Implementation Process and Evolution of a Laparotomy-Assisted 2-Port Fetoscopic Spina Bifida Closure Program

Abstract

<b><i>Introduction:</i></b> Prenatal closure of open spina bifida via open fetal surgery improves neurologic outcomes for infants in selected pregnancies. Fetoscopic techniques that are minimally invasive to the uterus aim to provide equivalent fetal benefits while minimizing maternal morbidities, but the optimal technique is undetermined. We describe the development, evolution, and feasibility of the laparotomy-assisted 2-port fetoscopic technique for prenatal closure of fetal spina bifida in a newly established program. <b><i>Methods:</i></b> We conducted a retrospective cohort study of women consented for laparotomy-assisted fetoscopic closure of isolated fetal spina bifida. Inclusion and exclusion criteria followed the Management of Myelomeningocele Study (MOMS). Team preparation involved observation at the originating center, protocol development, ancillary staff training, and surgical rehearsal using patient-matched models through simulation prior to program implementation. The primary outcome was the ability to complete the repair fetoscopically. Secondary maternal and fetal outcomes to assess performance of the technique were collected prospectively. <b><i>Results:</i></b> Of 57 women screened, 19 (33%) consented for laparotomy-assisted 2-port fetoscopy between February 2017 and December 2019. Fetoscopic closure was completed in 84% (16/19) cases. Over time, the technique was modified from a single- to a multilayer closure. In utero hindbrain herniation improved in 86% (12/14) of undelivered patients at 6 weeks postoperatively. Spontaneous rupture of membranes occurred in 31% (5/16) of fetoscopic cases. For completed cases, median gestational age at birth was 37 (range 27–39.6) weeks and 50% (8/16) of women delivered at term. Vaginal birth was achieved in 56% (9/16) of patients. One newborn had a cerebrospinal fluid leak that required postnatal surgical repair. <b><i>Conclusion:</i></b> Implementation of a laparotomy-assisted 2-port fetoscopic spina bifida closure program through rigorous preparation and multispecialty team training may accelerate the learning curve and demonstrates favorable obstetric and perinatal outcomes.

Exteriorization of the uterus reduces fetoscopic cannula‐induced stress and strain: A finite element model analysis

“…In the era of fetoscopic spina bifida repair, this is a particularly relevant finding. 3,22,23 Although a head-to-head comparison of percutaneous versus exteriorized uterus fetoscopic spina bifida repair has not been made, early data on the occurrence of membrane rupture and membrane separation, suggest these are higher with percutaneous rather than repair via exteriorized uterus, 3,9,[24][25][26] which is consistant with the results of this FEM study. The FEM we made probably oversimplifies, as it compares the forces calculated with abdominal wall versus without abdominal wall cannula insertion, and does not take other mechanical factors such as membrane fixation and closure into account, or other co-variates such as the working medium temperature and humidity, duration of operation, amniotic fluid volume shifts, localization of insertion, to name only a few.…”

Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France

“…An international registry of 300 children reported similar perinatal and neurosurgical outcomes in the first 12 months of life of children undergoing prenatal fetoscopic SBA repair compared to open surgery [20]. A recent publication reporting 16 cases describes similar outcomes to the ones we report hereby [21]. In our study, PROM occurred in 2/5 of cases.…”

Implementation and Assessment of a Laparotomy-Assisted Three-Port Fetoscopic Spina Bifida Repair Program

“…To report on our experience and then based on the IDEAL recommendations confirm the replication of the safety of this hybrid fetoscopic method, as already reported by other centers [22,23]. Other studies report the outcome of small groups of patients (seven cases, one case) but do not describe the implementation of the surgical approach or the establishment of a multidisciplinary team [24,25].…”