Automatic Detection of the Aortic Annular Plane and Coronary Ostia from Multidetector Computed Tomography.

Anatomic landmark detection is crucial during preoperative planning of transcatheter aortic valve implantation (TAVI) to select the proper device size and assess the risk of complications. The detection is currently a time-consuming manual process influenced by the image quality and subject to operator variability. In this work, we propose a novel automatic method to detect the relevant aortic landmarks from MDCT images using deep learning techniques. We trained three convolutional neural networks (CNNs) with 344 multidetector computed tomography (MDCT) acquisitions to detect five anatomical landmarks relevant for TAVI planning: the three basal attachment points of the aortic valve leaflets and the left and right coronary ostia. The detection strategy used these three CNN models to analyse a single MDCT image and yield three segmentation volumes as output. These segmentation volumes were averaged into one final segmentation volume, and the final predicted landmarks were obtained during a postprocessing step. Finally, we constructed the aortic annular plane, defined by the three predicted hinge points, and measured the distances from this plane to the predicted coronary ostia (i.e., coronary height). The methodology was validated on 100 patients. The automatic landmark detection was able to detect all the landmarks and showed high accuracy as the median distance between the ground truth and predictions is lower than the interobserver variations (1.5 mm [1.1-2.1], 2.0 mm [1.3-2.8] with a paired difference -0.5 ± 1.3 mm and p value <0.001). Furthermore, a high correlation is observed between predicted and manually measured coronary heights (for both R 2 = 0.8). The image analysis time per patient was below one second. The proposed method is accurate, fast, and reproducible. Embedding this tool based on deep learning in the preoperative planning routine may have an impact in the TAVI environments by reducing the time and cost and improving accuracy.

Enabling Automated Device Size Selection for Transcatheter Aortic Valve Implantation.

The number of transcatheter aortic valve implantation (TAVI) procedures is expected to increase significantly in the coming years. Improving efficiency will become essential for experienced operators performing large TAVI volumes, while new operators will require training and may benefit from accurate support. In this work, we present a fast deep learning method that can predict aortic annulus perimeter and area automatically from aortic annular plane images. We propose a method combining two deep convolutional neural networks followed by a postprocessing step. The models were trained with 355 patients using modern deep learning techniques, and the method was evaluated on another 118 patients. The method was validated against an interoperator variability study of the same 118 patients. The differences between the manually obtained aortic annulus measurements and the automatic predictions were similar to the differences between two independent observers (paired diff. of 3.3 ± 16.8 mm2 vs. 1.3 ± 21.1 mm2 for the area and a paired diff. of 0.6 ± 1.7 mm vs. 0.2 ± 2.5 mm for the perimeter). The area and perimeter were used to retrieve the suggested prosthesis sizes for the Edwards Sapien 3 and the Medtronic Evolut device retrospectively. The automatically obtained device size selections accorded well with the device sizes selected by operator 1. The total analysis time from aortic annular plane to prosthesis size was below one second. This study showed that automated TAVI device size selection using the proposed method is fast, accurate, and reproducible. Comparison with the interobserver variability has shown the reliability of the strategy, and embedding this tool based on deep learning in the preoperative planning routine has the potential to increase the efficiency while ensuring accuracy.

Procedure to describe clavicular motion.

BACKGROUND: For many years, researchers have attempted to describe shoulder motions by using different mathematical methods. The aim of this study was to describe a procedure to quantify clavicular motion. METHODS: The procedure proposed for the kinematic analysis consists of 4 main processes: 3 transcortical pins in the clavicle, motion capture, obtaining 3-dimensional bone models, and data processing. RESULTS: Clavicular motion by abduction (30° to 150°) and flexion (55° to 165°) were characterized by an increment of retraction of 27° to 33°, elevation of 25° to 28°, and posterior rotation of 14° to 15°, respectively. In circumduction, clavicular movement described an ellipse, which was reflected by retraction and elevation. Kinematic analysis shows that the articular surfaces move by simultaneously rolling and sliding on the convex surface of the sternum for the 3 movements of abduction, flexion, and circumduction. CONCLUSION: The use of 3 body landmarks in the clavicle and the direct measurement of bone allowed description of the osteokinematic and arthrokinematic movement of the clavicle.

Coronary fractional flow reserve measurements of a stenosed side branch: a computational study investigating the influence of the bifurcation angle.

BACKGROUND: Coronary hemodynamics and physiology specific for bifurcation lesions was not well understood. To investigate the influence of the bifurcation angle on the intracoronary hemodynamics of side branch (SB) lesions computational fluid dynamics simulations were performed. METHODS: A parametric model representing a left anterior descending-first diagonal coronary bifurcation lesion was created according to the literature. Diameters obeyed fractal branching laws. Proximal and distal main branch (DMB) stenoses were both set at 60 %. We varied the distal bifurcation angles (40°, 55°, and 70°), the flow splits to the DMB and SB (55 %:45 %, 65 %:35 %, and 75 %:25 %), and the SB stenoses (40, 60, and 80 %), resulting in 27 simulations. Fractional flow reserve, defined as the ratio between the mean distal stenosis and mean aortic pressure during maximal hyperemia, was calculated for the DMB and SB (FFRSB) for all simulations. RESULTS: The largest differences in FFRSB comparing the largest and smallest bifurcation angles were 0.02 (in cases with 40 % SB stenosis, irrespective of the assumed flow split) and 0.05 (in cases with 60 % SB stenosis, flow split 55 %:45 %). When the SB stenosis was 80 %, the difference in FFRSB between the largest and smallest bifurcation angle was 0.33 (flow split 55 %:45 %). By describing the ΔPSB-QSB relationship using a quadratic curve for cases with 80 % SB stenosis, we found that the curve was steeper (i.e. higher flow resistance) when bifurcation angle increases (ΔP = 0.451*Q + 0.010*Q (2) and ΔP = 0.687*Q + 0.017*Q (2) for 40° and 70° bifurcation angle, respectively). Our analyses revealed complex hemodynamics in all cases with evident counter-rotating helical flow structures. Larger bifurcation angles resulted in more pronounced helical flow structures (i.e. higher helicity intensity), when 60 or 80 % SB stenoses were present. A good correlation (R(2) = 0.80) between the SB pressure drop and helicity intensity was also found. CONCLUSIONS: Our analyses showed that, in bifurcation lesions with 60 % MB stenosis and 80 % SB stenosis, SB pressure drop is higher for larger bifurcation angles suggesting higher flow resistance (i.e. curves describing the ΔPSB-QSB relationship being steeper). When the SB stenosis is mild (40 %) or moderate (60 %), SB resistance is minimally influenced by the bifurcation angle, with differences not being clinically meaningful. Our findings also highlighted the complex interplay between anatomy, pressure drops, and blood flow helicity in bifurcations.

Semi-automated landmark-based 3D analysis reveals new morphometric characteristics in the trochlear dysplastic femur.

PURPOSE: The authors hypothesise that the trochlear dysplastic distal femur is not only characterised by morphological changes to the trochlea. The purpose of this study is to describe the morphological characteristics of the trochlear dysplastic femur in and outside the trochlear region with a landmark-based 3D analysis. METHODS: Arthro-CT scans of 20 trochlear dysplastic and 20 normal knees were used to generate 3D models including the cartilage. To rule out size differences, a set of landmarks were defined on the distal femur to isotropically scale the 3D models to a standard size. A predefined series of landmark-based reference planes were applied on the distal femur. With these landmarks and reference planes, a series of previously described characteristics associated with trochlear dysplasia as well as a series of morphometric characteristics were measured. RESULTS: For the previously described characteristics, the analysis replicated highly significant differences between trochlear dysplastic and normal knees. Furthermore, the analysis showed that, when knee size is taken into account, the cut-off values of the trochlear bump and depth would be 1 mm larger in the largest knees compared to the smallest knees. For the morphometric characteristics, the analysis revealed that the trochlear dysplastic femur is also characterised by a 10% smaller intercondylar notch, 6-8% larger posterior condyles (lateral-medial) in the anteroposterior direction and a 6% larger medial condyle in the proximodistal direction compared to a normal femur. CONCLUSIONS: This study shows that knee size is important in the application of absolute metric cut-off values and that the posterior femur also shows a significantly different morphology.

In vitro evaluation of the radial and axial force of self-expanding esophageal stents.

BACKGROUND AND STUDY AIMS: Technological innovation in esophageal stent design has progressed over the past decades, but the association between the mechanical properties of stent design and clinical outcome is still poorly understood. In this study the radial force and axial force of currently available stent designs were evaluated using an in vitro testing model. METHODS: A total of 10 partially and fully covered self-expanding metal stents (SEMSs), a self-expanding plastic stent (SEPS), and an uncovered biodegradable stent were evaluated. Radial force and axial force were measured using a radial force measurement machine (RX500) and a force gauge in an oven at 37°C. RESULTS: A wide range of radial force measurements were observed between the different stent designs, ranging from 4 to 83 N at 15  mm expansion. All braided nitinol stents displayed comparable mechanical characteristics with a relatively low radial force (<150 N) that gradually decreased to 0 N during expansion, whereas plastic and metal stents that were constructed in a nonbraided manner displayed an initially high radial force (>300 N) followed by a steep decline to 0 N during expansion. Conversely, peak axial force was relatively high for braided nitinol SEMSs (>1.5 N), whereas nonbraided SEMSs showed a much lower peak axial force (<1.5 N). Based on radial and axial force data, five groups of stents with comparable mechanical properties could be distinguished. CONCLUSIONS: All currently available stents have a characteristic radial and axial force pattern, which may aid in the understanding of the occurrence of specific symptoms and complications after stent placement. Nonetheless, the overall clinical behavior of a stent is probably more complex and cannot be explained by these factors alone.

A computational study of the hemodynamic impact of open- versus closed-cell stent design in carotid artery stenting.

The aim of this study is to analyze the shape and flow changes of a patient-specific carotid artery after carotid artery stenting (CAS) performed using an open-cell (stent-O) or a closed-cell (stent-C) stent design. First, a stent reconstructed from micro-computed tomography (microCT) is virtually implanted in a left carotid artery reconstructed from CT angiography. Second, an objective analysis of the stent-to-vessel apposition is used to quantify the lumen cross-sectional area and the incomplete stent apposition (ISA). Third, the carotid artery lumen is virtually perfused in order to quantify its resistance to flow and its exposure to atherogenic or thrombogenic hemodynamic conditions. After CAS, the minimum cross-sectional area of the internal carotid artery (ICA) (external carotid artery [ECA]) changes by +54% (-12%) with stent-O and +78% (-17%) with stent-C; the resistance to flow of the ICA (ECA) changes by -21% (+13%) with stent-O and -26% (+18%) with stent-C. Both stent designs suffer from ISA but the malapposed stent area is larger with stent-O than stent-C (29.5 vs. 14.8 mm(2) ). The untreated vessel is not exposed to atherogenic flow conditions whereas an area of 67.6 mm(2) (104.9) occurs with stent-O (stent-C). The area of the stent surface exposed to thrombogenic risk is 5.42 mm(2) (7.7) with stent-O (stent-C). The computer simulations of stenting in a patient's carotid artery reveal a trade-off between cross-sectional size and flow resistance of the ICA (enlarged and circularized) and the ECA (narrowed and ovalized). Such a trade-off, together with malapposition, atherogenic risk, and thrombogenic risk is stent-design dependent.

Pilot validation study on a quasi-static weight-bearing knee rig.

This article presents a pilot study on a quasi-static knee rig designed to investigate the influence of pathologies and surgical interventions on the patellofemoral kinetics of cadaveric knees. The knee rig allows cadaveric knees to flex and extend under a simulated body weight by transmitting a force to the quadriceps tendon. During the squat simulation, the ground reaction force stays within physiological values. Before using this device to answer clinical questions, two knee specimens were tested to assess the repeatability of the rig. Four repeated flexion-extension cycles were performed under a simulated body weight of 700 N, with an isolated force on the quadriceps tendon up to 2700 N and with a ground reaction force close to 350 N. The resulting patellofemoral contact area shifted from distal to proximal during knee flexion. From 20 degrees to 60 degrees of knee flexion, the mean contact area and pressure increased from 80.2 +/- 3.3 to 349.5 +/- 10.1 mm2 and from 0.9 +/- 0.2 to 5.9 +/- 0.7 MPa, respectively. The transmitted force on the quadriceps tendon, the ground reaction force and the patellofemoral contact area and pressure were continuously measured and showed a relative variability of 1.6%, 2.4%, 2.8% and 3.2%, respectively. The presented knee rig shows a good repeatability that allows us to use this knee rig to quantify the influence of anatomical changes on the patellofemoral contact area and pressures during a squat simulation.

FEops HEARTguide Patient-Specific Computational Simulations for WATCHMAN FLX Left Atrial Appendage Closure: A Retrospective Study.

Background: Three-dimensional transesophageal echocardiography (3D-TEE) is the primary imaging tool for left atrial appendage closure planning. The utility of cardiac computed tomography angiography (CCTA) and patient-specific computational models is unknown. Objectives: The purpose of this study was to evaluate the accuracy of the FEops HEARTguide patient-specific computational modeling in predicting appropriate device size, location, and compression of the WATCHMAN FLX compared to intraprocedural 3D-TEE. Methods: Patients with both preprocedural and postprocedural CCTA and 3D-TEE imaging of the LAA who received a WATCHMAN FLX left atrial appendage closure device were studied (n = 22). The FEops HEARTguide platform used baseline CCTA imaging to generate a prediction of device size(s), device position(s), and device dimensions. Blinded (without knowledge of implanted device size/position) and unblinded (implant device size/position disclosed) simulations were evaluated. Results: In 16 (72.7%) patients, the blind simulation predicted the final implanted device size. In these patients, the 3D-TEE measurements were not significantly different and had excellent correlation (Pearson correlation coefficient (r) ≥ 0.90). No patients had peridevice leak after device implant. In the 6 patients for whom the model did not predict the implanted device size, a larger device size was ultimately implanted as per operator preference. The model measurements of the unblinded patients demonstrated excellent correlation with 3D-TEE. Conclusions: This is the first study to demonstrate that the FEops HEARTguide model accurately predicts WATCHMAN FLX device implantation characteristics. Future studies are needed to evaluate if computational modeling can improve confidence in sizing, positioning, and compression of the device without compromising technical success.

Impact of carotid stent cell design on vessel scaffolding: a case study comparing experimental investigation and numerical simulations.

PURPOSE: To quantitatively evaluate the impact of carotid stent cell design on vessel scaffolding by using patient-specific finite element analysis of carotid artery stenting (CAS). METHODS: The study was organized in 2 parts: (1) validation of a patient-specific finite element analysis of CAS and (2) evaluation of vessel scaffolding. Micro-computed tomography (CT) images of an open-cell stent deployed in a patient-specific silicone mock artery were compared with the corresponding finite element analysis results. This simulation was repeated for the closed-cell counterpart. In the second part, the stent strut distribution, as reflected by the inter-strut angles, was evaluated for both cell types in different vessel cross sections as a measure of scaffolding. RESULTS: The results of the patient-specific finite element analysis of CAS matched well with experimental stent deployment both qualitatively and quantitatively, demonstrating the reliability of the numerical approach. The measured inter-strut angles suggested that the closed-cell design provided superior vessel scaffolding compared to the open-cell counterpart. However, the full strut interconnection of the closed-cell design reduced the stent's ability to accommodate to the irregular eccentric profile of the vessel cross section, leading to a gap between the stent surface and the vessel wall. CONCLUSION: Even though this study was limited to a single stent design and one vascular anatomy, the study confirmed the capability of dedicated computer simulations to predict differences in scaffolding by open- and closed-cell carotid artery stents. These simulations have the potential to be used in the design of novel carotid stents or for procedure planning.

A study on the efficacy of AFO stiffness prescriptions.

PURPOSE: Ankle foot orthosis (AFO) stiffness is a key characteristic that determines how much support or restraint an AFO can provide. Thus, the goal of the current study is twofold: (1) to quantify AFO prescriptions for a group of patients; (2) to evaluate what impact these AFO have on the push-off phase. METHOD: Six patients were included in the study. Three patients were prescribed an AFO for ankle support and three patients were prescribed an AFO for ankle and knee support. Two types of AFO - a traditional polypropylene AFO (AFOPP) and a novel carbon-selective laser sintered polyamide AFO (AFOPA), were produced for each patient. AFO ankle stiffness was measured in a dedicated test rig. Gait analysis was performed under shod and orthotic conditions. RESULTS: Patient mass normalized AFOPP stiffness for ankle support ranged from 0.042 to 0.069 N·m·deg-1·kg-1, while for ankle and knee support it ranged from 0.081 to 0.127 N·m·deg-1·kg-1. On the group level, the ankle range of motion and mean ankle velocity in the push-off phase significantly decreased in both orthotic conditions, while peak ankle push-off power decreased non-significantly. Accordingly, on the group level, no significant improvements in walking speed were observed. However, after patient differentiation into good and bad responders it was found that in good responders peak ankle push-off power tended to be preserved and walking speed tended to increase. CONCLUSIONS: Quantification of AFO stiffness may help to understand why certain orthotic interventions are successful (unsuccessful) and ultimately lead to better AFO prescriptions. Implications for rehabilitation AFO ankle stiffness is key characteristic that determines how much support or restraint an AFO can provide. In a typical clinical setting, AFO ankle stiffness is not quantified. AFO has to meet individual patient's biomechanical needs. More objective AFO prescription and more controlled AFO production methods are needed to increase AFO success rate.

Force distribution within the frame of self-expanding transcatheter aortic valve: Insights from in-vivo finite element analysis.

We sought to assess the amount and distribution of force on the valve frame after transcatheter aortic valve replacement (TAVR) via patient-specific computer simulation. Patients successfully treated with the self-expanding Venus A-Valve and multislice computed tomography (MSCT) pre- and post-TAVR were retrospectively included. Patient-specific finite element models of the aortic root and prosthesis were constructed. The force (in Newton) on the valve frame was derived at every 3 mm from the inflow and at every 22.5° on each level. Twenty patients of whom 10 had bicuspid aortic valve (BAV) were analyzed. The total force on the frame was 74.9 N in median (interquartile range 24.0). The maximal force was observed at level 5 that corresponds with the nadir of the bioprosthetic leaflets and was 9.9 (7.1) N in all patients, 10.3 (6.6) N in BAV and 9.7 (9.2) N for patients with tricuspid aortic valve (TAV). The level of maximal force located higher from the native annulus in BAV and TAV patients (8.8 [4.8] vs. 1.8 [7.4] mm). The area of the valve frame at the level of maximal force decreased from 437.4 (239.7) mm2 at the annulus to 377.6 (114.3) mm2 in BAV, but increased from 397.5 (114.3) mm2 at the annulus to 406.7 (108.9) mm2 in TAV. The maximum force on the bioprosthetic valve frame is located at the plane of the nadir of the bioprosthetic leaflets. It remains to be elucidated whether this may be associated with bioprosthetic frame and leaflet integrity and/or function.

Mechanical and morphometric study of mitral valve chordae tendineae and related papillary muscle.

The mitral valve (MV) apparatus is a complex mechanical structure including annulus, valve leaflets, papillary muscles (PMs) and connected chordae tendineae. Chordae anchor to the papillary muscles to help the valve open and close properly during one cardiac cycle. It is of paramount importance to understand the functional, mechanical, and microstructural properties of mitral valve chordae and connecting PMs. In particular, little is known about the biomechanical properties of the anterior and posterior papillary muscle and corresponding chords. In this work, we performed uniaxial and biaxial tensile tests on the anterolateral (APM) and posteromedial papillary muscle (PPM), and their respective corresponding chordae tendineae, chordaeAPM and chordaePPM, in porcine hearts. Histology was carried out to link the microstructure and macro-mechanical behavior of the chordae and PMs. Our results demonstrate that chordaePPM are less in number, but significantly longer and stiffer than chordaeAPM. These different biomechanical properties may be partially explained by the higher collagen core ratio and larger collagen fibril density of chordaePPM. No significant mechanical or microstructural differences were observed along the circumferential and longitudinal directions of APM and PPM samples. Data measured on chordae and PMs were further fitted with the Ogden and reduced Holzapfel - Ogden strain energy functions, respectively. This study presents the first comparative anatomical, mechanical, and structural dataset of porcine mitral valve chordae and related PMs. Results indicate that a PM based classification of chordae will need to be considered in the analysis of the MV function or planning a surgical treatment, which will also help developing more precise computational models of MV.

Intraluminal thrombus and risk of rupture in patient specific abdominal aortic aneurysm - FSI modelling.

Recent numerical studies of abdominal aortic aneurysm (AAA) suggest that intraluminal thrombus (ILT) may reduce the stress loading on the aneurysmal wall. Detailed fluid structure interaction (FSI) in the presence and absence of ILT may help predict AAA rupture risk better. Two patients, with varied AAA geometries and ILT structures, were studied and compared in detail. The patient specific 3D geometries were reconstructed from CT scans, and uncoupled FSI approach was applied. Complex flow trajectories within the AAA lumen indicated a viable mechanism for the formation and growth of the ILT. The resulting magnitude and location of the peak wall stresses was dependent on the shape of the AAA, and the ILT appeared to reduce wall stresses for both patients. Accordingly, the inclusion of ILT in stress analysis of AAA is of importance and would likely increase the accuracy of predicting AAA risk of rupture.

Computational and experimental evaluation of the mechanical properties of ankle foot orthoses: A literature review.

BACKGROUND: Ankle foot orthoses are external medical devices applied around the ankle joint area to provide stability to patients with neurological, muscular, and/or anatomical disabilities, with the aim of restoring a more natural gait pattern. STUDY DESIGN: This is a literature review. OBJECTIVES: To provide a description of the experimental and computational methods present in the current literature for evaluating the mechanical properties of the ankle foot orthoses. METHODS: Different electronic databases were used for searching English-language articles realized from 1990 onward in order to select the newest and most relevant information available. RESULTS: A total of 46 articles were selected, which describe the different experimental and computational approaches used by research groups worldwide. CONCLUSION: This review provides information regarding processes adopted for the evaluation of mechanical properties of ankle foot orthoses, in order to both improve their design and gain a deeper understanding of their clinical use. The consensus drawn is that the best approach would be represented by a combination of advanced computational models and experimental techniques, capable of being used to optimally mimic real-life conditions. CLINICAL RELEVANCE: In literature, several methods are described for the mechanical evaluation of ankle foot orthoses (AFOs); therefore, the goal of this review is to guide the reader to use the best approach in the quantification of the mechanical properties of the AFOs and to help gaining insight in the prescription process.

A validated computational framework to evaluate the stiffness of 3D printed ankle foot orthoses.

The purpose of this study was to create and validate a standardized framework for the evaluation of the ankle stiffness of two designs of 3D printed ankle foot orthoses (AFOs). The creation of four finite element (FE) models allowed patient-specific quantification of the stiffness and stress distribution over their specific range of motion during the second rocker of the gait. Validation was performed by comparing the model outputs with the results obtained from a dedicated experimental setup, which showed an overall good agreement with a maximum relative error of 10.38% in plantarflexion and 10.66% in dorsiflexion. The combination of advanced computer modelling algorithms and 3D printing techniques clearly shows potential to further improve the manufacturing process of AFOs.

Kinematic boundary conditions substantially impact in silico ventricular function.

Computational cardiac mechanical models, individualized to the patient, have the potential to elucidate the fundamentals of cardiac (patho-)physiology, enable non-invasive quantification of clinically significant metrics (eg, stiffness, active contraction, work), and anticipate the potential efficacy of therapeutic cardiovascular intervention. In a clinical setting, however, the available imaging resolution is often limited, which limits cardiac models to focus on the ventricles, without including the atria, valves, and proximal arteries and veins. In such models, the absence of surrounding structures needs to be accounted for by imposing realistic kinematic boundary conditions, which, for prognostic purposes, are preferably generic and thus non-image derived. Unfortunately, the literature on cardiac models shows no consistent approach to kinematically constrain the myocardium. The impact of different approaches (eg, fully constrained base, constrained epi-ring) on the predictive capacity of cardiac mechanical models has not been thoroughly studied. For that reason, this study first gives an overview of current approaches to kinematically constrain (bi) ventricular models. Next, we developed a patient-specific in silico biventricular model that compares well with literature and in vivo recorded strains. Alternative constraints were introduced to assess the influence of commonly used mechanical boundary conditions on both the predicted global functional behavior of the in-silico heart (cavity volumes, stroke volume, ejection fraction) and local strain distributions. Meaningful differences in global functioning were found between different kinematic anchoring strategies, which brought forward the importance of selecting appropriate boundary conditions for biventricular models that, in the near future, may inform clinical intervention. However, whilst statistically significant differences were also found in local strain distributions, these differences were minor and mostly confined to the region close to the applied boundary conditions.

Optimization of a Transcatheter Heart Valve Frame Using Patient-Specific Computer Simulation.

PURPOSE: This study proposes a new framework to optimize the design of a transcatheter aortic valve through patient-specific finite element and fluid dynamics simulation. METHODS: Two geometrical parameters of the frame, the diameter at ventricular inflow and the height of the first row of cells, were examined using the central composite design. The effect of those parameters on postoperative complications was investigated by response surface methodology, and a Nonlinear Programming by Quadratic Lagrangian algorithm was used in the optimization. Optimal and initial devices were then compared in 12 patients. The comparison was made in terms of device performance [i.e., reduced contact pressure on the atrioventricular conduction system and paravalvular aortic regurgitation (AR)]. RESULTS: Results suggest that large diameters and high cells favor higher anchoring of the device within the aortic root reducing the contact pressure and favor a better apposition of the device to the aortic root preventing AR. Compared to the initial device, the optimal device resulted in almost threefold lower predicted contact pressure and limited AR in all patients. CONCLUSIONS: In conclusion, patient-specific modelling and simulation could help to evaluate device performance prior to the actual first-in-human clinical study and, combined with device optimization, could help to develop better devices in a shorter period.

The Impact of Size and Position of a Mechanical Expandable Transcatheter Aortic Valve: Novel Insights Through Computational Modelling and Simulation.

Transcatheter aortic valve implantation has become an established procedure to treat severe aortic stenosis. Correct device sizing/positioning is crucial for optimal outcome. Lotus valve sizing is based upon multiple aortic root dimensions. Hence, it often occurs that two valve sizes can be selected. In this study, patient-specific computer simulation is adopted to evaluate the influence of Lotus size/position on paravalvular aortic regurgitation (AR) and conduction abnormalities, in patients with equivocal aortic root dimensions. First, simulation was performed in 62 patients to validate the model in terms of predicted AR and conduction abnormalities using postoperative echocardiographic, angiographic and ECG-based data. Then, two Lotus sizes were simulated at two positions in patients with equivocal aortic root dimensions. Large valve size and deep position were associated with higher contact pressure, while only large size, not position, significantly reduced the predicted AR. Despite general trends, simulations revealed that optimal device size/position is patient-specific.