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Techniques de positionnement Nicolas Dumonteil Cardiologie
CHU Rangueil, Toulouse
Pôle Cardiovasculaire et Métabolique
Dvir D. et al. JACC Cardiovasc Interv 2012,5:563-‐570
Operator-‐independant device-‐center upper movement during final deployment : 2 ± 1.43 mm
EXPEDITED PUBLICATION
3-Dimensional Aortic Annular Assessment byMultidetector Computed Tomography PredictsModerate or Severe Paravalvular RegurgitationAfter Transcatheter Aortic Valve ReplacementA Multicenter Retrospective Analysis
Alexander B. Willson, MBBS, MPH,* John G. Webb, MD,* Troy M. LaBounty, MD,†Stephan Achenbach, MD,‡ Robert Moss, MBBS,* Miriam Wheeler, MBBS,*Christopher Thompson, MD,* James K. Min, MD,† Ronen Gurvitch, MBBS,* Bjarne L. Norgaard, MD,§Cameron J. Hague, MD,* Stefan Toggweiler, MD,* Ronald Binder, MD,* Melanie Freeman, MBBS,*Rohan Poulter, MBBS,* Steen Poulsen, MD,§ David A. Wood, MD,* Jonathon Leipsic, MD*
Vancouver, Canada; Los Angeles, California; Giessen, Germany; and Aarhus, Denmark
Objectives This study sought to analyze multidetector computed tomography (MDCT) 3-dimensional aortic annular dimensionsfor the prediction of paravalvular aortic regurgitation (PAR) following transcatheter aortic valve replacement (TAVR).
Background Moderate or severe PAR after TAVR is associated with increased morbidity and mortality.
Methods A total of 109 consecutive patients underwent MDCT pre-TAVR with a balloon expandable aortic valve. Differ-ences between transcatheter heart valve (THV) size and MDCT measures of annular size (mean diameter, area,and circumference) were analyzed concerning prediction of PAR. Patients with THV malposition (n ! 7) wereexcluded. In 50 patients, MDCT was repeated after TAVR to assess THV eccentricity (1 – short diameter/longdiameter) and expansion (MDCT measured THV area/nominal THV area).
Results Moderate or severe PAR (13 of 102) was associated with THV undersizing (THV diameter – mean diameter !–0.7 " 1.4 mm vs. 0.9 " 1.8 mm for trivial to mild PAR, p # 0.01). The difference between THV size and MDCTannular size was predictive of PAR (mean diameter: area under the curve [AUC]: 0.81, 95% confidence interval[CI]: 0.68 to 0.88; area: AUC: 0.80, 95% CI: 0.65 to 0.90; circumference: AUC: 0.76, 95% CI: 0.59 to 0.91). An-nular eccentricity was not associated with PAR (AUC: 0.58, 95% CI: 0.46 to 0.75). We found that 35.3% (36 of102) and 45.1% (46 of 102) of THVs were undersized relative to the MDCT mean diameter and area, respec-tively. THV oversizing relative to the annular area was not associated with THV eccentricity or underexpansion(oversized vs. undersized THVs; expansion: 102.7 " 5.3% vs. 106.1 " 5.6%, p ! 0.03; eccentricity: median:1.7% [interquartile range: 1.4% to 3.0%] vs. 1.7% [interquartile range: 1.1% to 2.7%], p ! 0.28).
Conclusions MDCT-derived 3-dimensional aortic annular measurements are predictive of moderate or severe PAR followingTAVR. Oversizing of THVs may reduce the risk of moderate or severe PAR. (J Am Coll Cardiol 2012;59:000–000) © 2012 by the American College of Cardiology Foundation
Paravalvular aortic regurgitation (PAR) remains an impor-tant limitation of transcatheter aortic valve replacement
(TAVR) (1–3). Approximately 1 in 9 patients undergoingTAVR is left with moderate or severe PAR (3), which has
From the *Department of Medical Imaging and Division of Cardiology, St. Paul’sHospital, University of British Columbia, Vancouver, British Columbia, Canada;†Departments of Medicine, Imaging, and Biomedical Sciences, Division of Cardiol-ogy, Cedars-Sinai Medical Center, Los Angeles, California; ‡Department of Cardi-ology, University of Giessen, Giessen, Germany; and the §Department Cardiology B,Cardiac Imaging Center, Aarhus University Hospital Skejby, Aarhus, Denmark. Dr.Webb is a consultant for Siemens Medical and Edwards Lifesciences. Dr. Achenbach hasreceived grant support from Siemens and Bayer Schering Pharma; and speaker honoraria
from Siemens. Drs. Moss and Leipsic are consultants for Edwards Lifesciences. Dr. Minis on the Speaker’s Bureau and medical advisory board of GE Healthcare; is a consultantfor Edwards Lifesciences; and has equity interest in TC3. Drs. Toggweiler and Binder aresupported by unrestricted grants from the Swiss National Foundation. Dr. Wood hasrelationships with Edwards Lifesciences and St. Jude Medical. All other authors havereported that they have no relationships relevant to the contents of this paper to disclose.
Manuscript received October 12, 2011; revised manuscript received December 6,2011, accepted December 20, 2011.
Journal of the American College of Cardiology Vol. 59, No. 14, 2012© 2012 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00Published by Elsevier Inc. doi:10.1016/j.jacc.2011.12.015
by on February 24, 2012 content.onlinejacc.orgDownloaded from
been associated with increasedmorbidity and mortality (4). The2 main causes of PAR are under-sizing of the transcatheter heartvalve (THV) relative to the aorticannulus and incorrect device po-sitioning (5–7). Treatment of severePAR due to THV undersizing ischallenging and unsatisfactory.
Sizing THVs is traditionallyperformed using echocardiographicassessment of the aortic annulusrelying on a single 2-dimensionalmeasurement. The aortic annulus,however, is oval in configuration(8–10) and multidetector com-puted tomography (MDCT) of-fers a 3-dimensional alternative for
image reconstruction of the aortic annulus in a proven repro-ducible fashion (9). However, questions remain as to whetherMDCT annular measurements can predict significant PARafter TAVR and how MDCT should be integrated intoTHV-sizing protocols. This study aims to address this and toreview the impact of annulus eccentricity and THV oversizingon valve expansion and circularity.
Methods
Patient selection. A total of 109 consecutive patients whounderwent a screening MDCT before TAVR with a bal-loon expandable THV (Sapien XT or Sapien, EdwardsLifesciences, Irvine, California) were enrolled from 2 cen-ters (90 from St. Paul’s Hospital, Vancouver, Canada, and19 from Aarhus University Hospital Skejby, Aarhus, Den-mark) between January 2010 and June 2011. All patientsgave informed written consent. Subjects with renal impair-ment (glomerular filtration rate !30 ml/min) did not
undergo MDCT. The TAVR procedure has been previ-ously described (11,12).THV selection. During the course of this study, theSapien valve was available in 23- and 26-mm nominaldiameters and the Sapien XT in 20-, 23-, 26-, and 29-mmnominal diameters. In our institutions, THV sizing wasmultifactorial. In addition to transesophageal echocardiog-raphy (TEE) measures of the annulus, it was dependent onpatient size, sex, left main height, and root calcification. Forexample, in our cohort, there are patients for whom theintraprocedural TEE supported the implantation of a dif-ferent THV size than the operator elected to choose.MDCT was used for assessment of the iliofemoral system,coronary ostia height, and prediction of the fluoroscopicannular plane (13).THV position. THV position was retrospectively reviewedindependently by 2 experienced interventional cardiologists(J.W. and A.W.), who were blinded to the grade of aorticregurgitation, prosthesis size, and MDCT annular measure-ments. THV positioning was graded as correct, too high, ortoo low based on pre- and post-implant aortic root angiog-raphy. A prosthesis was considered high when the inflow ofthe prosthesis (and sealing cuff) was above the basal inser-tion of the native leaflets and low when the outflow portionof the sealing cuff was below the most basal insertion of thenative leaflets (Fig. 1). Subjects in whom the prosthesis wasimplanted too high or low (n " 7) were not included in theanalysis as malposition is a distinct and separate cause ofPAR (6,7).Assessment of aortic regurgitation by echocardiography.Pre-discharge transthoracic echocardiography was per-formed in all patients and interpreted by 3 experienced levelIII echocardiographers, who were unaware of the pre-operative annulus dimensions and size of prosthesis. Aorticregurgitation was graded mild, moderate, or severe accord-ing to the Valve Academic Research Consortium criteria(14). Trivial jets were defined as those that were extremely
Abbreviationsand Acronyms
CI ! confidence interval
IQR ! interquartile range
kVp ! peak kilovolts
MDCT ! multidetectorcomputed tomography
OR ! odds ratio
PAR ! paravalvular aorticregurgitation
TAVR ! transcatheteraortic valve replacement
TEE ! transesophagealechocardiography
THV ! transcatheter heartvalve(s)
Figure 1 Grading of THV Position
(A) Correct, (B) too high, and (C) too low. THV " transcatheter heart valve(s).
2 Willson et al. JACC Vol. 59, No. 14, 2012CT Predicts TAVR Paravalvular Regurgitation April 3, 2012:000–000
by on February 24, 2012 content.onlinejacc.orgDownloaded from
THV malposition : n = 7/109 (6,4 %)
relationship with residual AR, TAViTAV, 3° AVB
Dumonteil N. et al AHA 2011
Influence de la technique d’implantation
Importance de la profondeur d’implantation < 4 mm
0% 0%
36%
0%
5%
10%
15%
20%
25%
30%
35%
40%
Tertile 1 (≤ 2,8 mm) Tertile 2 (2,8 - 4,3 mm) Tertile 3 (≥ 4,4 mm)
Pos
t-pro
cedu
ral 3
rd d
egre
e AV
B (
%)
Mean depth of implantation (tertiles)
p<0,02 (Fisher's exact test)
Edwards : mean depth of implantaAon and post-‐procedural 3rd degree AVB
0%
33%
45%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Tertile 1 (≤ 2,8 mm) Tertile 2 (2,8 - 4,3 mm) Tertile 3 (≥ 4,4 mm)
Pos
t-pro
cedr
ual H
V le
nght
enin
g >
15 m
s
or 3
rd d
egre
e AV
B (%
)
Mean depth of implantation (tertiles)
p<0,02 (Fisher's exact test)
Edwards : mean depth of implantaAon and post-‐procedural HV lenghtening
Inflation en 2 temps : la technique
• 1er opérateur: - en appui avec le guide stiff au fond du VG, - prêt à effectuer de micro-ajustements push/pull en appui sur guide stiff pour voie TF, action directe sur cathéter pour TA,Tao
Inflation en 2 temps : la technique
• 1er opérateur: - en appui avec le guide stiff au fond du VG, - prêt à effectuer de micro-ajustements (push/pull pour voie TF, action directe sur cathéter pour TA,Tao)
• 2ème opérateur: - commande la stimulation, - déploie la valve 1er temps (1/3), - commande l’injection - demande retrait pig-tail - déploie 2nd temps complètement la valve 5 secondes
• Aide opératoire: - injection manuelle 10 cc à la demande 2è opérateur - retire la pig-tail de 10 cm à la demande 2è opérateur
Inflation en 2 temps : la technique
• 1er opérateur: - en appui avec le guide stiff au fond du VG,
- prêt à effectuer de micro-ajustements (push/pull pour voie TF, action directe sur cathéter pour TA,Tao)
• 2ème opérateur: - commande la stimulation, - déploie la valve 1er temps (1/3), - commande l’injection - demande retrait pig-tail - déploie 2nd temps complètement la valve 5 secondes
• Aide opératoire: - injection manuelle 10 cc à la demande 2è opérateur - retire la pig-tail de 10 cm à la demande 2è opérateur
• 23 mm balloon-expandable prosthesis in a patient with 21 mm interventricular septal buldge
• RV 180/min pacing, 2-steps slow inflation with contrast injection during deployment
Examples
During ventricular part of the balloon inflation, upward movement
that could have led to misplacement (possible consequence of septal buldge)
• RV 180/min pacing, 2-steps inflation with contrast injection during deployment
The stiff wire being a stable reference seated in the LV,
fine-tune of the position by slowly pushing on the catheter
5 ml manual injection allows to confirm final good position
Examples
• RV 180/min pacing, 2-steps inflation with contrast injection during deployment
Final full inflation and implantation of the prosthesis
Final result with good position and mild AR
Examples
Conclusion
555
© Europa Digital & Publishing 2013. All rights reserved.
C L I N I C A L R E S E A R C H
EuroIntervention 20
13
;9:555-563
DO
I: 10.42
44
/EIJV9
I5A
91
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Optimisation of transcatheter aortic balloon-expandable valve deployment: the two-step inflation technique!"##$%&'()*++,-%./0%1'#"+"234#54*%67*58*3',-%./-%1)/0%.2"'29%:29'9,-%./0%!2';%<=%>29(23$)23?-%./0%@*A23B2%CAD'3?-%./-%1)/0%1'#8#"%6=%/*#E#3B235,-%./-%1)/0%1'#8#"%>=%:8#AA2,F-%./-%1)/
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AbstractAims:%G*% #E2AD28#% 8)#% 8H*I58#J% '3+A28'*3% 8#4)3'KD#% 2'9#B%28% 24)'#E'37%*J8'92A%E2AE#% '9JA23828'*3%B#J8)%LB#+'3#B%25%MNO%*+%J"*58)#5'5%)#'7)8%#P8#3B'37%Q#A*H%8)#%A*H#"%5'3D5%Q*"B#"%*3%237'*7"2J)RS%BD"'37%Q2AA**3I#PJ23B2QA#%8"235428)#8#"%2*"8'4%E2AE#%'9JA23828'*3%LG6TUS=
Methods and results:%V#8H##3%:#J8#9Q#"%?N,N%23B%.2"4)%?N,W-%,NW%J28'#385% LXY% +#92A#5-%9#23%27#%ZN=[\]=X%R#2"5S%H#"#%8"#28#B%H'8)%8)#%̂ BH2"B5%:61U^&%_G%J"*58)#5'5%D5'37%8)#%8H*I58#J%'3+A28'*3%8#4)3'KD#=%U9JA23828'*3%B#J8)%H25%9#25D"#B%*3%237'*7"2J)R=%6%)'58*"'42A%4*38"*A%7"*DJ%L8"#28#B%H'8)%̂ BH2"B5%:61U^&S%H25% D5#B% +*"% 4*9J2"'5*3% L3`?NS=%/#E'28'*3% +"*9% 8)#% B#+'3#B% *J8'9D9% '9JA23828'*3% B#J8)% L#PJ"#55#B% 25%2%J#"4#3827#%*+%58#38%+"29#%)#'7)8S%H25%5'73'+'4238AR%A#55%'3%8)#%58DBR%7"*DJ%E#"5D5%4*38"*A5%LY=N%aW=MI,M=,bO%E5=%,W=[%a]=MI,Z=[bO0%J`N=NMZS=%T2AE#%JA24#9#38%H25%7"2B#B%c25% '38#3B#BdecH'8)'3%"237#dec*D8%*+% "237#d%
23B%W]OeMNOe?]O%*+%)'58*"'42A%4*38"*A5%LJ`N=N?S=%f*""#48'*35%'3%E2AE#%J*5'8'*3%H#"#%92B#%'3%?N%J"*4#BD"#5%L?NOS-% "#5DA8'37% '3%JA24#9#38%25% '38#3B#B% '3%,X%425#5% LZNOS-%H'8)%)'7)#58%#++'424R% '3% 8)#% 8"2352J'42A%23B%B'"#48%2*"8'4%2JJ"*24)#5=
Conclusions:%G)#% 8H*I58#J% '3+A28'*3% 8#4)3'KD#% '9J"*E#5% E2AE#% JA24#9#38% 8*H2"B5% *J8'92A% '9JA23828'*3%B#J8)%23B%92R%8)#"#QR%J"#E#38%2BE#"5#%#E#385%BD#%8*%92AJ*5'8'*3'37=
KEYWORDS
• balloon-expandable valve
• deployment• transcatheter aortic
valve implantation
555
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KEY
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EuroIntervention 2013;9:555-563
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IMPACT OF VALVE POSITION ADJUSTMENT@/0!*,%!)/A#-BC+*(%)*!#)-!#-BC+*(%)*!+CD20/C&+!(%-.#)!-%".#*./)!/E!*,%!/&*.(C(!.(&$#)*#*./)!-%&*,!F#+!46<7!G965AHI6JK!#)-!I657!G96IA86JK>! 0%+&%'*."%$1! 3&;<694?6! L,%0%!F#+! )/! +.2).E.'#)*! -.EE%0A%)'%!.)!-.+*0.DC*./)!/E!"#$"%!&$#'%(%)*!'$#++!D%*F%%)!*,%!+CD20/C&+!3&;<6=H?6!M!*0%)-!*/F#0-+!D%**%0!"#$"%!&$#'%(%)*!'/C$-!D%!0%'/2A).+%-!.)!*,%!#-BC+*(%)*!+CD20/C&>!#+!*,%!.)'.-%)'%!/E!"#$"%!&$#'%A(%)*!#+!.)*%)-%-!F#+!'/)+.-%0#D$1!,.2,%0!3J<6<!"+6!N5647:!&;<6H=?!(Figure 4)6!O#$"%!&$#'%(%)*!#+!.)*%)-%-!F#+!#',.%"%-!.)!NN647!/E!*,%! *0#)+E%(/0#$! 3);J?!#)-!#$$! *0#)+#&.'#$! 3);5?!#)-!-.0%'*! #/0*.'!&0/'%-C0%+!3);N?!F,%0%!#-BC+*(%)*+!*/!"#$"%!&/+.*./)!F%0%!(#-%6!P)! *,%! '#+%+! /E! "#$"%! &/+.*./)! #-BC+*(%)*! E#.$C0%! */! #',.%"%! #+!
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Figure 5.!"#$%&!'$#(&)&*+!($#,,!'&-!.-/0'1
.)*%)-%-!&$#'%(%)*!3);=?>!/"%0'/00%'*./)!3*//!%Q*%)+."%!'/00%'*./)!0%+C$*.)2!.)!#!-%".#*./)!/E!"#$"%!&/+.*./)!E0/(!*,%!/&*.(C(!.)!*,%!/&&/+.*%!-.0%'*./)?!F#+!/D+%0"%-!.)!/)%!&#*.%)*!#)-!C)-%0'/00%'*./)!3*//! $.**$%!'/00%'*./)!0%+C$*.)2! .)!0%+.-C#$!-%".#*./)!/E!"#$"%!&/+.A*./)?! .)! *,0%%!&#*.%)*+6!L,%!'#+%!/E!/C*!/E! 0#)2%!&$#'%(%)*! .)! *,%!#-BC+*(%)*!20/C&!F#+!-C%!*/!C)-%0'/00%'*./)!/E!"#$"%!&/+.*./)!.)!#!*0#)+E%(/0#$!&0/'%-C0%6
SHORT-TERM OUTCOME R,/0*A*%0(!/C*'/(%!.+!+C((#0.+%-!.)!Table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igure 6A!#)-!Figure 6B?6!M)!%$#D/0#*%!-%+'0.&*./)!/E!*,.+!'#+%!'#)!D%!E/C)-!.)!*,%!/)$.)%!+C&&$%(%)*6R*0/T%!F#+!$%++!&0%"#$%)*!.)!*,%!+*C-1!20/C&!'/(�%-!*/!*,%!,.+A
*/0.'#$!'/)*0/$!20/C&>!#$*,/C2,!)/*!+*#*.+*.'#$$1!+.2).E.'#)*!3H68!"+6!H<6<7:! &;<6H5?6! L,%! *F/! '#+%+! /E! +*0/T%! /D+%0"%-! .)! *,%! +*C-1!20/C&!3D/*,!.)!*,%!)/A#-BC+*(%)*!+CD20/C&?>!'/(&0.+%-!.+',#%(.'!%"%)*+!.)!#0%#+!+C&&$.%-!D1!*,%!(.--$%!'%0%D0#$!#0*%01!0%+C$*.)2!.)!,%(.�%+.+6!S)%!&#*.%)*!.(&0/"%-!#)-!F#+!-.+',#02%-!F.*,!/)$1!(.)/0! 0%+.-C#$!(C+'$%! F%#T)%++6! L,%! /*,%0! &#*.%)*! ,#-! +CEE%0%-!#!$#02%!+%"%0%$1!-.+#D$.)2!+*0/T%!#)-!F#+!-.+',#02%-! */!#!,/+&.'%!E/0!&#$$.#*."%!'#0%6!W#'%(#T%0!.(&$#)*#*./)!0#*%+!F%0%!'/(�#D$%>!#+!E/C0!&#*.%)*+!39687?!.)!*,%!+*C-1!20/C&!#)-!/)%!3I6<7?!/E!*,%!,.+A*/0.'#$!'/)*0/$+!0%'%."%-!#!&#'%(#T%0!-C%!*/!,.2,A-%20%%!MO!D$/'T6!L,%!+/$%!'#+%!/E!(1/'#0-.#$!.)E#0'*./)!.)!*,%!+*C-1!20/C&!/''C00%-!
Figure 6.!2&$#3&4!%#$%&!45,$/(#+5/*1!67!85*#$!5)'$#*+#+5/*!-&,0$+!/*!#*.5/.-#'93!4&)/*,+-#+5*.!$/:!%#$%&!'$#(&)&*+!:5+9!'-/'&-!%#$%0$#-!;0*(+5/*1!<7!6;+&-!#(0+&!/*,&+!/;!43,'*/&#=!&(9/(#-45/.-#'93!-&%&#$&4!4/:*:#-4!45,'$#(&)&*+!:5+9!+9&!'-/,+9&,5,!:5..$5*.!5*!+9&!$&;+!%&*+-5(0$#-!/0+;$/:!+-#(+!#$/*.!+9&!(#-45#(!(3($&=!(#0,5*.!/>,+-0(+5/*!#*4!,&%&-&!6?1
! !!
560
EuroIntervention 2013;9:555-563
"#$"%!&$#'%(%)*+!*,#*!-.-!)/*!(#*',!.(&$#)*#*./)!-%&*,!#+!.)*%)-%-!&0%-/(.)#)*$1!'/(&0.+%-!*//!,.2,!-%&$/1(%)*+!345657!#)-!85697:!&;<65=>!0%+&%'*."%$1?6
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igure 4)6!O#$"%!&$#'%(%)*!#+!.)*%)-%-!F#+!#',.%"%-!.)!NN647!/E!*,%! *0#)+E%(/0#$! 3);J?!#)-!#$$! *0#)+#&.'#$! 3);5?!#)-!-.0%'*! #/0*.'!&0/'%-C0%+!3);N?!F,%0%!#-BC+*(%)*+!*/!"#$"%!&/+.*./)!F%0%!(#-%6!P)! *,%! '#+%+! /E! "#$"%! &/+.*./)! #-BC+*(%)*! E#.$C0%! */! #',.%"%! #+!
%100
75
50
25
0Adjustment
(n=20)No-adjustment
(n=83)Study group
(n=103)Control group
(n=20)
5.015.0
13.325.0
40.0
35.0
11.7
22.3
66.0
24.1
62.780.0
p=0.41 p=0.02
Out of range Within range As intended
Figure 5.!"#$%&!'$#(&)&*+!($#,,!'&-!.-/0'1
.)*%)-%-!&$#'%(%)*!3);=?>!/"%0'/00%'*./)!3*//!%Q*%)+."%!'/00%'*./)!0%+C$*.)2!.)!#!-%".#*./)!/E!"#$"%!&/+.*./)!E0/(!*,%!/&*.(C(!.)!*,%!/&&/+.*%!-.0%'*./)?!F#+!/D+%0"%-!.)!/)%!&#*.%)*!#)-!C)-%0'/00%'*./)!3*//! $.**$%!'/00%'*./)!0%+C$*.)2! .)!0%+.-C#$!-%".#*./)!/E!"#$"%!&/+.A*./)?! .)! *,0%%!&#*.%)*+6!L,%!'#+%!/E!/C*!/E! 0#)2%!&$#'%(%)*! .)! *,%!#-BC+*(%)*!20/C&!F#+!-C%!*/!C)-%0'/00%'*./)!/E!"#$"%!&/+.*./)!.)!#!*0#)+E%(/0#$!&0/'%-C0%6
SHORT-TERM OUTCOME R,/0*A*%0(!/C*'/(%!.+!+C((#0.+%-!.)!Table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igure 6A!#)-!Figure 6B?6!M)!%$#D/0#*%!-%+'0.&*./)!/E!*,.+!'#+%!'#)!D%!E/C)-!.)!*,%!/)$.)%!+C&&$%(%)*6R*0/T%!F#+!$%++!&0%"#$%)*!.)!*,%!+*C-1!20/C&!'/(�%-!*/!*,%!,.+A
*/0.'#$!'/)*0/$!20/C&>!#$*,/C2,!)/*!+*#*.+*.'#$$1!+.2).E.'#)*!3H68!"+6!H<6<7:! &;<6H5?6! L,%! *F/! '#+%+! /E! +*0/T%! /D+%0"%-! .)! *,%! +*C-1!20/C&!3D/*,!.)!*,%!)/A#-BC+*(%)*!+CD20/C&?>!'/(&0.+%-!.+',#%(.'!%"%)*+!.)!#0%#+!+C&&$.%-!D1!*,%!(.--$%!'%0%D0#$!#0*%01!0%+C$*.)2!.)!,%(.�%+.+6!S)%!&#*.%)*!.(&0/"%-!#)-!F#+!-.+',#02%-!F.*,!/)$1!(.)/0! 0%+.-C#$!(C+'$%! F%#T)%++6! L,%! /*,%0! &#*.%)*! ,#-! +CEE%0%-!#!$#02%!+%"%0%$1!-.+#D$.)2!+*0/T%!#)-!F#+!-.+',#02%-! */!#!,/+&.'%!E/0!&#$$.#*."%!'#0%6!W#'%(#T%0!.(&$#)*#*./)!0#*%+!F%0%!'/(�#D$%>!#+!E/C0!&#*.%)*+!39687?!.)!*,%!+*C-1!20/C&!#)-!/)%!3I6<7?!/E!*,%!,.+A*/0.'#$!'/)*0/$+!0%'%."%-!#!&#'%(#T%0!-C%!*/!,.2,A-%20%%!MO!D$/'T6!L,%!+/$%!'#+%!/E!(1/'#0-.#$!.)E#0'*./)!.)!*,%!+*C-1!20/C&!/''C00%-!
Figure 6.!2&$#3&4!%#$%&!45,$/(#+5/*1!67!85*#$!5)'$#*+#+5/*!-&,0$+!/*!#*.5/.-#'93!4&)/*,+-#+5*.!$/:!%#$%&!'$#(&)&*+!:5+9!'-/'&-!%#$%0$#-!;0*(+5/*1!<7!6;+&-!#(0+&!/*,&+!/;!43,'*/&#=!&(9/(#-45/.-#'93!-&%&#$&4!4/:*:#-4!45,'$#(&)&*+!:5+9!+9&!'-/,+9&,5,!:5..$5*.!5*!+9&!$&;+!%&*+-5(0$#-!/0+;$/:!+-#(+!#$/*.!+9&!(#-45#(!(3($&=!(#0,5*.!/>,+-0(+5/*!#*4!,&%&-&!6?1
! !!
560
EuroIntervention 2013;9:555-563
"#$"%!&$#'%(%)*+!*,#*!-.-!)/*!(#*',!.(&$#)*#*./)!-%&*,!#+!.)*%)-%-!&0%-/(.)#)*$1!'/(&0.+%-!*//!,.2,!-%&$/1(%)*+!345657!#)-!85697:!&;<65=>!0%+&%'*."%$1?6
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igure 4)6!O#$"%!&$#'%(%)*!#+!.)*%)-%-!F#+!#',.%"%-!.)!NN647!/E!*,%! *0#)+E%(/0#$! 3);J?!#)-!#$$! *0#)+#&.'#$! 3);5?!#)-!-.0%'*! #/0*.'!&0/'%-C0%+!3);N?!F,%0%!#-BC+*(%)*+!*/!"#$"%!&/+.*./)!F%0%!(#-%6!P)! *,%! '#+%+! /E! "#$"%! &/+.*./)! #-BC+*(%)*! E#.$C0%! */! #',.%"%! #+!
%100
75
50
25
0Adjustment
(n=20)No-adjustment
(n=83)Study group
(n=103)Control group
(n=20)
5.015.0
13.325.0
40.0
35.0
11.7
22.3
66.0
24.1
62.780.0
p=0.41 p=0.02
Out of range Within range As intended
Figure 5.!"#$%&!'$#(&)&*+!($#,,!'&-!.-/0'1
.)*%)-%-!&$#'%(%)*!3);=?>!/"%0'/00%'*./)!3*//!%Q*%)+."%!'/00%'*./)!0%+C$*.)2!.)!#!-%".#*./)!/E!"#$"%!&/+.*./)!E0/(!*,%!/&*.(C(!.)!*,%!/&&/+.*%!-.0%'*./)?!F#+!/D+%0"%-!.)!/)%!&#*.%)*!#)-!C)-%0'/00%'*./)!3*//! $.**$%!'/00%'*./)!0%+C$*.)2! .)!0%+.-C#$!-%".#*./)!/E!"#$"%!&/+.A*./)?! .)! *,0%%!&#*.%)*+6!L,%!'#+%!/E!/C*!/E! 0#)2%!&$#'%(%)*! .)! *,%!#-BC+*(%)*!20/C&!F#+!-C%!*/!C)-%0'/00%'*./)!/E!"#$"%!&/+.*./)!.)!#!*0#)+E%(/0#$!&0/'%-C0%6
SHORT-TERM OUTCOME R,/0*A*%0(!/C*'/(%!.+!+C((#0.+%-!.)!Table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igure 6A!#)-!Figure 6B?6!M)!%$#D/0#*%!-%+'0.&*./)!/E!*,.+!'#+%!'#)!D%!E/C)-!.)!*,%!/)$.)%!+C&&$%(%)*6R*0/T%!F#+!$%++!&0%"#$%)*!.)!*,%!+*C-1!20/C&!'/(�%-!*/!*,%!,.+A
*/0.'#$!'/)*0/$!20/C&>!#$*,/C2,!)/*!+*#*.+*.'#$$1!+.2).E.'#)*!3H68!"+6!H<6<7:! &;<6H5?6! L,%! *F/! '#+%+! /E! +*0/T%! /D+%0"%-! .)! *,%! +*C-1!20/C&!3D/*,!.)!*,%!)/A#-BC+*(%)*!+CD20/C&?>!'/(&0.+%-!.+',#%(.'!%"%)*+!.)!#0%#+!+C&&$.%-!D1!*,%!(.--$%!'%0%D0#$!#0*%01!0%+C$*.)2!.)!,%(.�%+.+6!S)%!&#*.%)*!.(&0/"%-!#)-!F#+!-.+',#02%-!F.*,!/)$1!(.)/0! 0%+.-C#$!(C+'$%! F%#T)%++6! L,%! /*,%0! &#*.%)*! ,#-! +CEE%0%-!#!$#02%!+%"%0%$1!-.+#D$.)2!+*0/T%!#)-!F#+!-.+',#02%-! */!#!,/+&.'%!E/0!&#$$.#*."%!'#0%6!W#'%(#T%0!.(&$#)*#*./)!0#*%+!F%0%!'/(�#D$%>!#+!E/C0!&#*.%)*+!39687?!.)!*,%!+*C-1!20/C&!#)-!/)%!3I6<7?!/E!*,%!,.+A*/0.'#$!'/)*0/$+!0%'%."%-!#!&#'%(#T%0!-C%!*/!,.2,A-%20%%!MO!D$/'T6!L,%!+/$%!'#+%!/E!(1/'#0-.#$!.)E#0'*./)!.)!*,%!+*C-1!20/C&!/''C00%-!
Figure 6.!2&$#3&4!%#$%&!45,$/(#+5/*1!67!85*#$!5)'$#*+#+5/*!-&,0$+!/*!#*.5/.-#'93!4&)/*,+-#+5*.!$/:!%#$%&!'$#(&)&*+!:5+9!'-/'&-!%#$%0$#-!;0*(+5/*1!<7!6;+&-!#(0+&!/*,&+!/;!43,'*/&#=!&(9/(#-45/.-#'93!-&%&#$&4!4/:*:#-4!45,'$#(&)&*+!:5+9!+9&!'-/,+9&,5,!:5..$5*.!5*!+9&!$&;+!%&*+-5(0$#-!/0+;$/:!+-#(+!#$/*.!+9&!(#-45#(!(3($&=!(#0,5*.!/>,+-0(+5/*!#*4!,&%&-&!6?1
! !!
560
EuroIntervention 2013;9:555-563
"#$"%!&$#'%(%)*+!*,#*!-.-!)/*!(#*',!.(&$#)*#*./)!-%&*,!#+!.)*%)-%-!&0%-/(.)#)*$1!'/(&0.+%-!*//!,.2,!-%&$/1(%)*+!345657!#)-!85697:!&;<65=>!0%+&%'*."%$1?6
IMPACT OF VALVE POSITION ADJUSTMENT@/0!*,%!)/A#-BC+*(%)*!#)-!#-BC+*(%)*!+CD20/C&+!(%-.#)!-%".#*./)!/E!*,%!/&*.(C(!.(&$#)*#*./)!-%&*,!F#+!46<7!G965AHI6JK!#)-!I657!G96IA86JK>! 0%+&%'*."%$1! 3&;<694?6! L,%0%!F#+! )/! +.2).E.'#)*! -.EE%0A%)'%!.)!-.+*0.DC*./)!/E!"#$"%!&$#'%(%)*!'$#++!D%*F%%)!*,%!+CD20/C&+!3&;<6=H?6!M!*0%)-!*/F#0-+!D%**%0!"#$"%!&$#'%(%)*!'/C$-!D%!0%'/2A).+%-!.)!*,%!#-BC+*(%)*!+CD20/C&>!#+!*,%!.)'.-%)'%!/E!"#$"%!&$#'%A(%)*!#+!.)*%)-%-!F#+!'/)+.-%0#D$1!,.2,%0!3J<6<!"+6!N5647:!&;<6H=?!(Figure 4)6!O#$"%!&$#'%(%)*!#+!.)*%)-%-!F#+!#',.%"%-!.)!NN647!/E!*,%! *0#)+E%(/0#$! 3);J?!#)-!#$$! *0#)+#&.'#$! 3);5?!#)-!-.0%'*! #/0*.'!&0/'%-C0%+!3);N?!F,%0%!#-BC+*(%)*+!*/!"#$"%!&/+.*./)!F%0%!(#-%6!P)! *,%! '#+%+! /E! "#$"%! &/+.*./)! #-BC+*(%)*! E#.$C0%! */! #',.%"%! #+!
%100
75
50
25
0Adjustment
(n=20)No-adjustment
(n=83)Study group
(n=103)Control group
(n=20)
5.015.0
13.325.0
40.0
35.0
11.7
22.3
66.0
24.1
62.780.0
p=0.41 p=0.02
Out of range Within range As intended
Figure 5.!"#$%&!'$#(&)&*+!($#,,!'&-!.-/0'1
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Figure 6.!2&$#3&4!%#$%&!45,$/(#+5/*1!67!85*#$!5)'$#*+#+5/*!-&,0$+!/*!#*.5/.-#'93!4&)/*,+-#+5*.!$/:!%#$%&!'$#(&)&*+!:5+9!'-/'&-!%#$%0$#-!;0*(+5/*1!<7!6;+&-!#(0+&!/*,&+!/;!43,'*/&#=!&(9/(#-45/.-#'93!-&%&#$&4!4/:*:#-4!45,'$#(&)&*+!:5+9!+9&!'-/,+9&,5,!:5..$5*.!5*!+9&!$&;+!%&*+-5(0$#-!/0+;$/:!+-#(+!#$/*.!+9&!(#-45#(!(3($&=!(#0,5*.!/>,+-0(+5/*!#*4!,&%&-&!6?1
! !!
560
EuroIntervention 2013;9:555-563
"#$"%!&$#'%(%)*+!*,#*!-.-!)/*!(#*',!.(&$#)*#*./)!-%&*,!#+!.)*%)-%-!&0%-/(.)#)*$1!'/(&0.+%-!*//!,.2,!-%&$/1(%)*+!345657!#)-!85697:!&;<65=>!0%+&%'*."%$1?6
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igure 4)6!O#$"%!&$#'%(%)*!#+!.)*%)-%-!F#+!#',.%"%-!.)!NN647!/E!*,%! *0#)+E%(/0#$! 3);J?!#)-!#$$! *0#)+#&.'#$! 3);5?!#)-!-.0%'*! #/0*.'!&0/'%-C0%+!3);N?!F,%0%!#-BC+*(%)*+!*/!"#$"%!&/+.*./)!F%0%!(#-%6!P)! *,%! '#+%+! /E! "#$"%! &/+.*./)! #-BC+*(%)*! E#.$C0%! */! #',.%"%! #+!
%100
75
50
25
0Adjustment
(n=20)No-adjustment
(n=83)Study group
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(n=20)
5.015.0
13.325.0
40.0
35.0
11.7
22.3
66.0
24.1
62.780.0
p=0.41 p=0.02
Out of range Within range As intended
Figure 5.!"#$%&!'$#(&)&*+!($#,,!'&-!.-/0'1
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*/0.'#$!'/)*0/$!20/C&>!#$*,/C2,!)/*!+*#*.+*.'#$$1!+.2).E.'#)*!3H68!"+6!H<6<7:! &;<6H5?6! L,%! *F/! '#+%+! /E! +*0/T%! /D+%0"%-! .)! *,%! +*C-1!20/C&!3D/*,!.)!*,%!)/A#-BC+*(%)*!+CD20/C&?>!'/(&0.+%-!.+',#%(.'!%"%)*+!.)!#0%#+!+C&&$.%-!D1!*,%!(.--$%!'%0%D0#$!#0*%01!0%+C$*.)2!.)!,%(.�%+.+6!S)%!&#*.%)*!.(&0/"%-!#)-!F#+!-.+',#02%-!F.*,!/)$1!(.)/0! 0%+.-C#$!(C+'$%! F%#T)%++6! L,%! /*,%0! &#*.%)*! ,#-! +CEE%0%-!#!$#02%!+%"%0%$1!-.+#D$.)2!+*0/T%!#)-!F#+!-.+',#02%-! */!#!,/+&.'%!E/0!&#$$.#*."%!'#0%6!W#'%(#T%0!.(&$#)*#*./)!0#*%+!F%0%!'/(�#D$%>!#+!E/C0!&#*.%)*+!39687?!.)!*,%!+*C-1!20/C&!#)-!/)%!3I6<7?!/E!*,%!,.+A*/0.'#$!'/)*0/$+!0%'%."%-!#!&#'%(#T%0!-C%!*/!,.2,A-%20%%!MO!D$/'T6!L,%!+/$%!'#+%!/E!(1/'#0-.#$!.)E#0'*./)!.)!*,%!+*C-1!20/C&!/''C00%-!
Figure 6.!2&$#3&4!%#$%&!45,$/(#+5/*1!67!85*#$!5)'$#*+#+5/*!-&,0$+!/*!#*.5/.-#'93!4&)/*,+-#+5*.!$/:!%#$%&!'$#(&)&*+!:5+9!'-/'&-!%#$%0$#-!;0*(+5/*1!<7!6;+&-!#(0+&!/*,&+!/;!43,'*/&#=!&(9/(#-45/.-#'93!-&%&#$&4!4/:*:#-4!45,'$#(&)&*+!:5+9!+9&!'-/,+9&,5,!:5..$5*.!5*!+9&!$&;+!%&*+-5(0$#-!/0+;$/:!+-#(+!#$/*.!+9&!(#-45#(!(3($&=!(#0,5*.!/>,+-0(+5/*!#*4!,&%&-&!6?1
! !!
558
EuroIntervention 2013;9:555-563
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• 2-steps inflation with contrast injection during deployment has been proposed as an adaptation of the deployment technique with balloon-expandable prosthesis
Conclusion
• It allows to offset mild natural movement of the prosthesis and some unanticipated movements (particularly in case of LV septal buldge, calcified sino-tubular junction) that could lead to misplacement