OC30: Updated results of the FETO task group as a prelude to setup of clinical trials

Abstract

To review the effect of fetoscopic endoluminal tracheal occlusion (FETO) at 26–29 w on fetuses with severe congenital diaphragmatic hernia (CDH) and define a strategy for future clinical trials. Eligibility for FETO was single fetus with severe CDH (lung-to-head ratio (LHR) < 1 and intrathoracic liver) without associated problems. FETO was at 26–29 w gestational age (GA). Outcome measure was postnatal pulmonary outcome i.e. survival withoutor death due to pulmonary hypoplasia and/or hypertension. Regression analysis was used to investigate the effect on survival of LHR prior to FETOgestational age at FETO and at deliverypreterm amniorrhexis or prenatal removal of the balloon. 43 left and 10 right-sided CDH cases had a median LHR = 0.7 prior to FETO (range: 0.5–0.9). All but 1 operation were successful at 1st attempt with a median operation time of 10 min (range: 3–60). There were no maternal complications. Amniorrhexis occurred in 26% at < 32 wksin the last half it was 16%. Median GA at delivery was 35 wks (range 27–41). Airways were restored either perinatally (n = 18) or by planned retrieval at 34 wks (n = 35). Early neonatal survival resp. at discharge were 60% (32/53) and 51% (27/53). LHR prior to FETO is predicting survivalincreasing from 13% for LHR < 0.6 (n = 8) to 52% for LHR of 0.6⩽LHR < 0.8 (n = 25) and 65% for 0.8⩽LHR < 1 (n = 20). Left sided lesions did better than right sided. A learning curve is suggested by improving PPROM rates and GA at delivery (37 wks in the latter two thirds of a single surgeon experience with FETO (22/33). Survival after FETO is dependent on preoperative LHR and we suggest to stratify likewise. When LHR < 0.6 survival rate is only 13%therefore pulmonary response to very early FETO (< 24 w) should be studied. Survival in fetuses with CDH and 0.6⩽LHR < 1.0 is 58%. In the more common left sided group we suggest randomisation against optimal postnatal care.