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1.
Failure of bioprosthetic and synthetic three-leaflet valves has been shown to occur as a consequence of high tensile and bending stresses, acting on the leaflets during opening and closing. Moreover, in the stented prostheses, whether synthetic or biological, the absence of contraction of the aortic base, due to the rigid stent, causes the leaflets to be subjected to an unphysiological degree of flexure, which is related to calcification. It is shown that the absence of the stent, which gives a flexible aortic base and leaflet attachment, and leaflet fibre-reinforcement result in reduced stresses in the weaker parts of the leaflets in their closed configuration. It is postulated that this leads to a decrease of tears and perforations, which may result in a improved long-term behaviour. The effect of a flexible leaflet attachment and aortic base of a synthetic valve is investigated with a finite element model. Different fibre-reinforced structures are analysed with respect to the stresses that are likely to contribute to the failure of fibre-reinforced prostheses and compared with the results obtained for a stented prosthesis. Results show that for the stentless models a reduction of stresses up to 75% is obtained with respect to stented models with the same type of reinforcement.  相似文献   

2.

Background

Failure of bioprosthetics is usually caused by calcification of the leaflets as a consequence of high tensile stresses. The stentless valve resembles native mitral valve anatomy, has a flexible leaflet attachment and a suspension at the papillary muscles, and preserves annuloventricular continuity. In this study, the effects of the stentless valve design on leaflet stress were investigated with a finite element model.

Methods

Finite element models of the stentless quadrileaflet mitral valve were created in the close and open configurations. The geometry of the stented trileaflet mitral valve was also analyzed for comparative purposes. Under the designated pressures, the regional stresses were evaluated, and the distributions of stresses were assessed.

Results

Regardless of whether the valve is in the open or close configuration, the maximum first principal stress was significantly lower in the stentless valve than in the stented valve. For the stentless valves, limited stress concentration was discretely distributed in the papillary flaps under both close and open conditions. In contrast, in the stented valve, increased stress concentration was evident at the central belly under the open condition and at the commissural attachment under close condition. In either configuration, the maximum second principal stress was markedly lower in the stentless valve than in the stented valve.

Conclusions

The stentless valve was associated with a significant reduction in leaflet stress and a more homogeneous stress distribution compared to the stented valve. These findings are consistent with recent reports of the clinical effectiveness of the stentless quadrileaflet mitral valve.  相似文献   

3.
Regions of turbulence downstream of bioprosthetic heart valves may cause damage to blood components, vessel wall as well as to aortic valve leaflets. Stentless aortic heart valves are known to posses several hemodynamic benefits such as larger effective orifice areas, lower aortic transvalvular pressure difference and faster left ventricular mass regression compared with their stented counterpart. Whether this is reflected by diminished turbulence formation, remains to be shown. We implanted either stented pericardial valve prostheses (Mitroflow), stentless valve prostheses (Solo or Toronto SPV) in pigs or they preserved their native valves. Following surgery, blood velocity was measured in the cross sectional area downstream of the valves using 10MHz ultrasonic probes connected to a dedicated pulsed Doppler equipment. As a measure of turbulence, Reynolds normal stress (RNS) was calculated at two different blood pressures (baseline and 50% increase). We found no difference in maximum RNS measurements between any of the investigated valve groups. The native valve had significantly lower mean RNS values than the Mitroflow (p=0.004), Toronto SPV (p=0.008) and Solo valve (p=0.02). There were no statistically significant differences between the artificial valve groups (p=0.3). The mean RNS was significantly larger when increasing blood pressure (p=0.0006). We, thus, found no advantages for the stentless aortic valves compared with stented prosthesis in terms of lower maximum or mean RNS values. Native valves have a significantly lower mean RNS value than all investigated bioprostheses.  相似文献   

4.
In some cases of aortic valve leaflet disease, the implant of a stentless biological prosthesis represents an excellent option for aortic valve replacement (AVR). In particular, if compared with the implant of mechanical valves, it provides a more physiological haemodynamic performance and a reduced thrombogeneticity, avoiding the use of anticoagulants. The clinical outcomes of AVR are strongly dependent on an appropriate choice of both prosthesis size and replacement technique, which is, at present, strictly related to surgeon's experience and skill. This represents the motivation for patient-specific finite element analysis able to virtually reproduce stentless valve implantation. With the aim of performing reliable patient-specific simulations, we remark that, on the one hand, it is not well established in the literature whether bioprosthetic leaflet tissue is isotropic or anisotropic; on the other hand, it is of fundamental importance to incorporate an accurate material model to realistically predict post-operative performance. Within this framework, using a novel computational methodology to simulate stentless valve implantation, we test the impact of using different material models on both the stress pattern and post-operative coaptation parameters (i.e. coaptation area, length and height). As expected, the simulation results suggest that the material properties of the valve leaflets affect significantly the post-operative prosthesis performance.  相似文献   

5.
TAVI devices are manufactured with cylindrical frames. However, the frames are rarely cylindrical post-deployment since deformation due to localised under expansion can be induced by calcified material on the native valve leaflets exerting irregular forces upon the frame. Consequently, the leaflets within a deformed TAVI device may undergo elevated stress during operation, which may lead to premature device failure.Using computational analysis a complete TAVI device model was simulated undergoing deployment into an aortic root model derived from CT data for a patient with severe calcific aortic stenosis, followed by a pressure simulated cardiac cycle. The complete analysis was performed eight times, each with the device at a different rotational orientation relative to the native valve, with an increment spacing of 15°.The TAVI device frames consistently featured significant distortions associated with bulky calcified material at the base of the non-coronary sinus. It was found that the average von Mises stress in the prosthetic valves was only increased in one of the cases relative to an idealised device. However, the maximum von Mises stress in the prosthetic valves was elevated in the majority of the cases.Furthermore, it was found that there were preferable orientations to deploy the prosthetic device, in this case, when the prosthetic leaflets were aligned with the native leaflets. As device orientation deviated from this orientation, the stresses in the valve increased because the distance between the prosthetic commissures decreased. This potentially could represent a sufficient increase in stress to induce variation in device lifespan.  相似文献   

6.
目前临床使用的各种机械心脏瓣膜的主要问题是血栓栓塞和与抗凝治疗有关的出血,其缺陷在于瓣膜开启时,碟片和支架将瓣膜的整个血流通道分隔成三至四个较小的血流通道。在这种受阻隔的血流通宫,形成容易诱发血栓的高剪应力区、紊流和滞流区。我们研制的两种机械心脏瓣膜在瓣膜开启时,没有任何支架和碟片分隔瓣膜的血流通道,使血流与天然心脏瓣膜中的相类似,可减少对血液的危害,从而可减少换瓣病人对抗凝治疗的依赖程度。  相似文献   

7.
The bicuspid aortic valve (BAV) is a common congenital malformation of the aortic valve (AV) affecting 1% to 2% of the population. The BAV is predisposed to early degenerative calcification of valve leaflets, and BAV patients constitute 50% of AV stenosis patients. Although evidence shows that genetic defects can play a role in calcification of the BAV leaflets, we hypothesize that drastic changes in the mechanical environment of the BAV elicit pathological responses from the valve and might be concurrently responsible for early calcification. An in vitro model of the BAV was constructed by surgically manipulating a native trileaflet porcine AV. The BAV valve model and a trileaflet AV (TAV) model were tested in an in vitro pulsatile flow loop mimicking physiological hemodynamics. Laser Doppler velocimetry was used to make measurements of fluid shear stresses on the leaflet of the valve models using previously established methodologies. Furthermore, particle image velocimetry was used to visualize the flow fields downstream of the valves and in the sinuses. In the BAV model, flow near the leaflets and fluid shear stresses on the leaflets were much more unsteady than for the TAV model, most likely due to the moderate stenosis in the BAV and the skewed forward flow jet that collided with the aorta wall. This additional unsteadiness occurred during mid- to late-systole and was composed of cycle-to-cycle magnitude variability as well as high-frequency fluctuations about the mean shear stress. It has been demonstrated that the BAV geometry can lead to unsteady shear stresses under physiological flow and pressure conditions. Such altered shear stresses could play a role in accelerated calcification in BAVs.  相似文献   

8.
This work was concerned with the numerical simulation of the behaviour of aortic valves whose material can be modelled as non-linear elastic anisotropic. Linear elastic models for the valve leaflets with parameters used in previous studies were compared with hyperelastic models, incorporating leaflet anisotropy with pronounced stiffness in the circumferential direction through a transverse isotropic model. The parameters for the hyperelastic models were obtained from fits to results of orthogonal uniaxial tensile tests on porcine aortic valve leaflets. The computational results indicated the significant impact of transverse isotropy and hyperelastic effects on leaflet mechanics; in particular, increased coaptation with peak values of stress and strain in the elastic limit. The alignment of maximum principal stresses in all models follows approximately the coarse collagen fibre distribution found in aortic valve leaflets. The non-linear elastic leaflets also demonstrated more evenly distributed stress and strain which appears relevant to long-term scaffold stability and mechanotransduction.  相似文献   

9.
A finite element model of a bioprosthetic heart valve was developed to determine the influence of the stent height on leaflet stresses under various pressure loading conditions after valve closure. A nonlinear solution was used to obtain the stresses in the leaflets for stent heights of 14.6 mm, 19.0 mm and 22.0 mm respectively. The basic assumptions included an elliptic-paraboloid for a relaxed leaflet shape, a rigid stent, isotropic leaflet material property with a Poisson's ratio of 0.45, a uniform leaflet thickness and a stress dependent Young's modulus. The model predicted an increase of stresses on the closed leaflets as the stent height was reduced. This observation appears to mitigate, to some extent, the hemodynamic benefits thought to accompany the reduction of stent height of bioprosthetic valves.  相似文献   

10.
OBJECTIVE:: The purpose of this consensus conference was to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement, and to outline evidence-based recommendations for the use of stentless and stented bioprosthetic valves in adult aortic valve replacement. METHODS:: Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. At the consensus conference, evidence-based statements were created, and consensus processes were used to determine the ensuing recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation. RESULTS AND RECOMMENDATIONS:: Seventeen randomized studies published in 23 articles involving 1317 patients, and 14 nonrandomized trial published in 18 articles involving 2485 patients were included in the meta-analysis and consensus conference. All randomized trials inserted the stentless bioprosthetic valves in the subcoronary configuration. The consensus panel agreed upon the following statements and recommendations in patients undergoing aortic valve replacement:Because there were no randomized control trial comparing subcoronary stentless prosthetic valve and root replacement, the following recommendations are derived from expert opinion:  相似文献   

11.
Failure of synthetic heart valves is usually caused by tearing and calcification of the leaflets. Leaflet fiber-reinforcement increases the durability of these valves by unloading the delicate parts of the leaflets, maintaining their physiological functioning. The interaction of the valve with the surrounding fluid is essential when analyzing its functioning. However, the large differences in material properties of fluid and structure and the finite motion of the leaflets complicate blood-valve interaction modeling. This has, so far, obstructed numerical analyses of valves operating under physiological conditions. A two-dimensional fluid-structure interaction model is presented, which allows the Reynolds number to be within the physiological range, using a fictitious domain method based on Lagrange multipliers to couple the two phases. The extension to the three-dimensional case is straightforward. The model has been validated experimentally using laser Doppler anemometry for measuring the fluid flow and digitized high-speed video recordings to visualize the leaflet motion in corresponding geometries. Results show that both the fluid and leaflet behaviour are well predicted for different leaflet thicknesses.  相似文献   

12.
A successful mechanical prosthetic heart valve design is the bileaflet valve, which has been implanted for the first time more than 20 years ago. A key feature of bileaflet valves is the geometry of the two leaflets, which can be very important in determining the flow field. Laser Doppler anemometry (LDA) was used to perform an accurate study of the velocity and turbulence shear stress peak values (TSS(max)) fields at four distances from the valve plane. TSS(max) is a relevant parameter to assess the risk of hemolysis and platelet activation associated to the implantation of a prosthetic device, continuously interacting with blood. Two bileaflet valves were tested: the St. Jude HP and the Sorin Bicarbon, of the same nominal size (19mm). The former has flat leaflets, whereas the latter's leaflets have a cylindrical surface. A high regime (CO: 6l/min) was imposed, in order to test the two valves at maximum Reynolds number and consequent turbulence generation. The flat-leaflet design of the St. Jude generates a TSS field constant with distance; on the contrary, the Bicarbon's shear stress field undergoes an evident development, with an unexpected central peak at a distance comparable to the valve's dimensions (21mm). The two bileaflet valves tested, although very similar in design, behave very differently as for their turbulence properties. In particular, the concept of curved wake leads to conclude that the curvature of the leaflets' surface must be identified as an important parameter, which deserves careful attention in PHV design and development.  相似文献   

13.
While providing nearly trouble-free function for 10-12 years, current bioprosthetic heart valves (BHV) continue to suffer from limited long-term durability. This is usually a result of leaflet calcification and/or structural degeneration, which may be related to regions of stress concentration associated with complex leaflet deformations. In the current work, a dynamic three-dimensional finite element analysis of a pericardial BHV was performed with a recently developed FE implementation of the generalized nonlinear anisotropic Fung-type elastic constitutive model for pericardial BHV tissues (W. Sun and M.S. Sacks, 2005, [Biomech. Model. Mechanobiol., 4(2-3), pp. 190-199]). The pericardial BHV was subjected to time-varying physiological pressure loading to compute the deformation and stress distribution during the opening phase of the valve function. A dynamic sequence of the displacements revealed that the free edge of the leaflet reached the fully open position earlier and the belly region followed. Asymmetry was observed in the resulting displacement and stress distribution due to the fiber direction and the anisotropic characteristics of the Fung-type elastic constitutive material model. The computed stress distribution indicated relatively high magnitudes near the free edge of the leaflet with local bending deformation and subsequently at the leaflet attachment boundary. The maximum computed von Mises stress during the opening phase was 33.8 kPa. The dynamic analysis indicated that the free edge regions of the leaflets were subjected to significant flexural deformation that may potentially lead to structural degeneration after millions of cycles of valve function. The regions subjected to time varying flexural deformation and high stresses of the present study also correspond to regions of tissue valve calcification and structural failure reported from explanted valves. In addition, the present simulation also demonstrated the importance of including the bending component together with the in-plane material behavior of the leaflets towards physiologically realistic deformation of the leaflets. Dynamic simulations with experimentally determined leaflet material specification can be potentially used to modify the valve towards an optimal design to minimize regions of stress concentration and structural failure.  相似文献   

14.
Functional analysis of bioprosthetic heart valves   总被引:2,自引:0,他引:2  
Glutaraldehyde-treated bovine pericardium is used successfully as bioprosthetic material in the manufacturing of heart valves leaflets. The mechanical properties of bovine pericardial aortic valve leaflets seem to influence its mechanical behaviour and the failure mechanisms. In this study the effect of orthotropy on tricuspid bioprosthetic aortic valve was analysed, using a three-dimensional finite element model, during the entire cardiac cycle. Multiaxial tensile tests were also performed to determine the anisotropy of pericardium. Seven different models of the same valve were analysed using different values of mechanical characteristics from one leaflet to another, considering pericardium as an orthotropic material. The results showed that even a small difference between values along the two axes of orthotropy can negatively influence leaflets performance as regard both displacement and stress distribution. Leaflets of bovine pericardium bioprostheses could be manufactured to be similar to natural human heart valves reproducing their well-known anisotropy. In this way it could be possible to improve the manufacturing process, durability and function of pericardial bioprosthetic valves.  相似文献   

15.
Transcatheter aortic valve replacement (TAVR) is a safe and effective treatment option for patients deemed at high and intermediate risk for surgical aortic valve replacement. Similar to surgical aortic valves (SAVs), transcatheter aortic valves (TAVs) undergo calcification and mechanical wear over time. However, to date, there have been limited publications on the long-term durability of TAV devices. To assess longevity and mechanical strength of TAVs in comparison to surgical bioprosthetic valves, three-dimensional deformation analysis and strain measurement of the leaflets become an inevitable part of the evaluation. The goal of this study was to measure and compare leaflet displacement and strain of two commonly used TAVs in a side-by-side comparison with a commonly used SAV using a high-resolution digital image correlation (DIC) system. 26-mm Edwards SAPIEN 3, 26-mm Medtronic CoreValve, and 25-mm Carpentier-Edwards PERIMOUNT Magna surgical bioprosthesis were examined in a custom-made valve testing apparatus. A time-varying, spatially uniform pressure was applied to the leaflets at different loading rates. GOM ARAMIS® software was used to map leaflet displacement and strain fields during loading and unloading. High displacement regions were found to be at the leaflet belly region of the three bioprosthetic valves. In addition, the frame of the surgical bioprosthesis was found to be remarkably flexible, in contrary to CoreValve and SAPIEN 3 in which the stent was nearly rigid under a similar loading condition. The experimental DIC measurements can be used to characterize the anisotropic materiel behavior of the bioprosthetic heart valve leaflets and validate heart valve computational simulations.  相似文献   

16.
Blood damage and thrombosis are major complications that are commonly seen in patients with implanted mechanical heart valves. For this in vitro study, we isolated the closing phase of a bileaflet mechanical heart valve to study near valve fluid velocities and stresses. By manipulating the valve housing, we gained optical access to a previously inaccessible region of the flow. Laser Doppler velocimetry and particle image velocimetry were used to characterize the flow regime and help to identify the key design characteristics responsible for high shear and rotational flow. Impact of the closing mechanical leaflet with its rigid housing produced the highest fluid stresses observed during the cardiac cycle. Mean velocities as high as 2.4 m/s were observed at the initial valve impact. The velocities measured at the leaflet tip resulted in sustained shear rates in the range of 1500-3500 s(-1), with peak values on the order of 11,000-23,000 s(-1). Using velocity maps, we identified regurgitation zones near the valve tip and through the central orifice of the valve. Entrained flow from the transvalvular jets and flow shed off the leaflet tip during closure combined to generate a dominant vortex posterior to both leaflets after each valve closing cycle. The strength of the peripheral vortex peaked within 2 ms of the initial impact of the leaflet with the housing and rapidly dissipated thereafter, whereas the vortex near the central orifice continued to grow during the rebound phase of the valve. Rebound of the leaflets played a secondary role in sustaining closure-induced vortices.  相似文献   

17.
The high incidence of thromboembolic complications of mechanical heart valves (MHV) limits their success as permanent implants. The thrombogenicity of all MHV is primarily due to platelet activation by contact with foreign surfaces and by nonphysiological flow patterns. The latter include elevated flow stresses and regions of recirculation of blood that are induced by valve design characteristics. A numerical simulation of unsteady turbulent flow through a bileaflet MHV was conducted, using the Wilcox k-omega turbulence model for internal low-Reynolds-number flows, and compared to quantitative flow visualization performed in a pulse duplicator system using Digital Particle Image Velocimetry (DPIV). The wake of the valve leaflet during the deceleration phase revealed an intricate pattern of interacting shed vortices. Particle paths showed that platelets that were exposed to the highest flow stresses around the leaflets were entrapped within the shed vortices. Potentially activated, such platelets may tend to aggregate and form free emboli. Once formed, such free emboli would be convected downstream by the shed vortices, increasing the risk of systemic emboli.  相似文献   

18.
OBJECTIVE:: This meta-analysis sought to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement. METHODS:: A comprehensive search was undertaken to identify all randomized and nonrandomized controlled trials comparing stentless to stented bioprosthetic valves in patients undergoing aortic valve replacement available up to March 2008. The primary outcomes were clinical and resource outcomes in randomized controlled trial (RCT). Secondary outcomes clinical and resource outcomes in nonrandomized controlled trial (non-RCT). Odds ratios (OR), weighted mean differences (WMD), or standardized mean differences and their 95% confidence intervals (CI) were analyzed as appropriate. RESULTS:: Seventeen RCTs published in 23 articles involving 1317 patients, and 14 non-RCTs published in 18 articles involving 2485 patients were included in the meta-analysis. For the primary analysis of randomized trials, mortality for stentless versus stented valve groups did not differ at 30 days (OR 1.36, 95% CI 0.68-2.72), 1 year (OR 1.01, 95% CI 0.55-1.85), or 2 to 10 years follow-up (OR 0.82, 95% CI 0.50-1.33). Aggregate event rates for all-cause mortality at 30 days were 3.7% versus 2.9%, at 1 year were 5.5% versus 5.9% and at 2 to 10 years were 17% versus 19% for stentless versus stented valve groups, respectively. Stroke or neurologic complications did not differ between stentless (3.6%) and stented (4.0%) valve groups. Risk of prosthesis-patient mismatch was numerically lower in the stentless group (11.0% vs. 31.3%, OR 0.30, 95% CI 0.05-1.66), but this parameter was reported in few trials and did not reach statistical significance. Effective orifice area index was significantly greater for stentless aortic valve compared with stented valves at 30 days (WMD 0.12 cm/m), at 2 to 6 months (WMD 0.15 cm/m), and at 1 year (WMD 0.26 cm/m). Mean gradient at 1 month was significantly lower in the stentless valve group (WMD -6 mm Hg), at 2 to 6 month follow-up (WMD -4 mm Hg,), at 1 year follow-up (WMD -3 mm Hg) and up to 3 year follow-up (WMD -3 mm Hg) compared with the stented valve group. Although the left ventricular mass index was generally lower in the stentless group versus the stented valve group, the aggregate estimates of mean difference did not reach significance during any time period of follow-up (1 month, 2-6 months, 1 year, and 8 years). CONCLUSIONS:: Evidence from randomized trials shows that subcoronary stentless aortic valves improve hemodynamic parameters of effective orifice area index, mean gradient, and peak gradient over the short and long term. These improvements have not led to proven impact on patient morbidity, mortality, and resource-related outcomes; however, few trials reported on clinical outcomes beyond 1 year and definitive conclusions are not possible until sufficient evidence addresses longer-term effects.  相似文献   

19.
Edge-to-edge technique is a surgical procedure for the correction of mitral valve leaflets prolapse by suturing the edge of the prolapsed leaflet to the free edge of the opposing one. Suture presence modifies valve mechanical behavior and orifice flow area in the diastolic phase, when the valve opens and blood flows into the ventricle. In the present work, in order to support identification of potentially critical conditions, a computational procedure is described to evaluate the effects of changing suture length and position in combination with valve size and shape. The procedure is based on finite element method analyses applied to a range of different mitral valves, investigating for each configuration the influence of repair on functional parameters, such as mitral valve orifice area and transvalvular pressure gradient, and on structural parameters, such as stress in the leaflets and stitch tension. This kind of prediction would ideally require a coupled fluid-structural analysis, where the interactions between blood flows and mitral apparatus deformation are simultaneously considered. In the present study, however, an alternative approach is proposed, in which results obtained by purely structural finite element analyses are elaborated and interpreted taking into account the Bernoulli type equations available in literature to describe blood flow through mitral orifice. In this way, the effects of each parameter in terms of orifice flow area, suture loads, and leaflets stresses can be expressed as functions of atrioventricular pressure gradient and then correlated to blood flow rate. Results obtained by using this procedure for different configurations are finally discussed.  相似文献   

20.

Objectives

Replacement aortic valves endeavor to mimic native valve function at the organ, tissue, and in the case of bioprosthetic valves, the cellular levels. There is a wealth of information about valve macro and micro structure; however, there presently is limited information on the morphology of the whole valve fiber architecture. The objective of this study was to provide qualitative and quantitative analyses of whole valve and leaflet fiber bundle branching patterns using a novel imaging system.

Methods

We developed a custom automated microscope system with motor and imaging control. Whole leaflets (n = 25) were imaged at high resolution (e.g. 30,000×20,000 pixels) using elliptically polarized light to enhance contrast between structures without the need for staining or other methods. Key morphologies such as fiber bundle size and branching were measured for analyses.

Results

The left coronary leaflet displayed large asymmetry in fiber bundle organization relative to the right coronary and non-coronary leaflets. We observed and analyzed three main patterns of fiber branching; tree-like, fan-like, and pinnate structures. High resolution images and quantitative metrics are presented such as fiber bundle sizes, positions, and branching morphological parameters.

Significance

To our knowledge there are currently no high resolution images of whole fresh leaflets available in the literature. The images of fiber/membrane structures and analyses presented here could be highly valuable for improving the design and development of more advanced bioprosthetic and/or bio-mimetic synthetic valve replacements.  相似文献   

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