O’Brien CC, Lopes AC, Kolandaivelu K, Kunio M, Brown J, Kolachalama VB, Conway C, Bailey L, Markham P, Costa M, Ware J, Edelman ER. Vascular Response to Experimental Stent Malapposition and Under-Expansion.
Summary: Up to 80% of all endovascular stents have malapposed struts, and while some impose catastrophic events others are inconsequential. Thirteen stents were implanted in coronary arteries of seven healthy Yorkshire pigs, using specially-designed cuffed balloons inducing controlled stent malapposition and under-expansion. Optical coherence tomography (OCT) imaging confirmed that 25% of struts were malapposed (strut-wall distance <strut thickness) to variable extent (max. strut-wall distance malapposed group 0.51 ± 0.05 mm vs. apposed group 0.09 ± 0.05 mm, p = 2e-3). Imaging at follow-up revealed malapposition acutely resolved (<1% of struts remained malapposed at day 5), with strong correlation between lumen and the stent cross-sectional areas (slope = 0.86, p < 0.0001, R 2 = 0.94). OCT in three of the most significantly malapposed vessels at baseline showed high correlation of elastic lamina area and lumen area (R 2 = 0.96) suggesting all lumen loss was related to contraction of elastic lamina with negligible plaque/intimal hyperplasia growth. Simulation showed this vascular recoil could be partially explained by the non-uniform strain environment created from sub-optimal expansion of device and balloon, and the inability of stent support in the malapposed region to resist recoil. Malapposition as a result of stent under-expansion is resolved acutely in healthy normal arteries, suggesting existing animal models are limited in replicating clinically observed persistent stent malapposition..