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Breakthrough
Then a new breakthrough offered a gleam of hope to Dr. Wagoner's no-option patients -- a process called angiogenesis. The experimental procedure had shown great promise in two German studies, and the FDA had approved the launch of the first American clinical trial.The technique involves injecting the heart with a protein called fibroblast growth factor 1 (FGF-1), explains Thomas Stegmann, MD, the German heart surgeon who pioneered the treatment and brought it to the United States. "The protein is like a seed that causes new vessels to sprout, creating a network of capillaries and small arteries."
FGF-1 occurs naturally in the body, but the effects of injecting it were unknown. Would it have unexpected hazards, such as causing cancer or triggering blood vessel growth in places where it would be dangerous, like the eyes?
Dr. Stegmann initially tested it on animals. The 40 volunteers in his first human study, conducted in 1995, were very ill. Their blockages were so severe, they weren't expected to live more than two years at most. Twenty of them received two injections of the protein, along with standard bypass surgery.
Three months later, X-rays showed new vessels radiating from the injection sites and linking to the existing arteries, doubling or even tripling blood flow to the heart. "We were amazed at how much better the patients were. Some of them even went back to work when they were previously too disabled to lead normal lives," says Dr. Stegmann, who later tested FGF-1 as a sole therapy for 20 no-option patients, with similar increases in flow. In effect, the studies found, the sickest patients were growing their own natural bypasses.
What's more, almost all the once deathly ill patients from the 1995 study were still alive ten years later -- and healthy enough to attend a reunion. (Two died of unrelated causes.) "It was touching to see them celebrating and enjoying life," says Dr. Stegmann. Two of the survivors asked if they could be injected again because they'd developed new clogs.
Since FGF-1 had been tested on only 40 patients, the FDA set stringent rules for Dr. Wagoner's trial, which began in November 2003. Enrollment was limited to patients with heart pain who were too ill to benefit from bypass surgery but weren't so sick that they'd gone into heart failure. And Dr. Wagoner was allowed to treat only a few patients at a time. Then she had to spend 12 weeks evaluating their results before getting approval to inject the next group of patients.
After a week of tests, Keller was accepted into the trial. Dr. Wagoner warned her that the treatment had risks, including anesthesia reactions, growth of unwanted blood vessels elsewhere in the body, uncontrollable bleeding, even death. "I was concerned about the dangers but also thrilled and elated to finally have hope," Keller says. "I had nothing to lose, because the quality of my life was so bad."
On a Monday in late August 2004, John and Joan Keller took their daughter to the hospital. In the OR, she was sedated. Surgeons made an incision, carefully injected FGF-1 into the outside wall of her beating heart, and stitched her chest closed.
Within a week, though still recuperating from the operation, Keller began to notice a difference. "I had less chest pain," she describes, "and everything I did seemed easier."
Over the next several weeks, she felt herself slowly coming back to life. "Instead of getting out of breath after walking ten feet, I could go farther each day," she says. "Then I could go up and down stairs without any problem. And I didn't need to take naps every few hours, because the chronic fatigue was gone."
At first, Jim Blevins was too ill to qualify; his heart was too close to completely failing. But after Dr. Wagoner tried several medications, he improved enough to be accepted. It was March 2005. "Within 24 hours of having the injection, my chest pain was completely gone," Blevins says. "I could hardly believe it."
Home from his three-day hospital stay, Blevins, now 55 and retired, took it easy for six weeks while his incision healed. "After that, I was finding more and more strength. I could mow the lawn without stopping," he says. "I'd been dreading the future, thinking that I'd go into heart failure again and only have a few years left, but within a few months of being treated, my energy was up at least 50 percent. Everyone noticed how much better I was."
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