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Cardiology, Inside Pediatrics

Comparing Delayed Sternal Closure Results Reinforces Success at Children’s of Alabama

Leaving the chest open for a day or two after complex neonatal heart surgery has been standard procedure at Children’s of Alabama for about a dozen years. The practice is believed to be a “safety mechanism” that lessens compression on the heart and lungs as swollen babies begin to recover from their operations, according to Robert Dabal, M.D., chief of pediatric cardiothoracic surgery at Children’s and an associate professor of surgery at the University of Alabama at Birmingham (UAB).

But does the approach, known as delayed sternal closure, actually produce better outcomes than closing a newborn’s chest at the conclusion of surgery? The Pediatric Cardiac Critical Care Consortium (PC4) recently invited Children’s and University of Michigan’s C.S. Mott Children’s Hospital to debate the question by comparing each hospital’s outcomes. Unlike standard practice at Children’s, C.S. Mott cardiothoracic surgeons “tend to close a lot of complex neonates,” Dabal explained.

Children’s has been a member of PC4 – which aims to improve the quality of care to patients in North America and beyond with critical pediatric and congenital cardiovascular disease – since the group’s inception about 12 years ago. The head-to-head comparison of outcomes between Children’s and C.S. Mott showed survival rates to be higher at Children’s, though the gap was not statistically significant, Dabal said.

“We found that delayed sternal closure doesn’t really negatively impact patients in any way, either in length of stay or rate of complications, but it does make them a little easier to manage in the immediate postoperative period,” he said.

Mortality rates at Children’s for complex neonatal heart surgeries are consistently far lower than the U.S. average, he noted. For example, for the Norwood procedure – a three-step heart surgery for hypoplastic left heart syndrome – Children’s mortality rate has been about 5.5% over the last five years, compared with a national average of about 15%.

Possible complications from leaving the chest open after surgery include slightly higher odds of infection, “though we haven’t really seen that here,” Dabal said. The practice also requires greater sedation to prevent patients from “moving around a lot” in the days after surgery and a slight delay in removing ventilators.

But the PC4 debate results essentially reinforce Children’s approach, and Dabal expects delayed sternal closure to continue here as the standard of care. “I don’t think we’ll be making major changes, though we’re always interested in continuing to improve our results,” he said.

Cardiology, Inside Pediatrics

Using Stem Cells to Strengthen the Hearts of HLHS Patients

While advanced surgical techniques, ICU care and outpatient management have dramatically improved survival rates for children born with hypoplastic left heart syndrome (HLHS), additional treatment options are still very much needed. That’s why pediatric cardiologists at Children’s of Alabama are eager to join forces with the Mayo Clinic to test stem cell therapy on HLHS patients from Alabama and the surrounding region.

A year after joining the Mayo Clinic’s HLHS Consortium – about a dozen prominent children’s institutions spread across the United States and Canada – Children’s is taking part in clinical research to determine if stem cells from a patient’s own umbilical cord blood can strengthen the right side of the heart.

Born with an array of underdeveloped structures on the left side of their hearts, HLHS patients typically undergo three surgeries over their first four years of life. Children’s treats between 12 and 20 such patients every year.

“This was a uniformly fatal diagnosis before these operations were used,” said Waldemar Carlo, M.D., an associate professor of pediatrics in the Division of Pediatric Cardiology at Children’s and the University of Alabama at Birmingham (UAB). “Outcomes are ever-improving for this diagnosis, and we’ve gotten the first-year mortality down to under 10%. But we know that the decreasing function of the right ventricle over time limits how long these patients can live.”

The Phase 2 clinical trial, in which Children’s is completing enrollment, is based on successful Phase 1 results and will further determine the safety and efficacy using cell-based regenerative therapy to help manage HLHS. Parents expecting babies known to have HLHS are approached before childbirth and offered the opportunity to bank their baby’s umbilical cord blood. Stem cells derived from that blood are then injected directly into the infant’s right ventricular muscle during second-stage (Glenn) surgery.

To compare outcomes over time, the trial will also include a placebo arm of patients who do not receive stem cells during second-stage surgery. Several HLHS patients at Children’s will be included in each arm.

“The thought with this therapy is that stem cells would initiate a response in the right ventricle to strengthen the heart muscle over time – hopefully preserving its function longer than would otherwise happen,” Carlo said.

“We were chosen because we have very good clinical results in the care of children with HLHS at Children’s of Alabama,” Carlo added. “That is a prerequisite before participating in clinical research using novel therapies. It’s certainly an honor to participate with these other excellent centers.”

Cardiology, Inside Pediatrics

Planning Complex Heart Surgeries Made Easier with 3D Models

Viewing the heart up close in all its complexity was once only possible during surgery. But specialists at Children’s of Alabama are increasingly tapping the ability to create 3D heart models that help them to better plan intricate surgeries before they take place.

With 3D printing technology becoming far less expensive since its creation about a decade ago, Children’s has been printing hearts for about two years. The arrival of Christian Tan, M.D., a PGY-5 pediatric cardiology fellow at University of Alabama at Birmingham (UAB), has prompted an uptick in its use as he collaborates with specialists in Radiology and Imaging, which operates Children’s 3D printer.

“This provides an additional way for us as providers to assess and look at the anatomy of the heart,” Tan explained. “It gives you different insight when you’re actually able to hold and look at a model and see it from many different perspectives. We can do some of that with digital 3D constructions from CT scans, but it’s different when you can manipulate the heart with your hands and see it from any vantage point.”

Using various materials, including a harder, plastic resin and a softer, rubber-like substance, Children’s 3D printer produces models that realistically portray the heart itself along with outside structures such as the aortic arch and pulmonary arteries, Tan said.

The printer cost several thousand dollars, but 3D heart models cost around $12 apiece to produce, he noted. For a recent surgery on a newborn, the 3D model helped cardiac surgeons determine which pathway from the left ventricle to the great arteries would work best for the repair needed. Specialists at Children’s perform about 450 such surgeries each year on patients born with congenital heart defects.

“It helps the surgeon with some mental planning for the surgery, and it helps the cardiologist understand the anatomy better so when it’s explained to the surgeon, the findings are clearer,” Tan said.

Parents also appreciate the ability to “see” their children’s hearts, he added.

“This also helps us explain the anatomy to parents, especially those with no medical background,” Tan said. “It can be hard to understand the difficult problems these kids have.”

“I think it’s very meaningful to the parents,” he added. “In addition to being an educational tool, parents find it a way to connect to their children when they can see their kid’s heart.”

Cardiology, Inside Pediatrics

Leading the Nation in Norwood Procedure Results

Robert Dabal, M.D., chief of pediatric cardiothoracic surgery at Children’s of Alabama, attibutes “better resources and the evolution of a well-developed team” to the hospital’s impressive Norwood procedure mortality rate.

It is the most complex cardiothoracic surgery performed in newborns, one in which surgeons literally construct a new, larger aorta for babies born with hypoplastic left heart syndrome (HLHS). Called the Norwood procedure, it must be done within the infant’s first week of life, followed by a second surgery when the baby is 3 to 6 months, and a third at age 4 or 5.

In the past five years, surgeons at Children’s of Alabama have completed 54 Norwoods. Just three babies died, for a mortality rate of 5.5 percent. That compares to a national average of about 15 percent, based on statistics from the Society of Thoracic Surgeons Congenital Heart Surgery Database, which tracks all congenital heart surgeries in the country.  In addition, the one-year survival rate at Children’s is about 90 percent compared to the landmark Single Ventricle Reconstruction trial, which had a one-year mortality rate of about 70 percent.

“We are obviously really proud of where we are,” said Robert Dabal, M.D., chief of pediatric cardiothoracic surgery at Children’s.“It’s a combination of better resources and the evolution of a well-developed team.”

The cardiothoracic program truly took off in 2012, when the Benjamin Russell Hospital for Children opened and the program moved over from the University of Alabama at Birmingham (UAB). Before that, Dabal said, there were just seven pediatric cardiovascular intensive care unit (CVICU) beds; two dedicated pediatric cardiacintensivists; and nurses who took care of both adult and pediatric patients. Just one surgeon performed Norwood procedures.

Today, the Bruno Pediatric Heart Center, which occupies most of the fourth floor of the hospital, boasts a 20-bed CVICU with three surgeons performing Norwood procedures, seven dedicated intensivists and a large pool of nurses who only take care of children.

“We are much better in all phases of care,” Dabal said, including preoperative diagnosis. In the past, only about half of infants born with the condition were diagnosed in utero; today that figure is closer 80 percent. “It’s a testament to the hard work of the obstetricians and pediatric cardiologists who are making the diagnosis,” he said. The earlier notice enables surgeons to better plan for the surgery, ensures the mother delivers at UAB where the newborn can receive immediate care and helps the family begin to process and understand a life-changing diagnosis.

The team continually looks for opportunities to improve outcomes and isn’t afraid of change. For instance, Dabal said, they are now more aggressive about avoiding ventilation and try to get the babies to eat by mouth. They also encourage patient bonding with parents during the first few days after birth, “which we think is very important for later development.”

In addition, everything, from pre-operative to operative to postoperative care has become more standardized, leaving less room for error. While there are numerous techniques for the Norwood procedure, Dabal said, “we’ve tried to standardize our approach better so that all our babies get a very similar operation.”

Another contributing factor to the outstanding one-year survival is a home-based interstage monitoring program Children’s instituted. The hospital was an early national adopter of this program, in which parents use an iPad and special app to closely monitor their baby’s condition and keep nurses notified of any changes. The use of technology allows for much closer follow-up from a distance while still maintaining the same high levels of in-person care in the pediatric cardiology clinic.

But all the statistics in the world can’t make up for the most important improvement the Children’s program has seen, Dabal said, which is improved long-term survival with a good quality of life, the “ultimate goal” with congenital heart disease. “Success in congenital heart surgery can’t be measured in postoperative or one-year outcomes,” he said. “We strive to allow these babies to grow up and live the best lives that they can.”

Cardiology, Inside Pediatrics

Ventricular Assist Devices: Bridging the Gap Between Heart Failure and Transplant

Children’s of Alabama pediatric cardiologist F. Bennett Pearce, M.D., left, spearheaded the use of pediatric ventricular assist devices (VAD) at Children’s and the University of Alabama at Birmingham (UAB).

Ventricular assist devices (VAD), which help patients bridge the gap between late-stage heart failure and transplant or buy patients time while their hearts heal from trauma or infection, have been available for adults since the 1990s. But with no pediatric devices, Children’s of Alabama pediatric cardiologist F. Bennett Pearce, M.D., who, at the time, worked under the umbrella of the  the adult transplant program at the University of Alabama-Birmingham (UAB), tried to adapt adult VAD devices for adolescents and children as young as 12.

But the devices and hardware required to attach them to the failing heart were often too large to fit within a child’s smaller thoracic volume, and the blood capacity was so high the devices had to operate at a very low heart rate, increasing the risk of thrombosis.

That all changed when Pearce read an article about a new pediatric VAD, the Berlin Heart EXCOR, that was just entering clinical studies. He was on vacation at the time and when he returned immediately worked with the UAB team to ensure the university could join the trials.

Their first patient received the Berlin VAD in 2005, making UAB one of the first hospitals in the southeast to perform the surgery. A second child received it a year later. Both were highly successful, Pearce said. One child later received a transplant and the other recovered from myocarditis.

The results of that trial led to the device’s U.S. Food and Drug Administration approval in 2011, and in 2012 investigators from UAB were among the authors of a landmark paper published in The New England Journal of Medicine reporting the results of the trial.

Since then, other devices have entered the market, and the pediatric ventricular support transplant advanced heart failure program moved to Children’s of Alabama where it has flourished. “We have a very experienced team on the pediatric cardiology heart failure side with experienced transplant coordinators, excellent surgeons, outstanding  CVICU staff, and strong clinical research interests in pediatric circulatory support,” Pearce said. “That’s why it works so well today.”

Since 2001, 39 children, ranging from newborns to teenagers, most of whom are bridging to transplant, have received VADs; 27 since the program moved to Children’s. The success rates have improved over time, Pearce said, reflecting improvements in device technology, anticoagulation treatment and accumulated experience. “All patients supported in 2020 have had either successful bridge to transplant or recovery,” he said.

The children remain on the devices for weeks, months, “even close to a year,” Pearce said, often in the hospital. Even those who are discharged, however, require a high level of clinical support. Since many live hours away from Children’s, the team trains local clinicians, family and caregivers in the specialized support these patients need

The greatest advantage of our program, he said, “is that this kind of work, although intense, has the potential for tremendous satisfaction because of the often miraculous outcomes.”

Cardiology, E-News for Referring Offices, Inside Pediatrics

NEW PHYSICIANS JOIN PEDIATRIC CARDIOLOGY

Leslie Collins, M.D., Assistant Professor in Pediatric Cardiology, earned her medical degree at the East Carolina University – Brody School of Medicine. Dr. Collins completed her pediatric residency and pediatric cardiology fellowship at the University of Alabama at Birmingham. Her research/clinical interests include imaging, fetal ECHO, and heart failure and transplant.


Austin Kane, M.D.,AssistantProfessor in Pediatric Cardiologyearned his medical degree at Columbia University College of Physicians and Surgeons in New York, New York. Dr. Kane completed his pediatric residency at Northwestern University Feinberg School of Medicine in Chicago, Illinois. He completed a fellowship in pediatric cardiology at Emory University School of Medicine in Atlanta, Georgia and an additional fellowship in pediatric and congenital electrophysiology. Prior to joining the University of Alabama at Birmingham, he was a pediatric and congenital electrophysiology attending at Providence Sacred Heart Medical Center and Children’s Hospital in Spokane, Washington. 


Khalisa Syeda, D.O., AssistantProfessor in Pediatric Cardiologyearned her medical degree at the University of North Texas in Fort Worth, Texas. Dr. Syeda completed her pediatric residency at the University of Illinois at Chicago and her pediatric cardiology fellowship at the University of Texas Health Science Center in Houston, Texas. Her research/clinical interests include pediatric cardiology, imaging, fetal echocardiography and preventive cardiology. 

Cardiology, Inside Pediatrics

Children’s of Alabama Receives Prestigious Accreditation from Children’s Cardiomyopathy Foundation

Cardiomyopathy_WEB

Livie Wheeler of Pell City, Alabama was diagnosed with dilated cardiomyopathy and underwent a successful heart transplant at Children’s of Alabama. Livie was discharged home just in time for her second birthday.

Children’s of Alabama was recently named an accredited center of care by the Children’s Cardiomyopathy Foundation (CCF), a national nonprofit committed to improving the health outcomes and quality of life for children with cardiomyopathy.

“We’re glad to be able to participate,” said F. Bennett Pearce, M.D., outgoing medical director of the Pediatric Advanced Heart Failure and Transplant Program at Children’s of Alabama. “CCF promotes education and helps families connect and choose centers with experience in these kinds of patients.”

The Pediatric and Congenital Heart Center of Alabama at Children’s of Alabama is one of the largest pediatric cardiovascular programs in the Southeast. In 2018, its team of 250 dedicated professionals treated more than 230 patients with pediatric cardiomyopathy. The team includes surgeons, intensivists, cardiologists and many others, including nurses, social workers, child life specialists, genetic counselors, nutritionists, occupational and physical therapists, and chaplains.

“We have traditionally had very strong clinical abilities and success with treating a variety of these conditions,” Pearce said. “Over the 25 years that I’ve worked in the program, I feel we have been among the finest centers, but we have not been quite so active in getting the word out. That needs to change because we want to make families aware that there’s a good resource for them here.”

The CCF offers a plethora of educational and supportive programs for families, as well as a research grant program for basic, clinical, population/epidemiologic, or translational studies focused on primary pediatric cardiomyopathy.

Its accreditation program was established in 2017 to recognize excellence in diagnosing and treating pediatric cardiomyopathy and provide families with standardized center information to help them find an expert treatment center in their area. To date, 39 centers in the U.S. and Canada, including Children’s of Alabama, have been accredited.

The CCF has very strict criteria for accreditation. Centers must:

  • Manage 30 or more cardiomyopathy patients up to age 18 annually or 60 pediatric cardiomyopathy patient visits a year.
  • Have at least one pediatric cardiologist who treats patients with dilated, hypertrophic, restrictive arrhythmogenic and right ventricular or left ventricular non-compaction cardiomyopathy.
  • Be part of a teaching hospital affiliated with a medical school.
  • Offer the following:
    • Prenatal or fetal echocardiography
    • High quality imaging (echocardiogram, cardiac magnetic resonance imaging)
    • Interventional cardiology (catheterization, endomyocardial biopsy)
    • Pediatric cardiac electrophysiology
    • Cardiac surgical services (septal myectomy, cardiac device implantation)
    • Genetic testing and counseling
    • Pediatric neurology
    • Social work
    • Child life services
  • Centers must also have at least one of the following (Children’s of Alabama meets all four):
    • A specialized clinic or program focused on pediatric cardiomyopathy or familial hypertrophic cardiomyopathy with a dedicated team of professionals.
    • Involvement with the North American Pediatric Cardiomyopathy Registry, Pediatric Cardiomyopathy Repository or Pediatric Heart Transplant Study Group.
    • Engagement in pediatric cardiomyopathy research.
    • Advanced heart failure management and transplantation.

“We have everything needed to offer to this group of patients,” Pearce said. “And we want to make sure that when a family confronts this difficult diagnosis, they can easily find our program and be assured that it is a good resource.”

 

Cardiology, Inside Pediatrics, Nephrology

Children’s of Alabama Leads Consortium Dedicated to Improving Outcomes in Cardiac Surgery-Acute Kidney Injury

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Children’s of Alabama is one of 22 hospitals in the U.S. that is a member of the Neonatal and Pediatric Heart and Renal Outcomes Network (NEPHRON).

Neonatal acute kidney injury (AKI) occurs in 52 to 64 percent of patients undergoing cardiac surgery (CS) and is associated with increased morbidity and mortality.

However, because CS-AKI rates vary widely between centers, it appears that interventions to prevent or mitigate the condition could reduce the overall rate.

Yet, noted Santiago Borasino, M.D., medical director of Children’s of Alabama’s Cardiovascular Intensive Care Unit (CVICU), “there are critical gaps in our understanding as to how to best define CS-AKI, who is at risk, and which patients could best benefit from interventions to prevent or  mitigate the effects of CS-AKI.”

To improve understanding of CS-AKI in this population, Borasino is one of the leaders of the Neonatal and Pediatric Heart and Renal Outcomes Network (NEPHRON), composed of 22 children’s hospitals around the country. The consortium’s goals are to describe neonatal kidney injury epidemiology, evaluate variability in diagnosis and management, identify risk factors, investigate the impact of fluid overload and explore associations with outcomes. It involves multidisciplinary teams including clinicians from cardiac critical care, cardiology, nephrology, and cardiac surgery.

“NEPHRON is providing multicenter data on CS-AKI for the first time,” Borasino said. “The large size of the cohort will enable us to look at details that are not possible with single-center studies.”

NEPHRON published its preliminary results in April 2019, reporting an overall incidence of 54 percent among 2,240 patients in its database.[1] In November 2019, NEPHRON presented additional results during the American Heart Association’s annual meeting, showing a threefold variation in rates among centers, from 27 percent to 86 percent, with significant variations in KDIGO stage (adult AKI definition) to identify AKI (65 percent by oligo oligo-anuria versus 35 percent by creatinine).

The results also showed that the use of cardiopulmonary bypass, but not time spent on bypass, increased the odds of CS-AKI, and that only KDIGO Stage 3 was associated with mortality. There was no impact of CS-AKI on the duration of mechanical ventilation or hospital length of stay.[2]

“NEPHRON preliminary results highlight the limitations of the KDIGO definition and the need to better understand CS-AKI as it occurs with incredible variability among centers, opening the door for future quality improvement intervention,” Borasino said.

The next step is to develop an algorithm to predict which patients are more likely to develop AKI so physicians can intervene earlier. “Early recognition and proper management of AKI are at the forefront of critical care medicine,” said Children’s of Alabama pediatric nephrologist Tennille Webb, M.D. “However, most pediatric hospitals that perform cardiac surgeries do not have protocols in place for managing severe AKI post-operatively.” Webb is now working on developing a clinical pathway to identify patients at increased risk of AKI based on specific patient characteristics. “An advantage to developing this algorithm in the CVICU is that we are able to determine the exact timing and etiology of AKI development in individuals undergoing cardiopulmonary bypass,” she said. “If we can proactively identify risk factors that place these individuals at increased risk for AKI, we can provide earlier intervention, such as early initiation of renal replacement therapy, in an effort to mitigate some of the known severe consequences of AKI.”

“The work that we are doing is very important because we know that AKI post-cardiac surgery leads to worse outcomes and is associated with chronic kidney disease,” Webb said. “It’s great, and yet rare in other institutions, that we have been able to develop a strong relationship between the CVICU and nephrology to work as a cohesive team early AKI detection and prevention.”


[1] Gist KM, Blinder JJ, Bailly D, Neonatal and Paediatric Heart and Renal Outcomes Network: design of a multi-centre retrospective cohort study. Cardiol Young. 2019;29(4):511-518.

[2] Alten J, Cooper DS, Gist KM, et al. , Abstract 13177: Epidemiology of Neonatal Cardiac Surgery Induced Acute Kidney Injury From the Neonatal and Pediatric Heart and Renal Outcomes Network. Circulation. 2019;140(Suppl1).

 

Cardiology, Inside Pediatrics

Discharged with an iPad: Children’s of Alabama Uses Telehealth to Monitor Complex Heart Patients at Home

Telehealth_WEB

Children’s of Alabama has partnered with Locus Health to provide a special iPad app that connects parents with nurse practitioners who treat infants who have undergone complex surgery.

Babies born with a single ventricle must undergo three major open-heart surgeries by the time they are toddlers. The first and most complex surgery occurs at 1 to 2 weeks; the second between 4 and 12 months. The months spent at home between the two can be overwhelming for parents.

Now families served at Children’s of Alabama have a new tool to help them cope – an iPad containing a special app from Locus Health, a Charlottesville, Virginia-based company that develops software to ease the discharge process and transition from hospital to home. The app forms the core of a remote monitoring system that connects parents with the nurse practitioners at Children’s of Alabama who care for their infants.

“These parents have been through a tremendous amount of stress,” said Katelyn Staley, discharge coordinator for Cardiovascular Services at Children’s of Alabama. “Not only do they have a newborn, but the baby requires major open-heart surgery in that first week or two of life. Then they are discharged home; it’s an overwhelming process,” she said.

“The Locus platform was designed specifically for the pediatric patient population with congenital heart disease,” said Sarah Blair, RN, MSN, CRNP, of Children’s of Alabama’s Hearts at Home Program. More than a dozen of the country’s leading children’s hospitals now use the system, which studies find can reduce post-discharge emergency room visits as much as 40 percent and the total hospital days by up to two weeks.

Children’s of Alabama had been using another electronic program, but it was cumbersome, not user-friendly and difficult to extract data from. Before that, all data was collected the old-fashioned way – with paper and pencil.

With the Locus app, parents enter their child’s daily weight, oxygen saturation, heart rate, number of diapers, Synagis dosing and nutritional intake, noting if there is any vomiting or diarrhea. They can also upload photos and videos.

Timely information is critical. For instance, weight gain is vitally important because if the baby stops gaining or loses weight the team needs to intervene quickly before complications occur. In addition, values can be individualized for each infant depending on their medical status. “If a parent enters an out-of-range value it creates a red flag and prompts the caregiver to call the hospital immediately,” Staley said.

The data automatically populates the congenital heart clinical dashboard, which nurse practitioners and clinical nutritionists monitor. Parents can also see current and past data and even track trends across time, Blair said. Data can also be downloaded into a PDF and emailed to physicians.

The remote monitoring is also beneficial since many patients live hours from the hospital and may be followed by a local cardiologist. “Now we can share the information with the cardiologist where they live,” she said.

“It definitely keeps us in constant communication with the families,” Blair said. “We still call and talk to them, but it relieves some of that pressure.”

“Sending families home with the reassurance that nurse practitioners are logging into the system on a daily basis and that they have 24/7 access to a provider is very reassuring,” Staley said.

Cardiology, Uncategorized

Understanding Xenotransplantation’s Potential to Save Babies

The issue is simple: there are simply not enough hearts for all the children who need them. So 17% of all children who need a heart transplant die while waiting; this translates to 20% to 25% of infants.[1]

The University of Alabama at Birmingham (UAB) and Children’s of Alabama aim to change those dismal statistics with one of the most revolutionary approaches since the first heart was transplanted from one human to another in 1967 – xenotransplantation.  

Thanks to a $19.5 million grant from biotechnology magnate United Therapeutics Corporation, UAB and Children’s have launched one of the top programs in the world dedicated to developing genetically modified solid organs from pig models for transplantation.

The idea isn’t new. Pig tissue has been used to replace heart valves for years, said cardiothoracic surgeon David Cleveland, M.D., MBA, who leads the program at Children’s. The greatest challenge with solid organs, he said, is overcoming immunological and physiological barriers.

If they can do that, “We believe that there’s huge potential to improve the lives of children,” he said.  

Supporting Evidence

Earlier this year, Cleveland presented preliminary results from a study showing little reactivity in an infant’s blood to cells from a triple-knockout (TKO) pig. The pig had been genetically modified to delete the three major antigens that react with natural human anti-pig antibodies. Even those human cells that did react demonstrated a very mild reaction.

“We found that very promising,” Cleveland said.

Another area of interest is producing immune tolerance by transplanting porcine thymus tissue to “re-educate” the immune system to accept the pig heart, said cardiac intensivist Leslie Rhodes, M.D. The idea comes from the fact that children can develop an immune system via a human thymus transplant. “We wonder if we could we train their immune system to be tolerant to the pig thymus transplant,” she said.

Infants are the ideal starting place, Cleveland said, not only because they have the highest wait list mortality of any other demographic waiting for a solid organ transplant, but because their immune systems are still naïve. Indeed, they do not develop antibodies to pig glycans during at least the first three months of life, Cleveland and his team wrote in a recent journal article, providing a “window of opportunity” for the transplant.[2]

The next step is a transplant in a non-human primate. “The FDA won’t even consider it until we can prove consistent survival in a non-human primate,” Rhodes said. They hope to perform their first transplant later this year.

Societal Concerns Addressed

The team is also aware of the societal issues around xenotransplantation. To address that, they surveyed the families of patients on the transplant list and the nurses and physicians who will care for these children.

”I was surprised by how positive they were,” Cleveland said. “I thought there would be more pushback than there was.” Still, he said, “I think there has to be major education,” once xenotransplantation becomes a reality. “The idea of replacing a heart with a pig heart will take some people a little time to get over.”

He’s confident it will happen, though. “UAB is going to be one of the centers in the world with the potential to make this happen,” he said. “We have children living in our ICU because there’s not enough cardiac function; they are having their birthdays here. It totally changes entire families to have a child in the hospital forever. There has to be another way.“


[1] Dipchand AI. Current state of pediatric cardiac transplantation. Ann Cardiothorac Surg. 2018;7(1):31–55. doi:10.21037/acs.2018.01.07

[2] Cleveland D, Adam Banks C, Hara H, Carlo WF, Mauchley DC, Cooper DKC. The Case for Cardiac Xenotransplantation in Neonates: Is Now the Time to Reconsider Xenotransplantation for Hypoplastic Left Heart Syndrome? Pediatr Cardiol. 2019;40(2):437-444.

Cutting-Edge Research

Learn more about various research areas at the University of Alabama at Birmingham.