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Percutaneous fetoscopic closure of large open spina bifida using a bilaminar skin substitute
Lapa (Pedreira), D. A.; Acacio, G. L.; Gonçalves, R. T. ...
Ultrasound in obstetrics & gynecology,
October 2018, 2018-Oct, 2018-10-00, 20181001, Letnik:
52, Številka:
4
Journal Article
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ABSTRACT
Objective
We have described previously our percutaneous fetoscopic technique for the treatment of open spina bifida (OSB). However, approximately 20–30% of OSB defects are too large to allow ...
primary skin closure. Here we describe a modification of our standard technique using a bilaminar skin substitute to allow closure of large spinal defects. The aim of this study was to report our clinical experience with the use of a bilaminar skin substitute and a percutaneous fetoscopic technique for the prenatal closure of large OSB defects.
Methods
Surgery was performed between 24.0 and 28.9 gestational weeks with the woman under general anesthesia, using an entirely percutaneous fetoscopic approach with partial carbon dioxide insufflation of the uterine cavity, as described previously. If there was enough skin to be sutured in the midline, only a biocellulose patch was placed over the placode (single‐patch group). In cases in which skin approximation was not possible, a bilaminar skin substitute (two layers: one silicone and one dermal matrix) was placed over the biocellulose patch and sutured to the skin edges (two‐patch group). The surgical site was assessed at birth, and long‐term follow‐up was carried out.
Results
Percutaneous fetoscopic OSB repair was attempted in 47 consecutive fetuses, but surgery could not be completed in two. Preterm prelabor rupture of membranes (PPROM) occurred in 36 of the 45 (80%) cases which formed the study group, and the mean gestational age at delivery was 32.8 ± 2.5 weeks. A bilaminar skin substitute was required in 13/45 (29%) cases; in the remaining 32 cases, direct skin‐to‐skin suture was feasible. There were 12 cases of myeloschisis, of which 10 were in the two‐patch group. In all cases, the skin substitute was located at the surgical site at birth. In five of the 13 (38.5%) cases in the two‐patch group, additional postnatal repair was needed. In the remaining cases, the silicone layer detached spontaneously from the dermal matrix (on average, 25 days after birth), and the lesion healed by secondary intention. The mean operating time was 193 (range, 83–450) min; it was significantly longer in cases requiring the bilaminar skin substitute (additional 42 min on average), although the two‐patch group had similar PPROM rate and gestational age at delivery compared with the single‐patch group. Complete reversal of hindbrain herniation occurred in 68% of the 28 single‐patch cases and 33% of the 12 two‐patch cases with this information available (P < 0.05). In four cases there was no reversal; half of these occurred in myeloschisis cases.
Conclusions
Large OSB defects may be treated successfully in utero using a bilaminar skin substitute over a biocellulose patch through an entirely percutaneous approach. Although the operating time is longer, surgical outcome is similar to that in cases closed primarily. Cases with myeloschisis seem to have a worse prognosis than do those with myelomeningocele. PPROM and preterm birth continue to be a challenge. Further experience is needed to assess the risks and benefits of this technique for the management of large OSB defects. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.
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Revisiting MOMS criteria for prenatal repair of spina bifida: upper gestational‐age limit should be raised and assessment of prenatal motor function rather than anatomical level improves prediction of postnatal function
Trigo, L.; Chmait, R. H.; Llanes, A. ...
Ultrasound in obstetrics & gynecology,
January 2024, 2024-01-00, 20240101, Letnik:
63, Številka:
1
Journal Article
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ABSTRACT
ObjectivesTo determine if the lower‐extremity neurological motor function level in fetuses with open spina bifida deteriorates within the 4‐week interval between a first prenatal motor ...
assessment at around 22 weeks of gestation and a second evaluation, prior to ‘late’ prenatal surgery, defined as surgery at 26–28 weeks and, in certain situations, up to 30 weeks, and to assess the association between prenatal presurgical motor‐function level, anatomical level of the lesion and postnatal motor‐function level.
MethodsThis was a two‐center cohort study of 94 singleton fetuses with open spina bifida which underwent percutaneous repair using the skin‐over‐biocellulose for antenatal fetoscopic repair (SAFER) technique between December 2016 and January 2022. All women underwent two prenatal systematic ultrasound evaluations, approximately 4 weeks apart, with the second one being performed less than 1 week before surgery, and one postnatal evaluation via physical examination within 2 months of birth. Motor‐function classification was from spinal level T12 to S1, according to key muscle function. Each leg was analyzed separately; in case of discrepancy between the two legs, the worst motor‐function level was considered for analysis. Motor‐function‐level evaluations were compared with each other and with the anatomical level as observed on ultrasound. Independent predictors of a postnatal reduction in motor‐function level were assessed using a logistic regression model.
ResultsPrenatal motor‐function level was assessed at a median gestational age of 22.5 (interquartile range (IQR), 20.7–24.3) and 26.7 (IQR, 25.4–27.3) weeks, with a median interval of 4.0 (IQR, 2.4–6.0) weeks. The median gestational age at surgery was 27.0 (IQR, 25.9–27.6) weeks and the postnatal examination was at median age of 0.8 (IQR, 0.3–5.4) months. There was no significant difference in motor‐function level between the two prenatal evaluations (P = 0.861). We therefore decided to use the second prenatal evaluation for comparison with postnatal motor function and anatomical level. Overall, prenatal and postnatal motor function evaluations were significantly different from the anatomical level (preoperative assessment, P = 0.0015; postnatal assessment, P = 0.0333). Comparing prenatal with postnatal motor‐function level, we found that 87.2% of babies had similar or improved motor function compared with that prior to prenatal surgery. On logistic regression analysis, lower anatomical level of defect and greater difference between anatomical level and prenatal motor‐function level were identified as independent predictors of postnatal motor function (odds ratio, 0.237 (95% CI, 0.095–0.588) (P = 0.002) and 3.44 (95% CI, 1.738–6.813) (P < 0.001), respectively).
ConclusionsDuring a 4‐week interval between first ultrasound evaluation and late fetal surgical repair of open spina bifida, motor function does not change significantly, suggesting that late repair, ≥ 26 weeks, does not impact negatively on motor‐function outcome. Compared with the anatomical level of the lesion, preoperative neurological motor‐function assessment via ultrasound is more predictive of postnatal motor function, and should be included in preoperative counseling. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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Learning curves of open and endoscopic fetal spina bifida closure: systematic review and meta‐analysis
Joyeux, L.; De Bie, F.; Danzer, E. ...
Ultrasound in obstetrics & gynecology,
June 2020, Letnik:
55, Številka:
6
Journal Article
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ABSTRACTObjectiveThe Management of Myelomeningocele Study (MOMS) trial demonstrated the safety and efficacy of open fetal surgery for spina bifida aperta (SBA). Recently developed alternative ...
techniques may reduce maternal risks without compromising the fetal neuroprotective effects. The aim of this systematic review was to assess the learning curve (LC) of different fetal SBA closure techniques.
MethodsMEDLINE, Web of Science, EMBASE, Scopus and Cochrane databases and the gray literature were searched to identify relevant articles on fetal surgery for SBA, without language restriction, published between January 1980 and October 2018. Identified studies were reviewed systematically and those reporting all consecutive procedures and with postnatal follow‐up ≥ 12 months were selected. Studies were included only if they reported outcome variables necessary to measure the LC, as defined by fetal safety and efficacy. Two authors independently retrieved data, assessed the quality of the studies and categorized observations into blocks of 30 patients. For meta‐analysis, data were pooled using a random‐effects model when heterogeneous. To measure the LC, we used two complementary methods. In the group‐splitting method, competency was defined when the procedure provided results comparable to those in the MOMS trial for 12 outcome variables representing the immediate surgical outcome, short‐term neonatal neuroprotection and long‐term neuroprotection at ≥ 12 months of age. Then, when raw patient data were available, we performed cumulative sum analysis based on a composite binary outcome defining successful surgery. The composite outcome combined four clinically relevant variables for safety (absence of extreme preterm delivery < 30 weeks, absence of fetal death ≤ 7 days after surgery) and efficacy (reversal of hindbrain herniation and absence of any neonatal treatment of dehiscence or cerebrospinal fluid leakage at the closure site).
ResultsOf 6024 search results, 17 (0.3%) studies were included, all of which had low, moderate or unclear risk of bias. Fetal SBA closure was performed using standard hysterotomy (11 studies), mini‐hysterotomy (one study) or fetoscopy by either exteriorized‐uterus single‐layer closure (one study), percutaneous single‐layer closure (three studies) or percutaneous two‐layer closure (one study). Only outcomes for standard hysterotomy could be meta‐analyzed. Overall, outcomes improved significantly with experience. Competency was reached after 35 consecutive cases for standard hysterotomy and was predicted to be achieved after ≥ 57 cases for mini‐hysterotomy and ≥ 56 for percutaneous two‐layer fetoscopy. For percutaneous and exteriorized‐uterus single‐layer fetoscopy, competency was not reached in the 81 and 28 cases available for analysis, respectively, and LC prediction analysis could not be performed.
ConclusionsThe number of cases operated is correlated with the outcome of fetal SBA closure, and the number of operated cases required to reach competency ranges from 35 for standard hysterotomy to ≥ 56–57 for minimally invasive modifications. Our observations provide important information for institutions looking to establish a new fetal center, develop a new fetal surgery technique or train their team, and inform referring clinicians, potential patients and third parties. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
RESUMEN
Curvas de aprendizaje del cierre de la espina bífida fetal mediante cirugía abierta y endoscópica: revisión sistemática y metaanálisis
Objetivo
El ensayo del Estudio sobre la Gestión del Mielomeningocele (MOMS, por sus siglas en inglés) demostró la seguridad y eficacia de la cirugía fetal abierta para la espina bífida aperta (EBA). Las técnicas alternativas recientemente desarrolladas pueden reducir los riesgos de la madre sin comprometer los efectos neuroprotectores del feto. El objetivo de esta revisión sistemática fue evaluar la curva de aprendizaje (CA) de diferentes técnicas de cierre de la EBA fetal.
Métodos
Se realizaron búsquedas en las bases de datos de MEDLINE, Web of Science, EMBASE, Scopus y Cochrane, así como en la literatura gris, para identificar artículos relevantes sobre cirugía fetal para la EBA, sin restricción de idioma, publicados entre enero de 1980 y octubre de 2018. Se examinaron sistemáticamente los estudios identificados y se seleccionaron los que informaban de todos los procedimientos consecutivos y con seguimiento postnatal ≥12 meses. Los estudios se incluyeron sólo si informaban sobre las variables de resultado necesarias para medir la CA, definidas por la seguridad y la eficacia para el feto. Dos autores recuperaron los datos de forma independiente, evaluaron la calidad de los estudios y clasificaron las observaciones en bloques de 30 pacientes. Para el metaanálisis, los datos se agruparon mediante un modelo de efectos aleatorios cuando fueron heterogéneos. Para medir la CA, se usaron dos métodos complementarios. En el método de división de grupos, la competencia se definió cuando el procedimiento proporcionó resultados comparables a los del ensayo MOMS para 12 variables de resultados que representaban el resultado quirúrgico inmediato, la neuroprotección neonatal a corto plazo y la neuroprotección a largo plazo a ≥12 meses de edad. Luego, cuando se dispuso de los datos brutos de los pacientes, se realizó un análisis de suma acumulada basado en un resultado binario compuesto que definió el éxito de la cirugía. El resultado compuesto combinó cuatro variables clínicamente relevantes en cuanto a la seguridad (ausencia de parto pretérmino extremo <30 semanas; ausencia de muerte fetal a ≤7 días después de la cirugía) y eficacia (reducción de la hernia del rombencéfalo y ausencia de cualquier tratamiento neonatal de dehiscencia o derrame de líquido cefalorraquídeo en el lugar del cierre).
Resultados
De los 6024 resultados de la búsqueda, se incluyeron 17 (0,3%) estudios, todos ellos con un riesgo de sesgo bajo, moderado o incierto. El cierre de la EBA fetal se realizó mediante histerotomía estándar (11 estudios), mini histerotomía (un estudio) o fetoscopia, ya fuera mediante el cierre exteriorizado del útero de una sola capa (un estudio), el cierre percutáneo de una sola capa (tres estudios) o el cierre percutáneo de dos capas (un estudio). Sólo se pudieron metaanalizar los resultados de la histerotomía estándar. En general, los resultados mejoraron significativamente con la experiencia. Se alcanzó la competencia después de 35 casos consecutivos para la histerotomía estándar y se predijo que se alcanzaría después de ≥57 casos para la mini histerotomía y ≥56 para la fetoscopia percutánea de dos capas. En el caso de las fetoscopias percutánea y exteriorizada del útero de una sola capa, no se alcanzó la competencia en los 81 y 28 casos disponibles para el análisis, respectivamente, y no se pudo realizar el análisis de predicción de la CA.
Conclusiones
El número de casos operados está correlacionado con el resultado del cierre de la EBA fetal, y el número de casos operados necesarios para alcanzar la competencia estuvo entre 35 para la histerotomía estándar y ≥56–57 para las operaciones con mínima agresividad. Las observaciones realizadas proporcionan información importante para las instituciones que buscan establecer un nuevo centro fetal, desarrollar una nueva técnica de cirugía fetal o entrenar a su equipo, e informar a los médicos que remiten a especialistas a los posibles pacientes y a terceros. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
摘要
开放式和内窥镜下胎儿脊柱裂闭合术学习曲线:系统回顾和荟萃分析
目标
脊髓膜膨出研究管理(MOMS)试验证明了开放式胎儿手术治疗脊柱裂 (SBA) 的安全性有效性。最近开发的替代技术可以在不损害胎儿神经保护作用的情况下降低孕产妇风险。此次系统回顾旨在评估不同胎儿SBA闭合技术的学习曲线(LC)。
方法
检索了MEDLINE、Web of Science、EMBASE、Scopus和Cochrane数据库以及相关的灰色文献，查找1980年1月至2018年10月之间以任何语言出版的SBA胎儿手术相关文章。系统回顾了甄别出来的几个研究项目，选择了几个报告全部连续程序且术后随访期≥12个月的研究项目。只有当研究报告了根据胎儿安全性有效性定义的测量LC所需的结果变量时，才纳入研究。两位作者独立检索了数据，评估了研究质量，对30例患者进行分组观察。荟萃分析过程中，用一个随机效应模型进行
异构数据汇总。为测量LC，我们应用了两种非主流方法。在分组法中，当程序提供的结果与MOMS试验所得结果类似时，定义了12个结果变量的能力。这些变量表示≥12个月时的即刻手术结果、短期新生儿神经保护和长期神经保护。然后在可以获取病人原始数据时，我们根据决定手术成功与否的复合二元结果进行累积总和分析。综合结果结合了四个临床相关的安全性变量(无30周内极端早产，术后7天内无胎儿死亡)和疗效变量(后脑疝逆转，闭合处无任何新生儿裂开或脑脊液漏治疗)。
结果
在6024个检索结果中，纳入了17(0.3%)项研究。所有这些研究的偏倚风险较低，中度或不明。通过标准的子宫切开术(11项研究)、微型子宫切开术(1项研究)或子宫镜检查，通过室外子宫单层闭合(1项研究)、经皮单层闭合(3项研究)或经皮两层闭合(1项研究)进行胎儿SBA闭合。标准子宫切开术的结果才可以进行荟萃分析。总体而言，随着经验的积累，结果显著改善。连续35例标准子宫切除术后达到合格标准。
预计在微型子宫切开术≥57例，经皮两层胎儿镜检查≥56例后达到相关能力标准。经皮和体外子宫单层宫腔镜检查，分别有可供分析的81例和28例没有达到相关能力标准，无法进行LC预测分析。
结论
手术病例数与胎儿SBA闭合结果相关，
要求达到规定能力的手术病例数量，从标准子宫切开术的35例到微创改造术≥56‐57例不等。我们的观察结果为那些希望建立新的胎儿中心、开发新的胎儿手术技术或培训团队成员，以及临床转诊医生、潜在患者和第三方提供了重要信息。版权 © 2019 ISUOG。由威利父子公司(John Wiley & Sons Ltd)出版。
This article's has been translated into Spanish and Chinese. Follow the links from the to view the translations.
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Biocellulose patch technique for fetoscopic repair of open spina bifida in twin pregnancy
Lapa, D. A.; Acácio, G. L.; Trigo, L. ...
Ultrasound in obstetrics & gynecology,
October 2023, 2023-10-00, 20231001, Letnik:
62, Številka:
4
Journal Article
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ABSTRACT
Objectives
Twin pregnancy is currently an exclusion criterion for prenatal repair of open spina bifida (OSB). The main objective of this study was to report on our experience of treating ...
twin pregnancies with OSB using the skin‐over‐biocellulose for antenatal fetoscopic repair (SAFER) technique. We also discuss reconsideration of the current exclusion criteria for fetal OSB repair.
Methods
Eight fetuses with OSB from seven twin pregnancies underwent successful prenatal repair. Six pregnancies were dichorionic diamniotic with only one twin affected, and one was monochorionic diamniotic with both twins affected. Percutaneous fetoscopy was performed under CO2 insufflation of the sac of the affected twin. Neurosurgical repair was performed using a biocellulose patch to protect the placode, with the skin sutured to hold the patch in place, with or without a myofascial flap. Neurodevelopment was assessed using the pediatric evaluation of disability inventory scale in babies older than 6 months of adjusted age, whereas the Alberta scale was used for babies younger than 6 months of adjusted age.
Results
All 14 fetuses were liveborn and none required additional repair. Gestational age at surgery ranged from 27.3 to 31.1 weeks, and gestational age at birth ranged from 31.6 to 36.0 weeks. Four out of eight affected twins developed sepsis, but had a good recovery. No sequela of prematurity was found in any of the unaffected twins. Short‐term neurodevelopment was normal in all evaluated unaffected twins (5/5) and in all but one affected twins (7/8). In the affected group, only one baby required ventriculoperitoneal shunt placement.
Conclusions
Prematurity is frequent after fetal surgery, and the risk is increased in twin pregnancy. Nevertheless, prenatal surgery using the SAFER technique is feasible, with low risk to both twins and their mother when performed by a highly experienced team. Long‐term cognitive assessment of the unaffected twin is needed. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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Prevalence of supratentorial anomalies assessed by magnetic resonance imaging in fetuses with open spina bifida
Trigo, L.; Eixarch, E.; Bottura, I. ...
Ultrasound in obstetrics & gynecology,
June 2022, 2022-Jun, 2022-06-00, 20220601, Letnik:
59, Številka:
6
Journal Article
Recenzirano
Odprti dostop
ABSTRACT
Objectives
To determine the prevalence of brain anomalies at the time of preoperative magnetic resonance imaging (MRI) assessment in fetuses eligible for prenatal open spina bifida (OSB) ...
repair, and to explore the relationship between brain abnormalities and features of the spinal defect.
Methods
This was a retrospective cross‐sectional study, conducted in three fetal medicine centers, of fetuses eligible for OSB fetal surgery repair between January 2009 and December 2019. MRI images obtained as part of the presurgical assessment were re‐evaluated by two independent observers, blinded to perinatal results, to assess: (1) the type and area of the defect and its anatomical level; (2) the presence of any structural central nervous system (CNS) anomaly and abnormal ventricular wall; and (3) fetal head and brain biometry. Binary regression analyses were performed and data were adjusted for type of defect, upper level of the lesion (ULL), gestational age (GA) at MRI and fetal medicine center. Multiple logistic regression analysis was performed in order to identify lesion characteristics and brain anomalies associated with a higher risk of presence of abnormal corpus callosum (CC) and/or heterotopia.
Results
Of 115 fetuses included, 91 had myelomeningocele and 24 had myeloschisis. Anatomical level of the lesion was thoracic in seven fetuses, L1–L2 in 13, L3–L5 in 68 and sacral in 27. Median GA at MRI was 24.7 (interquartile range, 23.0–25.7) weeks. Overall, 52.7% of cases had at least one additional brain anomaly. Specifically, abnormal CC was observed in 50.4% of cases and abnormality of the ventricular wall in 19.1%, of which 4.3% had nodular heterotopia. Factors associated independently with higher risk of abnormal CC and/or heterotopia were non‐sacral ULL (odds ratio (OR), 0.51 (95% CI, 0.26–0.97); P = 0.043), larger ventricular width (per mm) (OR, 1.23 (95% CI, 1.07–1.43); P = 0.005) and presence of abnormal cavum septi pellucidi (OR, 3.76 (95% CI, 1.13–12.48); P = 0.031).
Conclusions
Half of the fetuses assessed for OSB repair had an abnormal CC and/or an abnormal ventricular wall prior to prenatal repair. The likelihood of brain abnormalities was increased in cases with a non‐sacral lesion and wider lateral ventricles. These findings highlight the importance of a detailed preoperative CNS evaluation of fetuses with OSB. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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Percutaneous fetoscopic spina bifida repair: effect on ambulation and need for postnatal cerebrospinal fluid diversion and bladder catheterization
Lapa, D. A.; Chmait, R. H.; Gielchinsky, Y. ...
Ultrasound in obstetrics & gynecology,
October 2021, Letnik:
58, Številka:
4
Journal Article
Recenzirano
Odprti dostop
Objective
A trial comparing prenatal with postnatal open spina bifida (OSB) repair established that prenatal surgery was associated with better postnatal outcome. However, in the trial, fetal surgery ...
was carried out through hysterotomy. Minimally invasive approaches are being developed to mitigate the risks of open maternal–fetal surgery. The objective of this study was to investigate the impact of a novel neurosurgical technique for percutaneous fetoscopic repair of fetal OSB, the skin‐over‐biocellulose for antenatal fetoscopic repair (SAFER) technique, on long‐term postnatal outcome.
Methods
This study examined descriptive data for all patients undergoing fetoscopic OSB repair who had available 12‐ and 30‐month follow‐up data for assessment of need for cerebrospinal fluid (CSF) diversion and need for bladder catheterization and ambulation, respectively, from eight centers that perform prenatal OSB repair via percutaneous fetoscopy using a biocellulose patch between the neural placode and skin/myofascial flap, without suture of the dura mater (SAFER technique). Univariate and multivariate logistic regression analyses were used to examine the effect of different factors on need for CSF diversion at 12 months and ambulation and need for bladder catheterization at 30 months. Potential cofactors included gestational age at fetal surgery and delivery, preoperative ultrasound findings of anatomical level of the lesion, cerebral lateral ventricular diameter, lesion type and presence of bilateral talipes, as well as postnatal findings of CSF leakage at birth, motor level, presence of bilateral talipes and reversal of hindbrain herniation.
Results
A total of 170 consecutive patients with fetal OSB were treated prenatally using the SAFER technique. Among these, 103 babies had follow‐up at 12 months of age and 59 had follow‐up at 30 months of age. At 12 months of age, 53.4% (55/103) of babies did not require ventriculoperitoneal shunt or third ventriculostomy. At 30 months of age, 54.2% (32/59) of children were ambulating independently and 61.0% (36/59) did not require chronic intermittent catheterization of the bladder. Multivariate logistic regression analysis demonstrated that significant prediction of need for CSF diversion was provided by lateral ventricular size and type of lesion (myeloschisis). Significant predictors of ambulatory status were prenatal bilateral talipes and anatomical and functional motor levels of the lesion. There were no significant predictors of need for bladder catheterization.
Conclusion
Children who underwent prenatal OSB repair via the percutaneous fetoscopic SAFER technique achieved long‐term neurological outcomes similar to those reported in the literature after hysterotomy‐assisted OSB repair. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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Proceedings of the First Annual Meeting of the International Fetoscopic Myelomeningocele Repair Consortium
Cortes, M. Sanz; Lapa, D. A.; Acacio, G. L. ...
Ultrasound in obstetrics & gynecology,
June 2019, 2019-Jun, 2019-06-00, 20190601, Letnik:
53, Številka:
6
Journal Article, Conference Proceeding
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