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> e-Journal of Cardiology Practice - Volume 20

Prosthetic heart valves: Part 1 –

Selection
Vol. 20, N° 1 - 26 May 2021

Dr. Roland R. Brandt , FESC

Prof. Philippe Pibarot , FESC

Valve replacement is increasingly performed and has dramatically improved

the outcome in patients with valvular heart disease. Bioprosthetic valves are
characterised by a favourable haemodynamic performance but are at risk for
structural valve degeneration, necessitating reintervention. In contrast, all
mechanical valves offer long-term durability but require lifelong
anticoagulation with the associated risk of bleeding and thromboembolism.
The choice of prosthetic valve type involves careful consideration of the risks
and benefits of each type of prosthesis and should also include patient
preference in a shared decision-making process. The age of the patient is a
very important factor. The negative impact of significant prosthesis-patient
mismatch is an argument for implanting a prosthetic valve with the largest
possible effective orifice area. The availability of transcatheter valve-in-valve
replacement for failed bioprosthetic valves is already changing the dynamics
of the Heart Team discussion regarding the trade-offs between mechanical and
bioprosthetic valves.

Topic(s): Interventional Cardiology and Cardiovascular Surgery;

Introduction

In patients with severe valvular heart disease, guideline-based surgical valve replacement
or transcatheter implantation of a prosthetic heart valve is associated with improved
survival and relief of symptoms. Prosthetic heart valves are designed to replicate the
function of native valves by maintaining unidirectional blood flow and can be separated
into two broad categories, mechanical and bioprosthetic (also called tissue) valves, each
with different advantages and disadvantages.

This mini-series is divided into 4 parts:

Part 1 – Prosthetic valves: selection

Part 2 – Prosthetic valves: antithrombotic therapy

Part 3 – Prosthetic valves: imaging

Part 4 – Prosthetic valves: complications and dysfunction, pregnancy

Part 1 – Prosthetic valves: selection

History
In 1954 Hufnagel and colleagues [1] reported their successful treatment of aortic
regurgitation by heterotopic implantation of a ball-valve prosthesis into the descending
thoracic aorta. This novel concept in the therapy of heart valve disease set the stage for
the development of a new disruptive technology that has caused a sea change. Since
then, major advances in technology, surgery, and anaesthesia have made valve
replacement a common procedure with relatively low mortality.

Mechanical heart valves

Mechanical heart valves (MHV) are made entirely from non-biological (artificial) materials
including metals (titanium, cobalt), pyrolytic carbon, and polymers in order to provide
mechanical stability and durability. Different types of MHV include caged ball valves such
as the Starr-Edwards valve, tilting disc valves, e.g., the Björk-Shiley and Medtronic valves,
and bileaflet valves such as the St. Jude Medical valve with various modifications on
these designs. Caged ball valves are no longer implanted; bileaflet valves are the most
common type used today. The primary components in this type are usually a fabric-
covered sewing ring, stent, hinge, and 2 occluders (also called discs or leaflets) in order to
be effective as a one-way valve.

The contemporary disc surfaces are characterised by improved blood biocompatibility

and are somewhat resistant to thrombus formation. However, the lack of endothelial
lining and blood stasis with the discs in closed position left mechanical valves at risk of
thromboembolic complications. The major advantage of mechanical valves is their
longevity; however, this benefit must be weighed against necessary lifelong
anticoagulation with the combined risk of haemorrhage secondary to anticoagulation and
thromboembolic complications in case of subtherapeutic anticoagulation.

The orientation of a bileaflet MHV influences intraventricular haemodynamics. An anti-

anatomic orientation (the MHV hinge line oriented towards the left ventricular [LV]
outflow tract and not parallel to the commissure line of the native valve) is associated
with a more favourable LV flow pattern [2]. This MHV positioning redirects the LV inflow
towards the LV outflow tract and may avoid unfavourable effects on LV energy kinetics
and decrease the risk of thrombus formation (Figure 1).

Figure 1. Three-dimensional transoesophageal echocardiographic image of a mechanical

bileaflet mitral valve, viewed en face from the left atrial side (surgical view) in diastole
with the leaflets in the open position. Please note the anti-anatomical position of one
lateral and one medial leaflet with the hinge line oriented towards the left ventricular
outflow tract and not parallel to the mediolateral commissure line of the native valve.

Bioprosthetic valves
Bioprosthetic valves (BPV) are, at least in part, made from animal (e.g., porcine, bovine or
equine) (heterograft or xenograft) or human (homograft or allograft) tissue mounted onto
a metal or polymer supporting structure with three pillars (also called struts or posts)
and have a trileaflet configuration that resembles the geometry of a native aortic valve.
While porcine aortic valves can be harvested whole with preservation of the natural
leaflet attachments (valvar hinges), bovine or equine pericardial tissue has to be trimmed
and fitted to a stent to mimic the functional architecture of valve leaflets.

Stentless valves have been introduced with the objective of improving haemodynamics,
are essentially metal free and produce few, if any, ultrasound artefacts such as acoustic
shadowing. Hence, their appearance on two-dimensional echocardiography and their flow
dynamics are close to native valves. In order to decrease the immunogenicity and avoid a
humoral or cellular immune system rejection when implanted in the human body, animal-
derived valvular or non-valvular tissue valves are fixed in glutaraldehyde, a process that
cross-links and masks the antigens and makes the tissue valve biocompatible [3].
Although BPV offer the advantage of avoiding lifetime anticoagulation, they are subject
to structural valve degeneration, resulting in limited durability and exposing the patient
to the risk of reintervention.

Transcatheter aortic valve implantation

The traditional treatment for severe symptomatic valve disease is surgical valve
replacement or repair, utilising an open chest approach or minimally invasive surgery and
cardiopulmonary bypass. With the advent of transcatheter aortic valve implantation
(TAVI), there has been a paradigm shift in the management of patients with aortic valve
stenosis in the last decade, with a rapid development of new devices and expansion to
high, intermediate and even low surgical risk populations. As these patients are generally
younger with a greater life expectancy, structural valve integrity becomes an important
issue. Because TAVI is still a young technology compared to conventional surgical aortic
valve replacement (SAVR), it will require several more years, possibly a decade, to
demonstrate the same favorable long-term durability.

Compared to SAVR, TAVI shows a higher incidence of paravalvular regurgitation but a

lower incidence of severe prosthesis-patient mismatch and lower transvalvular pressure
gradients. The number of TAVI procedures has outnumbered aortic valve replacement by
open heart surgery for treatment of symptomatic severe aortic stenosis in some
countries. This percutaneous technique is now available across the entire surgical risk
spectrum. In many patients, life expectancy may exceed transcatheter valve durability,
and these patients may require a reintervention. A second TAVI within the first TAVI (so
called TAV-in-TAV), which failed because of structural valve failure, is feasible and
associated with a similar favourable outcome compared to TAVI for surgical aortic valve
dysfunction [4].

Choice of prosthetic valves

The choice between a mechanical and a bioprosthetic valve is a complex decision based
on prosthetic valve characteristics, patient-related factors (e.g., comorbidities) and
patient preferences such as wishes and expectations. In general, all bioprosthetic valves
are at risk of structural valve degeneration leading to a higher rate of reoperation; all
mechanical valves require life-long anticoagulation to prevent thromboembolism, which is
associated with a higher risk of bleeding. While structural valve degeneration increases
with time and decreases with advanced age at the time of implantation, the risk of
bleeding grows with increasing age [5]. Life expectancy for patients at the time of valve
implantation is greater following aortic versus mitral valve replacement. Hence, patients
after aortic valve replacement are more likely to experience clinically relevant BPV
degeneration necessitating reintervention taking into account that not all BPV are alike in
terms of durability.

A key attraction of BPV is the non-existing requirement for chronic anticoagulation, but
the risks of bleeding and thromboembolism with mechanical prostheses are nowadays
acceptable, especially in compliant patients with appropriate internationalised normalised
ratio (INR) monitoring.

Therefore, the choice of valve depends heavily on the patients’ age, reflecting the time-
dependent trade-off between risk of bleeding and need for reoperation. The recent
institution of valve-specific U.S. guidelines, in accordance with the European guidelines
but with different age limits regarding the selection of MHV versus BPV, takes into
account the differences in outcome depending on the valve position [6]. Thus, the
balance between valve durability versus risk of bleeding and thromboembolic events
favours the choice of a mechanical valve in the aortic position in patients <50 years of
age [7] and <60 years of age [8] who require an aortic valve replacement, unless
anticoagulation is contraindicated, is not desired, or cannot be monitored (Figure 2). Both
guidelines recommend a BPV in patients >65 years of age for aortic valve replacement.
For middle-aged patients, both valve types are acceptable and, rather than setting
arbitrary age limits, the choice should be individualised through a shared decision-making
process with full discussion of the advantages and disadvantages. Anticoagulation with
vitamin K antagonists (VKA) requires regular visits for monitoring of INR, point-of-care
testing or self-testing (home monitoring) in connection with dietary restrictions, and may
be hazardous in case of physical or occupational activities which may lead to accidents.

Finally, the personal perception of many patients regarding valve-related events such as
bleeding or reoperation is emotionally charged. When a mitral valve repair is not possible,
the age cut-off for implantation of an MHV is set at 65 years [7,8]. In addition to the
patient and family, discussion by a Heart Team (consisting of a cardiologist, imaging
specialist, cardiac surgeon, anaesthesiologist and others) may be helpful in some cases to
take into account all available data and make a recommendation for the best choice and
management of prosthetic valve complications after careful, comprehensive evaluation.

Depending on the institutional surgical expertise, the so-called Ross procedure (native
pulmonary valve harvested and moved as an autograft to the aortic position combined
with a homograft placed in the pulmonary position) represents a relevant alternative in
younger patients in whom anticoagulation is either contraindicated or undesired (Class
IIb, level of evidence [LoE] B) [7]. The Ross procedure provides excellent valve
haemodynamics without the need for anticoagulation. However, both the pulmonic
homograft and the neoaortic autograft are at risk of structural degeneration and failure,
requiring reintervention at a later stage.

Figure 2. Societal recommendations for aortic and mitral prosthetic valve types according
to patient age [7,8].
Reoperation for prosthetic valve dysfunction is usually associated with increased risk of
morbidity and mortality when compared with the initial surgery due to advanced age and
a higher comorbidity burden, particularly in patients undergoing urgent or emergency
procedures. Although the in-hospital mortality rate has declined from more than 10%
before the 1980s, it remains approximately 5% in contemporary surgery practice [9].

Several other factors should be considered. A mechanical prosthesis may be preferred for
patients with another indication for permanent anticoagulation such as atrial fibrillation,
high risk of repeat open heart surgery (e.g., porcelain aorta or those with prior radiation
therapy) or a small aortic root size which precludes a future valve-in-valve procedure for
a structurally failed aortic bioprosthesis. On the other hand, it may be prudent to choose
a bioprosthetic valve even in patients who require anticoagulation for another indication
with a simultaneous high bleeding risk requiring frequent interruptions for an extended
period of time, which would place an MHV at serious risk of thromboembolism. Moreover,
certain subgroups of patients, such as continuing drug abusers, in whom life expectancy
is lower than the presumed durability of the bioprosthesis, may be candidates for a
bioprosthetic valve irrespective of age. A bioprosthesis should also be considered in
young women contemplating pregnancy, in whom a bioprosthetic valve is preferred, given
the risks of anticoagulation and thromboembolism during pregnancy (Class IIa, LoE C)
[10].

The mortality rate among dialysis patients remains high, especially after surgical valve
replacement. The current societal guidelines have ceased to have explicit criteria for
valve selection; this should be individualised to the patient [7,8]. Young patients without
diabetes or New York Heart Association (NYHA) Class III or IV symptoms might survive
long enough to justify placement of a mechanical valve, while a biological valve is suitable
for most patients as the default option despite accelerated calcification and degeneration
[11].

Following the TAVI trend, the ratio of surgically implanted BPV to MHV has been steadily
increasing over recent decades [12], owing to a favourable haemodynamic profile, low
thrombogenicity, and improvements in tissue processing intended to increase
performance and durability. From a lifelong management perspective, a lower age
threshold for implantation of BPV includes the consequence that not only will more
patients need a reoperation in the future but also that that need will occur at a higher
age with a negative impact on survival. The increasing use of BPV in younger patients
may also be attributable to the availability of transcatheter valve-in-valve (VIV)
implantation for failed aortic and mitral BPV as an acceptable alternative to redo surgery.
Since new percutaneous therapies employed for native valve disease also have the
potential to replace classic surgical reoperations in patients with deteriorated BPV, this
option already has a profound impact on the dynamic discussion regarding the trade-offs
between mechanical and bioprosthetic valves. However, transcatheter VIV implantation
could also result in several adverse events including suboptimal haemodynamics with
higher post-implantation gradients, coronary obstruction, and limited later access to
coronary arteries [13].

Table 1. Factors to be considered for the choice of prosthetic heart valve.

In favour of a bioprosthesis For AVR: age >65 years

For AVR: age <60/50 years

In favour of a mechanical valve
[7,8]

For MVR: age >70/65 years

In favour of a bioprosthesis
[7,8]

In favour of a mechanical valve For MVR: age <65 years

Anticoagulation contraindicated, not

desired, or cannot be monitored
In favour of a bioprosthesis

Other indication for anticoagulation (e.g.,

In favour of a mechanical valve atrial fibrillation)
 Desired pregnancy
In favour of a bioprosthesis
Limited life expectancy

Small aortic root size (preclusion of

future transcatheter valve-in-valve [VIV]
In favour of a mechanical valve implantation for failed aortic
bioprosthesis)

Patient preference (avoidance of risk or

In favour of a bioprosthesis inconvenience of anticoagulation)

Patient preference (avoidance of risk of

In favour of a mechanical valve reintervention)

In favour of a bioprosthesis In favour of a mechanical valve

For AVR: age >65 years For AVR: age <60/50 years

[7,8]

For MVR: age >70/65 years For MVR: age <65 years

[7,8]

Anticoagulation contraindicated, not Other indication for anticoagulation (e.g.,

desired, or cannot be monitored atrial fibrillation)

Desired pregnancy Small aortic root size (preclusion of

future transcatheter valve-in-valve [VIV]
Limited life expectancy
implantation for failed aortic
bioprosthesis)

Patient preference (avoidance of risk or Patient preference (avoidance of risk of

inconvenience of anticoagulation) reintervention)

Selection of valve prosthesis size

The term prosthesis-patient mismatch (PPM) was coined in 1978 by Rahimtoola [14] and
describes the situation where the effective orifice area (EOA) in a normally functioning
prosthetic valve is too small in relation to the patient’s body size to meet cardiac output
requirements with incomplete relief of symptoms. The concept of relating the EOA to the
body surface area in order to define PPM (severe <0.65 cm²/m², moderate 0.65–0.85
cm²/m² for aortic valves, and severe <0.9 cm²/m², moderate 0.9–1.2 cm²/m² for mitral
valves) has become widely accepted [15,16]. However, indexation to body surface area
may not be valid in obese patients; other indices based on the lean body mass or height
may be more meaningful in this patient population. To overcome this limitation, it is thus
recommended to use lower cut-off values of indexed EOA in patients with a body mass
index ≥30 kg/m² (severe <0.55 cm²/m², moderate 0.55–0.70 cm²/m² for aortic valves, and
severe <0.75 cm²/m², moderate 0.75–1.0 cm²/m² for mitral valves) [15]. PPM is a frequent
cause of a high transprosthetic gradient immediately after valve implantation and should
be suspected when the measured EOA is in accordance with the normal reference values
in a valve with normal leaflet structure and mobility. In contrast to structural valve
degeneration, abnormal valve haemodynamics are already present at the time of
prosthesis implantation and there is no deterioration in haemodynamics over time.

Of note, prosthetic valve dysfunction (stenosis and/or regurgitation) and PPM may
coexist. After aortic valve replacement, PPM is associated with worse haemodynamic
performance and diminished cardiac reverse remodelling, leading to impaired functional
capacity, accelerated structural valve degeneration (in bioprosthetic valves), and
increased perioperative and overall mortality proportional to its severity [17]. Likewise,
severe PPM after TAVI is associated with a higher mortality and heart failure
hospitalisation rate at 1 year [18].

PPM following VIV implantation for failed aortic bioprosthetic valves could also
negatively affect clinical and functional short- and long-term outcomes, specifically in
patients with small (internal diameter ≤20 mm) compared to large failed bioprostheses
and those with predominant valve stenosis as opposed to regurgitation [19,20]. A
potential solution to avoid PPM with the VIV procedure would be to fracture the
degenerated BPV preceding the new implantation, although not all BPV stents are
breakable. In this context, it would be advisable to surgically implant a valve as large as
possible and to avoid a small BPV with resultant PPM in order to preserve the option for a
future VIV implantation.

Finally, no randomised controlled trials comparing this technique with redo surgery are
available as yet. Nevertheless, this technology has recently been incorporated into the
U.S. guidelines for patients with a high or prohibitive risk for redo surgery (Class IIa, LoE
B) [7]. PPM after surgical mitral valve replacement has been less widely investigated.
Despite some conflicting results, it appears that severe PPM is also an independent
predictor of mortality after mitral valve replacement [21].

A prospective strategy to avoid or reduce the degree of PPM includes implantation of a

prosthesis with a size as large as possible or a newer-generation prosthesis with superior
haemodynamics. Occasionally, concomitant enlargement of the aortic annulus or root
may be necessary, permitting implantation of a larger-sized prosthesis. This, however,
adds complexity to the surgical procedure and possibly increases the operative risk. Most
patients tolerate a mild degree of PPM. For symptomatic patients with severe PPM
unresponsive to medical therapy and after exclusion of other causes of increased
transprosthetic gradients, the only effective intervention is redo surgery with
implantation of a larger prosthetic valve and/or annulus/root enlargement. This approach
requires careful consideration of the potential benefits versus the risk of reoperation.

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 Notes to editor

Authors:

Roland R. Brandt1, MD, FESC, FACC; Philippe Pibarot2, DMV, PhD, FAHA, FACC, FESC,
FASE, FCCS

1. Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany;

2. Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart
& Lung Institute, Laval University, Québec, QC, Canada

Address for correspondence:

Dr Roland R. Brandt, Department of Cardiology, Kerckhoff Heart Center, Benekestr. 2-8,

61231 Bad Nauheim, Germany
E-mail: r.brandt@kerckhoff-klinik.de

Author disclosures:

Prof. Philippe Pibarot has received funding from Edwards Lifesciences for
echocardiography core laboratory analyses with no personal compensation.

Dr. Roland Brandt has no conflicts of interest to declare.

The content of this article reflects the personal opinion of the author/s and is not
necessarily the official position of the European Society of Cardiology.