The artificial heart : prototypes, policies, and patients / Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute, Division of Health Care Services, Institute of Medicine ; John R. Hogness and Malin VanAntwerp, editors.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.). Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute.

Contributor:

Hogness, John R.

VanAntwerp, Malin.

National Heart, Lung, and Blood Institute.

Language:

English

Subjects (All):

National Heart and Lung Institute. Artificial Heart Program.

National Heart and Lung Institute.

Heart, Artificial.

Physical Description:

1 online resource (312 pages)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1991.

Language Note:

English

Summary:

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.

Contents:

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

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

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

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

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

The Borderline Cost-Effectiveness of Artificial Heart Use

Using Cost-Effectiveness to Decide Funding Levels

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

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

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

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

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

Posttrial Follow-up

Fostering Collaborative Interdisciplinary Research

Patients' Quality of Life and Treatment Preferences

Research Needs

Heart Failure 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

CURRENT TECHNOLOGICAL BARRIERS TO DEVELOPMENT OF A SUCCESSFUL MECHANICAL CIRCULATORY SUPPORT SYSTEM

What Is a Successful MCSS?.

Short-Term Devices (fewer than 180 days).

Notes:

"Support for this project was provided by the National Institutes of Health, National Heart, Lung, and Blood Institute, pursuant to contract no. NO1-HO-09008"--T.p. verso.

Includes bibliographical references and index.

ISBN:

9786610203642

9781280203640

1280203641

9780309556002

0309556007

9780585020051

0585020051

OCLC:

42328749