Non-invasive high-intensity focused ultrasound treatment of the placenta: a preliminary in-vivo study using a simian model.

OBJECTIVE: To demonstrate the feasibility and efficacy of high-intensity focused ultrasound (HIFU) for the non-invasive creation of placental lesions in a simian model. METHODS: Eight pregnant monkeys were exposed to HIFU treatment after anesthesia, using a toroidal HIFU 2.5-MHz transducer with an integrated ultrasound imaging probe. Lesions on the placental tissue were created non-invasively by placing the HIFU probe on the skin surface. Fetal and maternal parameters, such as maternal heart rate, fetal heart rate and subcutaneous and intra-amniotic fluid temperature, were recorded during HIFU exposure. Cesarean section was performed immediately after the procedure to extract the placenta and examine the fetus and the maternal abdominal cavity. Placental HIFU lesions were assessed by ultrasound, gross pathology and histology. RESULTS: The mean gestational age of the monkeys was 72 ± 4 days. In total, 13 HIFU procedures were performed. The acoustic power and exposure time were increased progressively. This gradual increase in total energy delivered was used to determine a set of parameters to create reproducible lesions in the placenta without complications. Five placental lesions were observed with average diameters of 6.4 ± 0.5 mm and 7.8 ± 0.7 mm and an average depth of 3.8 ± 1.5 mm. Ultrasound examination of the placentae revealed hyperechoic regions that correlated well with macroscopic analysis of the HIFU lesions. Necrosis of placental tissue exposed to HIFU was confirmed with macroscopic and microscopic analysis. There was no significant variation in maternal and fetal parameters during HIFU exposure. CONCLUSIONS: This study demonstrates the feasibility of HIFU applied non-invasively to the placental unit in an in-vivo pregnant monkey model. The technique is safe in the immediate short term and is potentially translatable to human pregnancy. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

High-intensity focused ultrasound applied to the placenta using a toroidal transducer: a preliminary ex-vivo study.

OBJECTIVE: To demonstrate in an ex-vivo model the feasibility of applying high-intensity focused ultrasound (HIFU) using a toroidal transducer for the creation of placental lesions. METHODS: In this study we used a toroidal transducer, composed of 32 ring-shaped emitters with an ultrasound probe at the center, operating at a frequency of 2.5 MHz. We examined 45 human placentae, following either normal vaginal delivery or medical termination of pregnancy between 17 and 40 gestational weeks. First, the attenuation coefficients of 12 human placentae were measured and integrated into a numerical model for simulating HIFU lesions. Then, using acoustic parameters from this preliminary study, we performed ex-vivo experiments with 33 human placentae, each overlain with an animal abdominal wall to simulate the maternal wall. We created single HIFU lesions in 25 of these placentae, and a series of six juxtaposed lesions in eight, studying these both sonographically and macroscopically. RESULTS: Human placental attenuation coefficients of the 12 human placentae ranged from 0.072 to 0.098 Np/cm/MHz, according to gestational age. The 25 single HIFU lesions created had an average diameter of 7.1 ± 3.2 mm and an average depth of 8.2 ± 3.1 mm. The average diameter of the eight series of six juxtaposed HIFU lesions was 23.0 ± 5.0 mm and the average depth was 11.0 ± 4.7 mm. The average thickness of the abdominal walls was 10.5 ± 1.8 mm. No lesions or damage were observed in intervening tissues. CONCLUSION: This study demonstrates, using an ex-vivo model, the feasibility, reproducibility, harmlessness and effectiveness of HIFU applied to the human placenta.