Texas Children’s Fetal Center performs milestone fetoscopic procedure on NTD patient

September 9, 2014

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Physicians at the Fetal Center completed their first fetoscopic procedure to repair spina bifida in-utero – an innovative approach that was developed by Dr. Michael Belfort, obstetrician and gynecologist-in-chief at Texas Children’s Pavilion for Women and Dr. William Whitehead, pediatric neurosurgeon at Texas Children’s.

“Our hope is that these types of innovations will lead us to a new era of fetal medicine and surgery,” Belfort said.

Myelomeningocele, or open neural tube defect (NTD), is a form of spina bifida and occurs in 3.4 out of every 10,000 live births in the U.S. and is the most common permanently disabling birth defect for which there is no known cure. Myelomeningocele is a developmental defect in which the spine is improperly formed and the spinal cord is open to, and fused with, the skin. It is usually associated with hydrocephalus, or the buildup of cerebrospinal fluid in the brain, which requires surgical treatment to drain the fluid via an implanted device called a shunt. Originally, closure of the defect occurred after the birth of the baby, which was associated with an 80-90 percent chance that a shunt would be required for life.

But after a breakthrough NICHD-funded study entitled the Management of Myelomeningocele Study (MOMS) demonstrated a significant decrease in the risk of hydrocephalus for select patients undergoing fetal closure of the spine, as well as possible improvement in lower extremity function, compared to patients who underwent standard closure after birth, the Fetal Center adopted this as a treatment option and began performing open fetal surgery to treat spina bifida. To date, we still have one of only a handful of centers in the country that is able to perform this complex in-utero repair. Texas Children’s Fetal Center has completed 23 of these surgeries since 2011, with excellent results.

This technique, the standard of care in the US, involves a uterine incision and can cause maternal complications. With this in mind, the team at the Fetal Center wanted to focus on reducing the risks to the mother and countering the risks of preterm delivery. Working in conjunction with Dr. Jose Luis Peiro and Dr. Elena Carreras of Vall D’Hebron Hospital in Barcelona, Spain, they developed a fetoscopic approach to the repair.

The surgery was over three years in the making and features an in-utero, single layer, sutured repair through only two, four millimeter incisions in the uterus (rather than the 5-6cm opening that is required for an open procedure). In order to practice and perfect performing the closure using a minimally invasive fetoscopic approach, the team built a simulator using a child’s kickball that replicated the mother’s uterus. Inside the kickball, a doll acted as the fetus including a spina bifida defect on the doll’s back. Drs. Belfort and Whitehead practiced closing the defect using a team approach in which they both carry out specific parts of the surgery in a coordinated fashion. The two surgeons performed more than 30 simulated procedures including two full simulations, gowned and gloved, under actual OR conditions with a full support team.

“We have a magnificent team of specialists from a number of departments working together in the best interests of our fetal and neonatal patients. I am incredibly proud to be a member of this outstanding team and to be able to play a role in this mission,” Belfort said.

With a multi-disciplinary structured program in place, clinical planning and training and full Institutional Review Board approval for this experimental procedure, the team performed the first in-utero spin bifida closure on their first patient on July 30, 2014. The procedure went as planned and so far mom and baby are doing well. Doctors are optimistic and are waiting to access the outcome of the repair once the baby has been delivered.

“It is important to note that this mother has not been exposed to a significant uterine incision and we are much less concerned about her risk of a ruptured uterus during this pregnancy than we are after an open repair,” Belfort said. “We look forward to an uneventful delivery and a healthy baby.”

In addition to an expert operating room team and nursing staff, a multidisciplinary team of specialists led this first surgery at Texas Children’s Fetal Center, including Dr. Michael Belfort, Dr. William Whitehead, Dr. Alireza Shamshirsaz, Dr. Oluyinka O. Olutoye, Dr. Olutoyin Olutoye, Dr. David Mann, and Dr. Rodrigo Ruano.

“With the ever-advancing technology and imaging capabilities and dedicated surgeons, I am excited to see what the future holds when it comes to repairing anomalies fetoscopically,” Belfort said. “I am so impressed by what can be achieved with our exceptional team.”