The SOURCE Family of Registries
  1 Year Results from Cohort 1 of the SOURCE Registry

   The European Registry of Transca...
Potential Conflicts of Interest

    Speaker’s name:         Dr Martyn Thomas

    I have the following potential conflic...
Background

    • Trans-catheter Aortic Valve Implantation (TAVI) is an
      alternative to open surgery in patients cons...
The SOURCE Family of Registries
                        Timeline
                                2009   2010   2011
      ...
Methods: EuroPCR 09
                                34 Centres Initially Participating in
                                ...
The SOURCE Registry Enrollment
    Site Name                                                 Pts   Site Name              ...
Baseline Demographics
                                 and Risk Factors
                                            TF    ...
Major Complications (≤ 30 Days)

                       To give Context of Early v Late Events
                           ...
SOURCE: COHORT 1
     1 Year Survival (All Approaches)




10
All Data as KM Curves
     Cohort 1: 1 YR (Events: Late)
      Freedom From: Stroke, PM, MI




11
SOURCE vs Normal Elderly Population
                                Cause of Late Stroke (30 Days to 1 Year)
      Type of...
All Data as KM Curves
                  Cohort 1: 1 YR (Events: Late)
     Freedom From: Vascular Complication, Endocardit...
Early Vascular Access Complications
                Relationship to 1 Year Mortality (NB 22/24F Device)
                 %...
ALL
                          179
                                                              Causes of Death
          ...
Influence of EuroSCORE - Cohort 1 –
     EuroSCORE as predictor of 30 Day Mortality




16
Univariate Analysis – 1YR Mortality (TA)
                                                             95% Lower    95% Upp...
Univariate Analysis – 1YR Mortality (TF)
                                                                95% Lower    95% ...
Multivariate Analysis – 1YR Mortality (TA)

                          Analysis of Maximum Likelihood Estimates

          ...
Multivariate Analysis – 1YR Mortality (TF)

                            Analysis of Maximum Likelihood Estimates
         ...
So what is the context for
          these results?




21
30 Day Survival   1 Year Survival
 SOURCE TA ES>20       87.4%             69.3%
 (Mean 36.1%)
 SOURCE TF ES>20       93.1...
Historical Comparison –
                                  TAVI Studies Included
     The data/outcomes of all historical m...
24
25
Is there a relationship
       between the logistic
     EuroSCORE and 1 year
            outcomes?



26
Relationship between EuroSCORE
               and Survival




27
Relationship between EuroSCORE
               and Survival




28
TF and TA
       Outcomes in “lower risk” patients




                     SOURCE-TA   SOURCE-TF
     I Yr Survival     7...
Are we learning in terms of the
       who should and who should
             not have TAVI?

     A glimpse into COHORT 2...
The SOURCE Registry
                              Timeline
                                          2009             2010...
Baseline Demographics and Risk Factors:
                                   All Cohort 1 vs. All Cohort 2
                 ...
Conclusions
     • Outcomes at 1 year for COHORT 1 of The SOURCE
       Registry show an improvement compared to
       hi...
Conclusions
     • COHORT 1 outcomes provide a benchmark against
       which future TAVI cohorts may be measured.
     • ...
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  1. 1. The SOURCE Family of Registries 1 Year Results from Cohort 1 of the SOURCE Registry The European Registry of Transcatheter Aortic Valve Implantation using the Edwards SAPIEN Valve Martyn Thomas, MD , Gerhard Schymik, MD, Thomas Walther, MD, Dominique Himbert, MD, Thierry Lefèvre, MD, Hendrik Treede, MD, Holger Eggebrecht, MD, Paolo Rubino, MD, Iassen Michev, MD, Rüdiger Lange, MD and Olaf Wendler, MD on behalf of the SOURCE investigators
  2. 2. Potential Conflicts of Interest Speaker’s name: Dr Martyn Thomas I have the following potential conflicts of interest to report: Research contracts Consulting for Edwards Lifesciences Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest 2
  3. 3. Background • Trans-catheter Aortic Valve Implantation (TAVI) is an alternative to open surgery in patients considered to be at high risk for the standard procedure. • Cohort 1 of The SOURCE Registry describes the outcomes in a consecutive group of patients treated in 32 European centres during the first year of commercialisation of the Edwards SAPIEN Valve from Nov 07 to Jan 31st 09. 3
  4. 4. The SOURCE Family of Registries Timeline 2009 2010 2011 Nov 07 SOURCE COHORT 1 SOURCE COHORT 2 PREVAIL SOURCE XT EU SOURCE XT Global 4
  5. 5. Methods: EuroPCR 09 34 Centres Initially Participating in Commercial Launch 1123 patients Excluded: Included: 2 Centres / 85 patients 32 centres • Unable to obtain Ethic Cte approval • Unable to secure administrative support 1038 patients • One missing patient due to admin. error We now present 1 year data that represents systematic follow-up on 98% of EuroPCR The SOURCE Registry has 100% procedure data implanted patients. 99.9% 30 Day Data 98% 30 day data 2010 All consecutively enrolled 5
  6. 6. The SOURCE Registry Enrollment Site Name Pts Site Name Pts Karlsruhe/Städisches Klinikum + Herzklinik – 89 Rouen/CHU – H Eltchaninoff, JP Bessou 31 G Schymik, H Schroefel Leipzig/Herzzentrum - T Walther, G Schuler 87 Madrid/S Carlos – C Macaya, E Rodriguez 31 London/St Thomas’ + King’s -M Thomas, O Wendler 75 Bern/Inselspital- P Wenaweser, T Carrel 31 Paris/Bichat – D Himbert, P Nataf 56 Münster – H Baumgartner, H Reinecke 30 Massy/Jacques Cartier - T Lefèvre, M Romano 51 Jena/Uniklinik – K Hekmat, M Ferrari 26 Hamburg/Uniklink- H Treede, O Franzen 48 Lund/Universitetssjukhuset – G Olivecrona, P Johnsson 23 Essen/Uniklinik – H Eggebrecht, M Thielmann 47 Bruxelles/St Luc – P Astarci, J Kefer 21 Mercogliano/Clinica Montevergine-P Rubino, G Sorrogpago 47 San Sebastian/Gipuzkoa – J Goiti, M Larman 20 Milan/S Raff – I Michev, F Maisano 41 Leuven/Gasthuisberg – C Dubois, P Herijgers 17 Munich/DHZ – R Lange 41 Frankfurt/Uniklinik –V Schächinger, M Doss 15 Athens/Onassis – K Spargias, G Stavridis 36 London/Brompton – M Mullen, N Moat 12 Milan/Monzino – P Bigliogli, M Fusari 35 Innsbruck/Uniklinik – L Mueller, T Bartel 10 Paris/HEGP – D Blanchard, JN Fabiani 34 Lübeck/Uniklinik – ED Kraatz, H Sier 8 Aarhus/Skejby- HR Andersen, KE Klaaborg 34 Cambridge/Papworth – C Densem, P Calvert 8 Zurich/KlinikimPark+Hirslanden- W Amann, F Bernet 34 TOTAL 1038 6
  7. 7. Baseline Demographics and Risk Factors TF TA (n=463) (n=575) P-Value Age (yrs) 81.7 80.7 0.022 Female 55.1% 55.8% NS Pulmonary Disease 24.6% 29.9% NS Renal Dysfunction 25.5% 32.5% 0.016 Logistic EuroSCORE 25.8 29.0 0.007 Peripheral Vascular Disease 10.6% 28.0% <0.001 Carotid Artery Stenosis (>50%) 7.1% 17.2% <0.001 Incidence of CAD 47.5% 55.1% 0.020 Porcelain Aorta 4.5% 11.3% 0.001 Prior CABG 17.5% 27.0% 0.003 Mitral valve disease 15.8% 32.0% <0.001 7 Data Snapshot 5/03/2010
  8. 8. Major Complications (≤ 30 Days) To give Context of Early v Late Events TF (n=463) TA (n=575) Total (n=1038) Death 6.3% 10.8% 8.8% Stroke 2.6% 2.4% 2.5% Renal Failure 1.3% 7.0% 4.4% Requiring Dialysis Permanent 6.0% 7.7% 6.9% Pacemaker 8 Data Snapshot 5/03/10
  9. 9. SOURCE: COHORT 1 1 Year Survival (All Approaches) 10
  10. 10. All Data as KM Curves Cohort 1: 1 YR (Events: Late) Freedom From: Stroke, PM, MI 11
  11. 11. SOURCE vs Normal Elderly Population Cause of Late Stroke (30 Days to 1 Year) Type of Stroke (Total =19 patients) n/% SOURCE HEMORRHAGIC (n=4/19) 4/21.1% Mean (days to adverse event ) 176 Median (days to adverse event ) 167 NORMAL ELDERLY POPULATION* 13% SOURCE NON-HEMORRHAGIC (n=13/19) 13/68.4% Mean (days to adverse event ) 163 Median (days to adverse event ) 117 NORMAL ELDERLY POPULATION* 87% SOURCE UNKNOWN (n=2) 2/10.5% Mean (days to adverse event) 158 Median (days to adverse event ) 158 *Lloyd-Jones D, et al. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. Erratum in: Circulation. 2010 Mar 30;121(12):e259. 12
  12. 12. All Data as KM Curves Cohort 1: 1 YR (Events: Late) Freedom From: Vascular Complication, Endocarditis, and Re-Operation 13
  13. 13. Early Vascular Access Complications Relationship to 1 Year Mortality (NB 22/24F Device) % Survival in Pts who did % Survival in Pts who did Approach not have vascular access have vascular access P-Value complications complications TF 83.9% 72.2% 0.0121 TA 73.2% 47.4% 0.0188 14
  14. 14. ALL 179 Causes of Death 30 Days to 1 Year Cardiac 45 (25.1%) Non Cardiac 88 (49.2%) Unknown 46 (25.7%) ALL Heart Failure Pulmonary*** Sudden Death 28 (62.2%) 21 (23.9%) 18 (39.1%) Myocardial Renal Failure Unknown Infarction 11 (12.5%) 18 (39.1%) 6 (13.3%) Endocarditis Cancer Other 3 (6.7%) 10 (11.4%) 10 (21.7%) Other* Stroke Other * = Arrhythmia, cardiac arrest 8 (17.8%) 9 (10.2%) Other** = Sepsis, vascular access related, major bleeding, infection, suicide, and multiple organ failure Pulmonary***= Respiratory Failure, Pulmonary Gastrointestinal Embolism and Pneumonia 5 (5.6%) Other** 32 (36.4%) 15
  15. 15. Influence of EuroSCORE - Cohort 1 – EuroSCORE as predictor of 30 Day Mortality 16
  16. 16. Univariate Analysis – 1YR Mortality (TA) 95% Lower 95% Upper Hazard Confidence Confidence Number of Variable P-Value Ratio Limit Limit Observations Used Deaths Scaled Logistic EuroSCORE (%/10) <.0001 1.2122 1.1145 1.3186 574 167 Renal insufficiency / Failure 0.0005 1.7205 1.2671 2.3362 575 168 EuroSCORE >= 30 0.0008 1.6851 1.2433 2.2840 574 167 Liver disease 0.0046 2.5271 1.3315 4.7963 575 168 Other 0.0051 1.6872 1.1703 2.4323 575 168 None 0.0126 0.5365 0.3289 0.8749 575 168 Carotid artery stenosis (over 50%) 0.0158 0.5549 0.3439 0.8952 575 168 Coronary Artery Disease 0.0212 1.4456 1.0566 1.9779 575 168 EuroSCORE >= 20 0.0227 1.5292 1.0612 2.2036 574 167 Cardiomyopathy 0.0329 2.4306 1.0746 5.4974 575 168 PTCA / stent 0.0467 1.3871 1.0048 1.9148 575 168 17
  17. 17. Univariate Analysis – 1YR Mortality (TF) 95% Lower 95% Upper Hazard Confidence Confidence Number of Variable P-Value Ratio Limit Limit Observations Used Deaths NYHA Class IV 0.0002 2.4224 1.5272 3.8422 453 93 Renal insufficiency / Failure 0.0005 2.0948 1.3842 3.1702 459 94 None 0.0012 0.4004 0.2304 0.6957 459 94 Hyperlipidemia / Hypercholesterolemia 0.0019 0.5065 0.3294 0.7788 459 94 Systemic Hypertension 0.0079 0.5774 0.3850 0.8658 459 94 Mitral valvuloplasty 0.0079 6.6950 1.6454 27.2410 459 94 Smoking 0.0098 1.8595 1.1616 2.9769 459 94 Scaled Logistic EuroSCORE (%/10) 0.0149 1.1764 1.0322 1.3407 458 94 Liver disease 0.0194 2.6851 1.1730 6.1464 459 94 Carotid artery stenosis (over 50%) 0.0390 0.1255 0.0175 0.9008 459 94 18
  18. 18. Multivariate Analysis – 1YR Mortality (TA) Analysis of Maximum Likelihood Estimates Hazard Parameter P-Value Ratio 95% Hazard Ratio Confidence Limits Scaled Logistic EuroSCORE (%/10) <.0001 1.200 1.098 1.311 Renal insufficiency / Failure 0.0047 1.592 1.154 2.197 Carotid artery stenosis (over 50%) 0.0014 0.454 0.280 0.737 Liver disease 0.0005 3.154 1.646 6.043 Other 0.0345 1.489 1.029 2.153 *Logistic EuroSCORE is most significant predictor for 1 year mortality in transapical patients* 19
  19. 19. Multivariate Analysis – 1YR Mortality (TF) Analysis of Maximum Likelihood Estimates Hazard Parameter P-Value Ratio 95% Hazard Ratio Confidence Limits NYHA Class IV 0.0067 1.948 1.203 3.153 Renal insufficiency / Failure <.0001 2.382 1.553 3.656 Hyperlipidemia / Hypercholesterolemia 0.0293 0.602 0.382 0.950 Systemic Hypertension 0.0317 0.622 0.403 0.959 Smoking 0.0009 2.268 1.399 3.677 Mitral valvuloplasty 0.0040 8.237 1.956 34.690 Coagulopathy 0.0073 5.178 1.558 17.208 *Logisitic EuroSCORE is not a predictor for 1 year mortality in patients treated with the transfemoral approach 20
  20. 20. So what is the context for these results? 21
  21. 21. 30 Day Survival 1 Year Survival SOURCE TA ES>20 87.4% 69.3% (Mean 36.1%) SOURCE TF ES>20 93.1% 81% (Mean 33.5%) 22
  22. 22. Historical Comparison – TAVI Studies Included The data/outcomes of all historical monitored EW THV clinical studies were pooled to provide a comparator to The SOURCE Registry “Monitored EW THV clinical trials” means 100% source data monitored, Core lab read and CEC adjudicated studies. No. of TA TF Study Dates of Study Principal Investigators Sites n= n= REVIVE 9 _ 106 Jan 2006 - Dec 2007 H Eltchaninoff REVIVAL 4 55 40 Dec 2005 - Feb 2008 W O’Neill, M Leon, C Smith T Walther, F Mohr, G Wimmer- TRAVERCE 3 172 _ Feb 2007 – Apr 2008 Greinecker, E Wollner PARTNER EU 9 69 61 Apr 2007- Jan 2008 T Lefèvre, G Wimmer-Greinecker 23
  23. 23. 24
  24. 24. 25
  25. 25. Is there a relationship between the logistic EuroSCORE and 1 year outcomes? 26
  26. 26. Relationship between EuroSCORE and Survival 27
  27. 27. Relationship between EuroSCORE and Survival 28
  28. 28. TF and TA Outcomes in “lower risk” patients SOURCE-TA SOURCE-TF I Yr Survival 78.4% 80.9% 29
  29. 29. Are we learning in terms of the who should and who should not have TAVI? A glimpse into COHORT 2 of the SOURCE Registry 30
  30. 30. The SOURCE Registry Timeline 2009 2010 2011 Nov 07 SOURCE COHORT 1 Feb 09 Dec 09 SOURCE COHORT 2 N = 1301 (482 TF/819TA) from 38 centers PREVAIL SOURCE XT EU SOURCE XT Global 31
  31. 31. Baseline Demographics and Risk Factors: All Cohort 1 vs. All Cohort 2 ALL ALL COHORT 1 COHORT 2 (n=1038) (n=1301) P-Value Age (yrs) 81.2 81.0 NS Female 576/55.5% 767/59.0% 0.05 Pulmonary Disease 286/27.6% 309/23.8% 0.03 Renal Dysfunction 305/29.4% 365/28.1% NS Logistic EuroSCORE 1035/27.6 1297/25.4 0.006 Peripheral Vascular Disease 210/20.2% 255/19.6% NS Carotid Artery Stenosis (>50%) 132/12.7% 150/11.5% NS Incidence of CAD 537/51.7% 694/53.3% NS Porcelain Aorta 86/8.3% 101/7.8% NS Prior CABG 236/22.7% 262/20.1% NS Mitral valve disease 257/24.8% 450/34.6% <0.0001 32 Data Snapshot 5/03/2010
  32. 32. Conclusions • Outcomes at 1 year for COHORT 1 of The SOURCE Registry show an improvement compared to historical controls. • Survival for the TF approach is now >80%. • There has been a marked improvement in the TA outcomes with survival now similar to historical TF results. • Lower risk TA (<20% euroscore) patients have the same 1 year outcome as TF. • Univariant and multivariant analysis of the COHORT 1 dataset should allow work to start on the development of a TAVI risk score. 33
  33. 33. Conclusions • COHORT 1 outcomes provide a benchmark against which future TAVI cohorts may be measured. • The lower risk profile of COHORT 2 patients may lead to further improvement in 1 year outcomes. • If the lower profile SAPIEN XT delivery systems result in lower vascular complications this should result in further improvement in 1 year survival. This will be tested in The SOURCE XT Registry. 34

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