Nemours Children's Clinic

A new type of surgically implanted pump that supports a child’s failing heart has performed well in the first stage of human testing, according to Stanford Medicine. The pump is a new type of ventricular assist device (VAD) surgically attached to the heart to help augment its blood-pumping action in patients with heart failure. Researchers designed the implant to extend a patient’s life to allow more time to find a donor heart. Stanford Medicine said that the pump could “close an important gap in heart transplant care for children.” Seven children in a feasibility trial received the new pump to support their failing hearts. Six of the patients ultimately had heart transplants, and one child’s heart recovered, making a transplant unnecessary, Stanford Medicine said. The researchers published the results in the Journal of Heart and Lung Transplantation. The Stanford School of Medicine led the study and included several medical centers in the U.S. Researchers suggest that the early results, if confirmed in a larger device trial, could make waiting for a heart transplant easier for small children and their families. More about the pump The pump, known as the Jarvik 2015 ventricular assist device, is slightly larger than an AA battery. It can be implanted in children weighing as little as 18 pounds. With the pump implanted, kids can still participate in many normal activities while awaiting a heart transplant. Stanford Medicine said there is only one ventricular assist device available for small children, the Berlin Heart. The Berlin Heart, in contrast, is not implantable and is as big as a large suitcase. Depending on the model, it weighs between 60 and 200 pounds and is attached to a patient with two cannulas almost as large as garden hoses. The researchers said that there is an increased risk of stroke associated with the Berlin Heart, and it requires hospitalization in most instances. “While we are extremely grateful to have the Berlin Heart, a life-saving device, ventricular assist devices for adults have been improving every decade, but in pediatrics we’re using technology from the 1960s,” said the study’s lead author, pediatric cardiologist Dr. Christopher Almond, professor of pediatrics at Stanford Medicine. Almond noted that implantable VADs have been available to adults for more than 40 years. The devices can fit inside a patient’s chest and are typically safer and easier to use than external devices like the Berlin Heart. He said there is a lag in the development of pediatric technology to solve similar problems. “There’s a huge difference in the medical technology available to kids and adults, which is an important public health problem that markets have struggled to fix because conditions like heart failure are rare in children,” Almond said in a news release. The early findings suggest a promising solution The Jarvik 2015 VAD feasibility trial included seven children with systolic heart failure. The condition affects the left ventricle, which helps pump blood from the heart throughout the body. Six children in the trial had a disease called dilated cardiomyopathy that caused systolic heart failure, and one child’s heart was failing because of a complete heart block stemming from lupus. All participants in the trial were on a heart transplant list. Each child in the feasibility trial had a Jarvik 2015 device surgically implanted in the left ventricle and was started on medication to prevent blood clots and lower the risk of stroke. The participants were 8 months to 7 years old and weighed 18 to 46 pounds. Stanford Medicine said the pump can be used for children who weigh up to 66 pounds. The trial assessed whether the pump could support patients for at least 30 days without ceasing to function or causing severe stroke. The researchers also collected preliminary safety and performance data to help design a larger pivotal trial for future FDA approval. Pump recipients remained in the hospital for monitoring until they received a heart transplant or recovered so that researchers could track their blood pressure and hemoglobin levels and monitor for complications. The median time the patients used the pump was 149 days. Some of the children in the trial had complications with the new pump, including the child who recovered had an ischemic stroke from a blood clot once the heart became strong enough to compete with the pump. The researchers removed the pump and the child continued to recover and was alive a year later. Another patient in the trial experienced failure of the right side of the heart and was transferred to a Berlin Heart pump to await a transplant. Most patients in the trial had manageable complications that were generally comparable to those physicians anticipate when using a Berlin Heart. Future feasibility trials on the horizon The researchers have received funding from the National Institutes of Health for an expanded trial to test the use of the new pump further to generate data for an FDA approval submission. The researchers have launched the next phase and hope to enroll the first patient by the end of 2024. The team wants to enroll 22 participants at 14 U.S. medical centers and two European sites. “We’re excited to launch the next phase of the research,” Almond said. “We’ve overcome a number of challenges to get the work this far, and it’s very exciting that there may be better options on the horizon for children with end-stage heart failure who require a pump that can act as a bridge to transplant.” Researchers contributed to the study from the University of Texas Southwestern; Texas Children’s Hospital, Houston; Columbia University; Children’s Healthcare of Atlanta; Nemours Children’s Hospital, Florida; Vanderbilt University Medical Center; the National Heart, Lung and Blood Institute; Carelon Research; Stollery Children’s Hospital; the Hospital for Sick Children, Toronto; Boston Children’s Hospital; Cincinnati Children’s Hospital; and the University of Oklahoma, Tulsa. The study was funded by a National Institutes of Health/National Heart, Lung, and Blood Institution contract.

WILMINGTON, Del., Oct. 30, 2023 /PRNewswire/ -- Nemours Children's Health announced today that Mark Marcantano, JD, will join the organization as Regional President for Nemours Children's Delaware Valley. Marcantano is a seasoned healthcare executive with significant operations, strategic planning and financial performance experience at prominent pediatric academic medical centers, including his most recent position at Johns Hopkins Children's Hospital (JHCH). Continue Reading Mark Marcantano Marcantano assumes his new role on January 1, 2024 and will be based in Wilmington, Del. He will report to Mark Mumford, Nemours Enterprise Chief Operating Officer (COO) for the multistate, multisite children's health system. "Mark brings a perfect blend of both ambulatory and inpatient experience to the new role of Regional President for Nemours Children's Health, Delaware Valley," said Mumford. "His six years at Boston Children's, experience leading Care New England's Women and Infants Hospital, and his most recent role at Johns Hopkins Children's Hospital, position him well to lead our commitment to purposeful growth, increased patient and associate engagement, innovation and value-based care." "There is no more inspiring focus than the mission and vision at Nemours Children's Health to provide the highest quality, value-based pediatric healthcare necessary to create the healthiest generations of children," said Marcantano. "I am incredibly humbled to join the amazing team at Nemours and energized to continue the important work ahead with one of the top pediatric integrated health systems in the nation." Marcantano's academic medicine experience includes lead administrative roles responsible for the strategy, operations, finances and budgeting with Johns Hopkins Children's Hospital and Albany Medical College. His wide-ranging career in healthcare encompasses work with a start-up healthcare technology company and serving as Chief Operations Officer of a not-for-profit company, nationally renowned market leader in school age education, early childhood development, research, training and innovation focused on children and their families both with and without special needs. He holds a Juris Doctor degree from Albany Law School of Union University, Albany, New York and a Bachelor of Science degree in Finance/International Business from New York University, Stern School of Business, New York, New York. He has also completed the Executive Leadership Program and the Quality and Safety Leadership Development Program from Harvard Business School, and is a member of the Bar in Washington, D.C., New York, and Connecticut. About Nemours Children's Health Nemours Children's Health is one of the nation's largest multistate pediatric health systems, which includes two free-standing children's hospitals and a network of more than 70 primary, specialty, and urgent care practices. Nemours Children's seeks to transform the health of children by adopting a holistic health model that utilizes innovative, safe, and high-quality care while also caring for the health of the whole child beyond medicine. Nemours Children's also powers the world's most-visited website for information on the health of children and teens, Nemours KidsHealth.org. The Nemours Foundation, established through the legacy and philanthropy of Alfred I. duPont, provides pediatric clinical care, research, education, advocacy, and prevention programs to the children, families, and communities it serves. For more information, visit Nemours.org. SOURCE The Nemours Foundation

Transaction Expands OCP's National Platform, Adding a Specialty in Complex Adult and Pediatric Spine Pathology FORT LAUDERDALE, Fla., June 13, 2023 /PRNewswire/ -- Orthopedic Care Partners (OCP), a leading orthopedic practice management platform, today announced a strategic affiliation with the American Spine & Orthopaedic Institute (ASOI), a renowned practice specializing in complex adult and pediatric spine pathology, based in Orlando, FL. Founded by James Manzanares, MD, ASOI has garnered a strong reputation for addressing a broad spectrum of spine-related issues, from traumatic to nontraumatic conditions, using both conventional and minimally invasive techniques. Dr. Manzanares and his team are recognized for their three primary areas of expertise: minimally invasive spinal surgery, advanced spine reconstruction, and sports-related injury. Dr. Manzanares completed his medical school and residency at the Mayo Clinic in Rochester, Minnesota, before undergoing advanced training in pediatric orthopedics at the Nemours Children's Clinic. He then completed an advanced spine reconstruction fellowship at Johns Hopkins School of Medicine. In addition to his medical career, Dr. Manzanares served in the US Armed Forces. He completed two combat tours in Iraq and later served in Egypt and Germany. ASOI's founding philosophy is that the patient always comes first – a commitment upheld by Dr. Manzanares and all ASOI staff, aligning perfectly with OCP's own patient-centric approach. Rich Gilbert, MD, CEO of OCP, stated, "We are excited to welcome Dr. Manzanares and his exceptional team at ASOI to our national platform. Their unique specialty in complex adult and pediatric spine pathology extends our current offerings, ensuring we can provide the highest standard of care to a wider range of orthopedic conditions. This affiliation fits perfectly with our strategy of partnering with market-leading practices that offer exceptional and comprehensive care." Dr. Manzanares added, "Our affiliation with OCP will enhance our mission of providing world-class spinal and orthopaedic care to our patients in central Florida. We look forward to leveraging the resources and network of OCP to further optimize patient outcomes, maintain our focus on minimally invasive techniques, and continue to place patients at the heart of all we do." About Orthopedic Care Partners: Orthopedic Care Partners (OCP) is the leading partner for high-performing, quality, and patient-focused orthopedic surgery practices. OCP provides a full spectrum of services and enhanced resources to help its family of practices thrive and grow while fostering the unique identities that have made them so successful. To learn more, visit . About American Spine & Orthopaedic Institute: The American Spine & Orthopaedic Institute, based in Orlando, Florida, is a leading practice specializing in complex adult and pediatric spine pathology. Founded by James Manzanares, MD, the practice prioritizes patient-centric care, using both conventional and minimally invasive techniques to address a broad spectrum of spine-related issues. To learn more, visit . Contact: Grady Wilson Chief Development Officer, Orthopedic Care Partners [email protected] SOURCE Orthopedic Care Partners