Ultrasound-guided high-intensity focused ultrasound is technically feasible and safe for occluding placental vessels in early-onset twin-twin transfusion syndrome
Abstract
Background: Twin-twin transfusion syndrome is a complication unique to monochorionic pregnancy, where shared placental vascular connections can lead to a circulatory imbalance, resulting in preterm delivery and attendant in utero or neonatal mortality. The only disease-modifying treatment is fetoscopic laser ablation of blood vessels, which has attendant risks of invasive intrauterine therapy.
Objective: In this first-in-human technical feasibility and safety study, we investigated noninvasive, ultrasound-guided high-intensity focused ultrasound to occlude placental vascular targets as identified by color Doppler. The 2 outcomes were (1) safety: number/rate of patients experiencing significant iatrogenic harm, for first 14 days after high-intensity focused ultrasound and (2) efficacy: number/rate of targeted placental vessels which appear occluded at the end of a high-intensity focused ultrasound treatment cycle, assessed using comparison of color Doppler imaging of target anastomoses prehigh-intensity focused ultrasound and posthigh-intensity focused ultrasound exposure.
Study design: Participants with anterior placenta and early-onset twin-twin transfusion syndrome were recruited to a Phase 1a clinical trial with co-primary endpoints of safety and efficacy of vessel occlusion at 12 to 17+6 weeks of gestational age.
Results: Ten participants underwent targeted ultrasound-guided high-intensity focused ultrasound occlusion of placental blood vessels that connected the 2…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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