Index
A
ABIOMED BVS System 5000, 217–218
ABIOMED/Texas Heart Institute total artificial heart, 29, 223–226
Access to health care.
See Patient access
Advance directives, 146–147
Agency for Health Care Policy and Research (AHCPR), 124, 125, 129, 178
Animal trials
survival rates in, 211–212
using total artificial hearts, 213–214
using ventricular assist devices, 217–220
Appropriate use
committee conclusions and recommendations concerning, 177–178
of mechanical circulatory support systems, 7–9, 122, 123, 125–131, 133, 177–178
of medical treatment, 127
of resources, 139
of technology, 122–124, 177–178
Artificial heart program.
See also Total artificial hearts (TAHs)
financial support needed for, 39–40
industrial-policy considerations of, 156–158
industry support and communication among researchers and, 168–170
interdisciplinary and industry-academe collaboration and, 163–168
questions generated by, 151
social benefits of, 155
Automatic implantable cardioverter defibrillator (AICD), 96–97, 161
B
Baxter Healthcare Corporation.
See Novacor Division
Biocompatibility
with pneumatic artificial heart, 216
with ventricular assist devices, 219
Biomaterials
limitations of current, 37
Biomedical engineering research, 163–165
Biomedical technology, 164
Biosensors, 242
Biventricular support, 78–79
Blood pumps, 232–234
C
Cardiomyoplasty, 36
Centrifugal external VADs, 27, 220
Class III medical devices, 62–63
Clinical effectiveness
of heart transplantation, 4, 65, 66, 266, 267
of mechanical circulatory support systems, 3–4, 65–73, 69–71, 175, 181–182
Clinical trials.
See also Novacor VAD
committee conclusions and recommendations regarding, 192–194
follow-up studies for, 129, 193–194
and quality-of-life considerations, 98–101
role of industry in, 158
status of, 14
with total artificial hearts, 213–214
use of, 29
with ventricular assist devices, 17, 217–220
Collaborative research
biomedical engineering research and, 164–165
committee conclusions and recommendations regarding, 167–168, 194–195
current examples of, 166–167
encouragement of, 163
Committee conclusions and recommendations regarding
appropriate use of mechanical circulatory support systems, 177–178
clinical and cost-effectiveness, 181–183
clinical trials and patient follow-up, 192–194
collaborative interdisciplinary research, 194–195
communication among researchers, 196
development of total artificial hearts, 12, 186–190
development of ventricular assist devices, 12–13, 158, 190–192
device research and development, 3, 10–11, 13, 63, 184, 186–190
patient access, 178–180
patients' quality of life and treatment preferences, 195
regulatory decisions for new technologies, 184–185
research on end-stage heart disease, 13, 82, 195–196
third-party payers, 185–186
Communication, among researchers, 168–169
Comorbidities
in end-stage heart disease patients, 70–71, 80
patient projections by presence of, 70–71, 252–254
Complete technologies, 136n
Congestive heart failure (CHF).
See also Heart failure
deaths from, 251–253
prevalence of, 257–258
quality of life of patients with, 95, 99
Congress, U.S., technology use and, 124, 125
Converters
electric motor-driven, 230–231
thermal heat-cycle energy, 231–232
Coronary heart disease (CHD)
deaths from, 253–255
explanation of, 15–16
prevalence of, 258
rate and prevention of, 71–72
Cost-benefit analysis (CBA)
capabilities and limitations of, 108–109
explanation of, 107–108
Cost-effectiveness
and appropriate use of resources, 139
committee recommendations and conclusions regarding, 182–183
further investment decisions and role of, 176
R&D decisions and anticipated, 45–48, 53–55, 115–117
of total artificial hearts, 6–7, 12, 109–114, 116–117, 175–176, 182–183, 262–283
of ventricular assist devices, 114, 182–183
Cost-effectiveness analysis (CEA)
to address moral and ethical concerns, 140
capabilities and limitations of, 108–109
and domains for utility assessment, 90–92
to examine mechanical circulatory support systems, 6–7, 45–46
explanation of, 107–108
in research funding decisions, 45–48, 115–117
role of health state utilities in, 88
and technology assessment, 127
for total artificial hearts, 109–114, 116–117, 262–283
in trials or studies, 99
Cost-effectiveness (C/E) ratios.
See also Cost-effectiveness analysis (CEA)
estimates used for, 11–12
evaluation of, 6–7, 112–114, 187–188
for heart disease treatments, 111–114, 274, 275
of R&D investments, 60–61
Costs.
See Health care costs
Credentialing guidelines, for technology use, 129–130
D
Death.
See also Mortality rates;
Survival rates
fear of, 93–94
Decision-making criteria, 51–60
advancement of knowledge, 54
beneficiary demographics, 56–57
concern about technology misapplication, 59
detailed evaluation of, 61–62
ethical considerations, 57
existing R&D support, 58
halfway vs. high technology, 57–58
health and life expectancy gains, 51–52
impact on health care costs, 55–56
impact on patients' families, 56
impact on U.S. global standing, 59–60
implementation time, 58
likelihood of R&D success, 53
nonfinancial impact on health care system, 56
number of persons benefited, 52–53
private-sector R&D support, 59
and protection of individual patient, 147, 148
relevance to NHLBI mission, 54–55
Design limitations, 37
Discount rates, 108, 268, 271–273, 278–281
Distributive justice issues, 136–139, 142–145
Donor heart supply, 36, 75, 76, 263
Durable power of attorney, 146–147
E
Elderly patients, expectations of treatment by, 95
End-stage heart disease.
See also Congestive heart failure (CHF);
Heart disease;
Heart failure
causes of, 1
cost-effectiveness of treatment to prevent, 114
epidemiological study of, 68, 74–77, 251–260
explanation of, 15–17
prevention of, 5
research needs regarding, 13, 80, 195
technologies for preventing and treating, 34–37, 66, 174–175.
See also Heart transplantation;
Medical treatment
End-stage heart disease patients
preference for life-sustaining treatment of, 73
projected mechanical circulatory support systems, need for, 4–5, 52–53, 73–74, 81, 157, 252–260
quality of life for, 86, 88, 90–102
See also Quality of life
Ethical issues
age of recipient and, 144
for mechanical circulatory support system implantation, 10
raised by incomplete technologies, 136–139
F
Family members and friends, 56, 85–86, 90
Federal Coordinating Council for Science, Engineering, and Technology (FCCSET), 168
Federal government
industrial policy and, 156–158
research and development support by, 39, 40, 152–154, 176
role in support for artificial heart program, 39–40, 152–154, 158–159
role in use of medical technology, 159–163
Food and Drug Administration (FDA)
classification of devices by, 62
committee recommendations regarding, 185
investigational device exemption (IDE), 27, 28
postmarketing surveillance requirem ents of, 193
projected ventricular assist device approval by, 75
regulatory activities of, 11, 160, 184
withdrawal of Symbion device approval by, 214–215
Funding.
See Industry research and development (R&D) funds;
Research and development (R&D);
Research and development (R&D) funding decisions
H
Halfway technology, 57–58
Health care
access to.
See Patient access
economics of, 159
maximizing benefits in provision of, 139–141
racial variations in access to, 140–141
Health care costs
for device implantation, 2
impact of R&D decisions on, 55–56
technology use and, 123
Health Care Financing Administration (HCFA), 161–163
Health care policy, access to mechanical circulatory support systems and, 9, 144–145, 149, 178–180
Health-related quality of life, 89–90.
See also Quality of life
Health state utilities, 88
Health states, 119–120
Health status, R&D funding and, 155
Heart
Heart disease.
See also End-stage heart disease;
Heart failure
cost-effectiveness ratios for various treatments of, 112, 113
deaths from, 251–253
international data regarding, 258–259
research needs concerning, 80–81
Heart failure.
See also Congestive heart failure (CHF);
End-stage heart disease
research concerning, 13, 80, 195
treatment of, 16–17, 34–36, 65
Heart transplantation
clinical effectiveness of, 4, 65, 66, 266, 267
cost-effectiveness of, 109–111
following use of mechanical circulatory support systems, 32–33
mechanical circulatory support systems vs., 36–37, 66, 68, 236–237
rate of, 75
suppy of donor hearts for, 36, 75, 76, 263
as treatment of choice, 79
Heart transplantation patients
quality of life for, 95–96
survival rates for, 17, 110, 228–229, 269–270
Hershey heart.
See Pennsylvania State University/Sarns–3M TAH
High technology, halfway vs., 57–58
Hospital charges, estimates for ventricular assist device and total artificial heart implant, 2
Hospital discharge data, 256
I
Implantation costs, estimates for ventricular assist device and total artificial heart, 2, 267–268, 283
In vitro device readiness testing, 29.
See also Bench testing
Incomplete technology, 135, 136, 141–142
Industry
effect of involvement on communication among researchers, 168–169
effect of regulaton of new technology on, 159
federal government and role of private, 157–159
role in mechanical circulatory support systems R&D, 176
Industry research and development (R&D) funds
decision criteria for, 62–63
extent of, 158
Informed consent, 146–148
Innovative process stages, 38
Institute of Medicine (IOM) study
focus of, 173–177
history and methods of, 1, 3, 24, 201–203
use of, 196–197
International trade considerations, 157–158, 189
Intra-aortic balloon pump, 35–36
Investigational device exemption (IDE), 27, 28, 160, 215, 243
J
Jarvik TAH, 20, 30, 87, 213, 214, 216
Judgment-based decision making, 45–47
L
Left ventricular assist device (LVAD), 78
Life expectancy
effect of early intervention on, 114
for heart transplantation patients, 110
Life-sustaining treatment
choice of, 94–95
patient preference for, 73
quality-of-life issues and, 96.
See also Quality of life
Limited resources model, 142
Living with Heart Failure Questionnaire (LHFQ), 99
Long-term mechanical circulatory support systems (MCSSs).
See also Mechanical circulatory support systems (MCSSs)
barriers to development of successful, 228–229
current state of technology of, 221–227, 243–244
development of, 28–29
health care coverage for, 180.
See also Patient access
implications of, 34
transplantation vs., 36–37, 66, 68
Long-term total artificial hearts (TAHs).
See also Total artificial hearts (TAHs)
current state of technology of, 222–227, 244
use of, 28–29
Long-term ventricular assist devices (VADs).
See also Ventricular assist devices (VADs)
current state of technology of, 221
types of, 29
use of, 29
Longevity, device, 32
M
Machine dependency, quality-of-life issues and, 93
Managed care, 124
Market failure theory, 152–153
Markov simulation model, 109, 263–265
Meaning and purpose of life, 93–94
Mechanical circulatory support system (MCSS) patients
clinical complications in, 32–34, 67, 69, 212, 216–217, 220, 233–235, 265–267
expectations of, 132
long-term care needs of, 8–9
projections of, 4–5, 73–77, 81, 174, 251–261
quality of life for, 5–6, 86, 94–102.
See also Quality of life
Mechanical circulatory support systems (MCSSs).
See also Artificial heart program;
Total artificial hearts (TAHs);
Ventricular assist devices (VADs)
appropriate use of, 7–9, 122, 123, 125–131, 133, 177–178
clinical effectiveness of, 3–4, 65–73, 69–71, 175, 181–182
clinical trials of.
See Clinical trials
cost-effectiveness of.
See Costeffectiveness;
Cost-effectiveness analysis (CEA)
current status of, 212–227, 243–245
development and use of, 1–2, 211–212
effects of new or emerging technologies on, 236–241
engineering assessment of, 29–32
ethical issues regarding, 135–150
heart transplantation vs., 36–37, 66, 68, 236–237
interdisciplinary and collaborative development of, 163–168
long-term.
See Long-term mechanical circulatory support systems (MCSSs)
mechanical failure of, 30–31
patient access to, 9–10, 178–180
patient need for, 4–5, 65, 67, 157
performance and reliability of, 69–70, 229–230
prospects for future of, 244–245
R&D expenditures for.
See Research and development (R&D);
Research and development (R&D) funding decisions
reliability of, 68–69
spin-off technologies from, 241–242
technology barriers to development of successful, 227–235
temporary use of.
See Temporary total artificial hearts (TAHs);
Temporary ventricular assist devices (VADs)
types of, 27–29
Medical technology
role of government in development of, 152–159
role of government in use of, 159–163
Medical Technology and Practice Patterns Institute (MTPPI), 161
Medical treatment, 17, 34–36, 65
appropriate use of, 127
cost-effectiveness of, 109–112, 114, 267, 270, 271
estimates of clinical parameters for, 266, 267
research concerning, 13, 80, 195
Medicare program
and access to new technologies, 180
coverage of high-cost technologies by, 130–131
impact of payment policies of, 160–161
role in practice guidelines, 126
Mortality rates.
See also Survival rates
current status of heart disease, 251–254
international, 259
projection of future, 254–255
Myocardial infarction (MI), 252–253, 258
N
NAS/NAE/IOM Government-University-Industry Research Roundtable, 168
National Heart, Lung, and Blood Institute (NHLBI), 1
artificial heart program of, 20–23, 131–132, 154–155, 201–203, 205–210
committee recommendation concerning decision making by, 184
committee recommendation to work with FDA on clinical trials, 185
policies governing cooperative relationships, 166–168
regulatory influence of, 148
types of decisions made by, 44, 45
National Hospital Discharge Survey, 256–258
National Science Foundation (NSF), 165
New York Heart Association, functional Class IV, 36n
NHLBI Cardiology Advisory Committee, 46
Nimbus/Cleveland Clinic TAH, 29, 213, 222–223
Novacor Division (Baxter Healthcare Corporation), 2, 14
Novacor VAD, 14, 29, 30, 217–218
design of, 18
trial use of, 14, 68, 160, 187, 189–190, 192
P
Pacemaker registries, 128
Patient access
clinically limited, 179–180
committee conclusions and recommendations regarding, 178–180
health care policy regarding, 9, 144–145, 149, 178–180
to incomplete technologies, 135–136, 141–142
to mechanical circulatory support systems, 9–10, 178–180
racial variations in, 140–141
third-party payers and, 144, 179, 180
to total artificial hearts, 144–145, 149
Patient registry, 128–129
Patients.
See End-stage heart disease patients;
Heart transplantation patients;
Mechanical circulatory support system (MCSS) patients
Peer review organizations (PROs), 124
Peer review process, for funding decisions, 10, 46, 184
Pennsylvania State University pneumatic artificial heart, 213, 243
Pennsylvania State University/Sarns–3M TAH, 27, 29, 225–226
Percutaneous transluminal coronary angioplasty, 128, 161–162
Performance characteristics, of mechanical circulatory support systems (MCSSs), 69–70
Pharmaceuticals, research and development costs for, 40
Pierce-Donachy device, 218
Pneumatic artificial hearts, 213–217
Postimplantation stage
aspects of care in, 97
costs of care, 2, 109–111, 135–136, 267–268
Postmarketing surveillance
committee conclusions and recommendations regarding, 193
of new technology, 127–129
Power of attorney, 146–147
Power sources
R&D involving alternative, 159
Practice guidelines, for technology use, 125–126
Premarket approval (PMA), 160
Prevalence data, for heart disease, 256–258
Prospective patients
primary group, 68, 74–76, 251–256
secondary group, 68, 76–77, 251, 256–258
Psychosocial functioning
in elderly patients, 95
in heart transplant patients, 96
in total artificial heart patients, 97–98
Q
Quality-adjusted life years (QALYs)
calculation of, 92
in cost-effectiveness analysis, 175–176, 271–275, 278–282
in R&D investment decisions, 60–61
Quality of care
assessment of, 87–88
definition of, 122
Quality of life
committee conclusions and recommendations regarding, 181–182, 195
cost-effectiveness and, 6, 270–271
determinants of, 72–73
and domains for utility assessment, 90–92
for end-stage heart disease patients, 86, 88, 90–102
health-related, 89–90
and machine dependence, 93
and meaning and purpose of life vs. fear of death, 93–94
and quality of care, 87–88
R
Race, variations in health care access and, 140–141
Registries, for mechanical circulatory support system patients, 8–9, 128–129
Regulatory activities
regarding new technologies, 11, 184
restraints on, 162–163
Research and development (R&D)
collaborative, 167–168.
See also Collaborative research
committee recommendations regarding, 13, 186–190
federal support for, 39, 40, 152–154
policy issues regarding, 10–11
private sector support of, 152–154.
See also Industry research and development (R&D) funds
Research and development (R&D) funding decisions
allocation issues in, 44–46, 176, 184
cost-effectiveness analysis used in, 45–48, 115–117, 183, 274, 276–283
judgment-based, 45–47
societal issues and, 137–139
by use of ranked criteria, 48–62.
See also Decision-making criteria
S
Sensitivity analysis
and cost-effectiveness of total artificial heart, 271–274
impact of use of, 112
and R&D funding, 116
Short-term mechanical circulatory support systems (MCSSs).
See Temporary total artificial hearts (TAHs);
Temporary ventricular assist devices (VADs)
Small Business Innovation Research (SBIR) program, 58, 156
Societal issues
costworthiness as, 101
incomplete technologies as, 136–139
total artificial hearts and, 145
Spiritual well-being, concept of, 94
Substantive justice, 140, 142, 143, 149
Surgical procedures
degrees of use of, 122
postmarketing surveillance and new, 127–128
Surgical treatment, for coronary artery disease, 16–17
Survival rates.
See also Mortality rates
animal, 211–214
for heart transplantation patients, 17, 110, 228–229, 269–270
for patients receiving medical management, 127
Symbion ventricular assist device, 218
Symbion/Jarvik TAH, 27, 213–216.
See also Jarvik TAH
T
TAHs.
See Total artificial hearts
Technology
access to incomplete, 141–142
application of spin-off, 54, 241–242
assessment of, 127
halfway versus high, 57–58
impact of new or emerging, 236–241
issues raised by incomplete, 136–142
regulation of, 159
Technology use
clinical practice guidelines for, 125–127, 131
credentialing for, 129–130
factors affecting future, 123
follow-up studies of, 129
limitations on, 124–125
participants involved in overseeing, 131–132
patient expectations regarding, 132
postmarketing surveillance for, 127–129
relationship between cost and, 123
resistance to, 123
selective medical coverage for, 130–131
Temporary total artificial hearts (TAHs)
barriers to development of successful, 227–228
current state of technology of, 212–213, 220–221, 243
types of, 27
Temporary ventricular assist devices (VADs)
barriers to development of successful, 227–228
current state of technology of, 217–221, 243
Thermedics (Thermo Cardiosystems) VAD, 29, 218
Third-party payers
access to health care via, 144, 179
committee conclusions and recommendations regarding, 185–186
establishment of adequate payment rate by, 163
impact of payment policies of, 160–161
implementation of practice guidelines by, 126
new technology coverage by, 9, 11, 124, 130–131
Total artificial heart (TAH) patients
informed consent for, 146–148
quality-of-life issues for, 97–98.
See also Quality of life
Total artificial hearts (TAHs).
See also Mechanical circulatory support systems (MCSSs)
animal and clinical results of, 213–214
clinical trials of.
See Clinical trials
committee conclusions and recommendations regarding development of , 10–12, 186–190
cost-effectiveness of, 6–7, 109–114, 116–117, 175–176, 262–283.
See also Cost-effectiveness;
Cost-effectiveness analysis (CEA)
criteria for use of, 144–145
estimates of clinical parameters for, 265–267
estimating patient need for, 4–5, 78–81, 157
heart transplantation versus, 236–237
quality-of-life issues and.
See also Quality of life
societal costs of use of, 145
state of technology for, 2, 37–38
survival rate estimates for, 269–270
temporary.
See Temporary total artificial hearts (TAHs)
ventricular assist devices versus, 78–80
Transcutaneous energy transmission systems (TETS), 229–230, 242
Transplantation.
See Heart transplantation
Treatment technologies.
See Heart transplantation;
Mechanical circulatory support systems (MCSSs);
Medical treatment;
Total artificial hearts (TAHs);
Ventricular assist devices (VADs)
U
United States
balance-of-trade considerations, 157–158, 189
as leader in health technology, 157
state of mechanical circulatory support systems in, 212
University of Perkinje heart, 213
University of Utah total artificial heart, 29, 222, 226
Utility assessment
domains for, 90–92
explanation of, 88
use of, 110–111
V
VADs.
See Ventricular assist devices
Ventricular assist devices (VADs).
See also Mechanical circulatory support systems (MCSSs)
clinical effectiveness of, 3–4, 181–182
clinical trials of, 17, 217–220
committee recommendations regarding development of, 12–13, 158, 190–192
cost-effectiveness of, 6–7, 114.
See also Cost-effectiveness;
Costeffectiveness analysis (CEA)
estimating patient need for, 4–5, 79, 81–82, 157
R&D costs for, 39–40, 157, 175.
See Research and development (R&D);
Research and development (R&D) funding decisions
temporary.
See Temporary ventricular assist devices (VADs)
total artificial heart versus, 78–80
