Mechanical performances of balloon post-dilation for improving stent expansion in calcified coronary artery: Computational and experimental investigations

Abstract

Stent deployment in a calcified coronary artery is often associated with suboptimal outcomes such as stent underexpansion and malapposition. Post-dilation after stent deployment is commonly used for optimal stent implantation. There is no guideline for choosing the post-dilation balloon diameter and inflation pressure. In this work, ex-vivo/in-silico experiments were performed to investigate the efficacy of post-dilation balloon diameter and inflation pressure in improving the stent expansion in a calcified lesion. Post-dilations with three balloon diameters (3 mm, 3.5 mm, and 4 mm) were performed. For each balloon diameter, three inflation pressures (10 atm, 20 atm, and 30 atm) were sequentially applied. In ex-vivo experiments, optical coherence tomography images were acquired during the stenting procedure, i.e., pre- and post-deployment of 3 mm diameter stent, as well as after each post-dilation. The results from in-silico experiments were compared with ex-vivo experiments in terms of lumen area. In addition, stretch ratio analysis was developed to predict the stent-induced lumen area, along with the strain analysis and the in-silico experiments. Results have shown that target lumen area could be achieved with an oversized nominal balloon diameter of +0.5 mm (i.e., 0.5 mm greater than reference lumen diameter) at an inflation pressure of 20 atm. After each post-dilation, fibrotic tissue demonstrated a larger strain, contributing to improved lumen gain. However, minimal changes were observed in calcification. Moreover, a strong correlation (R² = 0.95) between the stretch ratio of fibrotic tissue and lumen area after each post-dilation was observed. This indicated that the morphology of the fibrotic tissue could be a potential marker to predict the lumen gain. The detailed mechanistic quantifications of a single lesion cannot be generalized to all clinical cases. However, this work could be used to provide a fundamental understanding of the post-dilations, to develop experimental protocols for producing generalized guidelines, and to exploit their potential for optimal pre- and post-stent strategies.

Keywords: Balloon diameter; Cadaver; Calcification; Finite element method (FEM); Inflation pressure; Optical coherence tomography (OCT); Percutaneous coronary intervention (PCI); Post-dilation; Stent expansion.