Verification and Validation Methodologies for Prosthetic Heart Valves: Review and Considerations. ASME V&V40 Subcommittee Heart Valve Subgroup
|
|
|
- Karin Cameron
- 5 years ago
- Views:
Transcription
1 Verification and Validation Methodologies for Prosthetic Heart Valves: Review and Considerations. ASME V&V40 Subcommittee Heart Valve Subgroup
2 ASME V&V 40 Heart Valve Subgroup Members Andrew Rau (Exponent Failure Analysis Associates) Tina Zhao (Edwards Lifesciences) Shiva Arjunon (Georgia Tech) Marc Horner (ANSYS) Xue Mei Li (St. Jude Medical) Brandon Lurie (W.L. Gore) Christine Scotti (W.L. Gore) Min Yun (Georgia Tech)
3 Goal: Review State of the Art for V&V of Prosthetic Heart Valve Models Review V&V methodologies used in current heart valve modeling efforts Identify reoccurring V&V methodologies and level of V&V Gap Analysis: Identify missing elements/practices
4 Current Group Focus: Surgical Tissue Valve Anatomical location (Triscupid, Pulmonary, Mitral, Aortic) Surgical Tissue Mechanical Transcatheter Tissue
5 V&V methodologies can be grouped by type of analysis Solid Mechanics Stress/strain Fatigue Frame integrity Leaflet motion FSI Fluid Mechanics Blood damage Thrombosis Cavitation potential
6 Problems for Surgical Tissue Valves Solid Mechanics Frame Fracture Large-scale deformation Leaflet Calcification Closure Tearing (stress-strain) Thrombosis (kinematics)
7 Solid Mechanics - Current standards can be leveraged for frame analysis ISO 5840 Cardiovascular Implants Cardiac Valve Prostheses FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems ASTM F Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading Material property verification Mesh convergence study Radial force-displacement relationship Commissure-displacement relationship (no guidance) Dynamic failing mode verification (no guidance)
8 Common Target Parameters for Leaflet Model V&V (1) Calibration of constitutive models to material tests (2) Opening Area (GOA, EOA) (ISO 5840) (3) Leaflet deformation/displacement Qualitative vs. Quantitative
9 Common Target Parameters for Leaflet Model V&V (1) Calibration of constitutive models to material tests Labrosse et al., 2010 Smuts et al, 2011 Li and Sun, 2010
10 Common Target Parameters for Leaflet Model V&V (2) Opening Area (GOA, EOA, A EO ) Labrosse et al., 2010 Labrosse et al., 2010
11 Common Target Parameters for Leaflet Model V&V (3) Leaflet deformation Stevanella et al., 2011 Stevanella et al., 2011
12 Solid Mechanics (Leaflets) V&V Gap Analysis Leaflet testing/analysis Leaflet deformations and kinematics (more quantitative) Deformations while opening vs. closing Commissure displacement (assembly level)
13 Fluid Mechanics current standards (ISO 5840) Focus on measured or derived parameters from testing Steady flow conditions Pressure drop, Effective orifice area (EOA) under steady forward flow conditions Leakage volume (Regurgitant, paravalvular) under steady backpressure conditions Pulsatile conditions Pressure drop, EOA, closing volume, leakage volume (across different heart rates and cardiac outputs) Bernoulli relationship for the flow through the valve
14 Definitions from ISO 5840 Closing volume: component of the regurgitant volume that is associated with the dynamics of the valve closure during a single cycle is the sum of the transvalvular leakage volume and paravalvular leakage volume Leakage Volume: component of the regurgitant volume that is associated with leakage during closed phase of a valve in a single cycle and is the sum of the transvalvular leakage volume and paravalvular leakage volume Paravalvular Leakage Volume: component of the leakage volume that is associated with leakage around the close heart valve substitute during a single cycle Regurgitant Volume: volume of fluid that flows through a heart valve substitute in the reverse direction during one cycle and is the sum of the closing volume and leakage volume Transvalvular Leakage Volume: component of the leakage volume that is associated with leakage through the closed valve during a single cycle
15 Common Target Parameters for Fluids V&V (1) Pressure drop (2) Velocity profiles (quantitative/qualitative) (3) Opening Area (GOA, EOA) (ISO 5840) or other opening parameter
16 Common Target Parameters for Fluids V&V Valve Opening Velocity Profiles (qualitative/quantitative) Guivier-Curien et al., 2009 Guivier-Curien et al., 2009 Guivier-Curien et al., 2009 Suzuki et al., 2011
17 Fluid Mechanics V&V Gap Analysis Couple experimentation/computation to ensure consistency Spatial and temporal resolution of experimental systems may not be able to resolve hemodynamic flow characteristics Exploration/identification of additional computational parameters to validate models Better validation for biological/clinical outcomes, i.e. how we interpret our results and predict clinical effects Shear stresses, recirculation zones, etc.
18
19 Backup
20 Fluid Mechanics Recommendations for numerical modeling All current experimental fluid mechanics parameters (measured and derived) can be computed through numerical models Fluid-structure interaction models should be developed and validated to make this feasible Additionally, blood element damage models can be developed
21 FDA Draft Guidance: Heart Valves Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications
22 Dynamic Failure Modes Commisure Displacement under hydro-pressure Valv e Assembly Level TBD (e.g. Commisure Force-Displacement Relationship) TBD (e.g. Fabric wrapped stent) Sub-Assembly Level Frame (Metal, Polymer, etc.) Special to Valve application (e.g. Commisure Force- Displacement Relationship) Leverage V&V from stent group (e.g. Radial Force-Diameter relationship in crimping experiment) Leaflet (Tissue, Pyrolytic Canbon, etc.) A Load-Displacement Relationship with a piece of material constrained similar to the leaflet Cuff (Tissue, Fabric, etc.) Similar to Leaflet Bound (Suture, Glue, etc.) TBD (e.g. Suture: Tensile test) Component Level (Material property verification and mesh convergence study could be carried in this level)
23 Calculation of relevant parameters 1 P mean ( P) dt T peak systole P max( P) 1 P T P dt steady ( ) Q EOA 51.6 rms P mean systole
V&V 40 Subcommittee. V&V for Computational Modeling for Medical Devices
V&V 40 Subcommittee V&V for Computational Modeling for Medical Devices Carl Popelar, Chair, Southwest Research Institute Tina Morrison, Vice-Chair*, FDA Andrew Rau, Vice-Chair, Exponent Ryan Crane, Secretary,
HOW IMPORTANT ARE THESE ECHO MEASUREMENTS ANYWAY?
HOW IMPORTANT ARE THESE ECHO MEASUREMENTS ANYWAY? John D. Carroll, MD Professor, Director of Interventional Cardiology and Co-Medical Director of the Cardiac and Vascular Center, University of Colorado
Contents 1 Computational Haemodynamics An Introduction 2 The Human Cardiovascular System
Contents 1 Computational Haemodynamics An Introduction... 1 1.1 What is Computational Haemodynamics (CHD)... 1 1.2 Advantages of CHD... 3 1.3 Applications in the Cardiovascular System... 4 1.3.1 CHD as
Development of Computational Models for Evaluation of Mechanical and Hemodynamic Behavior of an Intravascular Stent
Development of Computational Models for Evaluation of Mechanical and Hemodynamic Behavior of an Intravascular Stent Kuang-Huei Lee, Hao-Ming Hsiao, Ying-Chih Liao, Yi-Hsiang Chiu, Yu-Seng Tee Dept. of
Simulating the Motion of Heart Valves Under Fluid Flows Induced by Cardiac Contraction
Simulating the Motion of Heart Valves Under Fluid Flows Induced by Cardiac Contraction Eann A. Patterson Department of Mechanical Engineering, The University of Sheffield Mappin Street, Sheffield, S1 3JD
Prosthetic valve dysfunction: stenosis or regurgitation
Prosthetic valve dysfunction: stenosis or regurgitation Jean G. Dumesnil MD, FRCP(C), FACC, FASE(Hon) Quebec Heart and Lung Institute, Québec, Québec No disclosures Possible Causes of High Gradients in
Echocardiographic Evaluation of Mitral Valve Prostheses
Echocardiographic Evaluation of Mitral Valve Prostheses Dennis A. Tighe, M.D., FACC, FACP, FASE Cardiovascular Medicine University of Massachusetts Medical School Worcester, MA www.asecho.org 1 Nishimura
Management of Difficult Aortic Root, Old and New solutions
Management of Difficult Aortic Root, Old and New solutions Hani K. Najm MD, Msc, FRCSC,, FACC, FESC Chairman, Pediatric and Congenital Heart Surgery Cleveland Clinic Conflict of Interest None Difficult
PROVEN PLUS. Introducing the Avalus Aortic Valve by Medtronic.
PROVEN PLUS. Introducing the Avalus Aortic Valve by Medtronic. With more than 40 years of heart valve innovations, we took proven valve design concepts and adapted them for excellent implantability for
Mitral Programme Update
Direct Flow Medical Innovations in the Aortic and Mitral Programmes Mitral Programme Update Azeem Latib MD EMO-GVM Centro Cuore Columbus and San Raffaele Scientific Institute, Milan, Italy Potential conflicts
The University of Sydney Slide 1
The University of Sydney Slide 1 SIMULATION DRIVEN BIOMEDICAL DESIGN Lecture 4 Presented by Dr Paul Wong AMME4981/9981 Semester 1, 2016 The University of Sydney Slide 2 Simulation Types There is more to
LivaNova Investor Day
LivaNova Investor Day TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) Paul Buckman General Manager, TMVR September 14, 2017 Safe Harbor Statement Certain statements in this presentation, other than purely
Echocardiographic Evaluation of Aortic Valve Prosthesis
Echocardiographic Evaluation of Aortic Valve Prosthesis Amr E Abbas, MD, FACC, FASE, FSCAI, FSVM, RPVI Co-Director, Echocardiography, Director, Interventional Cardiology Research, Beaumont Health System
PPM: How to fit a big valve in a small heart
PPM: How to fit a big valve in a small heart Hani K. Najm MD, Msc, FRCSC, FRCS (Glasgow), FACC, FESC King Abdulaziz Cardiac Centre National Guard Health Affairs Riyadh, Saudi Arabia GHA meeting Muscat
Figure 1 The Human Heart
ARTIFICIAL HEART VALVE MODEL INTRODUCTION The heart is a muscular pump with four chambers and four heart valves. The upper chambers, the right atrium and left, are thin walled filling chambers. Blood flows
3 rd TAVI Summit Seoul, August 9/10, 2013
3 rd TAVI Summit Seoul, August 9/10, 2013 Durability of the EW Sapien Valve and the MDT Core Valve Eberhard Grube MD, FACC, FSCAI University Hospital, Dept of Medicine II, Bonn, Germany Hospital Alemão
TAVI- Is Stroke Risk the Achilles Heel of Percutaneous Aortic Valve Repair?
TAVI- Is Stroke Risk the Achilles Heel of Percutaneous Aortic Valve Repair? Elaine E. Tseng, MD and Marlene Grenon, MD Department of Surgery Divisions of Adult Cardiothoracic and Vascular and Endovascular
Ian T. Meredith AM. MBBS, PhD, FRACP, FCSANZ, FACC, FAPSIC. Monash HEART, Monash Health & Monash University Melbourne, Australia
Two-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results From the REPRISE II
Congenital. Unicuspid Bicuspid Quadricuspid
David Letterman s Top 10 Aortic Stenosis The victim can be anyone: Echo is the question and the answer!!!! Hilton Head Island Echocardiography Conference 2012 Timothy E. Paterick, MD, JD, MBA Christopher
Role of Sutureless Valves in the Surgeon s Armamentarium Prof. Dr Malakh Shrestha Vice Chair, Director of Aortic Surgery Cardiothoracic,
Role of Sutureless Valves in the Surgeon s Armamentarium Prof. Dr Malakh Shrestha Vice Chair, Director of Aortic Surgery Cardiothoracic, transplantation and Vascular Surgery Hannover Medical School, Germany
Numerical Analysis of the Influence of Stent Parameters on the Fatigue Properties
Numerical Analysis of the Influence of Stent Parameters on the Fatigue Properties Lin Chen, Shen Jingfeng & Chen Bing School of mechanical engineering, University of Shanghai for Science & Technology,
Fetal cardiac function: what to use and does it make a difference?
17 th International Conference on Prenatal Diagnosis and Therapy Lisbon, June 2013 Fetal cardiac function: what to use and does it make a difference? Fàtima Crispi Department of Maternal-Fetal Medicine,
Assessment of Hemodynamics Properties of a New-Type Artificial Heart Valve Prosthesis Using Catheterization and Echocardiography
American Journal of Hematology 81:563 567 (2006) Assessment of Hemodynamics Properties of a New-Type Artificial Heart Valve Prosthesis Using Catheterization and Echocardiography Y.J. Zeng, 1,4 * S.W. Xu,
25 different brand names >44 different models Sizes mm
Types of Prosthetic Valves BIOLOGIC STENTED Porcine xenograft Pericardial xenograft STENTLESS Porcine xenograft Pericardial xenograft Homograft (allograft) Autograft PERCUTANEOUS MECHANICAL Bileaflet Single
Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They Work, Eligibility, Review of Data
Transcatheter Aortic Valve Replacement: Current and Future Devices: How do They Work, Eligibility, Review of Data Echo Florida 2013 Jonathan J. Passeri, M.D. Co-Director, Heart Valve Program Director,
3D Printing & Echocardiography
ASE SOTA Feb 19, 2018 3D Printing & Echocardiography Stephen H. Little, MD John S. Dunn Chair in Cardiovascular Research and Education, Associate professor, Weill Cornell Medicine Disclosures Personal
Successful Transfemoral Edwards Sapien Aortic. Valve Implantation in a Patient with Previous. Mitral Valve Replacement
Advanced Studies in Medical Sciences, Vol. 2, 2014, no. 1, 37-45 HIKARI Ltd, www.m-hikari.com http://dx.doi.org/10.12988/asms.2014.31213 Successful Transfemoral Edwards Sapien Aortic Valve Implantation
TSDA Boot Camp September 13-16, Introduction to Aortic Valve Surgery. George L. Hicks, Jr., MD
TSDA Boot Camp September 13-16, 2018 Introduction to Aortic Valve Surgery George L. Hicks, Jr., MD Aortic Valve Pathology and Treatment Valvular Aortic Stenosis in Adults Average Course (Post mortem data)
ON FLOW DYNAMICS IN TYPE B AORTIC DISSECTION (TBAD)
ON FLOW DYNAMICS IN TYPE B AORTIC DISSECTION (TBAD) A. Rabin 1, R. Karmeli 1, P. Bar-Yoseph 2 1- Vascular & Endovascular surgery department Hadassah university hospital, Jerusalem, Israel 2- Mechanical
PVL Assessment. Is paravalvular regurgitation after TAVR still an important consideration in 2018?
Joint Meeting 1 Aortic and Mitral Club Chairpersons: S.Adamopoulos, M. Vavuranakis, L. Michalis, P. Nihoyannopoulos PVL Assessment. Is paravalvular regurgitation after TAVR still an important consideration
Challenges in Development of Innovative Device
Challenges in Development of Innovative Device Robert Thatcher HBD East 2017 Think Tank Meeting At National Institute of Global Health and Medicine Tokyo, Japan: December 7, 2017 1 Disclosure Statement
Engineering perspective on transcatheter aortic valve implantation
review Engineering perspective on transcatheter aortic valve implantation Transcatheter aortic valve (TAV) implantation has emerged as a revolutionary, minimally invasive treatment for inoperable or high-risk
Echocardiographic Evaluation of Aortic Valve Prosthesis
Echocardiographic Evaluation of Aortic Valve Prosthesis Amr E Abbas, MD, FACC, FASE, FSCAI, FSVM, RPVI Co Director, Echocardiography, Director, Interventional Cardiology Research, Beaumont Health System
Prosthesis-Patient Mismatch or Prosthetic Valve Stenosis?
EuroValves 2015, Nice Prosthesis-Patient Mismatch or Prosthetic Valve Stenosis? Philippe Pibarot, DVM, PhD, FACC, FAHA, FASE FESC Canada Research Chair in Valvular Heart Diseases Université LAVAL Disclosure
REDUCING THE IMPACT OF SURGERY AND FACILITATING FASTER RECOVERY
REDUCING THE IMPACT OF SURGERY AND FACILITATING FASTER RECOVERY AORTIC SOLUTIONS PERCEVAL VALVE PERCEVAL THE BIOLOGICAL VALVE OF CHOICE IN AVR 0914 RE0210195/A AORTIC SOLUTIONS PERCEVAL THE BIOLOGICAL
Experience with 500 Stentless Aortic Valve Replacements
Experience with 500 Stentless Aortic Valve Replacements Dimitrios C. Iliopoulos, MD Cardiac Surgeon Ass. Professor of Surgery University of Athens, School of Medicine I declare no conflict of interest
TAVI Versus Suturless Valve In Intermediate Risk Patients
TAVI Versus Suturless Valve In Intermediate Risk Patients Walid Abukhudair FRCSc President of Saudi Society for Cardiac Surgeons Head of Cardiac Surgery in KFAFH Background AS is the most frequent cardiac
Transcatheter aortic valve implantation for severe aortic valve stenosis with the ACURATE neo2 valve system: 30-day safety and performance outcomes
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions
Early Experience of Transcatheter Mitral Valve Replacement Results from the Intrepid Global Pilot Study
Early Experience of Transcatheter Mitral Valve Replacement Results from the Paul Sorajja, MD for the Investigators Presenter Disclosure Information Within the past 12 months, I or my spouse/partner have
I will not discuss off label use or investigational use in my presentation.
I will not discuss off label use or investigational use in my presentation. Surgical valves Design and Durability Testing Potential Concerns Real Practice 1952-1962 1963-1966 1967-1969 1969-1977 1977-1984
TAVR 2018: TAVR has high clinical efficacy according to baseline patient risk! ii. Con
TAVR 2018: TAVR has high clinical efficacy according to baseline patient risk! ii. Con Dimitrios C. Angouras, MD, FETCS Associate Professor of Cardiac Surgery National and Kapodistrian University of Athens,
My Choice For Percutaneous Mitral Valve Replacement. Jose Luis Navia, MD.
My Choice For Percutaneous Mitral Valve Replacement Jose Luis Navia, MD. Disclosure Edwards Lifescienses St. Jude Medical MAQUET NaviGate Consultant, Investigator Consultant, Investigator Consultant, Investigator
Echo Assessment Pre-TAVI
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 Echocardiographic
Stainless Steel. Cobalt-chromium
Sapien is better than Corevalve! Raj R. Makkar, MD Associate Director, Cedars-Sinai Heart Institute Associate Professor, UCLA School of Medicine, Los Angeles Eberhard Grube: Pioneer in the field of TAVR
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
SUMMARY OF SAFETY AND EFFECTIVENESS DATA GENERAL INFORMATION Device Generic Name: Device Trade Name: Applicant Name and Address: Replacement Heart Valve Edwards SAPIENTM Transcatheter Heart Valve Model
Structural analysis of a bileaflet mechanical heart valve prosthesis with curved leaflet
Journal of Mechanical Science and Technology 22 (2008) 2038~2047 Journal of Mechanical Science and Technology www.springerlink.com/content/1738-494x DOI 10.1007/s12206-008-0621-4 Structural analysis of
MITROFLOW VALSALVA CONDUIT TM
TM Features the only bovine pericardium aortic root surgery system THE REPLICATES THE NATIVE SINUS, NATURALLY 2 TM LIVANOVA S INNOVATIVE IS DESIGNED TO: Provide a reproducible and easy solution for better
Progress In Transcatheter Aortic Valve Implantation
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
Case Reviews: Hemodynamic Calculations in Valvular Regurgitation
Case Reviews: Hemodynamic Calculations in Valvular Regurgitation Case 5 History: 69-year-old man with orthotopic heart transplant 15 years ago. Inferior MI several years ago. Recurrent CHF. Currently dyspneic
Echocardiographic Evaluation of Aortic Valve Prosthesis
Echocardiographic Evaluation of Aortic Valve Prosthesis Amr E Abbas, MD, FACC, FASE, FSCAI, FSVM, RPVI Director, Interventional Cardiology Research, Beaumont Health System Associate Professor of Medicine,
PATIENT BOOKLET MEDTRONIC SURGICAL VALVE REPLACEMENT. Tissue Valve for Aortic and Mitral Valve Replacement
PATIENT BOOKLET MEDTRONIC SURGICAL VALVE REPLACEMENT Tissue Valve for Aortic and Mitral Valve Replacement ARE MEDTRONIC SURGICAL TISSUE HEART VALVES RIGHT FOR YOU? Medtronic surgical heart valves are for
DISCLOSURE. Mitral ViV: why? Mitral Valve- in- Valve: Procedural Image Guidance with TEE, a Must Have or Nice to Have? UW Medicine NONE.
Mitral Valve- in- Valve: Procedural Image Guidance with TEE, a Must Have or Nice to Have? G. Burkhard Mackensen, MD, PhD, FASE Professor & Chief, Division of Cardiothoracic Anesthesia, Department of Anesthesiology
Outcome of Next-Generation Transcatheter Valves in Small Aortic Annuli: A Multicenter Propensity-Matched Comparison
Outcome of Next-Generation Transcatheter Valves in Small Aortic Annuli: A Multicenter Propensity-Matched Comparison Mauri, V. et al.: Circ Cardiovasc Interv. 2017;10:e005013 All trademarks are the property
3D Printing & Echocardiography
Echo Hawaii Jan 18, 2018 3D Printing & Echocardiography Stephen H. Little, MD John S. Dunn Chair in Cardiovascular Research and Education, Associate professor, Weill Cornell Medicine Rapid Prototyping
The Colibri heart valve: theory and practice in the achievement of a low-profile, pre-mounted, pre-packaged TAVI valve
INNOVATIONS / NOVEL TECHNOLOGIES The Colibri heart valve: theory and practice in the achievement of a low-profile, pre-mounted, pre-packaged TAVI valve R. David Fish 1 *, MD; David Paniagua 1, MD; Pedro
Clinical Needs Assessment at Strong Memorial Hospital
Clinical Needs Assessment at Strong Memorial Hospital Endoleaks in Endovascular Repair Endoleaks are a common problem during endovascular aortic repair and occur in 29% of all TEVAR (Thoracic Endovascular
MITRAL STENOSIS. Joanne Cusack
MITRAL STENOSIS Joanne Cusack BSE Breakdown Recognition of rheumatic mitral stenosis Qualitative description of valve and sub-valve calcification and fibrosis Measurement of orifice area by planimetry
Comments restricted to Sapien and Corevalve 9/12/2016. Disclosures: Core Lab contracts with Edwards Lifesciences, Middlepeak, Medtronic
Para-ValvularRegurgitation post TAVR: Predict, Prevent, Quantitate, Manage Linda D. Gillam, MD, MPH, FACC, FASE Chair, Department of Cardiovascular Medicine Morristown Medical Center/Atlantic Health System
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 EMPIRICAL TESTING CORP. 4628 Northpark Drive Colorado Springs, CO 80918 Dawn Lissy Phone: 719 264 9937 dlissy@empiricaltesting.com MECHANICAL Valid To: January
Planar Titanium Stent Design
NX CAE Symposium 2013 Andrew Jabola, Application Engineer, Saratech Inc. Shannon Gott (Ph. D. Candidate) & Masaru Rao (Assistant Professor), University of California - Riverside Planar Titanium Stent Design
TAVI: Transapical Procedures
Cardiology Update Davos TAVI: Transapical Procedures Volkmar Falk, MD University Hospital Zürich TA-AVI: antegrade, simple, safe The front door approach! Transapical TAVI Technical advantages of TA approach
ICE: Echo Core Lab-CRF
APPENDIX 1 ICE: Echo Core Lab-CRF Study #: - Pt Initials: 1. Date of study: / / D D M M M Y Y Y Y 2. Type of Study: TTE TEE 3. Quality of Study: Poor Moderate Excellent Ejection Fraction 4. Ejection Fraction
8/31/2016. Mitraclip in Matthew Johnson, MD
Mitraclip in 2016 Matthew Johnson, MD 1 Abnormal Valve Function Valve Stenosis Obstruction to valve flow during that phase of the cardiac cycle when the valve is normally open. Hemodynamic hallmark - pressure
Sutureless Mitral and Tricuspid Clamp Valves
Sutureless Mitral and Tricuspid Clamp Valves Simple non-stent annular attachment Dr. Eric Berreklouw, MD PhD Daidalos Solutions B.V. Eindhoven/Son, The Netherlands Disclosures and acknowledgements Author
Carpentier-Edwards ThermaFix Process: A Method for Extracting Calcium Binding Sites from Pericardial Tissue
Carpentier-Edwards ThermaFix Process: A Method for Extracting Calcium Binding Sites from Pericardial Tissue Jeffrey S. Dove, Principal Engineer Myron Howanec, Principal Engineer Mano J. Thubrikar, PhD,
Transcatheter Aortic Valve Implantation Present Status and Perspectives
Transcatheter Aortic Valve Implantation Present Status and Perspectives Angioplasty Summit TCTAP 2010 Alain Cribier, MD University of Rouen, France Transcatheter Aortic Valve Implantation has entered the
Outline. EuroScore II. Society of Thoracic Surgeons Score. EuroScore II
SURGICAL RISK IN VALVULAR HEART DISEASE: WHAT 2D AND 3D ECHO CAN TELL YOU AND WHAT THEY CAN'T Ernesto E Salcedo, MD Professor of Medicine University of Colorado School of Medicine Director of Echocardiography
Supplemental Appendix
Supplemental Appendix Appendix Table 1. Sub-Categorization of Medical Devices Included in Study Sample vel Medical Devices (N = 309) Cardiovascular Cardiac (ventricular) assist devices Cardiac prosthetic
Who will Benefit from Percutaneous Management of Mitral Regurgitation? An Imaging Guide to Management
Who will Benefit from Percutaneous Management of Mitral Regurgitation? An Imaging Guide to Management James D. Thomas, M.D., F.A.C.C. Department of Cardiovascular Medicine Heart and Vascular Institute
Team 19 Kaitlyn Clarke Brittany DePoi Andrew Reynolds Adarsha Selvachandran. Client: Dr. Wei Sun
Team 19 Kaitlyn Clarke Brittany DePoi Andrew Reynolds Adarsha Selvachandran Client: Dr. Wei Sun Dr. Sun has requested a testing device that will allow his research team to obtain physical evidence regarding
TAVR or SAVR: Beyond the STS Score
TAVR or SAVR: Beyond the STS Score Juan Crestanello, MD Division of Cardiac Surgery Lakshmi Prasad Dasi, PhD Department of Biomedical Engineering The Ohio State University Wexner Medical Center 1 Disclosures
Supplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical
P = 4V 2. IVC Dimensions 10/20/2014. Comprehensive Hemodynamic Evaluation by Doppler Echocardiography. The Simplified Bernoulli Equation
Comprehensive Hemodynamic Evaluation by Doppler Echocardiography Itzhak Kronzon, MD North Shore LIJ/ Lenox Hill Hospital New York, NY Disclosure: Philips Healthcare St. Jude Medical The Simplified Bernoulli
Trifecta Valve. Clinical Compendium. Five Year Data
Trifecta Valve Clinical Compendium Five Year Data Trifecta Valve Compendium INTRODUCTION The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic
Specializing in Mechanical Testing for Medical Devices. Office:
Specializing in Mechanical Testing for Medical Devices Office: 260.489.1444 Email: sales@jtlamerica.com www.jtlamerica.com Spine Spinal implant test standards can t keep up with the rapid pace of device
Conflict of Interests
Introduction to Interventional Echocardiography Roberto M Lang, MD Tomtec Conflict of Interests Research Grants Philips Medical Imaging Research Grants Speakers bureau Advisory bureau 1 Structural Heart
Medical Engineering & Physics
Medical Engineering & Physics 32 (2010) 1057 1064 Contents lists available at ScienceDirect Medical Engineering & Physics journal homepage: www.elsevier.com/locate/medengphy Mitral valve dynamics in structural
Lessons From The Computer Model and How We Do Root Replacement
Lessons From The Computer Model and How We Do Root Replacement Ehud Raanani, MD Cardiac Surgery Leviev Cardiothoracic and Vascular Center Sheba Medical Center Sackler School of Medicine, Tel Aviv University
The production of murmurs is due to 3 main factors:
Heart murmurs The production of murmurs is due to 3 main factors: high blood flow rate through normal or abnormal orifices forward flow through a narrowed or irregular orifice into a dilated vessel or
MITRAL (Mitral Implantation of TRAnscatheter valves)
MITRAL (Mitral Implantation of TRAnscatheter valves) 30-Day Outcomes of Transcatheter MV Replacement in Patients With Severe Mitral Valve Disease Secondary to Mitral Annular Calcification or Failed Annuloplasty
Update interventional Cardiology Hans Rickli St.Gallen
Update interventional Cardiology 2012 Hans Rickli St.Gallen 26.11.2012 Review of Literature ESC-Highlights TCT/AHA-Highlights Update interventional cardiology 2012 Structural Heart Disease Transcatheter
Multicentre clinical study evaluating a novel resheatable self-expanding transcatheter aortic valve system
Multicentre clinical study evaluating a novel resheatable self-expanding transcatheter aortic valve system Preliminary Results: Acute and 1-year Outcomes Ganesh Manoharan, MBBCh, MD, FRCP Consultant Cardiologist
Design and Simulation of Blocked Blood Vessel for Early Detection of Heart Diseases
Proceedings of the 215 2nd International Symposium on Physics and Technology of Sensors, 8-1th March, 215, Pune, India Design and Simulation of Blocked Blood Vessel for Early Detection of Heart Diseases
How to Avoid Prosthesis-Patient Mismatch
How to Avoid Prosthesis-Patient Mismatch Philippe Pibarot, DVM, PhD, FACC, FAHA, FASE, FESC Canada Research Chair in Valvular Heart Diseases INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC
Image Analysis and Cytometry in Three-Dimensional Digital Reconstruction of Porcine Native Aortic Valve Leaflets
Image Analysis and Cytometry in Three-Dimensional Digital Reconstruction of Porcine Native Aortic Valve Leaflets Introduction Chi Zheng, M1 - University of Pittsburgh; BSE - University of Michigan In association
Transcatheter valve-in-valve implantation for degenerated surgical bioprostheses
Review Article Transcatheter valve-in-valve implantation for degenerated surgical bioprostheses Dale J. Murdoch, John G. Webb Centre for Heart Valve Innovation, St. Paul s Hospital, Vancouver, Canada Contributions:
William A. Gray MD System Chief of Cardiovascular Services, Main Line Health President, Lankenau Heart Institute Wynnewood, Pennsylvania USA
William A. Gray MD System Chief of Cardiovascular Services, Main Line Health President, Lankenau Heart Institute Wynnewood, Pennsylvania USA Mitral Valve Disease Today Mitral regurgitation is the most
Numerical Simulation Transcatheter Aortic Valve Implantation and Mechanics of Valve Function
Numerical Simulation Transcatheter Aortic Valve Implantation and Mechanics of Valve Function M.S. Hamid, Ph.D. Advanced Computational Systems LLC Rochester, MI 48306 acssah027@gmail.com Abstract As the
Should We Reconsider using Anticoagulation for Biological Tissue Valves
Should We Reconsider using Anticoagulation for Biological Tissue Valves No Disclosures Disclosures Watching grass grow Complete with audio 1 hour 8 minutes 9884 views Subclinical Leaflet Thrombosis in
Neovasc Inc. Alexei Marko, CEO. January 2012 OneMedForum
Neovasc Inc. Alexei Marko, CEO January 2012 OneMedForum 2 Forward-Looking Statements Statements contained herein that are not based on historical or current fact, including without limitation statements
INTERNATIONAL JOURNAL OF PURE AND APPLIED RESEARCH IN ENGINEERING AND TECHNOLOGY
INTERNATIONAL JOURNAL OF PURE AND APPLIED RESEARCH IN ENGINEERING AND TECHNOLOGY A PATH FOR HORIZING YOUR INNOVATIVE WORK STUDY AND ANALYSIS OF KNEE IMPLANT IN HUMAN BODY GAJANAN D. MANDAVGADE Assistant
Successful percutaneous treatment of late-onset femoral pseudoaneurysm after transcatheter, aortic valve implantation procedure
Case Report Page 1 of 5 Successful percutaneous treatment of late-onset femoral pseudoaneurysm after transcatheter, aortic valve implantation procedure Murat Celik, Uygar Cagdas Yuksel Correspondence to:
CLINICAL COMMUNIQUE 16 YEAR RESULTS
CLINICAL COMMUNIQUE 6 YEAR RESULTS Carpentier-Edwards PERIMOUNT Mitral Pericardial Bioprosthesis, Model 6900 Introduction The Carpentier-Edwards PERIMOUNT Mitral Pericardial Valve, Model 6900, was introduced
CoreValve Evolut R Technology review and Clinical Results. Paul TL Chiam
CoreValve Evolut R Technology review and Clinical Results Paul TL Chiam MBBS (S pore), MMed, MRCP (UK), FAMS FRCP (Edin), FESC (EU), FACC (USA), FSCAI (USA) Cardiologist Mount Elizabeth Hospital Singapore
2/2/2011. Strain and Strain Rate Imaging How, Why and When? Movement vs Deformation. Doppler Myocardial Velocities. Movement. Deformation.
Strain and Strain Rate Imaging How, Why and When? João L. Cavalcante, MD Advanced Cardiac Imaging Fellow Cleveland Clinic Foundation Disclosures: No conflicts of interest Movement vs Deformation Movement
Surgery for Acquired Cardiovascular Disease
An in vitro assessment by means of laser Doppler velocimetry of the Medtronic Advantage bileaflet mechanical heart valve hinge flow Rahul Saxena, MS a Jack Lemmon, PhD a Jeffrey Ellis, PhD b Ajit Yoganathan,
Hardware in the Chest - From VADs to Valves
Hardware in the Chest - From VADs to Valves Cristina Fuss, MD Purpose Recognize the device Indication and function Cristina Fuss, MD Department of Diagnostic Radiology FROM VADS TO VALVES Implanting technique
Portico (St. Jude Medical Inc, St.
Review Article Portico Transcatheter Heart Valve Apostolos Tzikas 1,2, Michael Chrissoheris 2, Antonios Halapas 2, Konstantinos Spargias 2 1 Interbalkan European Medical Centre, Thessaloniki, 2 Hygeia
Proposal. Fabrication of Percutaneous Transvenous Mitral Annuloplasty Testing Device. Team 19
Proposal Fabrication of Percutaneous Transvenous Mitral Annuloplasty Testing Device Team 19 Andrew Reynolds Kaitlyn Clarke Adarsha Selvachandran Brittany DePoi Project for Dr. Wei Sun Client Contact: Dr.
The St. Jude Medical Biocor Bioprosthesis
The St. Jude Medical Biocor Bioprosthesis Clinical Evidence of Long-term Durability Long-term Biocor Experience A Review and Comparative Assessment Long-term Biocor Stented Tissue Valve Studies Twenty-year