Technical Success and Serious Adverse Events for Fetal Aortic Valvuloplasty in a Large 20-Year Cohort
Authors' conclusion
TS of FAV has improved over time, and failure is associated with smaller fetal left heart sizes. SAEs are common and are associated with smaller left hearts and longer procedure times.
Study context
- Population
- Fetuses with severe aortic valve stenosis and evolving hypoplastic left heart syndrome undergoing attempted fetal aortic valvuloplasty (FAV), 2000–2020165 FAVs attempted
- Participants
- 163 fetuses
- Outcome
- Technical success (TS) of FAV
Methodological detailssingle-centre
- Single-centre
Main finding
As reported in the abstract
FAV technical success
- Overall technical success (TS)
- 85% (141/165)
- TS 2010–2020 era vs earlier era
- 94% [85/90] vs 75% [56/75]; P < 0.001
- Pre-FAV left ventricle (LV) long axis dimension z-score >−0.10 independently associated with higher odds of TS
- P < 0.001
- Higher LVEF independently associated with higher odds of TS
- P = 0.037
Observational data: associations, not effects.
Safety
Serious adverse events (secondary outcome)
- Serious adverse events (SAEs)
- 117 SAEs in 67 attempted FAVs (41%)
- Fetal deaths
- 13 (7.9%)
- LV end-diastolic volume <4.09 mL, age-adjusted OR for SAE
- 4.71 (95% CI: 1.67-13.29; P = 0.004)
- Gestational age <21 weeks, or in older fetuses procedure time ≥39.6 minutes, associated with higher SAE rate (classification and regression tree analysis)
- Multivariable logistic regression correcting for gestational age
Original publication
Technical Success and Serious Adverse Events for Fetal Aortic Valvuloplasty in a Large 20-Year Cohort. JACC Adv. Published 2 February 2024. doi:10. 1016/ j. jacadv. 2024. 100835
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