Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition.

BACKGROUND: Lack of re-endothelialization and neointimal coverage on stent struts has been put forward as the main underlying mechanism leading to late stent thrombosis. Incomplete stent apposition (ISA) has been observed frequently in patients with very late stent thrombosis after drug eluting stent implantation, suggesting a role of ISA in the pathogenesis of this adverse event. The aim of this study was to evaluate the impact of different degrees of ISA severity on abnormal shear rate and healing response with coverage, because of its potential implications for stent optimization in clinical practice. METHODS AND RESULTS: We characterized flow profile and shear distribution in different cases of ISA with increasing strut-wall detachment distance (ranging from 100 to 500 µm). Protruding strut and strut malapposed with moderate detachment (ISA detachment distance <100 µm) have minimal disturbance to blood flow as compared with floating strut that has more significant ISA distance. In vivo impact on strut coverage was assessed retrospectively using optical coherence tomography evaluation on 72 stents (48 patients) sequentially at baseline and after 6-month follow-up. Analysis of coverage revealed an important impact of baseline strut-wall ISA distance on the risk of incomplete strut coverage at follow-up. Malapposed segments with an ISA detachment <100 µm at baseline showed complete strut coverage at follow-up, whereas segments with a maximal ISA detachment distance of 100 to 300 µm and >300 µm had 6.1% and 15.7% of their struts still uncovered at follow-up, respectively (P<0.001). CONCLUSIONS: Flow disturbances and risk of delayed strut coverage both increase with ISA detachment distance. Insights from this study are important for understanding malapposition as a quantitative, rather than binary phenomenon (present or absent) and to define the threshold of ISA detachment that might benefit from optimization during stent implantation.

Method for percutaneously introducing, and removing, anatomical stenosis of predetermined severity in vivo: the "stenotic stent".

Current in vivo models of arterial lesions often lead to unpredictable results in terms of lesion anatomy and hemodynamical significance. This study aimed to evaluate the impact of coronary stenosis using a novel in vivo adjustable stenosis model capable of mimicking advanced human coronary lesions. We developed a series of balloon expandable covered coronary stents with a central restriction, mimicking different intermediate to severe stenosis, and implanted them percutaneously in coronary arteries of eight healthy hybrid Landrace pigs. Optical coherence tomography (OCT) pullbacks and fractional flow reserve (FFR) were acquired along the artery after implantation of the stenotic stents for precise evaluation of anatomy and functional impact. Diameter and area stenosis after deployment of the stenosis implant were, on average, respectively, 54.1 ± 5.9 and 78.4 ± 5.8 % and average FFR value was 0.83 (SD 0.13). There was a low correlation between FFR and MLA evaluated by OCT (r = 0.02, p = 0.94), improved with percentage area stenosis (r = -0.55, p = 0.12), or OCT volumetric evaluation of the stenosis taking into account not only the MLA but also the length of the lesion (r = -0.78, p = 0.01). This study presents a method and proof of concept for percutaneously introducing, and removing, anatomical stenosis of predetermined severity in vivo. Such in vivo model may be used to create and evaluate the impact of focal stenoses on physiological parameters such as FFR.