New intrauterine shunt for treatment of fetal fluid accumulation: single‐center experience of first 17 cases

Nørgaard, Lone Nikoline; Søgaard, Kirsten; Jensen, Line; Ekelund, Charlotte Kvist; Kahrs, B.H.; Tabor, Ann; Sundberg, Karin

doi:10.1002/uog.19074

Cited by 7 publications

(16 citation statements)

References 6 publications

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“…The single case of in utero death that occurred 4 weeks after a successful shunting was not procedure related. We concur with Nørgaard et al [7] that the Somatex shunt is easy to handle when compared to other designs of shunts.…”

Section: Discussionsupporting

confidence: 91%

“…To our knowledge, our series of 8 pleural shunting procedures using the new Somatex shunt is the second report in the literature after that of Nørgaard et al [7]. The overall outcomes were satisfactory, with successful and smooth procedures and high survival rate, though minor complications commonly occurred afterward.…”

Section: Discussionmentioning

confidence: 65%

“…We had 1 case (16.7%) of ROM 1 week after bilateral shunting was performed at around 33 gestational weeks. The risk of ROM was 13.3% (2/15) in the study by Nørgaard et al [7]. The overall ROM rate from both series using the Somatex shunt would be 14.3% (3/21), which is comparable to a PROM rate of 6–15% in other series with other shunts [8].…”

Section: Discussionmentioning

confidence: 89%

“…Nørgaard et al [7] reported the first series using Somatex shunts for in utero treatment. Among their 17 cases, 5 were unilateral hydrothorax (3 also had hydrops), 10 were bilateral hydrothorax (hence 1 shunt for each side; 7 also had hydrops), and there was also 1 case of isolated ascites and 1 case of congenital cystic adenomatoid malformation.…”

Section: Discussionmentioning

confidence: 99%

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The Use of Somatex Shunt for Fetal Pleural Effusion: A Cohort of 8 Procedures

et al. 2021

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Introduction: Fetal pleural effusion may require in utero shunting which is associated with procedure-related complications. Objective: To evaluate the efficacy and complications of the newly designed Somatex shunt in treating fetal pleural effusion. Methods: Consecutive cases with primary fetal pleural effusion who were treated with the Somatex shunt between 2018 and 2019 were evaluated. Perinatal outcomes and complications were retrospectively analyzed. Results: There were 6 cases of unilateral and 1 case of bilateral pleural effusion, and hence a total of 8 pleuroamniotic shunting procedures were performed. The median gestational age at diagnosis and shunting was 20.7 and 22.6 weeks, respectively. All 8 procedures were successful, achieving complete in utero drainage. All but one were live births (85.7%) with a median gestational age of 38 weeks. The single case of in utero death occurred 4.7 weeks after successful shunting, and no cause could be identified after autopsy. The rates of preterm birth and premature rupture of membranes were 33.3% (2/6) and 16.7% (1/6), respectively. Four of the 8 procedures (50%) had minor shunt-related complications such as dislodgement and entrapment, occurring at a median of 7.7 weeks after shunting. None of the shunts became blocked. Conclusions: The Somatex shunt is effective in relieving fetal pleural effusions with good survival rate. Overall, it was a safe instrument, though minor shunt complications occurred.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 65%

Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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The Use of Somatex Shunt for Fetal Pleural Effusion: A Cohort of 8 Procedures

et al. 2021

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“…A smaller, more flexible, polyethylene catheter, with a 0.97 mm ID and 1.67 mm OD (5F), first reported by Harrison et al [28], is available in 15–35 mm length and is inserted via a 13 G needle (Cook Medical, Bloomington, IN, USA). Other shunts include an 18 G, OD 2.6 mm nitinol wire mesh shunt (Somatex® Medical Technologies, Berlin, Germany), so far only available in Europe [29], a 4F (1.33 mm OD) angiographic single pigtail catheter (Cordis, Cardinal Health, Santa Clara, CA, USA) [18] and a double-basket polyethylene catheter 0.9 mm ID and 1.47 mm OD (Hakko Co., Nagano, Japan) [30]. The latter is short and straight in shape and is the thinnest shunt available with theoretical benefits of clearer visualization on ultrasound and easier insertion in early pregnancy.…”

Section: Discussionmentioning

confidence: 99%

Perinatal Outcome in Fetuses with Dislodged Thoraco-Amniotic Shunts

et al. 2021

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Objective: Fetal thoraco-amniotic shunts (TASs) can dislodge in utero, migrating internally into the fetal thorax or externally into the amniotic cavity. Our objective was to evaluate the perinatal and long-term outcome of fetuses with TAS dislodgement and conduct a review of the literature. Methods: This is a retrospective review of all TAS inserted for primary pleural effusions and macrocystic congenital pulmonary airway malformations (CPAMs) in a tertiary fetal medicine center (1991–2020). Antenatal history, procedural factors, and perinatal and long-term outcomes were reviewed in all fetuses with dislodged shunts and compared to fetuses with shunts that did not dislodge. Results: Of 211 TAS inserted at a mean gestational age of 27.8 weeks ± 5.47 (17.4–38.1 weeks), 187 (89%) were inserted for pleural effusions and 24 (11%) for macrocystic CPAMs. Shunts dislodged in 18 fetuses (8.5%), 17 (94%) of which were for pleural effusions. Shunts migrated into the chest wall/amniotic cavity or into the thorax among 7/18 (39%) and 11/18 (61%) fetuses, respectively. Eleven (61%) fetuses were initially hydropic, which resolved in 8 (72%) cases. Effusions were bilateral in 9 (50%), amnioreduction was required in 6 (33%), and fetal rotation in 8 cases (44%). Four (22%) fetuses underwent repeat shunting, 12 (67%) neonates required ventilatory support, and 2 (11%) neonates required chest tubes. There was no significant difference in technical factors or outcomes between infants with shunts that dislodged and those that did not. Among 11 intrathoracic shunts, 2 (18%) were removed postnatally and the remainder are in situ without any shunt-related or respiratory complications over a follow-up period of 9 months to 22 years. Conclusion: TAS dislodged antenatally in 8.5% of fetuses, with 2/3 of shunts migrating into the thorax, and nearly 25% requiring re-shunting. Retained intrathoracic shunts were well tolerated and may not necessarily require surgical removal after birth.

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Development and in‐vitro characterization of a novel fetal vesicoamniotic shunt – The Vortex shunt

Sheth

Danzer

Johnson³

et al. 2022

Prenatal Diagnosis

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Objectives To develop and test a novel vesicoamniotic shunt (VAS) to treat fetal lower urinary tract obstruction (LUTO), decrease dislodgement and optimize shunt deployment in‐vitro. Methods Vesicoamniotic shunt design objectives included: (1) robust and atraumatic fixation elements, (2) kink resistant conduit to adjust to fetal movement and growth, (3) one‐way pressure valve to facilitate bladder cycling, and (4) echogenic deployment visualization aids. The force to dislodge the novel Vortex shunt was compared with existing commercially available shunts in a bench‐top porcine bladder model. Sonographic echogenicity was evaluated with ultrasound‐guided deployment, and the shunt valve pressure measured. Results A prototype novel Vortex shunt was developed using braided nitinol “umbrella‐type” ends with a kink‐resistant stem incorporating an internal one‐way valve. The peak force required to dislodge the Vortex shunt was significantly higher than commercially available shunts (p < 0.01). Shunt deployment in the bench‐top model was easily confirmed with ultrasound guidance and the brisk decompression of the inflated porcine bladder thereafter. In‐vitro valve gauge pressure testing mirrored bladder pressures in human LUTO cases. Conclusion In‐vitro testing shows that the Vortex shunt may improve deployment, sonographic visualization, kink resistance, and dynamic size adjustment. Validation in preclinical animal models are warranted and currently underway.

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New intrauterine shunt for treatment of fetal fluid accumulation: single‐center experience of first 17 cases

Cited by 7 publications

References 6 publications

The Use of Somatex Shunt for Fetal Pleural Effusion: A Cohort of 8 Procedures

The Use of Somatex Shunt for Fetal Pleural Effusion: A Cohort of 8 Procedures

Perinatal Outcome in Fetuses with Dislodged Thoraco-Amniotic Shunts

Development and in‐vitro characterization of a novel fetal vesicoamniotic shunt – The Vortex shunt

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