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Title: Septate uterus according to ESHRE/ESGE, ASRM and CUME definitions: association with infertility and miscarriage, cost and warnings for women and healthcare systems.
Author: Ludwin A, Ludwin I, Coelho Neto MA, Nastri CO, Bhagavath B, Lindheim SR, Martins WP.
Journal: Ultrasound Obstet Gynecol; 2019 Dec; 54(6):800-814. PubMed ID: 30977223.
Abstract:
OBJECTIVES: To estimate the differences in frequency of diagnosis of septate uterus using three different definitions and determine whether these differences are significant in clinical practice, and to examine the association between diagnosis of septate uterus, using each of the three definitions, and infertility and/or previous miscarriage as well as the cost of allocation to surgery. METHODS: This was a secondary analysis of data from a prospective study of 261 consecutive women of reproductive age attending a private clinic focused on the diagnosis and treatment of congenital uterine malformations. Reanalysis of the datasets was performed according to three different means of defining septate uterus: following the recommendations of the American Society for Reproductive Medicine (ASRM), a 2016 update of those of the American Fertility Society from 1988 (ASRM-2016: internal fundal indentation depth ≥ 1.5 cm, angle of internal indentation < 90° and external indentation depth < 1 cm); following the recommendations of the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy (ESHRE/ESGE), published in 2013 and reaffirmed in 2016 (ESHRE/ESGE-2016: internal fundal/uterine indentation depth > 50% of uterine-wall thickness and external indentation depth < 50% of uterine-wall thickness, with uterine-wall thickness measured above interostial/intercornual line); and using a definition published last year which was based on the decision made most often by a group of experts (Congenital Uterine Malformation by Experts; CUME) (CUME-2018: internal fundal indentation depth ≥ 1 cm and external fundal indentation depth < 1 cm). We compared the rate of diagnosis of septate uterus using each of these three definitions and, for each, we estimated the association between the diagnosis and infertility and/or previous miscarriage, and anticipated the costs associated with their implementation using a guesstimation method. RESULTS: Although 32.6% (85/261) of the subjects met the criteria for one of the three definitions of septate uterus, only 2.7% (7/261) of them were defined as having septate uterus according to all three definitions. We diagnosed significantly more cases of septate uterus using ESHRE/ESGE-2016 than using ASRM-2016 (31% vs 5%, relative risk (RR) = 6.7, P < 0.0001) or CUME-2018 (31% vs 12%, RR = 2.6, P < 0.0001) criteria. We also observed frequent cases that could not be classified definitively by ASRM-2016 (gray zone: neither normal/arcuate nor septate; 6.5%). There were no significant differences (P > 0.05) in the prevalence of septate uterus in women with vs those without infertility according to ASRM-2016 (5% vs 4%), ESHRE/ESGE-2016 (35% vs 28%) or CUME-2018 (11% vs 12%). Septate uterus was diagnosed significantly more frequently in women with vs those without previous miscarriage according to ASRM-2016 (11% vs 3%; P = 0.04) and CUME-2018 (22 vs 10%; P = 0.04), but not according to ESHRE/ESGE-2016 (42% vs 28%; P = 0.8) criteria. Our calculations showed that global costs to the healthcare system would be highly dependent on the criteria used in the clinical setting to define septate uterus, with the costs associated with the ESHRE/ESGE-2016 definition potentially being an extra US$ 100-200 billion over 5 years in comparison to ASRM-2016 and CUME-2018 definitions. CONCLUSIONS: The prevalence of septate uterus according to ESHRE/ESGE-2016, ASRM-2016 and CUME-2018 definitions differs considerably. An important limitation of the ASRM classification, which needs to be addressed, is the high proportion of unclassifiable cases originally named, by us, the 'gray zone'. The high rate of overdiagnosis of septate uterus according to ESHRE/ESGE-2016 may lead to unnecessary surgery and therefore unnecessary risk in these women and may impose a considerable financial burden on healthcare systems. Efforts to define clinically meaningful and universally applicable criteria for the diagnosis of septate uterus should be encouraged. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. Útero septo según las definiciones de ESHRE/ESGE, ASRM y CUME: la relación con la infertilidad y el aborto espontáneo, el costo y advertencias para las mujeres y los sistemas de salud OBJETIVO: Evaluar el rendimiento de la velocidad sistólica máxima de la arteria cerebral media fetal (MCA-PSV, por sus siglas en inglés) ≥1,5 múltiplos de la mediana (MdM) para la predicción de la anemia moderada-severa en fetos sometidos a transfusión y no sometidos. MÉTODOS: Se realizó una búsqueda sistemática para identificar estudios observacionales relevantes reportados en el período 2008-2018 que evaluaron el rendimiento de la MCA-PSV, utilizando un umbral de 1,5MdM para la predicción de la anemia fetal. El diagnóstico de la anemia fetal mediante la toma de muestras de sangre fue el estándar de referencia. Se utilizaron modelos de efectos aleatorios para la elaboración de una curva jerárquica resumen de las características operativas del receptor (hSROC, por sus siglas en inglés). Se realizaron análisis de subgrupos y metarregresión, según el número de transfusiones intrauterinas previas. RESULTADOS: En el metaanálisis se incluyeron doce estudios y 696 fetos. El área bajo la curva (ABC) hSROC para la anemia moderada-severa fue del 83%. La sensibilidad y especificidad agrupadas (IC 95%) fueron del 79% (70-86%) y 73% (62-82%), respectivamente, y los cocientes de verosimilitud positivos y negativos fueron 2,94 (IC 95%: 2,13-4,00) y 0,272 (IC 95%: 0,188-0,371). Cuando solo se consideraron los fetos no sometidos a transfusión, la predicción mejoró, pues se logró un ABC del 87%, una sensibilidad del 86% (IC 95%: 75-93%) y una especificidad del 71% (IC 95%: 49-87%). Se observó una disminución en la sensibilidad de la predicción de la anemia moderada-severa mediante la MCA-PSV ≥1.5MdM (estimación, -5,5% (IC 95%: -10,7 a -0,3%), P=0,039) en función del aumento del número de transfusiones previas. CONCLUSIONES: El uso de la MCA-PSV ≥1.5MdM para la predicción de la anemia moderada-severa en fetos no sometidos a transfusión muestra una precisión moderada (86% de sensibilidad y 71% de especificidad), que disminuye con el aumento del número de transfusiones intrauterinas. 基于ESHRE/ESGE、ASRM和CUME定义的纵隔子宫:与不孕和流产的联系, 以及妇女和医疗系统费用和警告目标: 根据三种不同的定义估算纵隔子宫诊断频率差异, 确定这些差异在临床实践中是否存在显著性, 根据三种定义中的每一种检视纵隔子宫诊断与不孕和/或先前流产、以及手术费用之间的联系。方法: 这是针对一项前瞻性研究的二次数据分析, 研究对象是261名连续育龄妇女, 她们参加了一家主治先天性子宫畸形的私人诊所组织的研究项目。根据三种不同的纵隔子宫定义方式对数据集进行二次分析:遵循美国生殖医学学会(ASRM)的建议, 1988年美国生育学会2016年最新建议(ASRM-2016:内底凹陷深度≥1.5厘米, 内凹角<90°和外部凹陷深度<1厘米)；遵循欧洲人类生殖与胚胎学会/欧洲妇科内窥镜检查学会(ESHRE/ESGE)2013年发布, 2016年再次确认的建议(ESHRE/ESGE-2016:内底/子宫凹陷深度大于子宫壁厚的50%, 外部凹陷深度小于子宫壁厚的50%, 测量子宫壁/角膜间线上部的子宫壁厚)；根据去年发布的, 基于专家组作出的最常见决定的定义(先天性子宫畸形专家组；CUME)(内底凹陷深度≥1厘米, 外底凹陷深度<1厘米)。我们根据这三种定义中的每一种比较纵隔子宫诊断率, 根据每一种定义估计疾病诊断与不孕和/或先前流产之间的联系, 根据猜测法预测相关的实施成本。结果: 尽管32.6%(85/261)的受试者符合三种纵隔子宫定义中的某一种标准, 但从全部三种定义来看, 只有2.7%(7/261)的受试者被定义为纵隔子宫患者。我们根据ESHRE/ESGE-2016诊断的纵隔子宫病例, 明显多于根据ASRM-2016(31%对5%, 相对危险度 (RR) 为6.7, P<0.0001)或CUME-2018标准(31%对12%, RR为2.6, P<0.0001)诊断的病例。我们还观察到一些无法根据ASRM-2016进行明确分类的常见病例(灰色地带:既不正常/呈弓形也不分隔；6.5%)。ASRM-2016(5%对4%)、ESHRE/ESGE-2016(35%对28%)或CUME-2018(11%对12%)表明, 不孕不育妇女与正常妇女的纵隔子宫患病率并无显著差异(P>0.05)。ASRM-2016(11%对3%；P=0.04)和CUME-2018(22%对10%；P=0.04)表明, 先前流产的妇女诊断罹患纵隔子宫的机率明显高于正常妇女, 但ESHRE/ESGE-2016标准(42%对28%；P=0.8)表明并无明显区别。我们的计算结果表明, 全球医疗系统成本基本上取决于临床实践中采用的纵隔子宫定义标准；相比ASRM-2016和CUME-2018定义, ESHRE/ESGE-2016定义的相关成本五年内可能额外增加1000-2000亿美元。结论: 基于ESHRE/ESGE-2016、ASRM-2016和CUME-2018定义的纵隔子宫患病率差异很大。需要克服ASRM分类的一个重要局限性, 即我们最初命名为“灰色地带”的不可分类案例的占比较高。基于ESHRE/ESGE-2016的较高的纵隔子宫过度诊断率可能导致不必要的手术, 从而给这些妇女带来不必要的风险, 可能给医疗系统带来巨大的经济负担。应该鼓励业界努力为纵隔子宫的诊断, 确定一个具有临床意义的普适标准。©2019 ISUOG版权所有。John Wiley & Sons Ltd.出版。.

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