Surgical Innovation

It took an act of Congress to save lives

Boosting research and innovation to find cures and develop new medical devices for children and adults who carry childhood and rare diseases will transform our health system and save lives.

Until now, medical research and innovation have been severely limited in the U.S. by regulations and lack of funding. On behalf of healthcare systems and medical innovators across the U.S., we applaud the House and Senate for their tremendous bipartisan effort to pass the 21st Century Cures Act that will transform our health and research system and enable us to more effectively fight diseases.

We are encouraged by the provisions in the act that break down regulatory barriers and expedite the approvals of drugs and devices. We are particularly excited about the provisions to increase funding to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), as well as the establishment of precision medicine, the cancer moonshot initiatives and new programs that will improve our mental health system and fight the worsening opioid epidemic. Boosting research and innovation to find cures and develop new medical devices for children and adults who carry childhood and rare diseases is at the core of our mission at Children’s National. Our researchers are working to find new biomarkers, map the human genome, develop medical devices for children and personalize medicine to make treatment and cures more targeted and effective. They are also studying pain and looking at new ways to detect the presence of opioids and cannabinoids. Thanks in large part to funding from the NIH, institutions like ours are able to continue groundbreaking biomedical research. This legislation brings hope to our children and their families, especially those who volunteer to participate in research, that our scientific breakthroughs will be translated to drugs, therapeutics and medical devices safer and faster.

Another victory for all of us in the pediatric medical device field is the expansion of the Humanitarian Use Device program to include devices used by up to 8,000 individuals rather than the current 4,000 individual cap. The hard cap at 4,000 individuals was excessively restrictive and was a significant disincentive blocking the development of devices for rare diseases and conditions, especially those affecting children. The 4,000 limit was also an obstacle for the development of diagnostic devices, since the FDA interprets the limitation to apply to the number of patients that would receive the diagnostic test, rather than the number of individuals affected or manifesting the rare disease.

Currently, medical device development for children lags woefully behind adults. Children have medical device needs that are considerably different from adults. The subtleties of developing devices for pediatric patients are fundamentally different than those for adults. The challenges include small markets, scarce financial incentives, regulatory issues, and the procedural dissimilarities of premarket clinical trials and post-market surveillance. The lack of available pediatric devices often forces clinicians to treat pediatric patients by using or modifying adult devices, adjusting implants designed for other purposes, and using implants designed decades ago. Because devices are being used “off-label,” clinicians and regulators are not able to collect information on their effectiveness. This act promises a faster regulatory approval process, which increases the enthusiasm of the venture community in investing in drug and device development, which in turn can help startup companies in the field secure private capital.

Thank you to everyone who worked tirelessly to create this bill and to those who lobbied on its behalf. It’s efforts like the 21st Century Cures Act, that break down regulatory barriers and provide the resources to expedite the approvals of life-saving drugs and devices, that save children’s lives.

About the Author

Kolaleh Eskandanian, Ph.D.
Executive Director
Sheikh Zayed Institute for Pediatric Surgical Innovation
Research interests: device development, entrepreneurship, innovation in health care

Study to evaluate heat-activated chemotherapy drug

Children’s National Health System and Celsion Corp., a leading oncology drug-development company, will be the first to launch a clinical study in the U.S. that evaluates the use of ThermoDox®, a heat-activated chemotherapy drug, in combination with noninvasive magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) to treat refractory or relapsed solid tumors in children and young adults.

The investigator-sponsored Phase I study, which is partially funded by an NIH R01 grant, will determine a safe and tolerable dose of ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), which can be administered in combination with MR-HIFU. Under the guidance of an MRI, the high-intensity focused ultrasound directs soundwave energy to heat the tumor and the area around the tumor. When heated, the liposome rapidly changes structure and releases doxorubicin directly into and around the targeted tumor.

“There is currently no known cure for many patients with refractory recurring solid tumors, despite the use of intensive therapy, so we need to identify new, smarter therapies that can improve outcomes,” said AeRang Kim, M.D., Ph.D., oncologist and member of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, who is also principal investigator for the study. “Recent advances in the use of noninvasive MR-HIFU coupled with novel therapies, such as LTLD, may provide us with a mechanism to noninvasively administer high concentrations of the drug directly to the site where it is most needed and avoid toxicity to other areas of the body.”

A First to Treat Childhood Cancer

This is the first time LTLD is being combined with MR-HIFU and the first time it is being evaluated in children.

“Celsion’s experience in combining ThermoDox with HIFU, a noninvasive next generation heating technology, supports this very important research in childhood cancers. From a safe dose, ThermoDox’s proven ability to deliver high concentrations of an effective chemotherapy directly to a heated tumor makes it an ideal candidate for a trial involving children and young adults,” said Michael H. Tardugno, Celsion’s chairman, president and CEO. “This study will further elucidate ThermoDox’s potential in combination with ultrasound-induced hyperthermia, and highlight potential applications of ThermoDox in combination with a broad range of heating technologies that could address an even larger population of patients.”

A Multidisciplinary Approach

The study targeting the treatment of childhood sarcomas will be carried out as a multidisciplinary collaboration between Children’s National, Celsion, and Dr. Bradford Wood’s team at the National Institutes of Health.

This is the latest study from the Image-Guided Non-Invasive Therapeutic Energy (IGNITE) program, a collaboration of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and the pediatric health system’s Divisions of Radiology, Oncology, Surgery, and Anesthesiology. The goal of the IGNITE program is to improve the quality of life and outcomes for pediatric patients through the development and clinical introduction of novel minimally invasive and noninvasive surgery technologies and combination therapy approaches. In 2015, doctors from Children’s National were the first in the U.S. to treat osteoid osteoma, a benign and painful bone tumor, using MR-HIFU.

ThermoDox is currently in late-stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and nonmuscle invading bladder cancers.

Minimally invasive surgery brings lasting relief to pediatric achalasia patients

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Achalasia affects only a small number of people around the world, estimated at 1.6 per 100,000, and children make up fewer than 5 percent of that total. In most cases, the causes are unknown, but it is attributed to a combination of heredity and autoimmune or nerve cell disorders. For adults, treatment might include oral medication to prevent narrowing, balloon dilation, or botulinum toxin injections to relax the muscle at the end of the esophagus. For a growing child, who faces not just months but a lifetime of injections and potential repeat procedures, these methods aren’t viable. Instead, surgical correction is the standard of care. In the past 10 years, the surgical option evolved from a traditional open procedure with weeks of recovery and pain to less-invasive approaches.

“The total number of children with achalasia is small,” says Timothy D. Kane, M.D., Division Chief of General and Thoracic Surgery at Children’s National Health System. “But Children’s National treats more of these cases than most other children’s hospitals around the world, and that gives us the ability to look at a larger population and see what works.”

Dr. Kane is senior author of a study recently published in the Journal of Pediatric Surgery that analyzed the outcomes from nearly a decade’s worth of these cases to gauge the effectiveness of two different minimally invasive surgical approaches for children with achalasia.

A look at the two surgical options

The most common surgical intervention is laparoscopic Heller myotomy, performed through small incisions in the belly. Additionally, Dr. Kane and the Children’s surgical team are one of only two teams in the country who perform a different procedure called peroral endoscopic myotomy (POEM) on children. The POEM procedure is completed entirely through the mouth using an endoscope, with no additional incision needed. The procedure is commonly used for adult achalasia cases, but is not widely available for children elsewhere as it requires specialized training and practice to perform.

“Heller myotomy works very well for most kids — that’s why it’s the standard of care,” Dr. Kane says. “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.”

The retrospective study included all children who had undergone surgical treatment for achalasia at Children’s from 2006 to 2015. Since achalasia cases are few and far between, with most children’s hospitals seeing maybe one to five cases over 10 years, collecting reliable data on outcomes is challenging. This study provides a large enough sample to allow doctors to use the findings as a guide to find the interventions that are the best fit for each patient.

“Now we’re very comfortable presenting families with two really good options and letting them choose the one that works best for them,” he concludes.

Imagine the feeling of food stuck in your throat. For children with esophageal achalasia, that feeling is a constant truth: The muscles in the esophagus fail to function properly and the lower valve, or sphincter, of the esophagus controlling the flow of food into the stomach doesn’t relax enough to allow in food — causing a backup, heartburn, chest pain, and many other painful symptoms. For children, surgery is the best hope for permanent relief.

Smart Tissue Autonomous Robot (STAR)

Popular Science awards smart tissue autonomous robot

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Technology developed in the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National has been named one of the 12 Most Important Health Innovations of the Year in the November/December 2016 issue of Popular Science. Smart Tissue Autonomous Robot (STAR), a technology that performed the first supervised, autonomous robotic soft tissue surgery on a live subject (in vivo) this year, has been awarded a 2016 Popular Science Best of What’s New Award in the Health category.

How the smart tissue autonomous robot works

STAR removes the surgeon’s hands from the procedure, instead utilizing the surgeon as supervisor, with soft tissue suturing autonomously planned and performed by the STAR robotic system.  The system integrates near infrared florescent (NIRF) markers and 3-D plenoptic vision to provide uninhibited tracking of tissue motion. This tracking is combined with an intelligent algorithm that autonomously adjusts the surgical plan in real time as tissue movements occur.

About Popular Science health innovations of the year

Each year, the editors of Popular Science review thousands of products in search of the top 100 tech innovations of the year—breakthrough products and technologies that represent a significant leap in their categories.

The Best of What’s New awards honor the innovations that shape the future,” says Kevin Gray, Executive Editor, Popular Science. “From lifesaving technology to incredible space engineering to gadgets that are just breathtakingly cool, this is the best of what’s new.”

3 ways to bring safe surgery to kids in remote regions

On Oct. 10, at the World Federation of Pediatric Surgeons (WOFAPS) Congress, in Washington, DC, the chief executives of four top North American pediatric hospitals held a candid discussion about bridging gaps in access to safe, high-quality surgical care for children everywhere. Below are three key strategies that emerged from the conversation.

1. Deploy innovative technologies

Kurt Newman, M.D., president and CEO of Children’s National Health System, kicked off Monday’s panel by describing a so-called innovation paradox. Game-changing innovations in pediatric medicine, he said, often emanate from both ends of the global development spectrum.

First-world technologies–such as telemedicine and remote robotics–developed in affluent regions are bringing important specialized care opportunities to lower-resourced communities. At the same time, pressures experienced in developing regions to adapt to challenging conditions and resource constraints can lead to creative solutions with implications well beyond the third world.

According to Michael Apkon, M.D., CEO of the Toronto-based Hospital for Sick Children, up to 85 percent of children in the developed world are cared for in emergency departments that have no specific in-house pediatric expertise. For the most part, he said, they are treated in general hospitals by physicians and nurses with no specific training in pediatric care.

In remote areas like rural Ontario, there simply isn’t enough volume to sustain in-house pediatric specialists in every hospital, Apkon explained, “but there’s a big opportunity to provide support from centers that do have that capacity.” Through telemedicine and remote robotics, “we can guide caregivers that are quite capable of doing interventions if they have the right support,” he said.

At the same time, technologies created to meet specific third-world needs are demonstrating potential for broader applications.

Dr. Newman highlighted one such technology – a low-cost, disposable, multifunctional incubator for at-risk, low-birth-weight babies – developed by the Center for Advanced Sensor Technology at University of Maryland Baltimore County. The technology won a major grant earlier this week as part of a device competition at the 4th annual Sheikh Zayed Pediatric Surgical Innovation Symposium.

Though it was developed specifically to help curb preventable deaths within the first week of birth in developing areas, the technology could have cost-reducing applications for hospitals around the world.

2. Provide training opportunities

Richard Azizkhan, MD, CEO of Children’s Hospital & Medical Center in Omaha, spent the early decades of his career working to reconstruct a functioning health care system in post-war Bosnia. A key starting point, he said, was building infrastructure for training and education.

For several years during the war, there were simply no training opportunities for in-country physicians and nurses, he explained. Working with colleagues, Azizkhan set up educational exchange programs and academic centers to teach skills in minimally invasive surgery and other modern techniques. Over time, trainees become trainers, and those skills propagated widely.

“I was training people who ultimately ended up becoming much better than I was,” said Azizkhan. “The first person I trained ended up doing more than 400 cases and becoming a leading trainer for the entire Balkans region.”

Success didn’t happen overnight. “It took literally 20 years to build that infrastructure,” he said. But today the country has capacity for very sophisticated care, including transplants and neonatal oncology.

Dr. Apkon echoed the value of training opportunities for care providers in under-resourced regions.

“Parts of the world that are blessed with the ability to have a specialized system have a moral obligation to help in whatever way they can to create capacity where it doesn’t yet exist,” he said.

Through the SickKids-Ghana Initiative, 1500 nurses in Ghana are being trained to provide very basic services in rural communities that lack a developed healthcare system. The work is aimed at training nurses in foundational elements of holistic pediatric care, including administering treatments for low oxygen, dehydration, and low blood sugar.

3. Build partnerships – locally and globally

In his former capacity at the Cleveland Clinic, Marc Harrison, MD, incoming CEO of Intermountain Healthcare, was tasked with building an entire new multispecialty hospital in Abu Dhabi.

When asked about the key to his success, Harrison didn’t hesitate.  “The biggest thing we did right was have the right partner,” he said.

Working with the Crown Prince of Abu Dhabi and many other local partners, Harrison gained insights about how health care is delivered in the region and any societal and political considerations that could impact the hospital’s operations.

“If you’re coming into a new place and are too arrogant to see that there are those who understand the environment better than you, you will fail,” he said. “It isn’t enough to have technical skills or a long track record … if you don’t have the ability to get things done on the ground, you won’t succeed.”

Dr. Azizkhan also emphasized the importance of partnerships – not just locally but globally.

In North America, he pointed out, over 100 institutions are working together to share data and best practices to improve quality and safety across systems. Ventilator-associated pneumonias, central line infections, and surgical site infections, he said, can be dramatically reduced by sharing best practices.

Dr. Newman closed the panel noting, “One thing I’ve found through my career as a surgeon,” he said, “is that the community of cooperation, friendship, and collaboration among pediatric surgeons is unparalleled.”

pediatric medical device competition winners

Winning innovators of pediatric medical device competition announced

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The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System hosted the 4th annual Pediatric Surgical Innovation Symposium on Oct. 8. One of the highlights: Six pediatric medical device innovations that address a significant unmet need were awarded a total of $250,000 in grant money by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).

Kurt Newman, M.D., President and CEO of Children’s National said: “Even though they are a small portion of the patient population, it’s critical for children to have medical devices that are built specifically for them. Children’s National is committed to bringing together the key stakeholders including innovators, clinicians, policy makers, and investors, to support advancements in the care of children.”

“We are honored to recognize these exciting innovations with this funding,” said Kolaleh Eskandanian, Ph.D., Executive Director of NCC-PDI and the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National. “It takes millions of dollars to bring a device to market and our program provides the funding needed to bridge the critical gap that often follows the prototyping phase in life cycle of the device.”

       Winning innovations receiving $50,000 awards are:

  • Maternal Life, Palo Alto, Calif. – low-cost closed system that captures and administers colostrum to newborns with zero percent loss
  • JustRight Surgical, Louisville, Colo. – second generation surgical 5mm stapler scaled for a wider range of pediatric surgical procedures and bringing the benefits of laparoscopy to patients
  • Lully, San Francisco – moisture sensor and Smart Pod monitor wirelessly connected to a smartphone app to prevent bedwetting episodes
  • Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore – low-cost, disposable multifunctional incubator for at-risk, low-birth-weight babies

Winning innovations receiving $25,000 awards are:

  • Nebula Industries, Melrose, Mass. – quick-release medical tape to prevent neonatal and pediatric skin injuries
  • May & Meadow, Inc., Redwood City, Calif. – low-cost, mobile medical device for assessing feeding ability in infants at risk for feeding problems

11 Children’s National surgeons and physicians to participate at WOFAPS 2016

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Pediatric surgeons, physicians, and scientists from around the world are meeting in the nation’s capital Oct. 8 to 11 , for the 5th World Congress of the World Federation of Associations of Pediatric Surgeons (WOFAPS) hosted by The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. It’s the first time that the meeting will be in North America. This year’s theme is “re-imagining children’s surgery through global innovation and integration.”

The 5th WOFAPS congress includes many scientific and research plenary sessions by pediatric surgical experts from around the world. Eleven Children’s National and Sheikh Zayed Institute surgeons and physicians are participating in panels covering different topics and areas of expertise including:

  • Minimally Invasive Surgery: Current State of Endoscopic & Minimally Invasive Bariatric Surgery
  • The Current Standards of Management & Controversies in Pediatric Tumors: Neuroblastoma & Wilms Tumor
  • Per Oral Endoscopic Myotomy (POEM) Techniques for Pediatric Achalasia: Approach, Techniques & Setting up Program
  • Hot Topics in Pediatric Urology: Controversies & Advances

Pediatric surgical innovation symposium approaches

This year, there were a record number of entries (91) for the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) competition, which will be held  Oct. 8 at the fourth annual Pediatric Surgical Innovation Symposium, hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. Twelve finalists have been selected to pitch their pediatric medical device innovation, and up to six innovations will be awarded up to $50,000 each, with awards based on presentations given before a panel of expert judges.

The finalists are:

  • PECA Labs, Pittsburgh, Pa. – synthetic vascular conduit for surgical repair of congenital heart defects that’s capable of minimally invasive, controlled expansion to grow with the patient
  • Maternal Life, Palo Alto, Calif. – low-cost closed system that captures and administers colostrum to newborns with zero percent loss
  • Magnamosis, Inc., San Francisco, Calif. – device to provide safer, less invasive repair of the esophagus in newborns with esophageal atresia/tracheoesophageal fistula, a condition requiring surgery that is currently performed by hand
  • JustRight Surgical, Louisville, Colo. – second generation surgical 5mm stapler sized for use with a wider range of pediatric surgical procedures and bringing the benefits of laparoscopy to patients
  • CareTaker Medical, Charlottesville, Va. – disposable, finger cuff for single patient use to continuously and non-invasively monitor neonatal  heart rate without adhesives, electrodes and wires
  • Nebula Industries, Melrose, Mass. – quick release medical tape to prevent neonatal and pediatric skin injuries
  • Lully, San Francisco, Calif. – moisture sensor and Smart Pod monitor, placed under the mattress, that are wirelessly connected to a smartphone app to prevent bedwetting episodes
  • Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, Md. – low-cost, disposable multifunctional incubator for at-risk, low birth weight babies
  • Multisensor Diagnostics, Baltimore, Md. – non-invasive portable handheld device designed to perform rapid medical assessment of key vitals for pediatric patients
  • May & Meadow, Inc., Redwood City, Calif. – low-cost, mobile medical device for assessing feeding ability in infants at risk for feeding problems
  • PediaStent, Cleveland, Ohio – novel pediatric bioresorbable stent for use in repairing congenital heart lesions
  • Averia Health Solutions, Alexandria, Va. – low-cost concussion screening and management system that uses smartphone technology

“The impressive number of well qualified applications we received from all over the US as well as from other countries speaks to the enthusiasm of Medtech innovators to develop and test devices specifically for children,” said Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation and NCC-PDI. “We are committed to building on this momentum and keeping the conversation going with all who applied and will provide consultation services if needed.”

Read more.

Spinal fusion surgical home helps kids go home sooner

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The first of its kind for pediatric patients, the Children’s National Spinal Fusion Surgical Home implements a newly developed model of care to streamline and optimize the spinal fusion process for adolescent idiopathic scoliosis patients.

Using frameworks of care used in adult models, along with best practices and literature reviews, a multidisciplinary team developed the first Spinal Fusion Surgical Home for pediatric patients. It standardizes the infection-control process, pain-management pathway, and physical-therapy program for patients undergoing spinal fusion.

“This model eliminates variability in the care process and increases the quality of care for pediatric patients,” said Matthew Oetgen, MD, MBA, Chief of Orthopaedic Surgery and Sports Medicine. “It’s just the start—by developing this model specifically for our young patients with adolescent idiopathic scoliosis, we are paving the way for a number of other kids that require different kinds of surgeries.”

Hallmarks of the spinal fusion surgical home
From pre-operative care through recovery, the Spinal Fusion Surgical Home streamlines care with an emphasis on increasing quality outcomes for patients. Children’s National provides an informational website and a single point of contact for scheduling procedures and pre-operative laboratory exams. Before surgery, patients and families attend an evening education class that features presentations from orthopaedic nurse practitioners, physical therapists, and anesthesiologists.

After surgery, a nurse follows up by phone to assess how the patient is handling pain and healing.

Increasing the quality of care
By implementing these standardized protocols, Children’s National has seen a decrease in the average length of stay for spinal fusion patients from about five days to three and a half days. The surgical home also has reduced the transfusion rate from 30 to 12 percent, and patient pain scores have decreased.  “Patients are getting better faster with less pain, and are getting to leave the hospital sooner,” says Karen Thomson, MD.

Children’s National also is creating surgical homes for sickle cell disease patients, who need a variety of different types of surgery, as well as for children who need Nissen fundoplication and heart surgery.

First 3D bioprinted placenta model for study of preeclampsia created

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Scientists at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, in partnership with the University of Maryland, are the first to create a 3D bioprinted placenta model and use it to study preeclampsia, a life-threatening pregnancy complication. Bioprinting is the three-dimensional printing of biological tissue and organs through the layering of living cells, with cell function and viability preserved within the printed structure. Because the Institute’s bioprinted placenta model mimics the organ’s complex cellular structure, the model creates unprecedented opportunities to understand and develop new treatments for life-threatening maternal conditions involving the placenta.

Read the full press release. 

Treating injured adolescents at pediatric trauma centers associated with lower mortality

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As children mature into adolescence, they also transition from being cared for by pediatric healthcare providers to being cared for by health professionals who primarily treat adults. Controversy remains about whether a primarily pediatric or adult treatment location is optimal to meet the needs of injured adolescents. For this reason, the cutoff age for triaging children to pediatric versus adult trauma hospitals varies in different settings. A research team led by Randall S. Burd, MD, PhD, Chief of the Children’s National Health System Division of Trauma and Burn Surgery, found that injured adolescents treated at pediatric trauma centers (PTCs) had a lower mortality rate than injured adolescents treated at adult trauma centers (ATCs) or mixed trauma centers (MTCs), facilities that treat both adults and children, even when controlling for differences in patients.Trauma is a leading cause of death and acquired disability among adolescents. To determine any potential association between the type of trauma center and mortality rates, the research team examined 29,613  records for patients aged 15 to 19 years old drawn from the 2010 National Trauma Data Bank.“Trauma centers dedicated to the treatment of pediatric patients see a different adolescent population than do ATCs and MTCs,” Dr. Burd and colleagues write in an article published June 27 by JAMA Pediatrics. “After controlling for these differences, we observed that adolescent trauma patients have lower overall and in-hospital mortality when treated at PTCs.”

These findings, bolstered by additional research, have the potential to change the approach for triaging injured adolescents, says Dr. Burd, the paper’s senior author. The study findings suggest that commonly used age thresholds of 14 or 15 years might be safely adjusted higher.

Because the data were obtained from a large dataset, making that case will require closer examination – perhaps chart-by-chart analysis for each patient – to tease out nuances that differentiate care adolescents receive at different types of trauma hospitals, Dr. Burd says. “Are there differences in the process of care – or availability of specific resources – that account for the differences in outcome? Or, do the patients treated at each hospital type have differences in their injuries that we have not yet identified?”

Most adolescents (68.9 percent) included in the study were treated at an adult trauma center. In addition to being older, these youths were more likely to be severely injured and more frequently suffered severe injuries to the head, chest, and upper extremities. The most common traumatic injuries seen at adult centers resulted from children being passengers in motor vehicles (32.6 percent). Penetrating injuries from firearms (12 percent) and cutting or piercing (7.1 percent) were more common at adult centers.

Some 1,636 patients (5.5 percent) were treated at a pediatric trauma center, with many being transferred there from another hospital. Adolescents treated at pediatric trauma centers were more likely to be injured by a blunt rather than penetrating mechanism. The most common injuries seen at pediatric centers were injuries from a fall (25.9 percent) or injuries that resulted from being struck (26.1 percent).

“Because adolescents straddle the gap between pediatric and adult medicine, identifying differences in care among PTCs, ATCs, and MTCs will help determine the most appropriate triage strategies or identify practice strategies that can optimize the outcome for patients in this age group,” the authors conclude.

Related resources: Research at a Glance 

Smart Tissue Autonomous Robot

Supervised autonomous in vivo robotic surgery on soft tissues is feasible

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Surgeons and scientists from Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System are the first to demonstrate that supervised, autonomous robotic soft tissue surgery on a live subject (in vivo) in an open surgical setting is feasible and outperforms standard clinical techniques in a dynamic clinical environment.

The study, published May 4, 2016 in Science Translational Medicine, reports the results of soft tissue surgeries conducted on both inanimate porcine tissue and living pigs using proprietary robotic surgical technology, Smart Tissue Autonomous Robot (STAR). This technology removes the surgeon’s hands from the procedure and, instead, utilizes the surgeon as a supervisor, with soft tissue suturing autonomously planned and performed by the STAR robotic system.

Soft tissues are the tissues that connect, support, or surround other structures and organs of the body such as tendons, ligaments, fascia, skin, fibrous tissues, fat, synovial membranes, muscles, nerves, and blood vessels. Currently, more than 44.5 million soft tissue surgeries are performed in the United States each year.

“Our results demonstrate the potential for autonomous robots to improve the efficacy, consistency, functional outcome, and accessibility of surgical techniques,” says Peter C.W. Kim, MD, CM, PhD, Vice President and Associate Surgeon-in-Chief, Sheikh Zayed Institute for Pediatric Surgical Innovation. “The intent of this demonstration is not to replace surgeons, but to expand human capacity and capability through enhanced vision, dexterity, and complementary machine intelligence for improved surgical outcomes.”

While robot-assisted surgery (RAS) has increased in adoption in healthcare settings, the execution of soft tissue surgery has remained entirely manual, largely because unpredictable, elastic, and plastic changes in soft tissues occur during surgery, requiring the surgeon to make constant adjustments.

To overcome this challenge, STAR uses a tracking system that integrates near infrared florescent (NIRF) markers and 3D plenoptic vision, which captures light field information to provide images of a scene in three dimensions. This system enables accurate, uninhibited tracking of tissue motion and change throughout the surgical procedure. This tracking is combined with another STAR innovation, an intelligent algorithm that guides the surgical plan and autonomously makes adjustments to the plan in real time as tissue moves and other changes occur.  The STAR system also employs force sensing, submillimeter positioning, and actuated surgical tools. It has a bedside lightweight robot arm extended with an articulated laparoscopic suturing tool for a combined 8 degrees-of-freedom robot.

“Until now, autonomous robot surgery has been limited to applications with rigid anatomy, such as bone cutting, because they are more predictable,” says Axel Krieger, PhD, technical lead for Smart Tools at Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National. “By using novel tissue tracking and applied force measurement, coupled with suture automation software, our robotic system can detect arbitrary tissue motions in real time and automatically adjust.”

To compare the effectiveness of STAR to other available surgical procedures, the study included two different surgeries performed on inanimate porcine tissue (ex vivo), linear suturing, and an end-to-end intestinal anastomosis, which involves connecting the tubular loops of the intestine. The results of each surgery were compared with the same surgical procedure conducted manually by an experienced surgeon, by laparoscopy, and by RAS with the daVinci Surgical System.

Intestinal anastomosis was the surgical procedure conducted on the living subjects (in vivo) in the study.  The Children’s research team conducted four anastomosis surgeries on living pigs using STAR technology, and all subjects survived with no complications. The study compared these results with the same procedure conducted manually by an experienced surgeon using standard surgical tools.

“We chose the complex task of anastomosis as proof of concept because this soft tissue surgery is performed over one million times in the U.S. annually,” says Dr. Kim.

All surgeries were compared based on the metrics of anastomosis including the consistency of suturing based on average suture spacing, the pressure at which the anastomosis leaked, the number of mistakes that required removing the needle from the tissue, completion time, and lumen reduction, which measures any constriction in the size of the tubular opening.

The comparison showed that supervised autonomous robotic procedures using STAR proved superior to surgery performed by experienced surgeons and RAS techniques, whether on static porcine tissues or on living specimens, in areas such as consistent suture spacing, which helps to promote healing, and in withstanding higher leak pressures, as leakage can be a significant complication from anastomosis surgery. Mistakes requiring needle removal were minimal and lumen reduction for the STAR surgeries was within the acceptable range.

In the comparison using living subjects, the manual control surgery took less time, 8 minutes vs. 35 minutes for the fastest STAR procedure, however researchers noted that the duration of the STAR surgery was comparable to the average for clinical laparoscopic anastomosis, which ranges from 30 minutes to 90 minutes, depending on complexity of the procedure.

Dr. Kim says that since supervised, autonomous robotic surgery for soft tissue procedures has been proven effective, a next step in the development cycle would be further miniaturization of tools and improved sensors to allow for wider use of the STAR system.

He adds that, with the right partner, some or all of the technology can be brought into the clinical space and bedside within the next two years.