Abstract

Objective: To test in a neonatal animal model the feasibility and biocompatibility of a new breakable stent that can be broken open by balloon dilatation during reintervention for use in neonates and infants.

Materials and methods: Medical grade stainless steel breakable stents (n  =  16) were interventionally implanted in systemic arteries in neonatal piglets (n  =  7). Patency of the stented segments was shown by repeated angiography. Stents were redilated up to three times. After a follow up of 18–165 days the animals were killed and the tissue block containing the stent was excised. Besides standard histological examination, scanning electron microscopy was used for biocompatibility screening.

Results: The stents were broken by redilatation with a conventional angioplasty balloon catheter. During follow up, patency of all stented segments was shown angiographically. One stent became dislocated during implantation. One vessel ruptured during redilatation when an inadequately large balloon catheter was used for dilatation. No other complications were observed. Scanning electron microscopy showed complete cellular coverage of the stent struts. Histological examination showed thinning of the vessel wall and partial rupture of the media at the site of stent breakage. An only mild inflammatory reaction was detected.

Conclusion: The new breakable stent can be broken open by simple angioplasty. Feasibility, effectiveness, and biocompatibility were shown in an animal model. Surgery to remove stents from paediatric patients due to disproportion between a previously implanted stent and the growing vessel may be avoided by the use of a breakable stent.