The Artificial Heart

Prototypes, Policies, and Patients

Author: VanAntwerp, Malin; Hogness, John R.
Publisher: National Academies Press
ISBN: 9780309045322
eISBN Pdf: 9780309556002
Place of publication: United States
Year of digital publication: 1991
Month: January
Pages: 313
Language: English

Caption

A significant medical event is expected in 1992: the first human use of a fully implantable, long-term cardiac assist device. This timely volume reviews the artificial heart program—and in particular, the National Institutes of Health's major investment—raising important questions.

The volume includes:

Consideration of the artificial heart versus heart transplantation and other approaches to treating end-stage heart disease, keeping in mind the different outcomes and costs of these treatments.
A look at human issues, including the number of people who may require the artificial heart, patient quality of life, and other ethical and societal questions.
Examination of how this technology's use can be targeted most appropriately.
Attention to achieving access to this technology for all those who can benefit from it.

The committee also offers three mechanisms to aid in allocating research and development funds.

The Artificial Heart
Copyright
Acknowledgments
Preface
Contents
The Artificial Heart
Executive Summary
- TECHNOLOGICAL PROGRESS AND BARRIERS
- MAKING DECISIONS ABOUT FUTURE RESEARCH
- CLINICAL EFFECTIVENESS
- PROJECTED PATIENT NEED
- HEALTH-RELATED QUALITY OF LIFE
- COST-EFFECTIVENESS
- APPROPRIATENESS OF USE OF MECHANICAL CIRCULATORY SUPPORT
- PATIENT ACCESS TO MCSSS
- ETHICAL CONSIDERATIONS
- RESEARCH AND DEVELOPMENT POLICY ISSUES
- REGULATORY DECISIONS ABOUT NEW TECHNOLOGIES
- DEVELOPMENT OF TOTAL ARTIFICIAL HEARTS
- CONTINUED DEVELOPMENT OF VENTRICULAR ASSIST DEVICES
- ADDITIONAL RESEARCH
- USING THIS REPORT
1 The Artificial Heart Program: Current Status and History
- END-STAGE HEART DISEASE
- HOW LONG-TERM IMPLANTABLE DEVICES COULD HELP
  - Ventricular Assist Devices
  - Total Artificial Hearts
  - Temporary Circulatory Support
- THE ARTIFICIAL HEART PROGRAM
- THE INSTITUTE OF MEDICINE STUDY
- REFERENCES
2 Total Artificial Hearts: Technological Potential and Research and Development Costs
- TEMPORARY CIRCULATORY SUPPORT
- LONG-TERM DEVICES UNDER DEVELOPMENT
- ENGINEERING ASSESSMENT OF MECHANICAL CIRCULATORY SUPPORT DEVICES
  - Mechanical Failure
  - Device Components as Limiting Factors
  - Device Longevity
- CLINICAL COMPLICATIONS WITH MECHANICAL CIRCULATORY SUPPORT DEVICES
- ALTERNATIVE TECHNOLOGIES FOR PREVENTING AND TREATING END-STAGE HEART DISEASE
  - Conventional Medical Treatment
  - Other Cardiac Assistance Technologies
  - Heart Transplantation
- SUMMARY OF THE CURRENT AND FUTURE STATE OF TOTAL ARTIFICIAL HEART TECHNOLOGY
- RESEARCH AND DEVELOPMENT COSTS OF TOTAL ARTIFICIAL HEARTS
  - Stages of the Innovative Process
  - Support for the Artificial Heart Program
  - Considering the Costs of Research and Development to Industry
- CONCLUSIONS
- REFERENCES
3 Decisions for Future Research and Development
- ALLOCATING RESEARCH FUNDS
- JUDGMENT-BASED DECISION MAKING
- QUANTIFIED AIDS TO DECISION MAKING
  - Cost-Effectiveness Analysis
  - Application of Methods
- DECISION-MAKING AIDS SUGGESTED BY THE COMMITTEE
  - Explicit Criteria for Allocation of Funds
  - The More Important Criteria
  - Important Criteria
  - Less Important Criteria
  - Application of Decision Criteria
- A NOTE ABOUT INDUSTRY RESEARCH AND DEVELOPMENT DECISIONS
- SUMMARY AND CONCLUSIONS
- REFERENCES
4 Clinical Effectiveness and Need For Long-Term Circulatory Support
- ESTIMATING THE NEED FOR LONG-TERM SUPPORT
- FROM TEMPORARY TO LONG-TERM USE
- PROJECTING DEVICE RELIABILITY AND EFFECTIVENESS
- RELATING CLINICAL EFFECTIVENESS AND DEVICE USE
  - The Role of Comorbidities
- OTHER INFLUENCES ON THE USE OF CIRCULATORY SUPPORT DEVICES
  - The Impact of Other Heart Disease Treatment Technologies
  - Quality-of-Life Determinants
  - Patient Preferences for Life-Sustaining Treatment
  - Other Factors
- EPIDEMIOLOGICAL PROJECTIONS
  - Previous Studies
  - The Committee's Projection
  - Effect of a Less-than-Ideal Device
  - Less Disabled Patients
  - Additional Potential Patients
- VENTRICULAR ASSISTANCE VERSUS A TOTAL ARTIFICIAL HEART
- THE NEED FOR MORE RESEARCH
  - Basic and Clinical Research Concerning Heart Failure
  - Epidemiological Research
- SUMMARY AND CONCLUSIONS
- REFERENCES
5 Quality of Life and Mechanical Circulatory Support Systems
- THE IMPORTANCE OF QUALITY-OF-LIFE CONSIDERATIONS
  - From the Perspective of the Patient
  - Methods for Assessing the Quality of Care
  - Health State Utilities
- HEALTH, HEALTH STATUS, AND QUALITY OF LIFE
- DOMAINS OF QUALITY OF LIFE RELEVANT TO END-STAGE HEART DISEASE PATIENTS
  - Domains for Utility Assessment
  - Other Domains Relevant to These Quality-of-Life Issues
    - Machine Dependence and Societal Reaction
    - Meaning and Purpose of Life Versus Fear of Death
    - Spiritual Well-Being
- QUALITY OF LIFE AND ITS DETERMINANTS FOR PATIENTS WITH END-STAGE HEART DISEASE
  - Heart Transplantation
  - Automatic Implantable Cardioverter Defibrillator
  - Providing Support in the Postoperative Phase
  - Perspectives from Prior Studies of the Artificial Heart
- IMPLICATIONS OF QUALITY-OF-LIFE CONSIDERATIONS IN CLINICAL TRIALS AND STUDIES OF MECHANICAL CIRCULATORY SUPPORT PATIENTS
  - Concepts and Methods
  - Costworthiness: Patients' and Societal Perspectives
- SUMMARY AND CONCLUSIONS
- REFERENCES
6 Cost-Effectiveness Analysis
- THE USE OF COST-EFFECTIVENESS ANALYSIS IN HEALTH CARE
  - Capabilities and Limitations
- COST-EFFECTIVENESS OF TOTAL ARTIFICIAL HEARTS
  - Sensitivity Analysis
  - Implications
    - Cost-Effectiveness of Ventricular Assist Devices
    - Treatment to Prevent End-Stage Disease
- COST-EFFECTIVENESS ANALYSIS AND RESEARCH FUNDING LEVELS
  - Sensitivity Analysis
  - Implications
- CONCLUSIONS
  - The Borderline Cost-Effectiveness of Artificial Heart Use
  - Using Cost-Effectiveness to Decide Funding Levels
- REFERENCES
- CHAPTER 6 APPENDIX: DESCRIPTION OF HEALTH STATES
7 The Appropriate Use of Technology
- WHAT APPROPRIATE TECHNOLOGY USE IS
  - The Relationship Between Technology Use and Cost
  - Factors That May Affect Future Use of New Technologies
  - Past Failures to Limit Technology Use
- WAYS TO PROMOTE APPROPRIATE USE OF MECHANICAL CIRCULATORY SUPPORT DEVICES
  - Clinical Practice Guidelines
    - Developing Practice Guidelines
    - Implementing Practice Guidelines
    - Appropriate Use of Other Technologies
  - Technology Assessment
  - Postmarketing Surveillance
  - Follow-Up Studies
  - Credentialing for Technology Use
  - Selective Coverage
- INVOLVING THE RIGHT PARTICIPANTS
- AVOIDING UNREASONABLE PATIENT EXPECTATIONS
- SUMMARY AND CONCLUSIONS
- REFERENCES
8 Ethical and Societal Issues
- ISSUES RAISED BY INCOMPLETE TECHNOLOGIES
  - Maximizing Benefits in the Provision of Health Care
  - Conceptualizing Access to Incomplete Technologies
- ISSUES RAISED BY THE TOTAL ARTIFICIAL HEART
  - Access to Total Artificial Hearts
  - Criteria for Use
  - Aggregate Societal Costs
- PROTECTING THE INDIVIDUAL PATIENT
  - Informed Consent and Advance Directives
- CONCLUSIONS
- REFERENCES
9 Roles of Government and Industry in Medical Technology Research, Development, and Use
- ROLE OF THE FEDERAL GOVERNMENT IN THE DEVELOPMENT OF MEDICAL TECHNOLOGY
  - Rationale for Federal Support of Research and Development
    - Theoretical Considerations
    - Practical Implications
  - Status of the Artificial Heart Program
    - Management and Accountability
    - Social (Health) Benefits
  - Industrial-Policy Considerations
  - Conclusions
- ROLE OF GOVERNMENT IN THE USE OF MEDICAL TECHNOLOGY
  - Food and Drug Administration
  - Medicare and Other Third-Party Payers
  - Conclusions About Regulatory Constraints
- ENCOURAGING INTERDISCIPLINARY AND INDUSTRY-ACADEME COLLABORATION
  - Role of Biomedical Engineering Research
  - Current Collaborative Structures
  - Conclusions About Collaborative Research
- EFFECT OF INDUSTRY SUPPORT ON COMMUNICATION AMONG RESEARCHERS
  - Conclusions
- SUMMARY AND CONCLUSIONS
- REFERENCES
10 Conclusions and Recommendations
- FOCUS OF THIS STUDY
- PROMOTING APPROPRIATE USE OF MECHANICAL CIRCULATORY SUPPORT DEVICES
- ACCESS BY ALL TO CIRCULATORY SUPPORT DEVICES?
  - Access via Third-Party Payers
  - Clinically Limited Access
  - Limiting Access by Inadequate Payments
- CLINICAL AND COST-EFFECTIVENESS
  - Clinical Effectiveness
  - Quality of Life
  - Cost-Effectiveness
    - Cost-Effectiveness in Research and Development Decisions
- MAKING IMPORTANT DECISIONS
  - Allocation of Research Funds
  - Regulatory Decisions About Technologies
    - Food and Drug Administration
    - Third-Party Payers
- CONTINUING DEVELOPMENT OF TOTAL ARTIFICIAL HEARTS
  - Considerations for the Next Decision Point
- OTHER RECOMMENDATIONS
  - Future Development of Ventricular Assist Devices
  - Clinical Trials and Patient Follow-up
    - Clinical Trials
    - Postmarketing Surveillance
    - Posttrial Follow-up
  - Fostering Collaborative Interdisciplinary Research
  - Patients' Quality of Life and Treatment Preferences
  - Research Needs
    - Heart Failure Research
    - Epidemiological Research
  - Communication Among MCSS Researchers
- HOW THIS REPORT SHOULD BE USED
- REFERENCE
Appendixes
- A History and Methods of This Evaluation
  - ADDENDUM
- B A Chronology of the National Heart, Lung, and Blood Institute Artificial Heart Program and Related Events
- C Technological Opportunities and Barriers in the Development of Mechanical Circulatory Support Systems
  - CURRENT STATE OF THE TECHNOLOGY IN MECHANICAL CIRCULATORY SUPPORT SYSTEMS
    - Short-Term-Use Devices (fewer than 180 days)
      - Total Artificial Heart
        Animal and Clinical Results
        Technological Development of Pneumatic Total Artificial Hearts
      - Univentricular or Biventricular Assist Devices
        Pulsatile Devices (Sac/Diaphragm)
        Steady-Flow Devices
      - Summary
    - Permanent or Long-Term-Use Mechanical Circulatory Support Systems (more than 180 days)
      - Unilateral Assist Devices
        In Vitro and In Vivo Test Results
      - Permanent Total Artificial Hearts
        University of Utah System
        Nimbus/Cleveland Clinic System
        ABIOMED/Texas Heart System
        Pennsylvania State University System
        Non-U.S. Systems
      - Summary
  - CURRENT TECHNOLOGICAL BARRIERS TO DEVELOPMENT OF A SUCCESSFUL MECHANICAL CIRCULATORY SUPPORT SYSTEM
    - What Is a Successful MCSS?
      - Short-Term Devices (fewer than 180 days)
      - Long-Term Devices (more than 180 days)
    - Performance and Reliability
      - Energy Sources
        Batteries
        Transcutaneous Energy Transmission System
      - Energy Converters
        Electric Motor-Driven Converters
        Thermal Heat-Cycle Energy Converters
      - Blood Pumps
        Sac/Diaphragm
        Valves
      - Thrombosis
      - Sepsis
      - Hemolysis
      - Calcification
      - Materials
      - Controls and Electronics
      - Bleeding
  - EFFECTS OF NEW OR EMERGING TECHNOLOGIES ON IMPROVEMENT IN MECHANICAL CIRCULATORY SUPPORT SYSTEMS
    - Materials Development
      - New Plastics and Polymers
        Surface Modifications
      - Improved Metals, Ceramics, and Composites
        Improved Metals
        Surface Treatments
        New Ceramics
        New Composites
    - Electronics Development
      - New Power Devices
      - New Microprocessors
      - Hall Effect Devices
      - Room-Temperature Superconductors
    - Magnetic Materials
    - Supercomputers
      - Computational Fluid Dynamics
      - Numerical Analysis Techniques
    - Summary
  - SPIN-OFF TECHNOLOGIES
    - Materials and Design
      - Grafts
      - Valves
      - Biomaterials
      - Biosensors
      - Battery Technology
      - Drug Actions
      - Development of Transcutaneous Energy Transmission Systems
  - SUMMARY
    - Current Status of Mechanical Circulatory Support Systems
      - Short-Term Devices
      - Long-Term Mechanical Circulatory Support Devices
      - Long-Term Implantable Total Artificial Hearts
    - Prospects for the Future of Mechanical Circulatory Support Systems
      - Three to Five Years
      - Five to Ten Years
      - Ten to Thirty Years
  - REFERENCES
- D Epidemiology of End-Stage Heart Disease
  - PRIMARY GROUP: CURRENT STATUS
  - PRIMARY GROUP: FUTURE PROJECTIONS
  - SECONDARY GROUP
    - Congestive Heart Failure
    - Coronary Heart Disease
  - INTERNATIONAL DATA
  - CONCLUSIONS
  - REFERENCES
- E Assessing the Cost-Effectiveness of Development and Use of the Total Artificial Heart
  - BACKGROUND
  - ESTIMATING THE COST-EFFECTIVENESS OF THE ARTIFICIAL HEART IN ROUTINE USE
    - Approach
    - Structure of the Model
    - Parameter Estimates
    - Base Case
    - Sensitivity Analyses
  - COST-EFFECTIVENESS OF TAH RESEARCH AND DEVELOPMENT
    - Description of Scenarios
    - Results
    - Sensitivity Analyses
  - CONCLUSION: MAJOR FINDINGS AND LIMITATIONS
- REFERENCES
Glossary
Index