Istanbul Course of Interventional Cardiology Istanbul, June 11, 2011
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1 Istanbul Course of Interventional Cardiology Istanbul, June 11, 2011
2 Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name Eberhard Grube, MD Company/Relationship Medtronic, CoreValve: C, SB, AB, OF Sadra Medical: E, C, SB, AB Direct Flow: C, SB, AB Mitralign: AB, SB, E Boston Scientific: C, SB, AB Biosensors: E, SB, C, AB Cordis: AB Abbott Vascular: AB Capella: SB, C, AB Valtec: E, SB Claret, SB Key G Grant and or Research Support E Equity Interests S Salary, AB Advisory Board C Consulting fees, Honoraria R Royalty Income I Intellectual Property Rights SB Speaker s Bureau O Ownership OF Other Financial Benefits
3 Percutaneous Intervention Interventional Evolution Coronary Valvular Stents New Devices (DCA etc) TAVI Drug Eluting Stents Balloon Angioplasty >2010
4 Do patients with valvular heart disease receive treatment according to established guidelines? 31.8% did not undergo intervention, despite NYHA class III/IV symptoms 92 hospitals from 25 countries 5,001 patients from April-July, 2001
5 Outcome of 108,687 patients after isolated Aortic Valve Replacement Risk-adjusted in-hospital mortality Mortality in-hospital vs Age % p< vs % *p< From 1997 till 2006, in-hospital mortality has fallen significantly from 3.5 to 2.3% The most significant reduction in mortality was observed in the elderly Brown, STS Database. J Thorac Cardiovasc Surg 2009;137:82-90
6 Nobody likes Surgery Not even the Surgeons!
7 No of proceduresa 609 TAVI SAVR % 6.5% 13% 20%
8
9 Transcatheter AVI Current Generation Devices Edwards >19,000 patients CoreValve >19,000 patients
10 18 French allowed considerable procedural Progress Evolution to true percutaneous cath lab procedure Local anesthesia Beating heart procedure Valve delivery without rapid pacing during deployment General anesthesia Surgical cutdown/repair Ventricular assistance
11 CoreValve Evolution: Past to Present Gen 3 18F 6 mm ,000 implants to date in 29 countries Porcine Pericardium Designed for TCV Supra-annular valve function 3 pieces for sealing Annulus range mm 50 % Feasibility study 21 F study 30-Days Mortality 14 % 15.1 % 18 F study 10.3 % EER 6.7 % 4.4 % Percutaneous, Local Anesthesia, No Bypass
12 TAVI F 1st Gen. CoreValve -Surgical Prep - CPB pump - General anesthesia TAVI F 3rd Gen. CoreValve - PCI-like procedure - Patient awake, sedated - No CV assist
13 CoreValve Experience: Over 18,000 Patients in Over 42 Countries since 2006
14 TAVI Procedural Outcomes TAVI vs SAVR Outcome of transcatheter aortic valve implantation (TAVI) TAVI Clinical Outcomes TAVI Quality of Life TAVI Hemodynamic Outcomes
15 Transcatheter AVR Clinical Data Sources Edwards CoreValve Transseptal Experience (RECAST, I-REVIVE; 36 pts) FIRST-in-MAN 25 Fr Transfemoral Experience (14 pts) REVIVE (OUS, TF, 106 pts) TRAVERCE (OUS, TA, 172 pts) REVIVAL (US, TF/TA, 95 pts) FEASIBILITY 21 and 18 Fr Transfemoral OUS Experience (177 pts) PARTNER EU (OUS, TF/TA 125 pts) SOURCE (OUS, TF/TA, 598 pts)* CE-APPROVAL 18 Fr Transfemoral OUS Experience (1,243 pts)* PARTNER FDA PIVOTAL RCT MDT/Core Valve, US Pivotal
16 PARTNER Study Design 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)
17 All Cause Mortality All-cause mortality (%) Standard Rx TAVI HR [95% CI] = 0.54 [0.38, 0.78] P (log rank) < at 1 yr = 20.0% NNT = 5.0 pts Months Numbers at Risk TAVI Standard Rx
18 On the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery Leon et al. NEJM /NEJMoa
19 Primary Endpoint: All-Cause Mortality at 1 Year TAVR AVR HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = No. at Risk Months TAVR AVR
![All-Cause Mortality Transfemoral (N=492) HR [95% CI] = 0.83 [0.60, 1.](/docs-images/94/121315860/images/20-0.jpg "15] P (log rank) = 0.25 26.4 22.2 No.")
20 All-Cause Mortality Transfemoral (N=492) HR [95% CI] = 0.83 [0.60, 1.15] P (log rank) = No. at Risk Months TAVR AVR
21 Study Study Size Number of Centers Follow-up to Date Status Medtronic Sponsored Studies 18 Fr Safety and Efficacy years Enrollment complete Australia-New Zealand Study months Enrolling REDO days Enrollment complete Advance Study 1000 Up to 50 NA Enrolling CoreValve US Pivotal Trial >1, NA Enrolling Italian Registry year Enrollment Complete Belgian Registry 328 (141 CoreValve) 13 (6 CoreValve) 1 year Enrollment Complete Independent Studies Spanish Registry months French Registry UK Registry German Registry 244 (78 CoreValve) 872 (460 CoreValve) 697 (588 CoreValve) 16 6 months 25 2 years days Enrollment Complete Enrollment Complete Enrollment Complete Enrollment Complete
22 Baseline Patient Characteristics 18 Fr Spanish S&E 1 ANZ 2 Registry 3 French Registry 4 Belgian Registry 6 German Registry 8 UK Registry 7 Italian Registry 8 N Age (years) 81.9 ± ± ± ± ± ± ± 6 Female 57.1% 40.7% 54.6% 51.5% 56% 55.8% 48% 56% Logistic EuroSCORE (%) NYHA Class III and IV 23.4 ± ± ± ± ± ± 13.3 Severe Aortic Stenosis in the elderly Patient >75 years with high surgical risk and log Euroscore >20% ± % 83.9% 58.4% 78% 88.2% 74% 70.6% LVEF % 51.6 ± ± ± ± ± ± 13 Mean Pressure Gradient (mmhg) 46.8 ± ± ± ± ± ± ± 17 Aortic Valve Area (cm 2 ) 0.72 ± ± ± ± ± ± See Reference slide for sources.
23
24 Consistently High Procedural Success 100% 95.8% 98.1% 97.0% 98.0% 98.7% 99.0% 98.1% Percent of Patients (%) 80% 60% 40% 20% 83.1%* 0% 18 Fr S&E 1 ANZ 2 Spain 3 French 4 Belgian 5 Germany 6 UK 7 Italian 8 N = 126 N = 118 N = 108 N = 78 N = 141 N = 588 N = 460 N = 772
25 Consistent Haemodynamic Improvement Across Studies Peak Gradient (mmhg) Mean Gradient (mmhg) Gradient (mmhg) Baseline Fr S&E 1 ANZ 2 Spanish 3 Italian Days Gradient (mmhg) Baseline 18 Fr S&E 1 ANZ 2 Spanish 3 Italian Days
26 Improvement in Functional Status 60% 50% 18 Fr S&E 1, N = 89 ANZ 2, N = 89 Paired 30-Day NYHA Classification 53.9% 46.1% 40% 30% 20% 16.9% 14.6% 23.6% 21.3% 10% 0% 0.0% 0.0% 1.1% 0.0% 4.5% 4.5% 4.5% 9.0% Worsened 3 Levels Worsened 2 Levels Worsened 1 Level No Change Improved 1 Level Improved 2 Levels Improved 3 Levels Approximately 80% of patients improved at least 1 NYHA class post-implant
27
28 Sustained Hemodynamic Performance at 2 Years Effective Orifice Area (cm 2) EOA Mean Gradient P < Mean Gradient (mmhg) 0 Baseline n = 109 Discharge n = Day n = 60 6 Months n = 47 1 Year n = 52 2 Years n = 37 0
29 Sustained Functional Improvement at 2 Years Percentage of Patients 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 6% 4% 16% 21% 59% 54% 15% 15% 1% 5% 4% Discharge n = Month n = 89 NYHA Classification 3% 7% 6% 7% 27% 29% 49% 47% 14% 6 Months n = 88 74% of patients sustained improvement of at least one functional class at 2 years (P < 0.01). 13% 5% 1 Year n = 83 18% 49% 16% 10% 2 Years n = 61 Improved 3 levels Improved 2 levels Improved 1 level No Change Worsened 1 level Worsened 2 levels Worsened 3 levels
30 Aortic Regurgitation at 2 Years 100% 90% 6% 6% 9% 6% 3% Percentage of Patients 80% 70% 60% 50% 40% 30% 20% 52% 42% 42% 52% 32% 39% 59% 55% 34% 37% 63% 63% Grade 4 Grade 3 Grade 2 Grade 1 None (0) 10% 0% Procedure N = 33 Discharge N = Days N = 75 6 Months N = 69 1 Year N = 62 2 Years N = 43
31 Two Year Safety Results Valve migrations 0 (0%) Frames fractures 0 (0%) Structural valve deterioration* Paravalvular leak adverse events 0 (0%) 1 (0.8%) * Change in NYHA function resulting from intrinsic valve abnormality resulting in stenosis or regurgitation. Grade 2 Aortic insufficiency post-implant; treated on day 127 for symptomatic paravalvular leak with percutaneous Amplatzer plug.
32 Various Access Sites
33 The Unsuitable Patient?
34 Access Choice Invasiveness Peripheral access» Transfemoral» Axillary Direct access» Apical» Ascending aorta Retroperitoneal Decision making factors General vs local anesthesia Risk of malpositioning Risk of complications Alternative routes are necessary in 15% of TAVI
35 Subclavian Access
36 Alternative access sites Trans-aortic Approach
37 TAVI Current Issues Device related Inaccuracies in Positioning / Lack of Repositionability ( One shot procedure) Paravalvular leackage Profile size Durability Non-Device related Which specialty? Logistics (Hybrid-OR) Reimbursement Complications Stroke, Vascular Complications Pacemaker need
38 Vascular Complications Bleeding Vessel obstruction (Vessel rupture)
39 Peri-procedural Complications Vascular Complications % ,5 CoreValve Edwards Sapien 17, , ,5 7, , ,9 1,8 Bleiziffer Mu Piazza Eur Petronio It Avanzas Sp Zahn Ger v.mieghem Net Tchetche Eltchaninoff Fr Web9 Webb Himbert Thomas Rod Rodés- EurJCVSurg EuroInterv Circ Interv EHJ EuroInt Circulation In press N=103 N=646 N=514 Rev Esp Card201 0 N=108 N=588 N=99 EuroInt 2010 EHJ in press Circulation 2009 N=21 N=21 N=113 JACC 2009 N=51 N=463 Cabau Circulation 2010 N=168
40
41 Aortic Atheroma: High Risk 268 of 3404 CABG patients (8%) had atheroma (>/= 5 mm) defined by epi-aortic US % of group had intra-operative stroke 1 1 Protruding aortic arch atheromas: risk of stroke during heart surgery with and without aortic arch endarterectomy. Stern et al. American Heart Journal Oct
42 Cerebral Ischemia After TAVI Kahlert PK et al. Circulation 2010;121: New Lesions Lesion Volume % mm 3
43 Cerebral Protection Devices Objetive Increase the Safety of the Procedure Embrella Deflector Double Filter Claret
44 Embolic Material JIM Live Transmission February 2011
45 Variety of Emboli Captured & Removed Embolic Material
46 Variety of Emboli Captured & Removed Embolic Material
47 Variety of Emboli Captured & Removed 7 mm 3.5 mm
48 Stroke Rate at 30 Days - CoreValve Avanzas RevEspCard 2010 N=108 Bleiziffer EurJCVSurg 2009 N=103 Büllesfeld N=126 submitted The Bern Experience N=150 Eltchaninoff EHJ in press N=78 Zahn EHJ in press N=588 Petronio Circ Interv 2010 N=514 Piazza EuroInterv 2008 N=646 Grube Circ Interv 2008 N=136 %
49 Duration
50 Degenerated Surgical Valves
51 Degnerated Sapien Valve Courtesy Gus Pichard
52 Degenerated Core Valve (6 years)
53 Restenosed Core Valve 26mm 2 nd generation porcine valve implanted in August 2005 Hammerstingl C, Grube E, CCI in press
54 Hammerstingl C, Grube El, CCI, in press Treatment Valve in Valve
55 Survival
56 All Cause Mortality at 30 Days % Medtronic CoreValve Edwards Sapien THV Büllesfeld submitted N=126 Grube Circ Interv 2008 N=136 Piazza EuroInterv 2008 N=646 Petronio Circ Interv 2010 N=514 Avanzas RevEspCard 2010 N=108 Webb Circulation 2006 N=18 Webb Circulation 2007 N=50 Webb Circulation 2009 N=113 Thomas Circulation 2010 N=463 Rodés- Cabau Circulation 2010 N=168
57 One Year Survival Survival rates comparable with octogenarians who have had savr or savr+cabg 5 100% Percent of Patients (%) 90% 80% 70% 60% 50% 40% 30% 20% 71.9% 79.0% 81.6% 85.1% 10% 0% 18 Fr S&E 1 N = 126 Belgian 2 N = 141 UK 3 N = 460 Italian 4 N = 772
58 Two Year Survival Percent of Patients (%) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 59.7% 18 Fr S&E 1 N = % UK 2 N = 460
59 New Valves
60 St Jude Medical (Portico Transcatheter Heart Valve) First Human Implant June 7 th, 2011
61 Direct Flow Medical Design Features Delivery System Polymer nylon sleeve Multilumen catheter 3 position and fill lumen 1 guide wire lumen Flexible nose cone Non-metallic delivery system and valve Flexible and trackable Precise positioning Retrievable with deflation and withdrawl into retrieval basket Position & Fill Lumens Aortic Ring Ventricular Ring Guidewire Lumen
62 Sadra Lotus Valve Locking Mechanism Braided Nitinol Frame Bovine Pericardium Adaptive Seal 62 Caution: Investigational device. Restricted under United States Federal Law to investigational use only. Not for sale in the U.S.
63 Upcoming trials ADVANCE: CoreValve, 10yr prospective FU ADVANCE 2: CoreValve, FU after conduction abnormalities SURTAVI: RCT, AVR vs TAVI in intermediate risk groups CoreValve US Pivotal Trial: RCT, TAVI vs medical Tx in high risk patients PREVAIL: 1yr FU results SOURCE 2: 1yr FU results
64 SURTAVI Screening Log 3300 patients 70 years and 2 but 4 risk factors 75 years and 1 but 3 risk factors 80 years and 2 risk factors Randomization 1100 patients SAVR Registry 1760 patients TAVI Registry 220 patients Medical Rx 220 patients SAVR 550 patients TAVI 550 patients
65 TAVI without Predilation Symptomatic, aortic valve stenosis qualifying for TAVI Medtronic CoreValve prosthesis 26 and 29mm Transfemoral TAVI without Predilation International, multi-center versus TAVI 18F CoreValve S&E study* N=60 N=126 Follow-Up Postprocedural 30 d 12 mo Primary Endpoint: Safety at 30 days Secondary Endpoints: Procedural Success, valve gradient, paravalvular regurgitation, symmetry PI: Eberhard Grube *GrubeE et al. J Am Coll Cardiol. 2011; in press
66 Procedural Results Study Group Control Group n=60 n=126 Technical Success Rate 96.7% (58) 81.7% (103) Valve embolization 0 0 Conversion to surgery 1.7% (1) 5.6% (7) Postdilation 16.7% (10) n.a.
67 Clinical Outcome at 30days Control Study Group Group n=60 n=126 All-cause Mortality 6.7% (4) 14.3% (18) Myocardial infarction 0 5.6% (7) Stroke/TIA 5.0% (3) 11.9% (15) Need for pacemaker implantation 11.7% (7) 27.8% (35) Vascular Access Complication 10.0% (6) 9.5% (12)
68 Case Example Symmetry Post Implant Circular configuration: 41 (68.3%) Non-circular configuration: 19 (31.7%)
69 Rules of Engagement? PARTNER CV Surgeon Interventional Cardiologist
70 PARTNER Rules of Engagement CV Surgeon Interventional Cardiologist
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