A collagen plug with shape memory to seal iatrogenic fetal membrane defects after fetoscopic surgery

Meuwese, Rob T.C.; Versteeg, E.M.M.; Drongelen, J. van; Hoog, Daniëlle de; Bouwhuis, Debora; Vandenbussche, Frank P.H.A.; Kuppervelt, Toin H. van; Daamen, Willeke F.

doi:10.1016/j.bioactmat.2022.06.007

Cited by 5 publications

(6 citation statements)

References 42 publications

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“…One previous systematic review on this topic was excluded [46] because the authors described the same cases as this review and included one article with iatrogenic PPROM and one article that raised concerns. Finally, 14 studies met the eligibility criteria and were included and analyzed in this systematic review [47][48][49][50][51][52][53][54][55][56][57][58][59][60]. Four studies [47][48][49][50] on the spontaneous premature rupture of membranes analyzed the outcomes for 141 pregnancies and sealing and healing methods: 82 cases using an amniopatch with autologous or donor platelet concentrates and cryoprecipitate inserted by the ultrasound-guided amnioinfusion technique and 59 cases using an immunologic sealant or a mechanical cervical adapter for sealing (Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…As the main differences from humans, animal models are represented by shorter gestation time and vascularized membranes [60]. Sealing materials applied in animal models have demonstrated a pathway of activation of the innate immune system and an increase in amniotic macrophages, which release limited and well-localized cytokines and growth factors such as TNF and IL-1β [52].…”

Section: Resultsmentioning

confidence: 99%

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Is Spontaneous Preterm Prelabor of Membrane Rupture Irreversible? A Review of Potentially Curative Approaches

et al. 2023

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There is still no curative treatment for the spontaneous preterm prelabor rupture of membranes (sPPROM), the main cause of premature birth. Here, we summarize the most recent methods and materials used for sealing membranes after sPPROM. A literature search was conducted between 2013 and 2023 on reported newborns after membranes were sealed or on animal or tissue culture models. Fourteen studies describing the outcomes after using an amniopatch, an immunologic sealant, or a mechanical cervical adapter were included. According to these studies, an increase in the volume of amniotic fluid and the lack of chorioamnionitis demonstrate a favorable neonatal outcome, with a lower incidence of respiratory distress syndrome and early neonatal sepsis, even if sealing is not complete and stable. In vivo and in vitro models demonstrated that amniotic stem cells, in combination with amniocytes, can spontaneously repair small defects; because of the heterogenicity of the data, it is too early to draw a thoughtful conclusion. Future therapies should focus on materials and methods for sealing fetal membranes that are biocompatible, absorbable, available, easy to apply, and easily adherent to the fetal membrane.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Is Spontaneous Preterm Prelabor of Membrane Rupture Irreversible? A Review of Potentially Curative Approaches

et al. 2023

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“…No previously developed device managed to reduce the risk of PPROM or PTD associated with fetoscopic surgery, which is likely due to inadequate integration and high resorption rates [30][31][32][33][34] . The newly proposed plug strategy is expected to overcome these limitations, as it is designed to remain fixed tightly within the defect due to its immediate expansion and shape memory upon employment 35 . Additionally, no sutures are required.…”

Section: Discussionmentioning

confidence: 99%

Plugging membranes after fetoscopy in congenital diaphragmatic hernia: early cost‐effectiveness analysis

Janssen¹,

Drongelen²,

Daamen

et al. 2023

Ultrasound in Obstet & Gyne

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Objectives Fetal endoscopic tracheal occlusion (FETO) improves neonatal survival of fetuses with congenital diaphragmatic hernia (CDH). However, FETO also increases the risk of preterm prelabor rupture of membranes (PPROM) and preterm delivery (PTD), as fetal membrane defects after fetoscopy do not heal. To solve this issue, an advanced sealing plug for closing the membrane defect is being developed. Using early‐stage health economic modeling, we aimed to estimate the potential value of this innovative plug in terms of costs and effects, and to determine the properties required for it to become cost‐effective. Methods Early‐stage health economic modeling was applied to the case of performing FETO in women with a singleton pregnancy whose fetus is diagnosed prenatally with CDH. We simulated a cohort of patients using a state‐transition model over a 45‐year time horizon. In our best‐case‐scenario analysis, we compared the current‐care strategy with the perfect‐plug strategy, which reduces the risk of PPROM and PTD by 100%, to determine the maximum quality‐adjusted life years (QALYs) gained and costs saved. Using threshold analysis, we determined the minimum percentage reduction in the risk of PPROM and PTD required for the plug to be considered cost‐effective. The impact of model parameters on outcome was investigated using a sensitivity analysis. Results Our model indicated that a perfect‐plug strategy would yield on average an additional 1.94 QALYs at a cost decrease of €2554 per patient. These values were influenced strongly by the percentage of cases with early PTD (27–34 weeks). Threshold analysis showed that, for €500 per plug, the plug strategy needs a minimum percentage reduction of 1.83% in the risk of PPROM and PTD (i.e. reduction in the risk from 47.50% to 46.63% for PPROM and from 71.50% to 70.19% for PTD) to be cost‐effective. Conclusions Our model‐based approach showed clear potential of the plug strategy when applied in the context of FETO for CDH fetuses, as only a minor reduction in the risk of PPROM and PTD is needed for the plug to be cost‐effective. Its value is expected to be even higher when used in conditions associated with a higher rate of early PTD. Continued investment in research and development of the plug strategy appears to provide value for money. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

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“…Furthermore, a driver of prematurity is PPROM, as the hole in the membrane created by the fetoscopic instruments does not heal, and up to 40% of all FLP will end in PPROM 10–12 . Various tocolytic regimens from magnesium to indomethacin to nifedipine have been evaluated postoperatively, without any particular regimen proven to impact the latency time from surgery to delivery, and much of the work on prevention of PPROM has focused on ways to close the defect created by the fetoscopic entry 13,14 . In one study, the use of an amnioinfusion during FLP was associated with preterm delivery, 15 it has been postulated that the fluid used may contribute to membrane breakdown, 10 and recent presentations have shown that even with a small uterine defect, repeatedly infusing fluid into the amniotic space is associated with high rates of PPROM 16 .…”

Section: Introductionmentioning

confidence: 99%

“…[10][11][12] Various tocolytic regimens from magnesium to indomethacin to nifedipine have been evaluated postoperatively, without any particular regimen proven to impact the latency time from surgery to delivery, and much of the work on prevention of PPROM has focused on ways to close the defect created by the fetoscopic entry. 13,14 In one study, the use of an amnioinfusion during FLP was associated with preterm delivery, 15 it has been postulated that the fluid used may contribute to membrane breakdown, 10 and recent presentations have shown that even with a small uterine defect, repeatedly infusing fluid into the amniotic space is associated with high rates of PPROM. 16 For this reason, we set to analyze specifically if a large volume amnioinfusion at the time of FLP adversely affected outcomes and if this occurred in a volume dependent fashion.…”

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confidence: 99%

Association of amnioinfusion volume at the time of surgery for twin‐twin transfusion syndrome and latency to delivery

et al. 2023

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ObjectiveTo evaluate the impact of amnioinfusion and other peri‐operative factors on pregnancy outcomes in the setting of Twin‐twin transfusion syndrome (TTTS) treated via fetoscopic laser photocoagulation (FLP).MethodsRetrospective study of TTTS treated via FLP from 2010 to 2019. Pregnancies were grouped by amnioinfusion volume during FLP (<1 L vs. ≥1 L). The primary outcome was latency from surgery to delivery. An amnioinfusion statistic (AIstat) was created for each surgery based on the volume of fluid infused and removed and the preoperative deepest vertical pocket. Regression analysis was planned to assess the association of AIstat with latency.ResultsPatients with amnioinfusion of ≥1 L at the time of FLP had decreased latency from surgery to delivery (61 ± 29.4 vs. 73 ± 28.8 days with amnioinfusion <1 L, p < 0.001) and increased preterm prelabor rupture of membranes (PPROM) <34 weeks (44.7% vs. 33.5%, p = 0.042). Amnioinfusion ≥1 L was associated with an increased risk of delivery <32 weeks (aRR 2.6, 95% CI 1.5–4.5), 30 weeks (aRR 2.4, 95% CI 1.5–3.8), and 28 weeks (aRR 1.9, 95% CI 1.1–2.3). Cox‐proportional regression revealed that AIstat was inversely associated with latency (HR 1.1, 95% CI 1.1–1.2).ConclusionAmnioinfusion ≥1 L during FLP was associated with decreased latency after surgery and increased PPROM <34 weeks.

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A collagen plug with shape memory to seal iatrogenic fetal membrane defects after fetoscopic surgery

Cited by 5 publications

References 42 publications

Is Spontaneous Preterm Prelabor of Membrane Rupture Irreversible? A Review of Potentially Curative Approaches

Is Spontaneous Preterm Prelabor of Membrane Rupture Irreversible? A Review of Potentially Curative Approaches

Plugging membranes after fetoscopy in congenital diaphragmatic hernia: early cost‐effectiveness analysis

Association of amnioinfusion volume at the time of surgery for twin‐twin transfusion syndrome and latency to delivery

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