Benachi, Alexandra

Deprest, Jan A

Flake, Alan W

Hypo, TOTAL Trial Severe

Losty, Paul D

Nicolaides, Kypros H

Stolar, Charles JH

To the Editor: The lower mortality reported by Deprest et al. (July 8 issue)1 among infants with severe congenital diaphragmatic hernia who were assigned to fetoscopic intervention than among those..

University of Liverpool Repository

Correspondencen engl j med 385;22 nejm.org November 25, 2021 2111mained noninferior to the standard biopsy strat-egy with respect to the detection of clinically significant prostate cancer (absolute difference, 0.5 percentage points; 95% confidence interval [CI], −3 to 4), and the detection probability of clinically insignificant cancers remained marked-ly lower in the experimental biopsy group than in the standard biopsy group, with a relative between-group difference of 42% (95% CI, 21 to 58).To definitively answer the question of wheth-er MRI-detected and systematic biopsy–detected prostate cancer are equivalent with regard to relevant cancer end points, long-term follow-up data from well-designed prospective and ade-quately powered trials are needed. Such data are currently not available (and may never be). The results presented here suggest that the evidence of noninferiority of combined biopsy (performed only in men with visible lesions on MRI) with respect to the detection of clinically significant prostate cancer is robust to adjustment for poten-tial inflation of the Gleason score and strengthen the indication that any difference in long-term outcomes is likely to be small. However, more research is needed to fully elucidate the effect of MRI on appropriate risk stratification in patients with prostate cancer and on reduction in mortal-ity from early detection.While we agree with Yoshida and Fujii that men with a negative MRI need further surveil-lance, in light of the high negative predictive value of MRI,1 we argue that such men can be followed within a screening program and un-dergo biopsy at future screenings if indicated by MRI or by a high predicted prostate cancer risk. To subject men with a negative MRI to standard biopsy would forgo the potential of MRI to re-duce the number of unnecessary biopsies and diagnoses of clinically insignificant disease.Martin Eklund, Ph.D. Andrea Discacciati, Ph.D. Tobias Nordström, M.D., Ph.D.Karolinska Institutet Stockholm, Sweden martin . eklund@ ki . seSince publication of their article, the authors report no fur-ther potential conflict of interest.1. Sathianathen NJ, Omer A, Harriss E, et al. Negative predic-tive value of multiparametric magnetic resonance imaging in the detection of clinically significant prostate cancer in the prostate imaging reporting and data system era: a systematic review and meta-analysis. Eur Urol 2020; 78: 402-14.DOI: 10.1056/NEJMc2115775Fetal Surgery for Severe Left Diaphragmatic HerniaTo the Editor: The lower mortality reported by Deprest et al. (July 8 issue)1 among infants with severe congenital diaphragmatic hernia who were assigned to fetoscopic intervention than among those who were assigned to expectant care should not be interpreted as endorsing broad application outside well-designed trials at experi-enced centers. Despite the standardized protocol, the report does not include information regarding adherence to standardized care2 during a trial period of more than 10 years at 10 fetal centers and 26 neonatal centers with variable experience treating infants with congenital diaphragmatic hernia. The low use of extracorporeal life sup-port appears inconsistent with “best practices,” perhaps limited by availability, center experience, and bias related to the lack of blinding.Higher mortality in the control group than that at U.S. centers with experience using per-missive hypercapnia or spontaneous ventilation3-5 raises the question of whether consistent im-provement in nonfetal intervention might simi-larly improve outcomes and decrease the ratio-nale for fetal intervention. Neonatal advances must consider long-term morbidity, especially among premature neonates, but, as acknowl-edged by the authors, the trial was not powered for and cannot effectively inform associated co-existing conditions in these premature infants. These issues require discretion in counseling vulnerable parents when congenital diaphrag-matic hernia is diagnosed prenatally.Charles J.H. Stolar, M.D.Columbia University New York, NY cjs3@ columbia . eduAlan W. Flake, M.D.University of Pennsylvania Philadelphia, PAPaul D. Losty, M.D.University of Liverpool Liverpool, United KingdomNo potential conflict of interest relevant to this letter was reported.The New England Journal of Medicine Downloaded from nejm.org at UNIVERSITY OF LIVERPOOL on December 3, 2021. For personal use only. No other uses without permission.  Copyright © 2021 Massachusetts Medical Society. All rights reserved. Correspondencen engl j med 385;22 nejm.org November 25, 202121121. Deprest JA, Nicolaides KH, Benachi A, et al. Randomized trial of fetal surgery for severe left diaphragmatic hernia. N Engl J Med 2021; 385: 107-18.2. Snoek KG, Reiss IKM, Greenough A, et al. Standardized postnatal management of infants with congenital diaphragmat-ic hernia in Europe: the CDH EURO Consortium consensus — 2015 update. Neonatology 2016; 110: 66-74.3. Wung JT, Sahni R, Moffitt ST, Lipsitz E, Stolar CJ. Congeni-tal diaphragmatic hernia: survival treated with very delayed sur-gery, spontaneous respiration, and no chest tube. J Pediatr Surg 1995; 30: 406-9.4. Wilson JM, Lund DP, Lillehei CW, Vacanti JP. Congenital dia-phragmatic hernia — a tale of two cities: the Boston experience. J Pediatr Surg 1997; 32: 401-5.5. Harrison MR, Keller RL, Hawgood SB, et al. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal con-genital diaphragmatic hernia. N Engl J Med 2003; 349: 1916-24.DOI: 10.1056/NEJMc2115673The authors reply: We thank Stolar et al. for their comments, and we agree with some of their concerns. We recommended that fetoscopic en-doluminal tracheal occlusion (FETO) be offered only by centers with extensive experience in fe-toscopy and balloon insertion and removal. With respect to long-term outcomes, we are collecting such data from the trial cohort and advocate pro-spective registration of future cases of congenital diaphragmatic hernia for which FETO would be appropriate as a second-best option to a random-ized, controlled trial.1,2Mortality in our control group was indeed higher than in the cited studies. Data from neo-natal management centers typically overestimate survival because they do not include intrauterine deaths, terminations, and fetal abnormalities.3 In addition, the single previous randomized, controlled trial included fetuses with moderate hypoplasia, which inevitably contributed to the higher survival.4We agree that in our trial, adherence to the standardized neonatal management protocol may have varied, but the same strategy and protocol were previously used successfully in another randomized, controlled trial.5 Extracorporeal life support may not have been offered by some cen-ters because of its unproven benefit in congeni-tal diaphragmatic hernia and its potential com-plications.Jan A. Deprest, M.D., Ph.D.University Hospitals KU Leuven Leuven, Belgium jan . deprest@ uzleuven . beKypros H. Nicolaides, M.D.King’s College Hospital London, United KingdomAlexandra Benachi, M.D., Ph.D.Hospital Antoine Béclère Clamart, Francefor the TOTAL Trial for Severe Hypoplasia InvestigatorsSince publication of their article, the authors report no fur-ther potential conflict of interest.1. Verweij EJ, de Vries MC, Oldekamp EJ, et al. Fetoscopic my-elomeningocoele closure: is the scientific evidence enough to challenge the gold standard for prenatal surgery? Prenat Diagn 2021; 41: 949-56.2. Van Calster B. The randomized TOTAL trials on fetal sur-gery for congenital diaphragmatic hernia: re-analysis using pooled data. Am J Obstet Gynecol (in press).3. Brownlee EM, Howatson AG, Davis CF, Sabharwal AJ. The hidden mortality of congenital diaphragmatic hernia: a 20-year review. J Pediatr Surg 2009; 44: 317-20.4. Harrison MR, Keller RL, Hawgood SB, et al. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal con-genital diaphragmatic hernia. N Engl J Med 2003; 349: 1916-24.5. Snoek KG, Capolupo I, van Rosmalen J, et al. Conventional mechanical ventilation versus high-frequency oscillatory venti-lation for congenital diaphragmatic hernia: a randomized clini-cal trial (the VICI–trial). Ann Surg 2016; 263: 867-74.DOI: 10.1056/NEJMc2115673Correspondence Copyright © 2021 Massachusetts Medical Society.instructions for letters to the editorLetters to the Editor are considered for publication, subject to editing and abridgment, provided they do not contain material that has been submitted or published elsewhere.Letters accepted for publication will appear in print, on our website at NEJM.org, or both. 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We will notify you when we have made a decision about possible publication. Letters regarding a recent Journal article may be shared with the authors of that article. We are unable to provide prepublication proofs. Submission of a letter constitutes permission for the Massachusetts Medical Society, its licensees, and its assignees to use it in the Journal’s various print and electronic publications and in collections, revisions, and any other form or medium.The New England Journal of Medicine Downloaded from nejm.org at UNIVERSITY OF LIVERPOOL on December 3, 2021. For personal use only. No other uses without permission.  Copyright © 2021 Massachusetts Medical Society. All rights reserved. 

Fetal Surgery for Severe Left Diaphragmatic Hernia

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Fetal Surgery for Severe Left Diaphragmatic Hernia

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