Safety and efficacy of fetal surgery techniques to close a spina bifida defect in the fetal lamb model: A systematic review.

ABSTRACT

OBJECTIVE: To determine the safety and efficacy of different neurosurgical techniques for closure of spina bifida (SB) in the fetal lamb model. METHOD: Systematic review of studies reporting on fetal lambs undergoing induction and closure of SB compared with non-operated normal lambs (negative controls) and/or lambs not undergoing closure of the defect (positive controls). Primary outcomes were (1) survival at birth (safety) and/or (2) presence of Somatosensory Evoked Potentials on hind limbs and/or improvement in quantitative histological spinal cord findings and/or reversal of hindbrain herniation (efficacy). RESULTS: Out of 1311, 36 full-text articles were eligible. Nineteen were included for quality assessment. Due to high bias, only 2 adequately powered studies were included in the final analysis. An open approach using a 2-layer closure (muscle flap or acellular-dermal-matrix patch plus skin) was the only safe (patch + skin) and effective (both techniques) technique for prenatal closure in this animal model. No comparable level of evidence was identified for other techniques. CONCLUSION: The experimental literature on prenatal SB closure underscores the lack of standardization. At present, there is animal experimental evidence that a 2-layer closure by hysterotomy is safe and effective. This technique is currently clinically used in a subset of patients. As new clinical techniques are introduced, it would seem logic to preclinically validate them against this experimental standard.