Fatigue of Metallic Stents: From Clinical Evidence to

Computational Analysis
Ferdinando Auricchio, Andrei Constantinescu, Michele Conti, Giulia Scalet

To cite this version:

Ferdinando Auricchio, Andrei Constantinescu, Michele Conti, Giulia Scalet. Fatigue of Metallic Stents:
From Clinical Evidence to Computational Analysis. Annals of Biomedical Engineering, Springer
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 Fatigue of Metallic Stents: From Clinical Evidence to Computational
Analysis
F. AURICCHIO,1 A. CONSTANTINESCU,2 M. CONTI,1 and G. SCALET1,2
1
Dipartimento di Ingegneria Civile e Architettura, Università di Pavia, Via Ferrata 3, 27100 Pavia, Italy; and 2Laboratoire de
Mécanique des Solides - CNRS UMR 7649, École Polytechnique, 91128 Palaiseau, France

Abstract—The great success of stents in treating cardiovas- nary interventions involve stents,31 adding up to more
cular disease is actually undermined by their long-term than 1 million stents per year.53
fatigue failure. The high variability of stent failure incidence The successful clinical use of stents has highlighted
suggests that it is due to several correlated aspects, such as
loading conditions, material properties, component design, issues associated with long-term endurance of
surgical procedure, and patient functional anatomy. Numer- implants.3 Fractured stents lose their ability to scaffold
ical and experimental non-clinical assessments are included in occluded arteries and may cause restenosis,75 throm-
the recommendations and requirements of several regulatory bosis,15 or artery perforation.52
bodies and they are thus exploited in the analysis of Stent failure can be caused by the mechanical
stent fatigue performance. Optimization-based simulation
methodologies have been developed as well, to improve the loading, either monotonic or cyclic loading during
fatigue endurance of novel designs. This paper presents a deployment or service, respectively. Cyclic loading is
review on the fatigue issue in metallic stents, starting from a due to the pulsatile blood pressure or to vessel move-
description of clinical evidence about stent fracture up to the ments imposing bending, torsion, or tension/compres-
analysis of computational approaches available from the sion on the stent. Other factors can contribute to stent
literature. The reported discussion on both the experimental
and numerical framework aims at providing a general insight failure, such as material properties, stent design,
into stent lifetime prediction as well as at understanding the physiological environment, surgical procedure, patient
factors which affect stent fatigue performance for the design functional anatomy and lifestyle.67
of novel components. In the following, we will refer to the failure due to
cyclic loading as fatigue. Although the word fatigue
Keywords—Metallic stent, Stent fatigue, Clinical evidence, is widely used in the engineering community, it is
Computational analysis, Fatigue criteria. rarely adopted in the medical community. As a clear
example, if you type the keyword ’stent fracture’ in
PubMed1, you get 1001 papers; on the contrary, if
INTRODUCTION you type ’stent fatigue’, you get only 198 papers,
most of them written from an engineering point of
Stents are medical devices used to restore the lumen
view.
patency of stenotic arteries, i.e., arteries narrowed by
Stents are small scale devices subjected to hundreds
atherosclerosis, a degenerative disease of the vessel
millions of in-service loading cycles and thus direct
wall. The stent is a tube-like lattice structure acting as a
experimental testing is difficult to perform. As an
mechanical scaffold for the vessel. Its implantation is
example, accelerated pulsatile testing at 65 Hz takes
performed by a minimally invasive procedure exploit-
about 72 days to complete 4 9 108 cycles.53 Therefore,
ing endovascular catheters.31 Currently, 85% of coro-
computer-based design modeling represents an assess-
ment tool for the prediction of stent performance and
lifetime.25,47 Such a tool allows for the improvement of
Address correspondence to G. Scalet, Dipartimento di Ingegneria
Civile e Architettura, Università di Pavia, Via Ferrata 3, 1
http://www.ncbi.nlm.nih.gov/pubmed.
27100 Pavia, Italy. Electronic mail: giulia.scalet@unipv.it

1
both clinical procedures and stent design and it is now CLINICAL EVIDENCE
also accepted by regulatory bodies.45,84
The present paper aims at providing an overview on Stent failure and fracture (SF) are an inherent risk
the fatigue issue in metallic stents manufactured from of stenting, having clinical consequences.1 The risk of
stainless steel, cobalt chromium, and Nitinol-based endovascular SF is increased by unfavorable biome-
shape memory alloys. The paper covers both the clin- chanical actions depending on the stent positioning in
ical evidence of stent fractures and the computational vascular sites: stents in coronary arteries are subjected
design approaches for lifetime assessment. We expect to mechanical stretching from repetitive heart con-
to bridge the gap between the engineering and medical tractions, while stents in femoral, popliteal, and car-
communities. The goal of the work is to resume and to otid arteries undergo repetitive conformational
critically discuss the existing framework available from deformations, i.e., traction and bending, imposed by
the literature and to open up new questions and future body movement.1
perspectives for the optimization of stent design, We now briefly discuss recent clinical evidences on
materials, and clinical procedures. SFs among the arterial regions often treated by stent-

FIGURE 1. Illustrative representation of the main arterial districts treated by stenting. The stent size, design, and mechanical
features depends on the specific artery to be treated. (left) Reprinted from Ref. 64, with permission from Elsevier; (top-right)
reprinted from Ref. 22, with permission from Elsevier; (middle-right) reprinted from Ref. 27, with permission from John Wiley and
Sons; (bottom-right) reprinted from Ref. 54, with permission from SAGE publications.

2
FIGURE 2. Multiple overlapping stents placed in the right coronary artery for 7 years. (a, b) All fractures occurred at the bend of
connecting links. (c) Representative fracture demonstrating multiple high-cycle fatigue crack initiation and propagation sites
surrounding the final overload zone, indicating the effect of bending forces. The irregular shape of the overload zone indicates the
presence of multiple forces, possibly due to the stent overlap and/or calcification (red circles: possible fatigue crack initiation
sites; small white arrows: high-cycle fatigue striations; black arrows: direction of fatigue crack propagation). Reprinted from Ref.
38, with permission from John Wiley and Sons.

ing (see Fig. 1), using the SF classification system re- correlated to stented lengths of 8, 8–16, and 16 cm,
cently proposed in Ref. 20. respectively. Restenosis of 50% was found in 32.8% of
the SF cases and a complete reocclusion was found in
34.4% of the SF cases. Although new generations of
Coronary Arteries
stents2 have increased the long-term durability of such
The cardiac contraction induces a consistent implants,29 failure is still a matter of clinical debate.61
movement of coronary arteries toward the left, infe-
rior, and anterior directions.76 SF incidence varies
Carotid, Renal, and Iliac Arteries
between different studies; as an example, it is reported
in 1–2% of patients at only 8- to 10-month follow-up Fractures of carotid stents are uncommon events,30
angiography; higher rate (up to 29%) after patient despite there are a free floating position of the artery
death (see Refs. 1,3,38 and references therein). It has subjected to torsion, flexion, and extension1 and an
been observed that long or multiple stents are sub- additional loading caused by swallowing and side-to-
jected to higher radial forces and consequently to side head turning.70 However, the rate of SF or
higher fracture risk (see Fig. 2), especially in the deformation was 15 and 50% at 2 and 4 years and has
presence of calcification or deployment in angulated been associated with the presence of heavy calcifica-
vessels (see Ref. 1 and references therein). tions.16 Similarly, only a limited number of renal artery
(see Ref. 71 and references therein) and iliac artery40
SFs has been reported.
Femoro-popliteal Arteries
Given their position, femoro-popliteal vessels are
subjected to additional external forces due to walking RECOMMENDATIONS AND REQUIREMENTS
and leg bending, compression, torsion, and elonga- BY REGULATORY BODIES
tion.18 Data reported in Ref. 75 clearly indicate a
relation between the vessel biomechanics and the Regulatory bodies provide precise recommenda-
fracture incidence of first generations of Nitinol fe- tions or requirements for the non-clinical validation of
moral stents: 24.5% stents showed fractures, classified stents and associated delivery systems.45,84
as minor (fracture of one strut) in 48.4% cases, mod- Particularly, such indications consider mechanical
erate (fracture of several struts) in 26.6% cases, and stress/strain and fatigue analyses as well as accelerated
severe (complete separation of stent segments) in 25% durability testing for the evaluation of the in-vivo stent
cases. Fracture rates were 13.2, 42.4, and 52.0% when performance. Testing results are obtained imposing 10

3
year equivalent pulsatile cycles on a mock artery with a TABLE 1. Stent designs analyzed or tested in fatigue litera-
ture.
deployed stent within a biological-equivalent environ-
ment (see, e.g., test systems44) and are completed by Material Stent design Ref.
failure analysis, together with the definition of fatigue
criteria and safety factors. Numerical and experimental 316L stainless steel PalmazShatz Refs. 26,33
Cypher Refs. 26,48
analyses will be discussed in more detail in next sec-
Medinol NIRTM Refs. 5,79
tions. JostentÓFlex Ref. 87
Cobalt chromium alloys Medinol NIRTM Ref. 82
Express Ref. 48
STENT MATERIALS AND DESIGNS Nitinol alloys Maris Plus Ref. 68
IsoStent Ref. 33
In view of the regulations discussed in ‘‘Recom- Cordis SMART Control Refs. 11,63,66
Protégé EverFlex Ref. 63
mendations and Requirements by Regulatory Bodies’’ Luminexx Ref. 63
section, rigorous numerical and experimental testing is LifeStent FlexStar Ref. 63
required for the development and verification of stents. Xceed Ref. 63
The aspects to consider when developing a stent are its Absolute Ref. 63
material and design, which are strictly connected and The table lists only the works explicitly reporting the investigated
strongly affect the performance of the final device. stent design
Stent fatigue performance is mainly related to com-
ponent dimensions and geometry, in-service loading, Stent Designs
physiological conditions, material microstructure, Stents are periodic assemblies of repeated unit cells
surface condition, heat treatment, and manufacturing and are manufactured either through welding of
process.3 We now briefly discuss the effect of materials microscopic wires or laser cutting from thin-walled
and design on fatigue performance. tubes. Both the manufacturing processes lead to a final
truss-type structure composed of struts connected by
Stent Materials hinges, with small cross-sections and radii (50–150 lm)
and large inclusions (~15 lm), affecting stent perfor-
Common material choices are metals as 316L mance due to high stress concentrations.3,88
stainless steels, L605 cobalt chromium, or Nitinol- Several stent designs, analyzed or tested in the fa-
based shape memory alloys, since they present essential tigue literature, are reported in Table 1. We remark
features as suitable mechanical properties for deploy- that some designs are no longer in use (e.g., Cypher or
ment and service, excellent corrosion resistance, and PalmazShatz), despite the recent date of the studies.
biocompatibility.3,19 When compared in terms of fati- The works permit however a critical comparison of the
gue resistance, L605 cobalt chromium alloys present a evolution of the design methods and are an illustration
higher fatigue strength than stainless steel. Descrip- of the growing market and of the need to continuously
tions of fatigue and fracture mechanisms in supere- update the analysis.
lastic Nitinol alloys remain incomplete even today, see,
e.g., Ref. 72 for a review. For all these alloys both the
cyclic hysteresis response and the fatigue behavior are COMPUTATIONAL APPROACHES FOR THE
sensitive to the microstructure and, particularly, to LIFETIME ASSESSMENT OF STENTS
grain size. Fine-grained materials have been shown to
be resistant to fatigue crack initiation, while coarse- Computational approaches are widely exploited in
grained materials are more resistant to fatigue crack the design process of stents and are also considered by
growth. For stents, fatigue crack initiation dominates regulatory bodies.45,84
lifetime and, therefore, a fine-grained material is highly Computational methods for the lifetime assessment
desirable (see Ref. 80 and references therein). Con- of stents are discussed based on a shakedown analysis
ventional thermomechanical processes can reduce the of the fatigue phenomena, as treated in, e.g., Ref. 21.
grain size up to approximately 10 lm for 316L stainless More precisely, the shakedown analysis classifies the
steel or cobalt chromium alloys and up to 100 nm for mechanical stress-strain response of a structure under
Nitinol alloys. As a consequence, the average number cyclic loading in three main categories: (i) elastic
of grains per cross-section is 10 for stainless steel and shakedown if the response is linear and no hysteretic
cobalt chromium alloys, compared to 1000 for Nitinol loop is observed, (ii) plastic shakedown if the response
alloys.72 exhibits a hysteretic loop, and (iii) ratcheting if the

4
FIGURE 3. Schematic representation of the fatigue phenomenon at the macroscopic and mesoscopic scales of a generic stent in
relation to the number of cycles to failure.

response is a non-closed path drifting to larger-and- assess the shakedown state. It can be per-
larger strains. These classes are precise a signature of formed using different computational tech-
energy dissipation and of the eventual underlying niques, such as structural finite element
damage mechanism, i.e., elastic shakedown is a re- analysis, and it is based on given geometry
versible cycle with no energy dissipation, whereas the (stent design, see ‘‘Stent Materials and De-
other two categories exhibit energy dissipation. signs’’ section), loading conditions (see
Failure and fatigue are associated to irreversible ‘‘Mechanical Analysis of Stents’’ section), and
material processes and are thus characterized by en- material constitutive law (see ‘‘Mechanical
ergy dissipation. Energy dissipation can be considered Analysis of Stents’’ section).
as a measure of the damage which is initially created at 2. a fatigue analysis to compute the number of
the microstructure scale and subsequently develops in cycles to failure through appropriate fatigue
crack and flaws inducing the complete failure of the criteria from the previously computed stabi-
stent. Such a remark shows that the shakedown anal- lized cycle (see ‘‘Fatigue Analysis of Stents’’
ysis should be applied both at the microscopic and the section).
macroscopic scale of the structure. The schematic view
The distinction between the mechanical and fatigue
of the described analysis and the different situations in
analyses assumes that the constitutive behavior is
terms of low- or high-cycle lifetime are displayed in
decoupled from the evolution of damage. Such an
Fig. 3. The reader is referred to section S1 of Supple-
approximation permits to speed up computations and
mentary Materials for details about the phenomenon
it has provided excellent prediction results in various
of fatigue.
engineering applications, e.g., Ref. 4. Recall, however,
As a consequence of the reported considerations,
that alternative approaches based on the continuum
the methodology adopted to assess stent lifetime can be
damage mechanics theory have been also been applied
denoted as a global computational approach and con-
to stents, e.g., Ref. 26.
sists of two steps:
The lifetime assessment considered in the following
1. a mechanical analysis to calculate the stabilized is essentially a prediction of crack initiation. Crack
state of the stent under cyclic loading and to propagation will be neglected in our discussion as the

5
number of cycles in this phase is generally far smaller presents four schematic examples of loading condi-
than the complete lifetime of the stent. Moreover, the tions. All the reported loading conditions are cyclic,
fatigue analysis will consider the failure of the stent i.e., assume a constant amplitude. The pulsatile pres-
when a single crack will initiate in a hinge or strut, sure is generally assumed to range between 60 and 160
since it will present a risk for the stenting procedure. mmHg. The values of compression and bending load-
ing are usually defined according to clinical evidences,
e.g., studies on cadavers.41,67 Such clinical data gen-
MECHANICAL ANALYSIS OF STENTS erally refer only to specific case-studies and we do not
dispose of detailed patient-specific databases to assess
The mechanical analysis should simulate as accu- these values. The imposed cyclic character of the
rately as possible stent material properties, design, and loading can be extended to variable amplitude loading
the entire processing history, i.e., manufacturing, as it is has already been done on engineering struc-
crimping on the delivery system, expansion/deploy- tures,46 but no discussion in this sense has been found
ment, recoil, and physiological loading. We first focus for stents.
on the physiological loading conditions and then on Other important loading configurations impacting
the material constitutive modeling. stent lifetime stem from the presence of atherosclerotic
plaques, calcifications, or stent overlapping configu-
Physiological Loading Conditions rations. Although the risk of fracture is high in case of
overlapping stents,75 due to fretting fatigue, there is
The in-vivo loading conditions of stents and the only one work investigating this issue, i.e., Ref. 57 (see
corresponding number of cycles per year are summa- Table 3).
rized from41,50 in Table 2. Table 3 reports the loading
conditions adopted in stent simulations and Fig. 4

Material Constitutive Modeling

TABLE 2. Standard in-vivo loading conditions for stents,
which depend on stent positioning in the human body (see Material constitutive laws can be presented in the
‘‘Clinical Evidence’’ section).
general form:
Loading Frequency (Hz) Cycles per year Ref.
r ¼ rðe; aÞ and a_ ¼ a_ ðe; aÞ ð1Þ
Diastole–systole 1.2 4 9 107 Ref. 41
Musculoskeletal 1 ~0.2 9 107 Ref. 50
where e is the total strain, r the stress tensor, a the
Breathing 0.3 ~1 9 107 Ref. 41 internal variable designating inelastic deformation,
phase change, etc. and a_ the time derivative of a.
Recall that the 10-year equivalent cycles required by regulatory The main constitutive laws used in stent computa-
bodies (see ‘‘Recommendations and Requirements by Regulatory
Bodies’’ section) translate in 4 9 108, 2 9 107, and 1 9 108 cycles
tions stem from the class of standard continuum
for diastole–systole, musculoskeletal, and breathing loading, mechanics. Constitutive models can be classified as
respectively. follows:

FIGURE 4. Schematic examples of cyclic loading conditions adopted in the mechanical analysis of stents. (a) Diastole–systole;
(b) compression; (c) bending; and (d) torsion.

6
 TABLE 3. Adopted loading conditions in stent fatigue literature.

Straight Curved Overlapping Plaque

Material Cyclic loading Fully-expanded vessel vessel stents Plaque calcification Ref.

316L Diastole–systole Ref. 56

stainless Diastole–systole x Refs. 5,13,26,79
steel Diastole–systole x x Refs. 10,12
Bending x Ref. 5
Cobalt Diastole–systole Ref. 53
chromium Diastole–systole x Refs. 55,82
alloys Diastole–systole x x Ref. 58
Diastole–systole x x Ref. 58
Diastole–systole/bending Refs. 41,42
Nitinol Diastole–systole Ref. 43
alloys Diastole–systole x Ref. 39
Diastole–systole x Ref. 39
Diastole–systole x x Refs. 57,67
Bending x Ref. 39
Bending x x Ref. 39
Bending x Ref. 39
Torsion x Ref. 39
Torsion x Ref. 39
Compression x Ref. 57
Compression x Ref. 57
Compression x x Refs. 24,67
Compression x x Ref. 57

(a) (b)

FIGURE 5. (a) Cypher stent geometry used in the three-dimensional homogeneous model (the blue domain highlights one of the
unit cells). (b) Example of a unit cell geometry used in the two-dimensional micromechanical model, containing approximately 1500
grains (personal communication of Dr. Raphael Guerchais).

 Macroscopic phenomenological models, describ- models allow to take into account grain size
ing the macroscopic mechanical behavior and effect on material hardening and fatigue
capturing microstructural effects only through behavior.
phenomenological internal variables, as plastic
or transformation strain.
A summary of the models used in the stent literature
 Crystal plasticity models, describing the
is presented in Table 4. Recall that the choice of a
mechanical behavior at the length scale of the
constitutive model represents an important step of the
grains. These models have an important com-
mechanical analysis, especially when dealing with
putational expense as the mesh should include
components where size effects are significant. More-
the precise grain distribution (see Figs. 5a and
over, the adopted material model should simulate both
5b).
monotonic and cyclic material behavior to account for
 Strain-gradient plasticity models, accounting for
the crimping, deployment, and cyclic loading.
size-scale-dependent material behavior. Such

7
 TABLE 4. Adopted constitutive models in stent fatigue literature.

Material Constitutive model Ref.

316L stainless steel Rate-independent J2 perfect plasticity Ref. 26

Rate-independent J2 plasticity with isotropic hardening Refs. 10,12,13
Rate-independent J2 plasticity with nonlinear kinematic/isotropic hardening Refs. 5,79
Rate-dependent crystal plasticity with Taylor isotropic hardening Ref. 56
Rate-dependent crystal plasticity with nonlinear isotropic and Armstrong– Ref. 79
Frederick kinematic hardening
Cobalt chromium alloys Rate-independent J2 plasticity with isotropic hardening Refs. 53,58
Rate-independent J2 plasticity with nonlinear kinematic/isotropic hardening Ref. 82
Rate-dependent crystal plasticity with nonlinear isotropic and Armstrong– Refs. 81,82
Frederick kinematic hardening
Rate-dependent strain-gradient crystal plasticity Refs. 80,81
Nitinol alloys Auricchio–Taylor–Lubliner 9,69 Refs. 24,39,43,57,66,67
Souza–Auricchio 8,78 Ref. 6
Lagoudas et al. 51 Ref. 34
Zaki-Moumni91 Ref. 59
Single-crystal model28 Ref. 86

TABLE 5. Parameters for the dissipated energy criterion in stent fatigue literature.

Material Approach b c (MPa) Ref.

316L stainless steel Hot spot 20.4687 431.4 Ref. 7

Volumetric (radius 0.01 mm) 20.6187 907.8 Ref. 7
Nitinol alloys Hot spot 20.3770 11.0 Ref. 59

FATIGUE ANALYSIS OF STENTS is the Goodman criterion, as also recommended in Ref.

84. It is defined in terms of stresses as:
The fatigue analysis is based on criteria which per-
ra rm
mit to compute stent lifetime. Such criteria are based þ 1 ð2Þ
on a damage parameter which characterizes the stabi- r 1 ru
lized cycle obtained from the mechanical analysis and where ra , rm , ru , and r 1 are the stress amplitude,
which can be correlated with lifetime. The criteria are mean stress, ultimate tensile stress, and fully reversed
then calibrated using appropriate experiments (see fatigue limit, respectively. Several works have pro-
‘‘Fatigue Testing of Stents’’ section). posed Goodman analyses for 316L stainless steel,10,12
In the literature various uniaxial and multiaxial fa- L605 cobalt chromium,41,42,53 and Nitinol24,43,57 stents.
tigue criteria have been applied to stents, as discussed The three-dimensional application of this criterion is
in the following. Recall that all the discussed criteria generally based on the use of the first principal strains/
predict crack initiation. Complementary approaches stresses as index of risk.24 However, since the stent is
considering crack propagation are based on flaw-tol- subjected to a multiaxial state of solicitations, the cri-
erant criteria which have been successfully applied to terion should consider equivalent mean and alternate
larger structures, e.g., orthopedic implants. Their stresses/strains.74 Moreover, the Goodman relation-
application to stents55,73 can be exploited for quality ship is generally conservative for ductile metals and it
control procedures during manufacturing to establish is not directly applicable to Nitinol alloys.83
inspection pass/failure criteria for use during visual
inspection of parts for surface defects. However, crack
size inspection for implanted devices is not possible Multiaxial Fatigue Criteria
and the cost of implant failure is high. This class covers criteria based on invariant quan-
tities extracted from the complete tensorial variables as
stress, strains, or plastic strain.
Uniaxial Fatigue Criteria A criterion commonly applied to the low-cycle fa-
tigue regime is the dissipated energy criterion, defined
This class includes criteria based only on stress or as:4
strain components associated with privileged directions
of specific experiments. A criterion commonly adopted Wp ¼ cNbf ð3Þ

8
 TABLE 6. Parameters for the Dang Van criterion in stent fatigue literature.

Material N Width (lm) aN bN(MPa) Ref.

316L stainless steel 2 9 106 – 1.50 420.0 Ref. 13

4 9 108 50 0.4821 111.93 Ref. 5
4 9 108 75 0.4821 137.50 Ref. 5
4 9 108 100 0.4821 146.84 Ref. 5
4 9 108 150 0.4821 165.0 Ref. 5
Nitinol alloys 1 9 107 – 0.808 137.77 Ref. 6

TABLE 7. Parameters for the microstructure-sensitive approach in stent fatigue literature.

Material Approach Constitutive model pcrit(–) wcrit (MJ/m3) Ref.

316L stainless steel Local (discrete) Crystal plasticity 43.3 12636 Ref. 79
Cobalt chromium alloys Local (discrete) Crystal plasticity 439.9 156300 Ref. 82
Non-local (averaged) Crystal plasticity 200.8 73200 Ref. 81
Local (discrete) Strain-gradient crystal plasticity 164.3 91900 Ref. 80
Non-local (averaged) Strain-gradient crystal plasticity 123.8 63900 Ref. 81

where R the dissipated energy per cycle of deployment, and during one fatigue cycle, respec-
Wp ¼ cycle r : e_ p dt is computed over the complete tively; wcrit , wrecoil , and wcyc are the corresponding
stabilized cycle, ep being the plastic strain, and b and c values for strain energy dissipation (see Table 7).
are material parameters (see Table 5). The criterion has
been successfully applied in Ref. 7 to match experi-
Difficulties and Perspectives
mental results on notched specimens used in stent
manufacturing.23,89 A first difficulty is that the inhomogeneous nature of
the microstructure, which determines a significant
Another criterion successfully applied to the high- scatter in fatigue,80 is neglected by most of the cited
cycle fatigue regime is the Dang Van criterion,85 which criteria, in spite of the small scale of the strut and the
is based on a multiscale approach and shakedown low number of grains. The Goodman criterion does
concepts. The criterion states that lifetime is infinite if not consider size effects nor high gradients. The Dang
the mesoscopic shear stress, sl ðtÞ, and the hydrostatic Van criterion successfully meets the need of
stress, rh ðtÞ, satisfy the following inequality (subscript microstructural representation in crack initiation pre-
l stands for mesoscopic variables): dictions, but cannot capture inhomogeneity effects
  observed in random crystalline microstructure model-
maxt sl ðtÞ þ aN rh ðtÞ  bN ð4Þ ing. On the contrary, the techniques based on a
aN and bN being material parameters, where subscript microstructural analysis of the inhomogeneities, cou-
N stands for finite lifetime (see Table 6). The multiscale pled with crystal plasticity and stress-gradient models,
characteristic of the criterion allows to take into have successfully captured the fatigue scatter.79–81
account the different phases of shape memory alloys,6 Another difficulty is the presence of small curvature
based on the shakedown theorems in Ref. 65. radii in stent struts, which are responsible for high
stress concentrations in the presence of a heteroge-
Recently, approaches based on microstructure-sen- neous microstructure. This has motivated the adoption
sitive fatigue indicator parameters and used in con- of volumetric approaches (see Tables 5 and 7), the
junction with crystal plasticity theory have been theory of critical distance,10 as well as stress-gradient
introduced to take into account microstructural inho- crystal plasticity models.80,81
mogeneities, as follows: To overcome such difficulties, the presence of
heterogeneous microstructures has been discussed in
Ni ¼ pcritpcycprecoil
(
Ref. 14 for the Dang Van criterion and extensions
ð5Þ
Ni ¼ wcritwcyc
wrecoil
including a probabilistic setting have been proposed in
Ref. 37. The dissipated energy criterion has been
where Ni is the number of cycles to crack initiation; combined with a defect growth law and a probabilistic
pcrit , precoil , and pcyc are the accumulated plastic slip analysis of the microstructure defects to account for
values at crack initiation (calibrated), at the beginning material variability in Ref. 17. These approaches ad-

9
FIGURE 6. Geometries of the microscopic components usually tested in the literature and corresponding loading conditions; see,
e.g., Refs. 66,74,82,88.

dress the scatter issue related with microstructural

inhomogeneities and could be future perspectives for
stent lifetime prediction.

FATIGUE TESTING OF STENTS

Fatigue testing, combined with computational

analysis, allows to provide an indication of stent
durability. It can be used for the validation of the fa-
tigue analysis and for the identification of the condi-
tions that are not modeled using computational
methods.45,84
Accelerated durability testing is usually conducted
on stents deployed inside synthetic arteries in specially
designed rigs simulating pulsatile loading, body tem- FIGURE 7. Fatigue-life assessment of a 316L stainless steel
perature, and salinity; see, e.g., Refs. 33,48,49,60,63,87. Medinol NIRTMstent. Application of the Dang Van criterion to
the stent strut (at the top). Isovalues of the Dang Van param-
The physiological environment can be phosphate-buf- eter (negative values indicate no failure; positive values
fered saline, Ringer’s, or Hank’s solution at 37 °C. indicate failure). Zoom of the region (at the bottom) where the
Loading frequencies range from 20 to 100 Hz (the critical points are located. Reprinted from Ref. 5, with per-
mission from Elsevier.
normal heart rate is approximately 1.2 Hz). Other
types of cyclic loading (e.g., bending, compression) or
different configurations of stents (e.g., overlapping) or Instead of accelerated durability testing, stress- or
synthetic arteries (e.g., bent to a curvature radius) can strain-based testing can be also performed on stents or
be considered; see, e.g., Refs. 48,49. representative specimens manufactured as stents, to
Since recent studies on explanted stents obtained provide fatigue performance information, constant life
from human autopsy retrievals have also revealed diagrams, and data for fatigue criteria calibration.47
in-vivo corrosion of stents, with significant release of Figure 6 shows several geometries of the representative
metallic ions into surrounding tissues (see Refs. 48,49 specimens usually tested in the literature.66,74,82,88 The
and references therein), tests including mechanisms as choice between stress- or strain-based testing requires
pitting, fretting, crevice, and galvanic corrosion are an understanding of the in-vivo cyclic conditions and
recommended. Corrosion studies on stents have been material type.19 Most Nitinol testing are strain-
presented in experimental campaigns as in Refs. 48,49, based,39,66,67,74 while most 316L stainless steel and
while no computational corrosion models are available cobalt chromium testing are stress-based.23,55,82,88
from the literature. For instance, it was shown in Some limitations of these approaches have also to be
Refs. 48,49 that biomechanical factors such as arterial considered: (i) due to size effects, specimens need to
curvature combined with stent overlapping or different have dimensions comparable to those of stent com-
overlapping materials increase the incidence of wear ponents;81 (ii) not all the manufacturing process can be
and fatigue fracture, due to micromotions between the reproduced; (iii) complex in-vivo loading conditions
overlapping portions. (e.g., bending) are difficult to simulate.

10
FIGURE 8. Fatigue-life assessment of a cobalt chromium
Medinol NIRTMstent. (a) Predicted site of fatigue failure for the
J2 continuum sub-model and (b) predicted sites of fatigue
crack initiation for the crystal plasticity sub-model. Reprinted
from Ref. 82, with permission from Elsevier.

NUMERICAL EVIDENCE

This section discusses the results of the computa-

tional fatigue approaches available from the literature,
by highlighting the main factors affecting stent lifetime.
Numerical results from the literature show that high
stresses/strains usually develop near the most curved
region of a stent strut due to stress concentration ef-
fects and small sizes,5,12,42,43,53,58,79,82 in accordance
with experimental evidences.48,53 Such zones are the
most vulnerable to the risk of long-term fatigue failure
and they present the highest fatigue indicator factors
(see Figs. 7 and 8).

The first factor affecting stent lifetime is the applied

cyclic loading condition. Fatigue experiments, e.g.,
Ref. 66, have shown in fact that stresses and strains
imposed by pulsatile loading are not the major
responsible for SF. In accordance to these experi-
mental observations, computational results have
FIGURE 9. Fatigue-life assessment of a Nitinol peripheral
quantified bending loading5 and cardiac wall move- stent. Contour plots of mean and alternating first principal
ments58 as more dangerous than pulsatile loading; the strain for each plaque shape in case of cyclic axial compres-
diastole–systole loading have been shown to impose sion: (a) plaque with high sharpness; (b) plaque with low
sharpness, and (c) plaque with a double peak. Values of mean
only very small changes of the strut diameter, which and alternating strain are reported in the red and green boxes,
correspond to very small amplitudes for the cyclic respectively. Reprinted from Ref. 24, with permission from
stresses.5 Axial compression has been revealed more Elsevier.
critical than bending for superficial femoral and po-
pliteal artery stents.24 distribution is influenced by the thickness and stiffness
The second factor affecting stent lifetime is the of the artery-plaque system: the maximum alternating
plaque morphology,24 since the vessel thickness influ- strains are located where the plaque exhibits a smaller
ences the local stiffness. Small thicknesses can easily thickness.24 Results in Ref. 58 also confirm the
shorten or bend, implying an increasing alternating increased risk of coronary SF associated to localized
strain and a decreasing mean strain. Figure 9 shows plaque calcifications, particularly for the points in the
that the mean strain distribution caused by cyclic axial curved region of the struts near the calcification. Re-
compression is similar for the considered plaques, due call, however, that current regulations84 do not require
to the equal stenosis rate, while the alternating strain vessel and plaque inclusion in the analysis.

11
 The third factor affecting lifetime is the stent design of the stenting procedures and it could provide an
and configuration (e.g, overlapping). The strut length excellent tool for the optimization of novel stent de-
and width have revealed the most substantial impact signs or materials (e.g., magnesium-based biore-
on fatigue resistance, followed by wall thickness and sorbable stents32,36) and for the improvement of their
radius.12,53 The Goodman analysis performed in Ref. fatigue performance. Three-dimensional numerical
12 shows that an increase in length or decrease in width procedures should however take into account for stent-
and thickness results in an increase of stent lifetime, artery interaction, material behavior, mechanical
while an increase in radius results in a moderate in- loading, and aggressive environment. Moreover, to
crease of fatigue-life. Stent oversizing has revealed an validate computational approaches, an accurate com-
important impact on stent lifetime from both numeri- parison with the results of purposely-designed experi-
cal11 and experimental66 results. Large oversizing and mental tests should be conducted. As a future
compliance was in fact needed to reach strains causing perspective, the fatigue performances of stent materials
fracture during experimental testing.66 could be compared on a common stent platform for a
Few numerical results have been validated on wide range of performance metrics. The comparison
experimental fatigue data. Li et al.53 performed an could be made through simulated bench testing, based
accelerated fatigue testing on a cobalt chromium stent. on finite element modelling, as already proposed for
The stent did not fracture, as correctly predicted by the monotonic testing and assessment in Ref. 35.
conducted Goodman analysis. Slip band induced by It is worth underlining three main considerations: (i)
cyclic loading were found at the curvature location of given the steady increase of life expectancy90 and the
rings, as predicted by numerical simulations showing persistent prevalence of cardiovascular disease in
high alternating stress distributed at curvature areas. Western Countries,62,77 it is reasonable to expect that
Petrini et al.68 performed experimental fatigue tests on the long-term efficacy of endovascular implants and
a NiTi stent in the free-expanded configuration under their fatigue resistance will be still an important
several combination of mean and alternating axial research and industrial issue; (ii) several numerical
displacement until 105 cycles. Numerical simulations works have focused on the fatigue-life assessment of
predicted correctly the experimental failure and also stent designs which are no longer in use; (iii) clinical
the rupture location in three over four cases. trials on stents are often targeting short- and medium-
The reported successful matching between numeri- term outcomes (from 6 months up to 1 year after
cal predictions and clinical/experimental observations stenting), neglecting possible fatigue failures. All these
encourages the employment of computational analysis considerations highlight the need and importance of
as a powerful tool for providing theoretical evidence, having an updated literature and experimental data
supporting the design process, and optimizing the stent regarding stent fatigue from the different point of
configuration. views, i.e., researchers, manufacturers, clinicians, to
Finally, we recall that the discussed results do not improve current stent designs and realize novel solu-
consider the influence of patient-specific aspects on tions.
stent fatigue resistance. The inclusion of patient-
specific image-based geometries allows a better char- ELECTRONIC SUPPLEMENTARY MATERIAL
acterization of the geometrical features of coronary
arteries in terms of vessel curvature, dimensions, and The online version of this article (doi:
plaque composition.58 Moreover, patient-specific 10.1007/s10439-015-1447-8) contains supplementary
modeling can be used as a validation tool through a material, which is available to authorized users.
direct comparison with stents extracted from patients.
However, these data are difficult to procure and this
approach may be less applicable to the initial stages of
stent fatigue design, prior to approval for in-vivo ACKNOWLEDGMENTS
operation.81
This work is partially funded by: the Cariplo
Foundation through the Project No. 2009.2822; ERC
CONCLUSIONS Starting Grant through the Project ISOBIO: Isogeo-
metric Methods for Biomechanics (No. 259229);
This paper has presented a review on the fatigue Ministero dell’Istruzione, dell’Università e della Ri-
problem in metallic stents. cerca through the Project No. 2010BFXRHS; the
The employment of numerical simulations in the French National Research Agency (Project Fast3D-
prediction of stent lifetime allows advanced modeling ANR-11-BS09-012-01).

12
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