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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.)

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.)

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.