6/23/2017 Eurolntervention Comparison of the new balloon-expandable Edwards Sapien 3 valve with the self-expanding Medtronic corevalve for transfemoral aortic...
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`Comparison of the new balloon-expandable Edwards Sapien 3 valve with the self-
`expanding Medtronic corevalve for transfemoral aortic valve implantation in 200
`patients
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`Published on 15 May 2015
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`Gonska B., Rodewald C., Trepte U., Baarts J., Seeger J., Markovic 8., Scharnbeck D., Rottbauer W., W6hrle J.
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`University of Ulm, Ulm, Germany
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`Euro15A—P08291
`Ill-I'D
`
`PCR
`Interventions for structural heart disease
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`Comparison of the new balloon-expandable Edwards Sapien 3 valve with the self-expanding Medtronic corevalve for transfemoral aortic valve
`implantation in 200 patients
`
`Gonska B., Rodewald C., Trepte U., Baarts J., Seeger J., Markovic 8., Scharnbeck D., Rottbauer W., W6hrle J.
`
`University of Ulm, Ulm, Germany
`
`In the randomised CHOICE trial device success was significantly higher with the balloon expandable Edwards Sapien XT (EXT) compared with
`Aims:
`the self-expanding CoreValve (CV) prosthesis in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation (TAVI). The new
`Edwards Sapien 3 valve was optimised regarding design to minimise the risk for paravalvular aortic regurgitation. We compared the outcome of the E83
`with the CoreValve in patients undergoing TAVI.
`
`Methods and results: The first 100 consecutive patients treated with the E83 were compared with the last 100 consecutive patients treated with the
`CoreValve (Clinical Trial Registration: NCT02162069). The mean STS-Score for mortality of the population was 10.217.9%. We evaluated post-
`procedural aortic regurgitation, rate of permanent pacemaker implantation, and device success according to VARC criteria. Device size was based on
`multislice computer tomography performed with a 256 Philips Brilliance iCT scanner. Measurements of aortic annulus,
`left ventricular outflow tract
`(LVOT) were performed with dedicated software (3mensio Structural Heart, version 7.0). Baseline characteristics were similar between the CoreValve
`and E83 population: age 8116 vs. 8216 years (p=0.24), female 49% vs. 52% (p=0.67), diabetes mellitus 34% vs. 38% (p=0.56), coronary artery disease
`61% vs. 60% (p=0.89), history of cardiac surgery 14% vs. 9% (p=0.27), pulmonary disease 36% vs. 60% (p<0.01). Also the following computer
`tomography acquired parameters did not differ significantly between the EXT and E83 population: aortic annulus area derived diameter 25.3122 vs.
`24.7124 mm (p=0.05), aortic annulus perimeter derived diameter 26.0123 vs. 25.4125 mm (p=0.07), aortic annulus area 508189 vs. 483196 mm
`(p=006), LVOT area derived diameter 25.4129 vs. 24.6126 mm (p=0.04), LVOT perimeter derived diameter 26.413.1 vs. 25.6126 mm (p=0.04), LVOT
`area 5151121 vs. 4801101 mm (p=0.03), heavy calcification of the aortic annulus (Rosenhek Grade IV) 85% vs. 88% (ns). Size of the CoreValve was 23
`mm in 2%, 26 mm in 17%, 29 mm in 75% and 31 mm in 6%. Numbers for E83 were 29%, 50% and 21%, respectively. Post dilation was necessary in
`11% after CoreValve implantation and in no patient after E83 implantation (p<0.01). Rate of device success according to VARC was significantly higher
`in the E83 population with 93% vs. 76% in the CV group (p<0.01). There was no annulus rupture, coronary obstruction or periprocedural death. The
`rate of postprocedural nondisabling or disabling stroke was similar (CV 2% vs. E83 4%, p=0.40). There was a statistical significance in the rate of
`paravalvular aortic regurgitation by postprocedural echocardiography with moderate or severe aortic regurgitation of 20% in the CV population vs. 1% in
`the E83 population (p<0.01). Numbers for mild regurgitation were 43% vs. 31% (p=0.22), none or trace 37% vs. 68% (p<0.01), respectively. Life
`threatening bleeding according to VARC was similar (CV 1% vs. E83 0%, p=0.37). There was a statistically significant lower rate of post-procedural new
`pacemaker implantation for the E83 with 15% vs. 31% for the CV (p<0.01).
`
`Conclusions: Transfemoral TAVI with the new E83 compared with the CoreValve was associated with a statistical significant lower rate of moderate or
`severe aortic regurgitation, significant lower need for pacemaker implantation and a significant higher rate of device success according to VARC.
`Edwards Lifesciences v. Boston Scientific Scimed
`
`IPR2017-00060, US. Patent 8,992,608, Exhibit 2061
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`6/23/2017 Eurolntervention Comparison of the new balloon-expandable Edwards Sapien 3 valve with the self-expanding Medtronic corevalve for transfemoral aortic...
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