Proof of Concept: A New Solution for Low-Profile Transcatheter Implantation of Optimus-L stents in Small Children

• Published in: Canadian journal of cardiology 2024-01, Vol.40 (1), p.77-86
• Main Authors: HADDAD, Raymond N., EICKEN, Andreas, ADEL HASSAN, Ahmed, GENDERA, Katarzyna, KASEM, Mohamed, GEORGIEV, Stanimir
• Format: Article
• Language: English
• Subjects: children; Congenital heart disease; infants; innovation; stent; transcatheter interventions
• ISSN: 0828-282X; 1916-7075
• DOI: 10.1016/j.cjca.2023.09.015

There is no stent designed or approved for use in infants. We sought to obtain in-vitro and in-vivo data on a new concept conceived to implant Optimus-L stents at infant vessel diameters and offer a potential long-term stent solution. Nineteen Optimus-L stents were mounted on 8 types of angioplasty balloons with diameters 6, 8, and 10mm using an injection-molded hand-crimper. We evaluated balloon-stent unit (BSU) stability before insertion and advancement through short Terumo introducers with incremental French (Fr)-size and possibility of side-arm contrast injections. Three types of long sheaths were tested. Stents were inflated to balloon nominal diameters and re-expanded to 18 and 23mm. Stent recoil, foreshortening, and fracture were evaluated. In-vivo implantations were performed afterward. In-vitro: Medtronic-EvercrossTM balloons and modified Terumo-DestinationTM sheaths were the best combination: BSUs were inserted in 6-Fr sheaths with possible injections (for 6 and 8mm balloons), and 7-Fr sheaths without injections (for the 10mm balloon). Retrieving BSUs inside the sheath required one additional Fr-size. Boston-Scientific-SterlingTM and Balton-Lovix balloons, as well as APT-BraidinTM-L guiding sheaths showed unsatisfactory performance. Dilation up to 23mm was possible, stent shortening was