Le TAVI pour tout le monde?
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1 Le TAVI pour tout le monde? Thierry Lefèvre Institut Cardiovasculaire Paris Sud, Massy
2 Disclosure Statement of Financial Interest I currently have, or have had over the last two years, an affiliation or financial interests or interests of any order with a company or I receive compensation or fees or research grants with a commercial company : Abbott Vascular, AstraZeneca, Boston Sci., Daiichi Sankyo, Edwards, Lily, Terumo
3 From compassionate cases # Patients RVAo TAVI Risk
4 To Surgical contraindication # Patients RVAo TAVI Risk
5 To Surgical contraindication # Patients RVAo TAVI Risk
6 To Surgical contraindication # Patients RVAo TAVI Risk
7 High-Risk Patients # Patients RVAo TAVI Risk
8 High-Risk Patients # Patients RVAo TAVI TAVI Futile Risk
9 Intermediate Risk and intermediate-risk patients # Patients RVAo TAVI TAVI Futile Risk
10 Very quick adoption Darren Mylotte
11 > cases in > 65 countries!
12 Inoperable Evidence for TAVI
13 TAVI vs Conservative treatment: Inoperable patients
14 Inoperable High surgical Risk Evidence for TAVI Unchanged indications since 2009
15 TAVI vs Surgical aortic valve replacement: High-Risk patients
![Mortality and None-Trace Total AR Transfemoral Patients HR [95% CI] = 0.64 [0.43, 0.95] p (log rank) = 0.03 60.9% 45.](/docs-images/94/121316305/images/16-2.jpg "2% Error Bars Represent 95% Confidence Limits No. at Risk TAVR 70 65 55 51 43 19 SAVR 181 137 126 105 78 36 M. Mack et al.")
16 Mortality and None-Trace Total AR Transfemoral Patients HR [95% CI] = 0.64 [0.43, 0.95] p (log rank) = % 45.2% Error Bars Represent 95% Confidence Limits No. at Risk TAVR SAVR M. Mack et al. ACC 2015
17 Inoperable High surgical Risk Evidence for TAVI Intermediate surgical risk
18 TAVI vs Surgical aortic valve replacement: Intermediate-Risk and All-comers Pts
19 All-Cause Mortality or Disabling Stroke (%) TF Primary Endpoint (AT) All-Cause Mortality or Disabling Stroke 1 2A TF Surgery TF TAVR HR: 0.78 [95% CI: 0.61, 0.99] p (log rank) = % 20.0% % 11.7% 16.3% 0 4.5% Number at risk: Months from Procedure TF Surgery TF TAVR
20 Other Clinical Endpoints (ITT) At 30 Days and 2 Years 2A Events (%) TAVR (n = 1011) 30 Days 2 Years Surgery (n = 1021) p-value* TAVR (n = 1011) Surgery (n = 1021) p-value* Rehospitalization MI Major Vascular Complications Life-Threatening / Disabling Bleeding < <0.001 AKI (Stage III) New Atrial Fibrillation < <0.001 New Permanent Pacemaker Re-intervention Endocarditis NA *Event rates are KM estimates, p-values are point in time
21 TAVI in intermediate risk Pts August 1, Medtronic Evolute R August Edwards Sapien XT and Sapien 3 August Edwards Sapien XT and Sapien 3
22 Inoperable High surgical Risk Evidence for TAVI Low surgical risk Intermediate surgical risk
23 TAVI in Low-risk Pts: Ongoing Trials
24 Safety Rationale for TAVI in Low-risk Pts
25 TAVI vs Surgical aortic valve replacement: Meta-analysis of randomised trials Siontis et al. Eur heart j 2016; 37:
26 All-Cause Mortality at 30 Days Edwards SAPIEN Valves PARTNER 1 and 2 20% 15% Inoperable High risk Combined inoperable and high risk Intermediate risk 10% 5% 6,3% 5,2% 3,7% 4,5% 3,5% 2,2% 1,6% 1,1% 1,1% 0% P1B (TF) P1A (All) P1A (TF) P2B (TF) P2B XT (TF) S3HR (All) S3HR (TF) S3i (All) S3i (TF) SAPIEN SXT SAPIEN 3
27 Strokes (All) at 30 Days Edwards SAPIEN Valves PARTNER 1 and 2 20% 15% Inoperable High risk Combined inoperable and high risk Intermediate risk 10% 5% 6,7% 5,6% Neurologist evaluations (pre- and post) 4,1% 4,3% 1,5% 2,6% 0% P1B (TF) P1A (All) P2B (TF) P2B XT (TF) S3HR (All) S3i (All) SAPIEN SAPIEN XT SAPIEN 3
28 Sub-Group Analysis for 3-Year Mortality ACC 2016
29 Notion Trial STS < 4% Sondergaard et al. TCT 2015
30 Safety Rationale for TAVI in Low-risk Pts Mismatch
31 Patient-Prosthesis Mismatch
32 Patient-Prosthesis Mismatch
33 Safety Mismatch Rationale for TAVI in Low-risk Pts Hospital stay PVL Recovery
34 PVL with New generation PHV 100% 80% 60% 40% 20% Severe Moderate Mild None / Trace 0% 30 Days 1 Year N= 364 N=364 PARTNER 2 S3 Trial
35 Paravalvular Leak at 30 Days PVL with New generation PHV 20% 15% 13,0% 11,4% 10% 9,0% 5% 5,4% 3,4% 0% CoreValve ADVANCE (N=697) CoreValve Extreme Risk (N=418) CoreValve High Risk (N=356) Evolut R US Study (N=227) Evolut R CE Study (N=58) 1 Linke, et al., Eur Heart J 2014; 35: ; 2 Popma, et al., J Am Coll Cardiol 2014; 63: ; 3 Adams, et al., N Engl J Med 2014; 370: ; 4 Williams, et al., presented at ACC 2016; 5 Manoharan, et al., J Am Coll Cardiol Intv 2015; 8:
36 Safety Mismatch Rationale for TAVI in Low-risk Pts Hospital stay Need for PPM PVL Recovery
37 Permanent Pacemaker implantation
38 Safety Mismatch Cost Lower Rationale for TAVI in Low-risk Pts Hospital stay Need for PPM PVL Recovery
39 Cost comparable to or lower than surgery Screening simplified and short Procedure simplification Short hospital stay Low complication rate Quick recovery Valve price decreasing
40
41 Valve Quality, Durability Cost Lower Safety Rationale for TAVI in Low-risk Pts Mismatch Hospital stay Need for PPM PVL Recovery
42 Valve in Valve International Registry
43 Legacy trials, 5-year follow-up REVIVE II, TRAVERCE, PARTNER EU 410 Pts, age 82.3±5.6 years, Log. EuroSCORE 28.4±13.3 % 114 patients survived Mean gradient 11.7±5.4 mmhg (+ 2.2±5.7 mmhg, p=0.0900) Aortic valve area 1.6±0.6 cm² (+ 0.1±0.7 cm², p=0.3956). 2 cases of valve thrombosis (first year of follow-up) No severe aortic regurgitation, no degeneration Lefèvre et al. ESC 2015
44 Aortic Valve Area p < Error Bars = ± 1 Std Dev TAVR SAVR M. Mack et al. ACC 2015
45 Valve Hemodynamics (P<0.001)
46 Notion Trial Baseline 3 mo 1 year 2 years Lars Sondergaard, TVT 2016
47 Rouen Experience 239 pts from FU > 5 years (98%) Freedom from reintervention, mean gradient > 40 mmhg or severe AR Only one patient with severe AR had reintervention (VIV) Eltchaninoff TVT 2016
48 Valve Quality, Durability Cost Lower Safety Rationale Bicuspid Valves for TAVI in Low-risk Pts Mismatch Hospital stay Need for PPM PVL Recovery
49 Epidemiology of Pts undergoing savr Roberts et al. Am J Cardiol 2012; 109:1632-6
50 Multicenter experience Mylotte, Lefèvre et al. JACC 2014; 64:2330-9
51 New-generation TAVI device Yoon et al. JACC 2016; 68:
52 TAVI for lower-risk Pts? Screening is now simple and very well defined The procedure is well standardised and simplified Femoral approach is the default approach when feasible The outcome is predictable The risk of stroke is low 30-day mortality is always < to STS or Euroscore Valve performance is excellent and mismatch very low Durability in younger patients will be carefully assessed through ongoing randomized studies
53 Merci pour votre attention!
54 Back up Slides
55 What conditions should be fulfilled in order to extend TAVI to all patients? Safety at least similar to surgery Patient-prosthesis mismatch at least similar Hospital stay and recovery shorter Risk of PVL acceptable Need for PPM acceptable Cost lower Valve performance and durability at least similar
56
57 Medtronic TAVR in low-risk patients
58 All-Cause Mortality or Disabling Stroke (%) Primary Endpoint (ITT) All-Cause Mortality or Disabling Stroke Surgery TAVR HR [95% CI] = 0.89 [0.73, 1.09] p (log rank) = % % 16.4% 14.5% 19.3% 0 6.1% Number at risk: Months from Procedure Surgery TAVR
59 All-Cause Mortality or Disabling Stroke (%) TF Primary Endpoint (AT) All-Cause Mortality or Disabling Stroke TF Surgery TF TAVR HR: 0.78 [95% CI: 0.61, 0.99] p (log rank) = % 20.0% % 11.7% 16.3% 0 4.5% Number at risk: TF Surgery TF TAVR Months from Procedure
60 Other Clinical Endpoints (ITT) At 30 Days and 2 Years Events (%) TAVR (n = 1011) 30 Days 2 Years Surgery (n = 1021) p-value* TAVR (n = 1011) Surgery (n = 1021) p-value* Rehospitalization MI Major Vascular Complications Life-Threatening / Disabling Bleeding < <0.001 AKI (Stage III) New Atrial Fibrillation < <0.001 New Permanent Pacemaker Re-intervention Endocarditis NA *Event rates are KM estimates, p-values are point in time
61 Notion Trial 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
62 Notion Trial Log. Euroscore: % Log. Euroscore: % Thyregod et al. JACC Interv 2015;65:
63 Notion Trial Thyregod et al. JACC Interv 2015;65:
64 Notion Trial Outcomes, % TAVR n=142 SAVR n=134 p-value Death, any cause Bleeding, life-threatening+major Cardiogenic shock Vascular lesion, major Acute kidney injury (stage II+III) Stroke TIA Myocardial infarction Atrial fibrillation <0.001 Pacemaker <0.001 Thyregod et al. JACC Interv 2015;65:
65 The PARTNER II S3 Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n = 1076 Patients Intermediate Risk Operable (PII S3i) SAPIEN 3 2 Single Arm Non-Randomized Historical-Controlled Studies High Risk Operable / Inoperable (PII S3HR) n = 583 Patients ASSESSMENT: Optimal Valve Delivery Access PII A SAVR PI A SAPIEN ASSESSMENT: Optimal Valve Delivery Access Transfemoral (TF) Transapical / Transaortic (TA/TAo) Transfemoral (TF) Transapical / Transaortic (TA/TAo) TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3 TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3
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