TY - JOUR
T1 - Fetoscopic laser coagulation of the vascular equator versus selective coagulation for twin-to-twin transfusion syndrome
T2 - an open-label randomised controlled trial
AU - Slaghekke, Femke
AU - Lopriore, Enrico
AU - Lewi, Liesbeth
AU - Middeldorp, Johanna M
AU - van Zwet, Erik W
AU - Weingertner, Anne-Sophie
AU - Klumper, Frans J
AU - DeKoninck, Philip
AU - Devlieger, Roland
AU - Kilby, Mark D
AU - Rustico, Maria Angela
AU - Deprest, Jan
AU - Favre, Romain
AU - Oepkes, Dick
N1 - Copyright © 2014 Elsevier Ltd. All rights reserved.
PY - 2014/6/21
Y1 - 2014/6/21
N2 - 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).
AB - 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).
KW - Adult
KW - Female
KW - Fetofetal Transfusion
KW - Fetoscopy
KW - Humans
KW - Laser Coagulation
KW - Placenta
KW - Pregnancy
KW - Treatment Outcome
KW - Vascular Surgical Procedures
U2 - 10.1016/S0140-6736(13)62419-8
DO - 10.1016/S0140-6736(13)62419-8
M3 - Article
C2 - 24613024
SN - 0140-6736
VL - 383
SP - 2144
EP - 2151
JO - The Lancet
JF - The Lancet
IS - 9935
ER -