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The History of Heart Valves an Industry Perspective: From Initial Designs to Today Erin M. Spinner, PhD Edwards Lifesciences [email protected] Edwards Lifesciences, Advanced Technologies Advanced Materials Strategy & Marketing Discovery From an Idea To Saving Lives Quality Engineering Biological Research Center Clinical & Regulatory Why does this matter? • Heart disease is the #1 cause of death for men and women in the US, claiming approximately 1 million lives annually • Every 33 seconds someone in the United States dies from cardiovascular disease • More die of heart disease than of AIDS and all cancers combined Theheartfoundation.org The Different Valves Goal of a heart valve: Unidirectional blood flow Modified from Carpentier A, Adams DH, Filsoufi F. Carpentier’s Reconstructive Valve Surgery. From Valve Analysis to Valve Reconstruction. 2010 Saunders Elsevier. Left Sided Valvular Diseases Prevalence of moderate or severe valve disease 14% Any Left Sided Valve Disease Mitral Aortic 12% 10% 8% Regurgitation = Replacement or Repair 6% Stenosis = Replacement 4% 2% 0% <45 45-54 55-64 65-74 Age (years) Graph adapted from Burden of Valvular Heart Disease: A Population Based Study (2006) Nkomo VT et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006; 368:1005-1011. 75+ Complexity in Structure Current Options and Trends Replacement Surgical Replacement Transcatheter Which Valve is Best? • If the patient is young…. Durability Materials, Design, Process Computation Fluid Dynamics to Improve Designs Platelet Activation = Shear Stress and/or Residence Time Simon HS Ann Biomed Eng. Mar 2010; 38(3): 841–853 Moving towards Blood Thinners Aspirin No Medications ? Which Valve is Best? • If the patient is young…. Durability Materials, Design, Process • If the patient cannot tolerate anti-coagulants Hemodynamics Fluid Mechanics Accelerated Wear Testing 9/15/2014 Change the Footer in the Master 12 Accelerated Wear Testing Time Zero 25 Simulated Years (0 Cycles) (1 Billion Cycles, ~2.5 years) Which Valve is Best? • If the patient is young…. Durability Materials, Design, Process • If the patient can not tolerate anti-coagulants Hemodynamics Fluid Mechanics • If the patient a high risk surgical candidate Implantation Anatomy Minimally Invasive Procedures Transcatheter Technologies Transcatheter Technologies Apical Access Femoral Access Aortic Access Transcatheter Landscape is Growing CoreValve 2007 Edwards SAPIEN JenaValve 2008 2009 2010 Edwards SAPIEN XT 2011 Symetis Medtronic CoreValve 2012 St. Jude Portico Direct Flow Medical 2013 Extending the Life of Tissue Valves Original Valve Transcatheter Valve Place a Valve in a Valve Transcatheter Valve Original Valve Which Valve is Best? • If the patient is young…. Durability Materials, Design, Process • If the patient can not tolerate anti-coagulants Hemodynamics Fluid Mechanics • If the patient a high risk surgical candidate Implantation Anatomy New Challenges Heartvalvesurgery.com Bloomfield G JACC: Cardiovascular Imaging. April 2012:441-55 Lerakis S JACC: Cardiovascular Imaging. February 2010:219-21 Gurvitch R JACC. November 2011: Vol 58, Issue 21 Left Sided Valvular Diseases Prevalence of moderate or severe valve disease 14% Any Left Sided Valve Disease Mitral Aortic 12% 10% 8% 6% Regurgitation = Replacement or Repair Stenosis = Replacement 4% 2% 0% <45 45-54 55-64 65-74 Age (years) Graph adapted from Burden of Valvular Heart Disease: A Population Based Study (2006) Nkomo VT et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006; 368:1005-1011. 75+ Current Options and Trends Replacement Repair Replacement Repair Surgical Transcatheter Transcatheter Mitral Valve Replacement Atrial Flange Leaflet Attachment Pre-clinical Animal Models “Transcatheter Mitral Valve Implantation is Complex” Transcatheter Mitral Valve Replacement Tiara - Neovasc Engager - Medtronic CardiAQ Transcatheter Mitral Valve Repair Cardioband Carillion Mitraclip The Future…. Planning for the best valve for the patient specific anatomy Expanding to help more patients 3D Computed Tomography 3D Echocardiography Computation Fluid Dynamics Helping Patients is Our Life’s Work, and
