title: Fetoscopic laser coagulation of the vascular equator versus selective coagulation for twin-to-twin transfusion syndrome: an open-label randomised controlled trial.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands Organization for the Health Research and Development (ZonMw 92003545).
authors.affiliation: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands.
authors.forename: Femke
authors.initials: F
authors.lastname: Slaghekke
authors.affiliation: Department of Pediatrics, Leiden University Medical Centre, Leiden, Netherlands.
authors.forename: Enrico
authors.initials: E
authors.lastname: Lopriore
authors.affiliation: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium.
authors.forename: Liesbeth
authors.initials: L
authors.lastname: Lewi
authors.affiliation: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands.
authors.forename: Johanna M
authors.initials: JM
authors.lastname: Middeldorp
authors.affiliation: Department of Medical Statistics, Leiden University Medical Centre, Leiden, Netherlands.
authors.forename: Erik W
authors.initials: EW
authors.lastname: van Zwet
authors.affiliation: Department of Obstetrics, University Hospital of Strasbourg, Strasbourg, France.
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Weingertner
authors.affiliation: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands.
authors.forename: Frans J
authors.initials: FJ
authors.lastname: Klumper
authors.affiliation: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium.
authors.forename: Philip
authors.initials: P
authors.lastname: DeKoninck
authors.affiliation: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium.
authors.forename: Roland
authors.initials: R
authors.lastname: Devlieger
authors.affiliation: Fetal Medical Centre, Birmingham Women's Foundation Trust and University of Birmingham, Edgbaston, Birmingham, UK.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Kilby
authors.affiliation: Department of Obstetrics, Fetal Therapy Unit, Children's Hospital Vittore Buzzi, Milan, Italy.
authors.forename: Maria Angela
authors.initials: MA
authors.lastname: Rustico
authors.affiliation: Department of Obstetrics, University Hospitals KU Leuven, Leuven, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Deprest
authors.affiliation: Department of Obstetrics, University Hospital of Strasbourg, Strasbourg, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Favre
authors.affiliation: Department of Obstetrics, Leiden University Medical Centre, Leiden, Netherlands. Electronic address: d.oepkes@lumc.nl.
authors.forename: Dick
authors.initials: D
authors.lastname: Oepkes
mesh_terms: D000328:Adult; D005260:Female; D005330:Fetofetal Transfusion / Q000601:surgery*; D005332:Fetoscopy; D006801:Humans; D017075:Laser Coagulation / Q000379:methods*; D010920:Placenta / Q000098:blood supply; D011247:Pregnancy; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000379:methods