The artificial heart : prototypes, policies, and patients

The artificial heart prototypes, policies, and patients

Detalles Bibliográficos
Autor principal: Institute of Medicine (U.S.).
Autores Corporativos: Institute of Medicine (U.S.). Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute (-), National Heart, Lung, and Blood Institute
Otros Autores: Hogness, John R. (-), VanAntwerp, Malin
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1991.
Edición:1st ed
Materias:
National Heart and Lung Institute. > Artificial Heart Program.
Heart, Artificial.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820323006719
Tabla de Contenidos:
  • 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).

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