Current Evidence in TAVI patients using ACURATE and LOTUS valves

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Current Evidence in TAVI patients using ACURATE and LOTUS valves Giuseppe Tarantini, MD, PhD, FESC, Professor and Director of Interventional Cardiology University of Padua GISE President

Potential conflicts of interest Speaker's name : Giuseppe, Tarantini, Padua I have the following potential conflicts of interest to report: Receipt of honoraria or consultation fees: Abbott, Boston Scientific and Symetis, Edwards Lifesciences, Medtronic, Philips Healthcare, Sanofi Aventis, St. Jude Medical

Evidences

ACURATE neo TM TF Clinical Program TF20 FIM FIM Study High Risk Patients with Severe AS N=20; single arm; 4 centers - 3 valve sizes (21mm-27mm) 1⁰ Endpoint: All-cause mortality at 30d Complete TF89 SAVI-TF Registry PROGRESS PVL CE Mark Study High Risk Patients with Severe AS N=89; single arm; 6 centers - 3 valve sizes (21mm-27mm) 1⁰ Endpoint: Freedom from all-cause mortality at 30d Post-Market Registry High Risk Patients with Severe AS N=1000; single arm; 25 EU centers - 3 valve sizes (21mm-27mm) 1⁰ Endpoint: All-cause mortality at 30d 2⁰ Endpoints: Procedure success post-implant, device performance at 7d and 12m, VARC-2 safety and NYHA class at 30d and 12m Post-Market Registry N=500; single arm; prospective; 35 international sites Assessment of PVL at 7d, 30d, and 1y with CoreLab Complete PUBLISHED COMPLETED

Percent of Patients SAVI-TF Registry 30-Days and 12-Months Result 15 30 Days 12 Months 13.0 10 9.9 9.6 8.0 8.3 8.4 7.3 5 3.5 4.1 3.4 1.4 1.9 1.8 1.8 0 0.0 0.2 All Cause Mortality All Stroke New Pacemaker Implantation PVL 2 (Moderate) PVL > 2 (Mod/Severe) Mean Gradient (mmhg) EOA (cm 2 ) NYHA III/IV #PVL 2, PVL>2, Mean Gradient, and EOA were measured at 7 days/discharge and 1 year; 1-Year Endpoints are estimated Kaplan-Meier incidence 30-Day Endpoints and 7-Days PVL: Möllmann, et al. EuroIntervention 2018; 1-Year Endpoints and PVL: Kim, et al. JACC Cardiovasc Interv 2018

ACURATE neo Published Clinical Studies MORENA München, Regensburg, Bad Nauheim ACURATE neo vs SAPIEN 3 Observational, 1:2 propensity-matched multicenter ACURATE neo (n = 311) and SAPIEN 3 (n = 622) 3 high volume centers in Germany Device failure and early safety at 30 days 30 Days MULTICENTER COMPARISON IN PTS WITH SMALL ANNULI (A<400 mmq) ACURATE neo vs SAPIEN 3 Retrospective, 1:1 propensity-matched multicenter ACURATE neo (N = 92) and SAPIEN 3 (N = 92) 5 high volume centers in Germany, safety and performance of ACURATE neo and SAPIEN 3 in patients with small aortic annuli (Area <400 mmq) 30 Days & 1 Year SINGLECENTER COMPARISON AMONG 3 THVs ACURATE neo vs. CoreValve vs SAPIENT XT Prospective registry - the ACURATE neo (n=49), CoreValve (n=56), or SAPIEN XT (n=57) in a single center VARC-2 safety, device success, individual clinical endpoints, periprocedural outcomes, and echocardiography findings 30 Days

#1:MORENA RESULTS SUMMARY 30-days VARC-2 Safety and Performance Endpoints (% of pts) PM Rate and Hemodynamic Performance (% of pts/mmhg) 20 15 10 [n.s.] 15.8 15.6 10.9 [n.s.] 9.6 20 15 10 [P = 0.024] 9.9 15.5 ACURATE neo SAPIEN 3 [P = 0.008] [P = 0.021] 6.9 [P 0.001] 9.0 13.0 [P 0.001] 8.0 12.0 5 5 4.8 1.8 3.2 0 Early Safety Composite Endpoint (30 days) Device Failure Composite Endpoint 0 Permanent Pacemaker Implantation (in-hospital) PVL 2 (acute) Elevated Gradients Mean Gradient 20 mmhg (acute) (mmhg, discharge) Mean Gradient (mmhg, 30 days) Husser O. et al. JACC Cardiovasc Interv 2017;10:2078-2087

#2: ACURATE neo vs. S3 in pts With Small Aortic Annulus Acute, 30-d, 1-y Outcome Summary (% of patients unless otherwise stated) Mauri V, et al. JACC Cardiovasc Interv 2017

#3: ACURATE neo Aortic Valve vs CV vs SAPIEN XT Clinical Outcomes at 30 days Mean age 83 years, 54% female, 75% NYHA Class III/IV; Few significant differences in baseline characteristics ACURATE neo (n=49) CoreValve (n=56) SAPIEN XT (n=57) VARC-2 Composite Early Safety 12% 25% 16% 0.21 All-cause Mortality 4% 11% 4% 0.22 Cardiovascular Death 4% 9% 2% 0.20 Stroke 0% 2% 2% 0.64 TIA 0% 5% 0% 0.06 Periprocedural MI 0% 4% 2% 0.40 AKI (Stage 2/3) 6% 7% 4% 0.69 Major vascular complication 2% 7% 5% 0.48 LT Bleeding 0% 4% 5% 0.29 Cardiac tamponade 0% 4% 2% 0.40 New PPMI 6% 25% 11% 0.01 Device Success 98% 86% 95% 0.04 P ACURATE neo compared favorably against CV and SXT CV was associated with lower device success due to higher valve embolization/ migration rates and higher PPMI Jatene, et al. Catheter Cardiovasc Interv 2017

ACURATE neo AS Study ACURATE neo2 Valve (n=120) Valve Hemodynamics* Paravalvular Regurgitation* Procedural success 97.5% Low rates of major vascular complications, life-threatening/disabling bleeding, and TAV-in-TAV deployment overall <5% 30-day safety outcomes were comparable to those observed in other TAVI studies in similar patient populations (Death + Disabling stroke <5%) * Core-lab adjudicated data. Values may not add to 100% due to rounding. As-treated population.

Learning Curve Effect - ACURATE neo Single Arm, Predictors of Procedural Outcome Study (N=500) First 100 cases Last 100 cases P-value Cover index, % 6.0 7.5 0.001 Device landing zone calcium volume, mm 3 648.0 547.0 0.006 Rapid pacing during deployment, % 82.0 0 <0.001 Upper crown adjacent to leaflet, % 76.0 90.0 0.005 All-cause 30-day mortality, % 5.0 1.3 0.18 Device success (VARC 2) 86.0 94.0 0.06 Paravalvular leak 2 11.0 3.0 0.03 Kim WK, et al. JACC Cardiovasc Interv 2018

Evidences

Lotus Clinical Program REPRISE I REPRISE II/II EXT RESPOND RESPOND Extension REPRISE III REPRISE Japan Feasibility Study for Acute Safety in High Risk Patients N=11; single arm; 23mm valve size 1⁰ Endpoint: Device success (VARC) without MACCE CE Mark Study + Extended Cohort in High Risk Patients N=250; single arm; 23mm & 27mm valve sizes 1⁰ Endpoint: 30d Mortality Post Market Study, Safety & Performance in All Comers N=1014; single arm; 23mm, 25mm, 27mm valve sizes 1⁰ Endpoint: Mortality at 30d and 1yr Post Market Study, Safety & Performance in Lotus With Depth Guard N=50; single arm; 23mm & 25mm valve sizes 1⁰ Endpoint: Mortality at 30d and 1yr Pivotal Study for FDA Approval in High Risk & InOpPatients N=1014; RCT; Lotus vs CoreValve (52% CV Classic/R 48% Evolut R ) 1⁰ Endpoint: 30d Mortality, stroke, LT/major bleed, AKIN Stage 2/3 or major vascular complications Safety for PMDA Approval: Safety & Effectiveness, High Risk & InOp N=50; single-arm; 23, 25, & 27mm valve sizes 1 Endpoint similar to REPRISE III; safety at 30d, effectiveness at 6m 5-yr f/u TCT 2017 4-yr f/u PCR LV 2018 2-yr f/u PCR 2018 30-d Results PCR 2017 2-yr Results TCT 2018 Tokyo Valves 6-m Results 2018

REPRISE II 4Y Follow-Up N=250 (As treated) Paravalvular Aortic Regurgitation* NYHA Class* Mortality Disabling Stroke At 4 Y FU, the fully repositionable and retrievable Lotus Valve continues to demonstrate: Good hemodynamic results, Sustained functional improvement, No repeat procedures for valve dysfunction required and KM analyses * Core-lab adjudicated data. Values may not add to 100% due to rounding. As-treated population. Minimal paravalvular regurgitation

CoreValve better Lotus better Similar REPRISE III Key Results N=607 Lotus & N=305 CoreValve (Intent-to-Treat) Primary Safety* (Noninferiority; 30d) Primary Effectiveness (Superiority; 1y) Disabling Stroke (Superiority; 1y) LOTUS CV/ER P Value 20.3% (117/576) 17.2% (51/297) 0.003 15.8% (82/520) 26.0% (68/262) <0.001 3.6% (21/587) 7.1% (21/297) 0.02 Moderate or greater PVL (Superiority; 1y) 0.9% (4/452) 6.9% (15/216) <0.001 Repeat Procedure (1y) 0.2% 2.0% 0.007 TAV-in-TAV (1y) 0.0% 3.7% <0.001 Valve Malposition 0.0% 2.6% <0.001 Valve Thrombosis (1y) 1.5% 0.0% 0.03 Pacemaker (30d) [no prior PM] 35.5% 19.6% <0.001 Gradient/EOA (1y) 12.3mmHg/ 1.5cm 2 7.9mmHg/ 1.7cm 2 <0.001 * Composite of all-cause death, stroke, life-threatening/major bleed, major vcs & stage 2/3 AKI (Implanted) Composite of all-cause death, disabling stroke & moderate or greater PVL

Overall Stroke (%) REPRISE III Disabling Stroke at 1 Year 15 CoreValve Lotus HR 0.53 [0.29, 0.96] P=0.03 10 2 year results - TCT 2018 5 7.4% 4.0% No. at risk CoreValve Lotus 0 0 30 60 90 120 150 180 210 240 270 300 330 360 390 297 282 276 264 251 200 577 555 541 527 511 415 Days Feldman T, et al. JAMA 2018;319:27-37

LOTUS Edge (1Y) Combined Cohort N=36 (As treated) Valve Hemodynamics Paravalvular Regurgitation* Low rates of death and stroke (~5%) Sustained haemodynamics and functional improvement 97.1% none/trace paravalvular leak 15.2% rate of new permanent pacemaker vs ~30% with first-generation Lotus Limitation: small feasibility study; results need to be confirmed in REPRISE IV trial * Among patients with evaluable echocardiograms. As assessed by an independent core laboratory.

New Permanent Pacemaker to 30 Days TAVI Clinical Studies Trial (N) % Patients CoreValve Ext. Risk (N=489) CoreValve High Risk (N=390) EVOLUT R (N=241) REPRISE III (N=303) REPRISE III (N=601) REPRISE II/III EXT (N=250) RESPOND Ext (N=50) RESPOND (N=1014) PARTNER Inoperable (N=179) PARTNER High Risk (N=348) MORENA (N=622) MORENA (N=311) Bagur et al. (N=19) Jatene et al. (N=49) ACURATE neo TF89 (N=78) SAVI TF (N=998) Toggweiler et al. (N=175) Jatene et al. (N=56) Jatene et al. (N=57) PARTNER 2A (N=1011) PARTNER 2S3i (N=955) SURTAVI (N=864) 2.3 3.4 3.8 5.3 6.0 8.3 8.5 10.2 10.3 11.0 10.2 16.4 15.8 16.4 18.0 21.6 19.8 25.0 25.9 29.1 28.9 30.0 High/ Extreme Risk Intermediate Risk CoreValve Evolut R Lotus, Lotus w/depth Guard Sapien Sapien XT Sapien S3 ACURATE neo Aortic Valve 0.0 40.0

New Permanent Pacemaker to 30 Days TAVI Clinical Studies Trial (N) CoreValve Ext. Risk (N=489) CoreValve High Risk (N=390) EVOLUT R (N=241) REPRISE III (N=303) REPRISE III (N=601) REPRISE II/III EXT (250) RESPOND Ext (N=50) RESPOND (N=1014) PARTNER Inoperable (N=179) PARTNER High Risk (N=348) MORENA (N=622) MORENA (N=311) Bagur et al. (N=19) Jatene et al. (N=49) ACURATE neo TF89 (N=78) SAVI TF (N=998) Toggweiler et al. (N=175) Jatene et al. (N=56) Jatene et al. (N=57) PARTNER 2A (N=1011) PARTNER 2S3i (N=955) SURTAVI (N=864) % Patients 16.4 15.8 21.6 19.8 CoreValve 29.1 Evolut R 28.9 18.0 30.0 Lotus, Lotus w/depth Guard 3.4 3.8 High/ 16.4 Extreme Risk Sapien 10.2 5.3 Sapien XT 6.0 10.3 Sapien S3 8.3 2.3 ACURATE neo Aortic Valve 25.0 11.0 7,1% 8.5 26,5% 12,7% Intermediate 10.2 Risk 25.9 0.0 40.0

All Stroke to 1 Year TAVI Clinical Studies Trial (N) % Patients CoreValve CoreValve Ext. Risk (N=489) CoreValve High Risk (N=390) 7.0 8.8 Evolut R EVOLUT R (N=241) 7.7 Lotus, Lotus w/depth Guard REPRISE III (N=297) REPRISE III (N=587) REPRISE II/III EXT (N=250) 7.0 8.4 9.4 High/ Extreme Risk Sapien Sapien XT RESPOND (N=988) PARTNER Inoperable (N=179) 4.9 7.8 Sapien S3 PARTNER High Risk (N=348) ACURATE neo TF89 (N=89) 5.1 6.7 ACURATE neo Aortic Valve SAVI TF (N=1000) PARTNER 2A (N=1011) 3.5 8.0 Intermediate Risk PARTNER 2S3i (N=930) 4.6 SURTAVI (N=879) 5.4 0.0 15.0

All Stroke to 1 Year TAVI Clinical Studies Trial (N) % Patients CoreValve CoreValve Ext. Risk (N=489) CoreValve High Risk (N=390) EVOLUT R (N=241) REPRISE III (N=297) REPRISE III (N=587) REPRISE II/III EXT (250) RESPOND (N=988) PARTNER Inoperable (N=179) PARTNER High Risk (N=348) ACURATE neo TF89 (N=89) SAVI TF (N=1000) 3.5 Intermediate PARTNER 2A (N=1011) 8.0 Risk 5,1% 6,8% 7% PARTNER 2S3i (N=930) 4.6 SURTAVI (N=879) 4.9 5.1 5.4 6.7 7.0 7.0 7.7 7.8 8.4 8.8 9.4 High/ Extreme Risk Evolut R Lotus, Lotus w/depth Guard Sapien Sapien XT Sapien S3 ACURATE neo Aortic Valve 0.0 15.0

Trial (N) Moderate/Severe PVL to 1 Year TAVI Clinical Studies % Patients Valve CoreValve CoreValve Ext. Risk (N=327) 4.2 Evolut R CoreValve High Risk (N=390) EVOLUT R (N=188) REPRISE III (N=216) 3.7 6.1 6.9 High/ Extreme Risk Lotus, Lotus w/depth Guard Sapien REPRISE III (N=452) REPRISE II/III EXT (N=250) 0.0 0.9 Sapien XT RESPOND (N=545) PARTNER Inoperable (N=179) PARTNER High Risk (N=348) 0.4 6.8 10.5 Sapien S3 ACURATE neo Aortic Valve ACURATE neo TF89 (N=66) 4.5 SAVI TF (N=587) PARTNER 2A (N=751) PARTNER 2S3i (N=900) 1.5 3.6 3.4 Intermediate Risk SURTAVI (N=599) 5.3 0.0 15.0

Trial (N) Moderate/Severe PVL to 1 Year TAVI Clinical Studies % Patients Valve CoreValve CoreValve Ext. Risk (N=327) CoreValve High Risk (N=390) EVOLUT R (N=188) REPRISE III (N=216) REPRISE III (N=452) REPRISE II/III EXT (250) RESPOND (N=545) PARTNER Inoperable (N=179) PARTNER High Risk (N=348) ACURATE neo TF89 (N=66) 0.0 0.4 0.9 3.7 4.2 SAVI TF (N=587) 3.6 Intermediate PARTNER 2A (N=751) 3.4 Risk 4% 0,4% 5% PARTNER 2S3i (N=900) 1.5 SURTAVI (N=599) 4.5 5.3 6.1 6.9 6.8 10.5 High/ Extreme Risk Evolut R Lotus, Lotus w/depth Guard Sapien Sapien XT Sapien S3 ACURATE neo Aortic Valve 0.0 15.0

New Performance benchmarks For low-risk patients (@30 days) All-cause mortality 1% Major (disabling) strokes 1% Major vascular complications <3% New permanent pacemaker <10% Moderate-severe PVL <3% Martin Leon, TCT 2016

New Performance benchmarks For low-risk patients (@30 days) All-cause mortality 1% Major (disabling) strokes 1% Major vascular complications <3% New permanent pacemaker <10% Moderate-severe PVL <3% Martin Leon, TCT 2016

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