Intrauterine fetoscopic laser surgery versus expectant management in stage 1 twin-to-twin transfusion syndrome: an international randomized trial - 30/04/21
, Femke Slaghekke, MD b, Nahla Khalek, MD c, Norbert Winer, MD d, Anthony Johnson, MD e, Liesbeth Lewi, MD f, Mona Massoud, MD g, Laurence Bussieres, MD a, Philippe Aegerter, MD h, Kurt Hecher, MD i, Marie-Victoire Senat, MD j, Yves Ville, MD aAbstract |
Background |
Selective fetoscopic laser coagulation of the intertwin anastomotic chorionic vessels is the first-line treatment for twin-twin transfusion syndrome. However, in stage 1 twin-twin transfusion syndrome, the risks of intrauterine surgery may be higher than those of the natural progression of the condition.
Objective |
This study aimed to compare immediate surgery and expectant follow-up in stage 1 twin-twin transfusion syndrome.
Study Design |
We conducted a multicentric randomized trial, which recruited from 2011 to 2018 with a 6-month postnatal follow-up. The study was conducted in 9 fetal medicine centers in Europe and the Unites States. Asymptomatic women with stage 1 twin-twin transfusion syndrome between 16 and 26 weeks’ gestation, a cervix of >15 mm, and access to a surgical center within 48 hours of diagnosis were randomized between expectant management and immediate surgery. In patients allocated to immediate laser treatment, percutaneous laser coagulation of anastomotic vessels was performed within 72 hours. In patients allocated to expectant management, a weekly ultrasound follow-up was planned. Rescue fetoscopic coagulation of anastomoses was offered if the syndrome worsened as seen during a follow-up, either because of progression to a higher Quintero stage or because of the maternal complications of polyhydramnios. The primary outcome was survival at 6 months without severe neurologic morbidity. Severe complications of prematurity and maternal morbidity were secondary outcomes.
Results |
The trial was stopped at 117 of 200 planned inclusions for slow accrual rate over 7 years: 58 women were allocated to expectant management and 59 to immediate laser treatment. Intact survival was seen in 84 of 109 (77%) expectant cases and in 89 of 114 (78%) (P=.88) immediate surgery cases, and severe neurologic morbidity occurred in 5 of 109 (4.6%) and 3 of 114 (2.6%) (P=.49) cases in the expectant and immediate surgery groups, respectively. In patients followed expectantly, 24 of 58 (41%) cases remained stable with dual intact survival in 36 of 44 (86%) cases at 6 months. Intact survival was lower following surgery than for the nonprogressive cases, although nonsignificantly (78% and 71% following immediate and rescue surgery, respectively).
Conclusion |
It is unlikely that early fetal surgery is of benefit for stage 1 twin-twin transfusion syndrome in asymptomatic pregnant women with a long cervix. Although expectant management is reasonable for these cases, 60% of the cases will progress and require rapid transfer to a surgical center.
Le texte complet de cet article est disponible en PDF.Key words : anastomoses, fetal death, fetal surgery, fetoscopic surgery, laser ablation, monochorionic twins, multifetal gestation, PPROM, preterm birth, Quintero, Quintero stage 1, randomized trial
Plan
| Contributor affiliations: From the Department of Obstetrics and Fetal Therapy, Leiden University Medical Center, Leiden, the Netherlands (Dr Oepkes); Center for Fetal Diagnosis and Treatment, Children’s Hospital of Philadelphia, Philadelphia, PA (Dr Moldenhauer); Department of Obstetrics and Gynecology, University Hospitals Leuven and Department of Development and Regeneration, Biomedical Sciences, Katholieke Universiteit Leuven, Leuven, Belgium (Dr Deprest); Fetal Medicine Unit, Hôpital Femme Mère Enfants, Hospices Civils de Lyon, Lyon, France (Dr Massardier); and University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany (Dr Bamberg). |
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| The authors report no conflict of interest. |
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| This clinical trial is registered under number NCT01220011. |
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| Cite this article as: Stirnemann J, Slaghekke F, Khalek N, et al. Intrauterine fetoscopic laser surgery versus expectant management in stage 1 twin-to-twin transfusion syndrome: an international randomized trial. Am J Obstet Gynecol 2021;224:528.e1-12. |
Vol 224 - N° 5
P. 528.e1-528.e12 - mai 2021 Retour au numéro
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