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Structural Effects of An Innovative Surgical Technique To Repair Heart Valve Defects
Structural Effects of An Innovative Surgical Technique To Repair Heart Valve Defects
Structural Effects of An Innovative Surgical Technique To Repair Heart Valve Defects
Abstract
The structural and functional effects of the ‘‘edge-to-edge’’ technique on the human mitral valve have been investigated, paying
particular attention to the diastolic phase. An advanced finite element model of the valve has been developed, using a hyperelastic
material schematization, suitable geometry and constraint conditions, and an effective fluidodynamic analysis. The edge-to-edge
suture has been applied on this model and the diastolic phase has been simulated. The results of this calculation show that the
operation increases the transvalvular pressure and the maximum stress in the leaflets, which reaches a level similar to that of the
systolic phase. The influence of suture position and extension, and the mitral annulus dimension has also been investigated. The
results indicate that a lateral location of the stitch is better than a central one, both regarding valve functionality (pressure level and
mobility) and internal stresses level, that a longer suture worsens the valve functionality but reduces the stresses level, finally, that the
dilatation of the mitral annulus does not affect the valve functionality but increases the stresses level.
r 2004 Elsevier Ltd. All rights reserved.
0021-9290/$ - see front matter r 2004 Elsevier Ltd. All rights reserved.
doi:10.1016/j.jbiomech.2004.10.005
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Fig. 1. (a) Blood flow scheme through the left human heart and (b) Mitral apparatus.
the edge-to-edge (E-to-E) technique, which restores Arts et al. (1983) schematised the leaflets as three-
valvular competence by anchoring the free edge of the dimensional (3-D) shells, supposing again a linear-
prolapsing leaflet to the corresponding free edge of the elastic material behaviour, thus obtaining the following
opposing leaflet (Alfieri et al., 2001; Fucci et al., 1995). relationship for the membranal stress sustained by the
When the prolapse is in the middle portion of a leaflet, valve
the correction creates a double orifice valve, while in
A0
case of commissural lesions, the correction results in a sX0:5 p ; (2)
single orifice valve with a smaller area. This technique is c0 h tv
simpler than traditional surgical solutions, and it can be where s is the radial stress in the leaflets, A0 the orifice
carried out in a shorter period of time, with mid- and area, c0 the orifice circumference, h the thickness of the
early-term results comparable with those obtained by membrane, and ptv the transvalvular pressure.
other techniques (Fig. 2) (Maisano et al., 2000, 1998). Miller and Marcotte (1987) and Miller et al. (1981)
The effects of E-to-E on MV functionality and on the furnished a very simple model in which the leaflets are
stresses generated near the stitch is not, however, clear: idealised as thin cylindrical shells
it is therefore very important to understand if they are
T ¼ 666 ðTPÞ ðANLÞ=HL; (3)
acceptable for every surgical configuration.
This is possible only with a detailed structural where T (dyne/cm) is the circumferential tension in the
analysis, able to simulate the behaviour of a MV cylindrical leaflets, TP (mmHg) is the transvalvular
subjected to E-to-E. Several studies have been carried pressure, ANL (cm) the annulus diameter, and HL (cm)
out in the past to perform the structural analysis of the is the leaflet thickness.
MV, both by analytical and finite elements methods More complex analyses have been carried out by
(FEM). using FEM models: they were in particular devoted to
Ghista and Rao (1972a, b) idealised the valve leaflets solve some controversies such as the risk of late
as two semi-circular membranes, supposed of a linear- degeneration and mitral stenosis.
elastic material, obtaining the following expression for Kunzelman et al. (1993) developed a 3-D finite
the maximum stress in the leaflets: element model: they made a symmetry assumption in
sffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi order to analyse only an half of the apparatus, using a
3 Eq20 a2 S n linear-elastic material schematisation, defined by the
s¼ ; (1) post-transition Young modulus. Only the systolic phase
p2 h2 ð1 nÞ
of cardiac cycle was analised, observing peak stresses
where E is the Young modulus, q0 the pressure applied near the fibrous trigone area and the leaflet mid-line.
to the valve, a the leaflet radius, Sn a numerical series Votta et al. (2002) used another FEM model to
getting the value of about 0.3279, h the thickness of the simulate the systolic phase, the diastolic phase and the
membrane, n the Poisson ratio. E-to-E repair with central suture of 4 or 8 mm. Their
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2462 F. Dal Pan et al. / Journal of Biomechanics 38 (2005) 2460–2471
Fig. 2. The E-to-E repair in its two typical configurations: (a) double orifice valve and (b) single orifice valve (para-commissural configuration).
The first model (E model, i.e. elastic model) considers 2.1. Geometry and mesh
a linear-elastic material behaviour and it is therefore
useful to compare the present results with those The mitral annulus geometry assumed for the
obtained from the pre-existent linear-elastic models. analyses is shown in Fig. 3. It has been taken as
The constraint introduced by the chordae tendineae is representative for the human heart on the basis of
obtained by an ‘‘equivalent’’ boundary condition medical literature (Brock, 1952; Chiechi et al., 1956; du
described in the following. Plessis and Marchand, 1964; Ormiston et al., 1981;
The second model (H model, i.e. hyperelastic model) Roberts, 1983; Rusted et al., 1952; Silverman and Hurst,
considers a non-linear hyperelastic material behaviour 1968) and direct observations. In particular, the annulus
and presents the same boundary conditions used in perimeter is 81.6 mm and the enclosed area is 492 mm2.
the E model to represent the effect of the chordae In Fig. 4a the 3-D geometry and the mesh of the valve
tendineae. model are shown. In the undeformed configuration the
The third model (FH model, i.e. full hyperelastic valve is almost closed. Its height is 8.7 mm, the anterior
model) considers a non-linear hyperelastic material leaflet middle section length is 16.8 mm, while the
behaviour together with a modelling of the chordae posterior is 10.0 mm. The mesh is composed of four
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Fig. 4. Finite elements models of the MV: (a) FH model, with inextensible chordae tendineae and (b) E and H models, with boundary conditions
simulating the chordae tendineae: all the leaflets free-edge points are constrained to move on a plane inclined 26.51 with respect to the annulus plane.
Experimental
gradients and when contact problems are involved 0.2 Reduced-polynomial
(Abaqus technical note (2003)). In particular, 2478 0.16
elements were employed for the anterior leaflet, 1882 for
the posterior one. A convergence analysis was carried 0.12
out to choose this mesh density: several models with 0.08
different mesh densities were examined for this aim,
stopping the process when a difference less than 3% in 0.04
the maximum stress was found by a further mesh 0
refinement. 0 0.04 0.08 0.12 0.16 0.2 0.24 0.28
Nominal strain
2.2. Material properties Fig. 5. Experimental leaflets material stress–strain curve and corre-
spondent reduced-polynomial strain energy potential schematisation
The characterisation of MV material is very complex, used in H and FH models.
due to the difficulty in obtaining and testing samples of
regular shape. The data available in the literature are
therefore very poor, variable and sometimes referring to experimental data shown in Fig. 5 refer to the loading
specific pathologies. curve. Considering also the unloading, a very small
Anyway, it has been verified (Barber et al., 2001; hysteresis is present, which has been neglected in the
Clark, 1973; Ghista and Rao, 1972a, b; Kunzelman and hyperelastic schematisation.
Cochran, 1991; Lim and Boughner, 1974) that the For this aim, the most comprehensive experimental
material of the MV presents a non-linear stress–strain data found in literature, those obtained by Barber
curve typical of many biological tissues, as reported with (Barber et al., 2001) by tensile tests on MV tissue, have
cross symbols in Fig. 5. The initial part of the diagram been at first elaborated in terms of nominal stress–strain
(pre-transition segment) is characterised by a small slope curve, as shown with cross symbols in Fig. 5.
(i.e. a low ‘‘tangent modulus’’), indicating a low material The hyperelastic material behaviour has been then
rigidity. After an intermediate zone, in which the slope described in terms of a strain energy potential U, which
begins to increase, the stress–strain curve appears very defines the strain energy stored per unit of a reference
steep in the final part of the diagram (post-transition volume. Assuming isotropy, the strain energy potential
segment), thus indicating a high material rigidity. can be formulated as a function of the strain invariants
Moreover, when the load is removed, the material and, taking the derivative of U with respect to strain,
returns in the undeformed condition. stress can be obtained. A number of different forms of
This kind of behaviour, also typical of rubbers, can be strain energy potentials have been developed in the past
well described by a hyperelastic schematisation, which and many of these are now available in most commercial
has been adopted in the H and FH models. Really, the FEM codes. In the present work, the strain energy
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2464 F. Dal Pan et al. / Journal of Biomechanics 38 (2005) 2460–2471
potential has been defined in the reduced polynomial to the whole valve surface to simulate the systolic phase
form of the cardiac cycle. Diastolic load was determined from
X
N XN the fluid-dynamic FEM model proposed by Redaelli et
1 el al. (2001). This model hypothesises a constant blood
U¼ C i0 ðĪ 1 3Þi þ ðJ 1Þ2i ; (4)
i¼1 i¼1
D i flow rate across the valve Q (l/min), determining the
where N; C i0 ; Di are material parameters, to be defined diastolic pressure drop (Dp, mmHg) as a function of the
on the basis of the test data, Ī 1 is the first deviatoric effective orifice area (A, mm2 ). The relationship
strain invariant and Jel is the elastic volume ratio between the above-described parameters, obtained from
(Abaqus Manuals, 2002). In our case, a fifth-order interpolations of FEM results, is
reduced polynomial was employed to fit the experi- Dp ¼ 0:16 ðQ=AÞ2 : (5)
mental data. The result is reported in Fig. 5 compared to
the experimental stress–strain curve, showing a very It is graphically shown in Fig. 17 and represents the
good agreement. loci of all the possible working points of the valve.
The calculations carried out with the E model Following the literature (Muntinga et al., 2000), a
consider on the contrary a simple linear-elastic material typical value of Q ¼ 13 l=min has been assumed in the
schematisation defined by a Young modulus of about present analyses, and the orifice area was computed
4 MPa and a Poisson coefficient n ¼ 0:45: These values approximating it as elliptical.
are representative of the material post transition zone The FEM models of the MV here presented could be
and have been chosen just to compare the results of the enhanced in the future, to take into account to actual
E model with those of the other FEM models available fluid-valve interaction, thus solving together the fluid-
in the literature, which also describe the material dynamics and the structural problems. These enhanced
behaviour in terms of linear-elastic schematisation models would be probably more realistic, but also
defined by the post-transition tangent modulus. It must significantly more complex and heavier from a compu-
be remarked, however, that this assumption implicates tational point of view. In our opinion, however, they
an excessive material rigidity in the first phases of would not give substantially different results in terms of
loading, which can lead to a not correct prediction of the systolic and diastolic stresses in the MV with respect to
stress and strain distribution. This fact will be discussed the present models, but only additional information on
in the following. the whole cardiac cycle and on the correspondent
instantaneous values of the stress cycle. Comparing the
2.3. Boundary conditions and interactions structural effects of the E-to-E surgical parameters in
the MV, being the aim of the present work, an
The following boundary conditions were applied to assessment based on the systolic and diastolic stresses
simulate physical constraints in the non-repaired valve: seems to be valid and sufficient.
Table 2
Comparison of hyperelastic model results
Fig. 7. The inextensible connector simulating the stitch, supplied with 3.1. Results and discussion
two ‘‘coupling’’ constraints, one for each leaflet.
Fig. 9 shows the strong effect of the suture (centred,
1-mm-long) in the opening mechanism of MV: E-to-E
generate a double-orifice valve, with a reduced mobility
e
in comparison with normal MV. Consequently, the
stress distribution is greatly changed, with a critical zone
in proximity of the connector.
While the stress distribution has been supposed to be
s not affected by the presence of the suture in the systolic
phase, the diastolic Von Mises maximum stress, which
Suture position Suture extension
was negligible in the non-repaired valve (0.027 MPa,
(a) (b)
see Table 2), resulted to a value of 0.245 MPa, be-
∇
+ A coming comparable to the systolic one (0.345 MPa, see
∇ Table 2). The immediate consequence is that during
- A
the cardiac cycle the leaflets are stressed twice with
respect to normal situation, as if the heart rate were
doubled and this fact had been observed by Votta
et al. (2002) too.
The load transmitted by the connector resulted in
(c) Annulus dilatation 0.264 N. This value is very close to that experimentally
measured during diastole by Nielsen (Nielsen and
Fig. 8. The three surgical parameters under examination: (a) suture Timek, 2001) in the suture of an ovine MV submitted
position, (b) suture extension and (c) annulus area variation.
to E-to-E. Taking into account the anatomical and
physiological differences and variabilities of the two
investigations, we have to consider this agreement quite
creation, at the end of which the approach load is fortuitous, anyway the same order of magnitude of the
removed, and the final step for diastole, i.e. the experimental and numerical results confirms the effec-
application of a differential pressure following for- tiveness of the H model in describing the behaviour of
mula (5). the MV and in particular the effect of the E-to-E on the
Three fundamental surgical parameters of the re- stress and strain distribution.
paired valve were investigated (Fig. 8): suture position,
suture extension, and annulus area variation. This last 3.1.1. Influence of suture position
modification is consistent with the common presence of The effect of the lateral shifting of the stitch
strongly dilated annulus in patients affected by MV (increasing s) on the valve mobility is to allow a better
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Fig. 9. Deformed shape and Von Mises stress contour of the MV in the diastolic phase: (a) before and (b) after E-to-E repair (1 mm long centred
suture). A highly stressed zone is well visible near the suture.
Fig. 11. Maximum Von Mises stress in the leaflets as a function of the
suture position.
Fig. 13. Maximum Von Mises stress in the leaflets as a function of the
suture extension.
Fig. 14. Von Mises stress along the suture in the anterior leaflet, for
each extension of the suture itself. A progressive stress redistribution as
the suture length increases can be noted.
0.25
Von Mises stress (N/mm2)
0.20
0.15
0.05
0.00
-20 -10 0 10 20 30
Annulus area variation, ∆A (%)
Fig. 16. Maximum Von Mises stress in the leaflets as a function of the annular area variation.
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2470 F. Dal Pan et al. / Journal of Biomechanics 38 (2005) 2460–2471
16
s
8
s =18
2
0
120 140 160 180 200 220 240 260 280 300
Total orifice area (mm2)
Fig. 17. Constant flow-rate curve (13 l/min) and working points representative of the examined E-to-E configurations.
have not been completely studied yet. This demonstrates Fucci, C., Sandrelli, L., Pardini, A., et al., 1995. Improved results with
the goodness of this technique, whose effectiveness and mitral valve repair using new surgical techniques. European
Journal of Cardio-Thoracic Surgery 9, 621–627.
medical benefits have been already largely ascertained.
Ghista, D.N., Rao, A.P., 1972a. Structural mechanics of the mitral
valve: stresses sustained by the valve, non-traumatic determination
of the stiffness of the in vivo valve. Journal of Biomechanics 5,
Acknowledgement 295–307.
Ghista, D.N., Rao, A.P., 1972b. Mitral-valve mechanics-stress/strain
The authors wish to thank Prof. Franco Docchio, characteristics of excised leaflets, analysis of its functional
mechanics and its medical application. Medical and Biological
whose efforts made possible the collaboration between Engineering November, 1973, 691–702.
engineers and medicians in this work. Kunzelman, K.S., Cochran, R.P., 1991. Stress/strain characteristics of
porcine mitral valve tissue: parallel versus perpendicular collagen
orientation. Journal of Cardiac Surgery 7 and 1, 71–78.
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