Learning curves of open and endoscopic fetal spina bifida closure: systematic review and meta-analysis.

Autor: Joyeux L; MyFetUZ Fetal Research Center, Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium.; Center for Surgical Technologies, Faculty of Medicine, KU Leuven, Leuven, Belgium.; Department of Obstetrics and Gynecology, Division Women and Child, Fetal Medicine Unit, University Hospitals Leuven, Leuven, Belgium., De Bie F; MyFetUZ Fetal Research Center, Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium.; Center for Surgical Technologies, Faculty of Medicine, KU Leuven, Leuven, Belgium.; Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.; The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Danzer E; Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.; The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Russo FM; MyFetUZ Fetal Research Center, Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium.; Center for Surgical Technologies, Faculty of Medicine, KU Leuven, Leuven, Belgium.; Department of Obstetrics and Gynecology, Division Women and Child, Fetal Medicine Unit, University Hospitals Leuven, Leuven, Belgium., Javaux A; Department of Mechanical Engineering, KU Leuven, Leuven, Belgium., Peralta CFA; Department of Fetal Medicine, The Heart Hospital, University of São Paulo, São Paulo, Brazil.; Department of Fetal Medicine, Pro Matre Hospital, São Paulo, Brazil., De Salles AAF; Neuroscience Institute, The Heart Hospital, University of São Paulo, São Paulo, Brazil., Pastuszka A; Department of Descriptive and Topografic Anatomy, Medical University of Silesia, Katowice, Poland.; Division of Dentistry, School of Medicine, Zabrze, Poland., Olejek A; Department of Gynecology, Obstetrics and Gynecologic Oncology, Medical University of Silesia, Bytom, Poland., Van Mieghem T; Department of Obstetrics and Gynecology, Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada., De Coppi P; MyFetUZ Fetal Research Center, Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium.; Center for Surgical Technologies, Faculty of Medicine, KU Leuven, Leuven, Belgium.; Department of Obstetrics and Gynecology, Division Women and Child, Fetal Medicine Unit, University Hospitals Leuven, Leuven, Belgium.; Specialist Neonatal and Paediatric Surgery Unit, Great Ormond Street Hospital, University College London Hospitals NHS Foundation Trust, London, UK., Moldenhauer J; Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.; The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Whitehead WE; Department of Neurosurgery, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.; Texas Children's Fetal Center, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA., Belfort MA; Texas Children's Fetal Center, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.; Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA., Lapa DA; Fetal Therapy Center, Hospital Israelita Albert Einstein, São Paulo, Brazil., Acacio GL; Department of Obstetrics and Gynecology, Taubate University, São Paulo, Brazil., Devlieger R; MyFetUZ Fetal Research Center, Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium.; Department of Obstetrics and Gynecology, Division Women and Child, Fetal Medicine Unit, University Hospitals Leuven, Leuven, Belgium., Hirose S; Fetal Care and Treatment Center, UC Davis Children's Hospital, Sacramento, CA, USA., Farmer DL; Fetal Care and Treatment Center, UC Davis Children's Hospital, Sacramento, CA, USA., Van Calenbergh F; Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium., Adzick NS; Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.; The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Johnson MP; Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.; The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Deprest J; MyFetUZ Fetal Research Center, Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium.; Center for Surgical Technologies, Faculty of Medicine, KU Leuven, Leuven, Belgium.; Department of Obstetrics and Gynecology, Division Women and Child, Fetal Medicine Unit, University Hospitals Leuven, Leuven, Belgium.; Institute of Women's Health, University College London Hospitals, London, UK.
Jazyk: angličtina
Zdroj: Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology [Ultrasound Obstet Gynecol] 2020 Jun; Vol. 55 (6), pp. 730-739.
DOI: 10.1002/uog.20389
Abstrakt: Objective: The 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.
Methods: MEDLINE, 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).
Results: Of 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.
Conclusions: The 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.
(Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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