Planning for Fetal MMC Repairs After MOMS
Driven primarily by concerns about how the MOMS results would translate into routine practice, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the agency that sponsored MOMS, organized an expert panel with representatives from 11 U.S. professional and patient groups to come up with recommendations on which centers should perform fetal MMC repairs and the clinical issues that the teams at each center should address. Participants came from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Institute of Ultrasound in Medicine, the Society for Maternal-Fetal Medicine, the Spina Bifida Association, and six other groups.
Formal publication of these recommendations had not occurred yet but was expected before the end of 2012. The article by Dr. Hirose and his coauthors provided a preview of some of the panel’s key recommendations, including a minimum annual volume of at least five MMC repairs as well as at least 30 fetuses with MMC evaluated for surgery; strict adherence to the MOMS protocol until improvements are proven better; comprehensive counseling that includes a reflective period for families of at least 24 hours; and participation in a national registry.
That article was removed from Clinics in Perinatology in early October at the request of the publication’s consulting editor.
According to a note on the publication’s website, "It was learned after publication that the guidelines for fetal repair of myelomeningocele that were presented as being published by the NIH were neither supplied by the NIH nor published by them. To prevent this information from being erroneously cited, the article has been removed."
At press time, the article was still accessible via the National Library of Medicine’s PubMed.gov.*
Dr. Julie S. Moldenhauer
Having a U.S. agency sponsor a major trial and then organize an expert panel to deliberate on how to best implement its results is unusual, but fetal MMC repair is unusual surgery, said Dr. Julie S. Moldenhauer, a maternal-fetal medicine physician and a representative to the NICHD panel appointed by the North American Fetal Therapy Network. "It is very high-risk surgery that is elective, it is an open procedure, not fetoscopic, and it depends on a very multidisciplinary team," she said in an interview. These are a combination of features that makes it unique, said Dr. Moldenhauer, who is an attending physician at the Center for Fetal Diagnosis and Treatment and the medical director of the special delivery unit, both at CHOP.
One other element of MOMS also adds to its special character: The trial lasted nearly 8 years and randomized just 183 patients, and during that time fetal MMC repair for U.S. patients was limited to three centers – CHOP, UCSF, and Vanderbilt University in Nashville, Tenn. Then, when the researchers reported their positive results last year, NICHD officials and others in this field faced the dilemma of how to make the surgery available elsewhere while ensuring that the results would be as good as in MOMS. "What the NICHD fears is that if MMC repair is offered uncontrolled, the outcomes won’t be what they were in MOMS," said Dr. Johnson.
Making Fetal MMC Repair Better
MMC repair is not easy and still has limitations, most notably the risk for extreme prematurity. "The risk of prematurity is the big obstacle to making it more mainstream," said Dr. Noel B. Tulipan, professor and director of pediatric neurosurgery at Vanderbilt University Medical Center.
Most fetuses treated in MOMS were delivered at 34 weeks’ gestation or later, and "these days, we almost don’t consider 34 weeks premature, because most of these babies do extremely well," Dr. Tulipan said in an interview. "But in MOMS, there was a 13% rate of extreme prematurity" with the infants delivered at less than 30 weeks.