the artificial heart: costs, risks, and benefits · ota background papersare documents containing...

The Artificial Heart: Costs, Risks, andBenefits

May 1982

NTIS order #PB82-239971

THE IMPLICATIONS OF

COST-EFFECTIVENESSANALYSIS OF

MEDICAL TECHNOLOGY

MAY 1982

BACKGROUND PAPER #2: CASE STUDIES OFMEDICAL TECHNOLOGIES

CASE STUDY #9: THE ARTIFICIAL HEART:COST, RISKS, AND BENEFITS

Deborah P. Lubeck, Ph. D.and

John P. Bunker, M.D.

Division of Health Services Research, Stanford UniversityStanford, Calif.

Contributors: Dennis Davidson, M. D.; Eugene Dong, M. D.; Michael Eliastam, M. D.;Dennis Florig, M. A.; Seth Foldy, M. D.; Margaret Marnell, R. N., M. A.;

Nancy Pfund, M. A.; Thomas Preston, M. D.; and Alice Whittemore, Ph.D.

OTA Background Papers are documents containing information that supplementsformal OTA assessments or is an outcome of internal exploratory planning and evalua-tion. The material is usually not of immediate policy interest such as is containedin an OTA Report or Technical Memorandum, nor does it present options for Con-gress to consider.

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b Office of Technology Assessment,+”-. Washington, D C 20510./, 4,, P YJ, ---,,, ,,,, ,,, ,.

Library of Congress Catalog Card Number 80-600161

For sale by the Superintendent of Documents,U.S. Government Printing Office, Washington, D.C. 20402

Foreword

This case study is one of 17 studies comprising Background Paper #2 for OTA’Sassessment, The Implications of Cost-Effectiveness Analysis of Medical Technology.That assessment analyzes the feasibility, implications, and value of using cost-effec-tiveness and cost-benefit analysis (CEA/CBA) in health care decisionmaking. The ma-jor, policy-oriented report of the assessment was published in August 1980. In additionto Background Paper #2, there are four other background papers being published inconjunction with the assessment: 1) a document which addresses methodologicalissues and reviews the CEA/CBA literature, published in September 1980; 2) a casestudy of the efficacy and cost-effectiveness of psychotherapy, published in October1980; 3) a case study of four common diagnostic X-ray procedures, published in April1982; and 4) a review of international experience in managing medical technology,published in October 1980. Another related report was published in September 1979: AReview of Selected Federal Vaccine and Immunization Policies.

The case studies in Background Paper #2: Case Studies of Medical Technologiesare being published individually. They were commissioned by OTA both to provideinformation on the specific technologies and to gain lessons that could be applied tothe broader policy aspects of the use of CEA/CBA. Several of the studies were specifi-cally requested by the Senate Committee on Finance.

Drafts of each case study were reviewed by OTA staff; by members of the ad-visory panel to the overall assessment, chaired by Dr. John Hogness; by members ofthe Health Program Advisory Committee, chaired by Dr. Frederick Robbins; and bynumerous other experts in clinical medicine, health policy, Government, and econom-ics. We are grateful for their assistance. However, responsibility for the case studies re-mains with the authors.

Director

Advisory Panel on The Implications ofCost= Effectiveness Analysis of Medical Technology

John R. Hogness, Panel ChairmanPresident, Association of Academic Health Centers

Stuart H. AltmanDeanFlorence Heller SchoolBrandeis University

James L. BenningtonChairmanDepartment of Anatomic Pathology and

Clinical LaboratoriesChildren’s Hospital of San Francisco

John D. ChaseAssociate Dean for Clinical AffairsUniversity of Washington School of Medicine

Joseph FletcherVisiting ScholarMedical EthicsSchool of MedicineUniversity of Virginia

Clark C. HavighurstProfessor of LawSchool of LawDuke University

Sheldon LeonardManagerRegulatory AffairsGeneral Electric Co.

Barbara J. McNeilDepartment of RadiologyPeter Bent Brigham Hospital

Robert H. MoserExecutive Vice PresidentAmerican College of Physicians

Frederick MostellerChairmanDepartment of BiostatisticsHarvard University

Robert M. SigmondAdvisor on Hospital AffairsBlue Cross and Blue Shield Associations

Jane Sisk WillemsVA ScholarVeterans Administration

OTA Staff for Background Paper #2

Joyce C. Lashof* and H. David Banta, **Health and Life Sciences

H. David Banta’ and Clyde J. Behney, **

Assistant Director, 07’ADivision

Health Program Manager

Clyde J. Behney, Project Director

Kerry Britten Kemp,*** EditorVirginia Cwalina, Research Assistant

Shirley Ann Gayheart, SecretaryNancy L. Kenney, Secretary

Martha Finney, **” Assistant Editor

Other Contr ibut ing Staf f

Bryan R. Luce Lawrence Miike Michael A. RiddioughLeonard Saxe Chester Strobel***

OTA Publishing Staff

John C. Holmes, Publishing Officer

John Bergling Kathie S. Boss Debra M. Datcher Joe Henson

*Until December 1981.● *From December 1981.

* ● *OTA contract personnel

Preface

This case study is one of 17 that compriseBackground Paper #2 to the OTA project on theImplications of Cost-Effectiveness Anlalysis ofMedical Technology * The overall project wasrequested by the Senate Committee on Laborand Human Resources. In all, 19 case studies oftechnological applications were commissionedas part of that project. Three of the 19 were spe-cifically requested by the Senate Committee onFinance: psychotherapy, which was issued sepa-rately as background Paper #3; diagnostic X-ray, issued as Background Paper #5; and respira-tory therapies. The other 16 case studies wereselected by OTA staff.

In order to select those 16 case studies, OTA,in consultation with the advisor-y panel to theoverall project, developed a set of selectioncriteria. Those criteria were designed to ensurethat

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as a group the case studies would provide:

examples of types of technologies by func-tion (preventive, diagnostic, therapeutic,and rehabilitative );examples of types of technologies by physi-cal nature (drugs, devices, and procedures);examples of technologies i n different stagesof development and diffusion (new, emerg-ing, and established);examples from different areas of medicine(such as general medical practice, pedi-atrics, radiology, and surgery);examples addressing medical problems thatare important because of their high fre-quency or significant impacts (such ascost ) ;examples of technologies with associateclhigh costs either because of high volume(for low-cost technologies) or high individ-ual costs ;examples that could provide informativematerial relating to the broader policy andmethtodological issues of cost-effectivenessor cost-benefit analysis (CEA/CBA); and

• examples with sufficient evaluable litera -ture.

On the basis of these criteria and recommen-dations by panel members and other experts,OTA staff selected the other case studies. These16 plus the respiratory therapy case study re-quested by the Finance Committee make up the17 studies in this background paper.

All case studies were commissioned by OTAand performed under contract by experts in aca-demia. They are authored studies. OTA sub-jected each case study to an extensive reviewprocess. Initial drafts of cases were reviewed byOTA staff and by members of the advisory

panel to the project. Comments were providedto uthors, along with OTA’S suggestions for-revisions. Subsequent drafts were sent by OTAto numerous experts for review nd comment.Each case was seen by at least 20, ad some by40 or more, outside reviewers. These reviewerswere from relevant Government agencies, pro-fessional societies, consumer and public interestgroups, medical practice, and academic med-icine. Academicians such as economists and de-cision analysts also reviewed the cases. In all,over 400 separate individuals or organizationsreviewed one or more case studies. Although allthese reviewers cannot be acknowledged indi-vidually, OTA is very grateful for- their com -ments and advice. In addition, the authors ofthe case studies themselves often sent drafts toreviewers and incorporated their comments.

These case studies are authored workscommissioned by OTA. The authors are re-sponsible for the conclusions of their spe-cific case study. These cases are not state-ments of official OTA position. OTA doesnot make recommendations or endorse par-ticular technologies. During the variousstages of the review and revision process,therefore, OTA encouraged the authors topresent balanced information and to recog-nize divergent points of view. In two cases,OTA decided that in order to more fullvpresent divergent views on particular techn-ologies a commentary should be added tothe case study. Thus, following the case

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studies on gastrointestinal endoscopy andon the Keyes technique for periodontal dis-ease, commentaries from experts in the ap-propriate health care specialty have beenincluded, followed by responses from theauthors.

The case studies were selected and designed tofulfill two functions. The first, and primary,purpose was to provide OTA with specific in-formation that could be used in formulatinggeneral conclusions regarding the feasibility andimplications of applying CEA/CBA in healthcare. By examining the 19 cases as a group andlooking for common problems or strengths inthe techniques of CEA/CBA, OTA was able tobetter analyze the potential contribution thatthese techniques might make to the managementof medical technologies and health care costsand quality. The second function of the caseswas to provide useful information on the spe-cific technologies covered. However, this wasnot the major intent of the cases, and t h e yshould not be regarded as complete and defini-tive studies of the individual technologies. Inmany instances, the case studies do represent ex-cellent reviews of the literature pertaining to thespecific technologies and as such can stand ontheir own as a useful contribution to the field. Ingeneral, though, the design and the fundinglevels of these case studies were such that theyshould be read primarily in the context of theoverall OTA project on CEA/CBA in healthcare.

Some of the case studies are formal CEAs orCBAs; most are not. Some are primarily con-cerned with analysis of costs; others are moreconcerned with analysis of efficacy or effec-tiveness. Some, such as the study on end-stagerenal disease, examine the role that formalanalysis of costs and benefits can play in policyformulation, Others, such as the one on breastcancer surgery, illustrate how influences otherthan costs can determine the patterns of use of atechnology. In other words, each looks at eval-uation of the costs and the benefits of medicaltechnologies from a slightly different perspec-

tive. The reader is encouraged to read this studyin the context of the overall assessment’s objec-tives in order to gain a feeling for the potentialrole that CEA/ CBA can or cannot play in healthcare and to better understand the difficulties andcomplexities involved in applying CEA/CBA tospecific medical technologies.

The 17 case studies comprising BackgroundPaper #2 (short titles) and their authors are:

Artificial Heart: Deborah P. Lubeck and John P.Bunker

Automated Multichannel Chemistry Analyzers:Milton C. Weinstein and Laurie A. Pearlman

Bone Marrow Transplants: Stuart O. Schweitz-er and C. C. Scalzi

Breast Cancer Surgery: Karen Schachter andDuncan Neuhauser

Cardiac Radionuclide Imaging: William B,Stason and Eric Fortess

Cervical Cancer Screening: Bryan R. LuceCimetidine and Peptic Ulcer Disease: Harvey V.

Fineberg and Laurie A. PearlmanColon Cancer Screening: David M. EddyCT Scanning: Judith L. WagnerElective Hysterectomy: Carol Korenbrot, Ann

B. Flood, Michael Higgins, Noralou Roos,and John P. Bunker

End-Stage Renal Disease: Richard A. RettigGastrointestinal Endoscopy: Jonathan A. Show-

stack and Steven A, SchroederNeonatal Intensive Care: Peter Budetti, Peggy

McManus, Nancy Barrand, and Lu AnnHeinen

Nurse Practitioners: Lauren LeRoy and SharonSolkowitz

Orthopedic Joint Prosthetic Implants: Judith D.Bentkover and Philip G. Drew

Periodontal Disease Interventions: Richard M,Scheffler and Sheldon Rovin

Selected Respiratory Therapies: Richard M.Scheffler and Morgan Delaney

These studies will be available for sale by theSuperintendent of Documents, U.S. Govern-ment Printing Office, Washington, D.C. 20402.Call OTA’s Publishing Office (224-8996) foravailability and ordering information.

,’ 111

Case Study #9

The Artificial Heart:Cost, Risks, and Benefits

Deborah P. Lubeck, Ph. D.

and


Division of Health Services ResearchStanford University

Stanford, Calif.

AUTHORS’ ACKNOWLEDGMENTS

We would like to express our thanks to the following individuals who respondedto our requests for interviews and information on economic and technological aspectsof the artificial heart: Yuki NOSé and Ray Kiraly of the Cleveland Clinic; Don Cole ofthe Department of Energy; Willem Kolff of the University of Utah; William Bernhardof Boston Children’s Hospital; Victor Poirier of Thermoelectron Corp.; John Moise ofAerojet General; Jack Chambers of Gould Measurement Systems; William Pierce ofPennsylvania State University, and John Norman of the Texas Heart Institute. DianaDutton, Allen Ream, and Ralph Silber of Stanford University read drafts of thematerial and provided valuable comments.

This work was carried out in conjunction with a grant entitled “Ethical Issues inBiomedical Decision-Making: Four Cases Studies” (Diana B. Dutton, principal in-vestigator) from the National Science Foundation under their program in Ethics andValues in Science and Technology.

ContentsPage

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3History of the Artificial Heart. . . . . . . . . . . . . . . . . 4Pool of Potential Recipients in the United States. 5

Sources of Candidates.. . . . . . . . . . . . . . . . . . . . 5Estimates of Potential Candidates in the

United States, 1979. . . . . . . . . . . . . . . . . . . . . . 6Patient Access to Implant Hospitals and

Patient Refusal . . . . . . . . . . . . . . . . . . . . . . . . . 8Economic Aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Artificial Cardiac Pacemaker. . . . . . . . . . . . . . . 8Coronary Artery Bypass Grafts. . . . . . . . . . . . . 9Heart Transplants . . . . . . . . . . . . . . . . . . . . . . . . . 9Device Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Summary of Costs . . . . . . . . . . . . . . . . . . . . . . . . 11Personnel and Facilities. . . . . . . . . . . . . . . . . . . . 12R&D Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Parallel Costs of Hemodialysis . . . . . . . . . . . . . . . . 16Estimates of the Potential Success of the

Artificial Heart . . . . . . . . . . . . . . . . . . . . . . . . . 18LVAD Research and Clinical Trials. . . . . . . . . . 18Instrument Reliability . . . . . . . . . . . . . . . . . . . . . 20

Quality of Life Parameters. . . . . . . . . . . . . . . . . . . 21Hemodialysis and Kidney Transplants. . . . . . . 21Cardiac Transplants. . . . . . . . . . . . . . . . . . . . . . . 22Problems of a Nuclear-Powered Heart . . . . . . . . 22Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Social Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Extension of Life. . . . . . . . . . . . . . . . . . . . . . . . . . 24Return to Work. . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Social Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Increased Social Expenditures. . . . . . . . . . . . . . . 29Distributional Issues. . . . . . . . . . . . . . . . . . . . . . . 31Social Costs of a Nuclear Device.. . . . . . . . . . . 31Opportunity Costs. . . . . . . . . . . . . . . . . . . . . . . . 31

Cardiac Disease Prevention . . . . . . . . . . . . . . . . . . . 32Policy Recommendations. . . . . . . . . . . . . . . . . . . . 35

Program Administration . . . . . . . . . . . . . . . . . . . 35Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Reimbursement and Distribution . . . . . . . . . . . . 37

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Appendix A: The Artificial Cardiac Pacemaker. . 41Appendix B: Cardiac Transplant Costs . . . . . . . . . 44Appendix C: NHLBI R&D Contracts and Grants. 45Appendix D: Stanford Heart Disease

Prevention Program Materials . . . . . . . . . . . . . . 90References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

LIST OF TABLES

Table No. Page1. Three Estimates of Major Items of Expense

Associated With Artificial HeartImplantation and Use. . . . . . . . . . . . . . . . . . . . 11

2. Effect of Numbers of Implants unavailableSocietal Resources . . . . . . . . . . . . . . . . . . . . . . . 12

Table No. Page3. NHLBI Devices and Technology Branch -

4.

5.

6.

7.

8.

9.

10.11.

12.

13.

14.A-1. Pacemaker Longevity Excluding Causesof

B-1.

B-2.

D-1.D-2.

Contract Funding, Fiscal Year;-1964-79. . . . . 14Financial History of the Artificial HeartProgram at the Department of Energy, . . . . . . 15Estimated Annual Costs for the ESRDProgram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Fraction of Those With IHD in Each AgeInterval That Gets the Device—Best and Worst Case. . . . . . . . . . . . . . . . . . . . . 25Proportion of Those Obtaining the DeviceThat Dies Due to Device Failure atSubsequent Ages-Best Case. . . . . . . . . . . . . . 26Proportion of Those Obtaining the DeviceThat Dies Due to Device Failure atSubsequent Ages-Worst Case. . . . . . . . . . . . 26Age-Specific Death Rates Due to AllCauses, 1977..... . . . . . . . . . . . . . . . . . . . . . . . 26Age-Specific Death Rates Due to IHD,1977. . 26Increase in Life Expectancy in Years forRandomly Selected Individuals ofSpecified Ages Who Mayor May NotDevelop IHD—Best and Worst Case. . . . . . . . 27Increase in Life Expectancy in Years forIndividuals of Specified Ages Who WillUltimately Develop IHD—Best andWorst Case..... . . . . . . . . . . . . . . . . . . . . . . . . 27Projected S-Year Sequence of TotalNational Expenditures on Artificial HeartImplantation and Patient Maintenance. . . . . . 30SHDPP Expenses by Media Campaign.. . . . . 34

D-3.

D-4,

Failure Other Than Battery Exhaustion. . . . 41Cardiac Transplant Hospitalization Costs,1969-75 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Cardiac Transplant Outpatient Costs,1969-75 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44SHDPP Three-Community Study Design.. 90Demographic Characteristics and SurveyResponse Rates in Each of the ThreeCommunities . . . . . . . . . . . . . . . . . . . . . . . . . . 90Risk Indicator and Knowledge Sources:Percentage Change From Baseline at l, 2,and 3 Follow up Surveys. . . . . . . . . . . . . . . . . 91SHDPP Expenses By Media Campaign . . . . . 91

LIST OF FIGURES

Figure No, Pagel. Comparative Program Growth: NIH,

NHLBI, and the Artificial Heart Program,Fiscal Years 1964-75. . . . . . . . . . . . . . . . . . . . . . . 14

2. Percentage Change in Risk of CHD After 1and 2 Years of Health Education in VariousStudy Groups From Three Communities. . . . . 33

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Case Study #9:

The Artificial Heart:Cost, Risks, and Benefits

Deborah P. Lubeck, Ph. D.

and


Division of Health Services ResearchStanford University

Stanford, Cal if.

INTRODUCTION

Current medical technology is often the resultof a convergence of clinical research and practicewith modern engineering. Advances in electron-ics, synthetic materials, pharmaceutical devel-opment, instrumentation, and computation re-sult in important applications in diagnosis,therapy, and rehabilitation. The artificial heartprogram is an example of this convergence.

Cardiovascular diseases are still the leadingcause of death in the United States. According tothe National Center for Health Statistics, heartattacks and strokes—the most lethal and well-known manifestations of cardiovascular disease—claim over 700,000 victims each year. In an ef-fort to prevent some of the deaths, the NationalHeart Advisory Council in 1963 recommended along-range program of research to develop apermanently implantable artificial heart thatcould be used to replace a failing natural heart.

At the time, there was considerable optimismthat the successful development of a permanent-ly implantable artificial heart would provide ameans of treating serious cardiac disease byIWO, well before biomedical advances were ex-pected to produce appropriate preventive treat-ment (42). The success of cardiac pacemakers,hemodialysis, and prosthetic joint replacementunderscored that optimism.

Today, after 15 years and over $180 million inFederal expenditures, * however, a total implant-able artificial heart is still a distant goal. Thiscase study, discusses the potential societal bene-fits, costs, and risks of continued investment inthis medical innovation. Many of our estimatesand forecasts are hampered by the fact that verylittle research is directed toward the nature oftechnical change in medicine and the supply sideof medical technology. We hope this case studypoints to some useful areas of further researchon the relationship of public policy to thedevelopment of new medical technologies. At aminimum, an assessment of the artificial heartprogram provides an opportunity to addresspolicy questions concerning the distribution ofresearch funds for treating heart disease, theequitable distribution of medical technology,and the potential costs to society before this life-saving technology is available for therapeuticuse.

● These Federal expenditures include $134 million in NationalHeart, Lung, and Blood Institute (NHLBI) contracts, approximate-ly $30 million in NHLBI grants, and $17 million in Department ofEnergy (DOE) funding.

4 ● Background Paper #2. Case Stud/es of Medical Technologies

HISTORY OF THE ARTIFICIAL HEART

The artificial heart program was created at theNational Heart Institute with special congres-sional approval in 1963. Its ultimate goal is todevelop a totally implantable mechanical heart—including an implantable power source—which can be used to replace a failing naturalheart. Since 1964, the program has had a succes-sion of organizational names: ArtificialHeart/Myocardial Infarction Program, MedicalDevices Application Branch (1970), Division ofTechnological Applications (1972), and Cardio-vascular Devices Branch (1973) of the NationalHeart and Lung Institute. The program is cur-rently administered by the Devices and Technol-ogy Branch (1974), of the Division of Heart andVascular Diseases, of the National Heart, Lung,and Blood Institute (NHLBI).

The effort to construct heart prostheses fol-lowed naturally from the successful design ofheart-lung pumps that could be used duringopen-heart surgery to assume (for short periodsonly) the functions of both the heart and lung.Many medical and technical advances suggestedthe feasibility of heart replacement: the implan-tation of artificial heart valves, the developmentand widespread use of cardiac pacemakers, in-creasingly successful blood dialysis as amechanical replacement for kidney function,and the achievement of kidney transplants inhumans and heart transplants in animals. Thesuccess of the aforementioned surgical tech-niques demonstrated the possibility of prostheticreplacement, while the immunological rejectionand shortage of donors associated with thetransplants helped demonstrate the need for amechanical heart. Other notable technologicalachievements included the revolution in mini-aturized engineering stimulated by the spaceprogram, advances in energy technologies (e.g.,the plutonium heat engine), and the develop-ment of synthetic materials (e.g., teflon andlycra) with outstanding engineering specifica-tions for wear and flexibility (45).

These developments helped set the stage forthe construction of prototype hearts by anumber of investigators—Adrian Kantrowitz,Michael DeBakey, and Willem Kolff. Much of

the earliest work on the artificial heart was car-ried out, without Federal sponsorship, in aca-demic and research centers.

The search for the large capital outlay neces-sary to finance the initial R&D for the artificialheart was given impetus by nature of the med-ical and engineering problems that were encoun-tered: finding hemocompatible materials able towithstand continual wear and flexion, finding apower supply, and developing sophisticatedminiaturized control systems. The magnitude ofthese problems discouraged independentdevelopment and created a demand for Govern-ment involvement.

The artificial heart program was launched in aperiod of both economic growth and great faithin the powers of science and technology. Heartresearchers, such as Michael DeBakey of BaylorUniversity, were enthusiastic about developingan artificial heart and were optimistic that a suc-cessful device might take as few as 3 years but nomore than 10 years to achieve. By early 1965,there was a 5-year plan for achieving the arti-ficial heart: roughly 1 year to assess the “state ofthe art,” 1 year to design, test, and develop thesystem, 2 years to develop heart prototypes, and1 year to test the model and determine standardsfor mass production (40).

It was widely believed that the approach tothe space race (i.e., systems analysis) could beused as a model for organizing technologicalprojects like the artificial heart. A similar ap-proach, including a built-in rivalry among scien-tists, was therefore adopted by the NationalHeart Institute. Several researchers worked onparallel development of the separate subsystemsof the heart—energy systems, control systems,blood interface materials—that were to be re-integrated into a working device at a later time(33). The decision was also made, based on thesuccess of the space program, to use targetedcontracts to private firms to develop parts andmaterials for the device, rather than the morecommon research grant procedure (35). This tar-geted approach, reflecting the specificity of engi-neering, was based on the assumption that the

Case Study #9; The Artificial Heart: Cost, Risks, and Benefits ● 5

basic scientific knowledge necessary to developa device was available.

In the artificial heart program’s early years,rapid growth in resources—from $500,000 in1964 to $8 million in 1967—nurtured anticipa-tion of early clinical results. Technical dif-ficulties were greater than anticipated, however,and the basic knowledge necessary to design andproduce the needed components was not avail-able. There was no solution to two major techni-cal problems: developing hemocompatible bio-materials and a power source. Researchers todayare still attempting to perfect an inner surfacematerial for the artificial heart that will notcause adverse chemical reactions when in con-stant contact with blood, yet is sufficientlydurable to flex more than once a second over adecade without cracking or chipping (41,69). Acompact, long-lived, and reliable power sourcehas still not been developed; permanently im-planted nuclear energy sources, popular in the1960’s, have been given a diminished priority,and greater emphasis is now placed on electricalengines that require a continuous energy supplyor recharging.

In 1974, in response to these problems, the ar-tificial heart program was moved into NHLBI’sDivision of Heart and Vascular Diseases. Thereit developed a more narrow focus, with an em-phasis on the development of circulatory-assistdevices that would augment the left ventricle ofthe heart by pumping blood from the left ventri-

cle to the aorta. In 1975, authorization wasgiven to begin clinical trials of a left-ventricular-assist device (LVAD) to be used temporarily inpatients unable to resume cardiac function at thecompletion of open-heart surgery. Clinical trialsfor a 2-year implantable LVAD are expected tobegin in an estimated 3 to 5 years. Targeted ef-forts beyond that include the development of a5-year implantable LVAD and electrically ener-gized engines. Researchers see the longer termimplantable LVAD as a significant step, possiblya decade away. *

Parallel work on totally implantable artificialhearts is still continuing. Willem Kolff, at theUniversity of Utah, has a number of calves inwhich his prototype heart has been successfullyimplanted. Nevertheless, the power source for atotally implantable artificial heart remains acontinuing source of concern. Kolff’s calves areon air-driven pumps, tethered to the wall; otherprototypes require that an external battery-packpower an implanted motor. Estimates as to

when a totally implantable artificial heartsystem capable of long-term support will beachieved are uncertain. The most commonforecast is “many years away. ” Since theachievement of a totally implantable artificialheart depends on significant advances in basicknowledge and in bioengineering, it remainstoday a distant goal.

*LVAD research and clinical trials are discussed at greaterlength in a separate section of this case study.

POOL OF POTENTIAL RECIPIENTS IN THE UNITED STATES

Sources of Candidates 10

The authors of this case study assume that inorder to be a candidate for heart replacement, a 2.person must be in the hospital, with death immi-nent or highly probable, and must survive for 1 3.hour after the “replacement” decision is made(i.e., the amount of time needed to set up theoperating room and get the patient on cardiopul-monary bypass). .

survivors of recent myocardial infarction(heart attack) and/or cardiac arrest withworsening course,persons with worsening chronic severeheart disease, andpersons having open-heart surgery whoseheart after surgery is unable to reassumethe hemodynamic load from the cardiopul-monary bypass pump.

order to be candidates, persons in the firstinThe following three groups are sources of group would have to survive their attack or car-. . . . .potential candidates: diac arrest through the following phases: home/

6 ● Background paper #2: Case Studies of Medical Technologies

work (attack and replacement decision times),transportation to hospital, treatment in theemergency room, and initial stabilization in thecoronary care unit. Candidates in the first andsecond groups would be primarily patients withischemic heart disease (IHD), but would also in-clude some patients with rheumatic heart disease(RHD).

The second group would include, in addition,persons with severe cardiomyopathy (heartmuscle disease) which has rendered the heart in-capable of supporting the body’s needs at anylevel of exertion above absolute rest, and per-sons with severe electrical instability of the heartwhich has been refractory to treatment withmedication. These individuals, we assume,would have to survive at least 1 hour of hospi-talization in order to be candidates.

The third group would consist of personswhose heart is unable to reassume the body’shemodynamic load after the heart has been me-chanically bypassed during open-heart surgery.Such surgery includes operations for coronaryartery bypass, cardiac valve replacement, andcardiac muscle resection in hearts with severemechanical or electrical dysfunction.

Our estimates of the number of potential re-cipients of an artificial heart are presentedbelow. These estimates are based on informationavailable from the Ad Hoc Task Force on Car-diacture

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Replacement in 1969 (1) and recent litera-regarding the following:

the percentage of persons experiencingmyocardial infarction or cardiac arrest whodie:—at home or work,—during transportation by mobile cor-

onary units,—in emergency rooms, or—during stabilization in coronary care

units;the distribution of “mobile coronary units”(i.e., urban v. rural);the total number and distribution of cardiacdeaths per year; andthe prevalence of severe, irreversible, po-tentially lethal noncardiac diseases in can-

didates (we assume no change from the1969 task force estimate of 262/1,000).

We differ from the 1969 task force as follows:

●

●

We do not consider that a patient’s priorknowledge of cardiac disease alters the pat-tern of patient delays in seeking medical as-sistance, nor that it alters the candidacystatus once a patient has been hospitalized.We do not concur with the task force’s cate-gory of “unexpected” deaths, neither withthe numerical estimates of such deaths norwith the significance attributed to them. Webelieve that cardiac deaths can be consid-ered “instantaneous” (occurring in less than1 to 2 minutes) or “sudden” (occurring inless than 1 hour). The 1969 estimate of 42percent (98/233) “unexpected” deaths seemsunreasonably high for “instantaneous”deaths.

Further, the 1969 report does not appearto exclude all persons who die within 1 hourafter onset of symptoms. As noted earlier,at least 1 hour after the replacement deci-sion is made will be required to prepare theoperating room and the patient for heartreplacement. We consider that if the patientsurvives for 1 hour or more in a hospital(avoids “sudden death”), he or she becomesa potential recipient, as reflected in ourestimates below.

Finally, we assume that there will be no “elec-tive” replacements, i.e., there will be no implan-tation in patents who are stable under medicalmanagement, regardless of the severity of suchpatients’ disease. This consideration mightchange over time if the artificial heart provedhighly successful.

Estimates of Potential Candidates inthe United States, 1979

Group 1: Survivors of Recent MyocardialInfarction and/or Cardiac Arrest

Three separate sets of figures from the medicalliterature (23,44,61) are employed in our anal-ysis of the number of potential candidates

Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 7

among persons suffering acute myocardial in-farction and/or cardiac arrest. Therefore, wepresent three separate estimates below and thenuse these to arrive at a pooled estimate.

Estimate A

1. Myocardial infarctions/year. . .............700,000less those who survive uneventfully (50% ). –350,000less those who die before hospitalization

(25%) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . –175,000less those die “suddenly” in hospital (s%). . . –35,000

Subtotal . . . . . . . . . . . . . . . . . . . . . .........140,0002. Cardiac arrests/year. . . . . . . . . . . . . . . . . . . . . .300,000

less those who die “at home”. . . . . . . . . . . . . . –80,000less those who die before hospitalization. . . . –80,000less those who die in hospital. . . . . . . . . . . . . . –80,000less survivors (no mechanical damage

to heart). . . . . . . . . . . . . . . . . . . . . . . . . . . . . –60,000Subtotal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0

Total estimate A. . . . . . . . . . . . . . . . . . . . . 140,000

Estimate B

Seventy-five percent of all cardiac deathsare said to occur within 2 hours of symptomonset. Thus, 25 percent of deaths occur after 2hours; one-sixth of these deaths occur “with-out warning. ”

Cardiac deaths/year. . . . . . . . . . . . . . . . . . . . . . 684,000less 75% who die within 2 hours. . . . . . . . . . –513,000

171,000less 1/6 who die “without warning”. . . . . . . . –28,500

Total estimate B. . . . . . . . . . . . . . . . . . . . . ..142,500

Estimate C

Fifty percent of all cardiac deaths are said tobe “immediate” (time undefined). Of the rest,so percent die before hospitalization, andone-sixth die in the hospital “suddenly. ”

Cardiac deaths/year. . . . . . . . . . . . . . . . . . . . . . 684,000less 50% whose deaths are “immediate”. . . –342,000

342,000less 5070 who die before hospitalization. . ...171,000

171,000less 1/6 who die in hospital “suddenly”. . . . . –28,500

Total estimate C. . . . . . . . . . . . . . . . . . . . . ..142,500

Pooled Estimate

Thus, in group 1 we estimate 140,000 to142,500 candidates for artificial hearts. Theround figure of 140,000 will be used hereafter. *

Group 2: Persons With Worsening ChronicSevere Heart Disease

Patients with severe cardiomyopathy and pa-tients with severe electrical instability of theheart are also prone to die instantaneously or“suddenly.” The percentage of those personswho survive 2 or more hours in the hospital, yethave a worsening course, is estimated fromfigures at Stanford University Medical Center,which serves as a referral center for medical andsurgical treatment of patients in both categories.We estimate 11,000 such patients per year.

Group 3: Persons Who Are Unable to Come Offthe Cardiopulmonary Bypass Pump FollowingOpen-Heart Surgery

Patients undergoing open-heart surgery occa-sionally survive the surgery but are “unable tocome off the pump, “ i.e., the patient’s heart willnot reassume the hemodynamic load when atransfer is attempted from the artificial cardio-pulmonary bypass machinery.

Approximately 100,000 coronary bypassoperations are performed yearly, as well asother open-heart surgery. Of the patientsundergoing these procedures, we estimate thatno more than 1,000 patients a year would be“unable to come off the pump. ”

All Groups

By combining the estimates presented above,we estimate the total number of potential can-didates for artificial hearts to be 140,000 +

*The figures used in the three estimates presented for this groupof potential candidates are compatible with data recently collectedin the area of Miami, Fla., which as of 1979 had not yet been pub-lished in manuscript form.

&3 ● Background Paper #2: Case Studies of Medical Technologies

11,000 + 1,000 = 152,000. Applying the 262/1,000 estimated prevalence of severe, irreversi-ble noncardiac disease (1) that would excludepotential candidates from consideration, wehave 0.262 x 152,000 = 39,824, the latter beingthe number of candidates who would be ex-cluded. Their exclusion leaves 152,000 — 39,824= 112,176, or approximately 112,000 can-didates of all ages.

Maximum Age Considerations

According to the National Center for HealthStatistics (NCHS), the following percentages ofall cardiac deaths occur at the ages listed:

<80 years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75%<75 years. . . . . . . . . . . . . . . . . . . . . . ...........57.5< 70 years. . . . . . . . . . . . . . . . . . . . . . . . . . .......42<65 years. , , . . . . . . . . . . . . . . . . . . . . . . . .......30

From the application of cardiac deaths to the112,000 candidates of all ages, we derive thefollowing numbers of candidates:

< 80 years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84,000< 75 years. . . . . . . . . . . . . . . . . . . . . ., . .......64,400< 70 years. . . . . . . . . . . . . . . . . . . . . . .........47,000<65 years. . . . . . . . . . . . . . . . . . . . . . .........33,600

Thus, our estimate is that there would be33,600 artificial heart candidates each yearunder the age of 65. Our estimate is not muchdifferent from the 1969 Ad Hoc Task Force on

ECONOMIC ASPECTS

The economic costs of diagnosis, implanta-tion, and postoperative care for artificial heartrecipients are not easily predictable from presentartificial heart prototypes, because there havebeen only a few human implantations and noneof a totally implantable device. To provide arange of estimates, therefore, in the discussionthat follows, we review the current cost infor-mation for three related medical technologies:1) cardiac pacemakers, 2) coronary arterybypass graft (CABG) surgery, and 3) cardiactransplants. Data on projected device costs forthe artificial heart were obtained from lettersand interviews with manufacturers, as well asNHLBI reports. Three estimates of the major

Cardiac Replacement’s estimate, based on dif-ferent assumptions and calculations, that therewould be 32,168 candidates each year under theage of 65(l).

Patient Access to Implant Hospitalsand Patient Refusal

We estimate above that 33,600 persons wouldbe candidates for artificial heart implantationeach year if all had access to hospitals capable ofimplanting an artificial heart and if all agreed tothe replacement.

If the device is initially highly successfuland/or if the patient selection criteria are relaxedovertime, as they have been for patients suffer-ing from end-stage renal disease (ESRD), thisfigure might increase substantially. To allow forthis possibility, we submit an “upper bound” oftwice this estimate, or approximately 66,000candidates.

Conversely, if large and intractable technicalor other problems are encountered and/or ifmany potential candidates choose not to accepttreatment with this device, the number of can-didates might be substantially lower. According-ly, we suggest a “lower bound” estimate of16,000 candidates.

items of expense associated with artificial heartimplantation and use are presented in table 1 onpage 11. Following that are a discussion of per-sonnel and facilities and a discussion of fundingfor R&D.

Artificial Cardiac Pacemaker

The implantable cardiac pacemaker is a com-plex device that, like the artificial heart, joinsphysicians with engineers and manufacturers.The first totally implanted pacemakers werereported in Sweden in 1959 and in the UnitedStates in 1960 (17,37,78). Clearly, the pace-maker is a clinical success. It has been dramati-

Case Study #9; The Artificial Heart: Cost, Risks, and Benefits ● 9

cally lifesaving and has enormously improvedthe quality of life for patients with heart blockand other abnormalities of conduction. For pur-poses of this analysis, however, we are con-cerned with the costs, reliability, and longevityrecords of pacemakers. (For additional informa-tion, see app. A.)

From the outset, manufacturers of cardiacpacemakers predicted that energy stored in thebattery would provide 5 years of pulse-genera-tion function. This 5-year figure was based onbattery capacity and calculated discharge rates;it did not include an allowance for the replace-ment of the pulse generator alone. Althoughsome investigators expressed reservations aboutheightened expectations (78), there was a con-sensus that a 5-year pacemaker was at hand(17,37). That projection proved overly optimis-tic. Early battery failure necessitated pacemakerreplacement in 60 percent of pacemaker recipi-ents within 3 or 4 years. Even as late as a decadeafter the therapy became accepted, many pulsegenerators required replacement at 18 months.In addition, wire fractures, high thresholds,other component failures (e. g., self-dischargewithin the battery, inward leakage of bodyfluids), and infection required reoperation inabout 30 percent of pacemaker recipients within3 years (55,56). The predicted longevity was notachieved until 1975, with the availability of newbattery technology (lithium).

The unanticipated complications of systemsfailures and recalls for recipients of cardiacpacemakers meant greater than estimated con-tinuing care costs. Although the expectation hadbeen for 3 to 5 years of fault-free system per-formance, the average system longevity duringthe first 3 years of pacing was only about 6months. Some patients had in excess of 15 oper-ations in 3 to 5 years.

A 1976 study (74) analyzed the financial rec-ords of patients with more than 4 years (an aver-age of 73 months) of cardiac pacing to establishbasic cost figures. A cost estimate of $7,500 in-cludes an average of $3,500 for the initial im-plantation and $4,000 for continuing pacemakermaintenance costs. Modern followup methods,apart from complications requiring hospitaliza-

tion and operative repair, are also costly. Elec-tronic monitoring, directly or indirectly bytelephone, represents the best available means offollowup. Electronic monitoring by telephonepromises to reduce the number of emergency ad-missions, but the procedure is costly. Third-party payers, Blue Cross and medicare, now pay$30 per telephone call; most patients aremonitored twice monthly, some as often asweekly. Thus, the monitoring cost can approx-imate $1,560 per year.

Coronary Artery Bypass Grafts

The costs of CABGs have become an issue asthe number of procedures has grown—from20,000 in 1971, to 50,000 in 1974 (75), to anestimated 70,000 in 1977 (11), to 100,000 in 1978(47). Figures from several studies analyzingsurgical costs of CABG patients (24,32,47,59,75)were updated with assumptions about patientcare for artificial heart recipients to arrive at thefigures given in column A of table 1.

A study by Befeler (11) presents the range ofcosts for 20 CABG patients. Hospital charges fora 17-day average stay ranged from $6,525 to$22,142, for an average of $10,103. This figureincludes charges for EKG analysis, cardiaccatheterization, blood flow rate measurements,and other hospital fees that would be incurredby artificial heart recipients. The professionalfees incurred by CABG patients provide themost recent comparable cost information forprofessional fees that might be incurred by ar-tificial heart recipients. The surgeon’s fee forCABG currently ranges from $2,000 to $2,400,averaging $2,200; the anesthesiologist’s feeaverages $974; and the cardiologist’s fee aver-ages $652. This brings the average professionalfees for CABG to $3,826. When these fees areadded to the hospital costs of CABG surgery,the total charges are $13,929. Allowing for infla-tion and national variation, we estimate an aver-age cost of $15,000 for CABG surgery.

Heart Transplants

RecentStanford

successes in cardiac transplantation atUniversity Medical Center provide a

IO ● Background Paper #.2: Case Studies of Medical Technologies

third cost comparison. Between 1969 and June1979, Stanford completed 179 cardiac trans-plants, with 71 survivors (62). The survival rateof patients who receive heart transplants nowrivals that of patients who receive kidney trans-plants from unrelated donors. About 70 percentsurvive to 1 year, and 50 percent survive aftersyears. The heart transplant patient selectioncriteria at Stanford are very stringent. Selectionis based on factors that include the absence of in-fection, a psychological evaluation, and eco-nomic criteria. Patients must show they can pro-vide transportation to and from Stanford duringpostoperative monitoring and must documentthat the patient’s family can provide financialsupport during this period. Many of the recipi-ents are young. Of 13 patients between 12 and21 years old, 7 are still alive, with a 64-percentsurvival rate to 4 years.

In February 1980, the former National Centerfor Health Care Technology (NCHCT) recom-mended that the Health Care Financing Admin-istration (HCFA) reimburse cardiac transplanta-tion at Stanford under medicaid. Previously, asubstantial portion of the costs was underwrit-ten by the National Institutes of Health (NIH). Afull recommendation on medicaid reimburse-ment for heart transplants is being prepared thatwill include suggestions for cost containment in-centives, “distributive justice” issues for patientsunable to afford the transportation to and fromStanford, and a consideration of whether it isnecessary to regionalize (limit to four or fivecenters) heart transplants. ’

Average costs for cardiac transplantation atStanford in 1977 are listed below (62):

Transportation and lodging. ... ... ... ... ..$ 5,600Evaluation cost. . . . . . . . . . . . . . . . . . . . . ., ., 3,500Hospital costs. . . . . . . . . . . . . . . . . . . . . . . . . . 62,000Professional fees. . . . . . . . . . . . . . . . . . . . . . . . 30,000

Total. . . . . . . . . . . . . . . . . . . . . ... ... ... . .$101,100

These figures for cardiac transplantation donot include fees for the heart donors, whichwould not be encountered in artificial heartsurgery. The largest contributing factor to thetotal cost of cardiac transplantation is the length

‘ The Blue Sheet, Feb. 20, 1980.

of hospital stay, which averages 65 patient days.The average daily costs are between $400 and$500 (not corrected for inflation). The first 30days after surgery are spent by cardiac trans-plant patients in intensive care at the highestservice intensity and costs. Much of artificialheart implantation would be emergency surgery,according to our earlier patient selection pool,and charges for transportation and lodgingwould not be incurred. We have deducted thesecharges and reduced the hospital charges for car-diac transplantation by one-half (to account forthe shorter hospital stay and fewer laboratorytests required by artificial heart patients) to ar-rive at the figures given in column C of table 1.

The annual cost of followup care for hearttransplant patients at Stanford, after the firstyear, is approximately $8,800 (62,71). Inpatientfollowup care (medical surveillance, chestX-rays, lab tests, and EKGs) costs about $7,300,and outpatient followup care about $l,500. Thehigher continuing care costs for the first yearand for those eight patients at Stanford whohave had second heart transplants are not in-cluded in the maintenance figure. (Tables sum-marizing the inpatient and outpatient costs atStanford are provided in app. B.)

Device Costs

Estimates of the cost of the artificial heartitself vary, depending on the energy supply. Thefollowing four energy supply systems are dis-cussed in the report of the 1973 Artificial HeartAssessment Panel (51): 1) electrically powered,internal heat energy storage, 2) long-term inter-nal secondary battery, 3) external secondarybattery, and 4) nuclear power.

Two of these energy systems are used onLVADS that are undergoing testing and researchtoday. One is an electrical-energy converterpowered by an electrochemical battery. Theother is a thermal-energy converter powered byan electrical or radioisotope-charged battery.Recent estimates of the future cost of theseLVADs from NHLBI contractors provide thebest proxies for what the potential cost of the ar-tificial heart may be when, and if, it is mass pro-duced. According to representatives from Ther-

Case Study #9: The Artificial Heart: Cost, Risks, and Benefits • 11

moElectron and Aerojet-General, an electro-mechanical LVAD designed for 2 years ofreliable use, at a production level of 5,000 peryear, will cost an estimated $10,000. A 5-yeardevice may cost $13,000 or $14,000. In addition,the batteries for such a device will cost severalhundred dollars a year. An LVAD driven by athermal engine will cost an estimated $14,000,with no additional costs expected for a 5-yearreliable form.

Willem Kolff, at the University of Utah, esti-mates that the first totally implantable artificialhearts will be air-driven and will cost around$14,000. However, many technical problems re-main to be resolved (e.g., the development ofreliable biomaterials), and costly solutionswould increase these figures.

There is little potential for declining costs withmass production of the devices because of thehigh level of reliability demanded for the devicesand the expensive marketing structure. Theo-dore Cooper, former director of NHLBI, con-firmed this point in a 1979 interview (22), statingthat he does not expect artificial hearts to be pro-duced on a competitive basis; therefore, satura-tion and declining costs for the device are notapt to be realized.

Summary of Costs

Table 1 contains three estimates of the majoritems of expense incurred in the diagnosis, im-plantation, and recovery of patients undergoingartificial heart implantation. These items havebeen discussed in the preceding sections.

Our lower bound cost estimate (A in table 1)is based on the CABG proxy, a low estimate forthe device of $10,000, and a low estimate forcontinuing care of $1,500 based on the experi-ence of cardiac pacemakers. * We do not expectthe technological and continuing surveillanceneeds of artificial heart recipients to be less thanemergency medical treatment and monitoring

● There is a considerable difference of opinion about continuingcost estimates. One reviewer felt that both the cardiac transplantand pacemaker continuing costs were too high. Another reviewerfelt that there would be numerous mechanical problems, so thateven cardiac transplant estimates were too Zow. In table 1 we havepresented a range of estimates, with $8,000 as the upper bound.

Table 1.—Three Estimates of Major Items ofExpense Associated With Artificial Heart

Implantation and Use

A B cCardiac

C A B G Calculated transplantItem of expense p r o x ya fees p r o x yb

ImplantationHospital care. . . . . . .Professional fees . . .Device costsc. . . . . . .

Total . . . . . . . . . . . .Continuing costsd

Medical care . . . . . . .Batteries. . . . . . . . . . .

Total yearly . . . . . .

$10,1033,826

10,000

$10,8225,300

12,000

$31,00030,00014,000

$23,929

$1,500300

$1,800

$28,122

$2,000300

$2,300

$75,000

$8,800—

$8,800aCABG proxy for costs of hospital care and professional fees; cardiac pacemak-

er proxy for costs of continuing medical care.bCardiac transplant proxy for costs of hospital care (adjusted), professional

fees, and continuing medical care.cBased on estimates for electromechanical LVAD.d An n u a l c o s t s s u b s e q u e n t t o i m p l a n t a t i o n .

SOURCE: Estimates are derived from information provided in the text.

costs of cardiac pacemakers. In addition to in-curring these continuing medical costs, recipi-ents will have to replace batteries yearly for the2-year reliable LVADs that are being devel-oped. * * These batteries will cost about $300 to

$500 annually.***

Our second cost estimate (B in table 1) isbased on our own calculations using currenthospital costs, professional fees, and a middleestimate of $12,000 for the device. Consultationswith cardiac surgeons suggest that the nonemer-gency patient will need to be hospitalized for 5to 7 days prior to artificial heart implantation.Immediately after surgery, the patient will beplaced in an intensive care unit for extensivemonitoring and treatment for an anticipatedperiod of 7 days. Normal progression of the re-covery processes would be expected to require ahospital stay of about 21 days. Combining theselength-of-stay figures with current hospitalcosts, we calculate that the recipient of an artifi-cial heart would incur total hospital costs of$10,822. That total includes $6,300 for 28 daysof care (7 days preoperatively, 21 days postoper-atively) at $225 per day* and $4,522 for 7 daysof intensive care at $646 per day.**— . . —

**See section on LVAD research below for a description.***Estimate from Thermoelectron.*Cost figures from the American Hospital Association.**The amount reimbursed by the Health Care Financing Admin-

istration (HCFA) for intensive care.

12 . Backgroimd Paper #2: Case Studies of Medical Technologies

We have added the professional fees stated forCABG patients ($3,826) and applied them to thesurgical demands of artificial heart implanta-tion. * The amount increases, because of the an-ticipated need for an associate surgeon (fee of$500) and two anesthesiologists, to $5,300.**When we add these fees to the hospital costs, wearrive at estimated charges of $16,122, wellwithin the range of coronary bypass surgery.(Many of our interviewees compared implanta-tion costs to present bypass costs. ) Followinghospitalization and discharge, the artificial heartrecipient would presumably spend a reasonablyprolonged period of recovery. We anticipatethat during this recovery period the patient willrequire frequent visits to the physician at thehospital where the surgery was performed. Forthis reason, we expect the first year’s costs to besimilar to those for cardiac transplant patients,but we have chosen a lower continuing costfigure of $2,000.

Our upper bound estimate (C in table 1)employs the cardiac transplant figures describedearlier. The only addition is the device figure of$14,000 for an air-driven heart, which wouldnot require batteries.

It must be noted that for all three estimates weassume no surgical complications such as throm-bosis, hemorrhage, and circulatory insufficien-cy. Such complications would require a longerhospital stay and could easily double the hos-pital costs.

● In an experimental procedure, professional fees are not ordi-narily charged. However, once the artificial heart is deemed to betherapeutic, these fees will be incurred.

● *See discussion of personnel and facilities in the next section ofthis case study.

In summary, the hospital and implantationcosts to the recipient of an artificial heart mayapproach the present fees associated with car-diac transplants and will certainly be higher thanthe present costs of CABG surgery. Table 2 listsvarying total societal costs for the range ofbiologic or mechanical heart implants discussedin the previous section of this case study andalso shows the impact on present facilities andpersonnel. Even the best estimates project an ex-pense that an individual recipient would not beable to afford completely and that private in-surance schemes would be expected to reimburseonly partially (as with dialysis and heart trans-plants). To meet these expenses, which couldeasily reach $3 billion annually, the Governmentwill have to consider new concepts in insuranceor social security coverage.

Personnel and Facilities

An important consideration in planning forthe clinical application of the artificial heart isthe adequacy of present medical facilities andsurgical teams. The agonizing selection of pa-tients associated with the early days of hemodi-alysis points up the problem that a shortage offacilities and skilled personnel may create ifpreparations for the artificial heart are inade-quate.

John Watson, Chief of the Devices and Tech-nology Branch of NHLBI, believes that existingopen-heart facilities should be adequate for ar-tificial heart surgery and postoperative recovery(77). The growth in emergency cardiac facilitiesand personnel during the last decade and theplans for mobile care units and coronary facil-ities throughout the United States should pro-

Table 2.—Effect of Numbers of Implants on Available Societal Resources

Implants per surgeon per Implants per facilityTotal costs per year (in millions) year with number of per year with number of

Replacements with implantation costs of: available surgeons: available facilities:

per year $24,000 $28,000 $75,000 800 1,000 1,200 600 800 1,000

16,000 . . . . . . . . . . . . $ 3 8 4 . 0 0 $ 4 4 8 . 0 0 $1,200.00 20.0 16.0 13.3 26.7 20.0 16.033,600 . . . . . . . . . . . . 806.40 940.80 2,520.00 42.0 33.6 28.0 56.0 42.0 33.647,000 . . . . . . . . . . . . 1,128.00 1,316.00 3,525.00 58.8 47.0 39.2 78.3 58.8 47.066,000 . . . . . . . . . . . . 1,584.00 1,848.00 4,950.00 82.5 66.0 55.0 110.0 82.5 66.0

SOURCE: Estimates are derived from information provided in the text.

Case Study #9: The Artificial Heart: Cost, Risks, and Benefits . 13

vide a facilities base suitable for the transporta-tion of candidates for artificial heart surgery. Asnoted below, however, artificial heart implanta-tions may severely strain existing personnelresources.

Interviews with cardiac surgeons indicate thatthe services of the current open-heart procedureteam plus an associate surgeon and an artificialdevice engineer will be required for artificialheart implantation. The estimated personnel re-quirements in the operating room are listedbelow:

HoursChief surgeon. . . . . . . . . . . . . . . . . . . . . . .........4-5Associate surgeon. . . . . . . . . . . . . . . . . . . . . . ......2-3Anesthesiologists (2). . . . . . . . . . . . . . . . . . . . . .. ...7-8Heart-lung machine operators (2). . .............7-8Residents (3). . . . . . . . . . . . . . . . . . . . . . ..........7-8Nurses (3). . . . . . . . . . . . . . . . . . . . . . .............7-8Technicians (2). . . . . . . . . . . . . . . . . . . . . . . . .. ....7-8Artificial device engineer. . . . . . . . . . . . . . . . . . . . . . 4-s

These personnel requirements are extensivewhen superimposed on present needs for skilledsurgeons and nurses for heart-lung work, hearttransplants, arterial grafts, and pacemaker im-plantations. Artificial heart surgery, like hearttransplantation, is likely to disrupt anyhospital’s schedule. In addition, the surgery isonly a small part of the patient care process,which requires the time and resources of nurses,lab technicians, physicians, and engineers.

It is difficult to estimate the present number ofcardiac surgeons, because currently availablemedical specialty statistics do not differentiatebetween cardiac and noncardiac thoracic sur-geons. In 1976, there were 2,020 thoracic sur-geons (3). Approximately 39 percent (780) areestimated to be active cardiovascular surgeons.The supply of cardiac surgeons has been increas-ing at about 15 percent per year (59), so shortlyalmost half of certified thoracic surgeons will beactive in cardiac surgery. Using these figures, wehave assumed that as few as 800 and probablycloser to 1,000 surgeons will be available to per-form artificial heart surgery in the comingdecade.

In 1976, an estimated 600 hospitals wereengaged in open-heart surgery, an increase from432 hospitals in 1972. Under the assumption that

no new facilities would be required for artificialheart implantation, if one postulates a total of33,600 implants a year* and 800 hospitals havecardiac facilities, each hospital would average 42implants per year. These centers will also havesubsidiary concerns, among them the blood re-quirements necessary to prime the heart-lungmachine for surgical bypass and emergency careof hemorrhage, pump oxygenators, and an in-ventory of artificial hearts available for im-mediate use. With a product whose demandcould vary from 16,000 to 66,000 per year andwhose reliability, longevity, and maintenancerecord still remain undocumented, accurate esti-mates of the major resource requirements arestill not feasible.

R&D Funding

The NHLBI-directed program for the devel-opment and assessment of circulatory-assist andcardiac replacement devices is partially fundedthrough contracts (see app. C). This family ofcontracts provides funds for researching bloodpumps, power sources, energy transmission andstorage, instrumentation, and biomaterials.There is no single major recipient of contractfunds. As shown in table 3, the targeted contractprogram of the Devices and Technology Branchgrew rapidly from $500,000 in fiscal year 1964 to$8 million by fiscal year 1976. Since then, theprogram has remained relatively stable at anaverage of $10 million a year. Figure 1 comparesrelative funding levels for NIH, NHLBI, and theartificial heart program for fiscal years 1964through 1975.

NHLBI has also supported basic research forthe artificial heart development programthrough extramural grant programs. The extentof these funds is difficult to delineate in theoverall Institute grant figures. The respon-sibilities of the Devices and Technology Branchwere broadened to include grants in 1975. Ac-tivities funded through regular and projectgrants include intra-aortic balloons, biomate-rials, and prosthetic heart valves (see app. C).The branch also has unrelated grant activities on

*The manner of arriving at this estimate was discussed in theprevious part of this case study.

—.

14. Background paper #2: Case Studies of Medical Technologies

Table 3.—NHLBI Devices and Technology Branch Contract Funding, Fiscal Years 1964-79

Programs

Energy Bioinstru- Special PhysiologicalFiscal year Materials systems Blood pumps mentat ion p r o g r a m s O x y g e n a t o r s testing Total

1964 . . . . . . $ 209,085 $ 93,856 $ 278,183 $ 0 $ 0 $ 0 $ 0 $ 581,1241965 . . . . . . 0 0 0 0 261,756 0 0 261,7561966 . . . . . . 843,242 728,500 316,555 0 1,680,857 0 335,777 3,904,9311967 . . . . . . 1,735,469 2,909,378 1,377,433 0 898,406 467,747 1,165,876 8,554,3091968 . . . . . . 2,130,569 1,365,749 1,533,379 617,456 149,818 590,440 1,454,113 7,841,5241969 . . . . . . 1,062,462 2,902,329 1,345,945 479,833 239,012 495,766 1,862,252 8,387,5991970 . . . . . . 1,089,083 2,660,840 1,476,869 312,657 9,000 338,460 3,388,334 9,275,2431971 . . . . . . 1,115,375 3,165,036 1,793,847 146,023 446,757 676,786 1,873,712 9,217,5361972 . . . . . . 905,044 3,897,469 2,386,193 251,386 62,548 381,161 2,700,718 10,584,5141973 . . . . . . 1,877,930 2,822,000 1,971,222 183,513 42,500 43,848 2,996,743 9,937,7561974 . . . . . . 557,214 3,471,258 2,466,405 560,030 44,978 0 851,655 7,961,5401975 . . . . . . 440,069 3,480)204 3,448,612 1,707,659 0 0 56,196 9,132,7401976 . . . . . . 3,274,000 3,182,000 3,082,000 1,492,000 908,000 0 0 11,938,0001977 . . . . . . 3,259,000 3,883,000 3,098,000 2,040,000 921,000 0 0 13,201,0001978 . . . . . . 2,373,000 4,034,000 2,899,000 2,235,000 577,000 0 0 12,118,0001979a. . . . . . 1,700,000 3,700,000 3,300,000 1,800,000 500,000 0 0 11,000,000

Total. . . . $ 2 2 , 5 7 1 , 5 4 2 $ 4 2 , 2 9 5 , 6 1 9 $ 3 0 , 7 7 3 , 6 4 3 $ 1 1 , 8 3 5 , 5 5 7 $ 6 , 7 4 1 , 6 3 2 $ 2 , 9 9 4 , 2 0 8 $ 1 6 , 6 8 5 , 3 7 6 $ 1 3 3 , 8 9 7 , 5 7 7aEst imated .

SOURCE: National Heart, Lung, and Blood Institute, Devices and Technology Branch, Bethesda, Md., 1979

Figure I.—Comparative Program Growth: NIH, NHLBI, and the Artificial Heart Program,Fiscal Years 1964-75

250

200

150

100

50

1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975

Fiscal y e a rSOURCE: National Heart, Lung, and Blood Institute, Bethesda, Md.


diagnostic instruments andJohn Watson, of NHLBI,grant spending since 1964

therapeutic devices.has estimated totalat $30 million. For

fiscal years 1977 through 1979, the grantsspecifically related to the development of the ar-tificial heart were $10 million. Approximately$3.5 million in grants were funded in fiscal year1978.

The $164 million spent to date on the NHLBIartificial heart program ($134 million in con-tracts, $30 million in grants) represents the bulkof the total cost of developing an artificial heart,but several research institutes and technologyfirms have held Department of Energy (DOE)contracts (totaling $17 million) to develop anuclear engine for an LVAD or totally implant-able artificial heart. Contractors include the Uni-versity of Utah, Westinghouse, Andros, Arco,and Aerojet-General. We have estimates fromonly one contractor on the size of these funds,though we have contacted other recipients forinformation. That firm has spent almost $7million to date on thermal energy development.The financial history of the artificial heart pro-gram at DOE is summarized in table 4.

In 1968, the Atomic Energy Commission(AEC), now DOE, initiated a program at LosAlamos Scientific Labs for the development ofplutonium-238 (Pu-238) fuel for the artificialheart. In 1971, contracts were awarded to sev-eral university research centers (University ofUtah, Cleveland Clinic, University of Washing-ton) to begin biomechanical and biomaterialsstudies. According to Donald Cole of DOE’s Of-fice of Health and Environmental Research (20),DOE funding has recently ended.

It is by no means clear, however, that interestin nuclear energy as a power source for the ar-tificial heart has ended. In early 1979, NIHsolicited proposals for research into a clinicalthermal energy system, and in November 1979,3-year contracts for $900,000 and $795,000,respectively, were awarded to Aerojet-Generaland the University of Washington. The thermalengine to be designed can be driven by one oftwo energy sources: thermal (e.g., lithium salts)or nuclear (e. g., Pu-238). Of these two sources,Pu-238 is acknowledged to be clinically the moreattractive, because lithium salts must be re-heated at intervals not exceeding 4 to 8 hours.

Table 4.—Financial History of the Artificial Heart Program at the Department of Energy

Period ofContractor performance

Westinghouse Electric Co. . . . . . . 4/19/71 - 6/30/78Hittman Associates . . . . . . . . . . . . 3/74 - 3/75

Universities Center. . . . . . . . . . . . . 8/1/73 - 7/31/74University of Washington . . . . . . . 6/15/71 - 9/14/78

TRW, Inc. . . . . . . . . . . . . . . . . . . . . . 4/19/71 - 6/30/75Cleveland Clinic . . . . . . . . . . . . . . . 2/15/72 - 12/31/77Cornell University. . . . . . . . . . . . . . 9/74 - 9/30/78

Sinai Hospital . . . . . . . . . . . . . . . . . 9/1/75 - 8/31/76University of Utah. . . . . . . . . . . . . . 6/15/71 - 6/30/79University of Utah. . . . . . . . . . . . . . 6/15/71 - 9/14/77

Westinghouse Electric Co. . . . . . . 5/1/72 - 4/30/73

Los Alamos Scientific Laboratory. 7/1/72 - 9/30/77Mound Laboratory . . . . . . . . . . . . . 7/1/72 - 6/30/73Pacific-Northwest Laboratory. . . . 7/1/72 - 6/30/74Pacific-Northwest Laboratory. . . . 7/1/72 - 9/30/77Pacific-Northwest Laboratory. . . . 7/1/73 - 10/1/76

Title Cumulative costsNuclear-powered artificial heart $10,005,103Development of a radioisotope heat source 16,000

subsystem for heart devicesArtificial heart controls support 19,033A program to evaluate the mechanical properties and 457,883

biocompatibility of materials for the ERDAartificial heart

Radioisotope heat source for an artificial heart 527,499Artificial heart supporting services 257,499Biological effects of implanted nuclear energy 371,666

sources for artificial heart devicesERDA artificial heart program review 9,874Biomedical engineering support 1,719,880Materials testing and requirements for the ERDA 357,208

nuclear-powered artificial heartAn investigation of high-performance thermal 132,421

insulation systemsFuels and source development 2,083,000Fuels and source development 59,000Recipient radiation exposure 163,000Population radiation exposure 145,000Pu-238 from Am-241 315,000

SOURCE Information provided by the Department of Energy, Washington, DC.

16 ● Background Paper #2: Case Studies of Medical Technologies

In addition to Federal contracts and grants,some private funding helps to support artificialheart research. For example, the ClevelandClinic has an NHLBI contract to develop a pumpsuitable for an implantable LVAD. Supplement-ing this contract, Parker-Hannifin Corp. pro-vides a philanthropic gift that covers approx-imately 10 percent of the clinic’s heart device re-search. TRW Corp. produces at its own expensecomponents that are contributed to the clinic.Goodyear Corp. contributes expertise andmanufactures the diaphragm for the pumps. Italso contributes one full-time employee whoworks on the clinic’s heart device program. Thissupport is part of Goodyear’s Aid to Medical Re-search Program. The Cleveland Clinic is alsotesting Medtronics’ LVADs with that firm’sequipment, service, and expertise. Testing andclinical trials of these devices are separate fromNHLBI funding.

Federal allocations for the artificial heart pro-gram have averaged $10 million since 1964, and

the present annual figure is approximately $15million in contracts and grants. The growth inallocations has not kept up with requests or in-flation. Some researchers, such as Yuki Nosé ofthe Cleveland Clinic, have estimated that aclinically useful, totally implantable LVAD maybe ready in 1983, and that a totally implantableartificial heart may possibly be available in1986. Other contractors say these estimates areoptimistic, given present funding, and someclaim that a totally implantable artificial heartmay not be ready until the year 2000. It couldhappen, then, that federally funded research willbe required for another 10 years. If annualallocations are held at the present level for 10years, this means an additional $150 million inFederal R&D funds—and $300 million is a po-tential figure if research continues until the endof the century.

PARALLEL COSTS OF HEMODIALYSIS

Hemodialysis and kidney transplantationemerged as life-extending therapies for victimsof ESRD in the early 1960’s. Here we examinethe experience of hemodialysis financing anddistribution in order to draw lessons that havepotential for application to the artificial heart.

Systematic funding efforts by NIH on behalfof the kidney program began in 1965 (64). Atthat time, the artificial kidney-chronic uremiaprogram of the National Institute of Arthritis,Metabolism, and Digestive Diseases (NIAMDD)was founded with a contract research programto build a better artificial kidney. The artificialkidney program was mandated by the Houseand Senate Appropriations Committees with the1966 budget, 1 year after the artificial heart pro-gram was founded in the National Heart Insti-tute. Though the artificial kidney was advancedwell beyond the artificial heart at the time,advocates of the artificial heart (such as MichaelDeBakey) appear to have been more powerful.

Human kidney transplantation, which follow-ing occasional attempts in the 1940’s had begunin earnest in the 1950’s, developed in parallelwith the artificial kidney. The availability ofhemodialysis helped the kidney transplantationprogram by making available pools of potentialtransplant recipients. NIH funding was availablefor transplantation research, because the re-searchers who worked on the immunologicalproblem were well known as basic researchers(64). Information concerning the total sumsspent on development of artificial kidney tech-nology or kidney transplantation is not readilyavailable.

In 1960, cost estimates for hemodialysis weremade by Belding Scribner and his colleagues atthe University of Washington in Seattle (63,64).Minus equipment, the cost per patient for once-weekly dialysis was estimated to be $5,533 an-nually. The later recognition that dialysis threetimes weekly would be better medically greatly


increased per patient costs (63). In 1963, at ajoint finance meeting of the American MedicalAssociation and the National Kidney DiseaseFoundation, costs were estimated to be about$20,000 per patient per year. The moral ques-tions involved in the availability of dialysis werebrought up at the same meeting. There was con-cern that 25 to 50 percent of those who neededdialysis were not able to obtain it (43).

In 1964, the Federal Government recognizedits potential fiscal role in treatment of ESRD,and the Senate Appropriations Committee saidthat the Public Health Service (PHS) had theauthority to provide demonstration and trainingfunds for artificial kidney programs (but not forpatient care) (63). Scribner and his colleagues inSeattle, through community fundraising andprivate philanthropy, had developed a com-munity treatment center in 1962. The first PHSdemonstration and training grant had beengiven to that center in 1963 (63), to be phasedout in 3 years. Also in 1964, NBC television waspreparing a documentary that was aired in 1965contrasting the millions the Government waswilling to spend on the space program to thesmall amount spent for dying individual in needof dialysis. A total of $3.4 million was allottedfor support of 14 community dialysis centers. In1968 and 1969, PHS took action to graduallystop funding these centers.

In 1967, despite these efforts, the Gottschalkcommittee (an advisory group convened by theBureau of the Budget) recommended Federalfinancing of patient care for ESRD through anamendment to the medicare component of theSocial Security Act. One month prior to the1972 election, Congress passed the Social Securi-

ty Amendments including section 2991 whichextended medicare coverage to the treatment ofESRD. Section 2991 was allotted less than 30minutes of discussion on the Senate floor andgiven only a few minutes of deliberation in thejoint House-Senate Conference Committee.President Nixon signed it into law on October30, 1972 (63). Senator Vance Hartke, who spon-sored section 2991, stated that estimated annualcosts at the end of 4 years would be $250 mil-lion, with a first year cost of $75 million (63). *

Ronald M. Klar, in the Office of the AssistantSecretary of Health at the Department ofHealth, Education, and Welfare (HEW), imme-diately saw problems with this estimate.Through information obtained from nephrolo-gists, Klar made new projections of the costs ofthe ESRD program based on a new cohort of pa-tients entering the program each year. Eachcohort would include about 10,000 patients,2,000 of whom would be transplanted; therewould be about a 20-percent annual mortalityrate; and the average annual cost of dialysiswould be $16,000. Thus, according to HEW in1972, the cost in 5 years would be an estimated$592.1 million for 40,000 patients. By the timethe program stabilized in 10 years, the costwould be $1 billion annually (64). Table 5 sum-marizes the 1972 HEW and 1974 Social SecurityAdministration (SSA) estimates of the annualcosts for the ESRD program (64).

The House Ways and Means Committee, in1975, estimated there would be 50,000 to 60,000patients by 1984 at a cost of $1 billion, and

*The Senate amendment included a 6-month waiting period forpatients before benefits should begin, which the House Ways andMeans Committee was able to change to 3 months.

Table 5.—Estimated Annual Costs for the ESRD Program (dollars in millions)

SSA estimates ofTotal patient medicare expenditures HEW estimates of total

Fiscal year population (1974) national costs (1972)1974 . . . . . . . . . . . . 9,980 $135 $157.71975 . . . . . . . . . . . . 18,754 176 281.51976 . . . . . . . . . . . . 26,746 223 394.51977 . . . . . . . . . . . . 34,036 278 497.81978 . . . . . . . . . . . . 40,685 — 592.1

S O U R C E : R. A. Rettig and T. C. Webster, “Implementation of the End-Stage Renal Disease Program: A Mixed Pattern of Sub-sidizing and Regulating the Delivery of Medical Services, ” 1977 (64),

94-283 c - 52 - 4


50,000 to 70,000 patients by 1990 at a cost of$1.7 billion (64). According to Barnes (9), theNational Dialysis Registry estimates an annualmortality rate of only 10.8 percent for patientson dialysis during the first 4 years of care. Sincethe highest mortality rate occurs in the first year,this estimate is in marked contrast to the esti-mate of a 20-percent annual mortality rate of theOffice of the Actuary of the SSA noted above.

A number of problems have occurred withregard to cost estimates for the ESRD program.Both Barnes (9) and Rettig (64) address themthoroughly. We summarize the most importantpoints below.

●

●

●

●

●

●

There has been persistent underestimationof total costs.The early hope of increased success withcadaveric transplantation has not beenrealized.The increased problem of poor quality oflife for patients and the small proportionrehabilitated was not anticipated. *Cost-reducing innovations in therapythrough R&D have not occurred.Prospects for disease prevention seemremote.The least expensive mode of treatment,home dialysis, is not being used as exten-

‘Quality of life parameters are discussed below in another partof this case study.

sively as expected. Some of this problem isthe result of taking marginal patients suchas the elderly and diabetics, as well as theresult of economic disincentives for homedialysis by patients and physician pro-viders.

The artificial heart program has received moreFederal research money than the hemodialysisprogram did at equivalent stages of develop-ment. Early meetings of the American Societyfor Artificial Internal Organs saw developmentof an artificial heart as much more complex thanthat of an artificial kidney, because a perma-nent, complete artificial heart must constantlyperform the full and precise function of thehuman heart, whereas a kidney can functionpart time and at a comparatively low capacity.

Anderton, et al. (4) have concluded that thereis no positive economic benefit for the treatmentof renal failure. In paying for such treatment,society is tacitly agreeing to pay for the intan-gible” benefits of avoidance of pain, discom-fort, grief, and premature loss of human life. Forthe artificial heart program, the dialysis experi-ence indicates that the allocation of scarce medi-cal resources for the saving or prolonging oflives deserves thoughtful deliberation.

**In economics, “intangibles” are those costs and benefits thatcannot be quantified or miced..

ESTIMATES OF THE POTENTIAL SUCCESS OFTHE ARTIFICIAL HEART

LVAD Research and Clinical Trials

Since its inception, the artificial heart pro-gram has advocated simultaneous research onboth permanent heart replacement and tempo-rary LVADs. Because of the obstacles encoun-tered in developing a totally implantable artifi-cial heart, however, the development of theLVAD now takes priority. NHLBI funding since1974 has been largely concentrated on the devel-opment of LVAD control systems, pump design,biomaterials, and beginning in 1975, clinicaltrials.

The goals of the LVAD program center atpresent on developing a long-term (2- to 5-year)implantable LVAD capable of taking over thepumping function of the weakened left ventricleof the heart and enabling its eventual recovery.The development of a long-term assist devicewill draw heavily on current experience with thetemporary (2-week) LVAD. Many models of thetemporary LVAD currently exist; these havebeen funded largely through NHLBI,2 but partly

2See Report of Cardiology Advisory Committee, ]ournal ofArtificial Internal Organs (}A1O), November 1977, for summaryof NHLBI devices.


through independent corporate investment (e.g.,by Medtronics and Arco Medical Products).Because of the recent emphasis on developing along-term implantable LVAD, explicit fundingof total artificial heart development has beenmuch less extensive; in 1978, NHLBI had onlyfour total artificial heart contracts, totaling $1million.

In 1974, NHLBI convened a workshop to con-sider the desirability and feasibility of conduct-ing LVAD clinical trials. Ruth Hegyeli andMichael Machesko, 1974 workshop partici-pants, reviewed in vitro and animal data on theThermoelectron LVAD (TECO models VII andX) used by John Norman of the Texas Heart In-stitute and William Bernhard of Boston Chil-dren’s Hospital (34). They concluded that clini-cal trials would be in order once biomaterialssuitable for short-term use were developed, ade-quate provisions were made to protect patient/subject rights, and criteria were established forpatient selection.

After meeting these criteria, Norman andBernhard received funding from NHLBI forclinical trials of the short-term (2-week) LVAD.Both the Texas Heart Institute and BostonChildren’s Hospital trials used the same patientselection protocol, which sets forth a number ofconditions to be met by potential LVAD recipi-ents. Only patients unable to resume cardiacfunction at the conclusion of cardiac pulmonarybypass were included. A total of 38 implants (23Texas, 15 Boston) were performed in this pro-gram (58). Three patients were alive at thiswriting (May 1980), 25, 24, and 18 months aftersurgery; one patient survived 7 months. Of thelast 14 implants, 8 were successfully supportedfor more than 40 hours (77). *

In addition to the NHLBI clinical trial contractprogram, several other clinical trials of differentLVAD models have taken place.** WilliamPierce, of Pennsylvania State University, hasused a smooth-surfaced, polyurethane-coatedpump in approximately nine patients and re-

*A summary of the clinical trial program is currently being de-veloped by NHLBI.

* *For example, see articles in the 1978 issue of JAIO devoted ex-clusively to LVADS.

ported the first long-term survivor (57). Limitedclinical use of other LVADs in at least 11 pa-tients has been reported, with 2 long-term sur-vivors (57). The extent of use of commerciallydeveloped pumps (e.g., Arco, Arothane) intherapeutic settings is unknown, because datafrom these implants are not formally reported.

Those who have conducted LVAD clinicaltrials believe they have obtained much valuableinformation that will contribute to the successfuldevelopment and use of future long-term de-vices. Such information includes confirmationof the hypothesis that temporarily taking overthe left ventricle pumping function can, in somepatients, lead to partial recovery of the de-pressed ventricle and the observation that rightheart function is not always necessary duringLVAD implantation (52).

Major problems in device design and functionstill exist, however. A primary challenge is thedevelopment of biomaterials that do not encour-age thrombogenesis (formation of blood clots)and do not decompose over long-term use. An-other challenge is the development of a portable,reliable energy source. Current prototypes usingelectric batteries have both mechanical andoperational liabilities; Pu-238-powered fuel cellsprovide a compact energy source but pose severeproblems due to health risks from radiation.***

NHLBI has given top priority to further re-search in the areas of biomaterials and energysources (16). A special biomaterials task forceissued recommendations in 1977 calling for theexploration of the comparative viability ofrough and smooth surfaces, the development ofoperational and quantitative definitions ofblood compatibility, theories that correlateblood compatibility with physiochemical char-acteristics of biomaterials, and adequate test andevaluation methods. There has been progress inthese areas, and advances will increase asNHLBI grants for basic research in biomaterialsexpand. Because of the magnitude of the tech-nical problems that must be solved in order todevelop a long-term (2-year) LVAD, estimatesfor commencement of clinical trials of the long-

***The problems of a nuclear-powered heart are discussedbelow in a separate section of this case study.

20 . Background Paper #.?: Case Studies of Medical Technologies

term LVAD range from 3 to 6 years. Industryrepresentatives (Thermoelectron and AerojetGeneral) note that even the 6-year estimate maybe overly optimistic if the level of Federal fund-ing does not increase.

Another factor complicating long-term devicedevelopment is the diversity of existing LVADprograms and the difficulty of coordinatingresearch or clinical trial results. Although datafrom NHLBI-sponsored LVAD programs havebeen difficult to compile, the existence ofprivately funded programs makes comprehen-sive data collection and coordinated research ef-forts even more difficult.

The experience of clinical trials of short-termLVADs appears to be of only limited use in pro-jecting the potential success of permanent de-vices, in part because the research protocols re-stricted potential recipients to very ill patientswho are likely to die regardless of the form oftreatment. Because the devices are implantedtemporarily, only short-term mechanical per-formance and negative side effects can be ob-served; medium- and long-term device perform-ance and side effects cannot be evaluated. Sincemost patients die on the operating table fromother causes, even potential complications dueto the short-term device cannot usually be iden-tified.

Instrument Reliability

Instrument reliability is of utmost importancein the effort to achieve a clinically successfultotally implantable artificial heart. With the pa-tient’s natural heart removed, sudden instru-ment failure would lead to the patient’s deathwithin minutes unless corrected. Reliability isdifferent from durability. The durability of theindividual components of a device can be benchtested and predicted with some confidence (e.g.,materials that will flex with every stroke of theheart pump can be tested for the enormous num-ber of such flexions to which the materials willbe subjected over the anticipated instrumentlife). The reliability of the assembled com-ponents under the conditions of use cannot bepredicted from bench tests alone, and testing hasnot yet been done in animals. Testing, when

begun, will have to extend for at least as long aperiod of time as the required life of the deviceand, perhaps, twice as long. * Thus, if the targetis for a 5-year device, it will be necessary to waitfor 5 to 10 years before reliability can be estab-lished. ” Further, since the concept of reliabilityis a statistical one, large numbers of trials mayneed to be carried out.

Experience with other medical devices offerssome basis for expectation and for concern. Thecardiac pacemaker, an enormously less complexinstrument, has presented a series of serious dif-ficulties which, after nearly 20 years of clinicaluse, have only now been resolved with reason-able success. These include lead breaks, batteryfailure, runaway pacemakers, electromagneticinterference, and errors in manufacture as wellas errors and complications in clinical applica-tion. *** The cardiac pacemaker is a simple,primarily electrical device with a low energy re-quirement. The artificial heart is a complex elec-tromechanical device which has high energy andmechanical requirements. Although pacemakerfailure is a serious complication, the patientoften survives long enough for replacement.Failure of the artificial heart, however, would inalmost all imaginable circumstances lead rapidlyto death.

Our consultants express confidence that anappropriate energy source (e.g., battery) with 5to 7 years predictable life is currently feasible.No such assurances have been offered for themechanical components or for the artificial heartsystem as a whole. Opinions have been offeredthat a system life as short as 60 days or as long asa year may be encountered. Contributing to theuncertainty is the existence of a number of iden-tifiable problems that have yet to be resolved.

● Accelerated aging at increased temperatures can be used toshorten the period of testing of implantable electronic devices butwould not be appropriate under the hemodynamic conditions ofthe artificial heart. A method to shorten the test period for the arti-ficial heart is urgently needed but cannot be counted on.

**In discussing this section, Kolff and others have pointed outthat a device of even as little as l-year reliability would be wel-comed by many patients and physicians.

***See app. A by Dr. Thomas Preston for a summary of the in-troduction of the pacemaker and difficulties encountered; see alsotestimony of Sidney M. Wolfe and Anita Johnson on medicaldevice legislation before the House Subcommittee on Health, July28, 1975 and Oct. 23, 1973.


Such problems include permeability to moisture activated pump. It can be assumed that prob-(undesirable) and to gases (desirable), and the lems that cannot be identified at present will alsoneed for volume and pressure compensation present themselves.behind the moving pistons in a mechanically

QUALITY OF LIFE

The stated goal of every transplantation pro-gram is to return patients to active, productivelives. The experience of heart transplants,kidney transplants and. dialysis suggests that,while for many patients the quality of life is con-sidered good, the replacement of a vital organoften produces unforeseen complications inother parts of the body. It is impossible topredict the spectrum of adverse outcomes thatwill be encountered with the artificial heart.Nevertheless, it may be possible to draw in-ferences concerning the chances for partial ortotal rehabilitation after implantation of an ar-tificial heart by examining related experiencewith these other major surgical and medical in-terventions. Therefore, we examine that ex-perience below. We also discuss the problemsthat might be associated with a nuclear-powereddevice.

Hemodialysis and Kidney Transplants

In general, short-term complications were ex-pected very early in the use of dialysis. These in-cluded hemolysis, bleeding from heparinization,calcium disturbances, and electrolyte disturb-ances, It was only after a few years that renalbone disease, neuropathies, and hepatitis wereseen (9). Some progress has been made withthese problems, but accelerated atherosclerosis,dialysis ascites, and dialysis dementia (an acutedeterioration of cerebral function) remain. In theUnited States, 55 percent of dialysis patients and34 percent of staff are carriers of hepatitis virusB. Of those infected, 70 percent of patients and15 percent of staff develop an anicteric hepatitis(9). Depression and rapid mood swings are re-curring or chronic problems and may be relatedin part to electrolyte changes and other physio-logic changes and in part to the psychic stressof ESRD. Barnes (9) quotes studies indicating

that as many as 11 to 18 percent of deaths ondialysis may result from progressive dialysis en-cephalopathy. This may be caused by excessivealuminum in thecan result frombind phosphatesaluminum in the

Family-related

central nervous system, whichaluminum hydroxide used toin the intestine or even fromwater supply.

problems occur frequently.Sometimes there is a reversal of dependencyrelations between spouses. Patients must restricttheir diet and fluid intake. Females are frequent-ly anovulatory and develop amenorrhea. Manymales are impotent (59 percent at Mt. ZionHospital). Women, especially, have self-imageproblems due to surgical scars from parathyroid-ectomies, splenectomies, sometimes nephrec-tomies, and transplant surgery (64). Levyreported on a study of 15 children in six familiesin which psychological assessment revealed thatall 15 were clinically depressed and showeddecreased academic achievement and somepsychomotor disorders (43). He also reportedthat children whose parents were dialysed incenters rather than at home did better and wereable to see the parent as more normal.

Serious dependence-independence conflictsare reported by several authors (4,25,43). Pa-tients who had been very independent initiallywere forced to depend on other people and ma-chines. Those who had always been dependenttended to regress and become extremely passive,refusing to participate in their care, attempt towork, etc. Levy reports that staff, who are alsounder constant strain of working with very ill,irritable, depressed patients, often use the powerdifferential to meet their own emotional needsand may contribute to forcing people to be evenmore dependent (43). It is a rare patient andfamily who are knowledgeable enough to over-come this.

—

,22 . Background Paper #2: Case Studies of Medical Technologies

A study on suicide by Abram, Moore, andWesterfield (1971) is reported in Levy (43). Thatstudy indicates that the rate of suicide by directaction is similar among patients with ESRD tothe rate among persons with other chronic dis-eases—seven times greater than the rate for thegeneral population. If one includes “indirect”suicide (e. g., that caused by ignoring dietarylimits, fluid overload, etc.), the rate is con-siderably greater.

Finally, cadaver transplants present anotherproblem. Patients often anticipate holiday week-ends with joy, since the highway death tollpresents them with a chance for a better life.Then they feel guilty for wishing for anotherperson’s death. For the patients who do not ob-tain a kidney, there is a “Christmas eve, noChristmas morning” syndrome of disappoint-ment and depression. Kidney transplantation isstill high-risk surgery. It also requires immuno-suppression, with many complications, for therest of the person’s life. Physicians, themselves,when suffering from ESRD almost never opt forkidney transplants (43), and one physician hasdescribed the agonies associated with treatment(15).

Rettig reports that one of the major disap-pointments and cost contributing factors of theESRD program is that quality of life has re-mained poor (64). At this time, there are fewsolutions to this. As older and sicker patients(e.g., diabetics) are put on dialysis, this problemis apt to worsen. Yet, in most centers, potentialand current patients are not routinely given anoption of not starting or of terminating treat-ment.

Heart Transplants

There are a number of problems that all car-diac transplant patients must deal with aftersurgery. After discharge from the hospital, eachpatient must make frequent clinic visits, stay ona special diet, maintain a good weight, and getregular but moderate exercise. Most important,patients must accustom themselves to a life-longdose of immunosuppressant drugs to prevent re-jection of the transplant. Artificial heart recip-ients would not encounter all of these problems,

but their quality of life maybe severely impairedby sequelae (aftereffects) of surgery, many ofwhich may be unforeseen.

The family of the cardiac transplant patientmust also make adjustments. It is sometimes dif-ficult for patients and their families to adjust tothe new roles in which they find themselves. Thesick role of the patient is no longer appropriateor desirable after transplantation, but some pa-tients find it difficult to give up. Other potentialproblems include insecurities regarding self-image, guilt feelings over the burden placed onfamily or society, and severe depression trig-gered by their new status as a heart transplantpatient. Of those patients who survive morethan a year, 90 percent have been rehabilitated.For some, this implies a return to previousemployment; for others, it means an active lifeas students, homemakers, or retirees (19).

It has been possible to rehabilitate the majori-ty of Stanford’s surviving cardiac transplant pa-tients, in part because of the stringent patientselection criteria which Stanford applies, and inpart because Stanford works intensively with asmall number of patients. * Medical criteria in-clude the presence of end-stage heart disease,absence of systemic disease, and minimal sec-ondary organ damage. The psychosocial criteriainclude a stable work history, a history of goodmedical compliance, a supportive family, and areasonable expectation that additional life willbe gained by transplantation. Patients undergoextensive evaluation for psychological problemsthat would preclude good rehabilitation. Thefact that recipients are very carefully selectedand are attended closely by Stanford staffbefore, during, and after surgery appears crucialfor the success of the Stanford program.

Problems of a Nuclear= Powered Heart

As mentioned earlier, Federal funding for re-search on a nuclear device has been ended—butmany researchers still believe that it is preferableto other potential sources of power and continue

*Rehabilitation following heart transplantation is defined as“restoration of physical and psychosocial capacity to a level atwhich the patient has the options to return to employment or to anactivity of choice” (73).


to cite it as an alternative. One drawback to thepneumatic systems that are currently being usedin clinical assist devices and experimental re-placement devices is that the patient or experi-mental animal is literally tethered to a source ofcompressed air. The associated noise and lack ofmobility would surely have profound psycho-logical effects on the patient were such a deviceto be used over a prolonged period. An addi-tional major drawback is the risk of infectionalong the track of the tubing passing through thepatient’s chest wall.

The risk of infection is also a seriousdrawback to electrically powered systems thatdepend on percutaneous electrical leads, but isavoided by chemical batteries that can be re-charged transcutaneously. Reliability, bulk, andother physical limitations are other problemswith electrical and battery systems that remainto be satisfactorily resolved.

The most advanced nuclear system dependson the principle of heat generation by radioac-tive decay. The heat powers a miniature gas/vapor engine, which in turn drives a bloodpump. Of several isotopes that might have beenselected, the isotope Pu-238 with a half-life of 87years has been used most extensively. The de-sign requires the system to respond to physio-logical demands; the waste heat of the energysource must be dissipated from and by the body,and the radiation exposure must be “tolerable. ”

The normal heart produces some 1.5 to 4watts of mechanical pumping power. (Thesepower levels are over 10,000 times higher thanthose required for cardiac pacemaking. ) Given asystem of 10-percent efficiency, approximately50 watts of energy must be produced, and 45watts of waste heat must be continuously rejectedto minimize a resultant rise of body tempera-ture.* The proposal for the use of radioisotopesin such devices arose when the concept of “max-imal permissible dose” was prevalent. Thistheory, postulating that there was a dose ofradiation below which there was no detectableadverse biological effect, is now discredited (49).

*Current thermal engines use 25 watts of heat and have efficien-cies of 13 percent or more (30).

Pu-238 was chosen as a power source on thebasis of its short half-life, relatively low radia-tion, containment technology, and costs. It is analpha-particle emitter that also has a spon-taneous fission half-life of 4.9 X 1010 years,which is a source of neutron and gamma radia-tion. Its decay scheme is complex and results inthe buildup of plutonium-236 (Pu-236), which inturn decays to emit energetic gamma. All thismakes shielding the most serious problem;shielding requirements need to be determined ex-perimentally.

A Pu-238 heat source and shielded capsulesufficient to produce 52 watts, as reported byNHLBI in 1972, was found to produce 2.7 radsper hour measured at the capsule surface and 0.6millirem per hour measured 1 meter from thesurface. Simple calculations indicate that the pa-tient would be exposed to 23,652 rads in 1 year.The radiation dose for a spouse sharing the samebed for 8 hours per night 1 meter distant wouldbe 1.752 rads in 1 year. To indicate the mag-nitude of these exposures, it should be noted thatnatural background radiation is about 100 milli-rem per year— the doubling dose of geneticmutation is estimated to fall in the range of 70 to200 rem, and exposure of the U.S. population to5 additional rem per 30 years could cause 3,000to 15,000 cancer deaths annually (depending onthe assumptions made in the calculation).

Discussion

From the information presented above, it canbe seen that in the case of kidney and cardiactransplant patients, there exist definite barriersto posttransplant rehabilitation. Although thegreatest medical problem for these patients—thehost immune response to the implanted organ—would not occur in artificial heart recipientsbecause the implanted organ would be complete-ly artificial, the psychosocial barriers to post-transplant rehabilitation are numerous. Whilemany dialysis and cardiac transplant patientshave been able to return to work and lead activelives, many more have had substantial difficultyin doing so. If recipients of the artificial heartfare no better than recipients of heart or kidneytransplants, then the claims regarding their


potential for health and economic productivitywill ring false.

It also should be noted that the artificial heartwill generate its own set of problems for pa-tients. Psychological stress may characterizerecipients who have difficulty coping with theirtotal reliance on an implanted machine for life.The inconvenience and anxiety related to re-charging batteries, the potential for suddenmechanical or electrical failure leading to death,or risks of radiation would clearly reduce thequality of life. The costs of implantation andcontinuing medical care could cause financialproblems that would make adjustment harderand induce guilt in recipients over depleting

SOCIAL BENEFITS

The development of emergency and tempo-rary devices (such as the intra-aortic balloonpump) en route to the artificial heart is atechnological benefit of the artificial heart pro-gram. Similarly, the successful fabrication ofbiomaterials may help in the development ofother artificial organs, making the research ex-penses incurred in the development of the artifi-cial heart less overwhelming. In the followingdiscussion, an effort is made to describe and esti-mate the social benefits that may result from asuccessful implantation program. The focus ison two of the most publicized potential benefits:1) the potential gain in years of life that mayresult among recipients of the device, and 2) thepotential for artificial heart recipients to returnto an active productive life.

Extension of Life

In the foregoing discussion of economicaspects of the artificial heart program, it wasnoted that there has already been a substantialinvestment in R&D and that the costs of clinicalapplication can be expected to be enormous.What will be the return on this investment? The1969 Ad Hoc Task Force on Cardiac Replace-ment (1), while providing an estimate of thenumber of prospective recipients which still ap-pears today to be a realistic one, made no effort

family resources. How well patients deal withthese problems will be determined by individualattitudes—and these will be shaped to some ex-tent by how the rest of society receives the in-novation, as well as by general concerns overour growing dependence on technology. Becauseso many factors affect the patient’s ability torecover from implantation, adequate counselingand psychiatric services should be a part of pre-implantation and postimplantation procedures.To the greatest extent possible, the decisionregarding implantation should actively involvethe patient so as to ensure the highest quality oflife possible.

to predict the success of replacement or howlong a recipient might expect to live. However,the members of the 1973 Artificial Heart Assess-ment Panel (51) did make such an effort. Thispanel assumed at the outset that the artificialheart would be perfect—i.e., that the instrumentwould not fail, that there would be no deathsassociated with its surgical implantation, andthat all deaths from heart failure would beprevented for the subsequent 10 years. These un-likely assumptions led to equally unlikely cal-culations that the lo-year mortality of recipientswould be substantially less than that of membersof the general population of equal age. Thus, inthe 10-year period following artificial heart im-plantation in a cohort of 1,000 60-year-olds, thepanel estimated that there would be 135 deaths—from cancer, stroke, and other conditions towhich we all are subject, but not from heart dis-ease. The 10-year mortality for 1,000 60-year-olds in the general population, as reflected in theU.S. Vital Statistics at that time, was 330, morethan twice that predicted for artificial heart re-cipients.

Though it appears that the estimates by the1973 panel were unduly optimistic, there is noway of knowing exactly how large an increase inlife expectancy among artificial heart recipientscan be reasonably anticipated. If a device of high

Case Study #9: The Artificial Heart Cost Risks and Benefits ● 25

reliability can be achieved, if the operation turnsout to be technically no more difficult than aheart transplant, and if major complicationssuch as hemorrhage and thromboembolic phe-nomena are infrequent, it is possible that the lifeexpectancy of a recipient might be similar to thatof other patients who have undergone successfulheart surgery of equal magnitude (e.g., CABGpatients). If, on the other hand, instrumentreliability is as large a problem as some fear, andif there are frequent and serious clinical com-plications, the life expectancy of a recipientmight more nearly approximate that of other pa-tients undergoing major medical and surgical in-terventions (e.g., recipients of heart transplants,patients with implanted pacemakers, patientssuffering from ESRD on hemodialysis, or recipi-ents of kidney transplants). The recipient of anartificial heart would not be subject to many ofthe unique difficulties encountered by theseother groups, but it is not unreasonable to an-ticipate that they may encounter difficulties ofequal magnitude.

With full appreciation of the uncertainties in-volved, we make “best case” and’’ worst case”assumptions that are described below. Fromthese assumptions and from relevant life tables,we calculate the potential impact of an artificialheart on the life expectancy of a randomlyselected member of the general population of agiven age, and its impact on the life expectancyof a member of the general public of a given agewho is destined to suffer death from ischemicheart disease (IHD) sometime in the future.

We have limited the analysis to potential re-cipients between the ages of 25 and 64. For our“best case,” we have assumed that approximate-ly one-sixth of patients dying of IHD will be can-didates for artificial heart replacement (see table6). * We also assume (see table 7) that 15 percentof recipients between the ages of 25 and 34 willdie at the time of surgery or in the following year(to these recipients we assign no added years oflife); we assume that an additional 30 percentwill die between the ages of 35 and 44, 30 per-cent more will die between the ages of 45 and 54,and the remaining 25 percent will die between

*See discussion above on the pool of potential recipients.

Table 6.—Fraction of Those With IHD in Each AgeInterval That Gets the Device—Best and Worst Case

Best case Worst caseAge Fraction Age Fraction

0-4 . . . . . . . . . . 0 0-4 ....., . 05-14 . . . . . . . . . 0 5-14 . . . . . . . . . 015-24 . . . . . . . . 0 15-24 . . . . . . . . 025-34 . . . . . . . . 1/6 25-34 . . . . . . . . 1/1 235-44 . . . . . . . . 1/6 35-44 . . . . . . . . 1/124 5 - 5 4 . . . . . . . , 1/6 45-54 . . . . . . . . 1/1255-64 . . . . . . . . 1/6 55-64 . . . . . . . . 1/1265-74 . . . . . . . . 0 65-74 . . . . . . . . 075-84 . . . . . . . . 0 75-84 . . . . . . . . 085 or more . . . . 0 85 or more . . . . 0

SOURCE Calculations by A, Whittemore with the assistance of G Kelly, 1980

the ages of 55 and 64. We make parallel assump-tions for recipients aged 35 to 44, 45 to 54, and55 to 64 (see table 7).

For our “worst case, ” we assume that onlyone-twelfth of patients dying of IHD will be-come candidates for replacement (see table 6).We also assume higher initial mortality and ahigher failure rate (see table 8). Other observersor investigators may choose to revise our calcu-lations using different sets of assumptions.

Calculations:

Using the age-specific death rates due to allcauses (see table 9) and to IHD (see table 10), wefirst estimated the “net” distribution of time tooccurrence of IHD. This is the distribution inthe hypothetical absence of all other causes ofdeath. We also estimated the net distribution oftime to death from other causes, in the absenceof death due to IHD. These computations weredone as described in Chiang (18).

To describe the impact of an artificial heartdevice, we assumed that a fraction 7\, of thosewho develop IHD in their ith age interval getsthe device (see table 6). We also supposed that aproportion rji of those getting the device in inter-val j dies due to complications associated withthe device in a subsequent interval i, i >= j. Theproportions rji are shown in table 7 (best case)and 8 (worst case).

We then computed a new net distribution ofdeath due to IHD, assuming that the device wasavailable. Note that in this case an individualcan die in the ith age interval from IHD in twoways: Either the person developed IHD and failsto receive the device, or the person dies as a re-


Table 7.—Proportion of Those Obtaining the Device That DiesDue to Device Failure at Subsequent Ages—Best Case

Age at which device was obtainedAge at which device failed o - 4 5 - 1 4 1 5 - 2 4 2 5 - 3 4 3 5 - 4 4 4 5 - 5 4 5 5 - 6 40-4. . . . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 05-14. . . . . . . . . . . . . . . . . . . . o 0 0 0 0 0 015-24 . . . . . . . . . . . . . . . . . . . O 0 0 0 0 0 025-34. . . . . . . . . . . . . . . . . . . O 0 0 0.15 0 0 035-44. . . . . . . . . . . . . . . . . . . o 0 0 0.3 0.2 0 045-54. . . . . . . . . . . . . . . . . . . 0 0 0 0.3 0.35 0.25 055-64. . . . . . . . . . . . . . . . . . . 0 0 0 0.25 0.35 0.4 0.365-74. . . . . . . . . . . . . . . . . . . 0 0 0 0 0.1 0.3 0.4575-84. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0.05 0.25850 or more. . . . . . . . . . . . . . . 0 0 0 0 0 0 0

SOURCE: Estimates by D. Lubeck and J. P. Bunker 1980.

Table 8.—Proportion of Those Obtaining the Device That DiesDue to Device FaiIure at Subsequent Ages—Worst Case

Age at which device was obtained

Age at which device fa i led O-4 5 - 1 4 1 5 - 2 4 2 5 - 3 4 3 5 - 4 4 4 5 - 5 4 5 5 - 6 4

0-4. . . . . . . . . . . . . . . . . . . . . o 0 0 0 0 0 05-14. . . . . . . . . . . . . . . . . . . . o 0 0 0 0 0 015-24. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 025-34. . . . . . . . . . . . . . . . . . . o 0 0.3 0 035-44. . . . . . . . . . . . . . . . . . . : o 0 0.6 0.4 0 045-54. . . . . . . . . . . . . . . . . . . 0 0 0 0.1 0.6 0.5 055-64. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0.5 0.665-74. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 0.475-84. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 085 or more . . . . . . . . . . . . . . . 0 0 0 0 0 0 0

SOURCE: Estimates byD. Lubeckand J. P. Bunker, 1980.

Table 9.—Age-Specific Death RatesDue to All Causes, 1977

Table 10.—Age-Specific Death RatesDue to lHD,1977

A g e Death rate0-4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.0006885-14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00034615-24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00117125-34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00136235-44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00247545-54 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00620755-64 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.0143465-74 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.03055675-84 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.07181985 or more . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.147259

A g e Death rateo-4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 05-14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 015-24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00000425-34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00004235-44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00038445-54 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00168355-64 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.00466565-74 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.01116475-84 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.02889585 or more . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.064201

SOURCE: Mont/r/y Vita/StafisficsReport (Hyattsville, Md: National Center for SOURCE: Monf/r/y Vita/ Statistics Freport (Hyattsville, Md~ National Canter forHealth Statistics). Health Statistics)


suit of complications associated with a devicereceived in a previous interval j<= i. The prob-ability of the first event is fi (l-~i), where fi is thenet probability of the occurrence of IHD in in-terval i. The probability of the second event is:

X fj ~j rjl

j<=i

Thus, the new net probability f'i of death dueto IHD in interval i is:

f 'i

= f i (l–Xi) + Z fj ‘Tj rji

j<=i

This new net distribution, together with thenet distribution for time to death due to othercauses, yielded a single distribution for time todeath, as described by Chiang (18), in the eventthat the device is available. By comparing thisdistribution with current death rates, we calcu-lated the increase in life expectancy due to thedevice that might be enjoyed by a randomlychosen individual in the U.S. population. Thegains in life expectancy for individuals who ulti-mately develop IHD were also calculated. Thesegains are shown in tables 11 and 12.

From table 11, we see that under our “bestcase” assumptions, a randomly chosen 25-year-old gains 0.0966 of a year (or approximately 35days) in life expectancy from the availability ofan artificial heart; under our “worst case”assumptions, the gain is reduced to 0.0218 of ayear (or about a week). The gain in life expec-tancy will accrue only to those 25-year-olds

Table 11 .—Increase in Life Expectancy in Years forRandomil Selected individuals of Specified Ages

Who May or May Not Develop IHD–Best and Worst Case

Best case Worst caseIncrease Increase

in life in lifeA g e expectancy A g e expectancy0-4 . . . . . . . . . . 0.096 0-4 . . . . . . . . . . 0.02145-14 . . . . . . . . . 0.0963 5-14 . . . . . . . . . 0.0214615-24 . . . . . . . . 0.0966 15-24 . . . . . . . . 0.021525-34 . . . . . . . . . 0.0966 25-34 . . . . . . . . 0.021835-44 . . . . . . . . 0.0963 35-44 . . . . . . . . 0.0209645-54 . . . . . . . . 0.0804 45-54 . . . . . . . . 0.015155-64 . . . . . . . . 0.0306 55-64 . . . . . . . . 0.001165-74a ., . . . . . – 0.0602 65-74a . . . . . . . . –0.01975-84a . . . . . . . – 0.0137 75-84 . . . . . . . . 0.085 or more. . . . 0.0 85 or more. . . . 0.0

aNegative values in persons over age 65 reflect the impact on this age group ofpatients who have received the artificial heart prior to age 65 and who bear theadded risk of death due to complications or disease.

SOURCE: Calculations by A. Whlttemore with the assistance of G. Kelly, 1960.

Table 12.—Increase in Life Expectancy in Years forindividuals of Specified Ages Who Will Ultimately

Develop IHD-Best and Worst Case

Best case Worst caseIncrease Increase

in life in lifeA g e expectancy A g e expectancy0-4 . . . . . . . . . . 0.6025 0-4 . . . . . . . . . . 0.13435-14 . . . . . . . . . 0.6029 5-14 . . . . . . . . . 0.134415-24 . . . . . . . . 0.6033 15-24 . . . . . . . . 0.134525-34 . . . . . . . . 0.6049 25-34 . . . . . . . . 0.134835-44 . . . . . . . . 0.59085 35-44 . . . . . . . . 0.128545-54 . . . . . . . . 0.4925 45-54 . . . . . . . . 0.092555-64 . . . . . . . . 0.1935 55-64 . . . . . . . . 0.00765-74a . . . . . . . . – 0.4925 65-74a . . . . . . . . – 0.134275-84a . . . . . . . -0.1430 75-84 . . . . . . . . 0.085 or more . . . . 0.0 85 or more . . . . 0.0aNegative values in persons over age 65 reflect the impact on this age group of

patients who have received the artificial heart prior to age 65 and who bear theadded risk of death due to complications or disease.

SOURCE: Calculations by A. Whittemore with the assistance of G. Kelly, 1980.

destined to develop IHD. As shown in table 12,the calculated increase in life expectancy forthese individuals, 0.6049 year (best case) and0.1348 year (worst case), is considerably greaterthan that for randomly selected 25-year-olds.

Comparable calculations are presented intables 11 and 12 for individuals in 10-year agegroups up to the age of 84. It should be notedthat at older ages the gain in life expectancybecomes smaller, because older individuals havea much shorter period of time in which to be-come candidates. It also should be noted thatthere is a decrease in average life expectancyamong persons over age 65. This results fromthe inclusion in this age group over time of indi-viduals who received an artificial heart prior toreaching age 65 (individuals age 65 and over arethemselves ineligible for the device). Such per-sons have a lower than average life expectancybecause of the risk of future complications asso-ciated with the artificial heart, so their inclusionin this age group decreases the overall average.

In order to arrive at the average populationincrease, the increase in life expectancy for arandomly selected individual in each age groupis multiplied by the fraction of the population inthat age group and summed. Under the “bestcase” conditions, the average increase is 0.0697year (25 days). Under the “worst case” condi-tions, the average increase is 0.0106 year (4

28 . Background Paper #2: Case Studies of Medical Technologies

days). For those individuals destined to developIHD, the average increase for the “best case” is0.4478 year (163 days). The average increase forthe “worst case” is 0.0926 year (34 days).

Return to Work

In order to estimate the possible effect of ar-tificial heart surgery on return to work, wereviewed the experience of patients undergoinghemodialysis and CABG surgery. The findingsfrom the studies cited below indicate that eachintervention has considerable impact on the oc-cupational situation of patients, especially in thecase of older individuals. The findings also castsome doubt on the early predictions that theartificial heart will be economically beneficial tosociety by returning large numbers of individ-uals from their sickbeds to gainful activity.

Hemodialysis Patients

Though several authors discuss the return-to-work issue for dialysis patients, all say that thedata are not very good (9,25,43,64). However,McKegeny, cited in Levy (43), reported thatmany dialysis patients could return to work parttime (20 hours per week), but do not do sobecause they would lose all benefits for theirtreatment. McKegney also comments that dialy-sis patients are still weak and anemic and haveintercurrent illnesses. Katz and Capron (39)report better experience for dialysis patients inthe United Kingdom. There, 66 percent of pa-tients are on home dialysis, which can be doneduring sleep at night. Sixty-five percent of thosepatients return to work full time.

CABG Patients

A study of 893 men at a median time of 14months after CABG surgery was reported byRimm, et al. (65). Seventy-six of the men wereretired at the time of surgery, leaving 817 men ofall ages and occupational groups in the study.The following six occupational groups were de-fined: 1) professionals; 2) administrators, mana-gers, officials, and providers; 3) clerical andsales workers; 4) skilled workers, foremen, andtradesmen; 5) metal processors, machinery

workers and factory workers; 6) semiskilled andunskilled workers.

Of the 817 men working before surgery, 52.9percent stayed in the same occupational group,31.1 percent changed occupational group, and17 percent retired. In the subgroup of 510 pa-tients less than 55 years of age who were work-ing before surgery, 56.1 percent stayed in thesame occupational group, 32.5 percent changedoccupational group, and 11.4 percent retired. Inthe subgroup of patients 55 years of age andolder, 47.6 percent stayed in the same occupa-tional group, 26 percent changed occupationalgroup, and 26.4 percent retired. In the latter agegroup, persons in occupational groups 4, 5, and6 had only a 60- to 70-percent overall return towork. The authors found that the observedretirement rate in the study population was 7.5times that of a comparable U.S. male populationfor those 35 to 54 years of age and 11.3 timesthat for those who were older.

Crosby, et al. (24) found that at an average of18 months after surgery for left main coronaryartery disease, 62 percent of 70 patients returnedto work; 32 percent retired on disability; and 6percent who were able to work chose to retire.Information disaggregated by age categories wasnot presented in this study.

A Toronto study (75) assessed the proximityto retirement age and its effects on employmentpatterns after CABG surgery. Of 329 patients(men and women), 178 were employed beforesurgery (54 percent). Of these 178, 122 wereunder 55 years of age, and 56 were older. Twoyears after surgery, 81 percent of those underage 55 and 75 percent of those over age 55 wereemployed. Overall, 79 percent of the 178 pa-tients returned to work.

Finally, in a review of the effect of CABG sur-gery on work status, McIntosh and Garcia (47)mention a study of patients at Emory Univer-sity. The effect of CABG surgery on patients’work status was less than its effect on their exer-cise tolerance levels. Its effect on work statusdepended on individual economic considera-tions (especially retirement provisions). Al-though 90 percent of the patients observed at


Emory had symptomatic improvement, only 50percent returned to work after surgery.

The evidence with regard to positive occupa-tional rehabilitation as a result of CABG surgeryis conflicting. Studies of patients in randomizedtrials show a lesser return to work for surgicalpatients than for medical patients (59). It seemsthat even if the procedure is successful, manypatients seize the opportunity to retire, which isat that time socially acceptable and legitimate.Factors that influence this choice are the dura-tion of postoperative recovery and the availabil-ity of compensation or retirement benefits.

Artificial Heart Recipients

Thus, we have several proxies on which tobase estimates of probability of return to workafter artificial heart implantation. The percent-age of cardiac transplant patients who return towork is 20 to 25 percent (62). Because cardiactransplantation leaves the recipient prone to in-fections and rejection from the body’s immunesystem, however, we believe that this percentage

SOCIAL COSTS

A comparison of the costs of the artificialheart must include not only the charges to theconsumer, but future economic effects on soci-ety as a whole. Below we discuss four prominentissues that arise in connection with proposeddevelopment of an artificial heart: 1) increasedsocial expenditures, 2) distributional issues, 3)social costs of a nuclear device, and 4) oppor-tunity costs.

Increased Social Expenditures

The extent of increased costs to society willdepend on the quality of the artificial heart inclinical application. A highly effective devicecould increase the productivity of midcareer re-cipients and greatly benefit society. An inade-quate device, however, would mean, in additionto losses in productivity, the loss to society of itsinvestment in R&D, and charges for implanta-tion, continuing medical care, welfare andrehabilitation programs.

is lower than might be expected among recipi-ents of an artificial heart.

Patients with coronary artery disease amena-ble to surgery are often in much better medicalcondition than those who would be receiving anartificial heart. Thus, we believe that the return-to-work figures for the coronary bypass grouprepresent an upper limit. From the study byRimm, et al. (65), we note a return-to-work per-centage of 70 to 80 percent for CABG patientsunder age 55 and from so to 70 percent forCABG patients between age 55 and 65. We alsonote an approximate percentage of 60 percent ofpersons with advanced kidney disease on homedialysis who are able to maintain a normalworking condition.

Thus, we would suggest as the overall per-centage of previously employed artificial heartrecipients who might return to work aftersurgery a lower limit of 20 percent (based on theexperience of heart transplant patients) and anupper limit of 60 percent (based on the ex-perience of CABG patients).

The potential burden on social security andother retirement programs is related not only tothe reliability and effectiveness of the artificialheart, but also to the quality of rehabilitationand the desire of recipients to return to activelives. The experience of cardiac transplant pa-tients emphasizes the importance of psychoso-cial and economic motivation for completerehabilitation. Likewise, the rapid diffusion ofCABG surgery, with its disappointing return-to-work figures, suggests that considerable plan-ning—with an eye toward comprehensive treat-ment, counseling and restricted development—should precede clinical application of the ar-tificial heart to ensure the best possible results.

Given the large number of patients who mightbenefit from artificial heart surgery, the costcould run into the billions, as predicted bySapolsky in 1978 (70). Yuki Nosé, of the Cleve-land Clinic, has expressed the opinion thatsocietal costs will equal those of present dialysis

30 ● Background Paperr #2 : Case Studies of Medical Technologies

payments by medicare (whichbillion).

From our own assumptions,cost of artificial heart surgery33,600 implantations are done

now exceed $1

if the averageis $28,000 andeach year, the

yearly aggregate cost for the surgery alonewould be $941 million (see table 2). Added to thecost of surgery are continuing care costs—esti-mated at $2,000 per patient per year—which willincrease incrementally as the number of pro-cedures (and patients) accrues.

Using our figures (which are conservativeestimates) for the cost of implantation and thepool of recipients, and applying these continuingcare costs ($2,000 per patient per year) to thesurvival rates of heart transplant patients atStanford (i.e., 70-percent survival for the firstyear and 5-percent attrition each succeedingyear, or 50-percent survival through 5 years)yields the 5-year cost projections in table 13. Ascan be seen in that table, first year costs for33,600 implantations at $28,000 per procedurewould be about $941 million. Second year costswould be $941 million for another 33,600 im-plantations (at $28,000 per procedure) plusmaintenance costs of about $47 million for the23,520 survivors (at $2,000 per survivor), or atotal of about $988 million. Third year costswould be $941 million for another 33,600 im-plantations plus maintenance costs of about $91million for the survivors, or a total of about$1,032 million. Fourth and fifth year costs,calculated similarly, would be about $1,072million and $1,109 million, respectively.

Even at these cost levels and projected patientpools, the artificial heart (when distributed on a

large scale) will incur costs equivalent to presentdialysis payments within 1 year. If the implanta-tion turns out to be more costly, then the pro-gram will rapidly approach $2 billion annually.The decision to finance hemodialysis and the re-cent recommendation to finance cardiac trans-plants through medicare indicates that the costsof artificial heart implantation will probably befederally financed. If the experience of hemo-dialysis is typical of procedures supported bypublic funds, then we can expect a progressiontoward more relaxed patient selection criteriafor and widespread availability of the artificialheart. Previously excluded candidates wouldthus be included. As the recipient group is ex-panded, and more resources are invested, themarginal quality-of-life improvements and lon-gevity improvements will lessen.

Though the impact of the artificial heart ontotal population growth may be small, an in-crease in the proportion of older citizens maynecessitate increased expenditures by socialsecurity and medicare to cover rehabilitationand early retirement. The present burden onsocial security due to our expanding elderlypopulation is already well documented and offiscal concern. The burden of increased socialsecurity expenditures will fall on all taxpayers. Ifrecipients of the device are substantially moreproductive than they would have been withoutit, costs of the program maybe made up throughincreased tax revenue, as was predicted in the1966 Hittman Report (35). Therefore, the devel-opment of a strong comprehensive rehabilitationprogram is crucial if the artificial heart is de-signed for large-scale distribution.

Table 13.—Projected 5-Year Sequence of Total National Expenditures on Artificial Heart Implantationand Patient Maintenance (dollars in millions)

First year Second year Third year Fourth year Fifth yearImplantation charges. . . . . . . . . . . . . . . . . . . . . . $940.80 $940.80 $ 9 4 0 . 8 0 $ 9 4 0 . 8 0 $ 9 4 0 . 8 0Maintenance

Year 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — 47.04 47.04 47.04 47.04Year2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — 43.68 43.68 43.68Year3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — — 40.32 40.32Year4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — — 36.96

Total costs . . . . . . . . . . . . . . . . . . . . . . . . . . $940.80 $987.84 $1,031 .52 –$1,071.84 $1,108.80

SOURCE: D. Lubeck and J. P. Bunker, 19S0. See text for assumptions.

—


Distributional Issues

In the experimental years of the artificial heartprogram, strict patient selection criteria (similarto those for cardiac transplantation) would limitdistribution and reimbursement problems. How-ever, as the procedure becomes established fortherapy, and medical criteria are relaxed, therewill be fewer clinical reasons to deny the artifi-cial heart to an individual able to benefit from it.Thus, financial considerations will gain in sig-nificance.

Even the most conservative estimates of thecost of the artificial heart project an amount thatwould be a severe burden on many families. In-surance companies, particularly in the earlyyears of the artificial heart’s availability, maybeunwilling to shoulder the high costs of such aninnovative treatment, just as they have been inthe case of cardiac transplants. Yet, in recentyears, Americans more and more have come tosee access to available modes of health care as abasic right that should not depend on one’s abili-ty to pay. The decision to cover hemodialysisunder medicare is the most notable illustration.In the case of the artificial heart, the demand forpublic financing would be strengthened by thefact that the device came into existence onlybecause citizens’ tax dollars financed its devel-opment.

If artificial hearts do become available, theFederal Government will be faced with a seriousdilemma—either to deny many citizens access toa device sponsored by a Government researchprogram or to embark on a subsidization planthat could run into billions of dollars annually.Patient selection criteria and the mode of reim-bursement will be the policy components thatestablish the scope and equity of artificial heartdistribution. The challenge will be to design eco-nomically realistic financing and allocation ar-rangements that will not ration life on the basisof the value of individual members to society.

Social Costs of a Nuclear Device

The social cost of a plutonium-fueled artificialheart relates to the associated environmentaland social hazards. Plutonium is an extremely

toxic material. Each capsule (containing about50 g of Pu-238) is the equivalent of many mil-lions of lethal doses to a human being. Frommanufacture through transportation and storageto implantation, the materials would have to beprotected from accidents and thefts that mightresult in breach of the capsule and release of thePu-238 into the environment. After a patient’sdeath, the material would have to be quickly re-covered and returned to the Government. Sincethe basic premise of developing a device is thatthe device will be widely distributed, it followsthat the safeguards associated with a nuclearpower source would also be widely applied. Theproblems that could arise under conditions ofunexpected use, theft, terrorism, or accident aredramatized by the estimate (with a very widerange of variability) that if the 50 g of Pu-238 inthe artificial heart were to be distributed as anideally aerosolized particle, that particle wouldbe the equivalent of 1.7 billion doses of, lungcancer (26).

In addition to these risks, another considera-tion is the capital costs. At the current price ofPu-238 ($1,000 per g), each device (containing50 g of Pu-238) would cost $50,000 for fuelalone. At 50,000 devices per year, the initialcosts for fuel alone would be $2.5 billion. If thiswere financed at lo-percent simple interest peryear, the finance charge would be $250 millionper year. These costs would be added on to theother costs previously mentioned.

Opportunity Costs

In considering the costs of the artificial heartprogram, one must also take into account poten-tial gains that might have accrued from othersocial expenditures precluded by the primacy ofartificial heart development. Although spendingon one project does not automatically precludespending on another program, the developmentand promotion of an artificial heart is likely toreemphasize the importance of alternative ap-proaches to the treatment of heart disease, aswell as increase social costs.

As noted earlier, distribution of the artificialheart may proportionately raise social expendi-tures financed through medicare and social secu-


rity, so funds will have to be diverted from otherprograms. This will be especially true if socialsecurity, in the future, is partially financed fromgeneral funds. There are additional potentialtradeoffs in the area of biomedical research.Thus, for example, the question may be askedwhether the research funds that support thetraining of new heart surgeons and technicianswill deter or undermine research on heart diseaseprevention or other forms of treating car-diovascular disease.

CARDIAC DISEASE PREVENTION

A perspective on heart replacement can be ob-tained by comparing replacement with alter-native programs that have the same criteria ofeffectiveness (i.e., increased life expectancy) andrepresent present investments for the future.One alternative is to try to prevent the occur-rence of heart disease by altering individual andinstitutional patterns of behavior.

Independent risk factors that contribute topremature cardiac disease are elevated serumcholesterol, cigarette smoking, and high bloodpressure. Much of the evidence supporting theimportance of these factors stems from theFramingham study, epidemiological studies thatcompare affluent, technology-based societieswith those less affluent, and collaboratingevidence from population studies.

The evidence establishing a constellation ofrisk factors related to coronary heart disease(CHD) led NHLBI in 1970 to fund several dec-ade-long, community-based clinical trials de-signed to develop methods of risk reduction ap-plicable to home, work, and community envi-ronments. The Stanford Heart Disease Preven-tion Program (SHDPP) was initiated in 1971 aspart of this NHLBI research.

To estimate the potential effectiveness ofmodifying risk factors in preventing CHD in theU.S. population, we have chosen to look at theresults of the SHDPP Three Community Educa-tion Study. This study, completed in 1975, hasdemonstrated increased community awarenessof heart disease factors, changes in targeted

Completion of the artificial heart, as noted inthe introduction to this case study, was pro-jected to occur long before an effective cardiacdisease prevention program. However, todaythere are several prevention programs that holdthe potential for reaching more people and atless cost than the artificial heart. The alternativeof cardiac disease prevention is discussed inmore detail below.

behavior (reductions in smoking and cholesterollevels), and a decrease in risk factors. It indicatesthe great potential of prevention in reducingdeath from CHD, though conclusive evidenceon whether a population or an individual willexperience an actual decline in mortality is notyet available (more information about theSHDPP study is presented in app. D).

Three comparable communities were selectedfor the study: one control town (Tracy) and twoexperimental towns (Gilroy and Watsonville).The experimental towns received health educa-tion through a mass campaign (radio, TV, news-paper, and direct mail) over 2 years. Additional-ly, high-risk individuals (those in the top quar-tile) were exposed to two different treatments:media education only (Gilroy) and a media pro-gram enriched by face-to-face instruction (Wat-sonville intensive instruction). Data weregathered through regular interviews of a randomsample of 35- to 59-year-old men and women,which measured knowledge about behavior re-lated to CHD, as well as daily dietary and smok-ing habits. After 2 years of intervention, a de-crease in overall risks of 23 to 28 percent was re-alized in the two experimental communities.There was a small increase in risk in the controlgroup (27). Figure 2 summarizes the changes inrisk for each community.

In order to determine the effectiveness of riskreductions, one must evaluate the frequency ofCHD risk factors in the population and thedegree of concentration within categories. Data


Figure 2.— Percentage Change in Risk of CHD After1 and 2 Years of Health Education in Various Study

Groups From Three Communities

Total participants

+ 3 0I

c

I

T = TracyW-recon. = Watsonville reconstituteda

v>

g + 15} i

.E + 10xt(n.- e

g:x(n.-.c.-al0)c2v

(0) (1) (2)

High-risk participants

(o) (1) (2)

awatsonville r e c o n s t i t u t e d = Watsonvllle g r o u p m i n u s Watsonvllle Intensiveinstruction group

bwatsonvllle randomized control = Watsonwlle high-risk grOuP minus Watson”vine Intensive Instruct Ion group

cwatsonvllle intensive Instruct Ion = Watsonvllle h!gh+lsk intensive 9rouP

SOURCE: Stanford Heart Disease Prevention Proqram, Stanford, Calif.

from the National Cooperative Pooling Project(2) indicate that 8 percent of 30- to 59-year-oldmen have three or more risk factors elevated; 30percent have two or more factors elevated; 45percent have one; and 17 percent have no ele-vated risk factors. By combining risk factors

with their associated mortality, one finds that ifonly 50 percent of those individuals in the cate-gory of having two or more elevated factors par-ticipated in a similar prevention program, therewould be a 23-percent reduction in new cases ofCHD. If all individuals in that category were toparticipate, there would be as much as a45-percent reduction in new cases.

Expected life extensions due to a directedprevention program can only be very generallyestimated until more data are collected. Tsaiused multiple decrement and cause-reIated lifetables to estimate the improvement in life expec-tancy due to a reduction in new cases of CHD(76). He found that if CHD is reduced by 20 per-cent, a member of the total population gains anaverage of 1.26 years of life. However, if a50-percent reduction in CHD is achieved (thepotential of a national program directed towardsthose with two or more elevated risk factors),the average gain is 3.7 years of life. These esti-mates far surpass any overall population life ex-pectancy increases that might result from theavailability of the artificial heart. *

In order to estimate the costs of a similarprevention program on a national scale, we haveevaluated the media and personnel costs of theSHDPP Three Community Education Study(27). A summary of program costs over theperiod from 1972 to 1975 is given in table14. The total cost for the three media campaignsfor the two experimental communities was$515,477. SHDPP has estimated that a similarprogram on a national level would cost approx-imately $1.5 billion.

We also reviewed another comprehensivecommunity program in Finland. The North Ka-relia Project was carried out from 1972 to 1977in the county of North Karelia, an area ofFinland with exceptionally high CHD rates (60).The objective was to reduce the mortality andmorbidity of CHD among middle-aged men(ages 25 to 59), through reduction of smoking,serum cholesterol levels, and elevated bloodpressure. More than 10,000 subjects werestudied, with a participation rate of around 90percent. Program activities were integrated with

● See extension of life estimates discussed earlier.


Table 14.—SHDPP Expenses by Media Campaign

Campaign 1 Campaign 2 Campaign 3 TotalMedia costs . . . . . . . . . . . . . . . . $120,150 $ 74,246 $ 3 3 , 9 3 0 $228,326Personnel. . . . . . . . . . . . . . . . . . 87,960 57,958 69,153 215,071Surveys and data. . . . . . . . . . . . 33,243 20,639 18,198 72,080

Total . . . . . . . . . . . . . . . . . . . . $241,353 $152,843 $121,281 $515,477Number of months . . . . . . . . . .Average/month . . . . . . . . . . . . . $8,045 $12,737 $10,107 $9,546

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Cal if,

existing social service structures and the media.The activities involved providing health serv-ices, advising individuals on changing personalbehavior, advising communities on environmen-tal changes, training personnel, and providingmedia information.

The results were evaluated by examining inde-pendent population samples at the start and atthe end of the project in North Karelia and in amatched reference county. An overall mean netreduction of 17.4 percent among all males wasobserved in the estimated CHD risk in NorthKarelia. Changes in individual risk factors weregreatest for hypertension (down 43.5 percent),followed by smoking (down 9.8 percent), cho-lesterol levels (down 4.1 percent), and bloodpressure (down 3.6 percent). However, althoughrisk factors were reduced in North Karelia, thechange in mortality was statistically the same inboth communities in the study.

A precise economic comparison of the cost ef-fectiveness of preventive programs v. the artifi-cial heart is not feasible until more informationis available on the costs, risks, and benefits ofboth approaches. The effectiveness of the artifi-cial heart is still not known, since such a deviceis not yet ready for clinical testing. By the sametoken, the effectiveness of the SHDPP in reduc-ing cardiac deaths remains to be documented,though the program is effective in reducing cer-tain CHD-related risk factors. An array of alter-native programs (including heart transplants)provides the context for decisions regardingpublic funding of disease treatment.

The two programs—cardiac disease treatmentand prevention—could coexist in a beneficialmanner, as many of our consultants noted. JohnWatson, of NHLBI, mentioned that the opportu-

nity and incentive to improve cardiac preven-tion programs will continue, despite the ad-vances due to the artificial heart. Yuki Nosé, ofthe Cleveland Clinic, mentioned that expensivetreatment programs may also lead to better diag-nostic equipment that may reverse or halt dis-ease progression for those not improved by car-diac disease prevention. The distribution andcost problems of the artificial heart might be re-duced if a prevention program were judiciouslyused to reduce CHD to a level where those per-sons in need of an artificial heart would haveeasier access to it. Cost containment or privatehealth insurance program incentives could beused to encourage this.

The data necessary for an economic evalua-tion of the two programs that would comparethe average cost per patient and the marginalcost per additional patient are not available.However, we can make some general state-ments. If the cost of an artificial heart will notdecline incrementally because it is a specializedtechnology and production competition will notbe realized, then no cost savings will be realizedthrough mass production. In contrast, the typesof prevention programs undergoing clinicaltrials now will have decreasing programing costsas educational programs are standardized anddistributed more widely in classrooms andthrough the mass media.

In assessing the cost effectiveness of a technol-ogy still in the R&D stage, one must consider thechances of attaining the desired effects and atwhat level. There are still great uncertainties tobe resolved in the development of the artificialheart (e.g., biomaterials and energy sources) andin prevention programs (e. g., their effect onreduction of cardiac deaths). A useful way to

Case Study #9: The Artificial Heart: Cost, Risks, and Benefits • 35

aim for future cost comparisons of these two ap-proaches would be to collect information in acentral registry over the next decade on the

POLICY RECOMMENDATIONS

Artificial heart research represents the firstprototype of a comprehensive Federal Govern-ment program to develop a concrete medicaldevice. As such, its significance extends beyondthe pure success or failure of the research to in-clude the lessons that affect future Federal com-mitment in applied health technology. In the fol-lowing discussion, we address three areas ofpublic policy raised by artificial heart develop-ment: 1) program administration, 2) regulation,and 3) reimbursement and distribution.

Program Administration

The Federal circulatory-assist devices programhas led to useful therapeutic inventions (such asthe intra-aortic balloon and temporary LVADs),yet the development of a clinically effective arti-ficial heart appears to be decades in the future.The manner in which research priorities are es-tablished is of fundamental importance for theartificial heart and alternative forms of treat-ment.

Previous allocation decisions led to a researchstrategy in which many identical contracts wereassigned in order to hasten the proliferation oftechnological options, rather than the usual sys-tem of investigator-initiated grants. Some con-sultants expressed the opinion that this approachresulted in unnecessary duplication of researcheffort, that it discouraged many talented re-searchers from becoming involved, and that theresulting competition interfered with the full ex-change of scientific information, thus com-pounding the magnitude of the biomaterials andenergy source problems discussed earlier. Therelative lack of dissemination of informationmay have substantially slowed the program’sprogress.

NHLBI has moved to correct these shortcom-ings through annual meetings of contractors anda larger emphasis on grants. A greater dialog be-

results of clinical trials of the LVADs and on theoutcomes of prevention programs.

tween Federal program administrators and re-searchers should be encouraged early in any re-search program to ensure widespread consensusabout the appropriate level, distribution, anddirection of research effort. If a mission-orientedapproach is deemed appropriate, it will be neces-sary to have a careful evaluation of the knowl-edge base that is necessary to identify areas ofstudy that may require further basic research.An adversarial proceeding that focuses orga-nized “skepticism” on the potential for successmay best uncover such areas.

The major responsibility for the evaluation ofthe program rests entirely with the communityof surgeons, engineers, and administrators whoare directly involved in the research. In the earlyyears, this led to an emphasis on technologicalissues and little consideration of the largersocietal needs and projected impact of thedevice. We certainly acknowledge the attemptsby NHLBI to assess a broader range of outsideopinion through the 1969 Ad Hoc Task Force onCardiac Replacement (2) and the 1973 ArtificialHeart Assessment Panel (51). However, thesebodies were charged only with advising NHLBIon internal policy in areas limited by theircharges, and they had no authority to evaluatealternative research strategies and weigh relativepriorities for the allocation of public funds.

It appears that the most comprehensiveevaluation of the costs and benefits of artificialheart research came from the Artificial HeartAssessment Panel (51), which did not stand tobenefit directly from the program in question.That panel was the first to examine in depth thecosts to society of using a nuclear power source.The panel’s recommendation that nuclear enginedevelopment be reemphasized led to the cessa-tion of nuclear research by NHLBI. In the case ofthe nuclear-powered artificial heart, taxpayersmight have recognized savings from an inde-


pendent, broad-based analysis earlier in the pro-gram, and the electrical systems under researchmight be considerably more advanced today.

Given the central role of such analyses in deci-sionmaking, it appears desirable to establish anindependent agency to consider the costs andbenefits—including the manifold social and eco-nomic implications—of medical innovations. Toensure that potential societal impacts are con-sidered early in the research process, analysis ofthe costs and benefits of medical innovationsmight take place before the initial allocation offunds by Congress. In rapidly changing areas ofbiomedical understanding, independent analysisshould also be undertaken at intervals during thelife of a program to avoid ongoing expenditureswhen more viable alternative approaches exist.The National Center for Health Care Technol-ogy (NCHCT) was established in 1978 to antici-pate and evaluate the impact of health technol-ogies and it represented a constructive steptoward such an independent authority. How-ever, its responsibilities now belong to a studysection of the National Center for Health Serv-ices Research (NCHSR), since NCHCT’s appro-priations were not renewed in 1982.

Regulation

The greatest Federal control over biomedicalinnovation is currently through regulating theintroduction of new innovations through com-prehensive legislation covering drugs and med-ical devices. A way to ensure that better infor-mation is available for making these regulatorydecisions is discussed below.

The process of developing a new medical tech-nology involves several types of testing—animalstudies, clinical trials, and experimental clinicaluse. Considerable controversy surrounded thedecision to use the 2-week LVAD in clinicaltrials of patients unable to resume cardiac func-tion after open-heart surgery in 1975. Com-pleted LVAD implants in animals had been suc-cessful, but, as is true with most experiments inanimals, the results could not readily be trans-lated to the clinical situation. At least one majorNHLBI contractor participated in the decision to

begin the clinical trials, raising serious questionsabout conflict of interest.

Ultimately, clinical trials of 2- and 5-year ver-sions of the LVAD are planned. Since each ofthese longer term devices confronts the majorproblems of the total artificial heart—energysupply, actuator and engine design, durable andhemocompatible materials—their testing canprovide an experimental model to assess the reli-ability, economic costs, and quality of life ex-pected from a total artificial heart. Before clin-ical trials with these LVADs begin, adequate in-formation on all LVADs under research shouldbe collected in order to select the best model fortesting. When clinical trials do take place, thereview process should set criteria and bound-aries to confirm their safety and ensure the pro-tection of human subjects. It is especially impor-tant that local institutional review boards befully involved in decisionmaking (i.e., that theynot be bypassed on the grounds that the deviceconstitutes “emergency therapy”). The largerimplications of such criteria might constructive-ly be addressed by the National Commission forthe Protection of Human Subjects of Biomedicaland Behavioral Research.

The Food and Drug Administration (FDA)was recently given authority by Congressthrough the Medical Device Amendments to de-velop and enforce standards for the perform-ance, efficacy, and safety of all medical devices.No regulations have yet been written for theLVAD or for the artificial heart. We recommendthat when FDA does develop regulations, itcoordinate efforts with NIH to develop a centralrepository of all (private and NIH) data onLVAD/artificial heart development, perform-ance, and clinical results. In addition to data ontechnical and protocol details, informationshould be collected on patient status (i.e., socio-economic status, age, race, sex) and details of in-formed consent measures. Submitting this infor-mation should be mandatory for all involved inorder to establish a knowledge base, and moni-toring should take place to maintain quality con-trol and compliance. This information should beused in determining criteria or regulations for


commercial marketing and device distribution,as well as R&D.

The 1973 report of the Artificial Heart Assess-ment Panel (51) called into question the activesearch for a nuclear-powered artificial heart.The panel expressed concern about the dangersof walking-plutonium proliferation and of ex-posure of the patient and relatives to higher thanacceptable levels of radiation. While suggestingthat development might proceed pending morecomplete evidence of risk, the panel specificallyrecommended against any experimental implan-tation in humans.

The potential costs of a nuclear-powereddevice may be very great. Aside from the healthrisks to the individual, the strict safeguardsnecessary to avoid theft or loss of plutoniummay well involve an unacceptable threat to thequality of life of the recipient and raise manythorny issues of civil liberties. However, thereremains to date no clear regulatory policy fullyexcluding the possibility that a nuclear devicemight be implemented in the future.

Meanwhile, the development of a clinicallyacceptable energy alternative is progressingslowly. The question arises, therefore, whetherresearch on the artificial heart is progressingwith the conscious or unconscious assumptionthat a nuclear power source is still a viable alter-native. Should we arrive on the brink of a suc-cessful device that lacks only an efficient powersource, it would be difficult to resist the pressureto go ahead with a nuclear engine. For this rea-son, we believe it is important that a firm com-mitment against the use of nuclear-powereddevices be reached.

Reimbursement and

As noted earlier in this

Distribution

case study, the cost toan individual for artificial heart implantationand continuing care will be very great. These ex-penses will place access of the device out of thehands of many needy patients, unless a plan forsocializing these costs is formulated. In the earlystages of availability, insurance companies

might well be expected not to assume the largecosts.

The prevailing trend already shows the Gov-ernment assuming responsibility for ensuringequitable access to expensive medical technol-ogies even for those technologies initially devel-oped without direct Government intervention(e.g., the artificial kidney). When the FederalGovernment underwrites the majority of re-search for an innovation, as it has with the ar-tificial heart, the issue of access assumes greatersignificance. In our opinion, in such an instance,the responsibility for ensuring equitable distri-bution rests clearly on the Government. The1973 Artificial Heart Assessment Panel noted(51):

Particularly in view of the substantial com-mitment of public funds for development of theartificial heart, implantation should be broadlyavailable, and availability should not be limitedonly to those able to pay. This objective can beaccomplished through either private or govern-ment insurance mechanisms.

At the same time, a decision by the FederalGovernment to assume this responsibility mustnot be taken lightly. A decision to finance im-plantation federally may well commit the Gov-ernment to an annual outflow of several billiondollars for a single therapeutic modality that willhave relatively little impact on national life ex-pectancy. Such a commitment is so great as todwarf all of the funds spent to date on the devel-opment of the artificial heart and other circula-tory-assist devices. This commitment also imp-lies planning and additional costs to ensure anadequate inventory, facilities, and personnel forimplantation, continuing medical care, and re-habilitation. The specific details of any cost-sharing program will obviously affect the speedand extent of clinical application. If there is noincentive to centralize resources or to encourageefficient use, the costs of application will rise asthe procedure diffuses throughout the country.The absence of cost-containment incentives mayalso result in a relaxation of medical criteria toprovide artificial hearts to patients not facedwith imminent death from cardiac disease.

.


Although the current situation with the arti-ficial heart represents a great responsibility, italso presents an opportunity. Whereas advancessuch as the computed tomography scanner wereintroduced by private industry and could not beeffectively influenced by post hoc regulation, theintroduction and distribution of circulatorydevice technology could be carefully controlledby the Government on its own terms. Westrongly believe that the time for discussing thismatter is now. At this point, a clinically effectiveartificial heart is still many years away. From theperspective of a member of society, investmentin artificial heart devices may contribute nomore to saving his or her life and health thanwould a comprehensive, effective cardiac dis-ease prevention program. This fact gives us con-siderable leeway in how we prefer to attack themassive costs of heart disease in our society.

Calabresi and Bobbitt, in their book TragicChoices (13), introduce the concept of first andsecond order decisions in the development andallocation of lifesaving technologies. The firstorder decision for the artificial heart is the deci-sion about whether or not to proceed with its de-velopment. The second order decisions are whoshould receive the device and who will pay forit. As Calabresi and Bobbitt point out, it is easierto stop or change direction at the first order deci-sion level than at the second.

The point at which Federal Government in-tervention is most likely to have a real leverageis at the first order decision level—whether tocontinue to fund the research that might makethe artificial heart a clinical reality. If abreakthrough were to occur that made a clinical-ly acceptable device a reality, or even a strongpossibility, it is likely that the demand of heartpatients, their families, and physicians for thispotentially life-extending treatment would over-whelm even carefully constructed regulatory

SUMMARY

Research to develop a permanently implanta-ble artificial heart that could be used to replace afailing natural heart has been funded by NHLBI

and financial checks on device diffusion. Thedialysis case is instructive here—nobody wantsto be put in the position of saying we will notsave identifiable lives because a procedure is tooexpensive. Consideration of regulatory and re-imbursement issues is important, both because itmay be effective to some limited degree in mak-ing the diffusion of the artificial heart more ra-tional and orderly and because it will heightenawareness of the magnitude of the potential im-pact of an artificial heart on the health caresystem.

In an era of limited resources, it is imperativethat such a potentially expensive innovation asthe artificial heart be carefully compared withother social and medical programs designed toextend life and improve its quality. Such a com-parison will require a full and candid under-standing of the likely costs and benefits of thedevice. We have found that before a completeunderstanding of the impact of an artificial heartmay be achieved, two very important questionsmust be resolved. First, the Government mustdecide whether it is willing and has the capabili-ty to ensure equitable access to the device—as-suming this responsibility may substantially in-crease the perceived cost of the program. Sec-ond, the acceptance or rejection of a nuclearpower source should be made explicit—the nu-clear heart device may substantially enhance theattractiveness of the device from a clinical stand-point, but will also involve substantial socialcosts and risks. These two decisions will have amarked influence on the balance of costs andbenefits of the device, and they should be fullydebated and resolved before a final commitmentto artificial heart development is reached. In-sofar as we may be faced with a $1 billion to $3billion annual ‘commitmenttime to make these decisions

in the future, theis now.

since 1964. At the program’s inception, therewas considerable optimism that the successfuldevelopment of such a device would provide a

/

—


means of treating serious cardiac disease by1970—well before biomedical advances were ex-pected to produce effective preventive treat-ment. But now, more than 15 years later, a total-ly implantable artificial heart is still a distantgoal. This case study has reviewed the potentialbenefits, costs, and risks of continued invest-ment in this medical innovation, as well as thetechnological problems that remain to be solved.

Cardiac disease kills over 800,000 personsyearly. The number of people that might benefitfrom total heart replacement depends on theseverity of concomitant illness, age restrictions,access to emergency coronary care, and thenature of the device itself. Our estimate of a poolof 33,600 candidates yearly assumes that a pro-spective candidate’s death is imminent, that cir-culation can be supported long enough for trans-portation to an institution with appropriate fa-cilities, that the patient does not suffer from seri-ous or chronic noncardiac disease, and that heor she is under 65 years of age. A lower estimateof 16,000 candidates is defined on the likelihoodof inadequate mobile coronary care and surgicalfacilities, at least initially, in some parts of thecountry. If the device is highly successful, weestimate that there might be as many as 66,000candidates annually.

If the artificial heart is perfected, it will have asubstantial impact on those who suffer from car-diac disease now or in the future. We estimatethat the availability of the artificial heart mayextend the lives of such individuals, on the aver-age, by 0.6 of a year (about 210 days). It mightextend the lives of randomly chosen 25-year-oldmembers of the population, on the average, byabout 0.0966 of a year (about 35 days). An op-timistic estimate is that 60 percent of artificialheart recipients employed prior to implantationmay return to work. The experience of patientsundergoing CABG surgery suggests that as fewas 50 percent of persons aged 55 to 65 yearswould return to work; the experience of hearttransplant patients suggests that the lower limitmight be 20 percent. The range of estimatesvaries with the reliability of the device and theadequacy of rehabilitative care.

As the technology becomes available, it willbe nearly impossible to deny the demand for itswidespread use, as the recent history of hemodi-alysis demonstrates. Even the minimum esti-mates of the cost for an individual to receive anartificial heart involve an amount that would bea severe burden on most families. Our estimatesfor the cost of manufacturing and surgically im-planting an electrically powered device (not in-cluding previous development costs) range from$24,000 to $75,000 per patient; these are initialcosts. Continuing medical and technologicalcare could range from $1,800 to $8,800 per pa-tient per year. Insurance companies will prob-ably be unwilling to cover the high costs of thistreatment without special premiums or other in-centives. Thus, the Federal Government will befaced with a serious dilemma—to allow thosewho cannot afford to pay privately to do with-out a lifesaving device, or, alternatively, to de-vote up to an additional $1 billion to $3 billionannually to this new medical technology. Such acommitment is so great as to dwarf all of thefunds spent to date on the development of theartificial heart and other circulatory-assistdevices.

A decision to finance artificial heart implanta-tion with Federal funds must not be taken light-ly. It involves additional costs and planning foradequate facilities, training of personnel, and astrong program to rehabilitate patients whomust deal with the inconvenience and anxietyrelated to daily recharging of batteries, potentialmechanical or electrical failure, and total reli-ance on an implanted machine. Cost considera-tions must also take into account potential lossof other social programs displaced by the de-velopment of the artificial heart. The artificialheart may proportionately raise social expend-itures financed through medicare and socialsecurity that will have to come from other socialprograms. Funds that support the training ofheart surgeons and technicians for a large-scaleimplantation program may deter the urgencywith which research on cardiac disease preven-tion or alternative treatments is pursued. Recentwork in cardiac disease prevention at StanfordUniversity (27) and in Finland (60) indicates that


an effective prevention program definitely re-duces the risk factors associated with CHD andmay have a greater potential to reduce deathfrom cardiac disease.

While artificial heart research has led to usefultherapeutic inventions and substantial advancesin understanding, the development of a clinical-ly acceptable artificial heart seems unlikely to berealized in the near future. As yet, neither ahemocompatible material nor a portable powersource that can meet the specifications for along-term, implantable heart in laboratory test-ing has been developed. Current prototypes of2- and 5-year LVADs use electrical battery sys-tems that still have mechanical and operationalliabilities. In clinical trials projected for themid-1980’s, these devices will provide an experi-mental model to assess the reliability of theengine under conditions of extended use, as wellas the quality of life that might be expected froman artificial heart. Production and implantationwill also result in a more accurate picture of totaleconomic costs of the device and surgical pro-cedure.

In addition to investment in battery-powereddevices, several million dollars of DOE funding(primarily through the Energy Research and De-velopment Agency) have been devoted to re-search on a nuclear power source. Should we ar-rive on the brink of a successful device that lacksonly an acceptable power source, it may be dif-ficult to resist the pressure to go ahead with aPu-238 powered engine. The costs and risks ofsuch a device are enormous. Because of its dan-gerous qualities and its value ($1,000 per g for adevice using 50 g of Pu-238), the material wouldhave to be closely guarded from manufacture,through transportation and storage, to implan-tation, until removal upon the death. Strict safe-guards would have to be imposed on recipientsto protect them from health risks due to radi-ation, physical injury, or kidnapping. In light ofthese considerations, we believe it is importantthat a firm commitment against the use of nucle-ar-powered devices be made so that the ultimatepotential for a safe and acceptable heart devicemay be evaluated.

The current situation with the artificial heartrepresents a great responsibility, but alsorepresents an opportunity to control with carethe introduction of circulatory device technol-ogy. At this time, a clinically effective artificialheart is still many years away. From the perspec-tive of a member of society, investment in artifi-cial heart devices may be no closer to saving hisor her life and health than a comprehensive, ef-fective cardiac disease prevention program. Thisfact gives us considerable leeway in how we pre-fer to attack the massive costs of heart disease inour society. For this reason, we should comparethe benefits and costs of the artificial heart incompetition with other social and medical pro-grams designed to extend life and improve itsquality. We must first decide whether to proceedwith development of the artificial heart, know-ing that it will require a large commitment ofresources. If we assume this commitment, wemust then consider issues of who should receivethe device, who will absorb the costs of manu-facture and implantation, and most important-ly, what opportunities will be lost through an in-ability to fund other social programs.

In sum, we believe that two major issues in-volving the development of the artificial heartmust be resolved in order to comprehend fullythe device’s total impact. First, the Federal Gov-ernment must decide whether it is willing andhas the capability to ensure equitable access tothe device—assuming this responsibility maysubstantially increase the perceived cost of theprogram. Second, the acceptance or rejection ofa nuclear power source should be made explicit—the nuclear heart device may substantiallyenhance the attractiveness of the device from aclinical standpoint, but will also involve verylarge social costs and risks. Because these twodecisions will have a marked influence on thebalance of costs and benefits of the device, theyshould be fully debated and resolved before afinal commitment to artificial heart developmentis made.

Case Study #9 The Artlflclal Heart Cost, Risks, and Benefits ● 41

APPENDIX A: THE ARTIFICIAL CARDIAC PACEMAKERby Thomas Preston

The first totally implantable cardiac pacemakerwas implanted in Sweden in 1959. This was followedby the development of implantable pacers by threecompanies in the United States in 1960 (17,37,78).Although animal investigations predicted a problemwith electrodes (rising excitation threshold), thisproblem was considered manageable, and there werewidespread forecasts for a 5-year pacemaker longev-ity. The 5-year longevity prediction was based onbattery capacity and calculated discharge rate. Thefirst commercially available pacemakers were de-signed with the pulse generator and leads as one in-separable unit, i.e., there was no design allowancefor replacement of the pulse generator alone, withoutdisturbing the electrical connections (leads) to theheart. Although some investigators voiced cautionabout heightened expectations (78), in general therewas optimism that a 5-year pacemaker was at hand(17,37).

Risks

The major risk of permanent pacing—operationmortality—initially was about 7.5 to 10 percent dueto the requirement for thoracotomy and epicardialelectrode placement. That risk was deemed accept-able because of the poor prognosis of untreated pa-tients and the dramatic relief of successfully pacedpatients (see the section below on benefits). Otherrisks that also usually meant pacemaker system fail-ure included infection at any part of the operativearea (from epicardium with myocardial abscess to in-fection around the pulse generator) and dehiscence(bursting) of the pulse generator. In its worst mani-festation, the patient had an acquired abscess withdraining fistula. These complications were relativelycommon initially (5 to 10 percent), but not unex-pected. Improved surgical technique solved most ofthese problems.

Complications peculiar to pacemakers that wererelatively or totally unanticipated are discussedbelow.

● Wire (lead) break. Fatigue of the metal leads re-sulted in premature system failure at a high rate,such that this was the primary limiting factor forthe first few years of permanent pacing. Thesolution of this problem required engineeringanalysis of fracture points and modes, followedby multiple design changes. Although leadbreaks still occur, this complication was con-

trolled to an acceptable incidence over a periodof 6 to 7 years.High threshold of cardiac excitation. As notedabove, animal testing revealed this complica-tion, which was medically unique to this tech-nology. The biotechnical factors involved werenot well worked out until about 1967, and elec-trode evolution pertaining to this feature stillcontinues. In the first 5 years of permanent pace-makers, at least 10 percent of system failureswere from this cause.Battery failure. The predicted battery longevitydid not materialize until about 1975 because ofdefects with the batteries and current shuntingdue to structural defects within the pulse genera-tor. Excluding all other failure modes, pulse gen-erator longevity as limited by battery exhaustionis listed in table A-1. The dramatic increase inpacemaker longevity from 1975 to 1979 reflectsthe development of a new technology battery(lithium).“Runaway” pacemakers. Rarely, but dramati-cally, pulse generators can fail with an acceler-ated rate (up to 800 impulses per minute). Insome cases, this complication was fatal. Al-though design changes have made this complica-tion quite rare, it still occurs (e.g., recall ofAmerican Pacemaker Co., June 1979).Electromagnetic interference. Interferencecaused by extrinsic noncardiac signals can alterpacemaker output signals. This problem wasgreatly magnified by creation of the sensing (“ondemand”) pacemaker, which must sense cardiacsignals but reject all other electrical signals. Thiscomplication (incorrect sensing) still occurs withapproximately 5 percent of implanted units.Competition with natural heart beats. Althoughthis complication was anticipated, it was not

Table A. 1.—Pacemaker Longevity Excluding Causes of Failure Other Than Battery Exhaustion

Year pacemaker implanted Longevity (50%)1961. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6to 12 months1965. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 months1970. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 months1975. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 months1979. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 years (est.)

SOURCES: S. Furman and D. Escher, Prirrc@es and Techniques of CardiacPacing (New York: Harper and Row, 1970); and M. Bilitch, “Perform-ance of Cardiac Pacemaker Pulse Generators,” PACE 2:259, 1979,


considered serious (78). Although it is an infre-quent occurrence, pacemaker stimulation duringthe vulnerable period of a preceding natural beatcan precipitate ventricular fibrillation and death(59). proper sensing of natural depolarizations(demand function) precludes this complication,but inadequate sensing still occurs with about 5percent of implanted units.Surgical inexperience. The use of a prosthetic de-vice posed new problems for surgeons. Manycomplications—e. g., incorrect connection ofpulse generator to leads, improper positioning ofelectrodes or pulse generator—are related to ex-pertise in this particular operation. Furthermore,normally functioning pacemaker systems havebeen removed, because the surgeon and/or car-diologist did not understand the proper func-tioning of the system. Trauma to the devicethrough mishandling still occurs in the hands ofthe inexperienced.Manufacturing errors.Sudden failure, From specifications and per-formance of the batteries (for the first 15 years,virtually all batteries were the same type), theexpected failure mode was a slow but detectablechange in pacer rate. Unexpected, sudden failurewithout prior detected rate change has occurredand still does occur for a number of reasons(lead break, component failure, short circuit,etc. ). For a patient who is pacemaker dependent,this mode of failure produces syncope (tempo-rary suspension of circulation) or death. Suddenunexpected failure is now uncommon (approxi-mately 1 in 50 to 100 pulse generators), but oc-curred with 5 percent or more of pulse genera-tors for the first 10 years of permanent pacing.

Benefits

● Survival. There never has been a well-controlledstudy comparing survival of patients with andwithout pacemakers, presumably because of theapparent immediate and dramatic success of pace-makers. Analysis of survival benefit has alwaysbeen made by comparison of prepacing and post-pacing groups. Patients with complete (or inter-mittent) heart block and syncopal episodes have al-year mortality of 50 percent (29,36), whereassimilar patients who are paced have a 2-year sur-vival of 70 to 80 percent (68). Survival analysis ofpatients paced for reasons other than completeheart block is virtually impossible, as no “naturalhistory” data exist for other conditions. T h ediagnoses of partial blocks and sick sinus syn-

●

●

●

drome appear to be a consequence of pacing, asthese disorders were relatively unknown prior topermanent pacing, and investigations into thesedisorders probably resulted from the innovation ofa treatment for them. Thus, the availability ofpacemakers led to investigation into nonheartblock causes of syncope. Pacemaker therapy wasapplied to other presumed causes of syncope assoon as a cause and effect relationship seemed toexist, as in sick sinus syndrome. The universallyacknowledged success of pacing for heart block ledto an uncritical extension of the therapy to patientswith “preheart block” EKG patterns, and sinusnode dysfunction. Consequently, there are no data(even uncontrolled) by which to judge the effect ofpacing on survival in these groups of patients.Some believe that the widespread use of pacing forpreheart block syndromes does not increase sur-vival (46). Of all patients receiving pacemakers,about 55 to 60 percent now survive 5 years (31).Treatment of symptomatic complete heart block.The advent of pacing led to legendary tales of howthe moribund rose to walk. For those who remem-ber the plight of patients with symptomatic com-plete heart block, the benefit in terms of decreasedsyncopal episodes and increased activity level isbeyond question. For patients with other maladies,however, the benefits are more questionable. Mostpatients with light-headedness spells, or true syn-cope, and without evidence of heart block or sinusarrest associated with syncope, end up with pace-makers. Many are not improved.Treatment of symptomatic bradycardia, Availabil-ity of pacing has created the option of adjunct ther-apy (e. g., large doses of propranolol) with pacingto avoid symptomatic bradycardia.Treatment of tachyrhythmias. An unanticipatednew use of pacemakers is in treatment of tach-yrhythmias, using overdrive or interruption tech-niques. This accounts for less than 1 percent of allpermanent pacing.

Capital Investment

• Initial cost. The cost of hospitalization and hard-ware was estimated easily and adequately at thetime of initiation of this technology.

● Followup care. The unanticipated complications ofsystems failures meant greater than estimated fol-lowup costs. I know of no studies in 1960-61 esti-mating followup costs. Although the anticipationwas for 3 to 5 years of fault-free system perform-ance, during the first 3 years of pacing, the averagesystem longevity was about 6 months. Some pa-


tients had in excess of 15 operations (some morethan 20) in 3 to 5 years, most of them thoracotomy(surgical incision of the chest wall). During thenext 5 years, the average system failure (anyfailure requiring surgical correction, e.g., wirebreak, displacement of catheter, generator failure)was about 1 in 12 months of pacing (or greater).

Exclusive of complications requiring hospitaliza-tion/operative repair, modern followup methodsnow cost from $100 to $1,600 per year, depending ●

on the mode of followup. Office visits (minimum,EKG; maximum, detailed pacemaker analysis at a“pacemaker clinic”) vary from 2 to 6 years inroutine followup. Electronic monitoring (even in-terrogation of implanted units) has become wide-spread in this country during the last 10 years. Itcan be done directly (with the patient present at aclinic) or indirectly by telephone, with or withoutautomatic computer analysis. The availability ofsuch monitoring has made it mandatory in theminds of most physicians, as this represents the“best” means of followup. Indeed, there is now awhole ancillary industry in this area. The artificialheart, for which monitoring would be even more

necessary, will undoubtedly have more advancedforms of electronic monitoring. Third-party payers(Blue Cross/Blue Shield, medicare) now pay $30per telephone call for pacemaker monitoring.Many patients are monitored weekly (there is ascale of allowable calls, as a function of the age ofthe pacemaker), meaning a monitoring cost of$1,560 per year. I anticipate a minimum of one callper week for artificial heart patients.Indirect cost (or gains), There are no data onreturn to employment of paced patients, but forthose who were incapacitated from symptomaticcomplete heart block, there is a return to normalexistence (excluding other limitations). Thus, forthe group heavily dependent on pacemakers, therewould appear to be a large net gain in return togainful employment. For others, the result is lessevident. To the degree that a patient is restored tonormal function, there should be an economicgain. The countereffect, as seen with coronaryartery surgery, of legitimation of illness and retire-ment may also be present. I know of no data onthis subject.


APPENDIX B: CARDIAC TRANSPLANT COSTS

Table B-1.–Cardiac Transplant Hospitalization Costs, 1969.75

Professional Blood DrugDays Insurance Grant fees credit credit Written off Total Cost/day

Year 1. . . . 1,788 $ 8 7 , 9 2 3 . 5 7 $ 4 9 3 , 3 8 5 . 2 0 $ 3 , 1 0 9 . 5 3 $ 3 2 5 . 0 0 – $ 3 6 , 4 8 5 . 9 6 $ 6 2 1 , 2 2 9 . 2 6 $ 3 4 7 . 4 4Year2. . . . 841 144,561.47 129,443.33 150.00 4 8 5 . 0 0 — 31,318.31 305,958.11 363.80Year 3. . . . 942 267,677.56 106,956.45 1,001.47 7 1 2 . 9 8 $ 1 8 . 4 0 796.85 377,163.71 400.39Year4. . . . 869 122,962.32 235,811.89 10,062.83 73.05 — 44,380.79 413,290.88 475.59Year5. . . . 922 360,158.01 186,294.45 12,177.33 8 3 4 . 0 0 2 1 1 . 8 4 326.17 5 6 0 , 0 0 1 . 8 0 6 0 7 . 3 8Year 6. . . . 198 — 101,887.09 3,444.00 – – — 6 9 , 4 8 9 . 6 5 5 3 4 . 5 4

Total. . . 5,560 $ 9 8 3 , 2 8 2 . 9 3 $ 1 , 2 5 3 , 7 7 8 . 4 1 $ 2 9 , 9 4 5 . 1 6 $ 2 , 4 3 0 . 0 3 $ 2 3 0 . 2 4 $ 1 1 3 , 3 0 8 . 0 8Percento f t o t a l — 4170 53% I % — — 5 %

Average/ $2,382,974.85 $428.59person . . 69 $12,139.29 $15,478.75 $369.69 $ 3 0 . 0 0 $ 2 . 8 4 $1,398.87 1 0 0 %

Average/ $29,419.44 $426. .37t r a n s p l a n t 6 5 $11,433.52 $14,578.82 $348.20 $ 2 8 . 2 6 $ 2 . 6 8 $1,317.54 $27,709.01 $426.29

SOURCE: Stanford Cardiac Transplantation Program, Stanford, Cal if.

Table B-2.–Cardiac Transplant Outpatient Costs, 1969-75

Professional Blood DrugVisits Insurance Grant fees credit credit Written off Total Cost/visit

Year 1. . . . 466 $ 5 8 0 . 1 0 $ 19,768.80 $1,095.00 – – $ 2 1 , 4 4 3 . 9 0 $46.02Year2. . . . 224 854.50 12,802.89 1,170.00 — — $ 877.95 15,705.34 70.11Year 3. . . . 112 74.85 8,434.04 – 8,508.59 75.97Year4. . . . 468

—7,774.72 41,269.30 6 3 2 . 6 4 851.95 50,528.61 107.97

Year5. . . . 523 5,970.50 48,956.87 1,620.90 — — 56,548.27 108.12Year 6. . . . 110 —

—9,306.10 786.00 — — — 10,092.10 91.75

Total. . . 1,903 $15,254.67 $140,538.00 $5,304.54 – – $1,729.90 $162,827.11 $85.56Percent

o f t o t a l — 9 % 86% 4% — — 1 % 100% —

Average/person . . 23 $188.33 $1,735.00 $65.49 – – $21.36 $2,010.21 $87.40

Average/t r a n s p l a n t 2 2 $177.38 $1,634.16 $61.68 – – $20.12 $1,905.34 $86.61

SOURCE: Stanford Cardiac Transplantation Program, Stanford, Cal if,

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DEVICES AND TECHNOLOGY DIS!XLP

DIVISION OF HEART AND VASCULAR DISEASES

OF THE

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

BETHESDA, mARYLAND 20205

RESEARCH AND DEVELOPMENT CONTRACTS

NOVEMBER, 1980

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

POWER SOURCES - ELECTRICAL D r . A l t i e r i

Dr. John MoiseAerojet Liquid RocketAerojet-General Corp.POB 13222, Dpt 2150Sacramento, CA 95813(916) 355-2018N O 1 - H V - 7 - 2 9 7 1Implantable Electrohydraulic Left Heart Assist DeviceExpired: 9/29/80

Dr. Peer H. PortnerAndros, Inc.2332 Fourth StBerkeley, CA9 4 7 1 0(415) 849-1377N O 1 - H V - 4 - 2 9 1 4Implantable Controlled Solenoid LVAsExpired: 9/2/80

.

?lr. J a c k ChamberaG o u l d Meaauremnt S y s tStatham Instr D i v2 2 3 0 Statham BlvdOxnard, CA 93030(805) 487-8511NO1-HV-8-2916Electrical Energy Converter for Heart Assiat DeviceaExpired: 9/18/80

M. Victor PoirierThermo Electron Corp101 Firat AveWaltham, MA 0 2 1 5 4(617) 890-8700NO1-HV-7-2976Electrical Energy Convertera for Heart Assist DevicesE x p i r e d : 9/29/8Q

Dr. Robert JarvikUniversity of UtahInst. Biomedical EngSalt Lake City, UT 84112(801) 581-6991N O 1 - H V - 7 - 2 9 7 5Reversing ElectroHydraulic Energy Converter for Assist DevicesExpired: 9/29/80

●

I

Power SOURCES - RENEWAL Dr. Altieri

Dr. John MoiseAerojet Liquid RocketAerojet Gen CorpPOB 13222, Dpt 2150Sacramento, CA 95813(916) 355-2018NO1-HV-9-2909Develop, Evaluate Stirling Cycle Conversion SystemFY 80: $893,176

Mr. Richard P. JohnstonUniv of Washington100 Sprout Rd.Richland, WA 99352(509) 375-3176NO1-HV-9-2908Develop, Evaluate Codified Stirlin% Cycle EngineFY 80: $792,306

CIRCULATORY ASSIST & ARTIFICIAL HEART DEVICES PROGRAM

Dr. Jeffrey L. PetersInst for Biomed EngUniversity of UtahBldg 518Salt Lake City, UT84112(801) 261-3141Single & Biventricular Cannulae Circulatory Support5 RO1 HL 23279-02

Dr. William S. PierceHershey Medical CtrPenn State University500 University DrHershey, PA 17033(717) 534-8328Development and Evaluation of an Artificial Heart2 RO1 HL 20356-04

Dr. William S. PierceHershey Medical CtrPenn State University500 University DrHershey, PA 17033

( 717) 534-8 3 2 8Left Ventricular Bypass for Myocardial Infarction5 RO1 HL 13426-11

Dr. Andreas F. Von RecumCollege of EngClemson University301 Rhodes Eng BlvdClemson, SC 29631(803) 656-3052Healing of Intestinal Mucosa to a Penetrating Conduit5 RO1 HL 23646-02

Dr. Andreas F. Von RecumCollege of EngClemson University301 Rhodes Eng BlvdClemson, SC 29631(803) 656-3052Treated Percutaneous Implants1 RO1 HL 25438-01

Dr. Frederick J. WalburnDept of MedicineHenry Ford Hospital2799 W. Grand BlvdDetroit, MI 48202(313) 876-3221Pulsatile Flow,Separation in Branching Tubes1 R23 HL 25839-01

THERAPEUTIC INSTRUMENTATION & DEVICES PROGRAM

Dr. Stanley A. BrillerAllegheny-Singe rResearch Corp320 E. North AvePittsburgh, PA15212(412) 237-3146Syntactic Pattern Analysis of 24-hr Helter Records1 RO1 HL 26066-01

Dr. K.B.C h a n d r a nMaterials Eng DivUniversity of IowaCollege of EngIowa City, IA 52242(319) 353-4192Pulsatile Flow Dynamics of Prosthetic Heart Valves1 RO1 HL 26269-01

Dr. Richard E. ClarkDept of SurgeryWashington University4960 Audubon AveSt Louis,MO 63110(314) 454-3457Advanced Cardiac Valvular and Vascular Prostheses5 RO1 HL 13803-07

Dr. Herman L. FalsettiDept of Internal MedUniversity HospitalsIowa City, IA 52242(319) 356-3412Fluid Mechanics of Heart Valve Prostheses3 RO1 HL 20829-03S1

Dr. Leslie A. GeddesPurdue UniversityBiomedical Eng CtrW. Lafayette, IN 47907

(317) 494-6151 X212An Automatic Implantable Blood Pressure Controller1 RO1 HL 25746-01

Dr. Howard C. HughesCollege of MedicinePenn State UniversityHershey, PA1 7 0 3 3(717) 534-8328Elimination of Reoperative Cardiac Pacemaker Surgery5 RO1 HL 13988-09

Dr. Janice L. JonesSchool of MedicineCase Western Univ2119 Abington RdCleveland, OH 44106(216) 368-3487Defibrillator Waveshape Optimization5 ROl HL 24606-02

Dr. Raymond J. KiralyD e p t .of Art. OrgansCleveland Clinic9500 Euclid AveCleveland, OH 44106(216) 444-2470Hexsyn Leaflet Valve1 RO1 HL 25689-01

THERAPEUTIC INSTRUMENTATION & DEVICES PROGRAM

Dr. Victor ParsonnetDept of SurgeryNewark Beth IsraelMedical CenterNewark, NJ 07112(201) 926-7330Extending the Life of Implanted Pacemakers5 RO1 HL 15247-07

Dr. Victor ParsonnetNewark Beth IsraelMedical Center201 Lyons AveNewark, NJ 07112(201) 926-7330Simulation of Pacemaker - ECG Interactions5 RO1 HL 24567-02

Dr. Lester R. SauvageProvidence Med Center528 18th AvenueSeattle, WA( 2 0 6 ) 3 2 6 - 5 8 9 1Prosthesis for Aorotocoronary Bypass2 RO1 HL 18644-04AI

Dr. John C. SchuderSurgery DepartmentUniv of MissouriColumbia,MO 65212(314) 882-8068Waveform Dependency in Defibrillating 100 KG Calves5 RO1 HL 18040-06

Dr. John C. SchuderSurgery DepartmentUniv of MissouriColumbia, MO 65212(314) 882-8068Development of Automatic Implanted Defibrillator5 RO1 HL 21674-03

Dr. William F. WalkerDept Mech EngRice UniversityPO BOX 1 8 9 2Houston, TX 77001

(713) 527-8101 x3549Cavitation Phenomena Near Prosthetic Devices5 RO1 HL 17821-04

DIAGNOSTIC & MEASUREMENT INSTRUMENTATIOIN & DEVICES PROGRAM

Dr. Herbert L. AbramsDept of RadiologyPetr Bent Brighm Hosp721 Huntington AveBoston, MA 02115(617) 734-8000 X2542Cineangiographic Studies of the Cardiovascular System5 RO1 HL 20895-05

Dr. Donald W. BakerCtr for BioengUniv of WashingtonSeattle, WA 98195(206) 543-6832Noninvasive Cardiovascular Measurements5 PO1 HL 07293-18

Dr. Dana H. BallardDept of Computer SciUniv of RochesterRochester, NY 14627(716) 275-3772Anatomical Modela in Computer-Aided Image Analysis5 R23 HL 21253-03

Dr. Joe D. BourlandBiomedical Eng CtrPurdue UniversityWest Lafayette, IN 47907(317) 494-6151Cardiac Output from the Pneumocardiogram5 RO1 HL 22321-03

Dr. Ruben D.BunagUniversity of KansasMedical CenterCollege of Health SciKansas City, Kansas66103(913) 588-7507Non-Invasive Blood Pressure Measurement5 RO1 HL 22854-02

Dr. David A. CheslerPhysics Research LabMass General HospitalBoston, MA 02114(617) 726-3805Gated Imaging with the MGH X-Ray Camera5 RO1 HL 20274-03

Dr. B. Neil CuffinMass Inst of Tech170 Albany StCambridge, MA 02139(617) 253-5562Accuracy of Electric & Magnetic heart Measurements2 R23 HL 24645-02

Dr. Cornelis J. DrostDept PhysiologyNY State Vet CollegeCornell UniversityIthaca, NY 14853(607) 256-2121Accurate Transcutaneous Doppler Bloodflow Monitoring5 RO1 HL 19019-05

DIAGNOSTIC & MEASUREMENT INSTRUMENTATION & DEVICES PROGRAM

Dr. Nancy C. FlowersU of LouisvilleSchool of Medicine323 E. Chestnut StLouisville, KY 40202(502) 589-4668Recording & Analysis of Low Level Cardiac Signals2 RO1 HL 19768-04

Dr. Fred K. ForsterU of WashingtonDept of Mech EngSeattle, WA 98195(206) 543-4910Fluid Dynamic-Ultrasonic Aspects of Blood Turbulence1 R23 HL 26706-01

Dr. Leslie A. GeddesBiomedical Eng CtrPurdue UniversityWest Lafayette, IN 47907(317) 494-6151 x321Indirect Mean Blood Pressure2 RO1 HL 18947-03

Dr. Edward A. GeiserDept. of MedicineUniversity of FloridaGainesville, FL 32610(904) 392-34813-D Analysis of Ventricular Contractile Performance1 R23 HL 25621-01

Dr. Don P. GiddensSch of Aerospace EngGeorgia Inst of TechAtlanta, GA 30332(404) 894-3044Hemodynamics of Normal and Diseased Carotid Arteries5 RO1 HL 22635-02

Dr. Raymond GramiakUniv of Rochester”601 Elmwood AveRochester, NY 14642(716) 275-2625New Concepts in Cardiac Ultrasound Technology5 RO1 HL 15016-09

Dr. Craig J. HartleyDept of MedicineThe Methodist Hosp6516 BertnerHouston, Tx 77030(713) 790-3252Ultrasonic Instrumentation for Cardiovascular Studies5 RO1 HL 22512-03

Dr. Gabor T. HermanDept of Computer SciSUNY at Buffalo4226 Ridge LeaAmherst, NY 14226(716) 831-1351Computer Technology for Transaxial Tomography5 RO1 HL 18968-05


Dr. Michael B. HistandDept of Mech EngColorado State UnivFort Collins, CO 80523(303) 491-5544Noninvasive Measurement of Cardiac Output5 RO1 HL 22326-03

Dr. Cecil J. HodsonYale University333 Cedar StreetNew Haven CT 06510(203) 432-4364Ultrasonic Monitoring of Visceral Blood Vessels5 RO1 HL 19791-03

Dr. Adrian KantrowitzDept Cardiovasc SurgSinai Hosp of Detroit6767 West Outer DrDetroit, MI 48235(313) 493-5775Quantitating In-Series Effects in Cardiac Arrhythmias5 RO1 HL 22274-02

Dr. Antti J. KoivoSchool of Elec EngPurdue UnivWest Lafayette, IN47907(317).493-9156The Use of Microprocessors in Medical Applications1 RO1 HL 22417-01

Dr. Paul C. LauterburDept of ChemistrySUNY at Stony BrookStony Brook, NY 11794(516) 246-5061Cardiovascular NMR Zeugmatography5 RO1 HL 19851-02

Dr. Richard L.LonginiBiotechnology ProgramCarnegie-Mellon UnivPittsburgh, PA 15213(412) 578-2528An Optimal Fetal Heart Monitor2 RO1 HL 20632-03

Dr. Roy W. MartinDept AnesthesiologyU of WashingtonSeattle, WA

(206) 545-1883Blood Flow Measurement by Ultrasonic Catheter Tip Method5 RO1 HL 14645-09

Dr. William E. MoritzDept of Elec EngUniv of WashingtonSeattle, WA 98195(206) 543-6049Ultrasonic Measurement of Cardiac Geometry and Flow5 RO1 HL 16759-06


Dr. P. David MyerowitzU of WisconsinDepartment of Surgery600 Highland AveMadison, WI

(608) 263-5215Noninvasive Computerized Fluoroscopic Cardiac Imaging1 RO1 HL 26586-01

Dr. Charles P. OlingerDept of NeurologyUniv of Cincinnati4305 Med Sci BldgCincinnati, Ohio 45267(513) 872-5431Computer Aided Bioacoustic Arterial Diagnostics5 RO1 HL 23671-02

Dr. T. Allan PryorDept of BiophysicsLatter-Day Saint Hosp325 8th AveSalt Lake City, UT 84143(801) 322-5761 X255Computer Controlled Two-Dimensional Echocardiography2 RO1 HL 16487-06

Dr. John M. ReidInst of AppliedPhysiology & Medicine556 18th AvenueSeattle, WA 98122(206) 442-734oUltrasonic Scattering Studies for Tissue Characterization5 RO1 HL 24805-02

Dr. Erick L. RitmanDept of PhysiologyMayo Foundation200 First St. SWRochester, MN 55901(507) 284-3495Cardiovascular and Lung Dynamics2 POl HL 04664-20

Dr. William P. SantamoreTemple UniversityPhiladelphia, PA(215) 221-4724Ventricular Interdependence1 RO1 HL 26592-01

Dr. Richard K. ShawSchool of MedicineYale University333 Cedar StreetNew Haven, CT 06510(203) 436-8259Long Term Assessment of Flow in Vascular Grafts5 RO1 HL 22352-02

Dr. Richard J. SpearsDept of CardiologyUSC Schl of Medicine2025 Zonal AveLos Angeles, CA 90033(213) 226-21523-D Analysis of Single Plane Coronary Cineangiograms1 R23 25272-01

I

II


Dr. Donald E. StrandnessDept of SurgeryUniv of WashingtonSeattle, WA 98195(206) 543-3653Ultrasonic Evaluation in Direct Arterisl Surgery2 RO1 HL 20898-03

Dr. Louis E. TeichholzDept of MedPit Sinai Schl of Med1 Gustave L Levy P1New York, NT 10029(212) 650-7785Pulse-Doppler Analysis of Left Ventricular Function1 RO1 HL 25277-01

Dr. Fredrick L. ThurstoneBiomedical Eng DeptDuke UniversityDurham, NC 27706(919) 684-6185Dynamic Cardiovascular Measurement Using Ultrasound5 RO1 HL 12715-12

Dr. John G. WebsterDept. of Elec. Eng.U of Wisconsin1500 Johnson Dr.Madison, WI 53706(608) 263-1574Portable Arrhythmia Monitor1 RO1 HL 25691-01

Dr. Mark L. YeldermanDpt of AnesthesiaStanford UniversityStanford, CA 94305(415) 497-6411A Continuous Cardiac Output Monitor5 RO1 HL 24798-02

BIOMATERIALS PROGRAM

Dr. Clarence P. AlfreyDept of Internal HedMethodist Hospital6516 BertnerHouston, TX 77030(713) 790-2155Effects of Physical Forces on Blood5 RO1 HL 16938-05

Dr. Harry R. AllcockDept of ChemistryPenn State UnivUniversity Park, PA 16802(814) 865-3527 “Polydiaminophosphazenes5 RO1 HL 11418-11

Dr. Joseph D. AndradeDpt of BioengineeringUniversity of UtahSalt Lake City, U1’ 84112(801) 581-8509Synthetic Hydrogels as Blood Tolerable Materials5 RO1 HL 16921-06

Dr. Joseph D. AndradeDpt of BioengineeringUniversity of UtahSalt Lake City, UT 84112(801) 581-8509Albumin and Hemocompatibility2 RO1 HL 18519-05

Dr. Joseph D. AndradeDpt of BioengineeringUniversity of UtahSalt Lake City, UT 84112(801) 581-8509Blood Interactions of Triblock Polymers5 RO1 HL 24474-02

Dr. Robert E. ApfelEng & Applied Sci DptYale UniversityNew Haven, CT 06520(203) 436-8674Characterization of Biomaterials by Elastic Property5 RO1 HL 22233-03

Dr. John AutianCollege of PharmacyUniv of TennesseeCtr for Health SciMemphis, TN 38163(901) 528-6020Acute Toxicity Evaluation of Biomaterials5 RO1 HL 24040-02

Dr. Sumner A. BarenbergDept of Chemical EngUniv of MichiganAnn Arbor, Michigan 48109(313) 764-7391Polyorganophosphazenes ; Molecular Motion & Thrombosis5 RO1 HL 23288-02


Dr. William E. BurkelDept of AnatomyUniv of Michigan4734 Medical Sci IIAnn Arbor, MI 48109(313) 764-4379Development of Cell-Lined Vascular Prostheses3 RO1 HL 23345-02S1

Dr- Allan D. CallowDept of SurgeryNew Eng Med Ctr Hosp171 Harrison AveBoston, MA 02111(617) 956-5596Platelet-Fibrin Dynamics in Healing Arterial Surfaces5 RO1 HL 24447-02

Dr. Hanson Y.K. ChuangDept of PathologyUniversity of UtahSchool of MedicineSalt Lake City, UT 84112(801) 581-7773Plasma Proteins Adsorbed to Artificial Organs7 RO1 HL 25808-01

Dr. Hanson Y.K. ChuangDept of PathologyUniversity of UtahSalt Lake City, UT 84112(801) 581-7773Interaction: Prothrombin, Thrombin, ATIII & Materials1 RO1 HL 25807-01

Dr. Stusrt L. CooperDept of Chem EngUniv of Wisconsin1415 Johnson DrMadison, WI 53706(608) 262-3641Protein and Thrombus Deposition on Vascular Graft5 RO1 HL 21001-03

Dr. Stuart L.CooperDept of Chem EngUniv of Wisconsin1415 Johnson DrMadison, WI 53706(608) 262-3641Transient Thrombotic Events at Polymeric Surfaces5 RO1 HL 24046-02

Dr. W. Jean DoddsDiv of Lab & ResearchNY St Dept of HealthEmpire St PlazaAlbany, NY 12201(518) 457-2663Blood-Materials Interactions: The Bridge Problems5 RO1 HL 24017-02

Dr. Robert C. EberhartDept of Mech EngUniversity of TexasEng Sci Bldg 610Austin, TX 78712(512) 471-7167Analysis of Blood Trauma From Microporous Oxygenators5 RO1 HL 19173-04

BIOMATERIALS PRO(WWbl

Dr. Eugene C. EcksteinBiomedical Eng DeptUniversity of MiamiPO B OX 2 4 8 2 9 4Coral Gables, FL 33124(305) 284-2442Platelet Concentration in the Marginal Layer2 RO1 HL 22455-03

Dr. L. Henry EdmundsDept of SurgeryUniversity of PA3400 Spruce StPhiladelphia, PA19104(215) 662-2091Platelet Function During Extracorporeal Perfusion5 RO1 HL 19055-05

Dr. Suzanne Gaston EskinDept of SurgeryBaylor College of Med1200 MoursundHouston, TX 77030(713) 790-4567’Response of Cultured Endothelial Cells to Flow5 RO1 HL 23016-02

Dr. Evan A. EvansDept of Biomed EngDuke UniversityDurham, NC(919) 684-5218RBC Membrane Adhesion & Deformation Energies1 RO1 HL 24796-01

Dr. John L. GloverPurdue Universityat IndianapolisIndianapolis, IN(317) 630-7491Seeding of Endothelial Cells in Vascular Prostheses1 RO1 HL 24247-O1A1

Dr. Donald E. GregonisUniversity of UtahSalt Lake City, UT(801) 581-7899Basic Studies on Blood-Polymer Interactions1 RO1 HL 26469-01

Dr. Frederick GrinnellDept of Cell BiologyUniversity of Texas5323 HarryHines BlvDallas, TX 75235(214) 688-2181Blood-Material Interactions: Adsorption of Fibronectin5 RO1 HL 24221-02

Dr. Jesse D. HellumsDept of Chem EngRice UniversityPO Box 1892Houston, TX 77001(713) 527-3497Effects of Physical Forces on Platelets5 RO1 ill 18584-05


Dr. Anne P. HiltnerDept Macromolec SciCase Western Res UnivUniversity CircleCleveland, OH 44106(216) 368-4186Long Term Biodegradation of Elastomeric Biomaterials1 RO1 HL 25239

Dr. Cornelis A. HoeveDept of ChemistryTexas A&M UniversityCollege Station, TX 77843(713) 845-3243Guidelines for Polymers Acting as Elastin Substitutes5 RO1 HZ 18441-03

Dr. Allan S. HcoffmanBioengineering CtrUniv of WashingtonSeattle, WA 98195(206) 543-9423Surface Thrombogenesis:Mechanisms and Prevention5 PO1 HL 22163-03

Dr. Thomas A. HorbettDept of Chem EngUniv of WashingtonSeattle, WA 98195(206) 543-6419Cellular Interactions with Foreign Materials2 RO1 HL 19419-05

Dr. Ting-Cheng HungSchool of MedicineU of PittsburghPittsburgh, PA 15261(412) 624-5369Study of Leukocyte Degradation Characteristics1 RO1 HL 25814-01

Dr. Lucija Stacic KaricInst of Med SciencesPacific Medical CtrClay & Webster StsSan Francisco, CA 94120(415) 563-2323 X2416Extracorporeal Circulation & Protein Denaturation5 R23 HZ 21271-03

Dr. Sung Wan KimSchool of PharmacyUniversity of UtahSkaggs HallSalt Lake City, UT 84112(801) 581-6801Initial Events in Thrombus Formation on Surfaces5 RO1 HL 17623-07

Dr. Sung W. KimSchool of PharmacyUniversity of UtahSkaggs HallSalt Lake City, UT 84112(801) 581-6801A Novel Approach to Nonthrombogenic Polymer Surfaces2 RO1 HL 20251-04

DEVICES AND TECHNOLOGY BRANCH

DIVISION OF HEART AND VASCULAR DISEASES

OF THE

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

BETHESDA, MARYLAND 20205

RESEARCH AND DEVELOPMENT GRANTS

NOVEMBER, 1980

U.S. DEPARTNENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH


Dr. William F. BernhardChildrens HospitalMedical Center300 Longwood AveBoston, MA 02115(617) 734-6000 X3261Evaluation of a Left Ventricular-Aortic Prosthesis5 RO1 HL 20037-03

Dr. William F. BernhardChildren’s HospitalMedical Center300 Longwood AvenueBoston, MA 02115(617) 734-6000 X3261Clinical Left Ventricular Bypass Studies1 RO1 HL 25882-01

Dr. Erich E. BrueachkeSt. Lukes Medical Ctr1753 W Congresa PkChicago, IL 60612(312) 942-7083Development of a Transcutaneous Power Transfer System5 RO1 HL 21632-03

Dr. John E. ChimoskeyDept of PhysiologyMichigan State UnivEast Lansing, HI 48824(517) 355-9269Left Heart Failure Model for Testing Assist Devices5 RO1 HL 24503-02

Dr. C. Forbes DeweyDept Mechanical EngMass Inst of TechRoom 3-250Cambridge, MA 02139(617) 253-2235Unsteady Flow in Arterial Bifurcations5 RO1 HL 21859-03

Dr. William H. DobelleDept of SurgeryColumbia University630 West 168th StNew York, NY 10032(212) 694-4198Simple Cardiac Assist (TALVB) Devices in Man5 RO1 HL 23941-02

Dr. Leonard A.R. GeldingDept Cardiothor SurgCleveland Clinic4500 Euclid AveCleveland, OH 44106(216) 444-6915Physiological Studies of Chronic Nonpulsatile Blood FlOW1 RO1 HL 26267-01

Dr. Robert K. JarvikInst Biomedical EngUniversity of UtahBldg 518Salt Lake City, UT84112(801) 581-6991Studies with Electric Total Artificial Hearts5 RO1 HL 24338-02


Dr. Adrian KantrowitzDept of SurgerySinai Hosp of Detroit6767 W Outer DrDetroit, MI 48235(313) 272-6000 X8205Active Prosthetic Myocardium: Effects on LV Function5 RO1 HL 22329-02

Dr. Willem KolffInst for Biomed EngUniversity of UtahBldg 518Salt Lake City, UT 84112(801) 581-6296Intra Aortic Balloon Pumping in Small Animals5 RO1 HL 20803-04

Dr. Willem KolffInst for Biomed EngUniversity of UtahBldg 518Salt Lake City, UT 84112(801) 581-6991Studies Towards An Acceptable Artificial Heart for Man2 PO1 HL 13738-09

Dr. Bayliss C. McInnisCullen College of EngUniversity of Houston4800 CalhounHouston, TX 77004(713) 749-1574Automatic Controls for the Artificial Heart1 RO1 HL 25029-OIA1

Dr. J. D. MortensenUtah Biomed Test Lab520 Wakara WaySalt Lake City, UT 84108(801) 581-6190Chronic Total Cardiopulmonary Mechanical Substitution5 RO1 HL 22661-02

Dr. Yukihiko NoseDept Artificial OrgnsCleveland Clin Found9500 Euclid AveCleveland, OH 44106(216) 444-2470Biventricular Assist and Replacement Studies5 RO1 HL 24286-02

Dr. Don B. OlsenDiv Artificial OrgnsUniversity of UtahSalt Lake City, UT 84112(801) 581-6991Artificial Heart Implant,Later Cardiac Transplant1 RO1 HL 24419-02

Dr. Don B. OlsenDiv Artificial OrgnsUniversity of UtahSalt Lake City, UT 84112(801) 581-6991Studies of the Pneumatic Artificial Heart in Calves1 RO1 HL 24561-01

BLOOD PUMPS - Dr. Watson

Dr. Peer M. PortnerAndros, Inc.2332 Fourth StreetBerkley, CA 94710(415) 849-1377NO1-HV-7-2938Development of a Left Heart Assist Blood PumpExpired: 9/14/80

Dr. David LedermanAvco Everett Res Lab2385 Revere Bch PkwEverett, MA 02149(617) 389-3000NO1-HV-7-2937Left Heart Assist Blood PumpsExpired: 9/14/80

Dr. Yukihiko NoseCleveland Clinic Fndn9500 Euclid AveCleveland, OH 44106(216) 444-2470NO1-HV-4-2960Development & Evaluation of Cardiac ProsthesesExpired: 9/29/80

Dr. John C. NormanTexas Heart Inst6720 Bestner StHouston, TX 77030(713) 521-3121NO1-HV-7-2936Left Heart Assist Device DevelopmentExpired: 9/29/80

Mr. Robert L. WhalenThermo Electron Corp101 First AveWaltham, MA 02154(617) 890-8700NO1-HV-7-2934Development of a Left Heart Assist Blood PumpFY 80: -O-

Dr. Philip LitwakThoratec Labs Corp2023 8th StreetEmeryville, CA 94710(415) 658-7787NO1-HV-7-2939Develop and Evaluate Left Heart Assist Blood PumpsFY 80: -O-

FABRICATION - D r . A l t i e r i

Mr. Victor PoirierThermo Electron Corp.101 First Ave.Waltham, MA 02154(617) 890-8700NO1-HV-9-2907Fabrication of Cardiovascular DevicesFY 80: $292,156

Mr. Keith S. BuckThoratec Labs Corp.4204 Hollis St.Emeryville, CA 94608(415) 658-7787NO1-HV-9-2906.Fabrication of Cardiovascular DevicesFY 80: $207,821

I

CLINICAL EVALUATION: LEFT VENTRICULAR ASSIST DEVICES - Dr. Watson

Dr. William F. BernhardChildrens HospitalMedical Center300 Longwood AveBoston, MA 02115(617) 734-6000 X3261NO1-HV-5-3007Clinical Evaluation: Model X LVADFY 80: $23,068Expired: 6/30/80

Dr. John C. NormanTexas Heart Inst6720 Bestner StreetHouston, TX 72025(713) 521-3121NO1-HV-5-3006Clinical Evaluation: Model VII LVADFY 80: $32,053Expired: 6/30/80

Mr. John M. KeiserThermo Electron Corp101 First AveWaltham, MA 02154(617) 890-8700 X409NO1-HV-5-3008LVAD: Clinical Evaluation of Temporary AssistFY 80: $31,809Expired: 6/30/80

IMPLANTABLE LEFT HEART ASSIST SYSTEMS - Dr. Altieri, Dr. Watson

Dr. John MoiseDr. Yukihiko NoseAerojet General CorpPOB 1322.2 Dept 2150Sacramento, CA 95813(919) 355-2018N O 1 - H V - O - 2 9 1 1Implantable Electrohydraulic Left Heart Assist DeviceFY 80: $1,076,181

Dr. Peer PortnerAndros, Inc.2332 Fourth StBerkeley, CA 94710(415) 849-1377N O 1 - H V - O - 2 9 0 8Implantable Left Heart Assist SyatemFY 80: $1,044,718

Dr. Param I.S i n g hDr. David LedermanAvco Everett Res Lab2385 Revere Bch PkwEverett, MA 02149(617) 389-300N O 1 - H V - O - 2 9 1 3Implantable Left Heart Assist DeviceFY 80: $1,038,454

Dr. John C. NormanMr. Jack ChambersTexas Heart Institute6720 Bestner StHouston, TX 77030(713) 521-3121N O 1 - H V - O - 2 9 1 5Implantable Left Heart Assist DeviceFY 80: $893,361

Mr. David B. OernesDr. William F. B e r n h a r dThermo Electron Corp.101 First A v eWaltham, MA 02154(617) 890-8700NO1 NV-O-2914Implantable Left Heart Assist DeviceFY 80: $1,083,466

I

PHYSICAL TESTING - Dr. Watson

Dr. Carl R. McMillinMonsanto Res Corp1515 Nicholas RdDayton, OH 45407(513) 268-3411 x211NO1-HV-7-2918Physical Testing of Circulatory Assist Device PolymersExpired: 8/31/80

Dr. Robert W. PennNatl Bureau of StndsMaterials Res InstGaithersburg, MD 20760(301) 921-2116YO1-HV-8-0003Physical Testing of Circulatory Assist Device PolymersExpired:9/30/80

Dr. John L. KardosWashington UniversityLinden & SkinkerSt. Louis, MO 6 3 1 3 0(314) 863-0100 x4577NO1-HV-7-2919Physical Testing of Circulatory Assist Device PolymersExpired: 8/31/80

PHYSICAL TESTING - Dr. Altieri

Dr. Carl R. McMillanMonsanto Res Corp1515 Nicholas RdDayton, OH 45407(513) 268-3411 x211NO1-RV-O-2909Physical Testing of Circulatory Assiat Device PolymersPY 80: $208,762

Dr. John L. KardoaWashington UniversityLinden & SkinkerSt Louis, MO 63130(314) 889-6062NO1-HV-O-291OPhysical Testing of Circulatory Assist Device PolymersPY 80: $145,992

ENERGY TRANSMISSION - Dr. Berson

Dr. Peer M. PortnerAndros, Inc2332 Fourth StreetBerkeley, CA 94710(415) 849-1377NO1-NV-7-2933Electrical Energy Transmission Technique DevelopmentFY 80: $219,323

Dr. Adrian KantrowitzSinai Hosp of Detroit6767 West Outer DrDetroit,MI 48235(313) 493-5775NO1-NV-8-2921Percutaneous Energy Transmission SystemsFY 80: $116,263

Dr. Benedict D.T. DalySt Elizabeth’s Hosp736 Cambridge StBoston, MA 02135(617) 956-5589NO1-HV-8-2919Percutaneous Energy Transmission SystemsFY 80: $141,092

Dr. Freeman FraimThermo Electron Corp101 First AveWaltham, MA 02154(617) 890-8700NO1-HV-O-2903Develop, Evaluate Transcutaneous Energy Transmission SystemFY 80: $202,507

INSTRUMENTATION - Dr. Berson

Dr. Ralph W. BarnesBowman GraySchool of Medicine300 Hawthorne RdWinston-Salem, N.C.27103(919] 727-4504NO1-HV-1-2902Noninvasive Detection of Atherosclerotic LesionsFY 81: $296,830

Dr. John D. HestenesCalif Inst of TechJet Propulsion Lab4800 Oak Grove DrPasadena, CA 91103(213) 354-2961Imaging of Deep Arterial Lesions by Swept Ultrasound

Dr. William R. BrodyStanford UniversityDept of RadiologyStanford, CA 94305(415) 497-5226NO1-HV-O-2922Energy Selective Methods for Intravenous ArteriographyFY 80: $246,359

Dr. Donald SashinUniv of PittsburghRC 406 Scafe HallPittsburgh, PA 15621(412) 647-3490NO1-HV-O-2929Noninvasive Detection of Atherosclerotic LesionsFY 80: $181,251

Dr. Charles A. HistrettaUniv of WisconsinClinical Science Ctr600 Highland Ave

Madison, WI 53706(608) 263-8309NO1-HV 1-2905Noninvasive Detection of Atherosclerotic LesionsFY 81: $296,830

INSTRUMENTATION - Mr. Powell

Dr. Ralph W. BarnesBowman GraySchool of Medicine300 S Hawthorne RdWinston Salem, N.C.27103(919) 727-4504NO1-HV-7-2925Ultrasonic Imaging andArterial MeasurementsExpired: 9/14/80

Dr. Frank E. BarberHarvard Med School44 Bimey StBoston, MA 02115(617) 732-3582NO1-HV-7-2927Ultrasonic Imaging and Tisaue CharacterizationExpired: 9/29/80

Dr. John M. ReidInstitute of AppliedPhysiology & Medicine701-16th AveSeattle, WA 98122(206) 442-7330NO1-HV-7-2926Ultrasonic Doppler I-ging with Automatic Line ScanningExpired: 9/14/80

Dr. Titus C. EvansMayo Foundation200 First Ave.Rochester, MN 55901(507) 282-2511NO1-HV-7-2928Ultrasonic Imaging with Flow Velocity ProfilesExpired: 9/17/80

Dr. David WilsonSRI InternationalBioengineering Res333 Ravenswood*AveMenlo Park, CA 94025(415) 326-6200 X4918NO1-HV-2900Duplex B-Scan Imaging System for Abdominal ArteriesFY 81: $346,130

Dr. Leon KaufmannUniv of Calif at SF400 Grandview DrSan Francisco, CA94080(415) 952-1366NO1-HV-O-2928Noninvasive Detection of Atherosclerotic LesionsN 80: $87,361

Dr. Charles P. OlingerUniv of CincinnatiStroke Research Lab4303 ?led Sci BldgCincinnati, OH 45267(513) 872-5431NO1-HV-7-2924Ultrasonic Imaging with Flow & Tissue CharacterizationFY 80: $266,478Expired: 9/1/80

Dr. Martin D. FoxUniv of ConnecticutSchool of EngStorrs, CT 06268(203) 486-4821NO1-HV-7-2929Crossed Beam Doppler and Sector ScansExpired: 9/1/80

INSTRUMENTATION - Mr . Powel l

Dr. David H. BlankenhornUniv of So. Cal.2025 Zonal AveLos Angeles, CA 90033(213) 224-7315NO1-NV-7-2930Enhanced X-ray Images and Ultrasonic Tissue ParametersExpired: 9/29/80

Dr. Theron W. OvittUniversity of ArizonaDept of RadiologyTucson, AZ 85724(602) 626-6007NO1-HV-7-2931Electronic X-ray Imaging & New Contrast AgentsExpired: 9/1/80

Dr. Theron W. OvittUniv of ArizonaDept of RadiologyHealth Sciences CtrTuscon, AZ 85724(602) 626-6007NO1-NV-1-2901Noninvasive Detection of Atherosclerotic LesionsFY 81: $257,159

BIOMATERIALS - D r . P i t l i c k

Dr. Peter MadrasDr. Robert C.CummingAvco Everett Res Lab2385 Revere Bch PkwEverett, MA 02149(617)389-3000NO1-HV-O-2912Blood Compatibility of Circulatory Assist DevicesFY 80: $142,885

Dr. Edward W.C. WongAvco Everett Res Lab2385 Revere Bch PkwEverett,MA 02149(617) 389-3000 X765NO1-HV-9-2932Procurement of Standard Reference MaterialsFY 80: $81,968

Dr. George HerzlingerAvco Everett Res. Lab2385 Revere Bch PkwEverett,MA 02149(617) 389-3000 X305NO1-HV-9-2901Complement-Biomaterial InteractionExpired: 3/31/80

Mr. Axel D. HauboldCarbomedics11388 Sorrento Vail‘San Diego, CA 92111(714) 452-8484NO1-HV-4-2928Carbon Film Composites for Prosthetic DevicesExpired: 4/30/80

Dr. G. C. BerryCarnegie-Mellon Inst.4400 Fifth AvenuePittsburgh, PA 15213(412) 578-3131NO1-HV-3-2949Interpenetrating Polymer Networksfor Biological Application:

Expired: 3/31/80

Dr. Paul DidisheimMayo Foundation200 First St. , SWRochester, MN 55901(507) 284-3049NO1-HV-9-2915Blood Compatibility of Circulatory Assist DevicesFY 80: $137,687

Mr. Robert S. WardThoratec Labs.Corp.2023 Eighth StreetBerkeley, CA 94710(415) 658-7787 NO1-HV-9-2933Procurement of Standard Reference MaterialsFY 80: $237,248

●

f310MATERIALS - Mr. Powell

Mr. Michael SzycherThermo Electron Corp.101 First AveWaltham, MA 02154(617) 890-8700N01-HV-3-2915Development & Testing of Integrally Textured Blood Pump BladdersFY 80: -O-


Dr. William W. LeeStanford Res Inst333 Ravenswood AveMenlo Park, CA 94025(413) 326-6200Blood Compatible Benzamidine Containing Polymers5 RO1 HL 21769-03

Dr. Robert I.LeiningerBattelle Mem InstColumbus Laboratories505 King AvenueColumbus,OH 43201(614) 424-7138An Evaluation of Blood-Surface Interactions5 RO1 HL 24015-02

Dr. Jane B. LianDept of SurgeryChildrns Hosp Med Ctr300 Longwood AveBoston, MA 02115(617) 734-6000 X3619Blood-Material Interactions5 RO1 HL 24029-02

Dr. Reginald G. MasonDept of PathologyUniversity of UtahSchool of MedicineSalt Lake City, UT 84112(801) 581-7773Endothelial Linings for Artificial Organs7 RO1 HL 25805-01

Dr. Reginald G. MasonDept of PathologyUniversity of UtahSchool of MedicineSalt Lake City, UT 84112(801) 581-7773An Inhibitor of Platelet Adhesion to Artificial Organs7 RO1 HL 25806-01

Dr. Larry V. McIntireDept of Chem EngRice UniversityPO BOX 1 8 9 2Houston TX 77001(713) 528-4141 X41OPerfusion Lung: Role of Traumatized Leukocytes5 RO1 HL 17437-05

Dr. Syed Fazal MohammadDept of PathologyUniversity of UtahSalt Lake City, UT 84112(801) 581-7773Platelet Factor 3 and Blood-Material Interactions1 RO1 HL 25804-01

Dr. John A. PennerDept of MedicineCollege of Human MedB220 Life SciencesE. Lansing, MI 48824

(517) 353-6625Control of Clotting on Biomaterials by Anticoagulants7 RO1 HL 27042-01


Dr. Ronald P. QuintanaDept Medicinal ChemUniv of TennesseeCenter for Hlth SciMemphis, TN 38163(901) 528-6085Surface-Active Antithrombotic Agents for Prostheses5 RO1 HL 22236-02

Dr. Ronald P. QuintanaU of TennesseeCtr for Health Sci800 Madison AvenueMemphis, TN 38163(901) 528-6085Moieties Affecting Platelet - Biomaterial Interactions1 RO1 HLGM 25884-01

Dr. Robert RodvienHeart Research InstInst of Medical Sci2200 Webster StSan Francisco, CA 94114(415) 563-2323 X2420Blood-Material Interactions5 RO1 HL 24018-02

Dr. Edwin W. SalzmanMass Inst TechnologyBldg 16 Rm 522Cambridge, MA 02139(617) 735-2000Thromboresistant Materials5 RO1 HL 20079-04

Dr. Jerome S. SchultzDept of Chemical EngUniv of Michigan2020 G.C. Brown LabAnn Arbor, MI 48109(313) 764-2383Effect of Flow on Fibrin Formation1 RO1 HL 23379-01

Dr. Jerome S. SchultzDept of Chemical EngUniv of Michigan2020 G C Brown LabAnn Arbor, MI 48109(313) 764-2383Blood Material Interface Interactions5 RO1-HL 24039-02

Dr. Michael V. SeftonDept of Chemical EngUniversity of TorontoToronto, Ontario MFS IA4(416) 978-4019Heparinized Material - Blood Interaction5 RO1 HL 24020-02

Dr. Kenneth A. SolenDept of Chemical EngBrigham Young Univ350 CBProvo, UT 84602(801) 378-1211 X2587Pulsatile Pressures in Microemboli Filtrations1 RO1 HL 25912-01

B1OMATER1ALS PROGRAM

Dr. Robert E.SparksDept of Chemical EngWashington UniversityLinden & SkinkerSt. Louis, MO 63130(314) 889-6003Biosorbable Thromboresistant Surfaces5 RO1 HL 18764-05

Dr. Salvatore P. SuteraDept of Mech EngWashington UniversityBOX 1 1 8 5St. Louis, MO 63130(314) 863-0100 X4343Blood Cells:Physical Properties,Structure & Function5 RO1 HL 12839-11

Dr. Leo VromanDownstate Medical Ctr450 Clarkson AveBrooklyn, NY 11203(212) 836-6600 X223Flow and Flexing at Blood/Biomaterial Interface5 RO1 HL 23899-03

Dr. Alan G. WaltonDpt Macromoleclr SciCase Western Res Univ801 Olin BldgCleveland, OH 44106(216) 368-4166Program Project in Biological Materials5 PO1 HL 15195-04

Dr. Michael C. WilliamsDept of Chem EngUniv of CaliforniaBerkeley, CA 94720(415) 642-4525Hemolysis Induced by Shear Flow5 RO1 HL 23274-02

Dr. Joseph E. WilsonDept of ChemistryBishop College3837 Simpsn-Strt RdDallas, TX 75241(214) 372-8170Development of Antithrombogenic Plastic Biomaterials2 RO1 HL 21194-03

Dr. Ioannis V. YannasDept of Mech EngMIT77 Mass AveCambridge, MA 02139(617) 253-4469Thrombogenic/Non-thrombogenic Collagen Fibers5 RO1 HL 24036-02

—


APPENDIX D: SHDPP MATERIALS

Table D-1.—SHDPP Three= Community Study Design

CommuniTY 1972 1973 1974 1975

Watsonville. . Baseline survey Media campaign Second survey Media campaign Third survey Maintenanceintensive instruc- intensive instruc- (Iow level)t ion for 2/3 tion for 2/3 media campaign

Gilroy . . . . . . Baseline survey Media campaign Second survey Media campaign Third survey Maintenance(low level)media campaign

Tracy. . . . . . . Baseline survey Second survey Third survey

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Calif.

Table D-2.—Demographic Characteristics and Survey Response Rates in Each of the Three Communities

Characteristics oft he community groups Tracy Gilroy Watsonvi l le

Entire town (1970 census)Population (total) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14,724Population (35 to 59 years of age). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4,283Mean age of 35-to 59-year-old group (years) . . . . . . . . . . . . . . . . . . . . . . 47.0Male/female ratio of 35-to 59-year-old group . . . . . . . . . . . . . . . . . . . . . 0.96

Random sample (ages 35 to 59)Original sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 659

Natural attrition (migration or death). . . . . . . . . . . . . . . . . . . . . . . . . . 74Potential participants for all 3 surveys. . . . . . . . . . . . . . . . . . . . . . . . . 585

Percentage of original sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 8 . 8 %Refusals and dropouts over 2 years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201Participants completing first and third survey . . . . . . . . . . . . . . . . . . . . 418Percentage of potential participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2 %Mean age at October 1972 (years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46.9Male/female ratio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.84Spanish speaking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.170Bilingual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . 0 %High school completed. . . . . . . . . . . . . . ., . . . . . . . . . . . . . . . . . . . . . . . 6 8 . 5 %Annual family income of $10,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 8 . 9 %

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Cal if.

12,6653,22446.2

0.88

79580

8 8 . 0 %183427

7 4 %

45.80.78

8.37017.9706 3 . 5 %6 5 . 3 %

14,5694,11547.6

0.86

833107

7268 7 . 1 %

30344962%48.4

0.757.8%9.5%

64.7%62.2%


Table D-3.—Risk Indicator and Knowledge Scores:Percentage Change From Baseline at 1,2, and 3 Followup Surveys

TreatmentWatsonville: media plus Watsonville: media only Gilroy: media only Tracy: control

Measurement face-to-face (N= 67) (N= 37) (N= 85) (N= 90)Risk score

Followup 1. . . . . . . . . .Followup 2. . . . . . . . . .Followup 3. . . . . . . . . .

Knowledge scoreFollowup 1. . . . . . . . . .Followup 2. . . . . . . . . .Followup 3. . . . . . . . . .

Dietary cholesterol (mg/day)Followup 1. . . . . . . . . .Followup 2. . . . . . . . . .Followup 3. . . . . . . . . .

Dietary saturated fat (g/day)Followup 1. . . . . . . . . .Followup 2. . . . . . . . . .Followup 3. . . . . . . . . .

Relative weightFollowup 1. . . . . . . . . .Followup 2. . . . . . . . . .Followup 3. . . . . . . . . .

Cigarette smokers (%)Followup 1. . . . . . . . . .Followup 2. . . . . . . . . .Followup 3. . . . . . . . . .

– 27.8a– 30.1 b–29.OC

– 11.6b

–25 .6b– 23.1 b

– 8 1 b

– 2 5 . 5 b

– 16.1

5.7– 2.3– 8.0

51 .6a53.3a5 7 . 0 a

2 7 . 4b

2 7 . 7b

2 7 . 9b

1 6 . 6b

2 8 . 0b

3 3 . 9b

2.24.8

14.0

–40.7d- 37.lb

–42.3b

– 26.1 b–22 .9b–27 .2b

–29 .8b–31 .8b–38 .6b

– 10.1– 6.5

– 13.4

–33 .4b–30 .5b–36 .4b

–20 .9b– 17.0–23 .9b

–25 .8b– 30.1 b–38 .4b

– 11.1– 5.1– 7.0

– 3.6a– 1.5– 0.4

0.00.0

– 0.8

– 0.3– 0.2

0.4

– 0.7– 0.4– 0.8

–32.5d– 47.5a–50.oa

0.0O . Ob e

O . Ob e

– 15.1– 15.1– 11.3

– 6.4– 10.6– 14.9

NOTE: The treatment groups consist of individuals who attended baseline and all three annual followup surveys. Data are reproduced from Meyer, et al.aThe between.group, one-tailed t-test with each other group iS Significant: P <005The between-group, one-tailed t-test with Tracy is significant: p <0.05.cThe betweefl-group, one-tailed t-test with Tracy and Gilroy is significant: P <005dThe between-group, one.tailed t test with Watsonville Control and Tracy iS signifiLa,lt: P <0.05.eBetween-group difference IS in the direction contrary to prediction.

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Calif.

Table D-4.—SHDPP Expenses by Media Campaign

Campaign 1 Campaign 2 Campaign 3 Total

Media costs . . . . . . . . . . . . . . . . $120,150 $ 7 4 , 2 4 6 $ 3 3 , 9 3 0 $228,326Personnel. . . . . . . . . . . . . . . . . . 87,960 57,958 69,153 215,071Surveys and data. . . . . . . . . . . . 33,243 20,639 18,198 72,080

Total . . . . . . . . . . . . . . . . . . . . $241,353 $152,843 $121,281 $515,477

Number of months . . . . . . . . . .Average/month . . . . . . . . . . . . . $8,045 $12,737 $10,107 $9,545

SOURCE. Stanford Heart Disease Prevention Program, Stanford, Cal if


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0