Fetoscopic myelomeningocoele closure: Is the scientific evidence enough to challenge the gold standard for prenatal surgery?

Since the completion of the Management of Myelomeningocoele Study, maternal-fetal surgery for spina bifida has become a valid option for expecting parents. More recently, multiple groups are exploring a minimally invasive approach and recent outcomes have addressed many of the initial concerns with this approach. Based on a previously published framework, we attempt to delineate the developmental stage of the surgical techniques. Furthermore, we discuss the barriers of performing randomized controlled trials comparing two surgical interventions and suggest that data collection through registries is an alternative method to gather high-grade evidence.

How we measure and determine competence: lessons from fetal myelomeningocele repair.

Linked Comment: Ultrasound Obstet Gynecol 2020; 55:730-739.

Open fetal surgery for myelomeningocele - is there the learning curve at reduction mother and fetal morbidity?

OBJECTIVES: We aimed to show how increased experience of a surgery team in fMMC repair influences maternal and fetal/neonatal outcomes. MATERIAL AND METHODS: We compare perinatal results of fMMC repair in our Fetal Surgery Center (FSC) in cohort groups for the early period (2005-2011 year; previous - PFSC, n = 46) and current period (2012-2015 year; current - CFSC, n = 74) to results of the randomized Management of Myelomeningocele Study (MOMS, 78 patients). RESULTS: The maternal morbidity due to fMMC repair was low and there was no difference comparing CFSC to PFSC and MOMS. The frequency of iatrogenic preterm labor (iPTL) ≤ 30 weeks of gestation decreased from 34.1% in PFSC to 23.9% in CFSC. Iatrogenic preterm premature rupture of membranes (iPPROM) was a common complication after fMMC repair in all cohorts. The total reduction rate of hindbrain hernation (HH) was similar in CFSC - 90.3% and PFSC - 82.1%. CONCLUSIONS: The increasing experience of our surgery team in fMMC repair majorly decreased the risk of iPTL.

An Overview of Contemporary Outcomes in Fetal Cardiac Intervention: A Case for High-Volume Superspecialization?

Fetal cardiac interventions (FCI) offer the opportunity to rescue a fetus at risk of intrauterine death, or more ambitiously to alter disease progression. Most of these fetuses require multiple additional postnatal procedures, and it is difficult to disentangle the effect of the fetal procedure from that of the postnatal management sequence. The true clinical impact of FCI may only be discernible in large-volume institutions that can commit to a standardized postnatal approach and have sufficient case volume to overcome their FCI learning curve.

A Comparison of Spinal Anesthesia Versus Monitored Anesthesia Care With Local Anesthesia in Minimally Invasive Fetal Surgery.

BACKGROUND: Minimally invasive fetal surgery is commonly performed to treat twin-to-twin transfusion syndrome with selective fetoscopic laser photocoagulation and twin-reversed arterial perfusion sequence using radiofrequency ablation. Although an increasing number of centers worldwide are performing these procedures, anesthetic management varies. Both neuraxial anesthesia and monitored anesthesia care with local anesthesia are used at different institutions. We sought to determine the efficacy and outcomes of these 2 anesthetic techniques for fetal procedures at our institution. METHODS: All patients undergoing minimally invasive fetal surgery for twin-to-twin transfusion syndrome or twin-reversed arterial perfusion sequence over a 6-year time period (2011-2016) were reviewed. Patients receiving monitored anesthesia care with local anesthesia were compared with those receiving spinal anesthesia in both selective fetoscopic laser photocoagulation and radiofrequency ablation fetal procedures. The primary outcome examined between the monitored anesthesia care and spinal anesthesia groups was the difference in conversion to general anesthesia using a noninferiority design with a noninferiority margin of 5%. Secondary outcome measures included use of vasopressors, procedure times, intraoperative fluids administered, maternal complications, and unexpected fetal demise within 24 hours of surgery. RESULTS: The difference in failure rate between monitored anesthesia care and spinal was -0.5% (95% CI, -4.8% to 3.7%). Patients receiving monitored anesthesia care plus local anesthesia were significantly less likely to need vasopressors, had a shorter presurgical operating room time, and received less fluid (P < .001). Operative time did not differ significantly. CONCLUSIONS: Monitored anesthesia care plus local anesthesia is a reliable and safe anesthetic choice for minimally invasive fetal surgery. Furthermore, it decreases maternal hemodynamic instability and reduces preincision operating room time.

Error traps in fetal surgery.

The growth of the field of fetal surgery over the last two decades driven by new indications and data from prospective randomized trials supporting prenatal intervention has resulted in techniques protocols and methodologies that have gained confidence by insuring good outcomes. Error traps are methods or techniques that usually work well in most of the cases, but which are apt to fail under certain specific circumstances. The very confidence the surgeon develops in these techniques or methodologies makes them a trap for the unwary surgeon. The purpose of this article is to discuss common error traps in fetal interventions, including ultrasound guided procedures, fetoscopic surgery, open fetal surgery and EXIT procedures. Awareness of these error traps and approaches to avoid them may enhance fetal surgical outcomes and reduce complications rates.

Establishing Prenatal Surgery for Myelomeningocele in Asia: The Singapore Consensus.

OBJECTIVES: The Management of Myelomeningocele Study (MOMS Trial) has inspired many fetal therapy centers (FTCs) to offer open fetal surgery for myelomeningocele (MMC). This is an initial effort to create a candidate model that can be applicable to many parts of Asia. MATERIAL AND METHODS: A limited selection of specialists from 4 established FTCs in Thailand, Hong Kong, India, and Singapore met for a round table discussion. Experts from Children's Hospital of Philadelphia (CHOP) involved in the Trial moderated the session. The practice suggestions in this statement were from a targeted literature review and expert opinion. RESULTS: A high prevalence of MMC in Asia supports an effort to adopt the procedure, but only in established FTCs with good maternal and neonatal ancillary supports. The falling incidence of MMCs may affect case volume and maintenance of skill. A regional approach was recommended. Fetal benefits have to be weighed against maternal risks, with a consideration of recent outcome data from the endoscopic approach. Responsible FTCs need standardized diagnosis and management, with their long-term outcome data available for an audit. CONCLUSIONS: It is envisaged that the information presented by this multidisciplinary team would be useful for FTCs in Asia or elsewhere that plan to establish more advanced fetal care in the future.

Fetoscopic laser therapy for twin-twin transfusion syndrome: beyond current gestational age limits.

Both "early" (< 16 weeks' gestation) and "late" (> 26 weeks' gestation) presentations of twin-twin transfusion syndrome (TTTS) are rare and challenging complications of monochorionic/diamniotic twin pregnancies. Growing evidence suggests that fetoscopic laser therapy for both "early" and "late" TTTS is feasible, safe, and yields similar outcomes to cases treated between 16 and 26 weeks' gestation. We suggest reevaluation of conventional gestational age guidelines for laser therapy for TTTS.

Tratamiento por fetoscopia de la transfusión feto-fetal: resultados en 500 casos consecutivos / Fetoscopic laser surgery for twin-to-twin transfusion syndrome: Outcome of 500 consecutive cases

Objetivos. Evaluar los resultados perinatales de 500 casos consecutivos de transfusión feto-fetal (TFF) tratados en nuestro Hospital mediante fetoscopia láser. Material y métodos. Estudio prospectivo con 500 casos de TFF grave tratadas con fetoscopia láser como primera opción. Evaluamos la supervivencia, evolución perinatal, complicaciones obstétricas y tasa de lesión neurológica a los 6 meses de vida. Resultados. La edad gestacional media al tratamiento fue 19,4 semanas (rango 15,0-31,4). La placenta fue anterior en el 48% (n=240). La tasa de conversión a oclusión de cordón fue del 1,2% (6/500). La supervivencia neonatal global fue del 74,8% (748/1.000), con un superviviente al menos en el 91,6% (458/500). La duración media del procedimiento fue de 29,4min (9-64). No se observó ningún caso de corioamnionitis o desprendimiento de placenta asociado al procedimiento. Se observó persistencia de TFF en 2 casos (0,4%) y TAPS en 8 (1,6%). Se produjo rotura prematura de membranas (RPM) antes de las 32 semanas en 32 casos (6,4%). La edad gestacional media al parto fue de 33,6 semanas (26,4-38,5), con un 92% después de las 28 semanas. El peso medio en receptores fue 1.920 g (rango 680-3.660) y en donantes 1.615 g (rango 440-2.530). La tasa de anomalías severas del neurodesarrollo fue del 6,4%. Conclusión. En una de las mayores series consecutivas de TFF en el mismo centro, los resultados se sitúan en rango alto de las series publicadas. La coagulación fetoscópica láser de las anastomosis vasculares es segura para la madre y presenta resultados consistentes en centros con experiencia(AU)

Objective. To evaluate the perinatal outcome in the 500 consecutive cases of severe twin-twin transfusion syndrome (TTTS) treated in a single centre with fetoscopic laser coagulation. Material and methods. A prospective study including 500 cases of severe TTS treated with laser therapy as a first option. Main outcome measures were survival, perinatal outcome, obstetrical complications and rate of neurological damage at 6-12 months of life. Results. Mean gestational age at therapy was 19.4 weeks (range 15.0-31.4). The placenta was anterior in 48% (n=240) of the cases. The rate of conversion to cord occlusion was 1.2% (6/500). Overall neonatal survival was 74.8% (748/1,000), with at least one survivor in 91.6% (458/500). Mean duration of surgery was 29.4min (range 9-64). There were no cases of intra- or post-operative abruptio placenta or chorioamnionitis. TTTS persisted in 2 cases (0.4%) and TAPS occurred in 8 (1.6%). Premature rupture of membranes (PROM) at <32 weeks occurred in 32 cases (6.4%). Mean gestational age at delivery was 33.6 weeks (26.4-38.5), with 92% beyond 28 weeks. Mean birth-weight was 1,920 g (range 680-3,660) in recipients and 1,615 g (range 440-2,530) in donors. Severe neurological damage was observed in 6.4%. Conclusions. In this large consecutive series of TTTS treated by fetoscopy in the same centre, results lie in the high range of those previously reported. Fetoscopic laser coagulation of the placental anastomosis is a safe therapy and offers consistent results in centres with experience(AU)

Fetal surgery is a clinical reality.

An increasing number of fetal anomalies are being diagnosed prior to birth, some of them amenable to fetal surgical intervention. We discuss the current clinical status and recent advances in endoscopic and open surgical interventions. In Europe, fetoscopic interventions are widely embraced, whereas the uptake of open fetal surgery is much less. The indications for each access modality are different, hence they cannot substitute each other. Although the stage of technical experimentation is over, most interventions remain investigational. Today there is level I evidence that fetoscopic laser surgery for twin-to-twin transfusion syndrome is the preferred therapy, but this operation actually takes place on the placenta. In terms of surgery on the fetus, an increasingly frequent indication is severe congenital diaphragmatic hernia as well as myelomeningocele. Overall maternal safety is high, but rupture of the membranes and preterm delivery remain a problem. The increasing application of fetal surgery and its mediagenicity has triggered the interest to embark on fetal surgical therapy, although the complexity as well as the overall rare indications are a limitation to sufficient experience on an individual basis. We plead for increased exchange between high volume units and collaborative studies; there may also be a case for self-regulation. Inclusion of patients into trials whenever possible should be encouraged rather than building up casuistic experience.

Analysis of the stepwise clinical introduction of experimental percutaneous fetoscopic surgical techniques for upcoming minimally invasive fetal cardiac interventions.

BACKGROUND: This study assessed the feasibility and safety of surgical techniques developed in sheep for fetoscopic fetal cardiac interventions during three selected less complex procedures for noncardiac fetal conditions in humans. On the basis of this assessment, the implications for the clinical introduction of minimally invasive fetoscopic fetal cardiac interventions in the near future are discussed. METHODS: The authors performed 16 percutaneous fetoscopic procedures in 13 human fetuses at between 19 + 2 and 34 + 6 weeks of gestation, then analyzed various parameters of surgical relevance for minimally invasive fetoscopic fetal cardiac interventions. Each of the three noncardiac malformations posed typical surgical challenges that will be critical for the technical success of minimally invasive fetoscopic cardiac interventions. RESULTS: Overall technical success was achieved in 14 of the 16 procedures. Percutaneous fetoscopic surgery did not result in any untoward effects and was well tolerated by all but two pregnant women: one with bleeding complication and one with mild postoperative pulmonary edema. No fetal complications or injuries from the various percutaneous fetoscopic surgical approaches were observed. CONCLUSIONS: The author's experience with surgical techniques introduced for percutaneous fetoscopic fetal cardiac intervention in selected noncardiac fetal lesions has led them to believe the time has come for the clinical introduction of fetoscopic fetal cardiac interventions. After an adequate learning curve supervised by committees of human research, the overall outcome and quality of postnatal life for the unborn patients ultimately will determine whether fetoscopic or other fetal cardiac interventions will be better therapeutic alternatives to currently available postnatal procedures.

Drainage y punción fetal. Estado actual / Drainage and fetal puncture. Current status

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[Diagnosis of vasa praevia by amnioscopy. Value of induced labor. A case report]. / Diagnostic d'un vaisseau praevia par l'amnioscopie. Intérêt de l'accouchement programmé. A propos d'un cas.

The authors report a case of vessel praevia diagnosed at routine examination prior to the induction of labour. They emphasize the dramatic risk of very serious hemorrhage occurring after rupture of the membranes and the value of prophylactic caesarean section once the diagnosis is known. Routine use of amnioscopy in determining whether the timing of labour is appropriate and the increased alertness which this imposes to the obstetrician appear to be the only method for the prevention of these dramatic complications. In the future, colour Doppler will offer an earlier diagnostic method.

[Amnioscopy as a routine method--results of 9 years experience]. / Die Amnioskopie als Routinemethode--Bilanz 9jähriger Erfahrungen

In the 9-years period (1967 to 1975) we are using the amnioscopy increasing generously. Nevertheless the percentage on pathological findings of the amniotic fluid altogether and in the seperate groups of indication is nearly has been always the same. It is'nt exact correlation between the severity of the symptoms of risk and the occurrence of the pathological findings in the amniotic fluid. The grand reliability of the amnioscopy also follows from the material of ourselves: The perinatal mortality in the group of supervised pregnant women by amnioscopy is clear less than in the group of nonsupervised. That comes true to all three parts of perinatal mortality. Our own experiences speak in generous use of the optical evaluation of amniotic fuuid by was of screening.