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Purpose: Patient-specific simulations of transcatheter aortic valve (TAV) using computational fluid dynamics (CFD) often rely on assumptions regarding proximal and distal anatomy due to the limited availability of high-resolution imaging away from the TAV site and the primary research focus being near the TAV. However, the influence of these anatomical assumptions on computational efficiency and resulting flow characteristics remains uncertain. This study aimed to investigate the impact of different distal aortic arch anatomies-some of them commonly used in literature-on flow and hemodynamics in the vicinity of the TAV using large eddy simulations (LES)., Methods: Three aortic root anatomical configurations with four representative distal aortic arch types were considered in this study. The arch types included a 90-degree bend, an idealized distal aortic arch anatomy, a clipped version of the idealized distal aortic arch, and an anatomy extruded along the normal of segmented anatomical boundary. Hemodynamic parameters both instantaneous and time-averaged such as Wall Shear Stress (WSS), and Oscillatory Shear Index (OSI) were derived and compared from high-fidelity CFD data., Results: While there were minor differences in flow and hemodynamics across the configurations examined, they were generally not significant within our region of interest i.e., the aortic root. The choice of extension type had a modest impact on TAV hemodynamics, especially in the vicinity of the TAV with variations observed in local flow patterns and parameters near the TAV. However, these differences were not substantial enough to cause significant deviations in the overall flow and hemodynamic characteristics., Conclusions: The results suggest that under the given configuration and boundary conditions, the type of outflow extension had a modest impact on hemodynamics proximal to the TAV. The findings contribute to a better understanding of flow dynamics in TAV configurations, providing insights for future studies in TAV-related experiments as well as numerical simulations. Additionally, they help mitigate the uncertainties associated with patient-specific geometries, offering increased flexibility in computational modeling., (© 2024. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Patient-specific aortic geometry and its influence on the flow in the vicinity of Transcatheter Aortic Valve (TAV) has been highlighted in numerous studies using both in silico and in vitro experiments. However, there has not yet been a detailed Particle Image Velocimetry (PIV) experiment conducted to quantify the relationship between the geometry, flow downstream of TAV, and the flow in the sinus and the neo-sinus. We tested six different patient-specific aorta models with a 26-mm SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA, USA) in a left heart simulator with coronary flow. Velocities in all three cusps and circulation downstream of TAV were computed to evaluate the influence of the ascending aorta curvature on the flow field. The in vitro analysis showed that the patient-specific aortic curvature had positive correlation to the circulation in the ascending aorta (p = 0.036) and circulation had negative correlation to the particle washout time in the cusps (p = 0.011). These results showed that distinct vortical flow patterns in the ascending aorta as the main jet impinges on the aortic wall causes a recirculation region that facilitates the flow back into the sinus and the neo-sinus, thus reducing the risk of flow stagnation and washout time., (© 2023. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Background: Leaflet thrombosis after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) may be caused by blood flow stagnation in the native and neosinus regions. To date, aortic leaflet laceration has been used to mitigate coronary obstruction following TAVR; however, its influence on the fluid mechanics of the native and neosinus regions is poorly understood. This in vitro study compared the flow velocities and flow patterns in the setting of SAVR vs TAVR with and without aortic leaflet lacerations., Methods: Two valves, (23-mm Perimount and 26-mm SAPIEN 3; Edwards Lifesciences) were studied in a validated mock flow loop under physiologic conditions. Neosinus and native sinus fluid mechanics were quantified using particle image velocimetry in the left and noncoronary cusp, with an increasing number of aortic leaflets lacerated or removed., Results: Across all conditions, SAVR had the highest average sinus and neosinus velocities, and this value was used as a reference to compare against the TAVR conditions. With an increasing number of leaflets lacerated or removed with TAVR, the average sinus and neosinus velocities increased from 25% to 70% of SAVR flow (100%). Diastolic velocities were substantially augmented by leaflet laceration. Also, the shorter frame of the SAVR led to higher flow velocities compared with the longer frame of the TAVR, even after complete leaflet removal., Conclusions: Leaflet laceration augmented TAVR native and neosinus flow fields, approaching that of SAVR. These findings may have potential clinical implications for the use of single or multiple leaflet lacerations to reduce leaflet thrombosis and thus potentially improve TAVR durability., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: Leaflet thrombosis is a potentially fatal complication after transcatheter aortic valve replacement (TAVR). Blood flow stagnation in the neo-sinus and aortic sinuses are associated with increased thrombus severity. Native aortic leaflet modification may be a potential strategy to improve the neo-sinus and aortic sinus fluid dynamics. However, limited data exist on the effect of leaflet geometry modification on the flow within the neo-sinus and aortic sinus regions. We evaluate the effect of aortic leaflet modification on the neo-sinus and aortic sinus flow stagnation after simulated TAVR., Methods: Particle image velocimetry measurements were performed under nominal (5 LPM) and low (2.5 LPM) cardiac output conditions for an intact leaflet (control) case, and 3 modified leaflet geometries. Aortic leaflet geometry modification via leaflet splay was simulated with increasing splay geometry (leaflet splay distance: 5 mm-narrow, 10 mm-medium, and 20 mm-wide)., Results: Leaflet geometry modification influenced flow features throughout the cardiac cycle, at both cardiac outputs, and allowed for flow communication between the neo-sinus and aortic sinus regions compared to the control. In the aortic sinus, flow stagnation reduced by over 64% at 5LPM, and over 36% at 2.5LPM for all simulated modified leaflet geometries compared to the control. However, only the medium and wide splay geometries enabled a reduction in neo-sinus flow stagnation compared to the control case., Conclusions: These findings suggest that aortic leaflet geometry modification (of at least 10 mm leaflet splay distance) may reduce flow stasis and potentially decrease valve thrombosis risk., (© 2022. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Objective: With the recent expanded indication for transcatheter aortic valve replacement to low-risk surgical patients, thrombus formation in the neosinus is of particular interest due to concerns of reduced leaflet motion and long-term transcatheter heart valve durability. Although flow stasis likely plays a role, a direct connection between neosinus flow stasis and thrombus severity is yet to be established., Methods: Patients (n = 23) were selected to minimize potential confounding factors related to thrombus formation. Patient-specific 3-dimensional reconstructed in vitro models were created to replicate in vivo anatomy and valve deployment using the patient-specific cardiac output and idealized coronary flows. Dye was injected into each neosinus to quantify washout time as a measure of flow stasis., Results: Flow stasis (washout time) showed a significant, positive correlation with thrombus volume in the neosinus (rho = 0.621, P < .0001). Neither thrombus volume nor washout time was significantly different in the left, right, and noncoronary neosinuses (P ≥ .54)., Conclusions: This is the first patient-specific study correlating flow stasis with thrombus volume in the neosinus post-transcatheter aortic valve replacement across multiple valve types and sizes. Neosinus-specific factors create hemodynamic and thrombotic variability within individual patients. Measurement of neosinus flow stasis may guide strategies to improve outcomes in transcatheter aortic valve replacement., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: A clinical study comparing the hemodynamic outcomes of transcatheter mitral valve replacement (TMVR) with vs. without Laceration of the Anterior Mitral leaflet to Prevent Outflow Obstruction (LAMPOON) has never been designed nor conducted., Aims: To quantify the hemodynamic impact of LAMPOON in TMVR using patient-specific computational ( in silico ) models., Materials: Eight subjects from the LAMPOON investigational device exemption trial were included who had acceptable computed tomography (CT) data for analysis. All subjects were anticipated to be at prohibitive risk of left ventricular outflow tract (LVOT) obstruction from TMVR, and underwent successful LAMPOON immediately followed by TMVR. Using post-procedure CT scans, two 3D anatomical models were created for each subject: (1) TMVR with LAMPOON (performed procedure), and (2) TMVR without LAMPOON (virtual control). A validated computational fluid dynamics (CFD) paradigm was then used to simulate the hemodynamic outcomes for each condition., Results: LAMPOON exposed on average 2 ± 0.6 transcatheter valve cells (70 ± 20 mm 2 total increase in outflow area) which provided an additional pathway for flow into the LVOT. As compared to TMVR without LAMPOON, TMVR with LAMPOON resulted in lower peak LVOT velocity, lower peak LVOT gradient, and higher peak LVOT effective orifice area by 0.4 ± 0.3 m/s (14 ± 7% improvement, p = 0.006), 7.6 ± 10.9 mmHg (31 ± 17% improvement, p = 0.01), and 0.2 ± 0.1 cm 2 (17 ± 9% improvement, p = 0.002), respectively., Conclusion: This was the first study to permit a quantitative, patient-specific comparison of LVOT hemodynamics following TMVR with and without LAMPOON. The LAMPOON procedure achieved a critical increment in outflow area which was effective for improving LVOT hemodynamics, particularly for subjects with a small neo-left ventricular outflow tract (neo-LVOT)., Competing Interests: KK has served as a consultant for Abbott Vascular. PB has served as a consultant for Edwards Lifesciences, Tendyne, Neovasc, and Circle Imaging. AG has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and has served as a consultant for and is an equity holder in Transmural Systems. VB has served as a consultant for Edwards Lifesciences and Abbott Vascular; and has served as a consultant for and is an equity holder in Transmural Systems. JK and RL were co-inventors on patents, assigned to the NIH, on devices for leaflet laceration. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Kohli, Wei, Sadri, Siefert, Blanke, Perdoncin, Greenbaum, Khan, Lederman, Babaliaros, Yoganathan and Oshinski.)

Aims: To characterize the dynamic nature of the left ventricular outflow tract (LVOT) geometry and flow rate in patients following transcatheter mitral valve replacement (TMVR) with anterior leaflet laceration (LAMPOON) and derive insights to help guide future patient selection., Methods and Results: Time-resolved LVOT geometry and haemodynamics were analysed with post-procedure computed tomography and echocardiography in subjects (N = 19) from the LAMPOON investigational device exemption trial. A novel post hoc definition for LVOT obstruction was employed to account for systolic flow rate and quality of life improvement [obstruction was defined as LVOT gradient >30 mmHg or LVOT effective orifice area (EOA) ≤1.15 cm2]. The neo-LVOT and skirt neo-LVOT were observed to vary substantially in area throughout systole (64 ± 27% and 25 ± 14% change in area, respectively). The peak systolic flow rate occurred most commonly just prior to mid-systole, while minimum neo-LVOT (and skirt neo-LVOT) area occurred most commonly in early-diastole. Subjects with LVOT obstruction (n = 5) had smaller skirt neo-LVOT values across systole. Optimal thresholds for skirt neo-LVOT area were phase-specific (260, 210, 200, and 180 mm2 for early-systole, peak flow, mid-systole, and end-systole, respectively)., Conclusion: The LVOT geometry and flow rate exhibit dynamic characteristics following TMVR with LAMPOON. Subjects with LVOT obstruction had smaller skirt neo-LVOT areas across systole. The authors recommend the use of phase-specific threshold values for skirt neo-LVOT area to guide future patient selection for this procedure. LVOT EOA is a 'flow-independent' metric which has the potential to aid in characterizing LVOT obstruction severity., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Purpose: This study examined changes in force distribution between the neochordae corresponding to different ventricular anchor locations., Description: Seven porcine mitral valves were mounted in a left heart simulator. Neochordae (expanded polytetrafluoroethylene) originated from either a simulated left ventricular apex, papillary muscle base, or papillary muscle tip location. The neochordae were attached at three sites along the P 2 leaflet segment: P 2Lateral ; P 2Center , and P 2Medial . Mitral regurgitation was induced by cutting posterior leaflet P 2 marginal chordae. The forces on each neochord required to restore normal mitral valve coaptation were quantified for different ventricular anchoring origins and leaflet insertion sites., Evaluation: The results showed that under both normotensive and hypertensive conditions, the force exerted was much higher at P 2Center than either P 2Lateral or P 2Medial , independent of ventricular anchor location. Also, forces on both P 2Lateral and P 2Medial were not statistically different., Conclusions: Artificial neochordae treatment for all anchoring locations was effective in correcting induced mitral regurgitation. The P 2 central neochordae had a significantly higher force than both lateral neochords under all conditions., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: This study assessed the long-term hemodynamic functional performance of the new Inspiris Resilia aortic valve after accelerated wear testing (AWT)., Methods: Three 21-mm and 23-mm Inspiris valves were used for the AWT procedure. After 1 billion cycles (equivalent to 25 years), the valves' hemodynamic performance was compared with that of the corresponding zero-cycled condition. Next, 1 AWT cycled valve of each valve size was selected at random for particle image velocimetry (PIV) and leaflet kinematic tests, and the data were compared with data for an uncycled Inspiris Resilia aortic valve of the same size. PIV was used to quantitatively evaluate flow fields downstream of the valve. Valves were tested according to International Standards Organization 5840-2:2015 protocols., Results: The 21-mm and 23-mm valves met the International Organization for Standardization (ISO) durability performance requirements to 1 billion cycles. The mean effective orifice areas for the 21-mm and 23-mm zero-cycled and 1 billion-cycled valves were 1.89 ± 0.02 cm 2 and 1.94 ± 0.01 cm 2 , respectively ( P  < .05) and 2.3 ± 0.13 cm 2 and 2.40 ± 0.11 cm 2 , respectively ( P  < .05). Flow characterization of the control valves and the study valves demonstrated similar flow characteristics. The velocity and shear stress fields were also similar in the control and study valves., Conclusions: The Inspiris Resilia aortic valve demonstrated very good durability and hemodynamic performance after an equivalent of 25 years of simulated in vitro accelerated wear. The study valves exceeded 1 billion cycles of simulated wear, 5 times longer than the standard requirement for a tissue valve as stipulated in ISO 5840-2:2015., (© 2021 The Author(s).)

In silico modeling has been proposed as a tool to simulate left ventricular (LV) outflow tract (LVOT) obstruction in patients undergoing transcatheter mitral valve replacement (TMVR). This study validated a simplified approach to simulate LV outflow hemodynamics in the setting of TMVR with anterior leaflet laceration, a clinical technique used to mitigate the risk of LVOT obstruction. Personalized, 3-dimensional computational fluid dynamics models were developed from computed tomography images of six patients who underwent TMVR with anterior leaflet laceration. LV outflow hemodynamics were simulated using the patient-specific anatomy and the peak systolic flow rate as boundary conditions. The peak outflow velocity, a clinically relevant hemodynamic metric, was extracted from each simulation (v sim-peak ) and compared with the clinical measurement from Doppler echocardiography (v clin-peak ) for validation. In silico models were successfully developed and implemented for all patients. The pre-processing time was 2 h per model and the simulation could be completed within 3 h. In three patients, the lacerated anterior leaflet exposed open cells of the transcatheter valve to flow. Good agreement was obtained between v sim-peak and v clin-peak (r = 0.97, p < 0.01) with average discrepancies of 5 ± 2% and 14 ± 1% for patients with exposed and unexposed cells of the transcatheter valve, respectively. The proposed in silico modeling paradigm therefore simulated LV outflow hemodynamics in a time-efficient manner and demonstrated good agreement with clinical measurements. Future studies should investigate the ability of this paradigm to support clinical applications.

Transcatheter aortic valve (TAV) leaflet thrombosis is a clinical risk with potentially fatal consequences. Studies have identified neo-sinus flow stasis as a cause of leaflet thrombosis. Flow stasis is influenced by the TAV leaflets, which affect the local fluid dynamics in the aortic sinus and neo-sinus. This study evaluated the effects of TAV leaflet features on the neo-sinus flow as a measure of leaflet thrombosis risk. Five TAVs of varied leaflet length and insertion height were tested in a simulator. Hydrodynamics and leaflet kinematics through en-phase imaging were quantified. Velocity fields were assessed using high-speed particle image velocimetry. Regions of flow stasis and particle residence times (PRTs) were quantified. TAVs with shorter leaflet length exhibited larger orifice areas and lower transvalvular pressure gradients. Shorter leaflet length and increased leaflet insertion TAVs additionally exhibited lower neo-sinus PRTs (0.44 ± 0.21 vs 2.83 ± 0.48 cycles, p < 0.05) and higher neo-sinus peak velocities (0.15 ± 0.009 vs 0.07 ± 0.005 m/s, p < 0.05) than TAVs with longer leaflet length and lower leaflet insertion. The average neo-sinus volume positively correlated with PRT(r = 0.810, p < 0.001), and extent of flow stasis (r = 0.682, p < 0.05). These results suggest that a small neo-sinus volume may reduce flow stagnation and particle residence, potentially reducing the risk of leaflet thrombosis. We propose that leaflet design features might be proactively controlled in the design of future transcatheter aortic valves.

Background: This study examined whether the presence of a sinus of Valsalva equivalent in the KONECT RESILIA aortic valved conduit (Edwards Lifesciences, Irvine, Calif) improves valve hemodynamics, kinematics, and performance., Methods: A 28-mm KONECT RESILIA aortic valved conduit was used to create an in vitro flow test model, and the same aortic valved conduit model without a sinus section was used as a control. Particle image velocimetry and hydrodynamic characterization experiments were conducted in the vicinity of the valves in a validated left-heart simulator at 3 cardiac output levels. In addition, leaflet kinematics of the valves were determined through en face high-speed imaging., Results: The KONECT RESILIA aortic valved conduit model exhibited lower mean and peak transvalvular pressure gradients than the control model at all 3 cardiac outputs. In addition, its leaflets opened more fully than did those of the valved conduit without the sinuses, yielding greater effective and geometric orifice areas. It was found that the presence of the sinuses not only facilitated the development of larger and more stable vortices at the initial stages of the cardiac cycle but also helped to maintain these vortices during the late stages of the cardiac cycle, leading to smoother valve closure., Conclusions: The KONECT RESILIA aortic valved conduit reproduces the bulged section of the aortic root corresponding to the sinuses of Valsalva. With this Valsalva-type conduit, larger orifice areas were observed, improving valve hemodynamics that may enhance performance., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: The initiation of thrombus formation in transcatheter aortic valves (TAVs) is not well understood. The foreign material components of a TAV may play a key role in TAV thrombogenesis. The goal of this study was to evaluate the thrombogenic potential of a TAV (entire valve) and its stent (with skirt)., Methods: Blood was collected from eight human donors with citrate anticoagulation and later reconstituted with calcium chloride. A low-volume steady flow loop (flow rate = 0.8 L/min) was designed to facilitate three separate conditions (experimental duration = 1 h) per donor blood: (1) control (n = 8), (2) stent-with-skirt (leaflets removed from a 23 mm SAPIEN XT valve; n = 8) and (3) entire valve (an intact 23 mm SAPIEN XT valve; n = 8). Samples were collected at the start and end of each experiment. Serum D-Dimer and thrombin-antithrombin (TAT) concentrations were measured as markers of thrombogenicity., Results: There was no significant change in serum D-Dimer and TAT concentration with time for the control group. An increasing trend in D-Dimer and TAT concentration was observed with time for the stent-with-skirt group. Interestingly, there was a decreasing trend in serum D-Dimer and TAT concentration with time for the entire valve (leaflet dominating) group. Moreover, changes in D-Dimer and TAT concentration were significantly different between the stent-with-skirt and entire valve (leaflet dominating) groups., Conclusion: Stent-with-skirt was found to impart the most prominent thrombogenic effect, indicating the significance of blood-stent and blood-skirt interactions in TAV thrombosis.

Thrombosis in post-transcatheter aortic valve replacement (TAVR) patients has been correlated with flow stasis in the neo-sinus. This study investigated the effect of the post-TAVR geometry on flow stasis. Computed tomography angiography of 155 patients who underwent TAVR using a SAPIEN 3 were used to identify patients with and without thrombosis, and quantify thrombus volumes. Six patients with 23-mm SAPIEN 3 valves were then selected from the cohort and used to create patient-specific post-TAVR computational fluid dynamic models. Regions of flow stasis (%Vol stasis , velocities below 0.05 m/s) were identified. The results showed that all post-TAVR anatomical measurements were significantly different in patients with and without thrombus, but only sinus diameter had a linear correlation with thrombus volume (r = 0.471, p = 0.008). A linear correlation was observed between %Vol stasis and thrombus volume (r = 0.821, p = 0.007). The combination of anatomy and valve deployment created a unique geometry in each patient, which when combined with patient-specific cardiac output, resulted in distinct flow patterns. While parametric studies have shown individual anatomical or deployment metrics may relate to flow stasis, the combined effects of these metrics potentially contributes to the biomechanical environment promoting thrombosis, therefore hemodynamic studies of TAVR should account for these patient-specific factors.

Objectives: We investigated the impact of (transcatheter heart valve) THV expansion at the level of the native annulus and implant depth on valve performance and neo-sinus flow stasis., Background: Flow stasis in the neo-sinus is one of the identified risk factors of THV thrombosis., Methods: A 29 mm CoreValve and 26 mm SAPIEN 3 were deployed under different expansions (CoreValve, SAPIEN 3) and implant depths (CoreValve) within a patient-derived aortic root in a pulse duplicator. Fluorescent dye was injected during diastole into the neo-sinus and imaged over 20 cardiac cycles. Washout times were computed as a measure of flow stasis for each deployment., Results: The 10% CoreValve under-expansion improved neo-sinus washout over full expansion by 8% (p < .001), and higher CoreValve implant depth improved neo-sinus washout (p < .001). The 10% SAPIEN 3 under-expansion improved neo-sinus washout by 23% (p < .001). Under-expansion of both valve types caused higher pressure gradients and smaller effective orifice areas than full expansion., Conclusions: Neo-sinus flow stasis is influenced by THV expansion and implant depth (CoreValve). The 10% valve under-deployment (oversizing) may facilitate reduced flow stasis in the neo-sinus with minimal increase in pressure gradients. This strategy may be helpful for patient anatomies, which are in-between transcatheter valve sizes., (© 2019 Wiley Periodicals, Inc.)

Objective: Rapid deployment surgical aortic valve replacement has emerged as an alternative to the contemporary sutured valve technique. A difference in transvalvular pressure has been observed clinically between RD-SAVR and contemporary SAVR. A mechanistic inquiry into the impact of the rapid deployment valve inflow frame design on the left ventricular outflow tract and valve hemodynamics is needed., Methods: A 23 mm EDWARDS INTUITY Elite rapid deployment valve and a control contemporary, sutured valve, a 23 mm Magna Ease valve, were implanted in an explanted human heart by an experienced cardiac surgeon. Per convention, the rapid deployment valve was implanted with three non-pledgeted, simple guiding sutures, while fifteen pledgeted, mattress sutures were used to implant the contemporary surgical valve. In vitro flow models were created from micro-computed tomography scans of the implanted valves and surrounding cardiac anatomy. Particle image velocimetry and hydrodynamic characterization experiments were conducted in the vicinity of the valves in a validated pulsatile flow loop system., Results: The rapid deployment and control valves were found to have mean transvalvular pressure gradients of 7.92 ± 0.37 and 10.13 ± 0.48 mmHg, respectively. The inflow frame of the rapid deployment valve formed a larger, more circular, left ventricular outflow tract compared to the control valve. Furthermore, it was found that the presence of the control valve's sub-annular pledgets compromised its velocity distribution and consequently its pressure gradient., Conclusions: The rapid deployment valve's intra-annular inflow frame provides for a larger, left ventricular outflow tract, thus reducing the transvalvular pressure gradient and improving overall hemodynamic performance.

Transcatheter heart valve (THV) leaflet thrombosis in the neo-sinus and associated reduced leaflet motion is of clinical concern due to risks of embolism and worsened valve hemodynamics. Flow stasis in the neo-sinus (the space between the native and THV leaflets) is a known risk factor, but the role of proximal coronary flow is yet to be investigated. We tested two replicas of FDA approved commercial THVs-intra-annular and supra-annular (similar to the SAPIEN 3 and CoreValve families)-in a left heart simulator with coronary flow. Velocity fields in the left coronary cusp (LCC) and non (NCC) neo-sinus were quantified using high speed particle image velocimetry and particle residence times (PRT) were computed to evaluate flow stasis in the region. The supra-annular THV LCC neo-sinus had shorter PRT than its NCC neo-sinus (0.66 ± 0.00 vs. 0.76 ± 0.04, p = 0.038), while the intra-annular THV LCC neo-sinus had similar PRT to its NCC neo-sinus (1.93 ± 0.05 vs. 1.92 ± 0.03 cycles, p = 0.889). The supra-annular valve LCC and NCC neo-sinuses had shorter PRT than their intra-annular valve counterparts (p < 0.001). These results showed that coronary flow reduces flow stasis in the supra-annular THV neo-sinus and, ostensibly, thrombosis risk in the region. This effect was not significant in the intra-annular valve.

Computational modeling can be used to improve understanding of tricuspid valve (TV) biomechanics and supplement knowledge gained from benchtop and large animal experiments. The aim of this study was to develop a computational model of the TV using high resolution micro-computed tomography (μCT) imaging and fluid-structure interaction simulations. A three-dimensional TV model, incorporating detailed leaflet and chordal geometries, was reconstructed from μCT images of an excised porcine TV obtained under diastolic conditions. The leaflets were described using non-linear stress-strain relations and chordal properties were iteratively adjusted until valve closure was obtained. The leaflet coaptation zone obtained from simulation of valve closure was validated against μCT images of the TV captured at peak systole. The computational model was then used to simulate a regurgitant TV morphology and investigate changes in closure dynamics. Overall, the mean stresses in the leaflet belly region and the chordae tendinae of the regurgitant TV were 7% and 3% higher than the same regions of the normal TV. The maximum principal strain in the leaflet belly of the regurgitant TV was also 9% higher than the same regions of the normal TV. It is anticipated that this computational model can be used in future studies for further understanding of TV biomechanics and associated percutaneous repairs.

While transcatheter mitral valve (TMV) replacement technology has great clinical potential for surgically inoperable patients suffering from mitral regurgitation, no TMV has yet achieved regulatory approval. The diversity of devices currently under development reflects a lack of consensus regarding optimal design approaches. In Part I of this two-part study, a test system was developed for the quantification of paravalvular leakage (PVL) following deployment of a TMV or TMV-like device in pressurized, explanted porcine hearts (N = 7). Using this system, PVL rate was investigated as a function of steady trans-mitral pressure (ΔP), TMV shape, and TMV-annular oversizing, using a series of "mock TMV plug" devices. Across all devices, PVL was found to approximately trend with the square of ΔP. PVL rates were approximately 0-15 mL/s under hypotensive pressure, 10-40 mL/s under normotension, and 30-85 mL/s under severe hypertension. D-shaped devices significantly reduced PVL vs. circular devices; however, this effect was diminished upon oversizing to the annulus by 6 mm inter-trigonal distance. In conclusion, this steady pressure, in vitro test system was effective to compare PVL performance across TMV-like designs. PVL exhibited complex dynamics in terms of its response to transvalvular pressure and TMV profile.

Transcatheter mitral valve (TMV) replacement technology has great clinical potential for surgically inoperable patients suffering from mitral regurgitation. An important goal for robust TMV design is maximizing the likelihood of achieving a geometry post-implant that facilitates optimal performance. To support this goal, improved understanding of the annular forces that oppose TMV radial expansion is necessary. In Part II of this study, novel circular and D-shaped Radial Expansion Force Transducers (C-REFT and D-REFT) were developed and employed in porcine hearts (N = 12), to detect the forces required to radially expand the mitral annulus to discrete oversizing levels. Forces on both the septal-lateral and inter-commissural axes (F SL and F IC ) scaled with device size. The D-REFT experienced lower F SL than the C-REFT (19.8 ± 7.4 vs. 17.4 ± 10.8 N, p = 0.002) and greater F IC (31.5 ± 14.0 vs. 36.9 ± 16.2 N; p = 0.002), and was more sensitive to degree of oversizing. Across all tests, F IC /F SL was 2.21 ± 1.33, likely reflecting low resistance to radial expansion at the aorto-mitral curtain. In conclusion, the annular forces opposing TMV radial expansion are non-uniform, and depend on final TMV shape and size. Based on this two-part study, we propose that radial force applied at the commissural aspect of the annulus has the most potent effect on paravalvular sealing.