Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
Queen Silvia Children's Hospital, Gothenburg, Sweden
Summary
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective. The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2/ to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3/ to also describe side effects and risks in fetuses and mothers of the fetal procedure.
Description
Routinely collected pre- and postnatal clinical data will be entered into a digital database and echocardiographic examinations will be uploaded to a server. A core lab will measure and analyze all echocardiographic examinations according to protocol. The growth of the left heart structures and the postnatal outcome will be compared between the intervention and non-intervention groups. The decision whether a fetal balloon dilatation shall be attempted is not part of the study protocol. The number of examinations of mother/fetus/infant in this study is not different from the number of examinat…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al): 1. Aortic valve stenosis with antegrade flow through the valve 2. Predominantly left-to-right shunt at the atrial level 3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels 4. Qualitatively depressed left ventricular function 5. Left ventricular end-diastolic diameter Z-score \> ±0 6. Left ventricular inlet length in diastole : 1. Gestational age ≤ 24+6: Z-score \> ±0 2. Gestational…
Interventions
- ProcedureFetal aortic balloon dilatation
Fetal valvuloplasty will be performed as described in Arzt W, Wertaschnigg D, Veit I, Klement F, Gitter R, Tulzer G. Intrauterine aortic valvuloplasty in fetuses with critical aortic stenosis: experience and results of 24 procedures. Ultrasound Obstet Gynecol. 2011;37:689-695. with minor variations between centers involved. Technical success is defined as improved forward flow and/or new aortic regurgitation.
Locations (13)
- Fetal Cardiovascular Program, University of California San FranciscoSan Francisco, California
- Congenital Heart Collaborative, Nationwide Children's HospitalColumbus, Ohio
- Kinderherzzentrum LinzLinz
- The Hospital for Sick Children TorontoToronto
- Department of Paediatric Cardiology, Helsinki University Children's HospitalHelsinki
- Pediatric Cardiology - University Hospital BonnBonn