Pulse Duplicator Research Articles

Assessing the Thrombogenic Potential of Heart Valve Prostheses: An Approach for a Standardized In-Vitro Method.

Thrombogenic complications are still a main issue in the general performance of cardiovascular implants, especially heart valves. To date, the thrombogenic potential of those prostheses is pre-clinically assessed in time consuming animal studies with questionable evidence. In this study, we present a new in-vitro method to assess and compare deficiencies of heart valve substitutes concerning their thrombogenic performance and locate initial clot formation under physiological conditions using porcine blood. Therefore, an athrombogenic pulse duplicator (THIA3) was developed that simulates the anatomic and hemodynamic conditions in the vicinity of the aortic valve. Validation of this tester was carried out with regard to hemodynamics, reproducibility and using positive and negative control valves and by comparison of clot locations with literature data from chronic animal trials with sheep using a St. Jude bileaflet valve. Validation of the tester showed quasi-physiological hemodynamics and reproducible clot formation. Identical clot formations were found comparing findings in vitro with chronic animal trials. The THIA 3 has proven its suitability for valid, reproducible evaluation of thrombogenic potential of heart valves in a short period of time.

A Durable Porcine Pericardial Surgical Bioprosthetic Heart Valve: a Proof of Concept

Bioprosthetic leaflets made from animal tissues are used in the majority of surgical and transcatheter cardiac valve replacements. This study develops a new surgical bioprosthesis, using porcine pericardial leaflets. Porcine pericardium was obtained from genetically engineered pigs with a mutation in the GGTA-1 gene (GTKO) and fixed in 0.6% glutaraldehyde, and used to develop a new surgical valve design. The valves underwent in vitro hydrodynamic test in a pulse duplicator and high-cycled accelerated wear testing and were evaluated for acute haemodynamics and thrombogenicity in a juvenile sheep implant study for 48 h. The porcine surgical pericardial heart valves (pSPHVs) exhibited excellent hydrodynamics and reached 200 million cycles of in vitro durability, with no observable damage. Juvenile sheep implants demonstrated normal valve function with no acute thrombogenic response for either material. The pSPHV incorporates a minimalistic construction method using a tissue-to-tissue design to cover the stent. This new design is a proof of concept alternative to the use of bovine pericardium and synthetic fabric in surgical bioprosthetic heart valves.

Spatiotemporal Complexity of the Aortic Sinus Vortex as a Function of Leaflet Calcification.

Several studies have shown the variation of aortic sinus structures' hemodynamics with different flow and geometric characteristics. They have also correlated aortic sinus hemodynamics with the progression and evolution of calcific aortic valve disease (CAVD). This study aims at visualizing aortic sinus fluid structure variations as functions of different leaflet calcification degrees and assessing their potential relationship with CAVD. A degenerated 23mm Carpentier-Edwards Perimount Magna valve extracted from a redo-surgery patient was implanted in an aortic root model and tested in a pulse duplicator left heart simulator. The valve has 3 leaflets with 3 different levels of calcium distribution: mild, moderate and severe. High-speed imaging and particle image velocimetry were performed to assess sinus vortices, leaflet tip position and velocity along with shear stress. Results have shown that (a) aortic sinus vortices initiation, entrapment and evolution varied with different calcified leaflet exposure; (b) higher velocities in the sinus were calculated with the mildly calcified leaflet compared to the moderately and severely calcified ones; (c) during systole, the mildly calcified leaflet sinus case shows the most spread-out and higher ranges of shear stress probabilities and highest magnitudes going from (- 1.5 to + 1.8Pa) compared with (- 1.0 to + 1.0Pa) for moderately and severely calcified leaflets. The higher the calcification degree the lower the shear stress range and likelihoods of having higher shear stress. This holds in diastole as well. This study shows the impact of calcification on the aortic sinus flow structures.

A novel trileaflet mechanical heart valve: first in vitro results.

Heart valve prostheses are the therapy of choice for patients with severe heart valve diseases. Two types of prostheses that can be implanted in patients are available: biological and mechanical. Though mechanical heart valves have some disadvantages like necessity of life-long anticoagulation, biological heart valve prostheses often necessitate reinterventions due to limited durability. Therefore, a new trileaflet mechanical heart valve was developed, featuring hinges in the systolic flow with the aim of function and thrombogenicity. We first compared the new trileaflet mechanical heart valve to conventional bileaflet heart valves (St. Jude Medical and On-X valves) in vitro. Haemodynamic measurements were performed in a pulse duplicator system, and clot formation was examined with an implemented method using enzyme-activated milk as the test medium. Haemodynamic measurements showed the largest effective orifice areas and smallest pressure gradients for the trileaflet prosthesis compared to the bileaflet valve. Opening and closing characteristics of the trileaflet valve and of the St. Jude Medical valve were comparable. Clotting tests depicted only minor isolated deposits for the new trileaflet valve whereas the bileaflet valves showed distinct clots in the area of the hinge in all experiments. Haemodynamic and clotting tests showed improvements for the new trileaflet valve compared to common bileaflet valves. The off-wall systolic position of the hinges, which eluded adverse flow areas, was a major advantage of the new valve.

New Device for the Treatment of Functional Ischemic Mitral Regurgitation: Proof of Concept in an In Vitro Model.

Optimal surgical treatment of functional ischemic mitral regurgitation (FIMR) is still controversy. Due to the underlying pathophysiology, stand-alone ring annuloplasty is assumed with a high recurrence rate of mitral regurgitation, thus additional subvalvular repair techniques might improve the results. This in vitro study introduces a new device for subvalvular mitral valve repair. We developed a new device for subvalvular mitral valve repair, consisting of two frames for papillary muscle (PM) attachment, which are connected with two holding bars serving for fixation of the device on an annuloplasty ring. In the first experimental run, porcine mitral valves including the chordae tendineae and PMs were fixated on a holding device, consisting of a holding ring simulating mitral annulus dilation and height-adjustable frames for PM attachment simulating leaflet tethering. In vitro regurgitant volume was determined in a pulse duplicator. Afterward, the frames for PM attachment were replaced by our newly developed device and the measurements were repeated. In the model simulating FIMR, the regurgitant volume was 44.3 ± 12.38 mL/stroke. After subvalvular reconstruction with our new device, the regurgitant volume was significantly reduced to 33.1 ± 11.68 mL/stroke (p = 0.009). In this specific in vitro model, our new device for subvalvular mitral valve reconstruction led to a significant reduction of the regurgitant volume, thus representing a promising technique to potentially improve the results of mitral reconstruction in ischemic functional mitral valve regurgitation. Additional studies are required to further investigate and improve our device.

Comparative Fluid-Structure Interaction Analysis of Polymeric Transcatheter and Surgical Aortic Valves' Hemodynamics and Structural Mechanics.

Transcatheter aortic valve replacement (TAVR) has emerged as an effective alternative to conventional surgical aortic valve replacement (SAVR) in high-risk elderly patients with calcified aortic valve disease. All currently FDA-approved TAVR devices use tissue valves that were adapted to but not specifically designed for TAVR use. Emerging clinical evidence indicates that these valves may get damaged during crimping and deployment- leading to valvular calcification, thrombotic complications, and limited durability. This impedes the expected expansion of TAVR to lower-risk and younger patients. Viable polymeric valves have the potential to overcome such limitations. We have developed a polymeric SAVR valve, which was optimized to reduce leaflet stresses and offer a thromboresistance profile similar to that of a tissue valve. This study compares the polymeric SAVR valve's hemodynamic performance and mechanical stresses to a new version of the valve- specifically designed for TAVR. Fluid-structure interaction (FSI) models were utilized and the valves' hemodynamics, flexural stresses, strains, orifice area, and wall shear stresses were compared. The TAVR valve had 42% larger opening area and 27% higher flow rate versus the SAVR valve, while wall shear stress distribution and mechanical stress magnitudes were of the same order, demonstrating the enhanced performance of the TAVR valve prototype. The TAVR valve FSI simulation and Vivitro pulse duplicator experiments were compared in terms of the leaflets' kinematics and the effective orifice area. The numerical methodology presented can be further used as a predictive tool for valve design optimization for enhanced hemodynamics and durability.

A Non-Invasive Material Characterization Framework for Bioprosthetic Heart Valves.

Computational modeling and simulation has become more common in design and development of bioprosthetic heart valves. To have a reliable computational model, considering accurate mechanical properties of biological soft tissue is one of the most important steps. The goal of this study was to present a non-invasive material characterization framework to determine mechanical propertied of soft tissue employed in bioprosthetic heart valves. Using integrated experimental methods (i.e., digital image correlation measurements and hemodynamic testing in a pulse duplicator system) and numerical methods (i.e., finite element modeling and optimization), three-dimensional anisotropic mechanical properties of leaflets used in two commercially available transcatheter aortic valves (i.e., Edwards SAPIEN 3 and Medtronic CoreValve) were characterized and compared to that of a commonly used and well-examined surgical bioprosthesis (i.e., Carpentier-Edwards PERIMOUNT Magna aortic heart valve). The results of the simulations showed that the highest stress value during one cardiac cycle was at the peak of systole in the three bioprostheses. In addition, in the diastole, the peak of maximum in-plane principal stress was 0.98, 0.96, and 2.95MPa for the PERIMOUNT Magna, CoreValve, and SAPIEN 3, respectively. Considering leaflet stress distributions, there might be a difference in the long-term durability of different TAV models.

Fluid Dynamic Characterization of Transcatheter Aortic Valves Using Particle Image Velocimetry.

Transcatheter aortic valves provide superior systolic hemodynamic performance in terms of valvular pressure gradient and effective orifice area compared with equivalent size surgical bioprostheses. However, in depth investigation of the flow field structures is of interest to examine the flow field characteristics and provide experimental evidence necessary for validation of computational models. The goal of this study was to compare flow field characteristics of the three most commonly used transcatheter and surgical valves using phase-locked particle image velocimetry (PIV). 26-mm Edwards SAPIEN 3, 26-mm Medtronic CoreValve, and 25-mm Carpentier-Edwards PERIMOUNT Magna were examined in a pulse duplicator with input parameters matching ISO-5840, that is, heart rate of 70 beats/min, cardiac output of 5 L/min, and mean aortic pressure of 100 mm Hg. A 2D PIV system was used to obtain flow velocity and viscous shear stress fields during the entire cardiac cycle. In vitro testing showed that the mean transvalvular pressure gradient was lowest for SAPIEN 3, followed by CoreValve, and PERIMOUNT Magna surgical bioprosthesis. In addition, the viscous shear stress magnitude within the jet boundary layer was higher in PERIMOUNT Magna than CoreValve and SAPIEN 3 at the peak of the flow. However, the measured shear stress values were below the known threshold for platelet activation and red blood damage. Therefore, shear-induced platelet activation is unlikely to take place during systole in the three bioprosthetic heart valves. The PIV measurements can be used for verification and validation of computational simulations.

Fluid-structure interaction of heart valve dynamics in comparison to finite-element analysis

Abstract An established therapy for aortic valve stenosis and insufficiency is the transcatheter aortic valve replacement. By means of numerical simulation the valve dynamics can be investigated to improve the valve prostheses performance. This study examines the influence of the hemodynamic properties on the valve dynamics utilizing fluidstructure interaction (FSI) compared with results of finiteelement analysis (FEA). FEA and FSI were conducted using a previously published aortic valve model combined with a new developed model of the aortic root. Boundary conditions for a physiological pressurization were based on measurements of ventricular and aortic pressure from in vitro hydrodynamic studies of a commercially available heart valve prosthesis using a pulse duplicator system. A linear elastic behavior was assumed for leaflet material properties and blood was specified as a homogeneous, Newtonian incompressible fluid. The type of fluid domain discretization can be described with an arbitrary Lagrangian-Eulerian formulation. Comparison of significant points of time and the leaflet opening area were used to investigate the valve opening behavior of both analyses. Numerical results show that total valve opening modelled by FEA is faster compared to FSI by a factor of 5. In conclusion the inertia of the fluid, which surrounds the valve leaflets, has an important influence on leaflet deformation. Therefore, fluid dynamics should not be neglected in numerical analysis of heart valve prostheses.

Hemodynamic influence of design parameters of novel venous valve prostheses

Abstract Venous ulcers of the lower limbs are one clinical manifestation of chronic venous insufficiency. Currently, there is no venous valve prosthesis available. This study presents novel venous valve prostheses made of threedimensional electrospun fibrous nonwoven leaflets. The aim of this study was to prove the feasibility of the manufacturing process as well as to investigate design features of the venous valve prostheses from a hemodynamic point of view. An adapted pulse duplicator system (ViVitrolabs, Victoria, BC, CA) was used for characterization of the hydrodynamic performance. For eight different venous valve prototypes flow rate, effective orifice area and regurgitation fraction was investigated in vitro. In particular, tricusp valve designs showed an up to 40% higher effective orifice area as well as 15% higher maximum flowrate compared to bicusp valve designs. However, the regurgitation fraction of the bicusp valve designs is up to 86% lower compared to tricusp valve. Additionally, the hemodynamic performance of the tricuspid valves showed a high sensitivity regarding the leaflet length. Bicuspid valves are less sensitive to changes of design parameters, more sufficient and therefore highly reliable.

Effect of size and position of self-expanding transcatheter valve on haemodynamics following valve-in-valve procedure in small surgical bioprostheses: an in vitro study.

The valve-in-valve (ViV) procedure has become a valuable alternative for the treatment of failed surgical bioprostheses (BP) in high-risk patients. However, in small BP, the clinical outcomes have been suboptimal due to high post-procedural gradients. We aimed to examine the effect of size and position of the self-expanding transcatheter heart valve (THV) CoreValve on the haemodynamics of ViV within small BP. Sizes 23 and 26 mm of the CoreValve were implanted in sizes 19 and 21 mm of three BP models: Trifecta, Mitroflow and Epic Supra. The THV was tested in three positions -normal (manufacturer recommendation), low (4 mm below normal) and high (4 mm above normal)- using a pulse duplicator. Haemodynamics were assessed by Doppler echocardiography and flowmeter, and GOA with a high-speed camera. Higher implantation was associated with lower residual gradients (normal position: -9%, high: -25% versus low). High position was, however, associated with increased risk of regurgitation in the Mitroflow and embolisation in the Epic Supra. Using a 26 mm THV instead of a 23 mm was associated with larger EOAs in the Trifecta, smaller in the Mitroflow, and increased risk of embolisation in the Epic Supra. Supra-annular positioning of the CoreValve THV is associated with improved post-ViV haemodynamics in small surgical BP. The haemodynamic outcomes are highly dependent on the model and size of surgical BP.

Fabrication and In Vitro Characterization of a Tissue Engineered PCL-PLLA Heart Valve

Heart valve diseases are among the leading causes of cardiac failure around the globe. Nearly 90,000 heart valve replacements occur in the USA annually. Currently, available options for heart valve replacement include bioprosthetic and mechanical valves, both of which have severe limitations. Bioprosthetic valves can last for only 10–20 years while patients with mechanical valves always require blood-thinning medications throughout the remainder of the patient’s life. Tissue engineering has emerged as a promising solution for the development of a viable, biocompatible and durable heart valve; however, a human implantable tissue engineered heart valve is yet to be achieved. In this study, a tri-leaflet heart valve structure is developed using electrospun polycaprolactone (PCL) and poly L-lactic acid (PLLA) scaffolds, and a set of in vitro testing protocol has been developed for routine manufacturing of tissue engineered heart valves. Stress-strain curves were obtained for mechanical characterization of different valves. The performances of the developed valves were hemodynamically tested using a pulse duplicator, and an echocardiography machine. Results confirmed the superiority of the PCL-PLLA heart valve compared to pure PCL or pure PLLA. The developed in vitro test protocol involving pulse duplicator and echocardiography tests have enormous potential for routine application in tissue engineering of heart valves.

How Do Transcatheter Heart Valves Fit in Mitral Annuloplasty Rings and Which Combination Can be Recommended?

Transcatheter heart valve (THV) as valve-in-ring is increasingly used in the mitral position. Semi-rigid rings may serve as a more appropriate scaffold for proper anchoring of a THV as they may change from their oval to a round shape thereby fitting to the implanted THV. One rigid and five semi-rigid rings of four manufacturers, Edwards Physio I and II, Sorin 3D Memo, Medtronic Simulus, and St. Jude Medical (SJM) Saddle and SJM Sequin, with sizes 28 to 36 mm and Edwards Sapien III THV 23, 26, and 29 mm were used. Preevaluation comprised insertion/inflation of the THV into the ring and visual inspection for the paravalvular gap ≥ 4 mm2. Only valves not showing paravalvular gap were then submitted to hemodynamic evaluation with a pulse duplicator. Cusp movement was assessed with a high-speed-camera. Mean transvalvular gradients (TVGs) were measured. SJM Saddle ring of all sizes and SJM Sequin ring 34 showed marked gaps combined with all THV sizes, thus not undergoing hemodynamic testing. It was further shown that ring sizes ≥ 36 mm did not allow for a proper fit of even the largest THV into the ring of all the manufacturers and were consequently not hemodynamically evaluated. The 23 mm THV was too small for any ring size. The lowest gradients were achieved with the 26 mm THV in 30 and 32 mm and the 29 mm THV in 32 and 34 mm rings. Not all currently available annuloplasty rings are ideal scaffolds for THV placement. It appears that a more proper fit can be achieved with semi-rigid rings than with rigid ones. Note that 23 mm THV appeared to be too small for an adequate anchoring in even the smallest available ring. Thus, 26 mm as well as 29 mm THV fit properly in ring sizes between 28 and 34 mm. Surgeons may consider to choose from those ring brands and sizes which allow for good placement of a THV in view of possible valve degeneration in the later course.

Fluid-structure interaction of a pulsatile flow with an aortic valve model: A combined experimental and numerical study.

The complex fluid-structure interaction problem associated with the flow of blood through a heart valve with flexible leaflets is investigated both experimentally and numerically. In the experimental test rig, a pulse duplicator generates a pulsatile flow through a biomimetic rigid aortic root where a model of aortic valve with polymer flexible leaflets is implanted. High-speed recordings of the leaflets motion and particle image velocimetry measurements were performed together to investigate the valve kinematics and the dynamics of the flow. Large eddy simulations of the same configuration, based on a variant of the immersed boundary method, are also presented. A massively parallel unstructured finite-volume flow solver is coupled with a finite-element solid mechanics solver to predict the fluid-structure interaction between the unsteady flow and the valve. Detailed analysis of the dynamics of opening and closure of the valve are conducted, showing a good quantitative agreement between the experiment and the simulation regarding the global behavior, in spite of some differences regarding the individual dynamics of the valve leaflets. A multicycle analysis (over more than 20 cycles) enables to characterize the generation of turbulence downstream of the valve, showing similar flow features between the experiment and the simulation. The flow transitions to turbulence after peak systole, when the flow starts to decelerate. Fluctuations are observed in the wake of the valve, with maximum amplitude observed at the commissure side of the aorta. Overall, a very promising experiment-vs-simulation comparison is shown, demonstrating the potential of the numerical method.

Development of an Experimental and Digital Cardiovascular Arterial Model for Transient Hemodynamic and Postural Change Studies: "A Preliminary Framework Analysis".

The ultimate goal of the present work is to aid in the development of tools to assist in the treatment of cardiovascular disease. Gaining an understanding of hemodynamic parameters for medical implants allow clinicians to have some patient-specific proposals for intervention planning. In the present work an experimental and digital computational fluid dynamics (CFD) arterial model consisting of a number of major arteries (aorta, carotid bifurcation, cranial, femoral, jejunal, and subclavian arteries) were fabricated to study: (1) the effects of local hemodynamics (flow parameters) on global hemodynamics (2) the effects of transition from bedrest to upright position (postural change) on hemodynamics, and (3) diffusion of dye (medical drug diffusion simulation) in the arterial system via experimental and numerical techniques. The experimental and digital arterial models used in the present study are the first 3-D systems reported in literature to incorporate the major arterial vessels that deliver blood from the heart to the cranial and femoral arteries. These models are also the first reported in literature to be used for flow parameter assessment via medical drug delivery and orthostatic postural change studies. The present work addresses the design of the experimental and digital arterial model in addition to the design of measuring tools used to measure hemodynamic parameters. The experimental and digital arterial model analyzed in the present study was developed from patient specific computed tomography angiography (CTA) scans and simplified geometric data. Segments such as the aorta (ascending and descending) and carotid bifurcation arteries of the experimental and digital arterial model was created from online available patient-specific CTA scan data provided by Charite' Clinical and Research Hospital. The cranial and coronary arteries were simplified arterial geometries developed from dimensional specification data used in previous work. For the patient specific geometries, a MATLAB code was written to upload the CTA scans of each artery, calculate the centroids, and produce surface splines at each discrete cross section along the lumen centerline to create the patient specific arterial geometries. The MATLAB code worked in conjunction with computer aided software (CAD) Solidworks to produce solid models of the patient specific geometries and united them with the simplified geometries to produce the full arterial model (CAD model). The CAD model was also used as a blueprint to fabricate the experimental model which was used for flow visualization via particle imaging velocimetry (PIV) and postural change studies. A custom pulse duplicator (pulsatile pump) was also designed and developed for the present work. The pulse duplicator is capable of producing patient-specific volumetric waveforms for inlet flow to the experimental arterial model. A simple fluid structure interaction (FSI) study was also conducted via optical techniques to establish the magnitude of vessel diameter change due to the pulsatile flow. A medical drug delivery (dye dispersion and tracing) case was simulated via a dye being dispersed into the pulsatile flow stream to measure the transit time of the dye front. Pressure waveforms for diseased cases (hypertension & stenotic cases) were also obtained from the experimental arterial model during postural changes from bedrest (0°) to upright position (90°). The postural changes were simulated via attaching the experimental model to a tile table the can transition from 0° to 90°. The PIV results obtained from the experimental model provided parametric data such as velocity and wall shear stress data. The medical drug delivery simulations (experimental and numerical) studies produce time dependent data which is useful for predicting flow trajectory and transit time of medical drug dispersion. In the case of postural change studies, pressure waveforms were obtained from the common carotid artery and the femoral sections to yield pressure difference data useful for orthostatic hypotension analysis. Flow parametric data such as vorticity (flow reversal), wall shear stress, normal stress, and medical drug transit data was also obtained from the digital arterial model CFD simulations. Although the present work is preliminary work, the experimental and digital models proves to be useful in providing flow parametric data of interest such as: (1) normal stress which is useful for predicting the magnitude of forces which could promote arterial rupture or dislodging of medical implants, (2) wall shear stress which is useful for analyzing the magnitude of drug transport at the arterial wall, (3) vorticity which is useful for predicting the magnitude of flow reversal, and (4) arterial compliance in the case of the experimental model which could be useful in the efforts of developing FSI numerical simulations that incorporates compliance which realistically models the flow in the arterial system.

Ex vivo hydrodynamics after central and paracommissural edge-to-edge technique: A further step toward transcatheter tricuspid repair?

ObjectivesTranscatheter approaches in heart valve disease became tremendously important and are currently established in the aortic position, but transcatheter tricuspid repair is still in its beginning and remains challenging. Replicating the surgical edge-to-edge technique, for example, with the MitraClip System (Abbott Vascular, Santa Clara, Calif), represents a promising option and has been reported successfully in small numbers of cases. However, up to now, few data considering the edge-to-edge technique as a transcatheter approach are available. This study aims to determine the ex vivo hydrodynamics after the central and paracommissural edge-to-edge technique in different pathologies. MethodsBecause of basal or apical dislocation of papillary muscles, leaflet prolapse or tethering was simulated in porcine tricuspid valves mounted on a flexible holding device. Central and paracommissural edge-to-edge techniques were evaluated successively in these pathologies. Regurgitant volume and mean transvalvular gradient were determined in a pulse duplicator. ResultsIn this ex vivo model, the isolated edge-to-edge technique reduced tricuspid regurgitation. In the prolapse model, regurgitant volume decreased significantly after central edge-to-edge technique (from 49.4 ± 13.6 mL/stroke to 39.3 ± 14.1 mL/stroke). In the tethering model, both the central and the paracommissural edge-to-edge techniques led to a significant decrease (from 48.7 ± 13.9 to 43.6 ± 15.6 and to 41.1 ± 13.8 mL/stroke). In all cases, the reduction of regurgitant volume was achieved at the cost of significantly increased mean transvalvular gradient. ConclusionsThis study provides a reduction of tricuspid regurgitation after the edge-to-edge technique in the specific experimental setup. Whether this reduction is sufficient to treat tricuspid regurgitation successfully in clinical practice remains to be established. Transcatheter approaches need to be evaluated further, probably with regard to concomitant annuloplasty for higher reduction of tricuspid regurgitation.

Role of Re-entry Tears on the Dynamics of Type B Dissection Flap

Mortality during follow-up after acute Type B aortic dissection is substantial with aortic expansion observed in over 59% of the patients. Lumen pressure differential is considered a prime contributing factor for aortic dilation after propagation. The objective of the study was to evaluate the relationship between changes in vessel geometry with and without lumen pressure differential post propagation in an ex vivo porcine model with comparison with patient clinical data. A pulse duplicator system was utilized to propagate the dissection within descending thoracic porcine aortic vessels for set proximal (%circumference of the entry tear: 40%, axial length: 2 cm) and re-entry (50% of distal vessel circumference) tear geometry. Measurements of lumen pressure differential were made along with quantification of vessel geometry (n = 16). The magnitude of mean lumen pressure difference measured after propagation was low (~ 5 mmHg) with higher pressures measured in false lumen and as anticipated the pressure difference approached zero after the creation of distal re-entry tear. False lumen Dissection Ratio (FDR) defined as arc length of dissected wall divided by arc length of dissection flap, had mean value of 1.59 ± 0.01 at pressure of 120/80 mmHg post propagation with increasing values with increase in pulse pressure that was not rescued with the creation of distal re-entry tear (p < 0.01). An average FDR of 1.87 ± 0.27 was measured in patients with acute Type B dissection. Higher FDR value (FDR = 1 implies zero dissection) in the presence of distal re-entry tear demonstrates an acute change in vessel morphology in response to the dissection independent of local pressure changes challenges the re-apposition of the aortic wall.

Impact of aortic root geometry on hydrody-namic performance of transcatheter aortic valve prostheses

Abstract Assessment of hydrodynamic performance of transcatheter aortic valve prostheses (TAVP) in vitro is es-sentially in the fields of development and approval of novel implants. For the prediction of clinical performance, in vitro testing of TAVP allows for benchmarking of different devic-es, likewise. In addition to the implant itself, also the testing environment has a crucial influence on leaflet dynamics and quantitative test results like effective orifice area (EOA) or aortic regurgitation. Therefore, within the current study we developed simpli-fied physiological and pathophysiological vessel models of the aortic root as a tool for in vitro hydrodynamic testing of TAVP in idealized and worst case conditions. We used 3D printing and silicone cast molding for manufacturing of aortic root models with variable degree of stenosis. Design of aortic roots with normal, mild and severe stenosis was developed according to Reul et al. For manufacturing of tripartite cast-ing molds, a 3D printer was used. Both outer mold parts and the mold core were manufactured from polylactide filament and water soluble polyvinylalcohol filament, respectively. In vitro hydrodynamic performance testing of an exemplary commercially available TAVP implanted in different aortic root models was conducted according to DIN EN ISO 5840-3:2013, using a pulse duplicator system. Manufactured aortic root models were highly transparent, dimensionally stable and therefore suitable for hydrodynamic testing of TAVP. Both, EOA and regurgitant fraction in-creased with increasing degree of stenosis from 1.6 ± 0.1 cm2 to 1.8 ± 0.1 cm2 and 8.6 ± 6.5% to 20.2 ± 4.2% (n = 30 cy-cles), respectively. We successfully developed a testing environment ena-bling sophisticated evaluation of hydrodynamic performance of TAVR in pathophysiological worst case conditions.

First ex vivo and preliminary sheep model results of the new TRIBIO aortic valve bioprosthesis in small aortic annuli.

Small aortic annuli are challenging in aortic valve replacement. Prosthesis-patient mismatch, accompanied by high transvalvular gradients and small orifice area, is an often faced problem impairing postoperative outcome. The new TRIBIO bioprosthesis aims to enable enhanced haemodynamics, being increasingly important with decreasing annular size. This study compares ex vivo hydrodynamics of TRIBIO with 2 established bioprostheses in small annuli at different stroke volumes, simulating 'rest' and 'exercise', and evaluates haemodynamics of TRIBIO in a sheep model. Ex vivo: Porcine aortic roots were hardened with glutaraldehyde, approaching the stiffness of decalcified roots. Each bioprosthesis (TRIBIO, Trifecta™, Perimount® Magna Ease), size 19 mm, was implanted in each aortic root and inserted into a pulse duplicator, determining hydrodynamics and geometric orifice area at different stroke volumes (74, 90, 104 ml). Sheep model: Postoperative transvalvular gradients were assessed after implantation of 19 mm TRIBIO in aortic position. Ex vivo: Mean transvalvular gradients were lowest in TRIBIO (7.3, 8.7, 10.2 mmHg at 74, 90, 104 ml) with significant difference to Perimount® Magna Ease. Geometric orifice area in TRIBIO was 2.7 cm2 and significantly larger compared to Perimount® Magna Ease and Trifecta™. Opening of TRIBIO was uniform and apparently complete, whereas leaflet's outward movement was restricted particularly in Perimount® Magna Ease. Sheep model: TRIBIO presented with low transvalvular gradients (δpmean 4.1 ± 2 mmHg, δpmax 7.8 ± 4.6 mmHg), unimpaired leaflet motion and no central or paravalvular leakage. Ex vivo, the TRIBIO achieved superior hydrodynamics compared to latest generation bioprostheses. These excellent data are supported by very low transvalvular gradients in a preliminary sheep model.

Evaluation of an aortic valve prosthesis: Fluid-structure interaction or structural simulation?

Bio-inspired polymeric heart valves (PHVs) are excellent candidates to mimic the structural and the fluid dynamic features of the native valve. PHVs can be implanted as prosthetic alternative to currently clinically used mechanical and biological valves or as potential candidate for a minimally invasive treatment, like the transcatheter aortic valve implantation. Nevertheless, PHVs are not currently used for clinical applications due to their lack of reliability. In order to investigate the main features of this new class of prostheses, pulsatile tests in an in-house pulse duplicator were carried out and reproduced in silico with both structural Finite-Element (FE) and Fluid-Structure interaction (FSI) analyses. Valve kinematics and geometric orifice area (GOA) were evaluated to compare the in vitro and the in silico tests. Numerical results showed better similarity with experiments for the FSI than for the FE simulations. The maximum difference between experimental and FSI GOA at maximum opening time was only 5%, as compared to the 46.5% between experimental and structural FE GOA. The stress distribution on the valve leaflets clearly reflected the difference in valve kinematics. Higher stress values were found in the FSI simulations with respect to those obtained in the FE simulation. This study demonstrates that FSI simulations are more appropriate than FE simulations to describe the actual behaviour of PHVs as they can replicate the valve-fluid interaction while providing realistic fluid dynamic results.