Machines in Our Hearts: The Cardiac Pacemaker, the Implantable Defibrillator, and American Health Care (review)

This is not a book to be read on an airplane trip, even one of transcontinental length. It is at once a reference book about two artifacts—the cardiac pacemaker and the implantable defibrillator—and their vital role in American health care, and a collection of fascinating anecdotes and analytic observations on how these two machines gave rise to a multibillion dollar industry. Kirk Jeffrey is a professional historian specializing in the history of technology. His work traces the early days of modern cardiac surgery, from the World War II removal of intracardiac foreign bodies by Dwight Harken, through the surgical palliation of Fallot's tetralogy by Alfred Blalock, and Wilfred G. Bigelow and John C. Callaghan's use of total body hypothermia to permit extended cardiac operations under total circulatory arrest.

When the hypothermic animals in Bigelow's experiments developed ventricular fibrillation or cardiac arrest, normal rhythm was restored by a pacemaker passed through the jugular vein into the right atrium. The team's presentation at a 1950 Clinical Congress of the American College of Surgeons was heard by Paul Zoll, a Boston physician who had served as cardiologist on Harken's wartime cardiac surgical team. Basing his own experimental work on freely shared data from Bigelow, Zoll went on to the ultimately successful treatment of a patient with intermittent, dangerously slow heart rate (Stokes-Adams attacks). From here it was a long road to permanent pacing with devices small enough for implantation. But as the market for pacing enlarged, multiple groups of clinicians and engineers in the United States and abroad began working in the late 1950s to develop reliable, miniaturized devices for long-term pacing. Infection risks from wires penetrating the skin enforced the need for external, transcutaneous radiofrequency transmitters—or ideally, for total implantation. Jeffrey's interviews with the principals in these engineering advances provide a lively account of the complex, controversial questions of priority, credit, and ultimately the 1962 patenting and commercial marketing of pacemakers such as the Chardack-Greatbach device.

The 1960s ushered in the takeover of the pacing field by device manufacturers. With industrialization came lawsuits over competing patents, aggressive marketing to the medical profession, and a role for company salesmen that put them, somewhat uneasily, into catheterization laboratories and operating rooms as technical consultants. Vigorous educational programs for community physicians raised the therapeutic consciousness of the profession and vastly expanded the number of potential patients to be treated for nonlethal arrhythmias. By the mid-1970s the annual number of pacemaker implantations reached 75,000, while the short life of pulse generators ensured that a new patient might need multiple replacements over a lifetime. Widespread prepaid reimbursement arrangements in the 1960s further facilitated the use of such expensive therapies.

In the 1980s the pacemaker industry was transformed by the introduction of the implantable cardioverter defibrillator (ICD), which later became known as the "implantable cardiac defibrillator"—thus downplaying its less dramatic function of converting certain relatively benign tachycardias, and emphasizing its lifesaving function of correcting otherwise fatal ventricular fibrillation. The ICD made its way into the "cardiac rhythm management industry" in ways that resembled the evolution of the pacemaker, but differed in that the Food and Drug Administration (FDA) was now the watchdog of commercial development, a process marked by dozens of patent applications and multimillion dollar costs for industrial production.

Among the episodes that enliven Jeffrey's narrative, the story of Michel Mirowski is striking for its portrayal of determined conviction against formidable odds. Driven from Poland in 1939 by the Nazi invasion, Mirowski achieved his medical education under adverse conditions in many countries, ending up in America as a cardiologist convinced that an implantable defibrillator was both vitally needed and theoretically feasible. Aside from the intrinsic...