Fetoscopic laser coagulation of the vascular equator versus selective coagulation for twin-to-twin transfusion syndrome: an open-label randomised controlled trial

Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique...

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Published inThe Lancet (British edition) Vol. 383; no. 9935; pp. 2144 - 2151
Main Authors Slaghekke, Femke, Lopriore, Enrico, Lewi, Liesbeth, Middeldorp, Johanna M, van Zwet, Erik W, Weingertner, Anne-Sophie, Klumper, Frans J, DeKoninck, Philip, Devlieger, Roland, Kilby, Mark D, Rustico, Maria Angela, Deprest, Jan, Favre, Romain, Oepkes, Dick
Format Journal Article
LanguageEnglish
Published Kidlington Elsevier Ltd 21.06.2014
Elsevier
Elsevier Limited
Subjects
Online AccessGet full text
ISSN0140-6736
1474-547X
1474-547X
DOI10.1016/S0140-6736(13)62419-8

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Abstract Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique). We undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245. Between March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35–0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3% vs 16% for the standard treatment; OR 0·16, 95% CI 0·05–0·49) and recurrence of twin-to-twin transfusion syndrome (1% vs 7%; 0·21, 0·04–0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred. Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome. Netherlands Organization for the Health Research and Development (ZonMw 92003545).
AbstractList Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique). Methods We undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245. Findings Between March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35-0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3%vs16% for the standard treatment; OR 0·16, 95% CI 0·05-0·49) and recurrence of twin-to-twin transfusion syndrome (1%vs7%; 0·21, 0·04-0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred. Interpretation Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome. Funding Netherlands Organization for the Health Research and Development (ZonMw 92003545).
Summary Background Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique). Methods We undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245. Findings Between March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35–0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3% vs 16% for the standard treatment; OR 0·16, 95% CI 0·05–0·49) and recurrence of twin-to-twin transfusion syndrome (1% vs 7%; 0·21, 0·04–0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred. Interpretation Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome. Funding Netherlands Organization for the Health Research and Development (ZonMw 92003545).
Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique). We undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245. Between March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35–0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3% vs 16% for the standard treatment; OR 0·16, 95% CI 0·05–0·49) and recurrence of twin-to-twin transfusion syndrome (1% vs 7%; 0·21, 0·04–0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred. Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome. Netherlands Organization for the Health Research and Development (ZonMw 92003545).
Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique).BACKGROUNDMonochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique).We undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245.METHODSWe undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245.Between March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35-0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3% vs 16% for the standard treatment; OR 0·16, 95% CI 0·05-0·49) and recurrence of twin-to-twin transfusion syndrome (1% vs 7%; 0·21, 0·04-0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred.FINDINGSBetween March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35-0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3% vs 16% for the standard treatment; OR 0·16, 95% CI 0·05-0·49) and recurrence of twin-to-twin transfusion syndrome (1% vs 7%; 0·21, 0·04-0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred.Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome.INTERPRETATIONFetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome.Netherlands Organization for the Health Research and Development (ZonMw 92003545).FUNDINGNetherlands Organization for the Health Research and Development (ZonMw 92003545).
Author Favre, Romain
Oepkes, Dick
Klumper, Frans J
Weingertner, Anne-Sophie
Middeldorp, Johanna M
Slaghekke, Femke
Deprest, Jan
Lopriore, Enrico
Kilby, Mark D
Lewi, Liesbeth
DeKoninck, Philip
Devlieger, Roland
van Zwet, Erik W
Rustico, Maria Angela
Author_xml – sequence: 1
  givenname: Femke
  surname: Slaghekke
  fullname: Slaghekke, Femke
  organization: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands
– sequence: 2
  givenname: Enrico
  surname: Lopriore
  fullname: Lopriore, Enrico
  organization: Department of Pediatrics, Leiden University Medical Centre, Leiden, Netherlands
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  givenname: Liesbeth
  surname: Lewi
  fullname: Lewi, Liesbeth
  organization: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium
– sequence: 4
  givenname: Johanna M
  surname: Middeldorp
  fullname: Middeldorp, Johanna M
  organization: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands
– sequence: 5
  givenname: Erik W
  surname: van Zwet
  fullname: van Zwet, Erik W
  organization: Department of Medical Statistics, Leiden University Medical Centre, Leiden, Netherlands
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  givenname: Anne-Sophie
  surname: Weingertner
  fullname: Weingertner, Anne-Sophie
  organization: Department of Obstetrics, University Hospital of Strasbourg, Strasbourg, France
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  givenname: Frans J
  surname: Klumper
  fullname: Klumper, Frans J
  organization: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands
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  givenname: Philip
  surname: DeKoninck
  fullname: DeKoninck, Philip
  organization: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium
– sequence: 9
  givenname: Roland
  surname: Devlieger
  fullname: Devlieger, Roland
  organization: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium
– sequence: 10
  givenname: Mark D
  surname: Kilby
  fullname: Kilby, Mark D
  organization: Fetal Medical Centre, Birmingham Women's Foundation Trust and University of Birmingham, Edgbaston, Birmingham, UK
– sequence: 11
  givenname: Maria Angela
  surname: Rustico
  fullname: Rustico, Maria Angela
  organization: Department of Obstetrics, Fetal Therapy Unit, Children's Hospital Vittore Buzzi, Milan, Italy
– sequence: 12
  givenname: Jan
  surname: Deprest
  fullname: Deprest, Jan
  organization: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium
– sequence: 13
  givenname: Romain
  surname: Favre
  fullname: Favre, Romain
  organization: Department of Obstetrics, University Hospital of Strasbourg, Strasbourg, France
– sequence: 14
  givenname: Dick
  surname: Oepkes
  fullname: Oepkes, Dick
  email: d.oepkes@lumc.nl
  organization: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands
BackLink http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28558699$$DView record in Pascal Francis
https://www.ncbi.nlm.nih.gov/pubmed/24613024$$D View this record in MEDLINE/PubMed
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Issue 9935
Keywords Medicine
Drug
Photocoagulation
Blood coagulation
Treatment
Surgery
Fetofetal transfusion
Blood vessel
Clinical trial
Circulatory system
Randomized controlled trial
Comparative study
Language English
License CC BY 4.0
Copyright © 2014 Elsevier Ltd. All rights reserved.
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Lopriore, Middeldorp, Oepkes, Klumper, Walther, Vandenbussche (bib13) 2007; 28
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24613025 - Lancet. 2014 Jun 21;383(9935):2108-9
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Snippet Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative...
Summary Background Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation....
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StartPage 2144
SubjectTerms Adult
Biological and medical sciences
Coagulation
Female
Fetofetal Transfusion - surgery
Fetoscopy
Fetuses
General aspects
Humans
Internal Medicine
Laser Coagulation - methods
Laser surgery
Medical sciences
Membrane separation
Morbidity
Mortality
Placenta
Placenta - blood supply
Pregnancy
R&D
Research & development
Transfusion
Treatment Outcome
Twins
Ultrasonic imaging
Vascular Surgical Procedures - methods
Women
Title Fetoscopic laser coagulation of the vascular equator versus selective coagulation for twin-to-twin transfusion syndrome: an open-label randomised controlled trial
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https://www.clinicalkey.es/playcontent/1-s2.0-S0140673613624198
https://dx.doi.org/10.1016/S0140-6736(13)62419-8
https://www.ncbi.nlm.nih.gov/pubmed/24613024
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https://www.proquest.com/docview/1539709522
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