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Please cite this article in press as: Auricchio F, et al. A computational tool to support pre-operative planning of stentless aortic valve implant. Med Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006 ARTICLE IN PRESS G Model JJBE-1889; No. of Pages 10 Medical Engineering & Physics xxx (2011) xxx–xxx Contents lists available at ScienceDirect Medical Engineering & Physics jou rnal h omepa g e: www.elsevier.com/locate/medengphy A computational tool to support pre-operative planning of stentless aortic valve implant F. Auricchio a,b,c , M. Conti a , S. Morganti a,, P. Totaro d a Dipartimento di Meccanica Strutturale (DMS), Università degli Studi di Pavia, via Ferrata 1, 27100 Pavia, Italy b Istituto di Matematica Applicata e Tecnologie Informatiche (IMATI), CNR, Pavia, Italy c Centro di Simulazione Numerica Avanzata (CeSNA), IUSS, Pavia, Italy d Dipartimento di Chirurgia Cardiotoracovascolare, IRCCS Policlinico San Matteo, Pavia, Italy a r t i c l e i n f o Article history: Received 6 December 2010 Received in revised form 9 May 2011 Accepted 11 May 2011 Keywords: Finite Element Analysis (FEA) Patient-specific model Aortic valve replacement (AVR) a b s t r a c t 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 to more classical surgical approaches, it provides a more physiological hemodynamic performance and a minor trombogeneticity avoiding the use of anticoagulants. The clinical outcomes of AVR are strongly dependent on an appro- priate choice of both prosthesis size and replacement technique, which are, at present, strictly related to surgeon’s experience and skill. Therefore, also this treatment, like most reconstructive procedures in cardiac surgery, remains “more art than science” [1]. Nowadays computational methodologies represent a useful tool both to investigate the aortic valve behavior, in physiologic and pathologic conditions and to reproduce virtual post-operative scenarios. The present study aims at supporting the AVR procedure planning through a patient-specific Finite Element Analysis (FEA) of stentless valve implantation. Firstly, we perform FEA to simulate the prosthesis placement inside the patient-specific aortic root; then, we reproduce, again by means of FEA, the diastolic closure of the valve to evaluate both the coaptation and the stress/strain state. The simulation results prove that both the valve size and the anatomical asymmetry of the Valsalva sinuses affect the prosthesis placement procedure. © 2011 IPEM. Published by Elsevier Ltd. All rights reserved. 1. Introduction Valvular heart pathologies represent a remarkable contribution to cardiovascular diseases (CVD) which are the major cause of death in the Western countries [2]. With respect to aortic valve, there are two main conditions which impair the native valve functionality: insufficiency and stenosis. In the first case, the valve is not able to close completely during diastole, causing blood regurgitation from the aorta to the left ventricle. In the second case, large calcium deposits on the valve contribute to the narrowing of its opening, thus reducing blood flow ejection. Different surgical treatments are adopted to restore valve functionality. In the literature many techniques for aortic root reconstruction are described, either sparing the valve leaflets [3,4], or involving the use of mechanical [5], stented [6,7] or stentless biological [8] prostheses as well as homograft and allograft valves [9,10]. Corresponding author. Tel.: +39 0382 985980. E-mail address: [email protected] (S. Morganti). If the aortic root wall does not show any remarkable patholog- ical dilation so that the valvular leaflets can be considered as the principal cause of disease, the aortic valve is replaced by means of mechanical or biological valves: many comparative studies are reported in the literature [11–13]. On the one hand, mechanical prostheses assure a long-term solution due to an excellent durability [14], on the other hand, they are associated with a greater incidence of hemorrhage than bio- prostheses which avoid the use of anticoagulants and determine a more physiological hemodynamics as well as a minor tromboge- neticity [15]; accordingly, especially for elderly patients, biological valves assure greater performances than mechanical ones and, in particular, stentless valves are preferable than stented ones, repre- senting an “excellent option for aortic valve replacement” [16]. The use of stentless valves, in fact, appears to potentially increase the long-term survival when compared to stented ones due to improved ventricular reverse remodeling [17]. At the same time, the hemodynamics is closer to physiologic behavior; finally, the use of a continuous suture technique reduces the crossclamp times and cardiopulmonary bypass. The surgical treatment of the stentless valve implant can be summarized by three main steps as described in Fig. 1 adapted from Glauber et al. [8]: 1350-4533/$ see front matter © 2011 IPEM. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.medengphy.2011.05.006

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Page 1: G ARTICLE IN PRESS Medical · useful tool both to investigate the aortic valve behavior, in physiologic and pathologic conditions and reproduce virtual post-operative scenarios. The

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ARTICLE IN PRESS Model

JBE-1889; No. of Pages 10

Medical Engineering & Physics xxx (2011) xxx– xxx

Contents lists available at ScienceDirect

Medical Engineering & Physics

jou rna l h omepa g e: www.elsev ier .com/ locate /medengphy

computational tool to support pre-operative planning of stentlessortic valve implant

. Auricchioa,b,c, M. Contia, S. Morgantia,∗, P. Totarod

Dipartimento di Meccanica Strutturale (DMS), Università degli Studi di Pavia, via Ferrata 1, 27100 Pavia, ItalyIstituto di Matematica Applicata e Tecnologie Informatiche (IMATI), CNR, Pavia, ItalyCentro di Simulazione Numerica Avanzata (CeSNA), IUSS, Pavia, ItalyDipartimento di Chirurgia Cardiotoracovascolare, IRCCS Policlinico San Matteo, Pavia, Italy

r t i c l e i n f o

rticle history:eceived 6 December 2010eceived in revised form 9 May 2011ccepted 11 May 2011

eywords:inite Element Analysis (FEA)atient-specific modelortic valve replacement (AVR)

a b s t r a c t

In some cases of aortic valve leaflet disease, the implant of a stentless biological prosthesis represents anexcellent option for aortic valve replacement (AVR). In particular, if compared to more classical surgicalapproaches, it provides a more physiological hemodynamic performance and a minor trombogeneticityavoiding the use of anticoagulants. The clinical outcomes of AVR are strongly dependent on an appro-priate choice of both prosthesis size and replacement technique, which are, at present, strictly relatedto surgeon’s experience and skill. Therefore, also this treatment, like most reconstructive procedures incardiac surgery, remains “more art than science” [1]. Nowadays computational methodologies representa useful tool both to investigate the aortic valve behavior, in physiologic and pathologic conditions and

to reproduce virtual post-operative scenarios. The present study aims at supporting the AVR procedureplanning through a patient-specific Finite Element Analysis (FEA) of stentless valve implantation. Firstly,we perform FEA to simulate the prosthesis placement inside the patient-specific aortic root; then, wereproduce, again by means of FEA, the diastolic closure of the valve to evaluate both the coaptation and thestress/strain state. The simulation results prove that both the valve size and the anatomical asymmetryof the Valsalva sinuses affect the prosthesis placement procedure.

. Introduction

Valvular heart pathologies represent a remarkable contributiono cardiovascular diseases (CVD) which are the major cause of deathn the Western countries [2].

With respect to aortic valve, there are two main conditionshich impair the native valve functionality: insufficiency and

tenosis. In the first case, the valve is not able to close completelyuring diastole, causing blood regurgitation from the aorta to the

eft ventricle. In the second case, large calcium deposits on the valveontribute to the narrowing of its opening, thus reducing blood flowjection.

Different surgical treatments are adopted to restore valveunctionality. In the literature many techniques for aortic rooteconstruction are described, either sparing the valve leaflets [3,4],r involving the use of mechanical [5], stented [6,7] or stentless

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

iological [8] prostheses as well as homograft and allograft valves9,10].

∗ Corresponding author. Tel.: +39 0382 985980.E-mail address: [email protected] (S. Morganti).

350-4533/$ – see front matter © 2011 IPEM. Published by Elsevier Ltd. All rights reserveoi:10.1016/j.medengphy.2011.05.006

© 2011 IPEM. Published by Elsevier Ltd. All rights reserved.

If the aortic root wall does not show any remarkable patholog-ical dilation so that the valvular leaflets can be considered as theprincipal cause of disease, the aortic valve is replaced by meansof mechanical or biological valves: many comparative studies arereported in the literature [11–13].

On the one hand, mechanical prostheses assure a long-termsolution due to an excellent durability [14], on the other hand, theyare associated with a greater incidence of hemorrhage than bio-prostheses which avoid the use of anticoagulants and determine amore physiological hemodynamics as well as a minor tromboge-neticity [15]; accordingly, especially for elderly patients, biologicalvalves assure greater performances than mechanical ones and, inparticular, stentless valves are preferable than stented ones, repre-senting an “excellent option for aortic valve replacement” [16].

The use of stentless valves, in fact, appears to potentiallyincrease the long-term survival when compared to stented onesdue to improved ventricular reverse remodeling [17]. At the sametime, the hemodynamics is closer to physiologic behavior; finally,the use of a continuous suture technique reduces the crossclamp

to support pre-operative planning of stentless aortic valve implant.

times and cardiopulmonary bypass.The surgical treatment of the stentless valve implant can be

summarized by three main steps as described in Fig. 1 adapted fromGlauber et al. [8]:

d.

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Fig. 1. The three main steps of the stentless valve placement procedure: (a) excisionof the diseased valve, (b) sizing of the aortic root and (c) placement of the prosthesisi

1

2

3

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Fig. 2. Flow chart representing the logical process of the present work: a CAD modelof the stentless prosthesis under consideration is properly created and coupled with

nside the aortic root.

. after transecting the ascending aorta for exposure, the diseasedvalve is excised (Fig. 1(a));

. the aortic annulus is sized with a dedicated aortic valve sizer(Fig. 1(b));

. stay sutures are placed and, subsequently, the valve is lowered:the prosthesis takes its position supra-annularly (Fig. 1(c)).

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

The clinical outcomes of AVR are related to an appropriate choicef both prosthesis size and replacement technique. At present, the

the geometrical model of the aortic root, obtained directly from medical images.Once the prosthesis placement has been simulated, the stentless valve performanceis evaluated virtually reproducing its behavior during diastole.

performance of the surgical operation is thus strictly dependenton surgeon’s expertise, especially in consideration of the fact thatthe technique is non-trivial. Hence, all these aspects make AVR astrongly surgeon-dependent procedure so that, also this treatment,like most reconstructive procedures in cardiac surgery, remains“more art than science” [1]. Moving from such considerations, in thepresent study we propose a patient-specific approach to optimizeprosthesis sizing to support pre-operative planning of AVR.

Stentless aortic valve replacement has received very limitedattention in computational studies and, in particular, to the author’sknowledge, the evaluation of the impact of different sizes on coap-tation and competence has not yet been dealt with. For this purpose,the technique for implant of a stentless biological aortic valveis studied through FEA, which nowadays represents a valid andspread methodology for biomedical investigation.

In particular, we simulate the implant of three different sizes ofthe Freedom SOLO (Sorin Biomedica Cardio, Saluggia, Italy) stent-less valve, starting from a single patient-specific aortic root model.Image processing procedures lead to a patient-specific computer-aided design (CAD) model of the aortic root wall which representsthe host structure for the stentless valve. Each prosthesis is placedalong three different supra-annular suture-lines, defining thusnine different scenarios. We evaluate, in particular, the coapta-tion height and area as well as the stress/strain state of the valveleaflets.

2. Materials and methods

The methodological process adopted in this paper and summa-rized in Fig. 2 consists of four principal steps:

1. a parametric CAD model of the supra-annular prosthesis is prop-erly created;

2. the CAD model of the aortic root is obtained performing imageprocessing procedures;

3. the AVR operation is mimicked by positioning the stentless tissue

to support pre-operative planning of stentless aortic valve implant.

valve inside the aortic root through a placement simulation;4. finally, a second simulation considering both aortic root and

valve is performed to evaluate the valve performance duringdiastole.

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Fig. 3. Geometric model of the valve by Labrosse et al. [20]: (a) the perspective view shows parameters Da, Dc, H and Lh; (b) the top view highlights Lfm and, again, Dc.

F he leaflet during diastole is represented in terms of nodes position for different meshd ed.

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Table 1Set of the chosen parameters highlighted in Fig. 3 adopted to model the stentlessprosthesis.

Prosthesis ID Da [mm] Dc [mm] H [mm] Lfm [mm] Lh [mm]

SIZE 25 25 23 17 31 17

ig. 4. Mesh convergence analysis for a single valve leaflet: (a) the behavior of timensions; (b) nodes belonging to the line of symmetry of the leaflet are highlight

In the following, we detail each one of the previous steps.

.1. Stentless prosthesis model

As stated by Xiong et al. [18], the prosthetic leaflet geometrylays a key-role for efficacy and durability in AVR procedures and,or this reason, it is important to accurately reproduce it in order toredict the realistic valve behavior. In our study, in the absence ofrosthesis technical data from the manufacturer, we generate theodel of the stentless valve assuming that the three leaflets to be

mplanted in the patient’s aortic root have the same geometricaleatures of a healthy aortic valve [19]. Consequently, the Labrosseeometrical guidelines are adopted to define the model [20].

The Labrosse model of the aortic valve is completely describedy five parameters as highlighted in Fig. 3 [21]:

the diameter of the annulus, Da;the diameter of the top of the commissure, Dc;the valve height, H;the leaflet free margin length, Lfm;the leaflet height, Lh.

The subcommissural triangles, i.e., the region included betweenhe base circle of the annulus and the line of the leaflet attachmentthe white area in Fig. 3(a)), are properly removed.

Three different valve models characterized by different sizes

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

re created based on product specifications of the Freedom SOLOrosthesis by Sorin Biomedica Cardio (Saluggia, Italy).

Two main dimensions are reported in the product technicalheet (see Appendix A): the maximum diameter (corresponding

SIZE 27 27 25 18 33 18SIZE 29 29 27 19 36 19

to Da in our model) and the prosthesis height (Hp as reportedin Appendix A). On the basis of these data, the whole set of theLabrosse parameters is obtained, as reported in Table 1.

In particular, given the diameter of the annulus, Da, andextracted the valve height, H, we can properly determine thediameter at the commissures, Dc, which is, in agreement withdimensions measured in normal human valves [22], 5–10% smallerthan Da. The leaflet free margin length, Lfm, is chosen to be approx-imately 25–30% greater than Da, according again to the same setof healthy valve data listed in Thubrikar et al. [22]. Finally, in theliterature it is highlighted that Lfm should be “less than twice” thanLh [20] and also this condition is respected by the values reportedin Table 1.

The leaflets are meshed within Abaqus v6.10 (Simulia, DassáultSystems, Providence, RI, USA) using 4200 four node membrane ele-ments M3D4R with 0.5 mm uniform thickness. A mesh convergenceanalysis has been performed on a single leaflet to identify the min-imum number of elements required to predict the correct behavior

to support pre-operative planning of stentless aortic valve implant.

during diastole. In Fig. 4(a) the position of the nodes belonging tothe line of symmetry (see Fig. 4(b)) of the leaflet is reported asconvergence analysis result.

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Fig. 5. DICOM image processing: (a) a starting snake is initialized as a circular bubble and placed inside the ROI defined by the contrast die; (b) the bubble evolves to takethe shape of the aortic bulb; (c) the STL patient-specific model of the aortic bulb is obtained.

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ig. 6. CAD model and mesh generation of the aortic root: (a) splines are extracted bithin Abaqus; (c) a quadrilateral shell element mesh is defined.

.2. Materials

The stentless valve is made of two bovine pericardial sheetsithout any fabric reinforcement. Even if fresh pericardial tissue

s anisotropic, the simplifying assumption of isotropic materials acceptable since the prosthetic valve after the fixation processehaves more as an homogeneous isotropic material [23,24].

Consequently, to represent the material behavior of the stentlessalve leaflets we adopt an incompressible isotropic hyperelas-ic Mooney–Rivlin model, defined by the following strain energyotential [25]:

= C10(I1 − 3) + C01(I2 − 3) (1)

here C10 and C01 are material parameters; I1 and I2 are the firstnd second deviatoric strain invariants defined as:

2 = �21 + �2

2 + �23 (2)

2 = �−21 + �−2

2 + �−23 (3)

here the deviatoric stretches are �i defined as �i = J−1/3�i, with the Jacobian of the deformation gradient F, and �i the principaltretches.

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

In particular, following the approach proposed by Ranga et al.26], which is based on a simplified model of the aortic valve,e adopt the following parameter values: C10 = 0.5516 MPa and

01 = 0.1379 MPa. The density is set to 1000 kg/m3.

essing the STL file; (b) the CAD model is obtained by performing a lofting procedure

Such a material simplification is also acceptable since we aremainly focusing on the global structural response and, in particular,we are looking at the performance of the prosthetic valve in termsof coaptation values and diastolic behavior.

2.3. Patient-specific model of the aortic root

Although it is known that transesophageal echocardiography(TEE) is a standard procedure prior AVR surgical intervention, webase the aortic root model on DICOM images of a cardiac CT-Asince it allows for an exact modeling of the complex asymmet-ric patient’s aortic root geometry, thus leading to a more realisticcomputer-based prediction of the AVR outcomes. The CT-A scanwas performed at IRCCS Policlinico San Matteo, Pavia, Italy, using aSOMATOM Sensation Dual Energy scanner (Siemens Medical Solu-tions, Forchheim, Germany) and a iodinated contrast die on a 46years old male patient who provided a written informed consentprior to undergoing CT-A. The scan data are characterized by thefollowing features: slice thickness: 0.6 mm; slice width × height:512 × 512; pixel spacing: 0.56 mm.

We process the resulting DICOM images using ITK-SNAP v2.0.0[27] in order to firstly enhance the contrast die, then extract a con-fined region of interest (ROI) from the whole reconstructed body

to support pre-operative planning of stentless aortic valve implant.

and, finally, apply an automatic segmentation procedure based onthe snake evolution methodology [28] to obtain a stereolithographic(STL) description of the anatomical region of interest. In Fig. 5(a) and(b) the evolution of the snake is shown from two different views,

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Fig. 7. Simulation strategy for the prosthesis placement: the black arrows representto

aS

dt

p

s

Different values of �s (0.5 mm, 2 mm and 5 mm) associated withthree different labels we refer in Section 3 (suture-line 1, 2 and 3,

Ftlw

he displacements to be computed and applied to the nodes of the prosthesis linef attachment.

xial and longitudinal, together with the rendering of the resultingTL aortic bulb model (Fig. 5(c)).

The STL file is processed within Matlab (Natick, MA, USA) toefine a set of splines identifying the cross sectional contours ofhe aortic bulb volume (see Fig. 6(a)).

The CAD model (Fig. 6(b)) is then obtained by means of a loftingrocedure from the spline curves imported in Abaqus.

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

Finally, the model is meshed with 43,260 linear quadrilateralhell elements S4R (Fig. 6(b)).

ig. 8. Definition of the suture lines: (a) the plane � containing the native line of attachmranslating � vertically; the line of attachment of the prosthesis leaflet is defined by the inines where the nodes of the prosthesis are tied with the nodes of the sinuses. (For interp

eb version of the article.)

PRESSg & Physics xxx (2011) xxx– xxx 5

Since both the displacements and the stress state experiencedby the aortic sinuses are less significant than the ones experiencedby the leaflets, we use also for the aortic bulb the same simpli-fied material properties adopted for the prosthetic tissue valve inagreement with Ranga et al. [26].

2.4. Prosthesis placement

As highlighted in Fig. 7, the prosthesis implant is simulated byconstraining the attachment lines of the leaflet (red lines in Fig. 7) tooverlap the so-called “suture-lines”, defined on the patient-specificaortic root model (blue lines in Fig. 7). (For interpretation of thereferences to color in this sentence, the reader is referred to theweb version of the article.)

To define the suture-line of each leaflet we proceed in threesteps:

• definition of the plane � passing through the reference points A,B, C and containing the line of the native leaflet attachment (seeFig. 8(a));

• definition of the plane �, obtained with a �s vertical translationof the plane � (see Fig. 8(b));

• definition of the supra-annular suture-line from the intersectionof � with the patient-specific CAD model of the Valsalva sinuses.

This sequence of geometrical operations is repeated for everyValsalva sinus to obtain the whole set of suture-lines (blue lines inFig. 8(b)).

A quasi-static FEA of the prosthesis placement is performedusing Abaqus Explicit solver; pre-computed displacements areimposed to the nodes of the prosthesis attachment line. Inertiaforces do not dominate the analysis since the ratio of kinetic energyto internal energy remains less than 5%. For quasi-static simula-tions involving rate-independent material behavior, the naturaltime scale is in general not important. For this reason, a mass scal-ing strategy, i.e., an artificial increase of the mass of the model, isused to reduce computational costs.

to support pre-operative planning of stentless aortic valve implant.

respectively) are taken into consideration to evaluate the behaviorof the valve implanted in different positions.

ent and passing through the points A, B and C is created; (b) the plane � is obtainedtersection of � with the sinus. The blue lines represent the whole set of attachmentretation of the references to color in this figure legend, the reader is referred to the

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Fig. 9. Simulation of prosthesis closure: (a) sketch of the applied boundary condi-tions; (b) the pressure on the leaflets adopted to reproduce the diastolic phase isr

2

iw

trweoc

a

pAstmes

FA

Fig. 11. The von Mises stress contour plot, outcome of the simulation of the SIZE25 prosthesis implant on the suture-line 1 (�s = 0.5 mm), is represented. The NonCoronary (NC), the Left Coronary (LC) and the Right Coronary (RC) sinuses are high-lighted.

epresented as a function of time.

.5. Prosthesis closure

To evaluate the performance of each valve replacement solution,.e., each combination of prosthesis size and suture-line position,

e simulate the diastolic phase of the cardiac cycle.The CT-A data adopted to generate the geometrical model of

he aortic root wall have been obtained at the end-diastole; for thiseason, a uniform pressure of 80 mmHg, is applied on the leafletshile the pressure acting on the internal wall of the sinuses is taken

qual to zero. The nodes belonging both to the top and to the bottomf the aortic root model are confined to the plane of their originalonfiguration.

In Fig. 9a representative sketch of the boundary conditionspplied to simulate valve closure is depicted.

The numerical analysis of the prosthesis closure is a non-linearroblem involving large deformation and contact. For this reason,baqus Explicit solver is used to perform large deformation analy-es; in particular, quasi-static procedures are used again assuminghat inertia forces do not change the solution. Kinetic energy is

onitored to ensure that the ratio of kinetic energy to internalnergy remains less than 10%. Also in this case, a mass scalingtrategy is adopted to reduce computational costs.

Please cite this article in press as: Auricchio F, et al. A computational tool to support pre-operative planning of stentless aortic valve implant.Med Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

ig. 10. Section view of the prosthesis at the end of diastole: the coaptation area,C, highlighted in grey and the coaptation height, HC, are shown.

Fig. 12. Stress distribution over the leaflets: (a) as a function of the prosthesis sizewith fixed suture-line position (suture-line 1), (b) as a function of the suture-lineposition with fixed prosthesis size (SIZE 25).

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Table 2Stress distribution in terms of �M (kPa) on the leaflets after the simulation of surgical prosthesis placement. The effect of the suture site and of the prosthesis size is highlightedfor each leaflet (Left-Coronary, LC, Non-Coronary, NC and Right Coronary, RC).

SIZE 25 SIZE 27 SIZE 29

LC NC RC LC NC RC LC NC RC

Sut.-line 1(�s = 0.5 mm) 509 137 390 259 47 175 100 42 63Sut.-line 2(�s = 2 mm) 698 212 520 195 11 107 417 77 286Sut.-line 3(�s = 5 mm) 945 364 728 632 161 459 370 41 245

Table 3The values of �M (kPa) are reported at the end of diastole for each investigatedconfiguration.

Prosthesis ID Sut.-line 1(�s = 0.5 mm)

Sut.-line 2(�s = 2 mm)

Sut.-line 3(�s = 5 mm)

SIZE 25 215 211 212SIZE 27 228 218 210SIZE 29 239 234 228

Table 4Set of the Freedom SOLO dimensions from the manufacturer.

REF. ART 23 SG ART 25 SG ART 27 SG

Ordering code ICV0902 ICV0903 ICV0904

2

ovvatipawa

wiv

eaht

3

3

tad

sdp

Fig. 13. The von Mises stress contour plot is represented at the end of diastole forthe SIZE 25 prosthesis implanted on the suture-line 1: a central gap is observable

A [mm] 25 27 29Hp [mm] 21 22 23

.6. Post-processing

The prosthesis placement has been analysed mainly focusingn the tensional state of the leaflets. In particular, we introduce theon Mises average stress, �M, properly defined. We neglect peakalues of the stress due to local concentration since they can beffected by numerical aspects and, consequently, they may alterhe comparison between the different replacement configurationsnvestigated in our work. For this reason, we consider only the 99ercentile with respect to the original leaflet area (i.e., only 1% of therea has stress above this value, �99). After excluding the elementsith the highest stress values, we compute the average stress, �M,

s:

M =∑N

i=1�iAi∑N

i=1Ai

(4)

here �i is the stress evaluated at the centre of each element, Ais the element area and N is the number of elements whose stressalue is below �99.

In addition to �M, other two basic parameters are measured tovaluate the prosthesis physiology: the coaptation area, AC, defineds the total area of the elements in contact, and the coaptationeight, HC, defined as the distance between the plane containinghe annulus and the point where the coaptation occurs (see Fig. 10).

. Results

.1. Prosthesis placement

We evaluate the positioning of three different sizes of stentlessissue valves in one aortic root model. Each prosthesis is placedlong three different supra-annular suture-lines, defining thus nineifferent scenarios.

The FEA of the stentless valve implantation into the patient-

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

pecific aortic bulb provides the tensional state of each leaflet. Asepicted in Fig. 11, the results of the prosthesis placement in onearticular case are reported in terms of von Mises stress pattern.

proving that the prosthesis size under consideration is not able to completely closeand will allow a retrograde blood flow during diastole.

It is possible to note that the stress distribution is not the samefor each leaflet; this is due to the asymmetric morphology of thehost aortic bulb, while the stentless valve has a symmetric shape.

To highlight this aspect we compute for each leaflet the vonMises average stress, �M, previously defined.

In Table 2 all the values of �M (kPa) obtained from the analysis ofthe prosthesis placement on different suture-lines are summarized.

In Fig. 12(a) and (b) �M is evaluated in the three leaflets(Non/Left/Right Coronary) and represented as a function of theprosthesis size and suture-line position, respectively.

3.2. Prosthesis closure

Once the prosthesis is implanted and sutured inside the aor-tic root, a uniform pressure is applied on the leaflets to evaluatethe performance of the surgical solution under consideration. InFig. 13, the SIZE 25 valve placed along suture-line 1 is representedat the end of the diastolic phase; the von Mises stress distributionis highlighted.

The bar graphs depicted in Fig. 14(a) and (b) show the impact ofboth the prosthesis size and the suture-line position on the coap-tation measurements. In particular, Fig. 14(a) highlights that theincrease of prosthesis size leads to the decrease of HC, while thesuture-line position does not affect significantly the coaptationheight.

On the contrary, both the coaptation area, AC, and the averagestress, �M (defined in Eq. (4)), increase with the prosthesis size

to support pre-operative planning of stentless aortic valve implant.

while the suture-line site has a minor impact on such values (seeFig. 14(b) and (c)). In Table 3 the values of �M (kPa) are reported foreach investigated configuration.

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Fig. 14. Trend of the coaptation measures and of the tensile state: (a) the coaptationhe

tatw

tions.

eight, HC, (b) the coaptation area, AC and (c) the average von Mises stress, �M, arevaluated as a function of the prosthesis size and the suture-line position.

The valve closure results show that the coaptation of thehree leaflets is not perfectly symmetric due to the physiological

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

symmetry of the aortic sinuses. For this reason, during the dias-olic phase, a central gap is observable (see Fig. 15, front view)hich implies insufficiency of the virtually implanted valve. Con-

PRESSg & Physics xxx (2011) xxx– xxx

sequently, we can speculate that the replacement solution underinvestigation could fail.

4. Discussion

In the literature, several finite element studies of the aortic valveare reported [18,29–31] but, to our knowledge, the behavior ofstentless valve prostheses with particular attention to the evalua-tion of the impact of different sizes on coaptation and competencehas not yet been dealt with.

In this work, we simulate by FEA the aortic valve replacementprocedure with a stentless tissue valve. Different prosthesis sizeshave been placed on different suture-line positions defined forone patient-specific aortic root model, directly obtained from CT-Aimages.

The discussion of results of the present study may focus on thefollowing issues.

The first one is the uneven distribution of stresses on the threeleaflets (see Fig. 12(a) and (b)) due to anatomical asymmetry of thenative aortic bulb in spite of uniformity of the prosthetic valve. Con-sistently, although the top view of the implanted valve of Fig. 15would suggest the absence of central leakage, we highlight thatthe simulation of valve closure displays a non-uniform coaptationof the leaflets (as highlighted in the front view of Fig. 15) duringthe diastolic phase, which means a potential incompetence of thesubstituted valve, i.e., the failure of the applied surgery. Moreover,we may state that our geometrical solution due to asymmetry isin agreement with the results presented in Fig. 4 by Sun et al.[32] who studied the implications of an asymmetric trans-catheteraortic valve deployment.

In dealing with this result we want to highlight that an impor-tant role is played by the geometry of the stentless valve and, inparticular, by the choice of its dimensions that, as previously said,are not coming directly from the manufacturer.

The second issue is the relevance of prosthesis size as to boththe coaptation area, i.e., the performance of the prosthetic valve(see Fig. 14(b)), and the stress distribution over the leaflets, i.e., thedurability of the prosthesis (see Fig. 14(c)), whereas no significantimpact has been shown by the suture-line site. This observationhighlights importance of the choice of prosthesis size while it seemsthat suturing the valve in a position slightly more distal or moreproximal with respect to conventional suture sites, i.e., at 2–3 mmfrom the host annulus of each sinus [8], does not affect significantlythe procedure outcome.

The computational reproduction of the patient aortic root fromimaging records (namely CT-A) as well as the reproduction of thecandidate prosthetic valve by the same means allows a matchingof both, which implies potential surgery choices better tailored tothe specific patient.

With regard to limitations of the study, the first observation isthat the computational model of the aortic root has to be repli-cated on a number of cases. Confirmatory value has to be searchedin postoperative measured parameters compared to the numericalresults.

Even though the geometrical modeling of the tissue prosthesesfeatured as healthy valves is accepted [19], the creation of pros-thetic geometries completely based on technical data of valvesreleased on the market would improve the computational out-comes and contributions to support the surgical planning. In thisdirection, also the consideration of more accurate material modelswould represent a step forward heading to more realistic simula-

to support pre-operative planning of stentless aortic valve implant.

Finally, a numerical study of the fluid-structure interactionbetween the prosthesis leaflets and blood could give additionalinformation about the surgical procedure planning and, in particu-

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Fig. 15. SIZE 29 prosthesis placed on suture-line 2 at the end of diastole: due to the asimplanted symmetric valve closes below the other two leaflets. Even if the top view of ththe front view which means that the replacement solution fails.

Fig. 16. Freedom SOLO model: (a) The geometrical model of the prosthesis asreported in the technical sheet is showed; (b) the two basic dimensions of our closedv

ls

i

5

isfhdtp

A

dht

ciDf

[

[

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alve model with reference to the technical sheet data are highlighted.

ar, it could make possible to evaluate the impact of different AVRolutions on the hemodynamics.

In future works, we are planning to further improve the modelncluding all these aspects.

. Conclusions

Conclusively, the computational tools may provide a deepernsight in physiology of heart valves in terms, for example, oftress/strain patterns and adequacy of coaptation, easily movingrom native to prosthetic models. Practically speaking, they mayelp the surgeon improve his technique choosing the optimalevices and they may anticipate the surgery outcome as well. Sohey are worth moving forward in the direction warranted by theresent study.

cknowledgements

S. Morganti has been supported by Ministero dell’Istruzione,ell’Universitá e della Ricerca (MIUR). F. Auricchio and M. Contiave been partially supported by the Cariplo Foundation throughhe Project no. 2009.2822 and by MIUR.

The authors would acknowledge Dott. R. Dore of IRCCS Poli-

Please cite this article in press as: Auricchio F, et al. A computational toolMed Eng Phys (2011), doi:10.1016/j.medengphy.2011.05.006

linico San Matteo, Pavia, Italy, for support to the medical andmaging aspects of the present work and Eng. Carolina Ferrazzano,ipartimento di Meccanica Strutturale, Universitá di Pavia, Italy,

or support to medical images processing.

[

ymmetry of the patient-specific sinuses, the non-coronary leaflet of the virtuallye closed valve could suggest valve functionality, a central gap is highlighted from

Conflict of interest statementAll authors disclose any financial and personal relationships

with other people or organisations that could inappropriately influ-ence (bias) their work.

Appendix A

In Table 4 the dimensions of the Freedom SOLO valve reportedon the prosthesis technical sheet are presented.

Fig. 16 highlights how such dimensions refer to the prosthesisgeometry.

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