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• W4384156622 abstract "We thank Cuneo et al for their detailed response to the article entitled “Society for Maternal-Fetal Medicine Consult Series #64: Systemic Lupus Erythematosus in Pregnancy”1Society for Maternal-Fetal Medicine Consult Series #64Systemic lupus erythematosus in pregnancy.Am J Obstet Gynecol. 2023; 228: B41-B60Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar and the concerns they raise about screening and management of patients with anti–Sjögren-syndrome related antigen A or B (anti-SSA/SSB) antibodies in pregnancy. We are encouraged by the many points of agreement we have. For example, we could not agree more that we must determine the care that optimizes outcomes for patients with these antibodies and their fetuses or infants. They, as we, also are clear that the evidence that screening and treatment accomplish those goals has not yet been obtained. As they state, “At this time, the scientific rigor of the data is insufficient.” It is unsurprising that we also agree on the need for additional studies to provide the data that will allow us to better manage pregnant patients and their fetuses or infants. Indeed, the marked evidence gaps have led investigators (many of whom are authors of the Cuneo et al response) to perform ongoing studies (ie, the “Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly [STOP BLOQ]” and the “Slow Heart Registry”) that will help to provide these crucial data. The Society for Maternal-Fetal Medicine (SMFM) highly supports these investigations, and we are not clear why the authors express concern that the Consult may “negatively impact recruitment” into these studies. The lack of evidence to support screening and treatment of fetal atrioventricular block should underscore for patients the value of foregoing nonevidence-based care and having the opportunity to participate in monitored research studies with careful and systematic collection of outcome and safety data. Similarly, other parts of the authors’ response are worth clarifying. The authors state that the conclusions presented in the Consult relied on older literature and did not include recent studies, citing those performed by Mawad et al2Mawad W. Hornberger L. Cuneo B. et al.Outcome of antibody-mediated fetal heart disease with standardized anti-inflammatory transplacental treatment.J Am Heart Assoc. 2022; 11e023000Crossref Scopus (7) Google Scholar and Sunderji et al3Sunderji S. Peyvandi S. Jaeggi E. et al.NAFTNet retrospective report on the treatment of anti-Ro/SSA mediated fetal heart block with dexamethasone.J Matern Fetal Neonatal Med. 2022; 35: 9263-9270Crossref PubMed Scopus (2) Google Scholar to support this claim. We are somewhat perplexed by this contention, because both studies were included in the Consult and, in fact, discussed in some detail. Indeed, although we appreciate the challenges in undertaking these investigations, they only strengthen our belief that the “scientific rigor of the data remains insufficient” to recommend screening and treatment. Given that these studies have been brought up, it is worth describing why they are not dispositive and do not alter our conclusions. The study by Mawad et al2Mawad W. Hornberger L. Cuneo B. et al.Outcome of antibody-mediated fetal heart disease with standardized anti-inflammatory transplacental treatment.J Am Heart Assoc. 2022; 11e023000Crossref Scopus (7) Google Scholar is a case series of 130 pregnant individuals who had fetuses with heterogeneous presentations of antibody–mediated fetal heart disease. All were treated with steroids and some with other treatment modalities. There was no comparison group of untreated fetuses within the study, and the conclusion of benefit rests on comparison with summary outcome frequencies from cases collected up to 53 years ago in other publications. There is little information about maternal complications, although 1 case of maternal psychosis related to steroid use was noted. In the retrospective cohort of Sunderji et al,3Sunderji S. Peyvandi S. Jaeggi E. et al.NAFTNet retrospective report on the treatment of anti-Ro/SSA mediated fetal heart block with dexamethasone.J Matern Fetal Neonatal Med. 2022; 35: 9263-9270Crossref PubMed Scopus (2) Google Scholar 98 individuals with anti-Ro/SSA antibodies who were treated with steroids were compared with 29 individuals with anti-Ro/SSA who were untreated. The overall survival was not different between the groups, although the authors performed an additional analysis after excluding those who underwent termination of pregnancy, which showed that, among that subgroup of survivors, those treated were less likely to have death or a transplant within 1 year. As might be expected, however, those who were untreated were systematically different from those who were treated. As an example, they were nearly 3 times more likely to have hydrops at presentation, which makes explicit the potential for confounding by indication. Regarding maternal outcomes, those in the treated group had complications such as thrush, shingles, mood disorders, insomnia, and new-onset diabetes mellitus; however, these complications were absent in the untreated group. It seems fair to say that the limitations of the data make it difficult to conclude that treatment is associated with better outcomes, let alone that there is a causal relationship. In summary, these studies (and others that have been cited) have serious limitations, including a lack of appropriate control groups for comparison, heterogenous treatment modalities, and small sample sizes. Accordingly, we stand by our determination that they do not provide the evidence necessary to conclude that screening and treatment hold more benefits than risks. Indeed, as Cuneo et al noted, it is important to evaluate articles in terms of the quality of the evidence they present and to derive conclusions based on the literature as opposed to anecdote or preference. We agree with these tenets, and it is this process (as exemplified above) that led to our conclusions. The SMFM Clinical Practice Guidelines Development Process is outlined in detail.4Society for Maternal-Fetal Medicine. SMFM clinical practice guidelines development process. 2023. Available at: https://s3.amazonaws.com/cdn.smfm.org/media/2569/Guidelines_Dev_Process_Public_for_website2.pdf. Accessed April 28, 2023.Google Scholar It involves a multilevel committee process and literature search with critique and feedback from members of the SMFM Publications Committee, Document Review Committee, and Executive Committee, and application of the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) letter and classification system for recommendations. As maternal-fetal medicine subspecialists, we believe that it is essential that the risks and benefits to both the pregnant patient and the fetus be considered given the consequences for both. This is all the more crucial for interventions hypothesized to benefit the fetus with no direct maternal benefit and possible maternal harm. Doing more does not translate into doing better, no matter how great the desire to help. In this context, it is difficult to argue that the current body of literature on screening and management of patients with anti-SSA/SSB antibodies rises to a standard that supports routine screening and treatment. We acknowledge that this is an uncommon condition and that it is difficult to perform trials. Nevertheless, trials for uncommon conditions have been done before for both pregnancy and rheumatologic conditions.5Adzick N.S. Thom E.A. Spong C.Y. et al.A randomized trial of prenatal versus postnatal repair of myelomeningocele.N Engl J Med. 2011; 364: 993-1004Crossref PubMed Scopus (1422) Google Scholar, 6Aggarwal R. Charles-Schoeman C. Schessl J. et al.Trial of intravenous immune globulin in dermatomyositis.N Engl J Med. 2022; 387: 1264-1278Crossref PubMed Scopus (14) Google Scholar, 7Deprest J.A. Nicolaides K.H. Benachi A. et al.Randomized trial of fetal surgery for severe left diaphragmatic hernia.N Engl J Med. 2021; 385: 107-118Crossref PubMed Scopus (112) Google Scholar, 8Luton D. Mitanchez D. Winer N. et al.A randomised controlled trial of amnioexchange for fetal gastroschisis.BJOG. 2019; 126: 1233-1241Crossref PubMed Scopus (0) Google Scholar, 9Shamshirsaz A.A. Lee T.C. Hair A.B. et al.Elective delivery at 34 weeks vs routine obstetric care in fetal gastroschisis: randomized controlled trial.Ultrasound Obstet Gynecol. 2020; 55: 15-19Crossref PubMed Scopus (6) Google Scholar It also bears remembering that the Management of Myelomeningocele Study on fetal treatment by Adzick et al5Adzick N.S. Thom E.A. Spong C.Y. et al.A randomized trial of prenatal versus postnatal repair of myelomeningocele.N Engl J Med. 2011; 364: 993-1004Crossref PubMed Scopus (1422) Google Scholar was undertaken after general agreement that individuals would not continue to provide an intervention based on observational data but instead perform a trial that would allow for more confident determinations of the potential benefits of treatment. We look forward to the results of the ongoing studies and other studies yet to be done in antibody–mediated fetal heart disease. Their results will help to resolve the dilemma of whether screening and treatment are beneficial and help us to determine the best approach to care. Knowledge is power: regarding SMFM Consult Series #64: Systemic lupus erythematosus in pregnancyAmerican Journal of Obstetrics & GynecologyPreviewThe premise of the recommendations listed in the Society for Maternal-Fetal Medicine (SMFM) Consensus Statement #641 regarding the risk of fetal atrioventricular block (AVB) owing to maternal anti-Ro/SSA (anti–Sjögren-syndrome related antigen A) antibodies is that surveillance by echocardiography is unwarranted and unnecessary because treatment is futile. The authors contend that treatment of incomplete (1° and 2°) AVB does not prevent its progression and treatment of complete (3°) AVB does not improve outcomes. Full-Text PDF" @default.
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• W4384156622 title "Society for Maternal-Fetal Medicine response to Cuneo et al" @default.
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