Transcatheter Aortic Valve Implantation. SSVQ November 23, 2012 Centre Mont-Royal 15:40
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1 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
2
3 First-in-Human Cribier-Edwards Cribier et al. Circulation 2002;106:
4 Dr. Jean-Claude Laborde 1 st generation CoreValve
5 January November
6
7 Carotid artery Ascending aorta Subclavian artery Left ventricular apex Femoral artery
8
9 Austria Belgium Denmark France Germany Italy Netherlands Portugal Spain Switzerland United Kingdom
10 Registry data
11
12 35 TAVI implants/million
13 Registry data
14 53 TAVI centers/country
15 Approximately 1 TAVI center/million
16 51 TAVI implants/ center
17 Mechanical SAVR Biological SAVR
18 Mechanical SAVR Biological SAVR TAVI
19 Mechanical SAVR Biological SAVR TAVI
20 Crossing of fortunes
21 Mechanical SAVR Biological SAVR TAVI Total numbers
22 TAVI SAVR % mortality
23 STS database % 66% Extreme risk/inoperable (STS >15%) High risk (STS > 10-15%) Intermediate risk (STS 4-10%) Low risk (STS <4%)
24 June 2007 June st 2nd 3rd 4th N=105 N=105 N=105 N=105 n = 420 patients Change in baseline characteristics Impact on 30-day and 6-month mortality
25 Q1 Q2 Q3 Q4 Age (yrs.) Logistic ES (%) STS (%)
26 11.4% Q1 4-fold reduction 3.8% Q4 Lange et al. JACC 2012
27 23.5% Q1 2-fold reduction Q4 12.4% Lange et al. JACC 2012
28 TAVI vs. SAVR Intermediate Risk Foundation for the SURTAVI trial Manuscript in submission
29 3666 patients enrolled TAVI 782 SAVR matched patients TAVI 392 SAVR matched patients (STS scores 3-8%) 2882 patients excluded based on propensity scores 274 patients excluded based on STS score <3% and >8% TAVI 255 patients analyzed SAVR 255 patients analyzed
30 Bern-Rotterdam-Munich Study
31 1-year Mortality (STS 3-8%) Bern-Rotterdam-Munich Study
32 CoreValve SURTAVI Trial Study Design
33 Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n=2000 Randomized Patients Yes Operable (STS 4) ASSESSMENT: Transfemoral Access No Two Parallel Randomized Trials +3 Nested Registries Inoperable ASSESSMENT: Transfemoral Access n=500 Randomized Patients Transfemoral (TF) Transapical (TA) Yes >7mm Yes 6-7mm No 1:1 Randomization 1:1 Randomization 1:1 Randomization 6-7mm Registry TF TAVR SAPIEN XT VS Surgical AVR TAVR: TA / TAO VS Surgical AVR TF TAVR SAPIEN XT VS TF TAVR SAPIEN TA Registry TAO Registry Primary Endpoint: All-Cause Mortality + Major Stroke at Two Years (Non-inferiority) Primary Endpoint: All-Cause Mortality + Major Stroke + Repeat Hospitalization at One Year (Non-inferiority) Transcatheter Valve-in-Surgical Valve Registry
34 Patient characteristics Access route Valve type and size
35 Echocardiography Coronary angiography CT imaging
36 Function Anchoring Sealing
37 Annular rupture Coronary obstruction Embolization Paravalvular leaks Conduction abnormalities Patient-prosthesis mismatch
38
39 Perimeter Area Diameters
40 Prosthesis dimension Annulus dimension Annulus dimension X 100 Prosthesis dimension = annulus perimeter
41
42 Edwards SAPIEN - PARTNER 1 RCT - PARTNER Continued Access Program - Source and Source XT registry Medtronic CoreValve - Advance Registry - National Registries
43 Stainless Steel Frame Bovine Pericardial Cribier-Edwards THV 23mm Edwards SAPIEN THV 23 mm and 26 mm Edwards SAPIEN XT THV 23 mm, 26 mm, and 29mm
44 PARTNER Trial Timelines May 07 Aug 09 Mar 09 Aug 09 Mar 11 Dec 11 PARTNER IB - TF Randomized continued access Cohort B - TF PARTNER IA - TF PARTNER IA - TA Transapical approach not available at start of PARTNER I Trial PARTNER continued access TA and TF PARTNER IIB - TF PARTNER IIA
45 Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 High Risk Total = 1,057 patients 2 Parallel Trials: Individually Powered Inoperable N = 358 ASSESSMENT: Transfemoral Access Yes No 1:1 Randomization Not In Study N = 179 TF TAVR VS N = 179 Standard Therapy Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)
46 Standard Rx TAVR HR [95% CI] = 0.53 [0.41, 0.68] p (log rank) < % All Cause Mortality (%) 50.8% 20.1% 30.7% NNT = 5.0 pts 68.0% 25.0% 43.0% NNT = 4.0 pts 54.1% 26.8% NNT = 3.7 pts Months
47 STS <5 STS STS 15 Cohort C Futile 100% 100% Death Incidence (%) 80% 60% 40% 20% p value (log rank) = % 60% 40% 20% p value (log rank) = % Months 0% Months 47
48 Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened N = 699 High Risk Total = 1,057 patients 2 Parallel Trials: Individually Powered Inoperable N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)
49 49
50
51 Goal of the registry was to allow investigators to maintain proficiency with the procedure and to continue to gather data - Over 2000 patients were enrolled between completion of the PARTNER trial in Aug 09 and initiation of the PARTNER IIA trial in Dec 11 All patients were treated with the Edwards Sapien valve from either the transapical or transfemoral approach depending on access Retroflex 3 catheter was used for all transfemoral cases Enrollment was limited by the FDA (39 patients/month initially) This allowed for 1-2 cases per site per month
52 PARTNER RCT n = 1057 PARTNER NRCA n = 2068 Cohort A TF Arm Cohort A TA Arm Cohort B TF Transfemoral n=1080 Transapical n = 988 TA TAVR (n=104) SAVR (n=103) NRCA TF n = 1080 TF TAVR (n=244) SAVR (n=248) TF TAVR (n=179) Medical (n=179) PMA TF n = 423
53 Characteristic PMA Cohort TF-TAVR (n=423) NRCA Cohort TF-TAVR (n=1080) p-value Age yr ± ± 7.75 <0.001 STS Score ± ± Logistic EuroSCORE ± ± <0.001 NYHA Class III - % Class IV - % CAD - % Previous MI - % Prior PCI - % Prior CABG - % Prior BAV - % < Cerebrovascular Disease - % Peripheral Vascular Disease - %
54 Surgical Cutdown - % < Total procedure time (skin-to-skin) (min) ± ± < Post-Dilatation <0.0001
55 All mortality no. (%) 24 (5.7) 53 (4.9) 0.54 Cardiac mortality no. (%) 18 (4.3) 36 (3.3) 0.39 Rehospitalization no. (%) 23 (5.4) 63 (5.8) 0.77 Death or rehosp no. (%) 44 (10.4) 114 (10.6) 0.93 Stroke or TIA no. (%) 26 (6.1) 41 (3.8) 0.05 Stroke 23 (5.4) 36 (3.3) 0.06
56 All mortality % Cardiac mortality % Stroke % Death or major stroke - %
57 PARTNER 1 RCT vs. NRCA All-cause mortality TF-TAVR 2-Yr Death (%) PMA NRCA HR: 1.31 [95% CI: 1.07, 1.62] Log-Rank p= % 29.5% Time in Months Number at risk PMA NRCA * Events adjudicated to one year
58
59 Registry Enrollment Time Cohort 1 N=1038 SOURCE Cohort 2 N=1269 SOURCE XT N=2681 Nov 07- Jan 09 Feb 09 Dec 09 Dec 10 Jun 11 THV SAPIEN SAPIEN XT TF Delivery System TA Delivery System Retroflex Novaflex Ascendra Ascendra 2
60 THV SAPIEN SAPEIN XT Centers Countries Access TF, TA TF, TA, TAO, SC THV SAPIEN 23mm, 26mm SAPIEN XT 23mm, 26mm, 29mm AE Definitions Non VARC VARC AE Adjudication Principal Investigators CEC Monitoring No Yes Follow-up 30 Days, annually to 2 Years 30 Days, annually to 5 Years
61
62 SOURCE Cohort 1 Cohort 2 SOURCE XT Nov 07- Jan 09 Feb 09 Dec 09 Jul 10 Oct 11 TF RetroFlex NovaFlex NovaFlex+ esheath 22/24 Fr. 18/19Fr 16/18Fr Ascendra Ascendra 2 TA 33/26 Fr 24/24 Fr
63
64 SOURCE SOURCE XT 3.7% 0.3% 62.7% 39.9% 33.3% 62.7% TF TA TAO Subclavian
65
66
67 All-cause Mortality (%) < Cardiac mortality (%) Any Stroke (%) < Vascular Complication Major (%)* < Major Bleeding (%) * < Ventricular Injury (%) MI (%) New pacemaker * Different definitions for SOURCE and SOURCE XT
68 Major Bleeding Major Vascular Complications (%) (%) P= P=0.0003
69 CoreValve ADVANCE Methods
70 CoreValve ADVANCE Baseline Characteristics
71 CoreValve ADVANCE Procedural Results
72 CoreValve ADVANCE 30-day Outcomes
73 CoreValve ADVANCE 6-month Survival
74 CoreValve ADVANCE 6-month Stroke
75 Paravalvular aortic regurgitation Stroke Conduction disturbances
76 PARTNER 1A ADVANCE Registry Mild AR associated with mortality? Moderate AR associated with mortality?
77 PARTNER 1 NRCA Only Mortality & Paravalvular leak 2-Year Death (%) NRCA-TF - None or Trace PVL at 30D NRCA-TF - Mild PVL at 30D NRCA-TF - Mod or Sev PVL at 30D 37.8% 21.7% 20.2% 10 Log Rank P= < Time in Days Number At Risk None or Trace PVL Mild PVL Mod or Sev PVL * Events adjudicated to one year
78 PARTNER 1 RCT TAVR vs. AVR 2-year Stroke p=0.12
79 PARTNER 1 RCT vs. NRCA 2-year Stroke TF-TAVR 2-Yr Stroke (%) PMA NRCA HR: 1.58 [95% CI: 1.03, 2.43] Log-Rank p= % 5.8% Time in Months Number at risk PMA NRCA * Events adjudicated to one year
80 CoreValve ADVANCE Freedom from Stroke
81 CoreValve National Registries Stroke 30-days
82
83 ADVANCE Registry Italian Registry No association between new-onset LBBB and mortality at 6-months, 1, and 2 years Urena et al. J Am Coll Cardiol 2012
84 CoreValve National Registries Pacemaker Implantation
85 CoreValve Advance Registry Impact of PPM
86 Introduction of new devices: head to head randomized trials or registries? Phase 1 Phase 2 Phase 3 Setting with no other US legally marketed transcatheter valve RCT TAVI vs. SAVR TAVI vs. medical treatment After transcatheter valve is on the US market for the same indications being sought RCT TAVI old vs. TAVI new Significant long-term data about transcatheter valves is available OPC can be developed Registry Single arm clinical trial
87 TAVI CANDIDATES 2012 Low Risk Intermediate Risk High Risk Inoperable SAVR PATIENTS? PARTNER II SURTAVI TAVI POPULATION
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