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Beyond the MOMS Trial: Four Years of Successful Outcomes in Fetal Repair of Myelomeningocele

On March 17, 2011, the New England Journal of Medicine published the results of the National Institutes of Health-sponsored Management of Myelomeningocele Study (MOMS) comparing open in-utero repair of myelomeningocele to the traditional postnatal repair.1 When the study found that fetuses treated in utero had improved motor function and a decreased need for ventriculoperitoneal shunting, pediatric surgeon KuoJen Tsao, M.D., and his colleagues at The Fetal Center at Children’s Memorial Hermann Hospital began screening patients for in-utero repair of the defect. Among the families referred to the Center were Dallas residents Ivan and Colette Hagler. Based on MOMS trial protocols, Dr. Tsao determined that Hagler was an ideal candidate for the procedure, and her daughter Faith became the first patient in Texas to undergo in-utero repair of myelomeningocele (MMC).

Duke-ScarToday, Dr. Tsao, who is co-director of The Fetal Center, calls Faith Hagler his “poster child” for the procedure. Delivered on July 4, 2012, Faith has met all of her developmental milestones. “Cognitively and linguistically, she’s right on board,” he says. “Much of her follow-up medical care now focuses on keeping an eye on things through her growth and development.”

The four-year-old program at The Fetal Center continues to produce good outcomes with patients chosen based on criteria established in the MOMS trial. “We’ve been very strict in maintaining the same selection criteria,” says Dr. Tsao, an associate professor in the department of Pediatric Surgery and department of Obstetrics, Gynecology and Reproductive Sciences. “As a member of the North American Fetal Treatment Network (NAFTNet), we’ve vowed to maintain our adherence to the best practices they’ve established. If any fetal spina bifida surgery varies from the MOMS criteria, it should be done under a research protocol.”

The selection process for in-utero MMC repair is based on a strict prenatal care algorithm (see page 5) that emphasizes education. “Patients come to us with one of two mindsets,” Dr. Tsao says. “Many have been given a diagnosis of spina bifida and have done their homework and want to know if they qualify for fetal surgery. Other families know very little about the defect and are overwhelmed by the diagnosis. They want to learn about the condition and fetal surgery, but the last thing they want to do is wade through websites with detailed medical descriptions. Because we view it as our obligation to teach families about the condition itself – not just fetal surgery – we approach both types of patients in the same way, preparing them to make an informed decision about their treatment options. We’ve made an impact on lives through fetal surgery but we feel our major impact has been in the area of spina bifida education as a consequence of the availability of surgery.”

As part of the education process, each patient referred to The Fetal Center, regardless of whether she and her baby qualify for fetal MMC repair, undergoes extensive counseling with experts in maternal-fetal surgery, fetal surgery and spina bifida. Over the span of two days, the family also meets with a pediatric surgeon, a pediatric neurosurgeon, a genetic counselor, a pediatric expert in long-term spina bifida outcomes, a neonatologist, an anesthesiologist, a social worker and a representative of Child Life services.

Pediatric spina bifida specialist Lynette Mazur, M.D., professor of pediatrics at UTHealth Medical School, is a key member of the multidisciplinary team that provides long-term care for children with myelomeningocele. An expert with more than 10 years of experience, she uses a specially designed doll to help parents understand the defect and complications their child may have based on the location of the lesion.

“Dr. Mazur’s consultation is incredibly important to the process because it’s here that parents can find answers to their foremost question: ‘What will happen to my baby after birth?’” Dr. Tsao says. “Although it’s never a completely clear-cut answer, she is able to provide information related to possible complications and what parents can expect in terms of the care their child will need throughout life. Some parents who come to us for fetal surgery change their minds, even if they qualify, and choose postnatal repair after their consultation because of the education provided.”

Baby_Faith_turns_3(1)Candidates are accepted for open fetal MMC surgery based on the criteria set forth by the MOMS trial. The risks and benefits to both mother and baby are considered in the process. Specific factors that exclude the fetus from surgery are variants of spina bifida not considered open neural tube defects, the presence of a significant fetal condition not related to myelomeningocele, kyphosis, multiple pregnancy, significant clubbing of the legs or evidence of existing paralysis. Maternal exclusion criteria include medical or personal reasons for withholding surgery or anesthesia, morbid obesity, previous or planned incision on the cervix or a documented history of a weak cervix, a cervix of less than 20 millimeters by vaginal ultrasound, preterm labor in the current pregnancy, a history of spontaneous preterm delivery in previous pregnancies, bleeding or placental abruption, red cell or platelet alloimmunization, insulin-dependent diabetes prior to pregnancy, abnormal anatomy of the uterus such as uterine fibroids, infection with HIV or hepatitis B or C, inability to adopt a lifestyle change of restrictive activity during the remaining portion of the pregnancy, and inability to travel to The Fetal Center or to comply with follow-up care requirements.

Early diagnosis of spina bifida is important. “Because we have a small window for fetal MMC repair, we like to see mothers at 22 or 23 weeks gestation, which allows them time to complete the consultation and go home and consider their decision,” Dr. Tsao says. “We don’t perform fetal repair past 26 weeks. Once a mother decides on fetal surgery, it’s a lifestyle change. If the family is from out of town, they’re in our city for two to three weeks after a five-day hospital stay. If there’s any complication, they may stay in the hospital for the duration of the pregnancy. In addition to the Greater Houston area, our patients come from across Texas and surrounding states. Recently, we’ve had patients from as far away as Hawaii, North Dakota and the East Coast.”

Dr. Tsao also credits the pediatric neurosurgery team for the growth of The Fetal Center’s spina bifida program. Stephen Fletcher, D.O., has been doing postnatal MMC repair at Children’s Memorial Hermann Hospital for the past 31 years and performed his first fetal repair on Faith Hagler in 2011. “Faith nearly gave me a heart attack preparing for and performing that first fetal surgery, and now look at her,” Dr. Fletcher says. “She’s doing great and didn’t need a shunt. She’s the phenomenon we hoped for when we started the fetal spina bifida surgery program.”

Two new faculty members have joined the pediatric neurosurgery team in the last two years. David I. Sandberg, M.D., FAANS, FACS, FAAP, an expert in minimally invasive endoscopic approaches to hydrocephalus, is director of pediatric neurosurgery at Children’s Memorial Hermann Hospital and a professor in the Vivian L. Smith Department of Neurosurgery and the department of Pediatric Surgery at McGovern Medical School at UTHealth. Dr. Sandberg joined Children’s Memorial Hermann Hospital and UTHealth Medical School from Miami Children’s Hospital and the University of Miami Miller School of Medicine in 2014.

Manish Shah, M.D., who is fellowship trained in pediatric neurosurgery with special expertise in pediatric epilepsy, craniofacial surgery and craniocervical spine surgery, was recruited from Washington University in St. Louis after completing his fellowship at St. Louis Children’s Hospital under world-renowned pediatric neurosurgeon Tae Sung Park, M.D.

“Although a diagnosis of spina bifida is very difficult for parents, in the matter of decision-making we have yet to meet a mom who won’t say ‘Do what you need to do for my baby,’” Dr. Tsao says. “We always advise her to think about herself and her future pregnancies. The mother is our first patient and her fetus is the second, but they’re both our patients. We consider them equally important.”

1Adzick NS, Thom EA, Spong CY, Brock JW III, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D’Alton ME and Farmer DL for the MOMS Investigators. A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele. N Engl J Med. 2011 Mar 17;364;993-1004.