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

Age, and MCSS access, 74, 144

Agency for Health Care Policy and Research (AHCPR), 124, 125, 129, 178

Animal trials

survival rates in, 211–212

use of, 29, 160

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)

details of, 20–23, 151

financial support needed for, 39–40

goals of, 1, 164, 173–174

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

status of, 14–15, 154–155

Automatic implantable cardioverter defibrillator (AICD), 96–97, 161

B

Batteries, 31, 229, 242

Baxter Healthcare Corporation.

See Novacor Division

Bench testing, 29–30, 160



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The Artificial Heart: Prototypes, Policies, and Patients 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 Age, and MCSS access, 74, 144 Agency for Health Care Policy and Research (AHCPR), 124, 125, 129, 178 Animal trials survival rates in, 211–212 use of, 29, 160 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) details of, 20–23, 151 financial support needed for, 39–40 goals of, 1, 164, 173–174 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 status of, 14–15, 154–155 Automatic implantable cardioverter defibrillator (AICD), 96–97, 161 B Batteries, 31, 229, 242 Baxter Healthcare Corporation. See Novacor Division Bench testing, 29–30, 160

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The Artificial Heart: Prototypes, Policies, and Patients Biocompatibility with pneumatic artificial heart, 216 with ventricular assist devices, 219 Biomaterials development of, 32, 241 limitations of current, 37 Biomedical engineering research, 163–165 Biomedical technology, 164 Biosensors, 242 Biventricular support, 78–79 Blood pumps, 232–234 C Calcification, 217, 234 Cardiomyopathy, 17, 78, 254 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 artery bypass surgery, 112, 113, 121

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The Artificial Heart: Prototypes, Policies, and Patients 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 cost-effectiveness, 53–55, 58 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 Economic theory, 152–153, 155 Elderly patients, expectations of treatment by, 95

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The Artificial Heart: Prototypes, Policies, and Patients 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 comorbidities in, 70–71, 80 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 Energy sources, 31, 229–232 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 cultural symbolism attached to, 85, 87, 92, 93 functioning of, 15, 16

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The Artificial Heart: Prototypes, Policies, and Patients 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 explanation of, 5, 15 research concerning, 13, 80, 195 treatment of, 16–17, 34–36, 65 Heart transplantation clinical effectiveness of, 4, 65, 66, 266, 267 complications of, 37, 72, 110 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 Hemolysis, 217, 220, 234 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).

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The Artificial Heart: Prototypes, Policies, and Patients 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 registry of, 8–9, 128–129 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

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The Artificial Heart: Prototypes, Policies, and Patients 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 mission of, 54–55, 154 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 assessment of, 22, 220, 221 design of, 18 trial use of, 14, 68, 160, 187, 189–190, 192 P Pacemaker registries, 128 Patient access age and, 74, 144 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

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The Artificial Heart: Prototypes, Policies, and Patients 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 problems with, 31, 37 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 use of, 6, 12, 110, 111 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 costs of, 40, 157, 175 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 considerations in, 3, 15 cost-effectiveness analysis used in, 45–48, 115–117, 183, 274, 276–283 judgment-based, 45–47 quantified aids to, 45, 47–48 societal issues and, 137–139 by use of ranked criteria, 48–62. See also Decision-making criteria

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The Artificial Heart: Prototypes, Policies, and Patients S Sensitivity analysis and cost-effectiveness of total artificial heart, 271–274 impact of use of, 112 and R&D funding, 116 Sepsis, 216–217, 220, 234 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 appropriate, 122–124, 177–178 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 use of, 20, 26, 136 Temporary ventricular assist devices (VADs) barriers to development of successful, 227–228 current state of technology of, 217–221, 243 types of, 20, 27–28 use of, 20, 26, 37–38, 136 Thermal power, 31, 231–232 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

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The Artificial Heart: Prototypes, Policies, and Patients new technology coverage by, 9, 11, 124, 130–131 Thromboembolism, 32, 34 Thrombosis, 216, 220, 233 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) access to, 144–145, 149 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 description of, 1–2, 19–20 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 R&D costs of, 38–40, 175 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 Valves, problems with, 31, 37 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) description of, 1, 17–18 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 types of, 20, 27–29, 78, 217–220