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First-in-man pulmonary artery stenting in children using the Bentley® BeGrow™ stent system for newborns and infants
Daniel Quandt1, Walter Knirsch1, Ina Michel-Behnke2
1Pediatric Cardiology, Pediatric Heart Center, Department of Surgery, University Children's Hospital Zurich, Switzerland.
Insights
The new Bentley BeGrow™ stent system allows for significant expansion in infants with congenital heart disease (CHD). This innovative stent accommodates somatic growth, reducing the need for repeat procedures in pediatric cardiovascular interventions.
Area of Science:
- Pediatric cardiology
- Interventional cardiology
- Biomaterials engineering
Background:
- Stent implantation is crucial for treating congenital heart disease (CHD) in children.
- Current stents have limited expansion, necessitating frequent redilation for somatic growth.
- Infants and children often require repeated interventions due to vessel growth post-stenting.
Observation:
- The Bentley BeGrow™ stent is a balloon-expandable L605 cobalt-chromium stent for newborns and infants.
- It is compatible with 4 French sheaths and 0.014-inch guidewires, suitable for small vessels (4-6 mm).
- The stent design allows post-dilation up to 11.5 mm with maintained radial force and uniform expansion.
Findings:
- The BeGrow™ stent exhibits controlled strut breakage at diameters exceeding 11.5 mm.
- Spiral arrangement of breaking points ensures residual radial force after expansion.
- Initial human implantations in newborns with univentricular and biventricular circulation are reported.
Implications:
- The low-profile BeGrow™ stent offers novel transcatheter treatment options for neonates and infants.
- Effective implantation was demonstrated in early cases.
- Further follow-up will assess the potential for accommodating somatic growth through stepwise redilation and controlled stent strut breakage.
Background:
Stent implantation into growing vessels is a common treatment option in infants and children with congenital heart disease (CHD) and corresponding vessel lesions. After stent implantation in small children, repetitive stent redilations are frequently necessary to accommodate for somatic growth. Until now, all available stents have limited final expansion diameters.
Material And Results:
The new Bentley BeGrow™ stent system for newborns and infants is a L605 cobalt‑chromium, pre-mounted, balloon expandable stent, which is compatible with a 4 French sheath and 0.014 inch guide wire thus allowing implantation in small vessels (4-6 mm). It offers a new, unique stent design that allows post-dilation steps up to Ø11.5 mm. While re-dilating up to Ø11.5 mm this new stent maintains radial force and shows uniform expansion with only minimal foreshortening. Predetermined breaking points allow the stent struts to break in a controlled manner when exceeding a diameter of 11.5 mm. Residual radial force maintains even after stent opening due to spiral arrangement of the predetermined breaking points. The 2 first-in-man pulmonary artery stent implantations in a newborn with univentricular circulation and a toddler with biventricular circulation are reported as part of the currently performed licencing trial (ClinicalTrials.govNCT03287024).
Conclusion:
The low-profile BeGrow™ stent system offers new treatment options for transcatheter stent implantations in newborns and infants. In our first experience, it can be effectively implanted. Longer follow-up will evaluate multiple, stepwise redilations and controlled stent strut breakage, which have the potential to accommodate for somatic vessel growth and/or subsequent implantation of larger stents.
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