the damage caused by lack of oxygen and perhaps extend the window of effectiveness
for other therapies, like tPA. Unlike the early cardiac surgeons, Mayer and these other Ice Doctors used a mild form of hypothermia,
generally cooling the body by 5 to 10 degrees Fahrenheit.
No doubt, Mayer had cold on the brain, and in 2000, he got more encouragement. A European research team, led by the Austrian
emergency medicine specialist Dr. Fritz Sterz, reported that chilling patients by about 7 degrees Fahrenheit was enough to
sharply improve the outcome in patients who suffered a life-threatening cardiac arrest. 17 Think about that. Think about the number of times we hear, “He or she died of a heart attack.” All the technology in the
world’s best hospitals could only do so much, but take away 7 degrees Fahrenheit… . When Mayer described all this to me, it
seemed counterintuitive that a neurologist would dedicate himself to changing cardiac care around the country. But the Ice
Doctor was hooked.
The thing was, Mayer couldn’t start cooling cardiac patients on his own simply because he thought it was a good idea. Just
because an article gets published doesn’t mean its ideas will become accepted practice. That’s doubly true if the work is
published overseas and even truer in a field like cardiac care, which is so strictly bound by rules and guidelines. In the
United States, no one was doing hypothermia. But in Europe, its use continued to grow, and a decade later—medicine moves slowly—there
was more ammunition for people like Mayer and for other devotees like the Penn Medicine team led by Lance Becker.
Once again, it came from Sterz’ group in Austria, this time under the heading of the Hypothermia After Cardiac Arrest Study
Group. The Austrians, led by Dr. Michael Holzer and Sterz, reported in the
New England Journal of Medicine
that they had cooled 136 cardiac arrest patients and 55 percent emerged from the hospital with healthy brain function. In
a control group of 137 patients—cardiac arrest victims who were
not
cooled—just 39 percent got better. 18 It wasn’t a large study, but it was a strong result published in a major U.S. medical journal. Mayer thought it would be
decisive, a triumphant breakthrough, for doctors like him who thought that hypothermia should be the standard treatment.
But that’s not how it worked out. With such common and deadly illnesses as heart attacks and strokes, physicians are loathe
to experiment—they stick closely to protocol. This is especially true in the United States, where the fear of lawsuits makes
doctors especially unwilling to deviate from what might be called the accepted standard of care. For three years after the
publication of Fritz Sterz’ groundbreaking European study, a handful of American doctors fumed as the American Heart Association
(AHA) refused to update its guidelines to require cooling as a treatment for cardiac arrest.
Stephan Mayer was especially steamed. In his view, as long as hypothermia was not considered standard of care, hospitals could
rationalize not doing it. After all, if the AHA didn’t think it was absolutely necessary, many would ignore it. In 2005, the
AHA’s guidelines for treating cardiac arrest were rewritten, as they are every five years, and they did list therapeutic hypothermia
as a
recommended
treatment—but still not that elusive standard of care. 19
A key hurdle to shifting that line, once and for all, was the FDA. In 2004, an FDA panel that makes recommendations on medical
devices gathered to discuss the evidence for hypothermia and whether companies could specifically market cooling systems for
the treatment of cardiac arrest patients. The European study was touted, along with a second study from Australia, which also
showed that cooling helped survival.
But things didn’t go as Mayer, among many, expected. An influential FDA representative was not swayed by evidence of
Jan (ILT) J. C.; Gerardi Greenburg