The ability to identify optimal surgical resection margins can improve surgical performance and patient outcome in terms of more targeted bowel resection and bowel preservation without anastomotic leakage,” Cha said. “This new optical imaging and quantitative assessment technology holds great promise to solving the long-standing issue of suboptimal assessment of intestinal viability.”

Intraoperative imaging techniques for the precise monitoring of blood flow, hemorrhage and oxygen saturation are needed to minimize errors caused by blood vessel ligation to reduce surgical blood loss and successfully isolate and resect ischemic regions.

When the blood flow, hemorrhage and oxygen are not monitored properly, anastomotic leak (AL) is a serious complication of intestinal surgery that can occur due to a technical error, and most frequently because of poorly vascularized intestine.

This complication of intestinal surgery carries with it a reported mortality ranging from 6 to 39%. The best time to prevent a possible AL is during its creation in the operating room.

Creating a healthy and safe intestinal anastomosis requires a good blood supply to the two ends of bowel to be joined. The tools for diagnosing well-perfused bowel intraoperatively are limited and often rely on the subjective evaluation of the surgeon.

“We are hoping that the use and application of multimodal LSCI/HSI imaging, capable of both non-invasive and quantitative gross tissue perfusion assessment, will provide colorectal/general surgeons with a convenient and objective method for assessment of bowel perfusion characteristics and facilitate surgical transection in tissues requiring colorectal anastomosis,” Cha said.

Recently, indocyanine green fluorescence angiography (ICG-FA) was introduced for intraoperative assessment of anastomotic perfusion. Preliminary evidence suggests that ICG-FA may reduce the rate of anastomotic leakage in gastrointestinal surgery.

Perfusion assessment at the site of anastomosis may alter surgical strategy and possibly reduce anastomotic leakage rates. However, ICG-FA evaluation requires an exogenous fluorophore and the surgeon must subjectively assess the quality of perfusion. For an ideal intestinal viability test, it is essential that the technique is easily performed by the surgeon, minimally invasive, objective and reproducible—which is what Lee et al. demonstrate with their new approach.

multimodal imaging system

pediatric cardiac and vascular MRI coil

Overcoming real and perceived barriers to pediatric device innovation

pediatric cardiac and vascular MRI coil

A working group of innovators, engineers and clinicians from Children’s National Hospital and other institutions came together to address the real and perceived barriers to the creation of pediatric devices, such as this pediatric cardiac and vascular MRI coil developed by Inkspace Imaging.

A working group of innovators, engineers and clinicians from Children’s National Hospital, Children’s Hospital of Orange County and other institutions came together to address the real and perceived barriers to pediatric device innovation through opportunities that may change the return-on-investment in this market and improve health outcomes.

The new report, published in the Journal of Translational Engineering in Health and Medicine, mentions barriers that impede the advancement of pediatric devices, including excessive limitations for testing and validation, lack of incentives, inadequate research models and inconsistent pediatric-related knowledge among companies, regulatory experts, ethic review panels and government reviewers.

To remove the real and perceived barriers fostering excessive limitations, the researchers suggest reducing the perceived risk by establishing guidelines that standardize the review process and ethical research models, incentivizing small companies to participate in pediatric device innovation.

To increase incentives, the researchers call for the development of pediatric versions of adult devices with or without enforcement of regulations, develop incentives for small, medium and large-size companies, extend patent protection and more.

Since science corroborates the device’s effectiveness and safety, tailored pediatric research models are needed to help advance pediatric device innovation. While randomized trials in well-defined cohorts are commonly used in the scientific quest, they do not reflect the clinical practice in the pediatric devices field.

“Overcoming this barrier will require greater opportunity for creativity in the design of clinical trials, including delayed entry, intent-to-treat analysis, personalized outcome measures, and post-hoc subgroup analysis,” said Terence et al. “Effective research for pediatric device innovation will require greater ability to rely on ‘real-world’ data from post-market use of the proposed device or similar devices.”

On the education side, stakeholders, such as device sponsors and researchers, must receive an improved education on pediatric devices, according to the authors. Pediatricians should also be added to the regulatory review panels and advisory boards, so decision-makers can receive the pediatric perspective and fold it into their considerations.

“The consensus outcome of this meeting is that there are multiple opportunities, and a flexible combination of new programs and regulatory changes can be created to benefit the multiple stakeholders in pediatric device development,” said Terence et al. “An essential component will be building a cadre of experts with the development, regulatory, and clinical expertise to support all innovators.”

Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital adds that supporting and expanding pediatric innovation is a key focus of the new Children’s National Research & Innovation Campus, the 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, the campus provides a rich ecosystem of public and private partners which will help bolster pediatric innovation and commercialization.

Authors from Children’s Hospital Orange County include Terence Sanger, M.D., Nadine Afari, M.S., Anthony Chang, M.D., William Feaster, M.D., Sharief Taraman, M.D., Debra Beauregard, Brent Dethlefs, Tiffani Ghere, R.D., C.S.P., Mustafa Kabeer, M.D., and George Tolomiczenko.

The hybrid tracking mount for the LUS transducer

New hybrid approach for AR visualization of ultrasound images has surgical use

Children’s National Hospital researchers combined augmented reality (AR) and ultrasound imaging technologies to improve visualization during laparoscopic procedures. The patent-pending hybrid tracking method improved accuracy compared with hardware-based and computer vision-based approaches, according to the pre-clinical study published in the Journal of Medical Imaging.

“The system that we developed can work reliably under challenging intraoperative conditions, which is exciting for us,” said Raj Shekhar, M.S., Ph.D., principal investigator at Children’s National and senior author in the study. “The surgical view is usually very complex with various tissues, tools, blood and smoke in the view. Our system has been evaluated on pre-clinical models and has shown to provide acceptable overlay accuracy even during extreme conditions.”

Augmented reality for surgery is an emerging trend, consisting of a computer-generated image for the operating surgeon to see. While using ultrasound during surgery allows the doctor to see the organ’s internal structures, when combined, the AR system significantly improves the surgeon’s comprehension of the ultrasound image in the context of the surgical view.

“The AR system that we developed will benefit patients because AR-guided surgeries can be more precise, safer and faster,” said Shekhar. “Through sustained research and development effort and robust clinical-technical partnership, Children’s National is leading in clinical translation and technology transfer of the laparoscopic AR visualization technology. Other solutions are more laboratory-based while our focus has been on building a clinically practical and viable solution from day one.”

Laparoscopic surgery is known to improve outcomes, cause less scarring and speed the recovery process since the surgeons create small incisions with the aid of a camera. Still, doctors have a limited view of anatomic structures and surgical targets below the exposed surfaces.

Given that AR is an emerging technology, this work would not have been possible until recently. According to the researchers, no other scientists in the field take advantage of both tracking hardware and computer vision-based approaches.

“This work is important because it features best of both worlds: relying on tracking hardware to ensure robustness while using computer vision to enhance accuracy. This will generate a more accurate and reliable AR system which is more feasible for clinical use,” said Shekhar.

The hybrid tracking mount for the LUS transducer

The hybrid tracking mount for the LUS transducer. The mount contains a six-DOF EM sensor and an AB with 21 markers fixed on three flat surfaces.

schematic of Mueller polarimetric imaging

Novel technique improved nerve visualization in head and neck surgery

In a pre-clinical model, researchers from Children’s National Hospital found that the Mueller polarimetric imaging, a novel technique that improves image contrast, may help identify nerves from other surrounding tissues during neck and head surgical procedures, avoiding accidental nerve damage.

“This technology holds great promise for the possibility of a truly noninvasive imaging approach and may help improve surgical outcomes by potentially reducing inadvertent, ill effects of nerve injuries in head and neck surgery,” said Bo Ning, Ph.D., R&D engineer at Children’s National and lead author of the study.

This pre-clinical study presents the first application of a full-field polarimetric imaging technique in vivo during head and neck surgery to highlight the vagus nerve (VN) and a branch that supplies all the intrinsic muscles to the larynx, known as recurrent laryngeal nerve (RLN).

“Unlike conventional nerve identification devices, this technique is noninvasive and less interruptive to intact tissues without disrupting surgical workflows,” said Ning et al. “Since the technique has an easy mechanism and promising performance in our study, this novel method holds great potential for real-time, noninvasive, and convenient nerve visualization.”

While some promising methods use polarimetric imaging for tissue characterizations, the current literature is still limited to ex vivo conditions due to the system complications and prolonged acquisition speeds.

“Recently, the industry released a new polarimetric camera, which is compact and allows fast and high-definition polarimetric imaging through simple snapshots. Enlightened by this technical advance, we have developed a practical polarimetric imaging method,” said Ning, who also develops compact and practical imaging systems for surgical innovation, including 3D, fluorescent, laser speckle and hyperspectral techniques. “It allows fast polarimetric analysis and can acquire birefringence maps over the whole field of view within 100 milliseconds, which provides an appropriate speed for directly surgical use.”

The new approach proofs that the concept is feasible to set up in live subjects during head and neck surgery, which can also be easily adapted for other surgeries. Among the seven subjects, the VNs and RLNs were successfully differentiated from arteries and other surrounding tissues.

Additional co-authors from Children’s National include Itai Katz, Ph.D., M.S., R&D staff engineer III; Anthony D. Sandler, M.D., Senior Vice President and Surgeon-in-Chief; Richard Jaepyeong Cha, Ph.D., research faculty assistant professor.

schematic of Mueller polarimetric imaging

Researchers at Children’s National used a novel technique that improves image contrast, which may help improve surgical outcomes.

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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 surgerygastroenterology and gastro-intestinal surgery, and urology.

newborn baby

Creating accessible platforms for innovation is essential to advancing children’s health

newborn baby

Children’s National Hospital continues in its efforts to educate and advocate about ways to address the unique challenges facing pediatric medical device innovation, such as small market size and a lack of industry investment. In a recent commentary for IEEE Pulse, the publication of the IEEE Engineering in Medicine and Biology Society, 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 the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), discussed how the FDA and children’s hospitals are stepping in to bridge critical funding gaps and build an accessible infrastructure that safely accelerates the development and commercialization of pediatric medical devices.

Kolaleh-Eskandanian

“Our goal is to provide direct funding [with] expert advising and support services to innovators of pediatric medical devices,” says Eskandanian.

“Our goal is to provide direct funding [with] expert advising and support services to innovators of pediatric medical devices,” says Eskandanian. “The notion that innovation follows investment, that really gave us the idea of competitions where if we announced a challenge and we could put grant money behind it—and open it to the entire world — then we could attract small businesses and start-up companies that could come forward and start thinking about developing a medical device more specifically for the pediatric population.”

Now in its 8th year, NCC-PDI’s “Make Your Medical Device Pitch for Kids!” competition focuses on identifying and supporting innovators that address specific unmet pediatric needs. This year’s competition focuses on innovations in pediatric devices that treat congenital heart disease (CHD), with an emphasis on electrophysiology (EP) devices such as pacemaker systems, ablation catheters, wearable monitoring devices and related technologies that address arrhythmias in children. 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.

To learn more about the consortium’s efforts to advance pediatric innovation, visit the NCC-PDI website.

sick child in palliative care hospital bed

How POEM may change the standard of care for pediatric achalasia

sick child in palliative care hospital bed

Today, Drs. Petrosyan and Kane have performed over 35 POEM procedures for children to resolve esophageal achalasia symptoms.

In 2016, pediatric surgeons Mikael Petrosyan, M.D., and Timothy Kane, M.D., published an article in the Journal of Pediatric Surgery reviewing their experience with the surgical treatment of achalasia and how peroral endoscopic myotomy (POEM) was a new technique being used at Children’s National Hospital to treat esophageal achalasia in children.

The procedure, first used in adults to treat esophageal achalasia, uses a different approach than the current minimally invasive standard of care for children, the Heller myotomy. At the time of the initial study, the team had performed only a few POEM procedures for children but was already starting to see the promise this procedure could offer if done correctly.

While esophageal achalasia affects only about one in every 1 million kids (versus one in 100,000 for adults), the condition, which occurs when the esophagus muscles fail to function properly and the lower sphincter of the esophagus doesn’t relax enough to allow food into the stomach, can have serious impacts on daily life. The tight sphincter may cause food backup, heartburn, chest pain, and many other painful symptoms. Unfortunately, medical interventions including balloon endoscopy or Botox injections, are only temporary fixes that don’t last longer than a month or so before further treatment is needed. For kids who have long lives ahead of them, a surgical solution is the best hope for permanent symptom relief.

At the time of the 2016 study, Dr. Kane said that, “Heller myotomy works very well for most kids — that’s why it’s the standard of care. Our study found that patients who underwent the POEM procedure experienced the same successful outcomes as Heller patients, and we already knew from adult data that POEM patients reported less pain following surgery — a win-win for children.”

Today, Drs. Petrosyan, the associate chief, and Kane, the chief, of General and Thoracic Surgery at Children’s National, have performed over 35 POEM procedures for children to resolve esophageal achalasia symptoms. Increasingly, they find themselves recommending the POEM for many reasons, including, of course, the faster recovery. Kids who have a POEM procedure also often go home in one to two days following surgery and report less pain — typically a sore throat from the endoscopy and the anesthesia, but very little pain at the surgical site.

The surgeons say that the while it takes a steep learning curve to perfect the technique of using POEM in children due to the size of the available instruments to perform the procedure coupled with the challenge of a child’s tiny esophagus, the benefits for patients are well worth it.

“There’s only a single incision in the esophagus, and no incision in the abdomen,” says Dr. Petrosyan. “Kids tolerate the surgery really well, report very little pain, and recover very quickly with minimal complications.”

Even better, he continues, unlike the Heller myotomy, POEM can be performed at any point in treatment, even if other therapies or surgical interventions (including a Heller myotomy) have been previously performed. It can also be repeated if needed — though so far, they haven’t needed to do any further revisions in the population at Children’s National.

Drs. Petrosyan and Kane have performed successful POEM procedures for children with esophageal achalasia between the ages of four and 12. Younger children, (under a year of age) with smaller anatomy, continue to be treated using the Heller procedure due to the limitations in size of the surgical instruments.

Children’s National Hospital is one of the only children’s hospitals in the country to offer the option of POEM for treatment of these conditions — and Drs. Kane and Petrosyan combined perform more of these procedures than any other pediatric surgeon in the United States.

A forthcoming peer-reviewed study will highlight the use of POEM for this population and weigh its success against the current standards of care for treating children with esophageal achalasia.

In the meantime, the surgeons at Children’s National continue to offer POEM as a primary intervention for children with esophageal achalasia and are also applying the same approach for pediatric gastroparesis as well.

Colorectal clinic with Marc Levitt, MD, and patient families

Early promise of sphincter reconstruction for Hirschsprung disease

Colorectal clinic with Marc Levitt, MD, and patient families

A team of surgeons, led by international pediatric colorectal expert Marc Levitt, M.D., has developed a new surgical approach to tighten, or reconstruct, the sphincters of Hirschsprung patients who have true fecal incontinence after a pull-through procedure.

A team of surgeons, led by international pediatric colorectal expert Marc Levitt, M.D., has developed a new surgical approach to tighten, or reconstruct, the sphincters of Hirschsprung patients who have true fecal incontinence after a pull-through procedure.

Early cases using this approach were outlined in a study published in the Journal of Pediatric Surgery. Though only performed in a handful of patients so far, the authors write, “We feel confident to offer this procedure to other patients with a similar anatomic concern.”

The people who care for Hirschsprung disease patients, including the team at the Pediatric Colorectal and Pelvic Reconstruction Division at Children’s National, continue to seek better approaches for these issues because soiling and fecal incontinence are rare but devastating complications that can occur after children have a pull-through procedure.

“In the presence of an intact continence mechanisms, the anal sphincters and the dentate line, patients with Hirschsprung disease should do well and have bowel control.  For some with soiling, this can be improved with treatment of constipation or hypermotility,” the authors write. “However, patients with a damaged anal canal and/or sphincter mechanism are unable to sense stool and distension of the neorectum or hold the stool in, which can lead to true fecal incontinence.”

Currently, there is no optimal treatment for the fecal incontinence that these patients experience. This repair procedure pioneered by surgeons at Children’s National offers a promising option to help get children with Hirschsprung disease one step closer to a happier, less stressful life.