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Machines in Our Hearts The Cardiac Pacemaker, The Implantable Defibrillator, and American Health Care One-Click Download

The book 'Machines in Our Hearts' by Kirk Jeffrey explores the history and development of cardiac pacemakers and implantable defibrillators within the context of American health care. It covers various aspects including the invention, industrialization, and the impact of these technologies on heart disease management. The narrative is supported by personal stories, historical accounts, and technological advancements in the field of cardiac rhythm management.

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201 views15 pages

Machines in Our Hearts The Cardiac Pacemaker, The Implantable Defibrillator, and American Health Care One-Click Download

The book 'Machines in Our Hearts' by Kirk Jeffrey explores the history and development of cardiac pacemakers and implantable defibrillators within the context of American health care. It covers various aspects including the invention, industrialization, and the impact of these technologies on heart disease management. The narrative is supported by personal stories, historical accounts, and technological advancements in the field of cardiac rhythm management.

Uploaded by

ghuang.riechpho.achquuong
Copyright
© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
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Machines in Our Hearts The Cardiac Pacemaker, the

Implantable Defibrillator, and American Health Care

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∫ 2001 The Johns Hopkins University Press
All rights reserved. Published 2001
Printed in the United States of America on acid-free paper
987654321

The Johns Hopkins University Press


2715 North Charles Street
Baltimore, Maryland 21218-4363
www.press.jhu.edu

LIBRARY OF CONGRESS CATALOGING-IN-PUBLICATION DATA

Jeffrey, Kirk.
Machines in our hearts : the cardiac pacemaker, the
implantable defibrillator, and American health care /
Kirk Jeffrey.
p. cm.
Includes bibliographical references (p. ) and index.
ISBN 0-8018-6579-4 (acid-free paper)
1. Cardiac pacing—History. I. Title.
RC684.P3 J444 2001
617.4%12059%09—dc21
00-009627

A catalog record for this book is available from


the British Library.
FOR FRANCES
CONTENTS

List of Illustrations and Tables ix

Acknowledgments xi

Introduction 1

CHAPTER 1 Heart Block and the Heart Tickler 14

CHAPTER 2 The War on Heart Disease and the


Invention of Cardiac Pacing 36

CHAPTER 3 Heart Surgeons Redefine Cardiac Pacing 58

CHAPTER 4 The Multiple Invention of


Implantable Pacemakers 83

CHAPTER 5 Making the Pacemaker Safe and Reliable 107

CHAPTER 6 The Industrialization of the Pacemaker 136

CHAPTER 7 The Pacemaker Becomes a Flexible Machine 161

CHAPTER 8 Slowing the Pace:


The Industry’s Time of Troubles 186

CHAPTER 9 Competition through Innovation:


Accelerating the Pace of Change 209

CHAPTER 10 Preventing Sudden Cardiac Death:


The Implantable Defibrillator 235
viii CONTENTS

CHAPTER 11 The 1990s and Beyond:


‘‘When Life Depends on Medical
Technology’’ 263

APPENDIX A Device Reliability, Qualification Tests,


and Improvements 291

APPENDIX B Number of Implantations 294

APPENDIX C ICHD Pacemaker Identification Code 296

Abbreviations 297

Notes 299

Bibliographical Note 353

Index 361
ILLUSTRATIONS AND TABLES

The First Published Electrocardiographic


Tracing of the Normal Heartbeat 16
ECG of Complete Heart Block 17

Structure of the Heart 20

Albert S. Hyman’s Pacemaker, 1932 21

Paul Zoll Demonstrates His External Pacemaker,


Mid-1950s 38
C. Walton Lillehei with a Young Patient
Recuperating from Open-heart Surgery, 1961 62

Warren Mauston with his External Pulse


Generator, 1959 63
Frank Henefelt and the First Chardack-
Greatbatch Pacemaker, 1960 88
A Chardack-Greatbatch Implantable Pacemaker
of the Early 1960s 112
P.S. Walking the Hallway of Montefiore
Hospital, Fall 1958 113
CPI’s Microlith-P Pacemaker and
Model 2000 Programmer, 1978 162
Dog Being Defibrillated, 1975 238

ECG of Ventricular Fibrillation 239

Guidant Model 2901 Programmer, 1997 267


x ILLUSTRATIONS AND TABLES

TABLE 1 Technologies of Heart-rhythm Management 9

TABLE 2 The Search for a Long-term Pacing System,


1956–1960 84
TABLE 3 Implantations Reported, January 1961–
August 1963 108
TABLE 4 Sales Income and Net Income at Medtronic,
1960–1972 139
TABLE 5 Some Indicators of Growth in American
Cardiovascular Medicine 155
TABLE 6 Selling and R&D Expenses at Medtronic,
Cordis, and Intermedics, 1980 195
TABLE 7 Estimated Market Shares of Pacemaker
Manufacturers, 1975 and 1980 217
TABLE 8 Market Introduction of DDD Pacemakers 223

TABLE 9 The Pacemaker/ICD Manufacturers in 1998 275


ACKNOWLEDGMENTS

I am grateful to many people and organizations for


encouraging and facilitating my work on the technologies and practices of
heart-rhythm management. John G. Truxal and Marian Visich Jr. started
me on a first-rate intellectual adventure when they commissioned me in
1989 to write a brief monograph about the pacemaker for the series they
edited in the Alfred P. Sloan Foundation’s New Liberal Arts Program.
Faculty development grants from Carleton College freed me to conduct
research and interviews and to attend medical conventions. I thank Eliz-
abeth McKinsey, the dean of the college, for her support and interest.
Arthur Norberg extended the hospitality of the Charles Babbage Institute
for the History of Computing at the University of Minnesota during a
formative stage of my research in 1991.
Help, suggestions, and information were provided by numerous physi-
cians—Drs. Agustin Castellanos, William Chardack, Howard W. Frank,
Seymour Furman, W. Bruce Fye, Jerry C. Griffin, Samuel W. Hunter,
Richard E. Kerber, C. Walton Lillehei, James D. Maloney, Victor Parson-
net, Ronald E. Vlietstra, and Paul M. Zoll—and nurse-specialist Susan L.
Song. Drs. Parsonnet, Laurence M. Epstein, and David W. Hayes permit-
ted me to observe pacemaker and ICD implantations at close range.
Several engineers, inventors, and business leaders discussed innovation
and competition in the heart-rhythm management industry with me. I par-
ticularly want to thank Earl E. Bakken, Alan D. Bernstein, Wilson Great-
batch, Ron Hagenson, Jerry Hartlaub, Thomas E. Holloran, J. Walter
Keller, and Peter Tarjan. Chicago patent attorney Edward W. Remus gave
me a crash course on patenting and patent litigation in the medical-device
industry.
As work on the book progressed, it often seemed that heart-rhythm
management was changing so rapidly that it would elude my attempt to
make sense of it. Patrik Hidefjäll, Dr. Joel D. Howell, Kai N. Lee, Rob-
ert C. Post, David J. Rhees, and anonymous readers for Technology and
xii ACKNOWLEDGMENTS

Culture and the Johns Hopkins University Press helped me clarify my inter-
pretive ideas.
At the office of the North American Society of Pacing and Electrophysi-
ology (NASPE), Dorothy Kelleher and Janet Giroux made the NASPE
Oral History Collection available for my use. Several pacemaker and ICD
patients talked to me about their experiences with heart-rhythm disorders
and implanted devices. Elmer A. Braun, Wesley Johnson, and Helen John-
son graciously consented to my using parts of their accounts in this book.
I am greatly indebted to the staff of the Biomedical Library at the Univer-
sity of Minnesota–Twin Cities, and to Steve Rasmussen, director of the
Medtronic Library in Fridley, Minnesota, and his staff. I would also like to
thank the staffs of the Bakken Library and Museum of Electricity in Life,
Minneapolis; the Guidant/CPI library in Arden Hills, Minnesota; the Baker
Library at Harvard Business School; the library at Heart House in Bethesda,
Maryland; the James J. Hill Reference Library in St. Paul; and the Laurence
McKinley Gould Library at Carleton College. Kristine Altenhafen, Ruth
Freiman, J. Walter Keller, Nikki Lamberty, Karen Larson, Carol Lindahl,
Dr. Berndt Lüderitz, Patti Peltier, and George Szarka helped me track
down hard-to-find people, publications, and photographs. Bruce Thomas
of the Carleton College Physics Department helped me breadboard Wilson
Greatbatch’s blocking oscillator circuit from the Chardack-Greatbatch im-
plantable pacemaker of 1960. Careful readings of the manuscript by Linda
Picone and Frances Long caught numerous awkward or unclear sentences.
This book draws on papers that I have previously published in the jour-
nals Pacing and Clinical Electrophysiology (NASPE), Cardiology Clinics (W. B.
Saunders), Technology and Culture (Society for the History of Technology),
Invention and Technology (Forbes), and Circulation (American Heart Associa-
tion), and the book Exposing Electronics (Harwood).
The opportunity to form friendships with men and women involved
with cardiac pacing and defibrillation has been for me the most satisfying
part of working on this book. Drs. Arthur Linenthal and Stafford I. Cohen,
both associates of Paul Zoll, faithfully kept track of my progress and offered
many helpful insights. It was a privilege to collaborate on a historical paper
with Dr. Victor Parsonnet and to work with Dr. Seymour Furman on the
NASPE Oral History Committee. Patrik Hidefjäll, a fellow explorer in the
world of implantable medical devices, contacted me in 1995 while working
on his doctoral dissertation in technology studies at the Linköping Univer-
sity in Sweden. When he visited the United States later that year, we jointly
interviewed several key industry leaders. We have shared ideas ever since; I
could not have written this book without his incisive criticism.
ACKNOWLEDGMENTS xiii

Most physicians and industry people have resisted the temptation to


advise me on how to organize and interpret the information I was gather-
ing. I know that the result will not please them in some respects, but I hope
that they will recognize this book as an observer’s serious attempt to under-
stand and do justice to the medical-industrial field they have done so much
to create. They will note, too, that my last word on heart-rhythm manage-
ment is an affirmative one.
My large and loving family have followed the progress of this book
and contributed to it in countless ways, not least by permitting me to
take advantage of their goodwill for years on end. Above all I thank my
wife, Frances Long, for her patience and support during the book’s long
gestation.
MACHINES IN OUR HEARTS
INTRODUCTION

In the spring of 1976, Elmer A. Braun, of Charles-


ton, West Virginia, underwent a physical examination when his former
employer changed insurance carriers for its retired workers. An electrocar-
diogram (ECG) revealed that something wasn’t right with Braun’s heart-
beat. A complex network of specialized cells initiates the heartbeat high in
the right atrium and passes it on through the two atria and then to the major
pumping chambers, the ventricles. In his heart, the electrical signals were
starting out in the normal fashion but were delayed en route to the left
ventricle. His ‘‘disorder’’ showed up only in the ECG—he felt fine. ‘‘I knew
that I had something,’’ he later wrote, ‘‘but I had no symptoms of the
problem.’’1
Braun’s doctor in Charleston recommended that he have a more thor-
ough diagnostic workup, so a few weeks after the insurance exam, he trav-
eled to the Cleveland Clinic for more tests. These lasted four days and
included stress testing through exercise, in which the heart is taxed by
having the patient walk and jog on a treadmill. He also underwent a coro-
nary angiography: a cardiologist advanced a catheter through an artery
from his groin into the aorta and coronary arteries, then injected a con-
trast medium so that the arteries would show up clearly in X-ray images.
(The disorder causing Braun’s heart-rhythm problem, known as left bundle
branch block, was highly associated with coronary artery disease.) At the
end of the four days, the doctors ‘‘told me that someday I would need a
pacemaker and that I would know that day as I would ‘get out of breath.’ ’’2
Five years passed, and then, while walking his dog one fall day, Braun
noticed that he was short of breath. That afternoon he went to a local clinic
to see a cardiologist, who put him into a wheelchair and pushed him across
the street to the hospital: his heart rate had fallen from the normal range of
60 to 100 beats per minute to 39. Two days later, a pacemaker team consist-
ing of a surgeon and a cardiologist made a small incision in Braun’s upper
chest and opened a vein, threaded a wire lead down into his right ventricle,

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