From Frustration to Reality: Fetal Surgery Offers Hope for Expectant Parents
Nationwide Children’s Hospital has the ability to correct a number of medical problems prior to a baby’s birth.
Dr. Oluyinka Olutoye begins each surgery he performs at Nationwide Children’s Hospital with an invocation.
“I pray every day that I may be the answer to someone else’s prayer,” says Olutoye, surgeon-in-chief at the hospital. “Even the so-called simple procedures I approach with awe.”
Olutoye is leading Nationwide Children’s into a new era. When it launches its new fetal surgery program, it will join an elite group of medical centers that perform surgery on the tiniest of patients, those who have not yet been born. Groundbreaking advances in cardiovascular disease, genetics and tissue engineering attracted Olutoye to Nationwide Children’s. “This is an opportunity to marry and integrate all of that,” he says.
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In Columbus, Olutoye has been working to build a multi-faceted program uniting top-tier personnel with leading-edge clinical research. The first procedure is expected to occur early in 2022, but only if every detail is in place. “As eager as we are to get started, we are more committed to doing it safely,” he says.
As surgeon-in-chief, Olutoye leads 11 surgical departments at Nationwide Children’s. He previously was co-director of the fetal center at Texas Children’s Hospital in Houston, where he helped start the center’s fetal surgery program some 20 years ago. A native of Lagos, Nigeria, he earned his doctorate in anatomy from Virginia Commonwealth University and completed fellowships in pediatric and fetal surgery at The Children’s Hospital of Philadelphia, one of the nation’s leading fetal surgery programs. He also leads research focused on fetal wound healing and other areas of early detection and treatment.
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Fetal surgery was first performed in 1965 via a blood transfusion to correct an incompatibility between mother and child. Since then, advances in prenatal diagnosis, including ultrasound, fetal echocardiograms and magnetic resonance imaging have allowed physicians to detect devastating birth defects months before a baby is born.
Surgeries can be performed as early as 19 weeks gestation, but most are done after 23 weeks. Surgeries are limited by when the diagnosis is made and how delicate the fetal tissue is before this time, Olutoye says. Most women with access to good prenatal care will get a comprehensive ultrasound at about 18 to 20 weeks, and that may signal the need for in utero medical care.
Fetal surgeries are still relatively rare. Children’s Hospital of Philadelphia performs about 150 to 200 a year, the highest volume of any center in the world, says Dr. N. Scott Adzick, surgeon-in-chief there.
Specialists in Philadelphia and at other centers are performing fetal procedures (some as part of clinical trials) to treat conditions such as congenital diaphragmatic hernia, spina bifida, congenital heart defects and tumors at the base of the spine.
From frustration to reality
Olutoye and Adzick remember when the idea of operating on a fetus was far-fetched. The field was born, in part, due to physicians’ frustrations that while they could detect serious and often fatal birth defects before birth, they could do nothing about them. By the time these children are born, the die is cast. “We have the opportunity to change that trajectory,” Olutoye says. “If we can provide that care, why wouldn’t we?”
That’s not to say fetal surgeons operate without license. Hospital ethics boards work closely with fetal medicine programs, asking the equivalent of “‘Are you guys crazy? What the heck do you think you’re doing?’” Olutoye says. “We don’t want our zeal to override reason.”
Fetal surgery, once reserved for cases in which the baby would otherwise die, has expanded to include non-lethal but devastating problems, and fetal medicine leaders say part of their role is to educate third-party payers that in utero surgeries are worth the expense. “You’re talking about early intervention versus a lifetime of complications,” Olutoye says.
One of the first fetal interventions to be covered by insurance is repair of myelomeningocele, the most severe form of spina bifida. It happens when nerves and parts of the spinal cord come through the open part of the spine, causing nerve damage and other serious disabilities. Seventy to 90 percent of children with this condition also have hydrocephalus, an accumulation of fluid on the brain.
Results of a landmark clinical study comparing outcomes of spina bifida repairs made in utero versus those made after birth were so compelling that the National Institutes of Health halted the trial in 2010. Results published the following year in The New England Journal of Medicine showed that children who had been operated on prior to their birth developed better motor skills. They were also twice as likely to be walking on their own by the time they were 2-1/2 years old as their counterparts.
Repair of myelomeningocele is accomplished primarily by using human tissue, and Nationwide Children’s is leveraging its work in tissue engineering to treat other conditions. Its tissue engineering program was the first in the world to grow and implant blood vessels in infants. The center also is home to the first U.S. human trial approved by the Food and Drug Administration to investigate the safety and effectiveness of tissue engineering to repair congenital heart defects.
The use of human tissue is vital to fetal medicine because it allows structural interventions such as spina bifida repair and heart valve replacement to occur in a growing being. While synthetic devices such as heart valves can be used in adults, those used in children must be able to expand and grow with a child, Olutoye says, noting that a fetus’ heart is about the size of a raspberry.
Gene therapy also has considerable potential in fetal interventions, including in utero treatment of sickle-cell disease, which is caused by a single gene defect. Olutoye says Nationwide’s robust genetics program gives the center a strong foothold in treating multiple conditions via those methods.
He and his colleagues have been deliberate about recruiting and training surgeons, nurses and other specialists to treat the smallest and most fragile patients. “In some senses, physicians who operate on preemies have a very similar skill set, but this requires them to go into the uterus carefully and delicately, avoiding the placenta and leaving the uterus as intact as possible,” he says.
Two lives at stake
Not to be lost in the finely focused work of fetal surgery is the fact that there are two patients to protect. “Most moms will do anything to save their children, even putting their own lives at risk,” Olutoye says. “If we have to choose, Mom is always No. 1.” The stark fact of fetal surgery is that you can lose two people. “You have the risk of a 200 percent mortality rate. … The mother undergoes a tremendous risk.”
Fetal medicine specialists counsel parents to make them fully aware of the risks and benefits of these new procedures, that there are no guarantees, and that there are alternatives. “We are frank and open with families so they are clear on what they’re signing up for,” Olutoye says. “It’s not just the surgery, there is a significant psychosocial component we need to address.”
Adzick says he draws strength from parents. “Particularly in the early days, moms were unbelievably courageous,” he says. “The mother is a medical innocent bystander … early on, our success rates were not high, and we were so discouraged. It was the moms who told us, ‘don’t you dare quit.’”
In addition to operating room nurses, Nationwide Children’s will provide nursing staff dedicated solely to the mother. “There is a lot of stress and anxiety, and having a familiar face there really does help,” says Rebecca Corbitt, nurse coordinator at the fetal center.
Plans for the hospital’s fetal surgery center call for using part of a surgical floor as a recovery room for mothers undergoing procedures. Olutoye says Nationwide Children’s is not in the business of setting up an obstetrics program, however, and that most deliveries will continue to take place at adult hospitals.
Telling parents that their child will be born with a life-limiting condition is among the most difficult of job responsibilities, Corbitt says. “We don’t know how long they will survive, but we know their lives will be shortened.” She says she is grateful for the “awe-inspiring” advances in fetal medicine that allow her to “give parents hope, to try to make a difference in a child’s outcome, and to do it safely. We have an amazing team here, and I’m just one person who loves her job.”
Adzick says advances in cellular and gene therapies could lead to exponential growth in the field of fetal interventions, with the potential to treat “hundreds and hundreds” of conditions.
Fetal surgery, he says, “is not just a phase. I think the future for fetal surgery is very, very bright.”
Ohio is unique in that it already has two fetal surgery programs, one at Cincinnati Children’s Hospital and the other at University Hospitals Rainbow Babies & Children’s Hospital in Cleveland. Nationwide Children’s has a partnership with the Cleveland hospital for treating congenital heart disease. Dr. Aimee Armstrong, Nationwide Children’s director of cardiac catheterization and interventional therapies, has performed surgery at the Cleveland Hospital to correct a heart valve problem in utero at 24 weeks gestation.
Having three fetal surgery centers in one state is more a factor of talent and geographical coincidence than any attempt to gain market share, Adzick and Olutoye say. Fetal medicine centers “are not something every city should have,” Olutoye believes. “This is a very high-stakes endeavor.”
Categories of Fetal Medicine
Minimally Invasive Surgery
Surgeons insert miniature cameras, or scopes, and fetal-sized surgical instruments through small incisions in the mother’s abdomen, allowing them to operate on the baby, umbilical cord or placenta without making a major incision in the mother’s abdomen and uterus.
When fetal procedures cannot be done using scopes, surgeons use open surgery, which requires an incision in the uterus. Anesthesiologists medicate the mother to prevent contractions, and both mother and baby are administered general anesthesia so that they do not feel anything during the procedure. The uterus and abdomen are closed after the procedure so the pregnancy can continue until as close as possible to the due date.
Ex-Utero Intrapartum Therapy
(Commonly referred to as EXIT)
This is a specialized type of fetal surgery performed at the end of a pregnancy. It is used in cases when waiting to operate until after delivery would pose a severe risk to the baby’s health. Surgeons make an incision in the mother’s abdomen, perform the necessary surgery to treat the baby and then complete the delivery.
Sources: Cincinnati Children’s Hospital; the Mayo Clinic; National Institutes of Health
What is Tissue Engineering and Stem Cell Therapy?
Fetal surgery often uses stem cells and tissue engineering to treat congenital abnormalities. Stem cells are the body’s raw materials. These are cells from which all other cells with specialized functions are generated.
Stem cells serve as the primary instrument of tissue engineering, a process in which fibroblasts, connective-tissue cells that act as scaffolding, are extracted from a patient and then used to artificially grow cells and tissues in a lab setting.
Sources: Cincinnati Children’s Hospital; the Mayo Clinic; National Institutes of Health
This story is from the 2022 issue of Columbus Monthly Health.