Is TAVI ready for prime time in: - Intermediate risk patients? - Low risk patients?
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1 Is TAVI ready for prime time in: - Intermediate risk patients? - Low risk patients? Didier TCHETCHE, MD. Clinique PASTEUR, Toulouse, France,
2 Conflicts of interest: -Consultant for Edwards LifeSciences -Consultant for Medtronic -Consultant for Boston Scientific
3 TAVI procedures worldwide > procedures in > 65 countries
4 What do we know about TAVI in intermediate-risk patients?
5 Key Message We are already treating intermediate risk patients
6 2014 ACC/AHA guidelines Low Risk (Must Meet ALL Criteria in this column) Intermediate Risk (Any 1 criterion in this column) High Risk (Any 1 criterion in this column) Prohibitive Risk (Any 1 criterion in this column) STS PROM* Frailty <4% AND None AND 4% to 8% OR 1 Index (mild) OR >8% OR 2 Indices (moderate to severe) OR Predicted risk with surgery of death or major morbidity (allcause) >50% at 1 y OR Major organ system compromise not to be improved postoperatively None AND 1 Organ system OR No more than 2 organ systems OR 3 Organ systems OR Procedure- specific impediment None Possible procedurespecific impediment Possible procedurespecific impediment Severe procedurespecific impediment
7 How frequent is a lower risk profile? Adams et al. NEJM 2014
8 Intermediate-risk patients are already reffered to TAVI Van Mieghem et al. EuroItervention 2016
9 Key Message Intermediate risk patients have a better outcome
10 PARTNER 1B R. Makkar et al. JACC 2014;63:
11 2-Year All-Cause Mortality CoreValve ADVANCE Registry 36% 7% 4% 26% 14% 21% CoreValve ADVANCE Study
12 Key Message TAVI is comparable to surgery in Intermediate risk patients
13 BERn-MUnich-rotterDAm BERMUDA 510 matched patients (STS scores 3-8%) 255 TAVR patients 255 SAVR patients Piazza, et al., J Am Coll Cardiol Intv 2013; 6:
14 BERn-MUnich-rotterDAm 30-day All-cause mortality 1-year All-cause mortality
15 PARTNER II
16 Key Message TAVI seems promising in low risk patients
17 Low Risk The NOTION trial was the first to randomize TAVI with CoreValve to SAVR in low and intermediate risk patients
18 The NOTION Trial Randomized Low-Risk Patients Main inclusion criteria Severe AS Age 70 years Life expectancy 1 year Suitable for TAVR & SAVR Main exclusion criteria Severe CAD Severe other valve disease Prior heart surgery Need for acute treatment Recent stroke or MI Severe lung disease Severe renal failure Thyregod et al., JACC 2015
19 The NOTION Trial Randomized Low-Risk Patients NOTION Trial Select Baseline Characteristics Characteristic, % or mean ± SD TAVI n=145 SAVR n=135 p-value Age (yrs) 79.2 ± ± Male STS Score 2.9 ± ± STS Score < 4% NYHA class III or IV Thyregod et al., JACC 2015
20 The NOTION Trial Randomized Low-Risk Patients P-Value (log-rank) = 0.43
21 The NOTION Trial Randomized Low-Risk Patients
22 Key Message FDA approved randomized trial for low risk patients: -TAVI vs SAVR -Age 65 -Medtronic / Evolut R -Edwards LifeScience/ Sapien 3 -Boston Scientific / Lotus
23 Key Message Remaining issues to solve before expanding TAVI indications
24 Important limitation for expanding TAVI to low risk patients 1-Unknown Durability 2-Pacemaker 3-Stroke 4-Access to coronary arteries 5-Vascular complications 6-TAVI in bicuspid valves
25 What do we know about TAVI durability?
26
27 TAVI durability up to 5 years CoreValve CE Pivotal Trial Kovac, Presented at ACC 2014 Mack et al., Lancet 2015
28 7 years follow-up of our CoreValve and SAPIEN XT patients 90 y.o. NYHA I No cardiovascular event EOA: 1.7 cm² / Mean gradient 9 mmhg Trace AR / LVEF 50% 86 y.o. NYHA I No cardiovascular event EOA: 1.78 cm² / Mean gradient 8 mmhg No AR / LVEF 48%
29 Corevalve Durability Example 2005: CoreValve case in Caracas. Jose Condado, MD. 2015: 10 y Follow up CoreValve 25 Fr PG: 14,6 mm Hg MG: 8 mm Hg Trivial PVL
30 What do we know about Stroke post TAVI?
31 Number of neurological events FRANCE 2 registry (n=3191) % at one year major stroke 2.2 % minor stroke 0.59 % TIA 1.19% Mean delay : 2 (IQR: 0-7) days 48.5% within 2 days Increased mortality Days from TAVI Tchetche et al, JACC CVI 2014
32 Van Mieghem et al, Circulation 2013 Embolic protection devices
33 Makkar et al. NEJM 2015 Leaflets thrombosis
34 What do we know about TAVI in bicuspid valves?
35
36 Procedural Challenges Heavily calcified leaflets Asymmetric orifice Highly angulated annulus Dilatation of the ascending Aorta Sizing issues: Basal virtual ring? Intercommissural distance? Mylotte et al, JACC 2014
37 What do we know about New generation TAVI devices?
38 Evidence Base New Technologies The evidence base with these new devices is growing rapidly. In 2015, data from almost 4,000 patients implanted with new valve systems has been reported Both clinical trial and real-world data are available for some systems US 1659 ACURATE neo JenaValve Portico Direct Flow OUS Lotus SAPIEN 3 Evolut R Patients With Data Reported
39 % Patients with Moderate / Severe PVL at 30 Days Paravalvular Leak Moderate / Severe at 30 Days 30% 25% 24,2% Valves designed to mitigate PVL have brought mod / severe rates to 5% or less 20% 16,9% 15% 11,4% 10% 9,0% 5% 5,3% 4,9% 3,8% 3,4% 0% SAPIEN XT PARTNER IIB N=236 SAPIEN PARTNER IIB N=225 CoreValve Extreme Risk N=418 CoreValve High Risk N=356 Portico CE Study N=169 ACURATE CE Trial N=89 SAPIEN 3 PARTNER II S3 N=1504 Evolut R CE N=58 1,4% Direct Flow DISCOVER CE 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 Linke, et. al. presented at PCR London Valves 2015; 5 Abizaid, et al., presented at CRT 2015; 6 Kodali, et al., presented at ACC 2015; 7 Manoharan, et al., presented at TCT 2015; 8 Naber, et al., presented at EuroPCR 2015; 9 Vahanian, et al., presented at EuroPCR 2015; 10 Schofer, et al., J Am Coll Cardiol 2014; 63: 763-8; 11 Meredith, et al., presented at PCR London Valves 2014
40 Major Vascular Complications Rates According to VARC 2 % Patients with MVC (VARC 2, 30 Days) 18% 16% 14% 15,5% Contemporary delivery systems have allowed treatment of a broader range of patients through transfemoral access while simultaneously bringing MVC rates down 12% 10% 8% 9,6% 8,3% 6% 4% 2% 5,2% 5,0% 3,4% 0% SAPIEN PARTNER IIB N=276 SAPIEN XT PARTNER IIB N=284 Evolut R CE Study N=60 LOTUS REPRISE II + Ext N=250 SAPIEN 3 PARTNER II S3 HR N=583 ACURATE CE Study N=89 Minimum Vessel Diameter (mm) Leon, et. al. presented at ACC 2013; 2 Meredith, et al., presented at EuroPCR 2015; 3 Meredith, et al., presented at PCR London Valves 2014; 4 Kodali, et al., presented at ACC 2015; 5 Abizaid, et al., presented at CRT 2015
41 % Patients with PPM at 30 Days Permanent Pacemakers Rate at 30 Days 30% PPM rates with the new valves are largely similar, with the exception of Lotus 28,9% 25% 20% 21,6% 19,8% 17,0% 15% 13,1% 14,6% 11,7% 10% 9,0% 6,4% 5,9% 5% 0% SAPIEN XT PARTNER IIB N=284 SAPIEN PARTNER IIB N=276 CoreValve Extreme Risk N=489 CoreValve High Risk N=390 Portico CE Study N=220 ACURATE CE Trial N=89 SAPIEN 3 P II S3 HR N=583 Evolut R CE N=60 Direct Flow DISCOVER CE N=100 Lotus REPRISE II + Ext N=250 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 Linke, et. al. presented at PCR London Valves 2015; 5 Abizaid, et al., presented at CRT 2015; 6 Kodali, et al., presented at ACC 2015; 7 Manoharan, et al., presented at TCT 2015; 8 Naber, et al., presented at EuroPCR 2015; 9 Vahanian, et al., presented at EuroPCR 2015; 10 Schofer, et al., J Am Coll Cardiol 2014; 63: 763-8; 11 Meredith, et al., presented at PCR London Valves 2014
42 Predictors of AV block after TAVI
43 Pacemaker after TAVI: no impact on mortality
44 CONCLUSION
45 TAVI is equal to surgery in intermediate risk patients. TAVI seems is safe in low-risk patients TAVI prostheses are durable up to five years and probably beyond. Examples of patients with functioning prosthesis up to 12 years TAVI is ready for prime time in intermediate risk patients Remaining issues to solve befor expanding indiatons to low risk patients
46 THANK YOU
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