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A new breakable stent for recoarctation in early infancy: Preliminary Clinical Experience
Jochen Grohmann1, Matthias Sigler2, Matthias Siepe3
1Department of Congenital Heart Defects and Pediatric Cardiology, Heart Center, University of Freiburg, Freiburg, Germany.
Insights
The Osypka BabyStent effectively treated aortic coarctation in infants, showing promising short-term results. Further multicenter studies are needed to confirm its long-term efficacy and support device approval.
Area of Science:
- Pediatric Cardiology
- Interventional Cardiology
- Medical Device Technology
Background:
- Transcatheter stent implantation is an established treatment for aortic coarctation (CoA).
- The Osypka BabyStent is a novel, low-profile, balloon-expandable stent designed for infants with CoA, featuring a breakable structure for growth.
- This study evaluates the initial clinical feasibility and efficacy of the BabyStent in critically ill infants or those at high risk for redo-surgery.
Purpose of the Study:
- To assess the feasibility and efficacy of the Osypka BabyStent for treating aortic coarctation in infants.
- To evaluate the BabyStent's performance in complex cases, including re-coarctation and re-obstruction after previous surgeries.
- To gather initial clinical data for potential device approval.
Main Methods:
- Retrospective single-center analysis of infants treated with the Osypka BabyStent.
- Interventions performed under fluoroscopy with conscious sedation and local or general anesthesia.
- Data collected on technical success, aortic dimensions, and stent-related complications during follow-up.
Main Results:
- Technical success was achieved in all five BabyStent implantations in four infants (median age 10 weeks).
- Aortic diameters significantly increased from a median of 2.25 mm to 5.3 mm post-implantation.
- Follow-up up to 26 months showed no stent-related complications.
Conclusions:
- Osypka BabyStent implantation is effective for treating recoarctation in infants.
- Initial experience is limited to short- and midterm follow-up, with no subsequent overdilation due to patient growth.
- A multicenter survey is underway to support device approval.
Objectives:
Transcatheter treatment of aortic coarctation (CoA) via stent implantation has become an established treatment option depending on the patient's age and CoA type.
Background:
The Osypka BabyStent(®) is a low-profiled, balloon-expandable cobalt-chrome stent to treat aortic CoA in infants, which is breakable to permit unrestricted growth. We hereby evaluated our initial clinical experience to demonstrate the feasibility and efficacy of this new nonlicensed device, which we have occasionally implanted in critically ill patients or when redo-surgery would entail an excessively high risk.
Methods:
Retrospective single-center analysis of all available data during and after treatment with a BabyStent implanted in infants with considerable re-CoA or reobstruction of the aortic arch after former surgery. All interventions took place under fluoroscopy and conscious sedation with local anesthesia or general anesthesia.
Results:
Five BabyStents were implanted in four infants with technical success in all of them-median age 10 weeks (range 5-21), median bodyweight 3.8 kg (range 2.7-4.5). Aortic diameters enlarged from median 2.25 mm (range 1.5-3.3) to median 5.3 mm (range 4.6-6.0). The follow-up period lasting up to 26 months (median 8.5, range 2-26) was uneventful concerning stent-related complications.
Conclusions:
BabyStent(®) implantation for recoarctation was effective. However, our initial experience with the device is limited to short- and midterm follow-up only. None of the stents was subsequently overdilated with the intention to break due to our patients' limited somatic growth so far. A multicenter survey has been initiated to justify device approval.
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