Frontiers in Cardiovascular Medicine | www.frontiersin.o rg 1 March 2020 | Volume 7 | Article 38Editedby: CrochanJohnO’Sullivan,… [614581]

ORIGINAL RESEARCH
published: 20 March 2020
doi: 10.3389/fcvm.2020.00038
Frontiers in Cardiovascular Medicine | www.frontiersin.o rg 1 March 2020 | Volume 7 | Article 38Editedby:
CrochanJohnO’Sullivan,
TriemliHospital,Switzerland
Reviewedby:
PabloCodner,
RabinMedicalCenter,Israel
GidonYehudaPerlman,
HadassahMedicalCenter,Israel
*Correspondence:
LuigiBiasco
[anonimizat]
†Theseauthorshavecontributed
equallytothiswork
Specialtysection:
Thisarticlewassubmittedto
StructuralInterventionalCardiology,
asectionofthejournal
FrontiersinCardiovascularMedicine
Received: 13November2019
Accepted: 27February2020
Published: 20March2020
Citation:
BiascoL,CerratoE,TersalviG,
PedrazziniG,WilkinsB,FaletraF,
FerrariE,DemertzisS,SenatoreG,
DiLeoA,VarbellaF,DeBackerOand
NombelaFrancoL(2020)WorldwIde
SurvEyonClinicalandAnatomical
FactorsDrivingtheChoiceof
TranscatheterAorticValve
pRostheses.
Front.Cardiovasc.Med.7:38.
doi:10.3389/fcvm.2020.00038WorldwIde SurvEy on Clinical and
Anatomical Factors Driving the
Choice of Transcatheter Aortic Valve
pRostheses
LuigiBiasco1,2*†,EnricoCerrato3†,GregorioTersalvi4,GiovanniPedrazzini1,4,BenWilkins5,
FrancescoFaletra4,EnricoFerrari6,StefanosDemertzis6,GaetanoSenatore2,
AngeloDiLeo2,FerdinandoVarbella3,OleDeBacker6andLuisNombelaFranco7
1DepartmentofBiomedicalSciences,UniversitàdellaSvizz eraItaliana,Lugano,Switzerland,2DivisionofCardiology,Azienda
SanitariaLocaleTO4,Ciriè,Italy,3InterventionalCardiologyUnit,SanLuigiGonzagaUniversi tyHospital,Orbassanoand
RivoliInfermiHospital,Rivoli,Italy,4DivisionofCardiology,CardiocentroTicino,Lugano,Swit zerland,5DivisionofCardiology,
Rigshospitalet,Copenhagen,Denmark,6DivisionofCardiacSurgery,CardiocentroTicino,Lugano, Switzerland,7Divisionof
CardiacSurgery,CardiocentroTicino,Lugano,Switzerlan d
Background: Following the success of the first human transcatheter aorti c valve
replacement (TAVR) in 2002, multiple transcatheter heart v alves (THVs) have become
available. However, guidelines or expert consensus on how t o optimize THV
choice according to patients’ anatomical and clinical char acteristics is missing. This
survey-based study aimed to identify patient-specific char acteristics deemed important
in the choice of THV type.
Methods and results: A web-based survey including 39 questions was completed by
71 experienced TAVR operators from 23 countries with a media n TAVR volume of 88
procedures in the year prior to survey completion (IQR 61-18 0). The survey covered five
topics: access, aortic annulus/leaflets, aortic root, left ventricular function and clinical
characteristics. Factors with the most impact on THV choice were reported to be a
calcified sinotubular junction, valve-in-valve procedure , annular dimension >575 mm2,
femoral diameter ≤5.0mm, low coronary ostia, calcification at the annular leve l and/or
protruding into the left ventricular outflow tract, and need for post TAVR PCI. Also, in
case of off-label use of THVs to treat bicuspid aortic valve d isease and isolated aortic
regurgitation, the choice of THV type was reported to be impo rtant.
Conclusions: Thissurvey-basedstudyidentifieskeypatientcharacteris ticsthatimpact
THV selection. As such, we present a guide, based on current p ractice, of which THV
types are best suited to these different patient-specific ch aracteristics. A patient-tailored
THV choice is likely to optimize TAVR outcomes.
Keywords: aortic stenosis, TAVI, TAVR, percutaneous aorti c valve replacement, access, aortic annulus, survey
INTRODUCTION
Since the first percutaneous transcatheter aortic valve replac ement (TAVR) performed in 2002
(1), a range of percutaneous aortic prostheses have been release d by numerous manufacturers.
Initialdevices were designed, trial-testedandreleasedf oruse inpatientswith severe symptomatic
aortic valve stenosis and contraindication to surgery ( 2). These early trials have informed

Biasco et al. The WISE-TAVR Survey
current TAVRexclusion/inclusion criteriainreal-worlds ettings.
With progress in the field of TAVR, extension of the indication s
to lower risk patients has widened the treatable population and
itsclinicalandanatomicallandscape( 3).
While producing TAVR systems for a wide range of patients,
manufacturers have developed significantly different prosthes es
in terms of valve design, release technology, and delivery
systems ( 4). In keeping with this, various patient characteristics
have influence over which device becomes more individually
favorable. Vascular access, tortuosity, potential complicat ions,
aortic anatomy, calcifications, conduction disturbances a nd
comorbiditiesmustbeconsideredinthecomplexpre-procedural
planningofTAVRandvalvechoice.
Criteria on a precise matching between different prostheses
and patients’ characteristics are not well defined. Nonethel ess,
TAVR operators are aware that interaction between the patient
and device can have a crucial influence on procedural success,
valvedurability,andpotentiallyonlongtermoutcomes( 5).
Recently, a European survey generically defined “patient’s
specific characteristics” as the main criterion guiding the
selection of a specific prosthesis ( 6). In addition, the European
guidelines (ESC/EACTS) on valvular heart diseases recogni zed
an initial set of general, anatomical, and technical aspects that
should be considered by the Heart Team for the decision
between surgical aortic valve replacement and TAVR in patient s
atincreasedsurgicalrisk( 2).
We therefore designed the WISE-TAVR survey, to clearly
identify clinical and anatomical characteristics deemed r elevant
in patient-prosthesis matching by a collective of expert TAVR
operators worldwide. Our aim was to investigate and describe
the clinical and anatomical aspects having an impact on the
operator’s choice for a particular transcatheter heart valve
(THV) and to provide a guide for a modern patient-tailored
THVtherapy.
MATERIALS AND METHODS
Survey Design
Thesurveywasdesignedbyateamofphysicianswithexperience
in TAVR (LB, EC, OD, LN). The survey engine was built under
supervision of one of the investigators (EC) using a dedicate d
onlineplatformhostedonacollaborativeresearchwebsite( www.
cardiogroup.org)andincludedatotalof39questionswithsi ngle,
multiple choice and open-ended answering options. The full
survey was designed to address five major domains related to
TAVR: vascular access, aortic annulus/aortic leaflets, aort ic root,
leftventricular,andclinicalcharacteristics.
In order to minimize possible misunderstandings in
interpreting questions, each scenario was correlated by a cl ear
definition and a descriptive image. Definitions of anatomical
characteristics have been derived from current literature or
inclusion/exclusion criteria of randomized clinical tria ls or CE
marktrialswhenavailable.Inallothercases,aworkingdefi nition
was developed. All definitions are available within survey te xt
(availableasanonline SupplementaryMaterial ).
For each clinical/anatomical scenario two questions were
proposed. As a first TAVR operators were asked whether theproposed characteristics would impact on the choice of the
prosthesis and a yes/no answer allowed. Then a second questio n
investigated how would they grade the suitability of the mos t
widelyusedTHVaccordingtotheproposedscenario.According
to the commercial availability of different THV at the time
of survey’s design five different platforms were investigated:
Edwards Sapien XT/3, Medtronic CoreValve Evolut R, Boston
Lotus,BostonAcurateNeo,andAbbotPortico.Responderscould
choosewhethertoanswerorskiptheproposedquestion.
Distribution of the survey was web- and mail-based aiming
at covering different geographic areas. More than 200 operators
with expertise on TAVR were contacted. Data acquisition was
kept open for 3 months. All forms were electronically acquired,
and data analyzed. The software allowed monitoring of result s
at all times. An ongoing monitoring for survey accrual and
completion was then performed in order to avoid duplicate
entry or missing data. Incomplete forms were defined as
those with empty fields regarding questions 1–5 and with
<80% of remaining answers provided. Participation was purely
voluntary and unpaid, and all responses were confidential. Thi s
survey was investigator initiated. No support from industry w as
received for design, development of the online platform, data
acquisition/analysis or writing. Ethical review process wa s not
requiredforourstudy,sinceaccordingtotheSwisslawCant onal
ethics committee is only responsible for the examination and
authorization of research projects conducted on human being s,
thusnotapplyingtooursetting.
Statistical Analysis
Categorical variables are expressed as percentages and
continuous variables as mean ( ±standard deviation) or median
(interquartile [IQR]: 25-75th percentile or range: minimum-
maximum) according to variable distribution. All analyses w ere
performedusingSPSS20(IBM,Armonk,NY,USA).
Factors determining the choice of THV have been split into
threecategories:Low( <60%ofrespondersagreedontheirrolein
thechoiceofTHV),intermediate( ≥60and <80%ofresponders),
and definite impact ( ≥80% of responders agreed on their role in
thechoiceofTHV).Whenaclinicaloranatomicalcharacteris tic
was recognized having a definite impact on the choice of THV
(>80%) but no consensus was reached on THV prosthesis
selection(i.e.,whenreaching <80%ofoperatorpreferences),this
wasidentifiedasanunmetneedfromcurrentdevices.
RESULTS
Participants
A total of 89 questionnaires were returned. Of these, 18 were
excluded for significant data incompleteness. 71 responses we re
analyzedincluding52European(73%),6NorthAmerican(8%),
5 Central and South American (7%), and 8 Asia or Australia
(11%).Mostresponderswereinterventionalcardiologists(91 %),
while the remaining were cardiac surgeons (6%) or imaging
specialists(3%).
Participating centers had a median experience of 500 total
TAVR procedures (IQR: 293 to 825 procedures), with 88 (IQR
61–180), procedures in the year prior to survey completion.
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Biasco et al. The WISE-TAVR Survey
AninvitationtotenderforTHVequipmentwasdeclaredby42%
of responders while 36% report the presence of package deals in
theircenter.
Procedures
Eighty-four percent of responders reported a preference for
local analgesia with conscious sedation. 64% offer alternati ve
access TAVR either via trans-subclavian/axillary, transao rtic,
transcaval,ortransapicalapproach.Onlyonedevicewasavail able
in 6% of centers while 37% reported to implant at least 2
different prostheses, 14% 3 devices, 27% 4 devices and 16%
more than 4 devices. Almost half (49%) of clinicians reported
CoreValve (Medtronic, Minneapolis, Minnesota) being their
most-used valve, followed by SAPIEN XT or 3 (41%) (Edwards
Lifesciences, Irvine, California), Portico (4%) (Abbott, S anta
Clara, California), and Acurate Neo (3%) (Boston Scientific,
Marlborough,Massachusetts).
Anatomical Characteristics Guiding the
Choice of TAVR
Access
THV type selection was definitely impacted ( >80% responder
agreement)bythepresenceoffemoralcaliberof5.0mmwithou tsignificant calcification or 5.5mm with moderate calcificati on.
The presence of other vascular access characteristics inclu ding:
iliofemoral artery 6.0mm, iliofemoral artery 6.5mm with sev ere
circumferential calcification, severe calcification of aor toiliac
bifurcation, severely tortuous, non-calcified iliofemoral arteries,
acute aortic arch angulation >90◦, horizontal ascending aorta,
and subclavian/axillary access had either low or intermedia te
impact only on THV type selection. None of the listed
vascular access characteristics was considered as definitel y
contraindicating femoral access. THV preference according
to access characteristics are shown in Figure1, with a
general preference for the CoreValve TVH in cases of
challengingaccess.
Characteristics of the Aortic Annulus
Large annular area between 575 and 660 mm2had a
definite impact on THV type selection with a consensus
for both CoreValve and Sapien platforms. Even larger
anatomy (annulus area >660 mm2) or calcification of the
left ventricular outflow tract (LVOT) extending >5mm
into the lumen also had a definite impact on TVH type
selection but no consensus on THV type was seen. A definite
impact on THV type choice was seen in cases of severe
FIGURE 1 | THV preferences according to access vessel characteristic s. Acu, Boston Acurate Neo; CV, Medtronic CoreValve; ES, Edw ards Sapien XT/3; Lot, Boston
Lotus; Por, Abbott Portico.
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Biasco et al. The WISE-TAVR Survey
annular calcification extending >5mm into the lumen, with
preference for CoreValve. Small annular area ( <325 mm2)
and severe annular calcification had an intermediate effect on
THV selection. Ellipticity index >2.5 had a low impact on
THVselection.
Figure2 shows THV preferences according to annular and
leafletcharacteristics.Characteristics of the Leaflets
Bicuspid aortic stenosis or isolated non-calcific, native va lve,
severe aortic regurgitation (AR) had a definite impact on THV
type selection. In the presence of bicuspid anatomy consensus
preference was for Lotus THV, whereas no consensus was noted
on specific valve choice for aortic regurgitation. Significan t non-
calcific thickening of aortic leaflets or severe bulky calcific ations
FIGURE 2 | THV preferences according to annular and leaflet characteris tics. Acu, Boston Acurate Neo; CV, Medtronic CoreValve; ES, Edwards Sapien XT/3; Lot,
Boston Lotus; Por, Abbott Portico.
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Biasco et al. The WISE-TAVR Survey
FIGURE 3 | THV preferences according to aortic root and clinical chara cteristics. Acu, Boston Acurate Neo; CV, Medtronic CoreVal ve; ES, Edwards Sapien XT/3; Lot,
Boston Lotus; Por, Abbott Portico.
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Biasco et al. The WISE-TAVR Survey
ofthecoronarycuspswerenotrecognizedasdeterminantsont he
choiceofTHV.
Aortic Root Characteristics
Aortic root characteristics were generally seen as importan t to
guiding THV selection, with low coronary take-off, small sin us
of Valsalva, calcified and small diameter sinotubular junct ion
and valve-in-valve TAVR procedure all having a definite impact .
For valve-in-valve cases, the CoreValve system was identifi ed as
most suitable, with no other consensus being reached for TVH
selection.AdilatedascendingaortahadonlylowimpactonTH V
typeselection.
Left Ventricular and Clinical Characteristics
Left ventricular function, conduction status and various c linical
characteristics were not seen as key determinants of TVH type
selection with no definite impact on THV type noted. The only
factor with a definite impact was need for PCI following TAVR
(80%ofresponders)where98%ofoperatorsidentifiedtheSapien
valve as a suitable choice in this scenario. LVEF <35%, RBBB
or LBBB, first-degree AVB, younger patient age (65–70 years)
and severe LV hypertrophy with small cavity had either low or
intermediateimpactonTVHtypeselectiononly.
Figure3showsTHVpreferencesaccordingtoaorticrootand
clinical characteristics. Table1summarizes survey’s findings by
reporting the percentage of responders declaring an impact of
the proposed clinical/anatomical scenario on the choice of a
peculiarTHV.
DISCUSSION
During early experience with TAVR, anatomical criteria from
initial randomized clinical trials ( 6–11) served as a reference
for case selection. Now, extension of TAVR into wider
patient groups (e.g., intermediate, low or extremely high-ri sk
surgical patients) or untrialled clinical situations (e.g. , aortic
regurgitation or valve in valve procedures) has created a gap
between the original trial guidelines and current accepted
practice ( SupplementaryFile1 ). For these reasons, application
of previous TAVR trial inclusion/exclusion criteria in a rea l-life
scenarioischallengingifnotoutdated.
The institutional norm for using multiple parallel THV
options points to the various strengths and weakness of each
system and confirms that no system has yet achieved a “one
size fits all” status. This highlights the importance of optimi zed
patient-THVmatching,anareaofTAVRpracticethatiscurrent ly
lacking in guidelines or consensus. Data derived from WISE-
TAVR allows a snapshot of current practice according to patient
specificcharacteristicsinhighvolumecentersandbyexperie nced
operators. It also identifies aspects of current TAVR practice
that have unmet needs and provides clues for the technical
developmentofnextgenerationprostheses.
We have identified a specific set of clinical and anatomical
characteristics which currently impact the choice of THV for
patients. Inparticular, small accessvessel caliber <5.0mmnon-
calcified or <5.5mm with moderate vessel calcification, large
annulus dimension >575 mm2, small sinus of Valsalva, lowTABLE 1 | Summary of survey’s findings: percent of responders reportin g impact
on the choice of THV for each clinical/anatomical characteri stic.
Impact on
choice
of THV (%)Impact on
choice
of access (%)
Definite impact ( >80%)
Calcified sino-tubular junction with small diameter 94
Iliofemoral artery =5.0mm 90 42
Large-sized aortic annulus (area 575–660 mm2) 90
TAVR in previous surgical bioprosthesis
(valve-in-valve)90
Severe calcification(s) >5mm protruding into the
LVOT89
Low take-off of coronary arteries 89
Iliofemoral artery 5.5mm (moderate calcifications) 85 34
Large-sized aortic annulus (area >660 mm2) 85
Small sinus of Valsalva 84
Aortic Regurgitation 83
Bicuspid Aortic Valve 83
Severe annular calcifications ( >5mm) 81
Needing PCI 80
Intermediate impact (60–80%)
Small-sized aortic annulus (area <325 mm2) 78
Severe calcification(s) of the aortic annulus 76
Subclavian/axillary access 73
Horizontal ascending aorta 72 10
Iliofemoral artery =6.5mm circumferential
calcifications71 31
Acute angulated aortic arch 71 22
LVEF<20% 67
Young patients 65
Severely tortuous, non-calcified iliofemoral
arteries64 39
Severe calcification(s) involving the aorto-iliac
bifurcation62 23
Non-calcific severe AS-thick leaflets 62
RBBB 61
Severe calcifications ( >5mm) at the RCC/LCC
leaflets61
Low impact ( <60%)
Patient with previously known PR-interval >
200ms51
Hypertrofic LV 49
Ilio-femoral arteries =6mm, no calcification 47 6
Elliptical aortic annulus 47
Dilated ascending aorta 41
LVEF<35% 32
LBBB 28
take off of coronary arteries, annular calcifications >5mm
protruding into the lumen at the annulus or LVOT, a small,
calcific sinotubular junction, valve in valve procedures, bi cuspid
aorticvalve,aorticregurgitationandneedforPCIhavethe most
effect on the current choice of THV type, with ≥80% of TAVR
operatorsagreeingontheirimpact.
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Biasco et al. The WISE-TAVR Survey
In addition, we identify that several patient characteristi cs
considered as exclusion criteria from most controlled tria ls
or potentially hampering procedural success of TAVR (e.g.,
horizontal aorta, tortuous accesses, severe LV impairment,
dilated ascending aorta) are not perceived as factors either to
denyTAVRortostronglyimpactthechoiceofaparticularTHV.
There is agreement that within the range of TAVR
devices, some are more suited to specific clinical and
patientconditions.
While the cilindric, short frame Edwards Sapien valve is
almost universally preferred in AS patients likely to undergo
PCI after TAVR, other platforms extending into the proximal
portion of ascending aorta such as Corevalve were reported as
unsuitable/notpreferred.
Due to intrinsic platforms limitations correlated with the
currently commercially available sizes, Lotus and Acurate
Neo and Portico were deemed unsuitable in large anatomies.
Conversely both CoreValve and Sapien platforms, due to
valve design and peculiar implant techniques, were considere d
appropriate choices in this setting. Vice versa, when facing
small annular dimensions, self-expandable prostheses
with dedicated small platforms such as the Portico and
CoreValve were preferred over other devices. Smaller and
flexible delivery systems such as the Medtronic Enveo R
or the Portico delivery system were preferred in complex
femoralaccesses.
Of interest, and potentially based on initial evidences
(12), presence of preprocedural conduction disturbances, and
in particular right bundle branch block or first degree AV
block resulted one of the main criterion the support the
choice of Acurate Neo, due to correlated low incidence of
pacemakerimplant.
However, when facing complex anatomical challenges,
opinions frequently diverge on as to which device is most
appropriate. In this situation, local device availability, te chnical
skills, personal preferences, and cost are likely to have an im pact
onTHVselection.ThisisconsistentwiththeWRITTENsurvey,
performed to obtain a global view of current practice related
to TAVR which emphasized the presence of several areas of
divergenceinTAVRproceduraldetailsandpatient’smanageme nt
betweencenters( 13).
Several anatomical features still represent an unmet need fo r
currentlycommerciallyavailableprostheses.Annulardimen sions
exceeding 660 mm2, low take-off coronary ostia, small sinus
of Valsalva, small, calcified sinotubular junction, and iso lated
aortic regurgitation, while being recognized as factors im pacting
on THV choice, were not well matched to any currently
available device. These characteristics represent challen ges to be
consideredinthetechnicaldevelopmentoffutureTHV,allow ingmore consistent, successful treatment of these challengin g
patientgroups.
LIMITATIONS
Severallimitationsofthepresentsurveyshouldbeacknowle dged.
Firstly, despite the attempt to achieve a wide response, only
a third of invited specialists completed the survey. Because
of market distribution and global TAVR practice, responders
were mainly CoreValve or Sapien users, while the remaining
prostheseswereusedlessfrequently,potentiallyimpactingon the
reportedpreferences.Duetotherecentimplementationofnewe r
THVgenerationsaftercompletionofthissurvey,wearenotab le
to provide data for all currently commercially available devi ces
(e.g.,CoreValvePRO).
In addition results were not weighted against
operator/centervolumes.
CONCLUSION
In this study a set of characteristics was identified as havin g
definite impact on the suitability of a patient for TAVR and the
typeofTHVselected.Inaddition,severalofthesecharacter istics
haveclearconsensusforwhichspecificTHVismostappropriate,
representing an initial guide for current international prac tice.
Other anatomical conditions were identified as definite fact ors
impacting on THV choice but were not well matched to any
specific THV—these represent unmet needs to be considered in
thetechnicaldevelopmentoffutureTHV.
DATA AVAILABILITY STATEMENT
The datasets generated for this study are available on reque st to
thecorrespondingauthor.
AUTHOR CONTRIBUTIONS
LB,OD,LN,andECdevelopedthesurvey,analyzedthedata,and
draftedthemanuscript.GT,GP,BW,FF,EF,SD,GS,AD,andFV
criticallyreviewedthemanuscript.
SUPPLEMENTARY MATERIAL
The Supplementary Material for this article can be found
online at: https://www.frontiersin.org/articles/10.338 9/fcvm.
2020.00038/full#supplementary-material
Supplementary File 1 | Survey text.
Supplementary File 2 | Summary of exclusion criteria used in randomized clinical
trials/CE mark trials according to different THV devices.
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Conflict of Interest: The authors declare that the research was conducted in the
absence of any commercial or financial relationships that could be c onstrued as a
potentialconflictofinterest.
Copyright © 2020 Biasco, Cerrato, Tersalvi, Pedrazzini, Wilkins, Faletra, Ferrari,
Demertzis, Senatore, Di Leo, Varbella, De Backer and Nombela Franco. This is an
open-accessarticledistributedunderthetermsoftheCrea tiveCommonsAttribution
License(CCBY).Theuse,distributionorreproductioninot herforumsispermitted,
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Frontiers in Cardiovascular Medicine | www.frontiersin.o rg 8 March 2020 | Volume 7 | Article 38