Safety and efficacy of smart tracheal occlusion device in diaphragmatic hernia lamb model

Basurto, David; Sananès, Nicolas; Bleeser, Tom; Valenzuela, Ignacio; Leon, Noelle de; Joyeux, Luc; Verbeken, Eric; Vergote, Simen; Veeken, Lennart Van der; Russo, Francesca Maria; Deprest, Jan

doi:10.1002/uog.23135

Cited by 25 publications

(14 citation statements)

References 32 publications

(61 reference statements)

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“…The dimensions of the Smart-TO balloon and material (latex) are the same as the Goldbal2® balloon. For this reason, it is anticipated that the Smart-TO will induce similar lung growth compared to the Goldbal2® balloon, as previously demonstrated in preclinical studies [12, 17]. Additional outcome measurements include the occurrence of membrane rupture and preterm delivery, which is consistently reported in all FETO series.…”

Section: Discussionmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 76%

“…In that experiment, deflation was successfully achieved regardless of the fetal position and the exact level of the fetus from the ground [12]. In vivo animal tests included the demonstration of similar lung growth and short-term tracheal side effects as the Goldbal 2 balloon in fetal lambs [12] [13]. In the latter experiment, fetal lambs expelled the Smart-TO balloon following exposure to the fringe field of a 3T MRI.…”

Section: Introductionmentioning

confidence: 99%

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Fetoscopic Endoluminal Tracheal Occlusion with Smart-TO balloon: efficacy of removal and safety

Sananès

Basurto

Cordier

et al. 2022

Preprint

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Introduction One of the drawbacks of fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia is the need for a second invasive intervention to reestablish airway patency. The “Smart-TO” (Strasbourg University-BSMTI, France) is a new balloon for FETO, which spontaneously deflates when positioned near a strong magnetic field, e.g., generated by a magnetic resonance image (MRI) scanner. Translational experiments have demonstrated its efficacy and safety. We will now use the Smart-TO balloon for the first time in humans. Our main objective is the efficacy of prenatal deflation of the balloon by the magnetic field generated by an MRI scanner. Material and methods This is a phase-I study conducted in the fetal medicine units of Antoine–Béclère Hospital, France, and UZ Leuven, Belgium. Conceived in parallel, protocols were amended by the local Ethics Committees, resulting in some minor differences. This trial is a single-arm interventional feasibility study. Twenty (France) and 25 (Belgium) participants will have FETO with the Smart-TO balloon. Balloon deflation will be scheduled at 34 weeks or earlier if clinically required. The primary endpoint is the successful deflation of the Smart-TO balloon after exposure to the magnetic field of an MRI, assessed through ultrasound immediately after MRI-exposure. The secondary objective is to report on the safety of the balloon. The percentage of fetuses in whom the balloon is deflated after exposure will be calculated with its 95% confidence interval. Safety will be evaluated by reporting the nature, number, and percentage of serious unexpected or adverse reactions. Conclusion This phase-I study may provide the first evidence of the potential to reverse the occlusion by Smart-TO and free the airways non-invasively, as well as safety data.

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Section: Discussionmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 76%

Section: Introductionmentioning

confidence: 99%

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Fetoscopic Endoluminal Tracheal Occlusion with Smart-TO balloon: efficacy of removal and safety

Sananès

Basurto

Cordier

et al. 2022

Preprint

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“…Surgeons continue to optimize FETO by developing new surgical techniques and devices that improve outcomes. One recent example is the development of a smart tracheal occlusion device that not only autoregulates lung fluid egression to optimize lung growth, but also eliminates the need for a second fetoscopic procedure to deflate the balloon ( 112 ). In the same vein, another group has developed a degradable hydrogel for tracheal occlusion that would also obviate the need for a second surgery ( 113 ).…”

Section: Discussionmentioning

confidence: 99%

The Cellular and Molecular Effects of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

et al. 2022

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Congenital diaphragmatic hernia (CDH) is a complex disease associated with pulmonary hypoplasia and pulmonary hypertension. Great strides have been made in our ability to care for CDH patients, specifically in the prenatal improvement of lung volume and morphology with fetoscopic endoluminal tracheal occlusion (FETO). While the anatomic effects of FETO have been described in-depth, the changes it induces at the cellular and molecular level remain a budding area of CDH research. This review will delve into the cellular and molecular effects of FETO in the developing lung, emphasize areas in which further research may improve our understanding of CDH, and highlight opportunities to optimize the FETO procedure for improved postnatal outcomes.

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“…After deflation, the balloon is either swallowed by the fetus or exits the mouth into the amniotic fluid. Tests in large animal models confirmed that this device has similar occlusive and tracheal side effects as the currently used “Goldbal” balloon (Balt, Montmorency, France) and that it spontaneously releases after MRI exposure 41‐43 . In Leuven and Paris, we have moved to the “first‐in‐human" trial, aiming to demonstrate the feasibility to deflate the balloon by exposing the fetus to the magnetic field generated by a clinical MRI scanner.…”

Section: Improvements In Fetal Surgerymentioning

confidence: 97%

Antenatal management of congenital diaphragmatic hernia: What's next ?

et al. 2022

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Congenital diaphragmatic hernia can be diagnosed in the prenatal period and its severity can be measured by fetal imaging. There is now level I evidence that, in selected cases, Fetoscopic Endoluminal Tracheal Occlusion with a balloon increases survival to discharge from the neonatal unit as well as the risk for prematurity. Both effects are dependent on the time point of tracheal occlusion. Fetoscopic Endoluminal Tracheal Occlusion may also lead to iatrogenic death when the balloon cannot be timely retrieved. The implementation of the findings from our clinical studies, may also vary based on local conditions. These may be different in terms of available skill set, access to fetal therapy, as well as outcome based on local neonatal management. We encourage prior benchmarking of local outcomes with optimal postnatal management, based on large enough numbers and using identical criteria as in the recent trials. We propose to work further on prenatal prediction methods, and the improvement of fetal intervention. In this manuscript, we describe a research agenda from a fetal medicine perspective. This research should be in parallel with innovation in neonatal and pediatric (surgical) management of this condition. Kypros H. Nicolaides and Jan Deprest have contributed equally to this manuscript.

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Safety and efficacy of smart tracheal occlusion device in diaphragmatic hernia lamb model

Cited by 25 publications

References 32 publications

Fetoscopic Endoluminal Tracheal Occlusion with Smart-TO balloon: efficacy of removal and safety

Fetoscopic Endoluminal Tracheal Occlusion with Smart-TO balloon: efficacy of removal and safety

The Cellular and Molecular Effects of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

Antenatal management of congenital diaphragmatic hernia: What's next ?

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