Affiliation:
1. Division of Maternal–Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences UTHealth The University of Texas McGovern Medical School and the Fetal Center at Children's Memorial Hermann Hospital Houston TX USA
2. HeartStitch Inc. Fountain Valley CA USA
Abstract
ABSTRACTObjectiveTo assess the feasibility of using a novel device designed for minimally invasive suturing to anchor fetal membranes to the uterine wall and to close surgical defects after fetoscopy.MethodsWe tested the WestStitch™ suturing device both ex vivo and in vivo. In the ex‐vivo studies, 12‐Fr trocar defects were created with a fetoscope in five specimens of human uterine tissue with fetal membranes attached. Specimens were examined for integrity of the anchoring stitch. For the in‐vivo studies, trocar defects were created in the two uterine horns of three pregnant ewes, each carrying twins at approximately 79–90 days' gestation. One trocar defect in each ewe was repaired using the suture device, and the other was left unrepaired as a control. The repair sites were examined for membrane‐anchoring integrity when the defect was created and at delivery.ResultsFetal membranes were anchored successfully to the uterine myometrium using the suture‐delivery device in all five experiments performed ex vivo. The in‐vivo experiments also revealed successful membrane anchoring compared with controls, both at the time of device deployment and 1–9 weeks after the procedure.ConclusionsWe successfully anchored amniotic membranes to the underlying myometrium using a suturing device, both ex vivo and in vivo. Further studies are needed to evaluate the efficacy of the device and to determine whether it can successfully anchor fetal membranes percutaneously in human patients. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.