The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians · 2024
Proof of concept testing of a vascular closure device for use in fetal surgery.
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Forde Braxton, Martin Samuel, Oria Marc, Kapke Jordan, Krispin Eyal, Peiro Jose L
Аннотация
OBJECTIVE: Prior clinical findings have demonstrated that maternal laparotomy with trans-amniotic trans-uterine suturing of the fetoscopic port site during in utero myelomeningocele repair reduces the risk of membrane rupture. However, due to laparotomy-associated morbidity, we aimed to explore the feasibility of using a vascular closure device for percutaneous trans-amniotic trans-uterine suturing.
METHODS: This IRB and IACUC-exempt study utilized 2 strategies for proof-of-concept testing of using the Abbott Perclose™ ProStyle™ Device for suture placement; 1. Ultrasound guided application on a high fidelity maternal abdominal uterus model used for fetal procedures and 2. Placement under direct visualization with sheep undergoing cesarean delivery for other research purposes. In the high-fidelity uterus model, the Abbott Perclose™ ProStyle™ device was used to place a transuterine/transamniotic stitch with accompanying video recording of the approach (https://go.screenpal.com/watch/cZfhoDVsYvW password: perclose). Regarding the second approach, at the time of a cesarean section, 12 French Checkflo® cannulas were inserted into the sheep amniotic space via different approaches: (1) Seldinger technique, (2) Seldinger technique insertion of Checkflo® cannula and subsequent use of the Abbott Perclose™ ProStyle™ device to suture the port site after check flow removal, (3) Abbott Perclose™ ProStyle™ device utilized in what is described as a "pre-close" technique, where prior to cannula placement, trans-uterine trans-amniotic stitches are placed followed by the insertion of a 12 French Checkflo® cannula over the same guidewire. Samples of the sutured uterine wall were sent to pathology and H&E staining was performed to assess uterine hole closure and amnion-to-uterus fixation.
RESULTS: The high-fidelity model confirmed that the Perclose™ ProStyle™ Device was easily visualized by ultrasound and suture deployment was without complication. In the animal model, the Perclose™ ProStyle™ device effectively sutured the amnion to the uterus in both the pre- and post-close approach. The pre-close technique achieved better amnion-to-uterus approximation and more appropriate uterine hole closure. H&E staining revealed that without suturing, amnion separation from the chorion layer occurred, and the uterine hole persisted. The post-close technique showed partial connection between the amnion and chorion, but inadequate uterine hole closure with amnion shift into the defect. Optimal closure, with secure amnion-to-chorion fixation and uterine closure, was achieved through the pre-close technique.
CONCLUSION: The Abbott Perclose™ ProStyle™ Device seems to be a feasible device for use of uterine port closure in maternal-fetal surgery, larger animal studies with mid-pregnancy application are needed to further validate or refute these findings.
METHODS: This IRB and IACUC-exempt study utilized 2 strategies for proof-of-concept testing of using the Abbott Perclose™ ProStyle™ Device for suture placement; 1. Ultrasound guided application on a high fidelity maternal abdominal uterus model used for fetal procedures and 2. Placement under direct visualization with sheep undergoing cesarean delivery for other research purposes. In the high-fidelity uterus model, the Abbott Perclose™ ProStyle™ device was used to place a transuterine/transamniotic stitch with accompanying video recording of the approach (https://go.screenpal.com/watch/cZfhoDVsYvW password: perclose). Regarding the second approach, at the time of a cesarean section, 12 French Checkflo® cannulas were inserted into the sheep amniotic space via different approaches: (1) Seldinger technique, (2) Seldinger technique insertion of Checkflo® cannula and subsequent use of the Abbott Perclose™ ProStyle™ device to suture the port site after check flow removal, (3) Abbott Perclose™ ProStyle™ device utilized in what is described as a "pre-close" technique, where prior to cannula placement, trans-uterine trans-amniotic stitches are placed followed by the insertion of a 12 French Checkflo® cannula over the same guidewire. Samples of the sutured uterine wall were sent to pathology and H&E staining was performed to assess uterine hole closure and amnion-to-uterus fixation.
RESULTS: The high-fidelity model confirmed that the Perclose™ ProStyle™ Device was easily visualized by ultrasound and suture deployment was without complication. In the animal model, the Perclose™ ProStyle™ device effectively sutured the amnion to the uterus in both the pre- and post-close approach. The pre-close technique achieved better amnion-to-uterus approximation and more appropriate uterine hole closure. H&E staining revealed that without suturing, amnion separation from the chorion layer occurred, and the uterine hole persisted. The post-close technique showed partial connection between the amnion and chorion, but inadequate uterine hole closure with amnion shift into the defect. Optimal closure, with secure amnion-to-chorion fixation and uterine closure, was achieved through the pre-close technique.
CONCLUSION: The Abbott Perclose™ ProStyle™ Device seems to be a feasible device for use of uterine port closure in maternal-fetal surgery, larger animal studies with mid-pregnancy application are needed to further validate or refute these findings.