Progress In Transcatheter Aortic Valve Implantation Gerald Yong MBBS (Hons) FRACP FSCAI Interventional Cardiologist Royal Perth Hospital Western Australia 4 th APCASH 8 th Sept 2013
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial Interest /arrangement or affiliation with the organization(s) listed below Affiliation/Financial Relationship Grant/ Research Support: Consulting Fees/Honoraria: Company Edwards Lifesciences (consultant & proctor) Major Stock Shareholder/Equity Interest: Royalty Income: Ownership/Founder: Salary: Intellectual Property Rights: Other Financial Benefit:
Lots of progress TAVR Manuscriptes in Pub Med 2012 and 20132 (thusfar) 900 800 700 600 500 400 300 200 100 0 Pub Med reviewed 835 532 303 (5 months) 2012 2013 Total
New Devices in TAVR Embolic protection devices New transcatheter valves
NEW TRANSCATHETER VALVES
Edwards SAPIEN 3 Edwards Centera Medtronic CoreValve Evolut Boston Scientific Lotus Direct Flow Medical St Jude Portico
Edwards SAPIEN 3 Balloon expandable system Cobalt chromium frame Bovine pericardiac tissue Longer 20mm Outer sealing skirt to reduced paravalvular regurg. Size: 23mm, 26mm, 29mm 14Fr e-sheath for 23 & 26mm valve; 16Fr e-sheath for 29mm valve Commander delivery system for TF Increased flexion incl distal flexion Fine Up and Down control for fine THV positioning Proximal Flex Distal Flex
Edwards Centera Self-expanding Nitinol frame Treated bovine pericardium Contoured frame designed for optimal seating and sealing in the annulus 23 mm, 26 mm, 29 mm sizes 14F esheath Pre-packaged (no loading needed) Motorized handle with touch deployment allows precise THV placement Repositionable Flex mechanism for enhanced trackability and optimal coaxial alignment Distal flex Touch deployment
Medtronic CoreValve Evolut Redesigned release mechanism for ease of separation from delivery catheter Shorted outflow More consistent inflow radial force to reduce paravalvular regurgitation Longer and extended skirt Enveo delivery system Nitinol reinformed capsule for recapturability and repositionability Flexible shaft for nagivation through tortuous anatomy Redesigned handle allowing 1-1 deployment control 14Fr equivalent with In-line Sheath TM
Boston Scientific Lotus Valve Bovine pericardium Nitinol frame Adaptive seal to reduce paravalvular regurgitation 18Fr access Pre-packaged Deployed via mechanical expansion Shortens as it expands Fully recapturable and repositionable even after full deployment 1. Elongated Configuration (for Delivery) ~70 mm 2. Intermediate Configuration 3. Final Locked Configuration 19 mm
Direct Flow Medical Expandable dacron polyester double ring design ie. Metal free! Bovine pericardial leaflets Sealing ring to reduce paravalvular regurgitation 18Fr access 3 positioning lines to adjust position Fully retrievable and repositionable
St Jude Portico Self-expanding Bovine pericardial leaflets Porcine pericardial sealing cuff Large cells to reduce paravalvular regurgication and improve coronary access 18Fr delivery system Fully recapturable and repositionable
Summary SAPIEN 3 Centera CoreValve Evolute Lotus Direct Flow Portico Access TF / TA TF TF TF TF TF /?TA Access size (Fr) 14/16 14 14 18 18 18 Procedural Success 100% 100% 100% 99% 100% Post-TAVR mean gradient / EOA PVL Mild >Mild 30-day Outcomes 13.0mmHg / 1.5cm 2 27% 0 10.6mmHg / 1.6cm 2 69% 8% 13.7mmHg / 1.5cm 2 18% 0 14.1mmHg / 1.43cm 2 26% 1% 13.3mmHg / 1.2cm 2 Death 0 13.3% 0 1.3% 0 Stroke 0 0 9.1% 2.7% 0 Major Vascular 0 0 0 2.7% 0 Life-threatening bleeding 0 6.7% 18.2% 4% 0 PPM 6.7% 27.7% 16% 0 45% 0