Fetal hemodynamic response to aortic valvuloplasty and postnatal outcome: a European multicenter study

Abstract

We report improvements in fetal hemodynamics and preservation of left heart growth following successful FV compared with NH. While the proportion of those achieving a BV circulation outcome was similar in both cohorts, FV survivors showed improved survival independent of final circulation to 10 years' follow-up. However, FV is associated with a 10% procedure-related loss and increased prematurity compared with the NH cohort, and therefore the risk-to-benefit ratio remains uncertain. We recommend a carefully designed trial incorporating appropriate and integrated fetal and postnatal management strategies to account for center-specific practices, so that the benefits achieved by fetal therapy vs surgical strategy can be demonstrated clearly. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Fetal aortic valvuloplasty to prevent progression to hypoplastic left heart syndrome in utero

“…Technical success has been reported to range from 77 to 94% (Friedman et al, ; Galindo et al, ; Kovacevic et al, ), with higher success rates at centers with greater experience. Similarly, although fetal demise rates of ~10% were previously described (Freud et al, ; Kovacevic et al, ; Moon‐Grady et al, ), a large center recently reported that their rate has decreased to <5% (Friedman et al, ). Importantly, no significant maternal complications have been reported (Wohlmuth, Tulzer, Arzt, Gitter, & Wertaschnigg, ).…”

“…In contrast, 80% (69 of 86) that underwent FAV were alive postnatally with 40% achieving a biventricular circulation (Moon-Grady et al, 2015). Most recently, improved survival at 10 years was noted among patients who underwent FAV in Europe (Kovacevic et al, 2018). While this survival advantage seemed to be independent of the final circulation, the numbers were quite limited.…”

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“…The Boston group's results were slightly better than those from 2 European studies showing 88% and 74% technical success rates, and biventricular repair rates of 36% and 78%, respectively . Given the lack of randomized trials in this field, it is still unclear whether the outcomes of intervention are better than the natural history of the disease and offset the increased risk of fetal death due to the procedure (6%–36%) .…”

“…46 The Boston group's results were slightly better than those from 2 European studies showing 88% and 74% technical success rates, and biventricular repair rates of 36% and 78%, respectively. 47,48 Given the lack of randomized trials in this field, it is still unclear whether the outcomes of intervention are better than the natural history of the disease and offset the increased risk of fetal death due to the procedure (6%-36%). 44,47,48 Indeed, Gardiner et al recently published a large "natural history" cohort that showed that approximately 1 in 3 fetuses fulfilling the criteria for intra-uterine intervention still had a biventricular postnatal circulation, even without the procedure.…”

“…47,48 Given the lack of randomized trials in this field, it is still unclear whether the outcomes of intervention are better than the natural history of the disease and offset the increased risk of fetal death due to the procedure (6%-36%). 44,47,48 Indeed, Gardiner et al recently published a large "natural history" cohort that showed that approximately 1 in 3 fetuses fulfilling the criteria for intra-uterine intervention still had a biventricular postnatal circulation, even without the procedure. 49 As such, fetal aortic valvuloplasty remains experimental, and further refinement of selection criteria or a randomized controlled trial comparing intervention to expectant management with standardized postnatal care are urgently needed.…”