Feasibility of fetoscopic spina bifida repair using a human umbilical cord meningeal patch: a nonrandomized clinical...

Open in-utero spina bifida repair surgery yields suboptimal long-term motor outcomes in affected children and high maternal risks due to hysterotomy. Minimally invasive fetoscopic repair could reduce maternal risks associated with hysterotomy. Using a cryopreserved human umbilical cord graft as a meningeal patch for neurosurgical closure of the neural tube defect could improve motor function by reducing spinal cord tethering after surgery.

This study assesses the surgical feasibility of fetoscopic spina bifida repair using human umbilical cord as a meningeal patch and reports perinatal and 12-month outcomes. Long-term motor outcomes are being evaluated in an ongoing efficacy trial.

The Fetoscopic NEOX Cord 1K Spina Bifida Repair nonrandomized clinical trial (NCT04243889) evaluated the feasibility of fetoscopic spina bifida repair using NEOX Cord 1K human umbilical cord graft as a meningeal patch under a Food and Drug Administration (FDA) Investigational Device Exemption at a quaternary center between September 2020 and May 2023. Pregnant patients with spina bifida in the fetus who were eligible for open in-utero spina bifida repair were offered participation. Fetoscopic spina bifida repair surgery was performed using a minimally invasive approach via laparotomy and three-port uterine entry. During fetoscopic repair, the human umbilical cord patch was sutured circumferentially over the neural placode, followed by primary skin closure or closure with a human umbilical cord patch. The primary outcome was successful surgical closure, as determined by 3 independent pediatric neurosurgeons who reviewed intraoperative images. Perinatal and 12-month outcomes are reported, including gestational age at delivery, preterm premature rupture of membranes, mode of delivery, and cerebrospinal fluid diversion at birth and by 12 months. These outcomes are compared with a historical cohort who underwent open repair at the same center from 2011 to 2020.

Of 53 eligible patients, 50 consented, and 49 underwent fetoscopic repair. The historical open-repair cohort consisted of 110 cases. Surgical closure was successful in all 49 fetoscopic cases. Vaginal delivery rates were higher in the fetoscopic repair than in the open repair group (53% vs 1%, P<0.001). There were no fetal or neonatal deaths after fetoscopic repair but 3 (2.7%) neonatal deaths after open repair. Gestational age at delivery, rates of preterm premature rupture of membranes and cerebrospinal fluid diversion, and other perinatal and 12-month outcomes were comparable between groups.

Fetoscopic spina bifida repair using human umbilical cord as a meningeal patch is feasible and, by avoiding hysterotomy, may permit vaginal delivery and reduce maternal morbidity. Perinatal and 12-month outcomes were comparable to a historical open-repair cohort; however, differences in both surgical approach and neurosurgical technique preclude attributing benefit to any single component.