TAVI limitations for low risk patients

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1 TAVI limitations for low risk patients Dr. T. Modine / P. Lancellotti MD, PhD, MBA CHRU de Lille, France

2 Potential conflicts of interest Speaker's name: Thomas Modine I have the following potential conflicts of interest to report: Affiliation/Financial Relationship Grant/Research Support Consulting Fees / Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company Edwards Abbott, Boston Scientific, Medtronic, Edwards, Cephea, Microport, GE Valmy Microport Valmy ltd Yes Nil

3 TAVI in the last years Huge improvements, but

4 TAVI vs. SAVR where does the evidence come from? Observational studies propensity score matching Randomized controlled trials

5 STS database n=141, % Intermediate risk (STS 4-8%) 79.9% Low risk (STS <4%) *Thourani, et al., Ann Thorac Surg 2015; 99: 55-61

6 Similar outcomes between TAVI & SAVR in matched intermediate risk... STS (%, mean) Log EuroSCORE (%, mean) TAVI (n=255 ) Piazza 1 OBSERVANT 2 Latib 3 SAVR (n=255) p TAVI (n=133) SAVR (n=133) p TAVI (n=111) SAVR (n=111) na na Day Mortality (%) Piazza, et al. J Am Coll Cardiol Intv 2013; 6: D Errigo, et al. Int J Cardiol 2013; 167: Latib, et al. Am Heart J 2012; 164:910-7 p

7 2-Year All-Cause Mortality CoreValve ADVANCE Registry 36% 26% 4% 14% 7% 21% CoreValve ADVANCE Study

8 Mortality and Stroke: S3i At 30 Days (As Treated Patients) 100 Mortality 100 Stroke All-Cause Cardiovascular All Stroke Disabling O:E = 0.21 (STS 5.3%) % % S3i S3i

9 TAVI in the last years Huge improvements, but Matter of debate Complications rate reduction

10 % All-Cause Mortality at 30 Days 30-day All-cause Mortality 10% 8,4% 8% 7,0% 6% 5,1% 4,4% 4% 2% 3,5% 3,3% 2,9% 2,2% 1,3% 1,1% 0% CoreValve Extreme Risk N=489 SAPIEN TVT HR N=12182 SAPIEN PARTNER IIB N=276 LOTUS REPRISE II + Ext N=249 SAPIEN XT PARTNER IIB N=284 CoreValve High Risk N=390 Portico CE Study N=103 SAPIEN 3 PARTNER II S3 HR N=583 Direct Flow DISCOVER N=75 SAPIEN 3 PARTNER II S3i N=1076 0,0% Evolut R CE Study N=60 1 Popma, et al., J Am Coll Cardiol 2014; 63: ; 2 Holmes, et al., JAMA 2015; 313: ; 3 Leon, et. al. presented at ACC 2013; 4 Meredith, et al., presented at PCR London Valves 2014; 5 Adams, et al., N Engl J Med 2014; 370: ; 6 Manoharan, et al., et. al. presented at TCT 2014; 7 Kodali, et al., presented at ACC 2015; 8 Schofer, et al., J Am Coll Cardiol 2014; 63: 763-8; 9 Meredith, et al., presented at ACC 2015

11 % Patients with Moderate / Severe PVL at 30 Days Moderate to severe PVL 30% 25% 24,2% 20% 16,9% 15% 10% 11,4% 9,0% 5% 0% SAPIEN XT PARTNER IIB N=236 SAPIEN PARTNER IIB N=225 CoreValve Extreme Risk N=418 CoreValve High Risk N=356 4,0% 3,8% 3,4% Portico CE Study N=75 SAPIEN 3 PARTNER II S3 N=1504 Evolut R CE Study N=60 1,4% Direct Flow DISCOVER N=74 0,6% LOTUS REPRISE II + Ext N=177 1 Leon, et. al. presented at ACC 2013; 2 Popma, et al., J Am Coll Cardiol 2014; 63: ; 3 Adams, et al., N Engl J Med 2014; 370: ; 4 Manoharan, et al., et. al. presented at TCT 2014; 5 Kodali, et al., presented at ACC 2015; 6 Meredith, et al., presented at ACC 2015; 7 Schofer, et al., J Am Coll Cardiol 2014; 63: 763-8; 8 Meredith, et al., presented at PCR London Valves 2014

12 % Patients with PPM at 30 Days 35% 30-day Permanent Pacemaker 30% 28,9% 25% 20% 21,6% 19,8% 17,0% 15% 10% 13,0% 11,7% 10,1% 9,7% 6,4% 5,9% 5% 0% LOTUS REPRISE II + Ext N=249 CoreValve Extreme Risk N=489 CoreValve High Risk N=390 Direct Flow DISCOVER N=100 SAPIEN 3 PARTNER II S3 HR N=583 Evolut R CE Study N=60 SAPIEN 3 PARTNER II S3i N=1076 Portico CE Study N=103 SAPIEN XT PARTNER IIB N=284 SAPIEN PARTNER IIB N=276 1 Meredith, et al., presented at PCR London Valves 2014; 2 Popma, et al., J Am Coll Cardiol 2014; 63: ; 3 Adams, et al., N Engl J Med 2014; 370: ; 4 Schofer, et al., J Am Coll Cardiol 2014; 63: 763-8; 5 Kodali, et al., presented at ACC 2015; 6 Meredith, et al., presented at ACC 2015; 7 Manoharan, et al., et. al. presented at TCT 2014; 8 Leon, et. al. presented at ACC 2013

13 % Patients with Stroke at 30 Days 30-day stroke rate 8% 7% 6,8% 6% 5% 4% 4,9% 4,3% 4,1% 4,0% 4,0% 3,9% 3% 2,6% 2,5% 2% 1,5% 1% 0% LOTUS REPRISE II + Ext N=249 CoreValve High Risk N=390 SAPIEN XT PARTNER IIB N=284 SAPIEN PARTNER IIB N=276 Direct Flow DISCOVER N=75 CoreValve Extreme Risk N=489 Portico CE Study N=103 SAPIEN 3 PARTNER II S3i N=1076 SAPIEN TVT HR N=12182 SAPIEN 3 PARTNER II S3 HR N=583 0,0% Evolut R CE Study N=60 1 Meredith, et al., presented at PCR London Valves 2014; 2 Adams, et al., N Engl J Med 2014; 370: ; 3 Leon, et. al. presented at ACC 2013; 4 Schofer, et al., J Am Coll Cardiol 2014; 63: 763-8; 5 Popma, et al., J Am Coll Cardiol 2014; 63: ; 6 Manoharan, et al., et. al. presented at TCT 2014; 7 Kodali, et al., presented at ACC 2015; 8 Holmes, et al., JAMA 2015; 313: Meredith, et al., presented at ACC 2015

14 Durability Just be patient to see how old it will GROW

15 The NOTION Trial all-cause mortality 31.1% 29.4% Number at risk: Courtesy L. sondergaard

16 The NOTION Trial conclusions Through 5 years follow-up of the NOTION trial: Excellent haemodynamic valve performance was maintained Bioprosthetic failure was low and similar for the selfexpanding transcatheter (CoreValve) and the surgical valves implanted Structural valve deterioration was significantly greater for SAVR compared with TAVI There was no valve thrombosis and similar rates of endocarditis for both groups Courtesy L. sondergaard

17 Medtronic TAVR in Low Risk Patients Trial Design Patient Population: Low Risk Cohort Determined by Heart Team to be low surgical risk Primary Endpoint: Safety: Death, all stroke, life-threatening bleeding, major vascular complications, or AKI at 30 days Efficacy: Death or major stroke at 2 years (One year analysis for early FDA submission) Sample Size: ~1200 Subjects Follow-up Evaluations: 30-days, 6-month, 18-month, and 1 Through 5 years Number of Sites: Up to 80

18 PARTNER 3 Low Risk Study Design & Registries Severe Calcific Aortic Stenosis PARTNER 3 Registries Aortic ViV (n = 100) Alternative Access Registry (TA/TAo/Subclavian) (n = 100) Low Risk ASSESSMENT by Heart Team AND STS < 4 1:1 Randomization (n = 1,228) Mitral ViR (n = 50) Mitral ViV (n= 50) TF - TAVR (SAPIEN 3) CT Imaging sub-study (n = 200) Actigraphy/QoL sub-study SAVR (Any approved Surgical Bioprosthetic Valve) CT Imaging sub-study (n = 200) Actigraphy/QoL sub-study PRIMARY ENDPOINT: Composite of all-cause mortality, all stroke, or re-hospitalization at 1 year post procedure Follow-up: Annually through 10 years

19 TAVR in Low-Risk Patients TAVR is now the preferred therapy in AS patients : Inoperable High-risk Some intermediate-risk Secondary benefits associated with TAVR Reduced ICU and hospital LOS, More rapid QOL recovery, Lower frequency of AKI, bleeding, and post-operative AF Improved valve hemodynamics. TAVR is now being studied in low-risk AS patients in randomized clinical trials!

20 Conclusions A systematic fall in surgical risk scores is evident (Europe > US) Lower risk patients are currently being treated (Europe > US) Clinical outcomes in patients with lower surgical risk scores are excellent Risk scores need to be reconsidered: AGE as a decision factor? RCT: Partner III, EvolutR low risk, NOTION II

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