In lieu of an abstract, here is a brief excerpt of the content:

CHAPTER 9 COMPETITION THROUGH INNOVATION: ACCELERATING THE PACE OF CHANGE By 1980, virtually all pacemakers depended on hyrid integrated circuitry and lithium batteries that would reliably manage the heartbeat for eight years or more. Using an external programmer, the physician could alter the pacer’s behavior in various ways and, in a few models, also interrogate the implanted device through coded magnetic signals and download information about its performance, the condition of the battery, and the behavior of the patient’s heart. But the life cycles of products were growing shorter and each generation of devices added new possibilities (or new layers of complexity) for the physician. By 1985, the six remaining U.S. pacemaker manufacturers had moved on from lithium and programmability to compete in a new technological arena, dual-chamber pacing. Now the top-of-the-line pacers boasted two leads threaded through a vein into the heart—one set up in the right atrium and the other in the right ventricle. Manufacturers and leading pacemaker physicians argued that dual-chamber pacing, by providing better coordination between the contractions of the heart’s upper and lower chambers, more closely emulated nature and offered important physiological benefits to the patient. But to the consternation of the industry, many doctors avoided dual-chamber pacemakers almost entirely for several years; in the main, the profession stuck with the familiar, single-lead, noncompetitive pacers that had come into use more than a decade earlier. Senior specialists in the field were troubled by what they viewed as a lack of technological sophistication on the part of many practitioner implanters. Between 1974 and 1979, a group of the leading specialists laid out guidelines of good medical practice in cardiac pacing, founded a journal, and organized a professional society; they hoped to improve standards of training, to raise the professional profile of cardiac pacemaker work, and to assert the independence of implanter physicians from the device manufacturing companies . These events and the lukewarm reception given to dual-chamber pacing once again suggest that device manufacturers, academic physicians 210 MACHINES IN OUR HEARTS heavily committed to pacing, and practitioner implanters saw the pacemaker itself and the medical field of cardiac pacing in rather different ways. THE ICHD REPORT AND THE PACEMAKER CODE In the 1970s, the physician community grew rapidly and changed in composition . Pacing had acquired the reputation of being a straightforward, problem-free procedure; as we saw in chapter 7, this attracted many doctors affiliated with community hospitals and many who did pacemaker work as one part of their broader practices in general surgery or clinical cardiology .1 Two distinct groups of doctors thus coexisted: a small group of specialists who worked in large medical centers, and a much larger group of occasional implanters. Yet despite its reputation, pacemaker work was far from simple. Diagnosing and treating the sick sinus syndrome was a more complex matter than managing complete heart block. SSS revealed itself more subtly in the patient’s ECG and had a broader spectrum of symptoms. In addition, the long-term survival of many paced patients entailed new responsibilities for physicians, such as setting up routine procedures for periodic reexaminations. And from 1973 on, manufacturers had introduced numerous pacemaker models with enhanced capabilities. At the beginning of the decade, an organization called the Inter-Society Commission for Heart Disease Resources (ICHD), a joint creation of the American Heart Association (AHA) and the American College of Cardiology (ACC), began to sponsor reports on the state of medical treatments for various diseases of the heart. The commission named a committee to report on the status of cardiac pacemaker implantation, but the eminent senior figures—Paul Zoll, William Chardack, and Dwight Harken, among others —were unable to reach consensus on most issues. Seymour Furman remembers a meeting at which the group debated at length the definition of a pacemaker but could agree only on ‘‘A pacemaker should pace the heart.’’ Eventually, the ICHD disbanded the original committee and asked Victor Parsonnet to convene a new ‘‘pacemaker study group’’ of his own selection. Parsonnet chose Furman and Nicholas P. D. Smyth, of George Washington University in Washington, D.C. The three men were all surgeons with long experience in pacing.2 The report of the ICHD Pacemaker Study Group (1974) proposed a simple, three-letter identification code of Smyth’s devising that implanters and manufacturers quickly adopted (see appendix C). Within a short time, everyone in pacing had learned to speak...

Share