Table of Contents
- Title page
- Copyright page
- List of Contributors
- Volume 1
- SECTION 1: History/Introduction
- Introduction
- CHAPTER 1: A Brief History of Clinical Organ Transplantation
- Introduction
- The Concept of Transplant Surgery
- Transplant Biology
- Early Clinical Implementation
- The modern Era of Immune Management
- Ethical Challenges
- Summary
- References
- SECTION 2: Transplantation Biology
- Immunology
- CHAPTER 2: An Overview of Physiologic Immunity
- Introduction
- Generalized Protective Barriers and Defense Factors
- Tissues and Organs of the Immune System
- Cells of the Innate and Adaptive Immune System
- Innate Immune Cells
- Adaptive Immune Cells
- The Complement System
- Cytokines
- Immunological Tolerance
- Immunological Memory
- Summary
- Acknowledgments
- References
- CHAPTER 3: Transplant Antigens: A Brief History of HLA
- Introduction
- Early Investigations
- HLA and Disease
- HLA and Transplantation
- HLA Antibodies
- Summary
- References
- CHAPTER 4: Transplant Antigen Biology
- Introduction
- Genetics of the Major Histocompatibility Complex (MHC)
- Nature of HLA Polymorphism
- Human Diversity in HLA Repertoire
- HLA Nomenclature
- HLA Epitopes and the Structural Basis of Cross-Reactivity
- Structure and Function of HLA Molecules
- Non-HLA Transplant Antigens
- Anti-MICA Antibodies
- Summary
- Acknowledgments
- References
- CHAPTER 5: Cellular Mechanisms of Adaptive Immunity
- Introduction
- T-Cell Recognition of Alloantigens: Direct, Semidirect, and Indirect Presentation
- Structural Recognition of Alloantigens by the TCR
- T-Cell Costimulation and Differentiation
- Innate Immune Signals that Influence T-Cell Responses
- Where Are T Cells Primed after Transplantation?
- Effector Phase of the Alloimmune Response: T Cells Go to the Graft
- Effector T Cells: Th1, Th2, Th17, and Cytotoxic T Cells
- Therapeutic Implications
- Summary
- Acknowledgments
- References
- CHAPTER 6: Humoral Mechanisms of Adaptive Immunity
- Introduction
- Antibodies
- Antigens
- Complement
- Complement Regulation
- Cells
- Types of Humoral Rejection
- Accommodation and Tolerance
- Summary
- References
- CHAPTER 7: Innate Immunity
- Introduction
- The Innate Immune System
- Innate Responses to Transplants
- Summary
- Acknowledgments
- References
- CHAPTER 8: Mechanisms of Immune Regulation
- Introduction
- Cell Death
- Anergy
- Immunoregulation
- Ignorance
- Summary
- Acknowledgments
- References
- CHAPTER 9: The Spectrum of Alloimmunity, Heterologous Immunity, and Relevant Autoimmunity
- Introduction
- The Spectrum of Alloreactivity
- Heterologous Immunity: Interactions of Pathogen Exposure and Alloreactivity
- Aging and Alloreactive Immune Competence
- Impact of Pre-Existing Autoimmunity on Alloreactivity
- Summary
- References
- CHAPTER 10: Fundamental Concepts Regarding Graft Injury and Regeneration: Tissue Injury, Tissue Quality, and Recipient Factors
- Introduction and Definitions
- Population Lessons—Causes and Consequences of Delayed Graft Function
- Molecular Changes Associated with AKI in Human Kidney Transplants
- Some Key Issues in AKI
- Aging and Somatic Cell Senescence in Relation to Organ Injury
- Clinical Treatment of AKI
- Summary
- References
- CHAPTER 11: Mechanisms of Allograft Tolerance
- Introduction
- Conceptual Considerations
- Chimerism
- Depletion
- Costimulation Blockade
- Regulation
- B Cells
- Summary
- References
- CHAPTER 12: Xenoimmunity
- Introduction
- Rejection of Porcine Vascularized Xenografts
- Rejection of Porcine Islet Xenografts
- Rejection of Other Types of Porcine Xenograft
- Reducing the Immunosuppressive Burden
- Limitations of the Pig-to-NHP Model
- Summary
- References
- Experimental Transplantation
- CHAPTER 13: In Vitro Models of Alloreactivity
- Introduction
- Stimulation of Alloreactive T-cell Proliferation
- Presentation of Alloantigens to T cells
- Analysis of Alloreactive Precursor Frequencies
- Naïve versus Memory T-cell Proliferation to Alloantigens
- Skewed Functional Development of Alloreactive T cells in Vitro
- Summary
- References
- CHAPTER 14: Small Animal Models of Transplantation
- Introduction
- Evolution of Solid Organ Transplant Models in Rodent Models
- Models of Alloimmune Injury: Acute Injury
- Models of Alloimmune Injury: “Chronic” Injury
- The Toxicity of Immunosuppressive Agents
- Small Animal Models of Transplantation Tolerance
- Ischemia–Reperfusion Injury
- Xenotransplantation
- Summary
- References
- CHAPTER 15: Large Animal Models of Transplantation
- Introduction
- Why Use Large Animals?
- Common Large Animal Models
- Canine Models in Transplantation
- Porcine Models in Transplantation
- NHP Models in Transplantation
- Xenotransplant Models
- Perioperative Care of Non-human Primates
- Small Molecule-based Immunosuppression
- Costimulation
- Adhesion Molecule Blockade
- Depletional Strategies
- Chimerism
- Summary
- References
- CHAPTER 16: Advancing Transplantation In Silico: Studying Global Gene Expression Using Functional Genomics for Transplantation Research
- Introduction
- Functional Genomics in Practice
- Next-generation qPCR—Digital and Single-cell qPCR
- Summary
- References
- Mechanisms of Immune Modulation
- CHAPTER 17: Current Pathways for Immune Manipulation
- Introduction
- Steroids
- Calcineurin Inhibitors
- mTOR Inhibitors
- Purine Analogues
- Monoclonal Biologics
- Belatacept
- Antithymocyte Globulins
- Intravenous Immunoglobulin (IVIG)
- Summary
- References
- CHAPTER 18: Future Pathways for Immune Manipulation
- Introduction
- Costimulatory Pathways in Transplantation
- Future Therapeutic Targets of B Cell and Antibody-mediated Injury
- IL-6
- Small Molecules
- Summary
- References
- SECTION 3: Organ Procurement
- Organ Procurement and Allocation
- CHAPTER 19: Administration of Organ Procurement and Allocation
- Introduction
- What Is an Organ Procurement Organization?
- State Law Framework
- Federal Law Framework
- How Does the System Work?: Step-by-Step from Recovery Through Allocation
- International Organ Donation Models
- Summary
- References
- CHAPTER 20: Deceased Donor Management
- Introduction
- Diagnosis of Brain Death
- Physiology of Brain Death
- Management for Organ Donation
- Assessment of Donor Quality
- Summary
- References
- Techniques for Organ Procurement
- CHAPTER 21: Techniques for Organ Procurement after Brain Death
- Introduction
- Profound Effect of Brain Death on the Cardiovascular System
- Endocrine Changes as a Consequence of Brain Death
- Morphological Changes in Donor Organs after Brain Death
- Technical Considerations of Organ Procurement in Heart Beating Donors
- Organ Packing
- Care of the Donor after Procurement
- Summary
- References
- CHAPTER 22: Techniques for Organ Procurement after Circulatory Death
- Introduction
- Definitions
- Outcomes
- Preoperative Phase
- Surgical Technique
- Summary
- Acknowledgments
- References
- CHAPTER 23: Techniques for Living Donor Kidney Procurement
- Introduction
- History and Current Status of Living Kidney Donation
- Evaluation, Selection, and Post-Donation Follow-Up of Living Kidney Donors
- Operative Technique
- Donor Outcomes Following Living Kidney Donation
- Summary
- References
- CHAPTER 24: Techniques for Living Donor Liver Procurement
- Introduction
- Donor Evaluation
- Graft Selection
- Anatomical Variants
- Surgical Techniques: Conventional Open Procedures
- Laparoscopic Donor Hepatectomy
- Perioperative Donor Management
- Donor Complications
- Summary
- References
- Organ Preservation and Resuscitation
- CHAPTER 25: Abdominal Organ Preservation and Resuscitation
- Introduction
- Factors Shaping the Development of Modern Organ Preservation
- Principles of Cold Preservation
- Hypothermic Storage
- Composition of Clinically Used Cold Storage Solutions
- Clinical Use of Hypothermic Preservation
- Resuscitation Protocols
- Summary
- Acknowledgments
- References
- CHAPTER 26: Thoracic Organ Preservation and Resuscitation
- Introduction
- Lung Preservation
- Normothermic Lung Preservation
- Ex-Vivo Lung Evaluation
- Heart Preservation Solutions
- Normothermic Heart Perfusion
- Summary
- References
- CHAPTER 27: Kidney Paired Donation Networks
- Introduction
- Which Recipients Are Most Likely to Benefit From Kidney Paired Donation?
- Kidney Paired Donation Matching Algorithms
- The Kidney Paired Donation Database, Software Matching Program, and Use of Solid Phase Antibody Testing
- Global Kidney Paired Donation Experience
- Future Expansion
- Summary
- References
- SECTION 4: Pre-operative Management of Transplant Patients
- Patient Selection and Indications for Organ Transplantation
- CHAPTER 28: Patient Selection and Indications for Kidney Transplantation
- Introduction
- Kidney Transplantation as Renal Replacement Therapy
- Selecting a Donor
- Optimal Timing of Kidney Transplantation
- The Transplant Evaluation
- Contraindications to Kidney Transplantation
- Additional Issues in Patient Selection
- Special Considerations
- Summary
- References
- CHAPTER 29: Patient Selection and Indications for Liver Transplantation
- Introduction
- Indications for Liver Transplantation
- Evaluation
- Summary
- References
- CHAPTER 30: Patient Selection and Indications for Heart Transplantation
- Introduction
- Heart Failure: A Symptomatic and Progressive Syndrome
- Heart Transplant Listing Outcomes
- Left Ventricular Assist Devices: Changing the Landscape of Stage D heart Failure Therapy
- Heart Allocation in the US
- Patient Selection for Listing for Heart Transplantation
- Decision Regarding Transplant Listing
- Summary
- References
- CHAPTER 31: Patient Selection and Indications for Lung Transplantation
- Introduction
- Indications
- Contraindications
- Obstructive Lung Disease
- Diffuse Parenchymal Lung Disease
- Cystic Fibrosis and Other Causes of Bronchiectasis
- Pulmonary Arterial Hypertension
- Summary
- Acknowledgments
- References
- CHAPTER 32: Patient Selection and Indications for Pancreas and Islet Transplantation
- Introduction
- History
- Patient Selection
- Simultaneous Kidney and Pancreas Transplantation
- Pancreas after Kidney Transplantation
- SPK Versus PAK
- Indications for Pancreas Transplantation Alone and Islet Cell Transplantation
- Summary
- References
- CHAPTER 33: Patient Selection and Indications for Intestinal and Multivisceral Organ Transplantation
- Introduction
- Intestinal Failure
- Parenteral Nutrition-Related Complications
- Other Indications Not Meeting the Standard Criteria
- Potential Evolution in Indications
- Summary
- References
- CHAPTER 34: Role of Primary Care Provider in the Referral and Care of Abdominal Organ Transplant Patients
- Introduction
- Coordination of Care
- Timing of Referral to Subspecialists
- Optimizing Adherence
- Chronic Medical Conditions Post Transplantation
- Fertility and Contraception
- Immunization
- Smoking in Transplant Recipients
- Cancer Screening
- Drug Interactions
- Summary
- References
- CHAPTER 35: Role of Primary Care Provider in the Referral and Care of Thoracic Organ Transplant Patients
- Introduction
- Coordination of Care
- Pretransplant Phase
- Post-Transplant Phase
- Summary
- References
- The Histocompatibility Lab
- CHAPTER 36: Alloantibodies, Sensitization and Virtual Crossmatching
- Introduction
- Assays
- Clinical Application of the Virtual Cross-match
- Summary
- References
- Waiting List Management
- CHAPTER 37: Waiting List Management for Kidney Transplantation
- Introduction
- United Network of Organ Sharing (UNOS) Waiting List Status
- Waiting Times for Listed Transplant Candidates
- Development of a New Kidney Allocation System: Time on Dialysis
- Maintaining and Monitoring Waitlisted Patients
- Listing Status Awareness
- Management of the Deceased Donor Waiting List: National Survey
- Future Studies
- Summary
- References
- CHAPTER 38: Waiting List Management for Liver Transplantation
- Introduction
- Waiting list
- Factors Influencing Waiting Times
- Cirrhosis and Related Complications
- Antiviral Therapy
- Liver Support Devices
- Hepatocellular Carcinoma
- Acute Liver Failure
- Alcohol and Smoking Screening
- Summary
- References
- CHAPTER 39: Waiting List Management for Heart Transplantation
- Introduction
- Management of Patients with Advanced Heart Failure on the Cardiac Transplant Waiting List
- Placement of Patients with Advanced Heart Failure on the Cardiac Transplant Waiting List
- Organ Allocation
- Management of the Sensitized Patient on the Heart Transplant Waiting List
- Clinical Assessment of Patients on the Heart Transplant Waiting List
- Summary
- References
- CHAPTER 40: Waiting List Management for Lung Transplantation
- Introduction
- Listing for Lung Transplant
- Patient Management While Listed
- Removal from the Lung Transplant Waitlist
- Summary
- References
- CHAPTER 41: Waiting List Management for Pancreas and Islet Transplantation
- Introduction
- Monitoring and Maintaining Patient's Active Status on the Waiting List
- Current Pancreas Graft Allocation System in the US
- Future US Pancreas Graft Allocation Schema
- Islet Transplant Waiting List Considerations
- Summary
- Acknowledgments
- References
- CHAPTER 42: Waiting List Management for Intestinal and Multivisceral Transplantation
- Introduction
- Type of Visceral Allograft
- Current UNOS/OPTN Regulations and Allocation Policy
- Clinical Management
- Summary and Future Considerations
- References
- Intensive Care in End Organ Failure
- CHAPTER 43: Intensive Care in Hepatic Failure
- Introduction
- Acute Liver Failure
- Acute on Chronic Liver Failure
- Summary
- References
- CHAPTER 44: Intensive Care in Cardiac Failure
- Introduction
- Intravenous Vasoactive Drugs
- Intra-Aortic Balloon Counter-Pulsation
- Mechanical Ventilation in a Transplant Candidate
- Lungs in End-Stage Heart Failure
- Kidneys in End-Stage Heart Failure
- Liver in End-Stage Heart Failure
- Summary
- References
- CHAPTER 45: Intensive Care in Pulmonary Failure
- Introduction
- Respiratory Physiology and Pathophysiology
- Pharmacology of the Lung
- Mechanical Ventilation for Respiratory Failure
- Acute Respiratory Distress Syndrome
- Diseases of Chronic Respiratory Failure
- Pulmonary Arterial Hypertension
- Extracorporeal Life Support
- Summary
- References
- Artificial Organs and Assist Devices
- CHAPTER 46: Dialysis
- Introduction
- Epidemiology
- Dialysis and Related Extracorporeal Therapies
- Dialysis Management Considerations in Renal and Extrarenal Transplant Recipients
- Summary
- References
- CHAPTER 47: The Artificial Liver, in vivo Tissue Engineering, and Organ Printing
- Introduction
- Extracorporeal Liver Support
- Liver Cell Transplantation
- Bioengineered Solutions
- Summary
- References
- CHAPTER 48: Ventricular Assist Devices
- Introduction
- History
- Continuous Flow Pumps in Current Clinical Use
- Complications
- Summary
- References
- CHAPTER 49: The Artificial Heart
- Introduction
- History
- Patient Selection
- SynCardia Total Artificial Heart
- Implantation and Explantation
- Anticoagulation
- Postoperative Complications
- Causes of Death
- Summary
- References
- CHAPTER 50: Artificial Lungs
- Introduction
- ECMO in Support of Lung Transplantation
- Artificial Lungs for CO2 Removal
- Paracorporeal Artificial Lungs
- Summary
- References
- CHAPTER 51: The Artificial Pancreas
- Introduction
- Glucose Sensing
- Sensor Augmented Pump Therapy
- Paradigm Veo™ Semi-Closed Loop System
- Closed Loop Research
- Closed Loop Systems
- Summary
- References
- CHAPTER 52: Tissue and Organ Bioengineering
- Introduction
- Tissue and Organ-Specific Approaches
- Summary
- References
- Organ Acceptance and Risk Management Assessment
- CHAPTER 53: Organ Assessment and Acceptance for Standard and Expanded Criteria Donors
- Introduction
- Standard Criteria Donors: A Shrinking Source of Donor Organs
- Expanded Criteria Kidney Donation
- Expanded Criteria Liver Donation
- Organ-Specific Donor Risk Indices
- Summary
- References
- CHAPTER 54: Organ Assessment and Acceptance for Donation after Circulatory Death Donors
- Introduction
- DCD Lung Transplantation
- Long-Term Outcome
- DCD Liver Transplantation
- DCD Pancreas Transplantation
- DCD Kidney Transplantation
- DCD Heart and Intestine Transplantation
- DCD Process
- Hospital Relations
- Summary
- References
- SECTION 5: Transplant Procedure and Surgical Technique
- CHAPTER 55: Kidney Transplantation Procedure and Surgical Technique
- Introduction
- Preoperative Considerations
- Back-Table Preparation of Kidney
- Incision and Exposure
- Revascularization
- Urinary Reconstruction
- Closure
- Special Circumstances
- Early Postoperative Period
- Technical Complications
- Summary
- References
- CHAPTER 56: Liver Transplantation Procedure and Surgical Technique
- Introduction
- Back-Table Preparation of Liver Allograft
- Recipient Hepatectomy
- Implantation of the Whole-Organ Hepatic Allograft
- Summary
- References
- CHAPTER 57: Living Donor Liver Transplantation Procedure and Surgical Technique
- Introduction
- Perioperative Considerations
- Operative Procedure
- Graft-Type-Specific Operative Procedures
- Summary
- References
- CHAPTER 58: Heart Transplantation Procedure and Surgical Technique
- Introduction
- Donor Operation
- Preparation and Transportation of the Allograft
- Recipient Operation
- Special Situations
- Summary
- Acknowledgments
- References
- CHAPTER 59: Lung Transplantation Procedure and Surgical Technique
- Introduction
- Anesthetic Details
- Patient Positioning and Choice of Incision
- Recipient Explantation
- Single Versus Bilateral Lung Transplantation
- Allograft Implantation
- Reperfusion
- Closure
- Cardiopulmonary Bypass
- Extracorporeal Membrane Oxygenation
- Potential Pitfalls
- Summary
- References
- CHAPTER 60: Pancreas Transplantation Procedure and Surgical Technique
- Introduction
- Pancreas Transplantation Categories
- Preparative Aspects of Pancreas Transplant Surgery
- Donor Pancreas Procurement
- Pancreas Transplantation Surgery
- Summary
- References
- CHAPTER 61: Islet Cell Transplantation Procedure and Surgical Technique
- Introduction
- Surgical Procurement of the Pancreas
- Clinical Islet Isolation and Culture
- Percutaneous Intraportal Islet Transplantation in the Recipient
- Open Techniques for Intraportal Access
- Summary
- Acknowledgments
- References
- CHAPTER 62: Intestinal Transplantation Procedure and Surgical Technique
- Introduction
- Surgical Technique
- Summary
- References
- CHAPTER 63: Multivisceral Transplantation Procedure and Surgical Technique
- Introduction
- Anesthetic Considerations
- Incision
- Removal of Abdominal Organs (Organectomy)
- Foregut-Sparing Multivisceral Transplantation
- Non-Foregut-Sparing Multivisceral Transplantation
- Transplantation of the Abdominal Wall
- Reduced-Size Allografts
- Summary
- References
- CHAPTER 64: Vascularized Composite Allograft Transplantation Procedure and Surgical Technique
- Introduction
- Recipient Selection, Wait List Management, and Donor Considerations
- Surgical Technique: Hand, Abdominal Wall
- Surgical Technique: Face
- Surgical Technique: Larynx, Trachea
- Summary
- References
- Volume 2
- SECTION 6: Post-transplant Management
- Immunosuppressive Therapy
- CHAPTER 65: Induction Immunosuppressive Therapy
- Introduction
- The Biologic Basis for Induction Therapy
- Clinical Results with Specialized Induction Agents
- Summary
- References
- CHAPTER 66: Maintenance Immunosuppressive Therapy
- Introduction
- Trends and Types of Maintenance Therapy
- Risk Factors and Maintenance Immunosuppression
- Infection and Maintenance Immunosuppression
- Cancer and Maintenance Immunosuppression
- Maintenance Immunosuppression by Time After Transplant
- Generic Immunosuppressants
- Maintenance Therapy for Kidney Transplant Recipients
- Maintenance Therapy for Pancreas Transplant Recipients
- Maintenance Therapy for Lung Transplant Recipients
- Maintenance Therapy for Liver Transplant Recipients
- Maintenance Therapy for Heart Transplant Recipients
- Maintenance Therapy for Intestine Transplant Recipients
- Summary
- References
- CHAPTER 67: Rescue Immunosuppressive Therapy
- Introduction
- Acute Renal Allograft Dysfunction
- Acute Cellular Rejection
- Acute Antibody-Mediated Rejection
- Subclinical Inflammation and Chronic Injury
- Approach to the Graft with Declining Function
- Calcineurin Inhibitor Avoidance or Cessation as Rescue Therapy
- The End-Stage Kidney Allograft
- Novel Methods of Assessing Allografts
- Rescue Therapy for Other Solid Organ Allografts
- The Future Role of “Rescue Therapy” in Improving Long-Term Allograft Survival
- Summary
- References
- CHAPTER 68: Desensitization Protocols for Organ Transplantation
- Introduction
- Desensitization in the Current Context of Kidney Transplantation
- Desensitization Protocols for Renal transplantation Across HLA Antibody Barriers
- Treatment Options for Desensitization Programs
- Inclusion Criteria for and Success of Desensitization Protocols
- Specific Desensitization Protocols
- Safety of Desensitization Protocols
- Desensitization Protocols for Renal transplantation Across ABO Blood Group Antibody Barrier
- Summary: Outstanding Issues in Desensitization Protocols
- References
- Clinical Allograft Rejection Syndromes: Diagnosis and Management
- CHAPTER 69: Clinical Allograft Rejection Syndromes in Kidney Transplantation
- Introduction
- Primary Non-Function
- Early Graft Dysfunction
- Chronic Slow Graft Deterioration
- Late Acute Graft Failure
- Management of the Recipient with a Failing Graft
- Summary
- References
- CHAPTER 70: Clinical Allograft Rejection Syndromes in Liver Transplantation
- Introduction
- Cellular Basis for Rejection
- Antibody Basis for Rejection
- Histopathology and Molecular Pathology in Diagnosis of Rejection
- Clinical Presentation of Liver Rejection
- Summary
- References
- CHAPTER 71: Clinical Allograft Rejection Syndromes in Heart Transplantation
- Introduction
- Cellular Rejection
- Antibody-Mediated Rejection
- Treatment Strategies
- Mimickers of Allograft Rejection
- Conclusions
- Acknowledgments
- References
- CHAPTER 72: Clinical Allograft Rejection Syndromes in Lung Transplantation
- Introduction
- Acute Allograft Rejection
- Chronic Allograft Rejection
- Summary
- References
- CHAPTER 73: Clinical Allograft Rejection Syndromes in Pancreas and Islet Transplantation
- Immunogenicity of the Pancreas Allograft—a Historical Perspective
- Clinical Presentation: Pancreas Graft Dysfunction
- Acute Pancreas Rejection
- Chronic Pancreas Rejection
- Immunogenicity of the Islet Allograft—a Historical Perspective
- Summary
- References
- CHAPTER 74: Clinical Allograft Rejection Syndromes in Intestinal Transplantation
- Introduction
- Acute Cellular Rejection
- Other Forms of Acute Rejection
- Chronic Rejection
- Summary
- References
- CHAPTER 75: Clinical Allograft Rejection Syndromes in Vascularized Composite Allotransplantation
- Introduction
- Diagnosis, Definition, and Mechanisms
- Management
- Summary
- Note
- References
- CHAPTER 76: Clinical Transplantation Tolerance
- Introduction
- Risk of Long-Term Immunosuppression
- Rationale of Tolerance Induction
- Indications for Tolerance Induction
- Strategies for Tolerance Induction
- Operational Tolerance in Liver Transplantation
- Biomarkers for Tolerance
- Summary
- References
- Clinical Recurrent Disease: Diagnosis and Management
- CHAPTER 77: Recurrent Disease after Kidney and Pancreas Transplantation
- Introduction
- Recurrent Disease After Kidney Transplantation
- Recurrent Disease After Pancreas Transplantation
- Concluding Remarks
- References
- CHAPTER 78: Recurrent Disease after Liver Transplantation
- Introduction
- Viral Disease
- Autoimmune Disorders
- Alcoholic Liver Disease
- Non-Alcoholic Fatty Liver Disease
- Hepatocellular Carcinoma
- Conclusions
- References
- CHAPTER 79: Recurrent Disease after Heart Transplantation
- Introduction
- Pathology
- Immune Mechanisms Contributing to CAV
- Influence of Non-Immune Factors in the Development of CAV
- Clinical Assessment
- Pharmacologic Therapy
- Treatment
- Cardiac Transplantation for Infiltrative Cardiomyopathies and Risk of Recurrence
- Conclusions
- References
- CHAPTER 80: Recurrent Disease after Lung Transplantation
- Introduction
- Sarcoidosis
- Lymphangioleiomyomatosis
- Pulmonary Langerhans Cell Histiocytosis
- Bronchioloalveolar Carcinoma
- Pulmonary Alveolar Proteinosis
- Emphysema Secondary to Alpha-1 Antitrypsin Deficiency
- Other Lung Diseases Recurring after Transplant
- Conclusions
- References
- Histopathological Syndromes of Graft Rejection and Recurrent Disease
- CHAPTER 81: Histopathological Syndromes of Kidney Allograft Rejection and Recurrent Disease
- Introduction
- Graft Rejection
- Atypical Rejection Syndromes
- Other Important Disorders Observed in Allografts
- Recurrent and De Novo Disease
- Future Directions in Biopsy Assessment
- Conclusions
- Acknowledgments
- Statement of Competing Financial Interests
- References
- CHAPTER 82: Histopathological Syndromes of Liver Allograft Rejection and Recurrent Disease
- Introduction
- Deceased Donor Biopsy Evaluation
- Living Donor Biopsy Evaluation
- Determination of Causes of Graft Dysfunction after Transplantation ()
- Vascular Complications
- Rejection
- Bacterial and Fungal Infections
- “Opportunistic” Hepatitis Viruses
- Considerations Involved in the Evaluation of Late Liver Allograft Dysfunction and Protocol Biopsies
- Recurrent Diseases and Diseases Induced by Transplantation
- Hepatitis Virus Infections
- Disorders of Dysregulated Immunity
- Metabolic Diseases and Toxic Insults
- Recurrent Alcoholic Liver Disease
- Recurrent Non-Alcoholic Steatohepatitis
- Idiopathic Post-Transplant Hepatitis
- Considerations in Immunosuppression Optimization Protocols
- Long-Term Changes Not Readily Explained by Recurrent Disease
- Conclusions
- Acknowledgments
- References
- CHAPTER 83: Histopathological Syndromes of Heart Allograft Rejection and Recurrent Disease
- Introduction
- Endomyocardial Biopsy
- Cardiac Allograft Rejection: Morphologic Aspects
- Antibody-Mediated Rejection (Humoral Arm of the Rejection Immune Response)
- Cardiac Allograft Vasculopathy
- Recurrent Diseases in the Allograft and the Patient
- Examination of the Allograft after Failure
- Conclusions
- References
- CHAPTER 84: Histopathological Syndromes of Lung Allograft Rejection and Recurrent Disease
- Introduction
- Histologic Grading of Lung Allograft Rejection
- General Recommendations
- Histologic Features of Acute Rejection
- Chronic Rejection
- Antibody-Mediated Rejection
- Role of Bronchoalveolar Lavage Fluid in the Diagnosis of Lung Allograft Rejection
- Conclusions
- References
- CHAPTER 85: Histopathological Syndromes of Pancreas and Islet Allograft Rejection and Recurrent Disease
- Introduction
- Principles and Practical Aspects of Histopathological Diagnosis of Allograft Rejection in Whole Pancreas Transplants
- Acute T-Cell-Mediated Allograft Rejection
- Acute Antibody-Mediated Allograft Rejection
- Chronic Allograft Rejection and Graft Sclerosis in Whole Pancreas Transplants
- Duodenal Graft Pathology
- Banff Pancreas Allograft Rejection: Banff Working Grading Schema
- Histopathological Syndromes of Islet Dysfunction
- Conclusions
- References
- CHAPTER 86: Histopathological Syndromes of Intestinal Allograft Rejection and Recurrent Disease
- Introduction
- Histopathological Evaluation
- Pathological Processes
- Conclusions
- References
- CHAPTER 87: Histopathological Syndromes of Vascularized Composite Allograft Rejection and Recurrent Disease
- Introduction
- Background
- Specimen Adequacy
- Acute Cell-Mediated Rejection: VCA Banff Scoring System
- Non-Alloimmune Pathology
- Chronic Rejection
- Imaging and Other Ancillary Technique Findings
- Antibody-Mediated Rejection
- Conclusions
- References
- Post-operative Monitoring
- CHAPTER 88: Cardiovascular Disease and Preventive Healthcare after Organ Transplantation
- Introduction
- Solid Organ Transplant Recipients and Independent Risk Factors
- Mechanisms of the Adverse Cardiovascular Effects of Immunosuppressive Medications
- Cardiovascular Disease in Cardiac Transplant Patients
- Cardiovascular Disease in Lung Transplant Patients
- Cardiovascular Disease in Kidney Transplant Patients
- Cardiovascular Disease in Pancreas Transplant Patients
- Cardiovascular Disease in Liver Transplant Patients
- Summary
- References
- CHAPTER 89: Monitoring for HLA Antibody after Organ Transplantation
- Introduction
- Rationale
- DSA and Transplant Outcomes
- Strategies for Post-Transplant DSA Monitoring
- Methods to Detect HLA DSA
- Summary
- References
- CHAPTER 90: Biomarkers and Alloimmune Monitoring after Organ Transplantation
- Introduction
- Identification and Evaluation of Biomarkers Relevant to Transplantation
- Principles of Cellular Alloimmune Monitoring
- Pretransplantation Biomarkers: Assessment of the Baseline Immunological Risk of Transplant Recipients
- Post-Transplantation Biomarkers: Acute Allograft Rejection and Chronic Allograft Injury
- Biomarkers of Over-Immunosuppression
- Biomarkers of Graft Accommodation and Allograft Tolerance
- Summary
- References
- CHAPTER 91: Protective Immune Competence after Organ Transplantation
- Introduction
- Protective Immunity
- Immune Competence Prior to Transplantation
- Summary
- References
- Transplant Infectious Diseases
- CHAPTER 92: Donor-derived Infections after Organ Transplantation
- Introduction
- General Considerations
- Screening
- Recipient Evaluation
- Limitations to Determining Donor-Derived Infections
- Consent Issues
- Reporting of Donor-Derived Infections
- Pathogen-Specific Issues
- Summary
- References
- CHAPTER 93: Perioperative Infections after Organ Transplantation
- Introduction
- Predisposing Factors
- Early Postoperative Infections
- Prevention of Early Postoperative Infections
- Summary
- References
- CHAPTER 94: Late Infectious Disease after Organ Transplantation
- Introduction
- Risk for Infection and the Timeline of Infection
- Selected Infections and Syndromes of Importance to Transplantation
- Summary
- References
- Malignancy in Transplantation
- CHAPTER 95: General Malignancy after Organ Transplantation
- Introduction
- Epidemiology
- Etiology and Risk Factors
- Cancer Types
- Cancer Screening in Solid Organ Transplant Patients
- Management of De-Novo Malignancies after Solid Organ Transplantation
- Summary
- References
- CHAPTER 96: Post-Transplant Lymphoproliferative Disorders
- Introduction
- Historical Perspectives
- Biology of Epstein – Barr Virus-Associated Post-Transplant Lymphoproliferative Disorder
- Epstein–Barr Virus-Negative Post-Transplant Lymphoproliferative Disorder
- Pathology
- Epidemiology
- Prevention of Epstein–Barr Virus-Associated Post-Transplant Lymphoproliferative Disorders
- Clinical Presentation and Diagnosis
- Treatment
- Prognosis and Outcome
- Summary
- References
- Pregnancy and Contraception in Transplantation
- CHAPTER 97: Pregnancy and Contraception in Transplantation
- Introduction
- Contraception for the Transplant Recipient
- Pregnancy after Transplantation
- Immunosuppressive Agents and Teratology
- Organ Groups
- Breastfeeding
- Management Options
- Pregnancy after Living Donation
- Male Recipients
- Summary
- Acknowledgment
- References
- The Transplant Pharmacopeia
- CHAPTER 98: Drugs Specifically Approved for Transplant Indications
- Introduction
- The Evolution of the FDA
- The Structure of the FDA
- New Drug Development Process
- New Drug Application
- Post Marketing Surveillance
- Orphan Drugs
- Abbreviated New Drug Applications
- Challenges in Drug Development Specific in Solid Organ Transplantation
- Summary
- Note
- References
- CHAPTER 99: Infectious Disease Prophylaxis after Organ Transplantation
- Introduction
- Prevention in Kidney, Pancreas, and Kidney/Pancreas Transplant
- Prevention in Liver Transplantation
- Prevention in Lung Transplantation
- Prevention in Heart Transplantation
- Prevention in Small-Bowel and Composite Vascular Allografts (CVA)
- Immunizations in Solid Organ Transplantation
- Summary
- References
- CHAPTER 100: Metabolic and Endocrine Management of the Organ Transplant Recipient
- Introduction
- Hyperglycemia and Diabetes Mellitus after Solid Organ Transplantation
- Hyperlipidemia after Solid Organ Transplantation
- Bone and Mineral Disorders after Solid Organ Transplantation
- Hyperuricemia and Gout after Solid Organ Transplantation
- Electrolyte Disturbances after Solid Organ Transplantation
- Summary
- References
- CHAPTER 101: Off-Label Use of Immunosuppressive Agents in Solid Organ Transplantation
- Introduction
- Off-Label Use in Transplantation
- FDA Regulatory Process for New Drug Approval
- Medicare Reimbursement Approval Process for off-Label Drug Use
- Off-Label Use of Immunosuppressive Drugs in Transplantation
- French Statutory Framework for Redefining off-Label Drug Use
- Off-Label Use, Standard of Care, and Investigational Use of Drugs
- Summary
- References
- CHAPTER 102: Drug Interactions in Organ Transplantation
- Introduction
- Pharmacokinetic Drug-Drug Interactions
- Pharmacodynamic Interactions
- Cholesterol Medications and Drug Interactions
- Herbal Products and Grapefruit and Drug Interactions
- Pharmacogenomics and Drug Interactions
- Summary
- References
- SECTION 7: Long-term Transplant Outcomes
- CHAPTER 103: Long-term Outcomes after Kidney Transplantation
- Introduction
- Long-Term Outcomes of Renal Transplant Recipients
- Organ Quality and Donor Factors
- Recipient Factors
- Recurrent or De Novo Glomerular Disease
- Immunologic Injury
- Infection and Post-Transplant Malignancy
- Social and Racial Determinants of Health
- Summary
- References
- CHAPTER 104: Long-term Outcomes after Liver Transplantation
- Introduction
- Causes of Late Deaths and Graft Failure
- Recipient Factors That Affect Long-Term Patient Outcomes
- Retransplantation
- ABO and HLA Matching
- Donor Factors That Affect Patient and Graft Survival
- Late Complications of Liver Transplantation
- Operational Tolerance
- Summary
- References
- CHAPTER 105: Long-term Outcomes after Heart Transplantation
- Introduction
- Long-Term Outcomes after Heart Transplantation
- Rejection
- Infection
- Malignancy
- General Medical Management
- Summary
- References
- CHAPTER 106: Long-term Outcomes after Lung and Heart-Lung Transplantation
- Introduction
- Long-Term Outcomes
- Acute Rejection
- Chronic Lung Allograft Dysfunction
- Infection
- Malignancy
- Other Medical Morbidities
- Summary
- References
- CHAPTER 107: Long-term Outcomes after Pancreas Transplantation
- Introduction
- Evolution of Surgical Technique in Pancreas Transplantation
- Long-Term Outcomes after Pancreas Transplantation
- Complications after Pancreas Transplantation
- Effect of Pancreas Transplantation on Secondary Complications of Diabetes
- Expanding the Donor Pool
- Role of Immunosuppressive Medications
- Summary
- Acknowledgments
- References
- CHAPTER 108: Long-term Outcomes after Islet Transplantation
- Introduction
- Risks of Diabetes and Alternative Intervention Strategies
- Patient Selection and Procedural Indications for Islet Transplantation
- Risks of Islet Transplantation
- Challenges of Immunosuppression
- A Practical Approach to Immunosuppression in Islet Transplantation
- Other Long-Term Risks in Islet Transplanted Patients
- Long-Term Outcomes
- Single-Donor Islet Transplantation
- Alternative Strategies in Current Clinical Trials
- Summary
- References
- CHAPTER 109: Long-term Outcomes after Intestinal and Multi-visceral Transplantation
- Introduction
- Long-Term Graft and Patient Survival
- Patient Function, Quality of Life and Graft Failure
- Summary
- References
- CHAPTER 110: Long-term Outcomes after Vascularized Composite Allograft Transplantation
- Introduction
- Acute and Chronic Rejection in VCA
- Complications in VCA
- Hand Transplantation
- Face Transplantation
- Abdominal Wall Transplantation
- Laryngeal Transplantation
- Knee Joint Transplantation
- Femoral Diaphysis Transplantation
- Other VCAs
- Summary
- References
- SECTION 8: Pediatric Transplant
- CHAPTER 111: An Introduction to Pediatric Organ Transplantation
- References
- CHAPTER 112: Developmental Immunity: From Birth to Adult
- Introduction
- Natural Development of the Immune System with Childhood Maturation
- Adolescence
- Behavioural Impact
- Implications of Immune Maturation on Transplantation and Vice Versa
- Transfer into Adulthood: The Recovering Immune System
- Summary
- References
- CHAPTER 113: Pediatric Kidney Transplantation
- Introduction
- Patient Selection and Indications for Transplantation
- Management of the Transplant List
- The Transplant Procedure
- Post-Transplant Transplant Management
- Outcomes and Risk Factors
- Summary
- References
- CHAPTER 114: Pediatric Liver Transplantation
- Introduction
- Deceased Donor Organ Allocation
- Indications for Liver Transplantation for Pediatric Patients
- Transplant Evaluation
- Transplant Procedure and Surgical Techniques
- Early Post-Transplant Surgical Complications
- Early Post-Transplant Management Considerations
- Late Post-Transplant Challenges
- Late Surgical Complications
- Late Allograft Dysfunction
- Non-Immune Complications of Immunosuppressive Agents
- Summary
- References
- CHAPTER 115: Pediatric Heart Transplantation
- Introduction
- Historical Notes
- Indications for Transplantation and Candidate Evaluation
- Wait-List Management and Outcomes
- Donor Evaluation, Surgical Techniques and Early Post-Transplant Management
- Postoperative Management and Early Complications
- Post-Transplant Management and Long-Term Complications of Transplantation
- Acute Rejection
- Infections
- Non-Immune Complications
- Post-Transplant Survival and Risk Factors
- Summary
- References
- CHAPTER 116: Pediatric Lung Transplantation
- Introduction
- Patient Selection and Indications for Transplantation
- Management on the Waiting List
- Transplant Procedure and Surgical Techniques
- Post-Transplant Management
- Outcomes and Risk Factors
- Summary
- References
- CHAPTER 117: Pediatric Intestinal and Multivisceral Organ Transplantation
- Introduction
- Indications and Patient Selection
- Wait-List Issues
- Graft Options and Surgical Techniques
- Immunosuppression and Rejection
- Outcomes
- Nutrition
- Summary
- References
- Special Pediatric Considerations
- CHAPTER 118: Growth and Development after Organ Transplantation
- Introduction
- Growth Retardation and Delayed Pubertal Development in Chronic Organ Failure
- Factors Affecting Post-Transplant Growth and Development
- Endocrine Mechanisms of Glucocorticoid-Induced Growth Failure
- Strategies to Optimize Post-Transplant Growth
- Summary
- References
- CHAPTER 119: Cognitive Development and Functional Outcomes after Organ Transplantation
- Introduction
- Cognitive Function
- Cognitive Function Summary
- Functional Outcomes
- Function Outcome Summary
- Summary and Implications for Long-Term Follow-Up
- References
- CHAPTER 120: Nonadherence, Psychosocial Adaptation and Its Effects in Pediatric Transplantation
- Introduction
- The Burden of Medication Non-Adherence on the Health of Transplant Recipients
- Under-Appreciation of the Incidence and Impact of Non-Adherence
- Unique Pediatric Implications
- Definitions of Non-Adherence
- Operational Definition of Non-Adherence in Organ Transplantation
- Prevalence of Non-Adherence with Immunosuppressive Medications in Pediatric Transplantation
- Psychosocial and Developmental Adaptation in Pediatric and Adolescent Transplant Recipients
- Factors Associated with Medication Non-Adherence in Pediatric Patients
- Barriers to Adherence
- Consequences of Medication Non-Adherence
- There Are Two Broad Categories of Non-Adherence Detection Methods: Direct and Indirect
- Interventions to Prevent or Improve Non-Adherence
- Summary
- References
- CHAPTER 121: Management of the Organ Transplant Recipient in the Transition from Pediatric to Adult Care
- Introduction
- Background
- Recommendations and Guidelines for the Provision of Care to the Transitioning Adolescent and Emerging Adult Transplant Recipient
- Transition Readiness
- Transition Outcomes and Research Needs
- Summary
- Conclusion
- References
- SECTION 9: Transplant Administration
- CHAPTER 122: Transplant Coordination
- Introduction
- History and the Evolution of the Role of the Transplant Coordinator
- Transplant Certification
- Procurement Coordinators
- Clinical Transplant Coordinators
- Role of the Coordinator in Education
- Role of the Advanced Practice Nurse as Coordinator
- Summary
- References
- CHAPTER 123: Transplant Pharmacy Services
- Introduction
- Evolution of Transplant Pharmacy
- Governing Body Support for Transplant Pharmacy
- Education and Training of the Transplant Pharmacist
- Description of Roles and Responsibilities on the Patient Care Team
- The Role of the Pharmacist in Clinical Research
- Financial Justification for Clinical Pharmacy Services
- Establishment of Mail Order Transplant Pharmacy Services — Impact of 340B Drug Pricing Program
- Summary
- References
- CHAPTER 124: Inpatient Transplant Unit Management
- Introduction
- The Physical Environment and Resources — Infection Control
- The Human Resource — Staffing
- The Thoracic Transplant Unit
- The Abdominal Transplant Unit
- Staffing the Abdominal Unit
- Certification
- Discharge Planning
- Quality Assessment and Performance Improvement
- Regulatory Issues
- Summary
- References
- CHAPTER 125: Transplant Clinic Management
- Introduction
- Role of Regulatory Agencies
- Design/Layout of Outpatient Transplant Clinics
- Clinic Scheduling Models
- Staffing
- Competencies
- Electronic Medical Record
- Patient Education/Informed Consent
- Summary
- References
- CHAPTER 126: Transplant Center Management and Leadership
- Introduction
- Evolution of Culture in Transplant Centers
- Intrapreneurship — Balancing the Entrepreneurial Spirit with the Corporate Culture
- Transplant Center Management: Structuring Intrapreneurship
- Summary
- References
- CHAPTER 127: Transplant Quality Programs
- Introduction
- Transplant Outcome Quality: The Role of registries
- Guidelines
- Quality Assessment of Different Organ Transplants
- The Impact of Pretransplant Risk Factors for the Outcome in Solid Organ Transplantation
- Access to Organ Transplantation
- Organ Procurement and Organ Quality Programs
- Living Organ Donation — Quality Program for the Donor
- Organ Quality
- Medical Quality Assessment Post Transplantation
- The Experience and the Number of Transplants for Quality Assessment
- The Quality of Long-Term Follow-Up Following Solid Organ Transplantation
- The Assessment of Quality of Life of Patients after Transplantation
- Summary
- References
- CHAPTER 128: National and International Transplant Management and Oversight
- Introduction
- Health and Human Services Oversight of the US Donation and Transplantation System
- Transplant Program Perspectives
- Global Policies
- Regional Policies
- International Associations
- Declaration of Istanbul
- Summary
- References
- Transplant Education
- CHAPTER 129: Abdominal Solid Organ Transplantation Fellowship Training
- Introduction
- History of Transplant Fellowships
- Requirements for Program Certification
- Matriculation into a Solid Organ Transplant Fellowship
- Future Directions for Abdominal Transplant Surgery Fellowships
- Summary
- References
- CHAPTER 130: Medical Solid Organ Transplant Fellowship Training
- Introduction
- History
- General Principles of Transplant Fellowship Training
- Current Organ-Specific Training Requirements
- Educational Opportunities
- Multiorgan Transplantation
- Pathology
- Pediatrics
- Procedures
- Living Donors
- Funding
- Research
- Work Hours Regulations
- Unaddressed Needs
- Summary
- References
- CHAPTER 131: Transplantation in General Medical Education
- Introduction
- Current Education
- Further Methods for Education and Training
- Summary
- References
- SECTION 10: Clinical Trials and Data Management
- CHAPTER 132: Building and Sustaining a Local Transplant Data Management Program
- Introduction
- Process
- Plan
- Design
- Deploy
- Evaluate
- Summary
- References
- CHAPTER 133: National Transplant Data Registries and Population Studies
- Introduction
- Advantages of Registry-Based and Population-Based Research
- Examples of National and Regional Transplant Registries
- The Role of Registry and Population-Based Research
- Study Design Considerations in Registry-Based Research
- Some Pitfalls in Registry-Based Studies
- Summary
- References
- CHAPTER 134: Clinical Research Methods and Analysis in Organ Transplantation
- Introduction
- Major Types of Study Designs
- Experimental Study Designs
- Observational Study Designs
- Experimental versus Observational Study Designs
- Random and Systematic Error
- Internal versus External Validity
- Major Types of Bias in Clinical Research
- Power and Sample Size Issues
- Data Sources: Strengths and Weaknesses
- Exploratory Data Analysis
- Univariable Analyses
- Multivariable Analyses
- Survival Analysis
- Diagnostic Testing
- Risk Adjustment
- Subgroup Analyses and Effect Modification
- Interpretation of Models
- Missing Data
- Endpoints in Transplantation
- Special Topics
- Summary
- References
- CHAPTER 135: Comparative Effectiveness in Transplantation
- Introduction
- Limitations of Random Clinical Trials for CER
- The Use of N-of-1 Study Design in CER
- Observational Data and Meta-Analyses in CER
- Decision Analysis and Cost Utility Effectiveness in CER
- CER in Renal Organ Transplantation
- Applying CER to Organ Transplantation
- Methodological Concerns of CER
- Summary and Future Directions
- References
- SECTION 11: Transplant Policy
- Transplant Ethics
- CHAPTER 136: Transplant Ethics for Clinicians
- Introduction
- The Final Rule
- Decision-Making in the Current System
- The Application of Ethical Principles
- The Inadequacy of the Current System
- Living Donor Organ Transplantation
- Donors Are Patients
- The Psychosocial Assessment
- Autonomy Versus Paternalism
- The Relationship of the Donor to the Recipient Influencing the Decision to Donate
- Assessment of Outcomes
- Summary
- References
- CHAPTER 137: The Ethics of Organ Allocation
- Introduction
- Organ Transplantation Is Unique
- Ethical Principles in the Allocation of Organs
- Legal and Regulatory Factors Influencing Organ Allocation Policy
- Access to the Waiting List
- Relationship between Organ Allocation Policy and the Decision to Donate
- The Future/Summary
- References
- CHAPTER 138: The Ethics of Living Donation
- Introduction
- Procedural Risks and Benefits
- Donor Follow-Up
- Altruism
- Non-Directed Donations
- Paired Donation
- Liver Donation
- Lung Donation
- Commercialization and Remuneration
- Summary
- References
- CHAPTER 139: Cultural Variations in Organ Transplantation
- Introduction
- Cultural Variations
- Transplant Commercialism
- Strategies to Decrease Global Variation and Prevent Transplant Commercialism
- Summary
- References
- Economic and Societal Impact of Transplantation and Transplant Policy
- CHAPTER 140: Federal and Private Insurance Coverage for Organ Transplantation
- Introduction
- Requirements To Be a Transplant Program or Center
- Government and Payment for Organ Transplantation
- The Cost of Obtaining Organs for Transplantation
- Government and Private Insurance and the Individual Recipient
- Balancing Patient-Need, Managing Outcomes and Finance Based Expectations
- Summary
- Further Reading
- US Authority for Organ Transplantation
- Organ Acquisition Cost Center
- Oversight and Impact on Organ Transplantation
- Payment Programs and Transplant Practice
- CHAPTER 141: Drug Development in Solid Organ Transplantation and the Approval Process for Transplant Immunosuppressants
- Introduction
- Discovery
- Product Characterization, Formulation, Delivery, Packaging Development
- Pharmacokinetics, Drug Disposition, Bioanalytical Testing
- Preclinical Toxicology Testing from Discovery to Approval
- Clinical Trials
- Road to Registration: Drug Approval Process
- Summary
- References
- CHAPTER 142: Organ Specific Benefits of Transplantation: Outcomes and Economics
- Introduction
- Kidney Transplantation
- Liver Transplantation
- Heart Transplant
- Conclusion
- References
- CHAPTER 143: National Healthcare Policy, Transplant-specific Statutes, and the Future of Organ Transplantation
- Introduction
- Legal and Regulatory Structure of Transplantation in the U.S.
- Federal Regulations and CMS Requirements
- Implications of the Patient Protection and Affordable Care Act (PPACA)
- Meeting a Growing Demand for Organs Through Donation Incentives
- Current Policy and Transplant Tourism
- Summary
- Referencess
- Subject Index
- End User License Agreement