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Journal of Biomechanics 41 (2008) 1053–1061 www.elsevier.com/locate/jbiomech www.JBiomech.com
Effects of different stent designs on local hemodynamics in stented arteries
Rossella BalossinoÃ, Francesca Gervaso, Francesco Migliavacca, Gabriele Dubini
Laboratory of Biological Structure Mechanics, Department of Structural Engineering, Politecnico di Milano, Piazza Leonardo da Vinci, 32, 20133 Milan, Italy Accepted 3 December 2007
Abstract Following the deployment of a coronary stent and disruption of an atheromatous plaque, the deformation of the arterial wall and the presence of the stent struts create a new ﬂuid dynamic ﬁeld, which can cause an abnormal biological response. In this study 3D computational models were used to analyze the ﬂuid dynamic disturbances induced by the placement of a stent inside a coronary artery. Stents models were ﬁrst expanded against a simpliﬁed arterial plaque, with a solid mechanics analysis, and then subjected to a ﬂuid ﬂow simulation under pulsatile physiological conditions. Spatial and temporal distribution of arterial wall shear stress (WSS) was investigated after the expansion of stents of different designs and different strut thicknesses. Common oscillatory WSS behavior was detected in all stent models. Comparing stent and vessel wall surfaces, maximum WSS values (in the order of 1 Pa) were located on the stent surface area. WSS spatial distribution on the vascular wall surface showed decreasing values from the center of the vessel wall portion delimited by the stent struts to the wall regions close to the struts. The hemodynamic effects induced by two different thickness values for the same stent design were investigated, too, and a reduced extension of low WSS region (o0.5 Pa) was observed for the model with a thicker strut. r 2007 Elsevier Ltd. All rights reserved.
Keywords: Stent; Computational ﬂuid dynamic; Wall shear stress; Numerical modeling
Introduction Many forms of vascular arterial disease can affect the ﬂow of blood through arteries near or farther away from the heart. Coronary arteries are the most subjected ones to atherosclerosis, the end result of atheromatous plaques accumulation within the walls of the arteries. In case of partial or total lumen obstruction, a medical intervention is mandatory to restore the normal blood ﬂow and avoid further complications. Stenting shows some advantages compared to other possible treatments, as it does not require any surgical operation and has less complications, pain and a more rapid recovery (Mullany, 2003). Since the ﬁrst implantation of stents in humans in 1986, many improvements, changes and discoveries have occurred to make them safer and more functional. The
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presence of a non-biological device inside an artery causes an inevitable inﬂammation response and inﬂuences the ﬂuid dynamic behavior in the regions next to the arterial wall. Parts of the stent struts protruding into the lumen may induce the formation of vortices and stagnation zones which affect wall shear stress (WSS) spatial and temporal distribution. These effects depend on the stent conﬁguration, its global length, the delivery system, the struts dimension, shape, spacing and many others (Tominaga et al., 1992; Rogers and Edelman, 1995). Moreover, lowmean shear stress, oscillating shear stress, high particleresidence times, and non-laminar ﬂow have all been shown to occur in the locations where early intimal thickening is the greatest (Ku et al., 1985; Jin et al., 2004; LaDisa et al., 2005; Katritsis et al., 2007). In particular, a correlation exists between low-WSS values less than 0.5 Pa (Ku, 1997; Henry, 2000), sites of intimal thickening and non-uniform spatial distribution, which appear to represent important initiating factors for the development
The new generation stents showed a less regular design compared to old stents (e. NJ. The methodology adopted to simulate the expansion of each stent inside the artery is described in a previous work (Migliavacca et al. NJ. Actually. A preliminary step was performed in which the stent was expanded against a stenosed artery. but is part of a whole coronary artery. a stent is pre-crimped in order to be mounted on the balloon catheter.g.15 mm. hollow cylinders (Fig. A solid mechanic analysis was combined with a ﬂuid dynamic one. The basic idea was to compare different stent models in a conﬁguration as close as possible to the real-life one. which becomes 1. Fig. 1997. Brieﬂy. Table 1 Main geometrical characteristics of the stent models Models Dint(mm) Thickness (mm) 0.. A ﬁrst attempt to consider this effect was done by LaDisa et al. Tokyo. 1 depicts the four stent models in their unexpanded conﬁguration and the single unit used in the numerical simulations. 1999. LaDisa et al. the other designs are considered new generation stents as their structures incorporate the presence of tubular-like rings and bridging members (links). otherwise the models were constructed on the basis of images and data available in the literature (Serruys and Kutryk. The internal diameter.46 mm after a pressurization of 100 mmHg. 2000). 1992.. The plaque is a symmetric plaque with a length of 3. Furthermore. STENT C and STENT D for Cordis BX velocity. Apart from the Palmaz–Schatz.68 mm. the latter has a length of 11. The novelty of the present study resides in the numerical simulation of the expansion of models resembling a number of commercially available stents inside a vessel in the presence of an atherosclerotic plaque. Warren.05 0. thickness and number of struts were found to inﬂuence the distribution of low and high shear stress values (Wentzel et al. length and the number of struts of the simulated models are reported in Table 1. They resemble four commercial intravascular stents: Palmaz–Schatz (Johnson & Johnson Interventional System. to avoid the rotation of the structure. The four models will be referred to as STENT A. Balossino et al. coaxial. (2003 and 2004) studied the localized alterations in coronary WSS by performing different CFD studies on 3D stent geometries with different struts number. Stent strut spacing.. creates a 10–20% greater degree of intimal thickening for the same degree of vessel injury. respectively. Pawtucket. It corresponds after pressurization to a stenosis of 76% in terms of area reduction in the central cross-section.95 1 .9 1 0. an internal diameter of 2. Most studies considered the artery as a simple symmetrical and cylindrical model..ARTICLE IN PRESS 1054 R. LaDisa et al. Computational ﬂuid dynamic (CFD) techniques have the advantage of a greater ﬂexibility and easiness of using with respect to the experimental or in vivo methods. Circumferential straightening introduced areas of high WSS among stent struts that were absent in the stented vessel model with circular crosssection. Conversely. thus resulting polygonal or straightened shape.p. moderate and high WSS do not seem to contribute to neointima hyperplasia (Malek et al. Sorin Carbostent (Sorin Biomedica S. 2004. USA) based on the ﬁnite element method.25 mm. (2005) by comparing two 3D models of vessel and stent. which becomes 3 mm after a pressurization of 100 mmHg. and a thickness of 0. Ku. Italy) and Jostent Flex (JOMED AB. width and thickness. The evaluation of ﬂuid dynamic effects caused by stent geometric parameters is thus important to optimize the stent design. (2002) compared a Clemson stent with a Palmaz one and showed that the former.68 mm. / Journal of Biomechanics 41 (2008) 1053–1061 of atherosclerosis.. Kleinstreuer et al.. and a thickness of 0. an internal diameter of 1. decreasing modestly with subsequent struts..5 mm. Plaque and artery were modelled as simple. so the unexpanded conﬁguration refers to the conﬁgurations immediately before the crimping process.075 0. 2a). Japan) when they were available. at least during the acute stage of the implantation. 2000). Many computational studies in the literature dealt with the inﬂuence of stent physical parameters on ﬂuid dynamic changes correlated with the restenosis process (Henry. 2001). The mechanical behavior of both artery and plaque was described with hyperelastic isotropic constitutive models. Jostent ﬂex. These conditions allowed the radial expansion of the artery. They can provide detailed information on critical local ﬂow parameters near the stent struts and the arterial wall.. Sullivan et al. Saluggia (VC). The highest WSS values were found over the surface of the stent. 1996).. the stent expansion was simulated with large deformation analyses by means of the commercial code ABAQUS (Abaqus Inc.. thickness. 2007). Methods Four different coronary stent designs were taken into consideration. and then the deformed conﬁguration was used to carry out ﬂuid dynamic simulations. the stents were analyzed by means of a Nikon SMZ800 stereo microscope (Nikon Corporation.1 Length (mm) 13 16 16 16 Strut number 6 10 10 – STENT STENT STENT STENT A B C D 0. Warren. Sorin Carbostent and Palmaz–Schatz. Palmaz–Schatz) with multiple links that provide higher ﬂexibility and consequently a lower chance to be perfectly symmetric after their expansion (Isenbarger and Resar. Rogers and Edelman. The outer cross-sections of the artery were constrained in the longitudinal direction to simulate the fact that the considered model is not a stand-alone segment. 1995. 2001). In vivo and in vitro studies have revealed that stent structure inﬂuences restenosis and thrombus formation between struts (Tominaga et al. 2000. To obtain the dimensions of the models. neglecting the circumferential vascular deformation after stent implantation that alters the WSS distribution. 2005). Cordis BX Velocity (Johnson & Johnson Interventional System. USA). STENT B. The artery had a circular cross-section in the former whereas it was conformed to the stent geometry in the latter. 2004). Lower values were instead detected before and after each stent strut and at transition between the vessel and the stent.A. three nodes forming the vertices of an equilateral triangle were constrained in the tangential direction in an axial section located in the center of the artery. USA). stents models were compared to suggest possible technical prescriptions to improve their performances. Sweden).45 mm. due to its thicker struts.15 0. By varying the stent design or strut thickness and keeping the same boundary conditions.. LaDisa et al. Berry et al. The former (inner) is shorter and has rounded extremities. Stent proﬁle or strut height was found to signiﬁcantly inﬂuence neo-intimal thickness (Barth et al. Helsingborg. RI.
covering the entire stenosis length. A single unit of stent.540. particular of the ﬁne discretization in the vessel area within the stent struts (d) and of the coarser mesh in the area outside the stented region.. Balossino et al. Stents models (left) and particular of the single stent units (right) used in the simulations. IN. The area weighted average WSS was calculated separately over the stent imprint and the vessel region around the stent struts. to guarantee an accurate evaluation of the signiﬁcant quantities. which is the stent imprint and the arterial wall within the stent struts (Fig. Indianapolis. 2e).000 cells and 160. Fig. PA. In the unstented portion a coarser mesh was generated (Fig.000. 203. Once the deformed conﬁgurations of artery. . / Journal of Biomechanics 41 (2008) 1053–1061 1055 With regard to the stent.0 Evaluation CAD program (McNeel & Associates. 2c). USA) to enable the mesh generation for the ﬂuid domain. was created using Rhinoceros 2. The relative errors were below the 5% for each mesh and the last three meshes showed no signiﬁcant differences in spite of the considerable increase in cell number. x nÀ1 Fig. the ﬂuid domain geometry delimited by the internal arterial and stent surfaces. 654. deformed conﬁguration after stent expansion (b). respectively). 2d). Canonsburg. was expanded under displacement control until a diameter of 3 mm was reached (Fig. The geometry was then imported into the commercial code Gambit (ANSYS Inc. and 689. boundary conditions were applied which constrain the three nodes forming the vertices of an equilateral triangle in the medial cross-section of the stent in the longitudinal and tangential directions. plaque and stent were obtained.700. 130.000 nodes. A very ﬁne discretization was prescribed in the region of interest.000. USA). ﬂuid domain (c).000. a thickness was prescribed for the stent according to the data reported in Table 1 to take into account the actual protrusion of the stent struts into the lumen.ARTICLE IN PRESS R. Each deployed conﬁguration was imported into the CAD program as a point cloud and then the surfaces and the volumes were rebuilt (Fig. 325. 3D CAD geometry of the plaque and the artery (a). The choice was for the mesh with 654. 1. A grid-sensitivity analysis was conducted on six different meshes with increasing number of elements (102. 2b). 2. The values were compared according to the relative error. A mixed grid was created by means of tetrahedral elements for the stented portion of the model and brick elements for the unstented one. n is the number of the different considered meshes and x is the WSS arithmetic mean. Since the stent was discretized using shell elements in the solid mechanic analysis. where s is the standard deviation. calculated as: y¼ 2 1=2 1 ðs2 þ s2 2 þ Á Á Á þ sn Þ Á 1 .200.
5 Pa 80 60 40 20 0 0s 0s 0. except for time points 0.32 s 0. . Comparing the four stent models.7 for momentum were used. Stent design Based on the suggestions in the literature indicating a threshold of 0.5 Pa as a critical WSS value to consider a region prone to restenosis. Under-relaxation factors of 0. STENT B shows the highest percentage of area with low WSS values during the cardiac cycle. the maximum values are located on the ‘stent area’. segregated and laminar solver was used with ﬁrst-order time implicit scheme employed to discretize the governing equations. / Journal of Biomechanics 41 (2008) 1053–1061 The ﬂow simulations were carried out by numerically solving the continuity and Navier–Stokes momentum equations for a pulsatile blood ﬂow. and 0. The histograms illustrate the trend for STENT A only. It can be noted that STENT A has the highest values along the cardiac cycle.. 5b reports the comparison in terms of maximum WSS values on the ‘stent area’.52 s) if compared to the slight decrease showed by the other three models. PA.16 s and 0. Such a behavior is common for all models with only slight differences for STENT D. whereas the other three models have 0. A secondorder upwind scheme was adopted for the discretization of momentum. 3 illustrates the ‘stent area’ (a) and the ‘vessel area’ (b) above deﬁned for the STENT A. 2005). Fig. Low and high values alternate during the entire cardiac cycle. It increases signiﬁcantly in the other time instants of the cycle. a reasonable assumption in the stented portion even though questionable in the other parts of the domain. Fig. The arterial wall was speciﬁed as rigid. Results The WSS results are reported with reference to the luminal side of the strut surface (‘stent area’) and to the luminal side of the bare vascular wall surface (‘vessel area’). named ‘stent area’ (a) and the luminal side of the bare vascular wall surface. an order of magnitude lower than the recommended value. the corresponding artery wall and stent percentage area was evaluated to compare the performances of the four stents. at time instants 0.ARTICLE IN PRESS 1056 R.40 s (systolic heart ejection phase) — the percentage area with WSSo0. 5a shows the comparison in terms of maximum WSS values on the ‘stent area’ and ‘vessel area’ at the six selected time points in the cardiac cycle. Fig.87). Standard discretization was followed for pressure with a PISO algorithm chosen for pressure-velocity coupling. Six time instants are properly selected inside the cardiac cycle to report the temporal changes.3 for pressure. 1 for density. At the outlet.40 s 0.. A time-varying velocity boundary condition with a parabolic proﬁle was imposed at the inlet with a userdeﬁned subroutine (with a Womersley number equal to 2.44 s 0. A three-dimensional double-precision. The adopted inlet blood-ﬂow velocity waveform was taken from the literature (LaDisa et al. Comparing the ‘vessel area’ and the ‘stent area’. USA). Canonsburg. being the same for the other ones. named ‘vessel area’ (b). that shows an increase in the area percentage in the last time instant (0.52 s 0. Fig. Fig. A no-slip condition was speciﬁed on the wall which makes all velocity components equal to zero. At blood-ﬂow peaks — i.16 s 100 % of vessel area < 0. Fluid domain regions used to describe the results: the luminal side of the strut surface.5 Pa is around 30% for all stent models. They remain above 1 Pa during the entire cardiac cycle and reach the maximum in the diastolic perfusion phase with a value of around 5 Pa. when area percentage is higher for STENT A.5 Pa for the four stent models reported at six time instants of the cardiac cycle.16 s (diastolic perfusion) and 0. Four cardiac cycles were simulated to guarantee a stable solution and the results referred to the last cycle.44 s 0.5 Pa for each stent model in the six selected time instants. Convergence criterion for continuity and velocity residuals was kept at 10À4. which was obtained from a canine coronary artery under normal resting conditions and the data were sampled obtaining a ﬁnal step function.e. Balossino et al. a zero-gauge pressure boundary condition was speciﬁed.16 s STENT A 0. A miniature of the time course of inlet velocity is also represented to help the reader to localize the time instants in the cardiac cycle. using the commercial package Fluent (ANSYS Inc.40 s Time STENT B STENT C 0. when blood ﬂow is either decelerating or minimum. Histograms of the percentage of vascular wall surface with WSS values lower than 0. indicated in the miniature on the top.52 s STENT D Fig. 4.40 s.32 s 0. 4 shows the histograms of the ‘vessel area’ percentage with a WSS magnitudeo0. based on the ﬁnite volume method. 3.
5c).5 [Pa] 1 0.16 s. STENT B and STENT C models the curved parts of the links are the sites where the maximum stresses concentrate.52 s STENT A 5 4 3 STENT B STENT C STENT D [Pa] 0. Fig. STENT C and STENT B. It can be observed that the links are the sites where WSS values are the highest for each model except for STENT D.16 s). 6 illustrates the WSS spatial distribution on the ‘stent area’ in the diastolic perfusion phase. where the highest values are localized in the thinner strut regions.44 s 0.05 mm to a value of 0. 2003). With regard to the ‘vessel area’ among the stent struts. at time point 0.15 mm.40 s Time 0..52 s 0. respectively.32 s 0.ARTICLE IN PRESS R. (b) comparison of WSS values on the ‘stent area’ for the four stent models and (c) comparison of WSS values on the ‘vessel area’ for the four stent models. / Journal of Biomechanics 41 (2008) 1053–1061 1057 5 4 3 2 1 0 0s 0. Balossino et al.44 s STENT A STENT B STENT C STENT D 0. 5. the histograms of the maximum WSS values show smaller differences among the four models with a little prevalence for STENT A (Fig.16 s 0. comparable results with decreasing values for STENT D. only.16 s 0. Fig. in this case) on the ﬂuid dynamic . Stent strut thickness The increase of the strut thickness was performed for STENT B model.32 s 0s 0.44 s [Time] 0.40 s 0.52 s Fig. This distribution is in a good agreement with that found in the literature (LaDisa et al. An increment of the strut thickness was applied from its baseline measurement of 0. Histograms of the maximum WSS values during a cardiac cycle: (a) comparison of the maximum values on the stent luminal side surface and the luminal side of the vascular wall surface within the stent struts for STENT A model.32 s 0. The pattern is quite similar for all models: the values increase from the zones near the stent struts towards the center of the vessel region.16 s 0.44 s 0.5 0 0s 0.52 s 0.15 mm allowed the evaluation of two different aspects: the inﬂuence of different thicknesses with the same stent design (STENT B.40 s 0.32 s VESSEL AREA STENT AREA [Pa] 0. at the same instant (t ¼ 0.40 s 0. In STENT A.16s [m/s] 2 1 0 0s 2 1. The choice of a higher thickness of 0. 7 reports the WSS spatial distribution on the ‘vessel area’ within the stent struts.
16 s. 6. behavior and that of two dissimilar designs (STENT B vs. STENT A) with the same thickness of 0. Fig. 8a) for the two models and conﬁrm the slightly minor extension of low-WSS regions for a thicker strut.5 Pa for STENT A and STENT B on the entire ﬂuid domain.52 s — end of ejection phase (systole). Contour plots of the WSS magnitude values on the arterial wall portion delimited by the links and the stent struts at the diastolic peak (0. Discussion Fig. 8b reports the area percentage of WSS values lower than 0. reduces the extension of these region.ARTICLE IN PRESS 1058 R. 8b) show an almost equal extension of low-WSS regions. Balossino et al.g. a thicker strut The results here reported refer to the immediate postexpansion situation when the natural strut embedding has not occurred yet.15 mm. e. In the insets the sites where the highest values are identiﬁed. 0. Although this conﬁguration does not correspond to the real one. 7. 8a shows the percentage vessel area subjected to low-WSS values for the two STENT B models on the entire ﬂuid domain. use of such models allows the evaluation across different stent designs of important ﬂuid dynamic aspects which could promote or retard the biological phenomena involved. indicating that STENT B has a higher percentage area with critical values for a longer period in the cardiac cycle with respect to STENT A. 0 s — early diastole. / Journal of Biomechanics 41 (2008) 1053–1061 Fig. Contour plots of the WSS magnitude values for the four stent models at 0.32 s — end of diastole and 0.16 s) for each stent model. Differences in percentage area are minimum during the acceleration phases. Temporal averages of the percentage area over the whole cardiac cycle are reported in the miniature (right side of Fig. Comparing the two models. but only during the deceleration instants. A correlation between the imposed input velocity waveform and the waveform of WSS on particular locations is . Fig. However temporal averages of the percentage area over the whole cardiac cycle (miniature histogram in Fig.
3 0. the increasing WSS magnitude values correspond to the increasing velocity values and vice versa.44 s 0.15 mm and averaged values over the whole cardiac cycle. The zones with low-WSS values are found near the stent struts at the diastolic peak and the largest ones are shown by the STENT A.ARTICLE IN PRESS R.32 s Time Fig.32 s 0. (b) comparison of STENT B and STENT A models with the same thickness of 0. the WSS distribution would be slightly dissimilar. the outer part of the ‘stent area’ shows high WSS values which decrease towards the vessel wall. the highest values are found at the center of the vessel wall area delimited by the stent strut and links. The time changes of maximum WSS magnitude at selected points or vessel areas follow the velocity waveform.15 mm. This portion of the vessel wall is proportional to the area delimited by the stent struts. With regard to the ‘stent area’.3 . for STENT B and STENT C. which has the widest space between the links in the circumferential direction.52 s found (results not shown). Histograms of the vessel area percentage with WSS values lower than 0. Comparing the extent of the areas with WSS lower than 0.8 57.5 Pa % 60.e.16 s STENT B STENT B THICK 0. to a lesser degree.5 Pa: (a) comparison of STENT B model with different thickness at different instants and averaged values over the whole cardiac cycle. This occurrence % 57. is indeed the one with the largest area exhibiting high shear stress values. This could be ascribed to the stent design and to the deformed conﬁguration reached after the expansion that creates regions more or less exposed to the blood ﬂow. STENT B %of vessel area < 0. STENT B seems to be the most inclined one to promote intimal thickening. which are the regions most exposed to the blood ﬂow. As a consequence. Observing the WSS spatial distribution on the vascular wall surface.6 57. These results are conﬁrmed by the higher percentage of low-WSS values shown by STENT B when compared to STENT A with the same thickness of 0. the highest WSS values are localized over the stent struts.5 Pa for the four stent designs. too.40 s 0.16 s 0. STENT B. STENT D model shows the most uniform spatial distribution due to its regular shape. It is nonetheless evident that the differences among the selected stent models are not so marked as expected. / Journal of Biomechanics 41 (2008) 1053–1061 1059 100 %of vessel area < 0.40 s 0. Two additional zones of high WSS can be seen at the inlet and outlet sites of the conﬁned arterial wall region for STENT A and. We believe that removing these limitations would yield greater differences in the ﬁnal deployed conﬁguration and hence in the vessel-stent interaction. Balossino et al. The comparison of two different thicknesses for the same stent design (STENT B) enlightens an unexpected behavior as a thicker strut reduces the overall percentage area with low WSS values in the deceleration phases. A possible reason resides in the absence of a vessel curvature and in the use of a single-stent unit.44 s 0.52 s STENT A 100 80 60 40 20 0 0s 0. In all the stents. 8.5 Pa 80 60 40 20 0 0s 0. i.
Hettrick. S. Acknowledgment This work has been partially supported by the Italian Institute of Technology (IIT). a thicker strut induces high WSS localized over the stent strut... PW. LE... JR. Use of the deformed artery conﬁguration derived from the expansion of a thin strut could also be criticized because it has been obtained expanding stents with different thickness values... 2007.. within the project ‘‘Models and methods for local drug delivery from nano/micro structured materials’’. 3789–3791. Kersten. Giddens. Guler. I. JM. 1992. However. WIT.. strecker tantalum stents and wallstents in canine iliac and femoral arteries.. Wall shear stress: theoretical considerations and methods of measurement. Henry.... Boston. Truskey. Newsome. Circulation 22. 424–430.. Ku. Critical Reviews in Biomedical Engineering 29. S. Kersten. JR. Conﬂict of interest On behalf of all Authors. JE. the implantation of a stent causes a straightening and a consequent stiffness of the vessel. Resar. 333-364.. LaDisa Jr.. Thus the assumption of rigid wall is acceptable in the stented portion. Audi. JR. Chaniotis.. (Ed. 171–175. DC. but decreases the extent of areas with critical low WSS on the vessel area during blood deceleration phases.. Olson.. Flow in stented arteries. References Barth. Moore. PS.. rigid geometry for the arterial vessel implies disregarding the natural curvature of the coronary tree.. Hemodynamic parameters and early intimal thickening in branching blood vessels. Warltier... Longest. Berry. L. 1995. Edelman. LaDisa Jr. P. Intra.. Garasic. Blood ﬂow in arteries. Olson. A ﬂuid structure interaction analysis could be useful to evaluate such a ﬂuid dynamic behavior.. Katritsis. DW. JF. the shape of the links and their number in the circumferential direction. J. JR. JP. Giddens. EP.. S. DP. Routh. 399–434. J. It is therefore suggested to keep it as limited as possible in order to reduce the portion with peak values and making WSS distribution more spatially uniform.. V. 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