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`JJCC-1307; No. of Pages 5
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`Journal of Cardiology xxx (2016) xxx–xxx
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`Contents lists available at ScienceDirect
`
`Journal of Cardiology
`
`j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / j j c c
`
`Original article
`
`Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral
`transcatheter aortic valve implantation: Difference of valve selection
`in the real world
`
`Takahide Arai (MD)a, Thierry Lefe` vre (MD, FESC, FSCAI)a,*, Thomas Hovasse (MD)a,
`Marie-Claude Morice (MD, FACC, FESC)a, Philippe Garot (MD)a, Hakim Benamer (MD)a,
`Thierry Unterseeh (MD)a, Kentaro Hayashida (MD, PhD, FESC)a,b,
`Yusuke Watanabe (MD)a,c, Erik Bouvier (MD)a, Bertrand Cormier (MD)a,
`Bernard Chevalier (MD, FESC, FSCAI)a
`a Ge´ne´rale de Sante´, Hopital Prive´ Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France
`b Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
`c Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
`
`A R T I C L E
`
`I N F O
`
`A B S T R A C T
`
`Article history:
`Received 7 March 2016
`Received in revised form 20 April 2016
`Accepted 28 April 2016
`Available online xxx
`
`Keywords:
`Severe symptomatic aortic stenosis
`Transcatheter aortic valve implantation
`SAPIEN 3
`SAPIEN XT
`
`Background: The SAPIEN 3 (S3; Edwards Lifescience, Irvine, CA, USA) is a new-generation percutaneous
`aortic valve with better profile, more precise handling and positioning, designed to reduce the risk of
`post-procedural paravalvular aortic leak (PVL). The aim of this study was to compare the S3 valve and
`SAPIEN XT valve (SXT).
`Methods: The last 89 transfemoral transcatheter aortic valve implantation (TAVI) cases using SXT were
`compared to the first 111 cases using the S3.
`Results: Patient age and logistic EuroSCORE were similar (83.1 years vs 83.0 years and 18.2% vs 16.6%) in
`the S3 and SXT groups, respectively as were other baseline characteristics. The ratio of valve diameter/
`calculated annulus average diameter (CAAD) by multi-detector row computed tomography was
`significantly lower in the S3 group (1.06 vs 1.09, p < 0.001) as was the annular area oversizing
`percentage (11.3% vs 20.5%, p < 0.001). Furthermore, a smaller valve was selected in S3 cases with
`borderline CAAD compared to SXT cases. Nevertheless, the frequency of paravalvular aortic leakage (PVL)
`2 tended to be reduced in the S3 group (5% vs 9%, p = 0.339). The rate of major vascular complications
`was significantly lower with S3 (3% vs 12%, p = 0.013). In addition, 30-day mortality was significantly
`lower in the S3 group (0% vs 5%, p = 0.044).
`Conclusions: Although TAVI using S3 tended to be carried out with a less oversized valve compared to
`TAVI using SXT, the frequency of post-procedural PVL 2 tended to be lower in the S3 group. The
`outcomes including vascular complications and 30-day mortality showed a trend in favor of the S3
`group.
`
`ß 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
`
`Introduction
`
`Transcatheter aortic valve
`implantation (TAVI) has gained
`increasing acceptance as a treatment option for patients with
`
`* Corresponding author at: Department of Interventional Cardiology, Ramsay
`Ge´ ne´ rale de Sante´ , Institut Cardiovasculaire Paris Sud, Hoˆpital Prive´ Jacques Cartier,
`6 avenue du Noyer Lambert, FR-91300 Massy, France. Tel.: +33 160134602;
`fax: +33 160134603.
`E-mail address: t.lefevre@angio-icps.com (T. Lefe` vre).
`
`severe symptomatic aortic stenosis (AS) who are considered at
`high risk for surgical aortic valve replacement [1–7]. Despite its
`minimally invasive nature, TAVI is invariably associated with
`complications such as paravalvular aortic leak (PVL) and access site
`complications, which remain limiting factors potentially affecting
`the outcome of this treatment strategy [2,8–10]. In order to
`overcome these problems, the balloon-expandable SAPIEN 3 pros-
`thesis (S3; Edwards Lifescience, Irvine, CA, USA) was designed to
`reduce post-procedural PVL by adding an outer skirt at the distal
`part of the prosthesis. In addition, the S3 sheath size was reduced
`
`http://dx.doi.org/10.1016/j.jjcc.2016.04.012
`0914-5087/ß 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
`
`Please cite this article in press as: Arai T, et al. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic
`valve implantation: Difference of valve selection in the real world. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.04.012
`
`Page 1 of 5
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-01293, U.S. Patent 8,992,608, Exhibit 2009
`
`

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`in order to improve the feasibility and safety of the transfemoral
`approach [11]. However, there are currently only limited data
`focusing on the differences between the two prosthesis genera-
`tions.
`The aim of this study was, therefore, to compare the two valves,
`especially regarding PVL and vascular complications.
`
`Materials and methods
`
`Study design
`
`From October 2006, all consecutive high-risk patients, with
`severe symptomatic AS treated with TAVI in Massy, France, were
`prospectively included in our dedicated TAVI database. Patients
`with severe AS were considered candidates for TAVI if they were
`deemed ineligible or high risk for surgical aortic valve replacement.
`The decision to proceed with TAVI was made by a dedicated heart
`team composed of experienced clinical and
`interventional
`cardiologists, imaging specialists, cardiovascular surgeons, and
`anesthesiologists. The analysis reported here included the first
`111 TF-TAVI procedures using the S3, which were performed
`between June 2013 and March 2015, and the last 89 using the
`SAPIEN XT valve (SXT), performed between June 2013 and August
`2014. Written informed consent was obtained from all patients.
`
`Vascular access and valve selection
`
`Patients were selected to undergo TAVI via the transfemoral
`approach (TF) or alternative approaches depending on the size,
`calcification, and tortuosity of the ilio-femoral arterial access. The
`type and size of valve prosthesis was mainly selected according to
`the team’s and main operator’s preference. In all cases, the aortic
`root was assessed by multi-detector row computed tomography
`(MDCT) before the procedure in terms of calcification volume and
`location, distance between annulus and coronary arteries, and
`annulus diameter, which was the calculated annulus average
`diameter (CAAD) derived from the annulus area. The nominal
`external valve area of an expanded S3 prosthesis is 409 mm
`(23 mm), 519 mm (26 mm), and 649 mm (29 mm), as previously
`described [12]. The percentage of oversizing or undersizing was
`calculated using the following formula: (prosthesis nominal area/
`MDCT annular area 1)  100.
`
`Procedures
`
`Aspirin (75 mg) and clopidogrel (75 mg) daily were recom-
`mended prior to TAVI. A loading dose of clopidogrel (300–600 mg)
`was administered to patients who were not already on clopidogrel
`before or immediately after the procedure. Only one antiplatelet
`therapy (aspirin or clopidogrel) was used in combination with
`warfarin in the majority of patients on long-term anticoagulant
`therapy. A bolus of heparin (70 IU kg1) was administered at the
`start of the procedure to achieve an activated clotting time of 250–
`300 s, and the activated clotting time was measured every 30 min
`thereafter. All procedures were performed by an experienced team
`according to our standard operating procedures, as previously
`described [13].
`
`Post-procedural assessment of PVL
`
`was as follows: 0 = absent, 1 = trace, 2 = mild, 3 = moderate, and
`4 = severe.
`
`Post-procedural care
`
`All patients were observed in the intensive care unit for at least
`implantation. Dual antiplatelet therapy was
`24 h after valve
`continued for 1–3 months and, thereafter, aspirin was continued
`indefinitely. In patients on warfarin, aspirin or clopidogrel was
`stopped after 1 month.
`
`Endpoints
`
`The main endpoints of this study were the frequency of PVL 2
`after the procedure, major vascular complications, combined
`30-day safety endpoint, and all-cause mortality at 30 days. The
`combined 30-day safety endpoint included all-cause mortality,
`major stroke, life-threatening bleeding, acute kidney injury (AKI)-
`stage 3, major vascular complications, and further intervention due
`to valve dysfunction, according to the valve academic research
`consortium (VARC)-2 criteria [15]. AKI-stage 3 was defined as a
`change in serum creatinine (SCr) up to 72 h compared with
`baseline: 3.0-fold
`in SCr or DSCr 4.0 mg/dl
`increase
`(354 mmol/l) according to VARC-2 criteria.
`
`Statistical analysis
`
`All statistical analyses were performed using SPSS version 21.0
`(Chicago,
`IL, USA). Continuous variables are expressed as
`mean  SD or with the corresponding interquartile range. Dichoto-
`mous variables are expressed as counts and percentages. Compar-
`isons between the two groups were performed using Pearson’s
`bivariate test and the chi-square test for categorical covariates, and
`unpaired Student t test
`for continuous covariates. A value of
`p < 0.05 was considered significant.
`
`Results
`
`Baseline characteristics stratified by prosthesis type
`
`The main characteristics of the two groups are summarized in
`Table 1. Patient age, 83.1 years vs 83.0 years (p = 0.940) and logistic
`EuroSCORE 18.2% vs 16.6% (p = 0.385) were similar in the S3 and
`SXT groups, respectively. Other baseline characteristics were also
`similar between the two groups.
`
`Annular assessment by MDCT and procedural characteristics stratified
`by prosthesis type
`
`Annular assessment by MDCT and procedural characteristics
`are summarized in Table 2. The CAAD by MDCT was similar
`(23.7 mm vs 23.9 mm, p = 0.534) as was the annular area by MDCT
`(450 mm2 vs 458 mm2, p = 0.556). On the other hand, the valve size
`was smaller
`in the S3 group compared to the SXT group
`(25.1  2.3 mm vs 26.2  2.2 mm, p = 0.002) as were the valve
`diameter/CAAD ratio (1.06 vs 1.09, p < 0.001) and the % of annular
`area oversizing (11% vs 20%, p < 0.001). The sheath size was also
`significantly smaller
`in
`the S3 group
`(14.3 mm vs 18.1 mm,
`p < 0.001).
`
`Annular assessment by MDCT stratified by valve size
`
`After the procedure, semi-quantitative grading of PVL was
`performed using transthoracic echocardiography and aortogra-
`phy. Echocardiography was performed in all patients by experi-
`enced echocardiographers using a multi-parametric approach
`proposed by the guidelines [14]. Semi-quantitative grading of PVL
`
`Annular assessment by MDCT stratified by valve size
`is
`summarized in Table 3. In recipients of 23-mm and 26-mm
`prostheses, the valve diameter/CAAD ratio was significantly lower
`in the S3 group as was the annular area % oversizing. Similarly, in
`
`Please cite this article in press as: Arai T, et al. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic
`valve implantation: Difference of valve selection in the real world. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.04.012
`
`Page 2 of 5
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`3
`
`Table 1
`Baseline clinical characteristics stratified by prosthesis type.
`
`Table 3
`Annular assessment by MDCT stratified by valve size.
`
`SXT (n = 89)
`
`S3 (n = 111)
`
`p-Value
`
`SXT (n = 89)
`
`S3 (n = 111)
`
`p-Value
`
`83.0  7.4
`44 (49%)
`27.0  5.2
`1.77  0.21
`85 (96%)
`1 (1%)
`19 (21%)
`3 (4%)
`1 (1%)
`18 (20%)
`61 (69%)
`46 (52%)
`4 (5%)
`16.6  11.7
`58.5  23.2
`
`51.1  15.5
`0.64  0.14
`48.0  15.5
`0.80  0.83
`1.08  0.93
`47.9  13.1
`7.7  1.2
`
`83.1  6.1
`47 (42%)
`26.2  5.2
`1.72  0.21
`109 (98%)
`0 (0%)
`17 (15%)
`8 (7%)
`1 (1%)
`31 (27%)
`77 (69%)
`51 (45%)
`3 (3%)
`18.2  12.1
`60.5  29.6
`
`54.9  11.3
`0.65  0.15
`50.7  14.7
`1.03  0.63
`1.16  0.77
`44.1  14.5
`7.5  1.2
`
`Baseline characteristics
`Age (years)
`Gender, male
`BMI (kg/m2)
`BSA (m2)
`NYHA classification (III/IV)
`Prior MI, n
`Prior PCI, n
`Prior CABG, n
`Prior stroke, n
`Diabetes mellitus, n
`Hypertension, n
`Dyslipidemia, n
`COPD, n
`Logistic EuroSCORE (%)
`Creatinine clearance (ml/min)
`Echocardiographic data
`LVEF (%)
`AVA (cm2)
`Mean gradient (mmHg)
`AR grade (0–4)
`MR grade (0–4)
`PAP (mmHg)
`Diameter of femoral artery (mm)
`Values are number (%) or mean  SD.
`BMI, body mass index; BSA, body surface area; NYHA, New York Heart Association;
`MI, myocardial
`infarction; PCI, percutaneous coronary
`intervention; CABG,
`coronary artery bypass grafting; COPD, chronic obstructive pulmonary disease;
`LVEF,
`left ventricle ejection
`fraction; AVA, aortic valve area; AR, aortic
`regurgitation; MR, mitral regurgitation; PAP, pulmonary artery pressure; SXT,
`SAPIEN XT valve; S3, SAPIEN 3 valve. Diameter of femoral artery was assessed by
`angiography.
`
`0.940
`0.319
`0.307
`0.154
`0.292
`0.456
`0.220
`0.416
`0.881
`0.205
`0.900
`0.422
`0.504
`0.385
`0.599
`
`0.057
`0.721
`0.288
`0.074
`0.533
`0.111
`0.443
`
`23 mm
`CAAD by MDCT
`Annular area by MDCT (mm2)
`Valve/CAAD
`Nominal area oversizing (%)
`26 mm
`CAAD by MDCT
`Annular area by MDCT (mm2)
`Valve/CAAD
`Nominal area oversizing (%)
`29 mm
`CAAD by MDCT
`Annular area by MDCT (mm2)
`Valve/CAAD
`Nominal area oversizing (%)
`Values are number (%) or mean  SD.
`MDCT, multi-detector computed tomography; CAAD, calculated aortic annulus
`diameter; SXT, SAPIEN XT valve; S3, SAPIEN 3 valve.
`
`21
`20.9  0.9
`348.4  30.1
`1.09  0.05
`20.0  11.1
`41
`23.5  0.9
`439.4  36.1
`1.10  0.04
`21.5  9.1
`27
`26.6  1.3
`556.6  48.5
`1.09  0.05
`19.6  10.8
`
`52
`21.7  0.9
`372.1  32.5
`1.05  0.04
`10.7  10.2
`37
`24.3  1.0
`463.8  37.6
`1.07  0.04
`12.6  9.2
`22
`27.4  1.4
`593.3  62.7
`1.06  0.05
`10.5  11.1
`
`0.004
`0.012
`0.003
`0.003
`
`0.003
`0.009
`0.003
`<0.001
`
`0.079
`0.031
`0.074
`0.007
`
`Post-procedural characteristics stratified by prosthesis type
`
`Post-procedural characteristics are summarized in Table 4. The
`frequency of paravalvular aortic leakage (PVL) 2 tended to be
`lower in the S3 group (5% vs 9%, p = 0.339). The rate of major
`vascular complications was significantly lower in recipients of the
`S3
`(3% vs 12%, p = 0.013), while
`the need
`for pacemaker
`implantation was not increased (7% vs 4%, p = 0.341). In addition,
`30-day mortality was significantly lower in the S3 group (0% vs 5%,
`p = 0.044).
`
`Impact of prosthesis type on 2-month survival after TAVI
`
`The median follow-up period of this cohort was 82 days.
`Cumulative survival rates were calculated using the Kaplan–Meier
`method and compared with the log-rank test (Fig. 2). Although, the
`2-month survival rate was not significantly different between the
`two groups, there was a trend in favor of the S3 group (log-rank
`p = 0.053).
`
`Discussion
`
`The present study shows that compared to the SXT, the
`frequency of PVL 2 tended to be decreased in the S3 group.
`Furthermore, device downsizing and more precise valve position-
`ing may reduce the risk of 30-day mortality.
`Amat-Santos et al. reported that the frequency of PVL decreased
`with S3 compared to SXT in a small series of 27 S3 compared to
`50 SXT [16]. Yang et al. also reported that the frequency of PVL
`decreased with S3 compared to SXT in a series of 61 S3 compared to
`92 SXT [12]. Moderate to severe PVL after TAVI has been reported
`to be associated with poor outcomes [17] and even mild PVL may
`lead to unfavorable outcomes as shown by an increasing volume of
`data [18,19]. In order to address this issue, the S3 was designed to
`reduce PVL after the procedure by means of an additional outer
`skirt at the distal part of the prosthesis. Our study clearly shows
`that the use of the S3 valve is associated with a lower risk of PVL
`despite a relatively small ratio between valve diameter and CAAD.
`We recently reported the importance of the valve diameter/
`CAAD ratio for predicting the risk of post-procedural PVL after
`implantation of the SAPIEN valve [20] with a mean valve diameter/
`CAAD ratio of 1.09 in patients with PVL <2 and 1.05 in patients
`with PVL 2. In the present study, this ratio was significantly lower
`in the S3 group compared to SXT (1.06 vs 1.10), while the risk of
`significant PVL was reduced. With the SXT valve, a relatively high
`
`patients treated with 29-mm prostheses, the valve diameter/CAAD
`ratio tended to be lower in the S3 group as was the annular area
`oversizing percentage.
`
`Valve selection trends for cases with borderline annulus
`
`The valve selection trends for cases with borderline annulus are
`summarized in Fig. 1A (CAAD: 22–23.5 mm) and Fig. 1B (CAAD:
`25–26.5 mm). A significantly smaller valve size was selected in S3
`cases with borderline annulus.
`
`Table 2
`Annular assessment by MDCT and procedural characteristics stratified by
`prosthesis type.
`
`SXT (n = 89)
`
`S3 (n = 111)
`
`p-Value
`
`MDCT-guided valve sizing
`Short-axis diameter of
`annulus by MDCT (mm)
`Long-axis diameter of
`annulus by MDCT (mm)
`CAAD by MDCT
`Annular area by MDCT (mm2)
`Aortic valve calcium
`volume (mm3)
`Procedural characteristics
`Sheath size (Fr)
`Size of valve (mm)
`Valve/CAAD
`Nominal area oversizing (%)
`Contrast underfilling
`Contrast overfilling
`Values are number (%) or mean  SD.
`MDCT, multi-detector computed tomography; CAAD, calculated aortic annulus
`diameter; SXT, SAPIEN XT valve; S3, SAPIEN 3 valve.
`
`89 (100%)
`22.1  2.2
`
`26.7  2.8
`
`111 (100%)
`21.7  2.1
`
`26.4  2.7
`
`23.9  2.3
`458.7  87.3
`561.2  570.0
`
`23.7  2.4
`450.4  94.6
`634.0  363.3
`
`18.1  1.6
`26.2  2.2
`1.09  0.04
`20.5  10.0
`8 (9%)
`8 (9%)
`
`14.3  0.8
`25.1  2.3
`1.06  0.04
`11.3  10.0
`8 (7%)
`6 (5%)
`
`1.000
`0.242
`
`0.523
`
`0.534
`0.556
`0.630
`
`<0.001
`0.002
`<0.001
`<0.001
`0.646
`0.326
`
`Please cite this article in press as: Arai T, et al. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic
`valve implantation: Difference of valve selection in the real world. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.04.012
`
`Page 3 of 5
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`Fig. 1. (A) Valve selection trends (valve selection patterns) for cases with borderline annulus (CAAD: 22–23.5 mm). (B) Valve selection trends (valve selection patterns) for
`cases with borderline annulus (CAAD: 25–26.5 mm). CAAD, calculated annulus average diameter; SXT, SAPIEN XT valve; S3, SAPIEN 3 valve.
`
`Table 4
`Post-procedural characteristics stratified by prosthesis type.
`
`SXT (n = 89)
`
`S3 (n = 111)
`
`p-Value
`
`Post-procedural variables
`Procedural success
`0.083
`110 (99%)
`85 (96%)
`30-Day mortality
`0.044
`0 (0%)
`4 (5%)
`30-Day combined safety endpoint
`0.160
`5 (4%)
`8 (10%)
`Major stroke
`–
`0 (0%)
`0 (0%)
`AKI
`0.946
`2 (2%)
`2 (4%)
`Major vascular complication
`0.013
`3 (3%)
`11 (12%)
`Life-threatening bleeding
`–
`0 (0%)
`0 (0%)
`Annulus rupture
`0.320
`0 (0%)
`1 (2%)
`Pacemaker implantation
`0.341
`8 (7%)
`3 (4%)
`2-Valve implantation
`0.321
`1 (1%)
`0 (0%)
`Post-procedural PVL grade 2
`0.339
`6 (5%)
`8 (9%)
`11.0  5.4
`9.6  3.6
`Mean gradient by TTE (mmHg)
`0.319
`Values are number (%) or mean  SD. AKI, acute kidney injury; PVL, paravalvular
`aortic leakage; TTE, transthoracic echocardiography; SXT, SAPIEN XT valve; S3,
`SAPIEN 3 valve.
`
`ratio was applied in order to limit the risk of PVL 2, which can
`potentially
`lead to an
`increased risk of annulus rupture or
`perforation. The possibility of decreasing this ratio, while reducing
`the risk of PVL 2, is clearly a major technological advancement,
`which could lower the risk of not only 30-day but also longer-term
`mortality.
`Another improved feature of the S3 seems to be the reduced
`profile of the delivery system. The 14 Fr E-sheath can accommo-
`date a 23- and 26-mm valve and the 16Fr E-sheath a 29-mm valve.
`It has been reported that using a larger sheath can lead to a higher
`risk of vascular complications, which are considered major
`
`Fig. 2. Survival curves stratified by prosthesis type among all patients. SXT, SAPIEN
`XT valve; S3, SAPIEN 3 valve.
`
`likely to affect the outcome of TAVI patients
`complications
`[21,22]. This study showed that the sheath size was significantly
`reduced, and the incidence of major vascular complications tended
`to be lower with the S3 valve.
`Tarantini et al. reported that the frequency of post-procedural
`pacemaker implantation was higher in recipients of the S3 valve
`compared to the SXT (20.7% vs 3.4%, p < 0.0001) and that deep
`valve
`implantation was associated with a higher need
`for
`permanent pacemaker implantation [23]. In the study presented
`here, the valve was positioned sufficiently high according to
`the recommendations provided by experts, which explains the
`relatively low rate of pacemaker implantation (7%) and the absence
`of significant differences between the S3 and SXT.
`The present study revealed that 2-month survival tended to be
`better in the S3 group compared to SXT group. The lower rate of
`PVL and vascular complication in the S3 group seems to lead to the
`better outcome. Recently, Del Trigo et al. reported that smaller size
`of SXT was related to valve hemodynamic deterioration according
`to the follow-up echocardiographic data [24]. The present study
`revealed that smaller valve tended to be selected in S3 group.
`Further studies are required to clarify longer outcomes including
`survival and hemodynamic change of S3.
`Finally, these preliminary data are promising. Indeed, should
`the 30-day and longer-term results be confirmed, the S3 valve
`could pave the way for percutaneous treatment of patients at
`intermediate risk.
`
`Study limitations
`
`limitations that should be
`The present study has several
`addressed. Firstly, this was a single-center retrospective observa-
`tional study conducted in a limited cohort. Further studies with
`larger cohorts and multi-center analysis are required to confirm
`our results. Secondly, the mean follow-up period was 82 days and
`long-term follow-up is needed to confirm the S3 safety.
`
`Conclusions
`
`Although TAVI using the S3 tended to be carried out with a less
`oversized valve compared to TAVI using the SXT, the frequency of
`post-procedural PVL 2 tended to be lower in the S3 group. The
`outcomes including vascular complications and 30-day mortality
`showed a trend in favor of the S3 group.
`
`Conflict of interest statement
`
`Thierry Lefe` vre is a proctor for transfemoral-TAVI for Edwards
`Lifesciences, and is a consultant for Symetis, Direct Flow Medical,
`Boston Scientific, and Medtronic. Kentaro Hayahida is a proctor for
`transfemoral-TAVI for Edwards Lifesciences. Yusuke Watanabe is a
`
`Please cite this article in press as: Arai T, et al. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic
`valve implantation: Difference of valve selection in the real world. J Cardiol (2016), http://dx.doi.org/10.1016/j.jjcc.2016.04.012
`
`Page 4 of 5
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`JJCC-1307; No. of Pages 5
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`proctor for transfemoral-TAVI for Edwards Lifesciences. Bernard
`Chevalier is a consultant and proctor for Medtronic.
`
`Acknowledgments
`
`The authors thank Mrs Catherine Dupic for her assistance in the
`preparation of this manuscript.
`
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