Evan M. Zahn, Eason Abbott, Neil Tailor, Shyam Sathanandam, Dustin Armer
Cedars Sinai Medical Center. Renata Medical Company. Morgan Stanley Children’s Hospital. LeBonheur Children’s Hospital.
United States
Catheterization and Cardiovascular Interventions
Catheter Cardiovasc Interv 2021; 98: 117-127
DOI: 10.1002/ccd.29706
Abstract
Objectives: This study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ability to be enlarged to adult dimensions.
Background: There are no endovascular stents designed for or approved for use in infants, nor is there a stent capable of being implanted at infant vessel diameters and achieving adult size while maintaining structural integrity. The Minima stent was designed to address these needs.
Methods: This study was performed in 6 piglets who underwent implantation of 22 Minima stents into the following locations: aorta (n = 11), branch pulmonary arteries (n = 6), and central veins (n = 5).
Results: Successful deployment occurred in 21/22 attempts. Two instances of post-deployment migration occurred. Stents were re-expanded at 1, 2, 3 and 5 months after implant. All stents regardless of location could be re-dilated to the intended diameter to keep pace with somatic growth (implant diameter 6.9 +/- 1.2 mm; final diameter 16.1 mm +/- 1.4 mm). Histopathology at 1 and 5 months demonstrated widely patent vessel lumens with stent apposition to vessel wall, early mild inflammatory response surrounding stent struts, typical vascular damage and healing response to acute dilation and a progressive smooth neointimal growth covering stent struts over time.
Conclusions: In this in vivo study of the Minima stent, there was high implant success, predictable re-dilatability to adult diameters and favorable histopathology. Further study is warranted.
Category
Segmental Pulmonary Arterial Disease
Animal Models of Pulmonary Vascular Disease and Therapy
Surgical and Catheter-mediated Interventions for Pulmonary Vascular Disease
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Filed (PHiled). Greater than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: Yes