Professional Documents
Culture Documents
Bmmechanm
Vol. 26. No.
Printed in Great Britain
8. pp
929-943.
1993.
1X.21 -9290/ 93
$6.00+.00
1993 Pergamon Press Ltd
INTRODUCTION
Bioprosthetic heart valve implants have proven clinically successful over the short term, but their long-term
performance has been disappointing (Bortolotti et al.,
Received in jnal
form
28 December
Address correspondence
to: Ivan
Robarts
Research
Institute,
P.O.
Ontario, Canada N6A 5K8.
1992.
S. KRUCINSKIet al.
930
METHODS
In finite element methods, the volume of an analysed structure is subdivided into small but finite
subvolumes called elements. If these elements are of
finite thickness and curved, they can approximate the
shape of the valve very well. In our approach, we have
chosen 20-node isoparametric brick elements for both
the valve leaflets and the supporting stent. The shape
of the valve leaflet was adapted from existing clinically
available pericardial valves, as described by Quijano
(1989). The leaflets were symmetrical, with a top freeedge angle of 17.5 and a bottom angle of 36.5. The
shape of the cusp was spherical, with a flattened
coaptation region (Fig. 1). Coaptation height was
6.4 mm at the commissures, and zero at the centre,
where all three cusps came together. The leaflets were
assumed to be 0.5 mm thick, and the connection
between the stent and the leaflets was assumed to be
perfect, in the sense that nodal displacements at the
attachment surface were identical for the leaflet and
the stent.
Our modelling approach utilized non-linear continuum mechanics to describe the highly non-linear
material characteristics of the valve leaflets, and the
large deformations that occur during valve opening.
We have used true three-dimensional brick elements,
rather than shell elements, for accurately simulating
leaflet stresses (as suggested by Black et al., 1991), and
have paid particular attention to simulating contact
between the cusps during valve opening and closure
to model valve coaptation (Black et al., 1991). We
have also relied heavily on experimentally acquired
data of flexural stiffness to model properly the valve
opening process and realisticatty simulate the magnitude of flexural stresses.
The finite element model was deformed by a timevarying physiological pressure waveform, incrementally applied to both the inflow and outflow surfaces
of the valve leaflets. The deformed shape of the pros-
thetic valve was solved iteratively after each incremental increase in applied pressure. The equilibrium
shape of the valve at time t was characterized by the
principle of virtual displacements referred to the initial unstressed configuration, as given by the relation
+ r fT6(uT- U,)dS.
J sc
In equation (1) Sij and Eij denote components of the
second Piolla-Kirchoff stress tensor and the Lagrange strain tensor, respectively. The f: and fi are
components of the externally applied body and surface force vectors due to the hydrostatic force, and the
6Ui symbolize the ith component of the virtual displacement vector that deforms the mesh. The last two
terms on the right-hand side define an additional
constraint due to the contact condition, which prevents any point in space to be in the interior of more
than one body. The use of such a contact algorithm
enabled realistic simulations of the leaflets in contact
both during opening and closure. Rather than constraining the finite element mesh not to deform past
a given point, as done by Hamid et al. (1986), Christie
and Medland (1982) and Huang et al. (1990), we used
a Lagrangian multipliers approach to simulate contact, as first described by Chaudhary and Bathe
(1985). In this approach, the distance between contacting bodies is measured by a gap function. As any
points of the body come into contact, the value of the
gap function for the points decreases and eventually
reaches zero when contact is established. The Lagrangian multipliers are solved at every node in the vicinity of the coaptation region, but the coaptation region
does not have to be known exactly beforehand. If the
nodes slide, the ratio of the tangential to normal force
is determined by the coefficient of friction and the
nodal forces are adjusted appropriately. A coefficient
of friction of zero was selected to simulate the absence
of friction at the leaflet interface. The material for the
valve leaflets, the pericardium, was assumed to be of
uniform thickness and isotropic. While some investigators have reported that pericardium is mildly anisotropic in its extensibility (Crofts and Trowbridge,
1988; Lee et al., 1989), there is no evidence that
pericardial valves are constructed to accommodate
this mild anisotropy in a systematic way. The material
model also assumed that the pericardium was elastic
in the sense that during a closed deformation cycle the
strain energy is stored and released so that no net
work is done on the body. The strain energy function
of the material can, therefore, be expressed in terms of
invariants of tensor E,
w=
W(II E ,I ~ E V ~ ~ E ),
(2)
931
relationship
as
1 ,
.
0.8
-.__
9.
Experimental Data
Fitted Function
0.2
0.1
Strain
Fig. 2. The stressstrain curve used for the modelling of the bovine pericardium. A power approximation
fitted to the experimental
data obtained from van Noort et al. (1982). and the shape of the curve was
modified in the extremely low strain portion (below 5% strain) to reflect the very low bending stiffness of the
material.
932
S. KRUCINSKIet nl
Pressure Waveform
150
300
The
450
600
750
in milliseconds
Fig 1. Oblique and outflow views of the model pericardial valve used in the finite element simulations. The geometry of the valve was approximated
from published information
on a size 25 A
(24.34 mm base diameter, 20.7 mm top diameter) Carpentier-Edwards
bovine pericardial xenograft. Other than the size and approximate
geometry, no other design features were duplicated.
Open
Fig. 4(a). Stress map of a valve with a rigid stem in the closed and open configurations. A map of the major principal stresses is superimposed on one half of the
undeformed leaflet for the sake of clarity. The right edge of the leaflet is the line of symmetry. Red denotes the compressive stresses that are potentially damaging to
bioprosthetic tissues. Note the high concentration of compressive stress at the region of the commissures in the open configuration. The stent has zero stress sjnce it was
assumed to be perfectly rigid and, therefore, did not deform. The colour bar denotes stresses in kPa.
Closed
Rigid Stent
Rigid Stent
Fig. 4(b). An oblique view of the whole valve in the closed and open configuration.
Note the high reverse
flexing of the leaflets in the open configuration
and the sharp curvatures
near the stent posts.
Open
Fig. 5 (a). Stress map of a valve with a pliable stent in the closed and open configurations. This valve had a stem that deflected only by the action of the leaflets pushing the
posts outward. Note the high concentration of compressive stress near the central coaptation region, due to the inward movement of the stent posts during valve closure.
Also note that such a pliable stent did not significantly reduce the compressive commissural stresses in the open configuration. The deflection of the stem in diastole
created the high tensile and compressive stresses.
Closed
Pliable Stent
Pliable Stent
Fig. 5(b). An oblique view of the whole valve in the closed and open configuration.
Note the sharp
curvatures
near the stent posts that were not eliminated by this type of stent design.
93-l
Open
Fig. 6(a). Stress map of a valve with pivoting stent posts. In this simulation, the stent posts were prescribed to pivot outward about the base such that the separation of the
commissures increased by 10% during systole. Note the decrease in compressive stress at the commissures, compared to the previous two designs. Since the stent was
prescribed to move only during systole, it behaves like a rigid stent in diastole and is, therefore, not stressed.
Closed
Fig. 6(b). An oblique view of the whole valve in the closed and open configuration.
Note the wide leaflet
excursion, and the much more gentle free-edge curvatures of this stent design.
939
Real Valve
Fig. 7. Comparison images of our finite element simulation of a pericardial valve in the open configuration and a pericardial valve open in a pulse duplicator system. Note the similarity of
the flexure pattern at the free edge. The image on the right has been reprinted by kind permission of Sorin Biomedica.
Simulation
The relatively good durability of some bioprosthetic valves, and the premature failure of others, is
likely related to design parameters. The early failure
of pericardial valves employing an alignment stitch at
the commissures
is a typical example of a design
feature that proved to be catastrophic
(Walley and
Keon, 1987; Walley et al., 1987). We feel that another
detrimental feature of all stent mounted tissue valves
is the inability of the supporting
stent to expand
radially with the recipient aortic root. The natural
aortic root has clearly been shown to expand during
the ejection phase of the cardiac cycle (Brewer et al.,
1976; Thubrikar et al., 1980; Vesely et al., 1990b), yet
no existing valve mounting frame has addressed this
phenomenon.
Presently. most supporting stents have
pliable stent posts that aim to reduce shock loading
on the leaflets during valve closure. No stent design,
to our knowledge, has attempted to reduce the commissural flexing that damages valve leaflets (Vesely et
al., 1988). and contributes
to leaflet tearing in the
absence of calcification (Ishihara et al., 1981: Pomar et
al.. 1984; Stein et al., 1985). We have, therefore,
simulated the flexure patterns that occur during valve
opening with our three-dimensional
modelling capability, and have examined how varying the design of
the stent can affect leaflet stresses.
This model, like most numerical analyses of bioprosthetic valves. has three primary limitations: (i) it
does not mimic the interaction of fluid flow with tissue
deflection; (ii) it is an elastic model that does not take
into account the viscous nature of the valve tissue; and
(iii) it employs a solid mechanics approximation
of
a composite material that has poorly characterized
constituents.
The principal advantage of this model
over works published
to date, however, is that it
simulates flexure patterns in three-dimensions
during
complete valve opening. The ideal simulation
that
could duplicate the complexity of the leaflet motion
during valve opening would require a coupling of the
fluid flow during the ejection phase to the motion of
the valve leaflets in a mutually dependent way. Such
a coupled simulation. lo our knowledge, has never
been done on heart valves because of the difficulty of
the problem, and the large computational
power required to do so. An uncoupled simulation that would
deflect the leaflets by a prescribed flow field was not
941
942
S. KRUCINSKIet al.
deed, if one examines the patterns of tears on explanted pericardial heterografts and porcine xenografts (Gabbay et al., 1988; Ishihara et al., 1981; Stein et
al, 1985; Wheatley et al., 1987), there is a high correlation between the sites of tears and the location of
stress concentrations produced by our simulation.
These simulations have also demonstrated that
valves with stent posts that pivot about their attachment to the base can significantly reduce leaflet
tlexure and the associated leaflet stresses. While additional iterative studies need to be performed to determine the optimal amount of expansion that can reduce compressive stresses the most, a 10% radial
expansion at the commissures appears to be adequate.
Conversely, a simple, pliable stent support that relies
on the compressive forces generated within the valve
cusps to deflect the stent posts outward does not
provide a sufficient amount of stress reduction. While
it can be argued that a stent constructed from a more
pliable material would have deflected more and could
have performed better in systole, a more pliable stent
would have collapsed under diastolic loads. In our
simulation, the stent posts deflected inward by
0.37 mm, increasing the free-edge angle from 17.5 to
19. A greater stent post flexibility would have deformed the leaflets to such an extent that leaflet coaptation during diastole would be compromised. With
this engineering exercise, we have shown that one type
of stent design can significantly reduce commissural
stressing, while another equally plausible design cannot. It is, therefore, clear that detailed mathematical
simulations of preliminary valve designs can provide
valuable contributions to the development of new
bioprosthetic valves. Perhaps, the best stent would be
one that functions in harmony with the patients aortic root. Ideally, the tops of the stent posts should be
fastened to the recipient aortic root such that the
expansion of the aorta during ventricular contraction
will pull the tops of the stent posts outward with it.
Such motion will enable the reduction of leaflet stresses during valve opening and may reduce the incidence of leaflet tearing at the flexure points.
Because of the inherent simplicity of pericardial
tissue relative to aortic valves leaflets, we chose to
investigate the pericardial valve first. Such an approach, however, does not need to be limited to
pericardial valves. Our primary interest lies in the
porcine aortic valve xenograft, with its more physiological construction. The mechanism that we propose to
reduce flexural stresses at the commissures already
exists in natural aortic valves. The commissures of
aortic valves naturally move outward during systolic
valve opening as the root expands (Brewer et al., 1976;
Thubrikar et al., 1980; Vesely et al., 1990b). It is,
therefore, logical to assume that the mechanism of
stress reduction proposed for the pericardial valve can
be readily applied to porcine aortic valve xenografts
as well. It should be noted, however, that because of
the much greater complexity of the natural aortic
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