Heart Valves: From Design to Clinical Implantation

Description

This state-of-the-art handbook is dedicated to cardiac valve anatomy, models for testing and research methods, clinical trials; and clinical needs and applications. In this new edition, chapters are updated with the latest research in addition to new chapters on complex repair of CHD requiring conduits, new trends for valve replacement like the Ozaki procedure, as well as complex procedures in TAV, SAV, HARPOON, and BASILICA, with case studies for each type of procedure. This volume serves as a helpful reference for patients, educators, students, device designers and developers, clinical study specialists, clinicians, and other associated healthcare providers. Preface Contents Part I: Anatomy, Physiology, Congenital Defects, and Disease Chapter 1: The Anatomy and Function of the Atrioventricular Valves 1.1 Introduction 1.2 Attitudinally Correct Anatomy 1.3 The Cardiac Skeleton 1.4 The Atrioventricular Valves 1.4.1 Atrioventricular Valve Function 1.4.2 Valve Histologies 1.5 The Mitral Valve 1.6 The Tricuspid Valve 1.7 Atrioventricular Valve Co-location with Other Cardiac Structures 1.8 Clinical Imaging of the Atrioventricular Valves 1.9 Conclusions References Chapter 2: The Anatomy and Function of the Semilunar Valves 2.1 Introduction 2.1.1 Historical Perspective 2.1.2 Attitudinally Correct Cardiac Anatomy 2.2 The Cardiac Skeleton 2.3 Anatomical Features of the Semilunar Valves 2.3.1 The Functioning of the Semilunar Valves 2.3.2 Histologic Features of the Semilunar Valves 2.4 The Aortic Valve 2.4.1 The Aortic Root 2.4.2 The Aortic Leaflets 2.5 The Pulmonary Valve 2.6 Semilunar Valve Co-location 2.7 Common Clinical Imaging of the Semilunar Valves 2.8 Conclusions References Chapter 3: Congenital Heart Defects Which Include Cardiac Valve Abnormalities 3.1 Inherited Valve Diseases 3.1.1 Aortic Valve Stenosis 3.1.2 Aortic Valve Regurgitation 3.1.3 Pulmonary Valve Stenosis 3.1.4 Pulmonary Valve Regurgitation 3.1.5 MV Stenosis 3.1.6 MV Regurgitation 3.2 Ebstein’s Malformation of the Tricuspid Valve (TV) 3.3 Atrioventricular Septal Defects (‘AV Canal’ Defects) 3.3.1 Tetralogy of Fallot 3.3.2 Truncus Arteriosus 3.4 Shone’s Complex 3.5 Congenitally Corrected Transposition of the Great Arteries (CC-TGA) with Ebstein’s Anomaly 3.5.1 Complex Left Ventricular Outflow Tract Obstruction 3.5.2 Pulmonary Stenosis with VSD 3.6 Subaortic VSD and Aortic Insufficiency 3.7 Valve Disease Late After Repair of Congenital Heart Defects 3.8 Valve Disease Related to Inherited Conditions References Part II: Valve Repair and Replacement Chapter 4: Heart Valve Disease 4.1 Introduction 4.2 A New Frontier—Valve Replacement 4.2.1 Mechanical Prosthetic Valves 4.2.2 Biological Prosthetic Valves 4.2.3 Biological Versus Mechanical Valves 4.3 Specific Valvular Diseases: Etiologies and Treatments 4.3.1 Aortic Valve Disease 4.3.1.1 Aortic Stenosis 4.3.1.2 Aortic Sclerosis 4.3.1.3 Aortic Regurgitation 4.3.2 Diseases of the Mitral Valve 4.3.2.1 Mitral Stenosis 4.3.2.2 Mitral Regurgitation 4.3.3 Tricuspid Valve Disease 4.4 Summary References Chapter 5: History of Heart Valve Repair 5.1 Introduction 5.2 Brunton’s Era (1897–1922): Thinking About Valve Repair 5.3 The First Successful Valve Repairs (1912, 1925): Finger Fracture Valvuloplasty 5.3.1 The First Successful Closed Surgery: Aortic Stenosis 5.3.2 The First Successful Closed Surgery: Mitral Stenosis 5.4 Cutler’s Era (1923–1928): Exchanging Stenosis for Insufficiency 5.5 Bailey, Harken, and Brock (1948–1957): Moving Away from Iatrogenic Insufficiency 5.5.1 A Race to Repair Mitral Stenosis 5.5.2 Repairing Aortic Stenosis 5.5.3 Repeated Repair Pulmonary Stenosis 5.5.4 After the First Ten Years of Valve Repair 5.6 Lewis, Gibbon, Lillehei, and Kirklin (1953–1955): Development of the Open Field 5.6.1 Cold Heart Logic 5.6.2 The Mechanical Heart and Lungs 5.6.3 Controlled Cross Circulation 5.6.4 The First Reliable Success with the Pump Oxygenator 5.7 Attempts to Repair Insufficiency (1956–1965): Before Carpentier 5.7.1 Earliest Attempts: Before the Open Field 5.7.2 First Successful Repair of Mitral Insufficiency: Open Heart 5.7.3 First Successful Repair of Aortic Insufficiency: Open Heart 5.7.4 First Successful Repair for Tricuspid and Pulmonary Insufficiency: Open Heart 5.8 Carpentier’s Era (1968–1983): Development of the Rigid Ring Prosthesis and Techniques to Repair Insufficient Aortic, Mitral, and Tricuspid Valves 5.9 Improving upon Carpentier (1975–Present): The Evolution of Annuloplasty and Annuloplasty Rings 5.10 Frater and David (1985–Present): Replacement of Chordae Tendineae with ePTFE 5.11 Kan, Inoue, and Cribier (1982–Present): Resurgence of Repair with the Advent of Balloon Valvuloplasty and Other Percutaneous Technology 5.12 Minimally Invasive and Robotic Techniques (1996–Present): The Key to Reducing Cost and Mortality 5.12.1 Cosgrove, Gundry, Falk, and Chitwood: Incisions and Aortic Occlusion 5.12.2 Video Assistance 5.12.3 Carpentier: Robotic Innovations 5.13 Concluding Remarks References Chapter 6: The Ross Procedure 6.1 Introduction 6.2 Evolution and Different Techniques for the RP 6.3 Advantages and Disadvantages of RP 6.4 Results of RP 6.5 RP in Combination with Other Cardiac Surgical Procedures 6.6 Surgical Alternatives to the RP References Chapter 7: Echocardiographic Imaging of Cardiac Valves 7.1 Introduction 7.2 Basics of Ultrasound 7.2.1 Ultrasound Physics 7.2.2 Doppler Physics 7.2.3 Quantitative Echocardiography 7.2.4 Other Echocardiographic Calculations to Evaluate Heart Valves 7.3 Basic Transesophageal Echocardiographic Exam 7.4 Aortic Valve 7.4.1 Aortic Valve Stenosis 7.4.2 Aortic Insufficiency 7.5 Mitral Valve 7.5.1 Mitral Valve Echocardiography Exam 7.5.2 Mitral Stenosis 7.5.3 Mitral Regurgitation 7.6 Tricuspid Valve 7.6.1 Tricuspid Stenosis 7.6.2 Tricuspid Regurgitation 7.6.3 Carcinoid Disease 7.7 Pulmonic Valve 7.7.1 Pulmonic Stenosis 7.7.2 Pulmonic Insufficiency 7.8 Endocarditis 7.9 Surgical Treatment of Valvular Disease 7.9.1 Mechanical Valves 7.9.2 Bioprosthetic Valves 7.9.3 Aortic Valve Replacement and Repair 7.9.4 Mitral Valve Replacement and Repair 7.9.5 Tricuspid Valve Replacement 7.9.6 Pulmonic Valve Replacement 7.10 Conclusion References Chapter 8: Advanced 3D Imaging and Transcatheter Valve Repair/Implantation 8.1 Introduction 8.2 Imaging in the Context of Transcatheter Valve Procedures 8.2.1 Transcatheter Aortic Valve Implantation 8.2.1.1 Anatomy 8.2.1.2 Imaging 8.2.2 Transcatheter Mitral Valve Procedures 8.2.2.1 Anatomy 8.2.2.2 Imaging 8.2.3 Transcatheter Tricuspid Valve Procedures 8.2.3.1 Anatomy 8.2.3.2 Imaging 8.3 From Bench to Bedside: Imaging and Device Design/Development 8.4 Conclusion References Untitled Chapter 9: Transcatheter Mitral Repair and Replacement 9.1 Introduction 9.2 Design Criteria for Transcatheter Repair and Replacement 9.2.1 General Design Requirements 9.2.2 Mitral Replacement 9.2.2.1 Accurate Positioning and Migration Resistance 9.2.2.2 Access 9.2.2.3 Mechanism for Valve Expansion 9.2.2.4 Valve Performance 9.2.2.5 Anatomic Interactions 9.2.2.6 Preservation of Native Valve Structures 9.2.2.7 Applicability for Various Sizes and Conditions 9.2.3 Indirect Annuloplasty 9.2.4 Direct Annuloplasty 9.2.5 Transcatheter Edge-to-Edge Repair (TEER) 9.2.6 Chordal Replacement 9.2.7 LV Repair 9.3 Transcatheter Mitral Replacement Versus Transcatheter Mitral Repair 9.4 Conclusions/Summary References Chapter 10: Percutaneous Pulmonary Valve Implantation: 20 Years of Development 10.1 Introduction 10.2 Balloon Expandable Devices 10.2.1 Medtronic Melody® Valve 10.2.1.1 Clinical Experience 10.2.2 Edwards Lifesciences Sapien (XT, S3, Ultra) 10.2.2.1 Clinical Experience 10.3 Self-Expanding Devices 10.3.1 Medtronic Harmony® Valve 10.3.1.1 Clinical Experience 10.3.2 Alterra Adaptive Prestent 10.3.2.1 Clinical Experience 10.3.3 Venus P-Valve 10.3.3.1 Clinical Experience 10.3.4 Pulsta Valve 10.3.4.1 Clinical Experience 10.4 Engineering Studies in PPVI 10.4.1 Stent Fracture 10.4.2 Patient Selection 10.4.3 Device Design 10.5 Conclusion References Chapter 11: Transcatheter Aortic Valve Implantation 11.1 Introduction 11.2 Patient Selection 11.3 Clinical Criteria 11.3.1 Surgical Risk 11.3.2 Age 11.3.3 Frailty 11.3.4 Coronary Artery Disease 11.3.5 Mixed Valve Disease 11.4 Anatomical Criteria 11.4.1 Valve Anatomy 11.4.2 Assessment of the Aortic Valve Complex 11.4.3 Vascular Access (Transfemoral and Alternative Access Sites) 11.5 TAVI Procedure 11.5.1 Pre-procedural Planning 11.5.2 Transfemoral TAVI: Procedural Steps 11.6 Antithrombotic Management 11.7 TAVI-related Complications 11.8 Cardiac Complications 11.8.1 Paravalvular Regurgitation 11.8.2 Conduction Disturbances 11.8.3 Coronary Artery Obstruction 11.8.4 Aortic Annular Rupture 11.8.5 Valve Embolization 11.8.6 Valve Thrombosis 11.8.7 Endocarditis 11.9 Non-cardiac Complications 11.9.1 Stroke 11.9.2 Vascular Complications 11.10 THV Durability 11.11 Emerging Indications 11.11.1 TAVI for Bicuspid Aortic Valve Patient 11.11.2 Valve-in-Valve for Surgical Bioprostheses 11.11.3 Pure Native Aortic Valve Regurgitation 11.12 Conclusion References Chapter 12: Post-TAVI PCI 12.1 Introduction 12.2 Coronary Access After TAVI Implantation 12.3 Coronary Artery Occlusion Prevention 12.4 Ostial Coronary Stenting Through the Prosthesis Frame 12.5 Conclusion References Chapter 13: Tissue-Engineered Heart Valves 13.1 Introduction 13.2 Current Methods of Heart Valve Tissue Engineering 13.2.1 Tissue-Engineered Matrix TEHVs 13.2.2 In Vitro Culture of Tissue-Engineered Matrix TEHVs 13.2.3 Bioresorbable Polymer TEHVs 13.3 In Vivo Results: Preclinical and Clinical Studies 13.4 Future Directions 13.5 Summary References Chapter 14: Anticoagulation Management for Mechanical Valves in the On-X Era 14.1 Introduction 14.2 Risk of Mechanical Valve Thrombotic and Thromboembolic Complications 14.3 What Determines the Thrombotic Risks of the Mechanical Valve 14.3.1 Biomaterials 14.3.2 Hemodynamics 14.3.3 Cavitation 14.3.4 Patient Factors 14.4 INR Targets for Mechanical Valves 14.5 The On-X Mechanical Valve and Newer Generation Bi-Leaflet Valves 14.6 Complications of Anticoagulation in Mechanical Valve Replacements 14.7 Are DOACS a Reasonable Option? 14.8 Anticoagulation Considerations in Special Populations 14.8.1 Anticoagulation in the Pregnant Patient with a Mechanical Valve 14.9 Perioperative Management of Anticoagulation in Patients with Mechanical Valves 14.9.1 Dental Procedures 14.9.2 Endoscopic Procedures 14.10 Atrial Fibrillation and Mechanical Valves 14.10.1 Anticoagulation in Patients with a Mechanical Valve, Atrial Fibrillation, and Coronary Disease 14.11 Anticoagulation with Allergies/Adverse Reactions 14.12 Concluding Remarks References Part III: Testing, Regulatory and Training Issues Chapter 15: In Vitro Testing of Heart Valve Substitutes 15.1 Introduction 15.2 Primary Functions of a Heart Valve Substitute 15.3 Heart Valve Substitute Use Conditions 15.3.1 Device Implantation 15.3.2 Device In Vivo Operation 15.4 Risk Assessment 15.5 In Vitro Evaluations 15.5.1 Component Material and Mechanical Property Testing 15.5.2 Device Acute Performance Testing 15.5.2.1 Frame/Housing Crush Resistance 15.5.2.2 Frame Deflection 15.5.2.3 Sewing Ring Integrity 15.5.2.4 Frame Creep 15.5.2.5 Radial Stiffness, Recoil, Radial Resistive Force (RRF), and Chronic Outward Force (COF) 15.5.2.6 Device Integrity 15.5.2.7 Corrosion 15.5.2.8 Hydrodynamic Performance 15.5.2.9 Migration Resistance 15.5.2.10 Thrombogenic and Hemolytic Potential 15.5.2.11 Cavitation Potential 15.5.3 Fatigue Assessment 15.5.3.1 Stress or Strain Analysis 15.5.3.2 Material Fatigue Characterization 15.5.3.3 Structural Reliability Assessment 15.5.3.4 Component Fatigue Demonstration Testing 15.5.4 Valve Durability Assessment 15.5.4.1 Accelerated Wear Testing (AWT) 15.5.4.2 Dynamic Failure Mode (DFM) Testing 15.5.4.3 Real-Time Wear Testing (RWT) 15.5.5 System Testing 15.5.6 Packaging Testing 15.6 Summary References Chapter 16: Perspectives on Heart Valve Modelling: Contexts of Use, Risk, Validation, Verification and Uncertainty Quantification and End-to-End Example 16.1 Introduction to VV40 16.2 Context of Use (COU) and Model Risk for Heart Valve Modelling 16.2.1 Challenges of Validating Patient-Specific Models 16.2.2 Model V&V Reporting 16.3 Summary and Conclusion Appendix I: End-to-End Example VVUQ Transcatheter Valve Background Question of Interest Define Context of Use (COU) Assess Model Risk Establish Credibility Goals Model Description Credibility Activities Assessment (ASME V&V 40 5.2.3) Applicability (ASME V&V 40 5.2.3) References Chapter 17: Numerical Methods for Design and Evaluation of Prosthetic Heart Valves 17.1 Brief History of Analyses of Prosthetic Heart Valves 17.2 Best Practices in Modeling Valve Prostheses 17.2.1 Problem Definition 17.2.2 Materials and Constitutive Models 17.2.2.1 Balloon-Expandable Transcatheter Frames 17.2.2.2 Self-Expandable Transcatheter Frames 17.2.2.3 Tissue Leaflets 17.2.3 Geometry/Mesh/Element Type 17.2.4 Loading Conditions (Constraints and Loads) 17.2.5 Physics/Solution Method 17.2.6 Model Verification and Validation 17.2.7 Interpretation 17.2.8 Documentation 17.2.9 Peer Review 17.3 Summary and Conclusions References Chapter 18: Animal Models for Cardiac Valve Research 18.1 Introduction 18.1.1 Acute Versus Chronic Testing 18.1.2 Regulations 18.2 Choosing the Correct Animal Model 18.2.1 Spontaneously Occurring Animal Models of Congenital Valve Disease 18.2.2 Species-to-Species Variability 18.2.2.1 Comparative Anatomy 18.2.2.2 Rate of Growth 18.3 Basic Experimental Design 18.3.1 Anesthetics and Monitoring 18.3.2 Accessing the Heart 18.4 Replacement Heart Valve Testing 18.4.1 Percutaneously Placed Valve Testing 18.4.2 Surgically Placed Valve Testing 18.5 Good Laboratory Practice and FDA Submission 18.6 Summary References Chapter 19: The Preclinical Uses of Isolated Heart Models and Anatomic Specimens as Means to Enhance the Design and Testing of Cardiac Valve Therapies 19.1 Introduction 19.2 Anatomical Specimens and Static Imaging 19.3 The Visible Heart® Human Specimen Library 19.4 In Vitro Isolated Heart Models 19.5 How Can an Isolated Heart Prep Augment and Compliment Benchtop Testing? 19.6 The Importance of Species Selection in In Vitro Cardiac Valve Research 19.7 Understanding and Modulating Heart Function In Vitro 19.8 Comparative Imaging in the Visible Heart® Apparatus 19.9 A Portable Visible Heart® or “VH Mobile” 19.10 Limitations of Visible Heart® Methodologies 19.11 Acute Testing of Pathological Animal Models 19.12 Future Directions 19.13 The Atlas of Human Cardiac Anatomy 19.14 Conclusion References Chapter 20: Clinical Trial Requirements for Cardiac Valves 20.1 Introduction 20.2 Regulatory Bodies 20.2.1 Food and Drug Administration (United States) 20.2.2 Other Regulatory Bodies 20.2.3 Good Clinical Practice Oversight 20.3 The Generalized Clinical Trial Cycle/Process 20.3.1 Features of a Trial Design for a Newly Developed Heart Valve 20.3.2 Reimbursement and Payer Information 20.3.3 Clinical Trial Site Selection 20.3.4 Clinical Trial Execution 20.3.5 Data Collection Within the Clinical Trial 20.3.6 Data Collected for Each Subject Enrolled into a Clinical Trial 20.3.7 Clinical Trial Sample Size and Follow-Ups 20.3.8 Complications and Management of Adverse Events 20.4 Summary/Conclusion References Chapter 21: Clinical Applications of 3D Modeling and Printing for Intracardiac Valves 21.1 Introduction: A Brief History of 3D Modeling and Printing 21.1.1 3D Printing Background 21.1.1.1 3D Printing History 21.1.1.2 Printing Processes and Materials 21.1.1.3 Considerations, Advantages, and Disadvantages for Clinical Use Cases 21.1.2 Clinical Workflow: From Scan to Model and Beyond 21.1.3 3D Printing Access 21.2 3D Modeling and Printing for Cardiac Clinical Applications 21.2.1 Overview of Cardiac Clinical Applications 21.2.1.1 Rapid Prototyping in Medical Device Design 21.2.1.2 Patient-Specific Medical Devices and Implants 21.2.1.3 Patient-Specific Anatomical Modeling and Virtual Prototyping 21.2.2 Usage Cases: Intracardiac Valve Modeling 21.2.2.1 Pediatric Case: Evaluation for TPVR 21.2.2.2 Adult Case: Prediction of TAVR Complications 21.3 Today and Tomorrow: Where Are We Now, and Where Are We Headed? 21.3.1 Current Technologies and Ongoing Research 21.3.2 Future Advancements References Chapter 22: Procedural Training and Education: A Multimodal and Interactive Approach 22.1 Introduction 22.2 3D Modeling of Cardiac Structures and Associated Vasculature 22.3 3D Printing of Cardiac Structures and Surrounding Blood Vessels 22.4 Virtual Reality of Cardiac Structures and Surrounding Blood Vessels 22.4.1 General Human Anatomical Education 22.4.2 Transcatheter Aortic Valve Replacement 22.5 A Multimodal Approach for Teaching Transesophageal Echocardiography (TEE) 22.6 Conclusion References Index