Background
Fetal aortic valvuloplasty (FAV) is performed in cases of severe mid-gestation aortic stenosis with the goal of preventing HLHS. We aimed to evaluate the effect of technical aspects of FAV on procedural and pregnancy outcomes.
Methods
The International Fetal Cardiac Intervention Registry was queried for patients who underwent FAV from 2004 to 2018, excluding a single high-volume center. Patients were excluded if a cardiac puncture was not attempted or significant data was unavailable.
Results
Of 128 patients [mean gestational age (GA) 26.1±3.4 wks] considered for FAV, 108 had an attempted cardiac puncture and met inclusion criteria. The interventional needle was 17g in 6%, 18g in 64%, and 19g in 30%. 71% had 1 cardiac puncture, 19% had 2, 6% had 3, and 4% were missing this data. Intra-procedural complication occurred in 48%, including bradycardia (34%), pericardial (22%) or pleural effusion (3%), and balloon rupture (6%). Of the 100 with balloon inflation across the aortic valve, 90 were technically successful (increased forward flow or new regurgitation). Death within 48 h of procedure occurred in 18/108 (17%). There was 1 fetal demise beyond 48 h. 8 pregnancies were terminated. Of 81 patients born alive (median GA 38.1, IQR 36.1-39.0 wks), 59 were discharged home, 34 of whom were biventricular. Multiple cardiac punctures (>1) was associated with higher rates of procedural complications (p < 0.01), including bradycardia (p < 0.01), pleural effusion (p = 0.02), and death (p = 0.03). Needle size larger than 19g was associated with pericardial effusion (28% vs 9%, p = 0.04) but not death. Median balloon:annulus ratio (n= 65) was 1.1 (IQR 1-1.2). A larger ratio was not associated with technical success. On multivariate analysis, technical success was associated with live birth (OR 8.6, 95% CI 1.9-38.2, p < 0.01). For every 1 week increase in GA, the odds of live birth increased (OR 1.5, 95% CI 1.2-2, p < 0.01). For every 1 mm increase in balloon size, the odds of hospital discharge increased (OR 3.7, 95% CI 1.4-9.7, p < 0.01).
Conclusions
FAV is a high-risk procedure. Multiple cardiac punctures are associated with increased rates of complications and mortality. Later GA, technical success, and larger balloon size are associated with improved outcomes.