Biomechanical Impact of Wrong Positioning of a Dedicated Stent for Coronary Bifurcations: A Virtual Bench Testing Study

Chiastra, Claudio; Grundeken, Maik J.; Collet, Carlos; Wu, Wei; Wykrzykowska, Joanna J.; Pennati, Giancarlo; Dubini, Gabriele; Migliavacca, Francesco

doi:10.1007/s13239-018-0359-9

Cited by 16 publications

(16 citation statements)

References 70 publications

(42 reference statements)

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“…However, the literature data are quite representative of the entire spectrum of plaque material properties and we feel that they did not deviate from the true plaque properties. In accordance with previous studies 17 , 30 , we used the idealized multi-wing crimped balloon model. We adopted the material properties for compliant, semi-compliant and non-compliant balloons from literature 15 .…”

Section: Discussionmentioning

confidence: 99%

Patient-specific computational simulation of coronary artery bifurcation stenting

Zhao

Samant

et al. 2021

Sci Rep

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Patient-specific and lesion-specific computational simulation of bifurcation stenting is an attractive approach to achieve individualized pre-procedural planning that could improve outcomes. The objectives of this work were to describe and validate a novel platform for fully computational patient-specific coronary bifurcation stenting. Our computational stent simulation platform was trained using n = 4 patient-specific bench bifurcation models (n = 17 simulations), and n = 5 clinical bifurcation cases (training group, n = 23 simulations). The platform was blindly tested in n = 5 clinical bifurcation cases (testing group, n = 29 simulations). A variety of stent platforms and stent techniques with 1- or 2-stents was used. Post-stenting imaging with micro-computed tomography (μCT) for bench group and optical coherence tomography (OCT) for clinical groups were used as reference for the training and testing of computational coronary bifurcation stenting. There was a very high agreement for mean lumen diameter (MLD) between stent simulations and post-stenting μCT in bench cases yielding an overall bias of 0.03 (− 0.28 to 0.34) mm. Similarly, there was a high agreement for MLD between stent simulation and OCT in clinical training group [bias 0.08 (− 0.24 to 0.41) mm], and clinical testing group [bias 0.08 (− 0.29 to 0.46) mm]. Quantitatively and qualitatively stent size and shape in computational stenting was in high agreement with clinical cases, yielding an overall bias of < 0.15 mm. Patient-specific computational stenting of coronary bifurcations is a feasible and accurate approach. Future clinical studies are warranted to investigate the ability of computational stenting simulations to guide decision-making in the cardiac catheterization laboratory and improve clinical outcomes.

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Section: Discussionmentioning

confidence: 99%

Patient-specific computational simulation of coronary artery bifurcation stenting

Zhao

Samant

et al. 2021

Sci Rep

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“…A crucial step in the development of the models is the selection of the material model and hence the calibration of the material parameters. In this work, as better described in the following, a simple linear elastic model was adopted for the balloon [ 27 ], which allowed to use a straightforward procedure based on experimental results for the parameter calibrations. Concerning the stent, the experimental results confirmed the rate-dependent mechanical behaviour of Tyrocore TM , requiring the adoption of a non-linear viscous model, characterized by several parameters.…”

Section: Methodsmentioning

confidence: 99%

“…A linear elastic model was adopted for describing the balloon elastomeric material behaviour [ 27 ].…”

Section: Methodsmentioning

confidence: 99%

“…The balloon folding was modeled in a simplified manner [ 27 , 28 ] to properly mimic its pressure-diameter relation and allow the correct expansion of the stent. This was obtained by considering the presence of thirty wings along the balloon surface, rather than describing the three major folds of the real balloons, as suggested by Martin et al [ 29 ].…”

Section: Methodsmentioning

confidence: 99%

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From the real device to the digital twin: A coupled experimental-numerical strategy to investigate a novel bioresorbable vascular scaffold

et al. 2021

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The purpose of this work is to propose a workflow that couples experimental and computational activities aimed at developing a credible digital twin of a commercial coronary bioresorbable vascular scaffold when direct access to data about material mechanical properties is not possible. Such a situation is be faced when the manufacturer is not involved in the study, thus directly investigating the actual device is the only source of information available. The object of the work is the Fantom® Encore polymeric stent (REVA Medical) made of Tyrocore™. Four devices were purchased and used in mechanical tests that are easily reproducible in any mechanical laboratory, i.e. free expansion and uniaxial tension testing, the latter performed with protocols that emphasized the rate-dependent properties of the polymer. Given the complexity of the mechanical behaviour observed experimentally, it was chosen to use the Parallel Rehological Framework material model, already used in the literature to describe the behaviour of other polymers, such as PLLA. Calibration of the material model was based on simulations that replicate the tensile test performed on the device. Given the high number of material parameters, a plan of simulations was done to find the most suitable set, varying each parameter value in a feasible range and considering a single repetitive unit of the stent, neglecting residual stresses generated by crimping and expansion. This strategy resulted in a significant reduction of computational cost. The performance of the set of parameters thus identified was finally evaluated considering the whole delivery system, by comparing the experimental results with the data collected simulating free expansion and uniaxial tension testing. Moreover, radial force testing was numerically performed and compared with literature data. The obtained results demonstrated the effectiveness of the digital twin development pipeline, a path applicable to any commercial device whose geometric structure is based on repetitive units.

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“…For this reason, the complexity related to the replication of the real balloon folded structure was not considered. Hence, a multi-wings geometry, slightly tapered at the extremities, with the same length and expanded diameter of the real balloon (Figure 3) was adopted following the previous studies (Chiastra et al, 2018;Morris et al, 2018). The geometrical dimensions of the balloon were defined according to the information provided by the manufacturer and to measurements taken on images recorded during the experimental free inflation of the device (see Appendix).…”

Section: The Pebax® Balloonmentioning

confidence: 99%

Validation of the computational model of a coronary stent: a fundamental step towards in silico trials

Antonini

Mandelli

Berti

et al. 2021

Journal of the Mechanical Behavior of Biomedical Materials

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The proof of the reliability of a numerical model is becoming of paramount importance in the era of in silico clinical trials. When dealing with a coronary stenting procedure, the virtual scenario should be able to replicate the real device, passing through the different stages of the procedure, which has to maintain the atherosclerotic vessel opened.Nevertheless, most of the published studies adopted commercially resembling geometries and generic material parameters, without a specific validation of the employed numerical models.In this work, a workflow for the generation and validation of the computational model of a coronary stent was proposed. Possible sources of variability in the results, such as the inter-batches variability in the material properties and the choice of proper simulation strategies, were accounted for and discussed. Then, a group of in vitro tests, representative of the device intended use was used as a comparator to validate the model. The free expansion simulation, which is the most used simulation in the literature, was shown to be only partially useful for stent model validation purposes. On the other hand, the choice of proper additional experiments, as the suggested uniaxial tensile tests on the stent and deployment tests into a deformable tube, could provide further suitable information to prove the efficacy of the numerical approach.

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Biomechanical Impact of Wrong Positioning of a Dedicated Stent for Coronary Bifurcations: A Virtual Bench Testing Study

Cited by 16 publications

References 70 publications

Patient-specific computational simulation of coronary artery bifurcation stenting

Patient-specific computational simulation of coronary artery bifurcation stenting

From the real device to the digital twin: A coupled experimental-numerical strategy to investigate a novel bioresorbable vascular scaffold

Validation of the computational model of a coronary stent: a fundamental step towards in silico trials

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