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October 4, 2017Ultrasound in Obstetrics and GynecologyOpen Access

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

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Key result

Fetal valvuloplasty improved survival of liveborn infants compared with natural history cases (HR 0.38; 95% CI 0.23-0.64; P=0.0001), independent of final circulation.

Why the study?

Does fetal valvuloplasty improve survival and biventricular circulation in fetuses with aortic stenosis compared to natural history?

Population

214 fetuses with aortic stenosis, European multicenter cohort.

Comparison

Fetal valvuloplasty performed between 2005 and… vs Contemporaneously enrolled natural history cases…

Design

Cohort

Follow-up

up to 10 years

Authors

AKAlexander KovacevicAÖAnna ÖhmanGTGerald Tulzer

Discussion

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Overview

May support counseling for fetal aortic stenosis; leaves open randomized confirmation amid procedure risks.

Key Points

  • To evaluate the efficacy of fetal aortic valvuloplasty compared to natural history by assessing postnatal survival, left heart growth, and the preservation of biventricular circulation.
  • Retrospective multicenter study comparing fetuses with aortic stenosis undergoing fetal valvuloplasty (FV, n=67) between 2005 and 2012 against contemporaneous natural history (NH, n=147) controls.
  • Propensity score modeling and inverse probability of treatment weighting (IPTW) restricted to propensity scores of 0.14–0.9 created a balanced cohort of 42 FV and 29 NH cases.
  • Primary outcomes evaluated overall survival and biventricular circulation, alongside secondary evaluations of left heart growth and hemodynamic changes using regression models.
  • FV was technically successful in 59/67 (88%) fetuses at a median gestational age of 26 weeks, with procedure-related losses occurring in 7/72 (10%) and delivery at < 37 weeks in 22/53 (42%).
  • IPTW demonstrated significantly improved postnatal survival in liveborn infants following FV compared with NH cases (hazard ratio, 0.38; 95% CI, 0.23–0.64; P = 0.0001) after adjusting for circulation and surgical center.
  • Biventricular circulation was achieved in 36% of the FV cohort versus 38% of the NH cohort, while successful FV was associated with improved hemodynamics and reduced deterioration of left heart growth (P ≤ 0.01).

Study Design

Type

Cohort (n=214)

Multicenter

Yes

Structured PICO

Does fetal valvuloplasty improve survival and biventricular circulation in fetuses with aortic stenosis compared to natural history?

P
Population
214 fetuses with aortic stenosis (67 undergoing fetal valvuloplasty and 147 natural history cases) followed for up to 10 years.
E
Exposure
Fetal valvuloplasty (FV) performed between 2005 and 2012
C
Comparator
Contemporaneously enrolled natural history (NH) cases sharing similar characteristics at presentation but not undergoing FV
O
Outcome
Overall survival, biventricular (BV)-circulation survival and survival after birthhard clinical

Main Result

Hazard Ratio: 0.38 (95% CI 0.23–0.64)

p-value: p=0.0001

Fetal valvuloplasty for aortic stenosis improves postnatal survival compared to natural history, but is associated with significant procedure-related mortality and prematurity.

Limitations

  • 10% procedure-related loss
  • Increased prematurity compared with the natural history cohort
  • Uncertain risk-to-benefit ratio
  • Potential confounding by center-specific practices
  • Retrospective design
  • Center-specific practices

Cite This Study

Kovacevic et al. (2017) conducted a cohort in Fetal aortic stenosis (n=214). Fetal valvuloplasty vs. Natural history (no fetal valvuloplasty) was evaluated on Survival of liveborn infants (HR 0.38, 95% CI 0.23-0.64, p=0.0001). Fetal valvuloplasty improved survival of liveborn infants compared with natural history cases (HR 0.38; 95% CI 0.23-0.64; P=0.0001), independent of final circulation.

synapsesocial.com/papers/6a9761947f1bd40ee0e32ea0https://doi.org/10.1002/uog.18913
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Natural history of 107 cases of fetal aortic stenosis from a European multicenter retrospective study2016 · 87 citations
  2. 2Predictors of Technical Success and Postnatal Biventricular Outcome After In Utero Aortic Valvuloplasty for Aortic Stenosis With Evolving Hypoplastic Left Heart Syndrome2009 · 313 citations
  3. 3Intrauterine aortic valvuloplasty in fetuses with critical aortic stenosis: experience and results of 24 procedures2011 · 137 citations
  4. 4Fetal aortic valve stenosis: a critique of case selection criteria for fetal intervention2015 · 31 citations
  5. 5International Fetal Cardiac Intervention Registry2015 · 167 citations