A Review of Medtronic CoreValve TAVI Clinical Results: Focus on Learning Curve Issues and Outcomes Ganesh Manoharan MBBCh, MD, FRCP(I), FRCP(Edin) Consultant Cardiologist, Royal Victoria Hospital Co-Director, CACR, University of Ulster Hon. Senior Lecturer, Queens University Belfast, UK

Ganesh Manoharan, MBBCh, MD Advisory Committee Boston Scientific Corporation Cordis Corporation Consulting Fees Medtronic, Inc. Honoraria St. Jude Medical, Inc.

CoreValve Experience More than 12,000 implants over 30 countries

CoreValve Clinical Experience Study Study Size Number of centers Follow-up to date Status 18 Fr Safety and Efficacy Trial1 126 9 2 years Enrollment complete Australia-New Zealand Study2 375 10 6 months Enrolling REDO9 18 4 30 days Advance Study10 1000 Up to 50 NA Italian Registry8 772 14 1 year Enrollment Complete Belgian Registry5 328 (141 CoreValve) 13 (6 CoreValve) Spanish Registry3 108 3 French Registry4 244 (78 CoreValve) 16 UK Registry7 872 (460 CoreValve) 25 German Registry6 697 (588 CoreValve) 22 Medtronic Sponsored Studies Independent Studies 1. Medtronic. Data on file. 2. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, 2009. San Francisco, CA. 3. Petronio AS. The Italian CoreValve Registry. 6. Eltchaninoff H. FRANCE Registry: French Aortic National CoreValve and Edwards Registry. Presented at the American Heart Association Scientific Sessions 2009, November 14-18, Orlando, FL. 7. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. See reference slide for sources.

Baseline Patient Characteristics 18 Fr S&E1 ANZ2 Spanish Registry3 French Registry4 Belgian Registry6 German Registry8 UK Registry7 Italian Registry8 N 126 118 108 66 141 588 460 772 Age (years) 81.9 ± 6.4 82.3 ± 7.7 78.6 ± 6.7 82.5 ± 5.9 82 ± 6 81.4 ± 6.4 83 Female 57.1% 40.7% 54.6% 51.5% 56% 55.8% 48% Logistic EuroSCORE (%) 23.4 ± 13.8 18.4 ± 11.9 16 ± 13.9 24.7 ± 11.2 25 ± 15 20.8 ± 13.3 20.3 22.9 ± 13.5 NYHA Class III and IV 74.6% 83.9% 58.4% – 78% 88.2% 74% 70.6% LVEF % 51.6 ± 13.1 57.8 ± 13.0 51 ± 15 59 ± 13 52.1 ± 15 51 ± 13 Mean Pressure Gradient (mmHg) 46.8 ± 15.9 50.6 ± 16.2 55 ± 14.3 46 ± 15 49 ± 16 48.7 ± 17.2 52 ± 17 Aortic valve area (cm2) 0.72 ± 0.17 0.71 ± 0.21 0.63 ± 0.2 0.71 ± 0.16 0.63 ± 0.13 0.64 ± 0.18 0.71 Medtronic. Data on file. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, 2009. San Francisco, CA. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Patients currently treated with CoreValve are all high risk patients See reference slide for sources. 5

Percent of Patients (%) Procedural Success 98.1% 97.0% 98.0% 98.7% 99.0% 98.1% 100% 95.8% 83.1% * 80% 60% Percent of Patients (%) 40% 20% 0% 18 Fr S&E1 ANZ2 Spain3 French4 Belgian5 Germany6 UK7 Italian8 N = 126 N = 118 N = 108 N = 78 N = 141 N = 588 N = 460 N = 772 Procedure Success is not defined consistently across all studies. * Technical Success is reported here. 1. Medtronic Data on File. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009. 2. Meredith I. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. Transcatheter Cardiovascular Therapeutics 2010, Washington, DC. 3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. 4. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 6. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 6

Has experience reduced complication rates?

Learning Curve - CoreValve The Bern Experience (August 2007 – July 2010) - N=150 First Cohort (0-75) Second Cohort (76-150) % % CAVE Siegburg – Follow up not completed (analysis for the first 50 patients) missing data: european, italian, munich, Büllesfeld, germany Bern 2year fup: 18.6% completed

30-Day All-Cause Mortality 25% 20% 15.2% 15.1% 15% 12.4% % 10% 9.0% 7.4% 7.2% 5.5% 5.6% 5% Medtronic. Data on file. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, 2009. San Francisco, CA. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 0% 18 Fr S&E1 N = 125 ANZ2 N = 118 Spain3 N = 108 French4 N = 66 Belgian5 N = 119 German6 N = 588 UK7 N = 460 Italian8 N = 772 1. Medtronic Data on File. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009. 2. Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC. 3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. 4. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 6. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 9

One-half of all Mortality Occurs Within 30 Days 12 100 90 10 80 70 8 60 Number of Deaths 6 % of All Mortality 50 40 4 30 20 2 10 2 4 6 9 11 14 16 22 26 31 33 37 43 52 61 69 78 87 93 106 113 121 151 171 186 201 225 267 283 294 311 349 502 515 709 1007 Days of follow-up Petronio, AS. The Italian CoreValve Registry, EuroPCR 2010. 10

Percent of Patients (%) One Year Survival 100% 90% 85.1% 81.6% 79.0% 80% 71.9% 70% 60% Percent of Patients (%) 50% 40% 30% 20% 10% 0% Medtronic. Data on file. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, 2009. San Francisco, CA. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 18 Fr S&E1 N = 126 Belgian2 N = 141 UK3 N = 460 Italian4 N = 772 Survival rates comparable with octogenarians who have had sAVR or sAVR+CABG5 Survival rates reported are based on Kaplan-Meier Analysis. 1. Medtronic. Data on file. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009. 2. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 3. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 4. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Moat, Neal. UK TAVI Registry, TAVI Mid and Long-term Clinical Outcomes. EuroPCR 2010. 11

Percent of Patients (%) Two Year Survival 100% 90% 77.6% 80% 70% 59.7% 60% Percent of Patients (%) 50% 40% 30% 20% Medtronic. Data on file. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, 2009. San Francisco, CA. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 10% 0% 18 Fr S&E1 N = 126 UK2 N = 460 Survival rates reported are based on Kaplan-Meier Analysis. 1. Gerckens, Ulrich, MD. Safety, Durability and Effectiveness at Two Years with the 18 Fr CoreValve Transcatheter Aortic Valve. EuroPCR 2010. 2. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 12

30-Day Stroke Rate Stroke Rate at 30 days 20% 15% 10% 5% 0% 9.6% 10% 5% 4.5% 4.0% 4.0% 2.6% 1.9% 1.7% 0% 18 Fr S&E*1 N = 125 ANZ2 N = 118 French3 N = 66 Belgian4 N = 119 German5 N = 588 UK6 N = 460 Italian7 N = 772 Stroke is not defined consistently across all studies *Stroke is defined as permanent neurologic defects, included patients who had reversible neurologic events if there was structural evidence of an intracranial event Medtronic. Data on file. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009. Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 13 13

Post-Procedure Aortic Regurgitation 0% 0% 0% 0.3% 100% 0% 2% 6% 8.6% 90% 15.2% 24.1% 80% 42.9% AR grade 4 70% 52% 60% AR grade 3 54.9% 46.3% Percent of Patients (%) 50% AR grade 2 40% AR grade 1 30% 39.0% None 20% 42% 27.8% 27.6% 10% 9.5% 0% 18 Fr S&E1# N = 84 ANZ2# N = 105 Spanish2* N = 108 German3*† N = 689 # Measured with echo *Measured with angiography †German registry data includes both patients treated with CoreValve, 84.5%, and EDW Sapien, 15.5% Gerckens, Ulrich, MD. Safety, Durability and Effectiveness at Two Years with the 18 Fr CoreValve Transcatheter Aortic Valve. EuroPCR 2010. Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. Zahn, et al. Transcatheter Aortic Valve Implantation: First Results from Multi-center Real World Registry. EHJ [epub ahead of print].

Residual AR has an Impact on In-hospital Mortality 20 18 P < 0.001 16 14.1 14 12 In-hosptial Mortality % 10 8 5.9 6 4 2 Residual AI 0-I (82%) Residual AI ≥ II° (18%) Zahn R. The German TAVI Registry, EuroPCR 2010.

Proper Implant Location Results in Less ParaValvular Leak 35 P = 0.09 P = 0.19 P = 0.05 30 P = 0.10 25 20 Good Grade >1 Paravalvular Leak (%) Suboptimal 15 10 5 1 mo 3 mos 6 mos 12 mos N = 326 Proper implant location defined as 4 to 8 mm below annulus. De Carlo. Serial Echocardiographic Evaluation of the CoreValve Aortic Bioprosthesis: Italian Registry EuroPCR 2010.

Vascular Complications 30% 25% 19.5% 20% Percent of Patients (%) 15% 9.5% 10% 7.5% 6.7% 6.5% 5% 3.9% 0% 18 Fr S&E1* N = 125 ANZ2# N = 118 French3† N = 66 German4‡ N = 588 UK5§ N = 460 Italian6|| N = 772 Medtronic. Data on file. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, 2009. San Francisco, CA. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Vascular complication is not defined consistently across studies. *Defined as arteriovenous fistula, bowel ischemia, hematoma, pseudoaneurysm, and retroperitoneal bleed. #Defined using proposed VARC definitions, Serruys EuroPCR 2010. Includes both major (1.9%) and minor complications (4.6%). †Definition unknown. ‡Defined as groin problems, including major and minor. §Defined as major vascular injury or later vascular injury requiring surgery. ||Defined as severe bleeding/surgery of femoral access. Medtronic. Data on file. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009 Meredith. VARC-adjudicated Outcomes in Inoperable and High Risk AS Patients. TCT 2010, Washington, DC. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Zahn, et al. Transcatheter Aortic Valve Implantation: First Results from Multi-center Real World Registry. EHJ [epub ahead of print. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 17

Pacemaker Implantation Varies Between Studies Procedural variability, anatomical differences and clinical practice variation impact pacemaker implant rates:9,10 Depth of implant may induce conduction disturbances11 Valvuloplasty balloon size may impact conduction system11 Anatomical and patient-related factors may impact conduction disturbances12 Inter-hospital variability due to physician subjectivity, country-based healthcare norms and reimbursement strategies9 New Pacemaker Implants at 30 days Weighted Average 28.5% Weighted Average 28.5% Weighted Average 28.5% 60% 60% 60% 50% 50% 50% 42.5% 42.5% 42.5% 40% 40% 40% 40% 40% 40% 35.2% 35.2% 35.2% 31.3% 31.3% 31.3% Percent of Patients (%) Percent of Patients (%) Percent of Patients (%) 30% 30% 30% 26.9% 26.9% 26.9% 26% 26% 26% 23% 23% 23% 18.5% 18.5% 18.5% 20% 20% 20% 10% 10% 10% 0% 0% 0% 18 Fr S&E1 N = 125 18 Fr S&E1 N = 125 18 Fr S&E1 N = 125 ANZ2 N = 118 ANZ2 N = 118 ANZ2 N = 118 Spain3 N = 108 Spain3 N = 108 Spain3 N = 108 French4 N = 66 French4 N = 66 French4 N = 66 Belgian5 N = 119 Belgian5 N = 119 Belgian5 N = 119 German6 N = 588 German6 N = 588 German6 N = 588 UK7 N = 460 UK7 N = 460 UK7 N = 460 Italian8 N = 772 Italian8 N = 772 Italian8 N = 772 1. Medtronic Data on File. COR 2006-02: 18 Fr Safety& Efficacy Study Re-Analysis, August 14, 2009. 2. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009, September 21-25, 2009. San Francisco, CA. 3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148. 4. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 6. German Registry data on file. New pacemakers with Corevalve 240/565. 7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. 8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France. See Reference slide for sources 1-8 See Reference slide for sources 1-8 See Reference slide for sources 1-8 9. N. Piazza, “AV-Block and Pacemaker Requirements Associated with Medtronic CoreValve TAVI: Incidence, Outcomes and Treatment Strategies”, TCT 2009. 10. Latsios et al. Device Landing Zone” Calcification, Assessed by MSCT, as Predictive Factor for Pacemaker Implantation after TAVI. Catheter Cardiovasc Interv. 2010 [Epub ahead of print]. 11. N. Piazza, “AV-Block and Pacemaker Requirements Associated with Medtronic CoreValve TAVI: Incidence, Outcomes and Treatment Strategies”, TCT 2009. 12. N. Piazza, “Persistent Conduction Abnormalities and Requirments for Pacemaking 6 Months after TAVI”, PCR 2010. 18 18

Pacemaker Implantation Varies by Center Italian Registry – Pacemaker Implantation Rate by Center 50% Average Pacemaker Implantation Rate 18.5% 45% 40% 36.2% 35.7% 35.0% 35% 32.3% 30% 24.1% Pacemaker Implantation Rate (%) 25% 21.4% 18.6% 18.2% 20% 14.7% 15.4% 14.9% 15% 11.1% 10% 3.7% 5% 0% Legnano Mirano Pisa, University Brescia, H. Civile Milano, Niguarda Padova, University Catania, University Roma, S. Camillo Firenze, Careggi Milano, S. Ambrogio Firenze, University Milano, S. Raffaele Bologna, University Petronio, AS. The Italian CoreValve Registry, EuroPCR 2010.

Is TAVI outcome related to Euroscore?

CoreValve Australia-New Zealand Study Baseline Characteristics Mean ± SD, or % Age (years) 82.3 ± 7.7 Logistic EuroSCORE (%) 18.4 ± 11.9 STS (%) (Mortality) 5.6 ± 2.7 Female 40.7% NYHA Class I: 0.0% Class II: 16.1% Class III: 62.5% Class IV: 21.4% Aortic valve area (cm2) 0.71 ± 0.21 Peak gradient (mmHg) 81.5 ± 23.6 Mean gradient (mmHg) 50.6 ± 16.2 LVEF (%) 57.8 ± 13.0

CoreValve Australia-New Zealand Study 30-Day All-Cause Mortality 25% 20% 15.2% 15.1% 15% 12.4% % 10% 9.0% 7.4% 7.2% 5.5% 5% 5.6% 0% 18 Fr S&E N = 125 ANZ N = 118 Spain2 N = 108 French1 N = 66 Belgian1 N = 119 German1 N = 588 UK1 N = 460 Italian1 N = 772

CoreValve Clinical Portfolio Evaluate Long-term Performance & QOL Evaluate Procedural Best Practices Evaluate Performance in Expanded Patient Populations 18 Fr Safety & Efficacy ADVANCE II Study SURTAVI ANZ Study REDO ADVANCE Study US Pivotal Extreme Risk (Inoperable) Cohort US Pivotal High Risk Surgical Cohort

Conclusions (1) TAVI with the Medtronic CoreValve is safe and effective Continued improvements in technique, understanding patient selection (clinical and technical suitability) and post procedural management impacts on outcome Continued emphasis on teaching, training and dissemination of information will impact on outcome

Conclusions (2) Standardisation of event reporting (VARC) will allow more transparent comparisons to be made Technological iterations will further enhance the safety and efficacy of this technique Long term durability and outcome awaited