• A Review of All Available Self-Expanding Transcatheter Valve Clinical Results

    Ganesh Manoharan Consultant Cardiologist Regional Cardiology Department Royal Victoria Hospital Belfast, UK I am a consultant for- St. Jude Medical Medtronic CardioVascular GDS Inc Clinically approved (European CE Mark) Transfemoral (+Other Access Route) Transapical Emerging Systems Transfemoral Transapical Tissue valve sutured to frame Medtronic CoreValve System Trileaflet heart valve 20 21 22 23 24 25 26 27 28 29 Annulus Size (mm) Over-the-wire 0.035 compatible AccuTrak® Stability Layer 15Fr 12Fr 18Fr 7mm 20 21 22 23 24 25 26 27 28 29 Annulus Size (mm) Flexible frame conforms to native annulus shape while maintaining bioprosthesis in a higher position This decoupling of the valve from native annulus shape minimizes the impact of ellipticity at the valve level post deployment1 Data on file at Medtronic See reference slide for sources. Patients currently treated with CoreValve are all high risk patients 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 severeaortic 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. N = 126 N = 118 N = 108 N = 78 N = 141 N = 588 N = 460 N = 772 Percent of Patients (%) 83.1% 95.8% 98.1% 97.0% 98.0% 98.7% 99.0% 98.1% 0% 20% 40% 60% 80% 100% 18 Fr S&E1 ANZ2 Spain3 French4 Belgian5 Germany6 UK7 Italian8 * 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 patientswith 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. 15.2% 5.6% 7.4% 15.1% 9.0% 12.4% 5.5% 7.2% 0% 5% 10% 15% 20% 25% 18 Fr S&E1N = 125 ANZ2N = 118 Spain3N = 108 French4N = 66 Belgian5N = 119 German6N = 588 UK7N = 460 Italian8N = 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. 71.9% 79.0% 81.6% 85.1% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 18 Fr S&E1N = 126 Belgian2N = 141 UK3N = 460 Italian4N = 772 Percent of Patients (%) 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. 9.6% 0% 5% 10% 15% 20% 18 Fr S&E*1N = 125 French3N = 66 Belgian4N = 119 German5N = 588 UK6N = 460 Italian7N = 772 4.5% 4.0% 2.6% 4.0% 1.7% Stroke Rate at 30 days ANZ2N = 118 1.9% Post-Procedure Aortic Regurgitation # 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]. 42% 27.8% 27.6% 52% 46.3% 54.9% 6% 24.1% 15.2% 2% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 18 Fr S&E1#N = 84 Spanish2* N = 108 German3*†N = 689 AR grade 4 AR grade 3 AR grade 2 AR grade 1 None Percent of Patients (%) 0.3% 0% 0% 0% 9.5% 39.0% 42.9% 8.6% ANZ2#N = 105 0% De Carlo. Serial Echocardiographic Evaluation of the CoreValve Aortic Bioprosthesis- Italian Registry EuroPCR 2010. Proper implant location defined as 4 to 8 mm below annulus. 0 5 10 15 20 25 30 35 1 mo 3 mos 6 mos 12 mos Good Suboptimal Grade >1 Paravalvular Leak (%) P = 0.09 P = 0.19 P = 0.05 P = 0.10 N = 326 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, TA

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