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CRT 2010 Washington DC, January 21, 2010 Medtronic - Core Valve Device Evolution, Technique and Clinical Trial Update Eberhard Grube, MD, FACC, FSCAI St.Elisabeth Hospital, Heart Center Rhein-Ruhr, Essen, Germany Instituto Cardiologico Dante Pazzanese, São Paulo, Brazil DISCLOSURES Eberhard Grube, MD Consulting Fees – Abbott Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson Company, Medtronic CardioVascular, Inc. Honoraria – Biosensors International , Boston Scientific Corporation, Medtronic CardioVascular, Inc Ownership Interest (Stocks, Stock Options or Other Ownership Interest) – Biosensors International , Medtronic CardioVascular, Inc. I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation. I intend to reference off-label use of stents and valve prosthesis. CoreValve Prosthesis CoreValve : 3 Generations 2004 25 fr 21 fr 2005 2006 18 fr B.Sauren 18 French Procedural Progress Evolution to a « true percutaneous cath lab procedure » within the first 40 Patients of 18 Fr study • • • • • General anesthesia Surgical cutdown/repair Ventricular assistance Pre-closing with ProStar™ Local Anesthesia Beating heart in normal sinus rhythm Valve delivery without rapid pacing No cardiac assistance CoreValve 2005 - 24 F 1st Gen CoreValve - Surgical Prep - CPB pump - General anesthesia CoreValve 2010 - 18 F 3rd Gen CoreValve - PCI-like procedure Transcatheter AVR Clinical Data Sources CoreValve Edwards Transseptal Experience (RECAST, I-REVIVE; 36 pts) REVIVE (OUS, TF, 106 pts) TRAVERCE (OUS, TA, 172 pts) REVIVAL (US, TF/TA, 95 pts) PARTNER EU (OUS, TF/TA 125 pts) SOURCE (OUS, TF/TA, 598 pts)* PARTNER RCT (US/OUS, TF/TA 456 pts) FIRST-in-MAN 25 Fr Transfemoral Experience (14 pts) FEASIBILITY 21 and 18 Fr Transfemoral OUS Experience (177 pts) CE-APPROVAL 18 Fr Transfemoral OUS Experience (1,243 pts)* PIVOTAL RCT CoreValve US Pivotal Trial In Planning with FDA Overall Clinical Experience Study N Follow-ups Status 18 Fr Safety and Efficacy Trial 126 4 years On-going Australia-New Zealand Registry 140 2 years On-going Italian Registry 514 to date 6 months On-going German Series, Siegburg >536 to date 30 days On-going Expanded Evaluation Registry 1483 Up to 2 years Completed French Registry 78 to date 6 months On-going Advance Study 1,000 Up to 10 years Upcoming US IDE Study TBD TBD Upcoming 10 Baseline Clinical Characteristics 18 Fr S&E (N=126) Siegburg (N=86) ANZ (N=62) Age (years) 81.9 ± 6.4 82.3 ± 5.9 83.7 ± 5.4 Female 72 (57.1%) 56 (65%) 30 (48.4%) NYHA Class I and II NYHA Class III and IV 32 (25.4%) 94 (74.6%) 15 (17%) 71 (83%) 11 (19.3%) 46 (80.7%) 21.7 ± 12.6 18.7 ± 12.9 (N=58) Logistic EuroSCORE (%) 23.4 ± 13.8 Peak Pressure Gradient (mmHg) 72.8 ± 23.0 70.9 ± 22.8 18.7 ± 12.9 (N=58) Mean Pressure Gradient (mmHg) 47.8 ± 14.3 43.7 ± 15.4 48.6 ± 16.3 Aortic valve area (cm2) 0.73 ± 0.16 0.60 ± 0.16 0.7 ± 0.2 11 Procedural Success 100% 98.5% 96.8% EER ANZ 86.5% 80% 60% 40% 20% 0% 18FR S&E Procedural success has markedly improved over time Successful implant defined as no conversion to surgery or device-related mortality during the procedure and proper valve function immediately post-implant. The 18Fr S&E uses technical success (procedural success in re-adjudicated data was 72.6%). 12 30-Day All-Cause Mortality N = 126 N = 86 30-day all-cause mortality has improved over time 13 Pre- and Post-operative Gradients Peak Gradient (mmHg) Mean Gradient (mmHg) 90 80 60 76.3 75.5 18 F S&E ANZ 50 70 60 49.6 46.4 18 F S&E ANZ 40 50 30 40 30 20 17.7 17.0 20 9.3 8.4 10 10 0 0 Baseline 30-Day Baseline 14 30-Day Change in NYHA Class Paired 30-Day NYHA Classification 15 CoreValve long term Outcomes are quite positive ● In over 7,500 implants, not a single device migration or fracture was ever reported ● The higher leaflets are intended to promote leaflets long term durability and performance ● Two-year follow up of 18 Fr S&E shows 63% survival ● Longest implant to date from 2004; patient still alive and well. Number at Risk Number Failed Survival (%) 126 107 3 18 97.6 85.7 93 30 76.0 78 35 71.8 45 43 62.7 Source: 18 Fr S & E Study: LongTerm Survival Siegburg CoreValve TAVI Experience Study Patient n Time period 25 F 21 F 18 F 18 F 18 F S&E 2008 2009 10 24 102 187 253 2004 2005 03/2006 01/2008 01/2009 to to to 03/2008 12/2008 12/2009 - Five years, Three generations, 576 patients In-hospital Events (%) Siegburg CoreValve TAVI Experience 50 45 40 35 30 25 20 15 10 5 0 Death Stroke 8.3 8.3 9.8 9.8 5.8 2.9 21 F 18 F 2006 2.9 18 F 2007 2.1 18 F 2008 3.3 0 18 F 2009 CoreValve Clinical Results HELIOS Heart Center Siegburg % Survival 100 100 100 95 95 90 90 90 85 85 80 8080 75 75 70 7070 65 65 60 6060 55 55 50 5050 45 45 40 4040 35 35 30 3030 25 25 20 2020 15 15 10 1010 5 5 0 0 0 18F until 08/2009 18F until 03/2008 0 30 90 120 210 240 330 360 00 30 50 60 60 90 120 150 180 250 210 240 270 300 330 360 100 150 150 200 180 300 270 350 300 Number at risk Number at risk 184 180 172 172 171 167 166 163 158 155 152 142 125 114 104 101 184 180 172 172 171 167 166 163 158 155 152 142 125 114 104 10189 89 80 80 80 80 79 79 79 79 78 78 73 73 64 64 46 46 Days Survival Curves up to 1 Year CoreValve – The Unsuitable Patient Severe Calcifications of the Access Which is the preferred access? Surgical Transapical Subclavian Interventional Transfemoral Complexity / Invasiveness Predictors for Procedural Success of TAVI Procedural predictors Buellesfeld et al. EHJ 2010 in-press CoreValve Delivery Profile and Flexibility are critical ● Truly percutaneous delivery: minimizes risk of bleeding and vascular complications ● Easier delivery: for less experienced physicians 18 Fr 24 Fr ● Treating more patients: delivery is less hindered by peripheral artery disease ● Better options for additional approaches: such as subclavian and transaortic approaches Drawn to scale Low Profile ! Lower profile and flexibility means that CoreValve has a low rate of Vascular Complications Vascular Complications Patrick W. Serruys - PCR'08 Transcatheter aortic valve implantation: State of the art REVIVAL II REVIVE 18Fr S&E 12% 22% Vancouver TF 11% 4% CoreValve Edwards Aortic Regurgitation should be avoided CoreValve Design: ● The long sealing tunnel allows the valve to effectively function within a range of depth placements ● The conformability of nitinol allows proper apposition of the valve to the native annulus ● The supra annular position of the leaflets is a design feature that is meant to allow CoreValve to function better even when the annulus itself is in an out-of-round position ● The conformation of the leaflets allow them to have good coaptation and provide durable performance CoreValve is functioning well in Out-ofRound Situations ● CoreValve has been shown to retain a round mid-section (where the leaflets are), even when the annulus was out of round - “Dual source MSCT demonstrated incomplete and non-uniform expansion of the CRS frame, but the functionally important mid-segment was well expanded and almost symmetrical. Anatomical under sizing and incomplete apposition of struts was seen in the majority of patients.” (09/09) Schultz CJ, Weustink A, Piazza N, Otten A, Mollet N, Krestin G, van Geuns RJ, de Feyter P, Serruys PW, de Jaegere P. Geometry and degree of apposition of the CoreValve ReValving system with multislice computed tomography after implantation in patients with aortic stenosis. J Am Coll Cardiol 2009;54(10):911-918 Aortic Regurgitation(PVL) 18 Fr S&E 100% 6% 6% 5% 9% 3% 0% 32% 39% 90% 80% 70% 42% 33% 32% 52% Grade 4 Grade 3 Grade 2 Grade 1 none (0) 60% 50% 40% 30% 20% 52% 59% 62% 65% 61% 6 Month n=60 1 Year n=60 2 Year n=33 42% 10% 0% Procedure Discharge 30 Days n=75 n=84 n=33 Source: 18Fr S&E 33 There Is a Higher Incidence of Pacemaker Implant Associated with CoreValve New Permanent Pacemaker within 30 Days % patients 40 33 32 30 20 20 19 23 25 10 0 (n=30) (n=102) (n=34) (n=91) (n=1521) (n=126) Calvi (PACE 2009) Grube (Circ Interv 2008) Jilaihawi (Am Heart J 2009) Rotterdam 18F EER 18F S & E Weighted average = 23% (n=1990 patients) It is important to remember that Pacemaker Implantation may not mean Pacing Need New Permanent Pacemaker within 30 Days 18F Safety and Efficacy Study (n=126) * 2 centers with < 5 implants excluded from the presentation; both centers had 0% 30-day 50 permanent pacemakers 60 % patients 50 40 33 30 20 20 10 56 36 25 5 0 A B C D E F G Participating Centers Physicians’ decision to prophylactically implant play a big role in the variability among centers Depth of Implantation May Play a Role in the Onset of Rhythm Disturbances Rotterdam Experience (n=91) New-onset LBBB acquired during or after valve implantation 10.3 mm No new-onset LBBB or new-onset LBBB acquired during procedure but before valve implantation 7.3 mm 6.0 mm My Prediction: Repetition of an Old Story TAVI PCI sAVR CABG 1980’s, 1990’s 2000’s, 2010’s With the same result… Thank you for your attention ! Questions ? Clinical Experience to Date Over 7,500 implants to date Over 243 sites in 29 countries 40 Thank you for your attention !