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

Femke Slaghekke MD , Enrico Lopriore MD , Prof Liesbeth Lewi MD , Johanna M Middeldorp MD , Erik W van Zwet PhD , Anne-Sophie Weingertner MD , Frans J Klumper MD , Philip DeKoninck MD , Prof Roland Devlieger MD , Prof Mark D Kilby DSc , Prof Maria Angela

The Lancet, Volume 383, Issue 9935, 21–27 June 2014, Pages 2144–2151

Editor’s comment: Prof. Jim Thornton: Full laser coagulation of the vascular equator is preferable to selective coagulation for twin to twin transfusion syndrome

This open randomised trial changed its sample size and primary outcome after trial registration. However the changes were made prior to any data analysis. The trial was originally designed to test whether full coagulation of the vascular equator reduced recurrence of TTTS or twin anaemia polycythaemia sequence. Both are susceptible to ascertainment bias, but were apparently reduced. Overall mortality was not altered, but a composite outcome of death, recurrence or severe neonatal morbidity was reduced.

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.

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Commentaries by Editor Prof. Jim Thornton