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Aortic Prosthesis
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designed for supra-annular placement in the aortic position. The valve is fabricated using a
polyester-covered titanium stent. The stent, excluding the sewing cuff, is then covered with
porcine pericardial tissue. This covering is designed to provide protection from mechanical
wear by allowing only tissue-to-tissue contact during valve function. A silicone insert in the
polyester sewing cuff is slightly contoured to conform to the shape of the native annulus. The
valve leaflets are fabricated from bovine pericardium. The porcine and bovine pericardium
are preserved and crosslinked in glutaraldehyde. Glutaraldehyde, formaldehyde and ethanol
are used in the valve sterilization process. Additionally, the Trifecta valve is processed with
LinxTM anti-calcification technology, a patented proprietary anti-calcification treatment that
in animal studies has demonstrated resistance to calcification [7-10].
These are the external stent mounted valve (Crown and Trifecta). The following models
mounted the leaflets inside the stent:
The Carpentier-Edwards Perimount Magna Ease is a recent stented aortic bioprosthesis
developed by Edwards Lifesciences, with a device design based on its two predecessor
models (the Perimount and the Perimount Magna aortic valves). The advanced CarpentierEdwards Perimount Magna ease aortic bioprosthesis adds enhanced implantability to the
unsurpassed hemodynamics of the Magna valve platform, setting the new standard for tissue
valve performance. In particular, the low valve profile enables easier insertion and aortotomy
closure minimizing the risk for coronary obstruction[11-18]. In addition, the presence of
suture markers aids in valve orientation and suture placement. The implantation of the
Carpentier- Edwards Perimount Magna Ease aortic valve seems to result in improved
hemodynamic performance, as suggested by industry-leading effective orifice areas (EOA)
and low gradients documented in multiple studies, with hemodynamic stability reported up to
20 years post- implantation. According to the manufacturer, this model is designed for
endurance as it is built on the proven performance of Perimount aortic valves, with over 27
years of clinical experience [19, 20]. The Carpentier-Edwards ThermaFix process is the only
anti-calcification technology designed to compare both major calcium binding sites.
However, no clinical data are available to evaluate the long-term impact of the Edwards
Lifesciences tissue treatment in patients.
Medtronic offers three stented aortic bioprostheses, including the Hancock II, the Mosaic
and the Mosaic Ultra tissue valve that will be described here. The Mosaic Ultra valve is
delivered with a Cinch® implant System that facilitates aortic valve insertion, particularly
through a tight sinotubular space (and helps prevent suture “looping” around the stent posts
for mitral valve replacement) [21-27]. It is mounted on a flexible stent that reduces tissue
stress, making this bioprosthesis especially suited for minimally invasive procedures.
Thirteen-year results demonstrate clinical safety and excellent performance. Third-generation
tissue technology - aoa® (alpha amino oleic acid) tissue treatment and Physiologic
FixationTM - has improved the durability of this valve and helps mitigate valve calcification
while preserving leaflet structure, with leaflets that function similarly to native aortic valves.
However, again no clinical data are available to evaluate the long-term impact of the aoa®
tissue treatment and Physiologic Fixation process in patients. Because tissue valves open
physiologically as native valves, they provide excellent forward flow.
Different from the other bioprosthetic valves, the Mosaic Ultra is made from a single
porcine aortic valve, using physiological pressure fixation that maintains the natural leaflet
form and function. By contrast, aortic valve reconstruction with bovine pericardium is usually
performed when using the other three valve models [28-33]. The Mosaic Ultra has a reduced
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sewing cuff that allows greater flexibility to implant a larger valve size for improved
hemodynamics. Its scalloped sewing ring conforms to the aortic annulus for complete supraannular placement.
HEMODYNAMIC PERFORMANCE AND DURABILITY
It is essential to underline that the two aspects of hemodynamic performance and
durability, or structural valve degeneration, are concepts that must be followed
simultaneously also because this says the definition of SVD. In fact, according to the new
unified definition of SVD, it is not only necessary to consider the cases of SVD that lead to
re-intervention but also the cases in which the prosthesis over time has moderate or severe
valve insufficiency or if it develops gradients above 20 or 40 mmHg. Therefore, a worsening
of hemodynamic performance corresponds “by definition” to a poor durability of the valve.
We suggest reading the recent review (2020) on this reflection: New Year’s Eve, Søndergaard
L. How to Define Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves: Facts
and Misconceptions. JACC Cardiovasc Interv.
A number of studies evaluated the hemodynamic performance of stented aortic valves,
although hemodynamic data mostly refer to old models with longer follow-up, as only scanty
information is available in the literature on the latest generation of these valves.
It is difficult to compare data on the hemodynamic performance of stented pericardial and
porcine aortic valves. It has been demonstrated that aortic valve replacement with a
pericardial bioprosthesis provides superior hemodynamic performance, resulting in
significantly lower transvalvular gradients. However, is there an influence of that on the
durability? Andreas et al., compared a porcine prosthesis with a traditional pericardial heart
valve with leaflets sutured inside of the stent and found that patients with a porcine
bioprosthesis had a higher postoperative transvalvular gradient. Durability comparisons are
made between the three types of pericardial aortic valves, given the different structural profile
of the Mosaic Ultra porcine bioprosthesis. Again, data are mostly derived from studies
conducted with the predecessor models, which include longer follow-up periods. In particular,
durability after aortic valve replacement with the Mitroflow and Perimount pericardial
bioprostheses has been evaluated, but no long-term follow-up data are available for both the
Crown PRT and Magna/Magna Ease valves. Conversely, mid-term data are available for the
Trifecta valve [34-40].
In summary, we therefore consider it essential to read and comment on 3 recent studies to
be able to give a “to date” answer to the hemodynamic/durability ratio:
First, Wang M. et al., (Ann Thorac Surg. 2017) did a meta-regression of published
studies at that time. The aim of this study was to extract published SVD information on the
four most widely used aortic bioprosthetic heart valve types (Medtronic and Edwards porcine
and Sorin and Edwards pericardial), to compare their durability [41]. They conclude that
Sorin pericardial valves have a significantly shorter main time to valve failure than the other
three valve types. There were no significant differences in main time to valve failure among
the Edwards pericardial valves and the Hancock and Edwards porcine valves.
This analysis, together with other more recently published data, indicate that the
importance of the classification of biological prostheses in two large families based on the
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tissue of origin (porcine valve or bovine pericardium) has less importance than it seemed in
terms of degeneration risk [42-44].
Second, an intersting paper from Biancari F. et al., (Ann Thorac Surg. 2020) [45]. This is
a comparative analysis of the outcome of the Trifecta and Perimount Magna Ease
bioprostheses from the FinnValve registry, a Finnish nationwide database including patients
with aortic stenosis who underwent aortic valve replacement with a bioprosthesis. They
conclude that the Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat
aortic valve replacement for structural valve failure compared to the Perimount Magna Ease
bioprosthesis. These results are of clinical significance because the early degeneration of the
Trifecta bioprosthesis was observed in an advanced age cohort and such a risk could be
higher in younger patients. These findings highlight the importance of a vigilant assessment
of the long-term outcome of surgical aortic valve replacement bioprostheses.
The pathological basis underlying Biancari’s clinical results can be found in the third
important and recent paper (Vriesendorp M. D. et al., Interact Cardiovasc Thorac Surg. 2020)
[46-48]. In this elegant paper an in vitro methodology for the assessment of long-term
mechanical durability of prosthetic tissue valves was conducted using accelerated wear
testing. Valves were cycled between 10 and 20 Hz for 600 million cycles, which corresponds
to 15 years of simulated use.
These authors conclude that externally mounted leaflet valves showed superior
hydrodynamic performance but inferior mechanical durability versus internally mounted
leaflet valves after 600 million cycles of testing. The primary failures were because of
significant mechanical abrasion at the commissural region, which may warrant close
monitoring of externally mounted leaflet valves over the course of long-term follow-up.
In summary, up to now 2020, we can speculate that the most important factor to influence
SVD is the “design.” Hemodynamics, gradients, patient-prosthesis mismatch, porcine or
bovine valves appear to have a low impact on the destiny of the valve [49-52].
In this direction we can say that a new prosthetic model with stent characteristics
mounted inside, in bovine pericardium with good immediate hemodynamic data, gave very
encouraging results in its trial for marketing (PERIGON trial) with data at one year.
Following these hypotheses, the results on durability should also be very encouraging from a
distance (See: Robert J. M. et al., Eur J Cardiothorac Surg. 2017) [53].
In conclusions, part of the above-described types of stented aortic valves have only
recently been introduced into the market, which makes direct comparisons challenging.
Second and third-generation prosthetic valves were considered and, hence, comparative
analysis is of limited value. The data derived from the different studies also pose
interpretation issues, either because of the small sample size or because each cardiac surgery
center usually performs aortic valve replacement predominantly with the same prosthesis
model, which further limits interstudy comparisons. However, early structural valve
deterioration of the “external mounted stent valves” has also been reported. These
observations call for a cautious use of these prosthetic valves.
The assessment of hemodynamic performance is commonly performed through
measurement of EOA and mean pressure gradients, and these two indicators allow for
comparisons between the different prosthesis models. Also the cited guidelines to define SVD
used these parameters. However, in the context of the competing transcatheter approach and
an increased focus on quality of life, it would be more appropriate to consider additional
functional parameters that may provide an estimate of the impact on the myocardium and not
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merely on left ventricular mass. Such information could be obtained through
echocardiographic parameters for myocardial tissue characterization (e.g., tissue Doppler
imaging) that enable assessment of left ventricular diastolic function after correction of aortic
stenosis.
Despite the advances in stent structure and anti-calcification technology, contemporary
aortic bioprostheses suffer from the same disadvantages of the early models, including the
risk of degenerative bioprosthetic stenosis or regurgitation and the need for suture lines.
Future research should aim at developing faster and easier suturing techniques, so as to
compete with sutureless devices and achieve shorter implantation and ischemic times - the
Cinch® Implant System on the Mosaic Ultra valve partially meets this need. In addition,
further refinement in the field of biomaterials should be pursued to obtain more ideal
autologous prostheses and minimize the risk for immunoreaction and bioprosthetic valve
failure.
Indeed, the search for new biomaterials with enhanced biocompatibility and for the
production of autologous aortic valves has been going on for many years, but none of these is
yet commercially available. However, the enlargement of the prosthetic heart valve market to
emerging countries and failure to eradicate several infectious diseases (e.g., rheumatic heart
disease in developing areas of the world) are expected to draw interest in the development of
more ideal autologous devices. This means that hopefully in the near future, stent and aortic
bioprostheses will be biocompatible, less expensive and free from the risk of valve
degeneration, will not require anticoagulant medication, and will adapt to patient growth from
childhood into adulthood.
Probably the biggest innovation we currently have on the market in terms of new
biomaterials is the RESILIA tissue from the Inspiris Edwards prosthesis. RESILIA tissue is
made of bovine pericardium that undergoes integrity preservation technology. This
technology consists of stable capping that permanently blocks calcium (Ca2+) binding sites,
and glycerolization that allows dry storage of the bioprosthesis prior to implant. The
RESILIATM tissue was incorporated within a standard bioprosthesis design and called
“Edwards Inspiris.” Bartus K. et al., (J Thorac Dis. 2019) have reported their experience (the
first ever published) on the first 4 years of implants with very encouraging results, but it is
still too early for real results in terms of long-term durability [22].
As for the “innovations” for mechanical valve prostheses in an aortic position, the
discussion is much simpler. This is because in recent years, probably due to the small number
of patients who need or require a mechanical prosthesis, new products have not been
marketed, but the two-disc prostheses have been the same on the market for years.
Mechanical valves remain the most durable option for valve replacement with most new
generation valves reporting 0% structural failures with follow-up of >10 years and valve
thrombosis risk <1% in both the aortic and mitral positions.
Based on current guidelines in North America and Europe, mechanical valves are
recommended in patients <50 years old who can tolerate anticoagulation and should be
considered in patients between 50 and 65 years old after a discussion of the risks and benefits.
Moreover, an important innovation was introduced last year for the Sorin Bicarbon
mechanical prosthesis. This prosthesis had - on the basis of a 2010 study (Torella M., et al.,
“LOWERING-IT” Trial. Am Heart J) - approval for a lower INR anticoagulation regimen
(1.5-2.5) [54-55]. This value, while maintaining the same degree of protection from
thromboembolic complications, ensures a lower risk of bleeding events. The consequence of
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all this could be a greater use of mechanical prostheses, since the risk of anticoagulant therapy
is lower. In fact, we are skeptical in this regard, given that for years there has been an on the
mark (On-X) prosthesis that has approved this anticoagulation regimen, but this has not
increased the number of patients in whom mechanical prostheses were impanted. Other
reasoning could be, in perspective and in a speculative sense, if the new direct anticoagulants
can be approved for mechanical prostheses and, therefore, these “would compete again” with
biological prostheses even in patients of advanced age.
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In: Perspectives in Aortic Valve Disease ISBN: 978-1-53618-769-4
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Editor: Giovanni Concistrè © 2020 Nova Science Publishers, Inc.
Chapter 18
NEW GENERATION OF AORTIC BIOPROSTHESIS:
SUTURELESS AND RAPID DEPLOYMENT VALVES
Giovanni Concistrè
Fondazione Toscana Gabriele Monasterio, Massa, Italy
Over the last decade, the therapeutic options for patients with aortic valve disease
have expanded considerably as demonstrated by the exponential growth of catheter-based
aortic valve implants, the popularizing of minimally invasive surgical aortic valve
replacement (AVR) techniques and the introduction of new valve technologies such as
sutureless and rapid deployment (SURD) bioprostheses. SURD technologies reduce
operative times and facilitate complex procedure and minimally invasive AVR.
This chapter aimed to explain cheracteristics, surgical technique and published
results of these two very similar but very different new generation of aortic bioprostheses.
Keywords: aortic valve, valvular disease, aortic valve prosthesis, aortic valve replacement,
conventional aortic valve replacement, minimally invasive aortic valve replacement
Historically, aortic valve replacement (AVR) has been the gold standard for patients with
aortic stenosis (AS) since the 1960. In the recents years we have observed an increase in the
number of elderly patients undergoing aortic valve surgery with high surgical risk profile due
to presence of multiple comorbidities. Although much of this growth will likely be
transcatheter AVR (TAVI), technologic advances in valve design and materials continue to
improve the procedural success and long-term safety and performance of surgical aortic
Corresponding Author’s Email: gioconci@libero.it.
, MD, Francesca Chiaramonti, PhD, MD
and Marco Solinas, MD
Ospedale del Cuore “G. Pasquinucci,”
ABSTRACT
INTRODUCTION
Giovanni Concistrè, Francesca Chiaramonti and Marco Solinas
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valves. Technologies have been improved to find any solutions to spread the indication of
surgery for a broader spectrum of patients with AS. In this setting, the sutureless and the rapid
deployment (SURD) bioprostheses can represent a good option. The sutureless concept of
aortic valve implantation was developed in the early 60s. However, this approach was
abandoned due to frequent valve-related thromboembolic complications and severe
paravalvular leakage [1]. More recently, this concept has been reintroduced based on modern
experience with TAVI and with the advent of bovine pericardial material for tissue valves.
SURD valves are designed to allow faster and easier aortic valve implantation avoiding the
need for sutures, reducing the cardiopulmonary bypass (CPB) and the aortic cross clamp
(ACC) times. These characteristics make it especially suitable for minimally invasive
approaches (MIA) and for patients requiring AVR and concomitant surgery. The rapid
deployment aortic bioprosthesis Edwards INTUITY-Elite® valve (Edwards Lifesciences,
Irvine, CA, USA) received CE Mark European approval in April 2014 and the sutureless
aortic bioprosthesis Perceval (LivaNova, London, United Kingdom) in February 2011.
Starting from these dates more than sixty-thousand Perceval and twenty-thousand Intuity
valves have been implanted worldwide.
METHODS
Sutureless Perceval S Bioprosthesis
Perceval Platform Technology
Perceval is a biological prosthesis composed of bovine pericardium stabilized in a
buffered glutaraldehyde solution and assembled on a nitinol stent. This sutureless technique is
achieved by the nitinol stent, which has the dual role of valve support and anchoring to the
aortic root. A distinctive design built around a super elastic stent with unique features and
mechanical behavior. The elastic structure aims at reproducing the stress absorption
properties of the native tissue at the valve commissures level. The Perceval stent is able to
adapt to the movements of the aorta during the cardiac cycle (Figure 1). Perceval gives
patients even broader treatment options for their future. Its exclusive stent design allows even
circumferential expansion to accommodate future transcatheter valves. The nitinol stent
provides clear visibility under fluoroscopy. The inflow ring can be evenly and
circumferentially expanded to accommodate transcatheter aortic valve placement. The
sinusoidal struts allow identification of clear landmarks which may help avoid coronary ostia
obstruction at annulus level.
Thanks to dedicated accessories (Figure 2), the valve diameter can be reduced prior to
implantation, increasing visibility and facilitating more complex procedures.
Perceval is not crimped and it has been shown in literature that the collapsing procedure
of Perceval does not affect leaflet integrity (Figure 3).
Pericardial leaflets are not connected to the stent directly but through an intermediate
outer layer to minimize the stress transferred to the leaflets (Figure 4).
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