Results of Transfemoral Transcatheter Aortic Valve Implantation

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Mervyn Rodgers
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1 Results of Transfemoral Transcatheter Aortic Valve Implantation Saudi Heart Association, February Rüdiger Lange, MD, PhD Nicolo Piazza, MD, FRCPC, FESC German Heart Center, Munich, Germany Division of Cardiac Surgery Market forecast Improving outcomes Transfemoral Outcomes registries SAVR vs. Quality of Life 1

2 Pandemania European and US Market European US Assuming FDA approval Procedures Millenium Research Group European Heart Valve Market

3 Relative European numbers Aortic Tissue Valve Procedures SAVR 2% 10% 25% 28% # of procedures Germany, France, Italy, UK, European Heart Valve Market Forecast % Procedures PHVT 0.2% 41.1% Millenium Research Group European Heart Valve Market

4 Changing practice patterns German Heart Center Munich 55% Surgical aortic valve replacement 45% Transcatheter aortic valve implantation PubMed word search Transcatheter Aortic Valve Implantation Doubling yearly! # of pu blications per year 4

5 Market forecast Improving outcomes Transfemoral Outcomes registries SAVR vs. Quality of Life Country-based registries Presented in Paris at EuroPCR 2010 Belgium (n=328) France (n=244) Germany (n=697) United Kingdom (n=872) Italy (n=772) 5

6 Baseline Characteristics 6

European Registry Results Relative Usage Ratio MDT

47 60% 50% 40% 85 100 30% 20% 43 32 53 10% 0%

Results 30-day mortality 14 12.7% 12 % 10 8 9% 7.

7 European Registry Results Relative Usage Ratio MDT CoreValve Edwards SAPIEN 100% 90% 15 80% 70% % 50% 40% % 20% % 0% Belgium France Germany UK Italy European Registry Results 30-day mortality % 12 % % 7.5% 7.2% 6.9% Belgium France Germany UK Italy 7

MDT CoreValve Edwards SAPIEN 50 European

20 41 Need for standardization of 27 26 23

France Germany UK Italy Word of caution about

8 MDT CoreValve Edwards SAPIEN 50 European Registry Results New Permanent Pacemaking Need for standardization of practice patterns Belgium France Germany UK Italy Word of caution about Registry Data Site selection bias 2. Patient selection bias 3. Physician reporting bias 4. No Core lab involvement 5. Consistency of endpoint definitions 8

9 VARC Market forecast Improving outcomes Transfemoral Outcomes registries SAVR vs. Quality of Life 9

Quality of Life CoreValve 1 Edwards 2 5-month follow-up 12-month follow-up PF=physical functioning; RP=role physical; BP=bodily pain; GH=general health; VT=vitality;

10 Quality of Life CoreValve 1 Edwards 2 5-month follow-up 12-month follow-up PF=physical functioning; RP=role physical; BP=bodily pain; GH=general health; VT=vitality; SF=social functioning; RE=role emotional; MH=mental health Marked improvement in all 8 domains of the SF12 questionnaire at early and intermediate-term follow-up. 1. Ussia et al. EHJ 2009;30: Pooled REVIVE and REVIVAL data Quality of Life at 1 year follow-up German Heart Center Munich (n=186) Improvement in physical quality of life maintained at 1 year follow-up No improvement in mental quality of life at 3-months or 1 year follow-up Krane et al. Am Heart J 2010;160:451-7 Krane et al. submitted

SAVR 30-day mortality outcomes = 114 SAVR = 1008 * IPT Inverse probability of treatment

11 Market forecast Improving outcomes Transfemoral Outcomes registries SAVR vs. Quality of Life Bern-Rotterdam Risk Adjusted Comparison: vs. SAVR 30-day mortality outcomes = 114 SAVR = 1008 * IPT Inverse probability of treatment weighted * Kurth T et al. American journal of epidemiology 2006; 163(3): ) Piazza et al. EuroIntervention 2009;5:

Bern-Munich-Rotterdam Propensity Score Matched Analysis = 782 SAVR = 2884 Age 79 years Logistic EuroSCORE 17% Cumulative Hazard Ratio After propensity score matching Before matching 30 day mortality

12 Bern-Munich-Rotterdam Propensity Score Matched Analysis = 782 SAVR = 2884 Age 79 years Logistic EuroSCORE 17% Cumulative Hazard Ratio After propensity score matching Before matching 30 day mortality 1.58 ( ) p= year mortality 1.72 ( ) p< in favor of SAVR After matching 30 day mortality 0.94 ( ) p= year mortality 1.16 ( ) p= no significant difference 12

[Epub ahead of print] Hemodynamic Results: vs. SAVR mmhg 15 10 5 Mean Gradient (mmhg) 13 14 13 10 10 9 cm 2 2 1.5 1 0.5 Effective orifice area (cm 2 ) 1.61 1.

13 Leipzig Propensity Score Matched Analysis: vs. SAVR 1-year survival outcome = 100 SAVR = 100 Transapical AVI 73% Surv vival probability Conventional AVR 69% Walther et al. Eur Heart J 2010 March 16. [Epub ahead of print] Hemodynamic Results: vs. SAVR mmhg Mean Gradient (mmhg) cm Effective orifice area (cm 2 ) Discharge 1 Follow-up 2 0 Discharge Follow-up 1 2 Transcatheter valve Surgical stented valve Surgical stentless valve % Patient-prosthetic mismatch (%) Discharge Follow-up 20 Clavel et al. J Am Coll Cardiol 2009; 53:

14 vs. SAVR Low EF Propensity score adjusted LVEF <50% LVEF <30% LVEF % SAVR P<0.001 LVEF % SAVR P= Baseline Discharge 1-year Baseline Discharge 1-year No. Risk Clavel et al. Circulation 2010;122: vs. SAVR: Low EF 58% vs. SAVR 20% with LVEF > 50% at 1-year follow-up Clavel et al. Circulation 2010;122:

15 PARTNER US (Edwards SAPIEN) ACC 2011 TCT 2010 September

16 All Cause Mortality ll-cause mortality (%) A Standard Rx HR [95% CI] = 0.54 [0.38, 0.78] P (log rank) < Months PARTNER US Cohort B All Cause Mortality Standard Rx at 1 yr = 20.0% NNT = 5.0 pts ll-cause mortality (%) A 50.7% 30.7% Months PARTNER US Cohort B 16

17 Mortality or Major Stroke All-cause mortality or Major Stroke (%) 100 Standard Rx HR [95% CI] = 0.58 [0.43, 0.78] 80 P (log rank) = Months PARTNER US Cohort B Mortality or Major Stroke All-cause mortality or Major Stroke (%) Standard Rx at 1 yr = 18.3% NNT = 5.5 pts 51.3% 33.0% Months PARTNER US Cohort B 17

Major bleeding Predictor of Mortality Major Bleed (n=46) No

Predictor of Mortality Major Vascular Complication (n=31) No

18 Major bleeding Predictor of Mortality Major Bleed (n=46) No Major Bleed (n=133) P (log rank) = Mortality (%) 43.5% 26.3% Months PARTNER US Cohort B Major vascular complications Predictor of Mortality Major Vascular Complication (n=31) No Major Vascular Complication (n=148) P (log rank) = Mortality (%) 47.2% 27.7% Months PARTNER US Cohort B 18

19 Major stroke Predictor of Mortality Major Stroke (n=15) P (log rank) < No Major Stroke (n=164) 66.7% Mortality (%) 27.7% Months PARTNER US Cohort B Paravalvular Aortic Regurgitation No changes over time 30 Day 6 Month 1 Year None/Trace Mild Moderate Severe PARTNER US Cohort B 19

20 NYHA class P = 0.68 P < P < P < Percent Standard Rx Standard Rx Standard Rx Standard Rx Baseline 30 Day 6 Month 1 Year I II III IV PARTNER US Cohort B Partner B Quality of Life Kansas City Cardiovascular Questionnaire (KCCQ) 80 Control = 13.9 = 20.7 = 24.5 P<0.001 P<0.001 P< Baseline 1 month 6 month 12 month 20

21 Market forecast Improving outcomes Transfemoral Outcomes registries SAVR vs. Quality of Life Learning Curve 1-year survival outcome (CoreValve System) 18F (n=102) - 84% 21F (n=24) - 80% 25F (n=10) 60% Grube et al. Circ Cardiovasc Intervent

22 Learning Curve 30-day survival outcome (Edwards THV) % survival 93.5% 68% What is the major contributor to the improvements in outcomes? 1. Patient-related factors 1. Procedural- or operator-related factors 1. Device-related factors 22

23 Treatment Options for Aortic Stenosis German Heart Center, Munich Munich Experience (n=550) Q1 Q2 Q3 Q4 Age (yrs.) Logistic ES (%) STS (%)

24 Munich Experience (n=550) Q1 Q2 Q3 Q4 Intubation (%) Contrast use (ml) Unadjusted Cox Proportional Hazard s Model 30-day mortality HR (95% CI) p-value Q4 vs. Q1 033( ( ) 00) (3.8% vs. 11.4%) 6-month mortality HR (95% CI) p-value Q4 vs ( ) Q1 (12.4% vs. 22.4%) 24

25 Adjusted Cox Proportional Hazard s Model Baseline characteristics 30-day mortality HR (95% CI) p-value Q4 vs. Q1 029(008108) 0.29 ( ) month mortality HR (95% CI) p-value Q4 vs. Q1 067(025177) 0.67 ( ) Obstacles towards truly lower risk patients... Paravalvular regurgitation Left bundle branch block & permanent pacemaker Long-term Durability 25

(cm 2 ) 2 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 No. at Risk 0.72 Baseline (n=109) 1.81 176 1.76 174 1.

26 Device-Patient Interface Post-mortem (2.8 years) Gurvitch et al. Circulation 2010;122: MDT CoreValve 2-year follow-up 18F Safety & Efficacy Study ( ) EOA (cm 2 ) No. at Risk 0.72 Baseline (n=109) Discharge (n=73) Effective Orifice Area EOA(cm 2 ) 1-month (n=60) 1-year (n=52) 2-year (n=37) Medtronic CoreValve. 18F Safety and Efficacy Study 26

27 Edward SAPIEN 3-year follow-up Vancouver Experience EOA (cm 2 ) P< Effective Orifice Area (EOA) 0.4 (cm 2 ) Baseline Post-procedure 12-months 24-months 36-months No. at Risk Gurvitch et al. Circulation 2010;122: ? Conclusion We need data from well-designed and appropriately conducted studies to convince the medical community and reimbursement authorities, and also to better inform patients, about the potential benefits of transcatheter aortic valve implantation 27

Transcatheter Aortic Valve Implantation. SSVQ November 23, 2012 Centre Mont-Royal 15:40

Transcatheter Aortic Valve Implantation SSVQ November 23, 2012 Centre Mont-Royal 15:40 Nicolo Piazza MD, PhD, FRCPC, FESC, FACC McGill University Health Center German Heart Center Munich 1 First-in-Human