Tuesday, May 31, 2005
"It's not a Frankenstein thing," Bill Redfern joked, as a medical attendant at Shady Grove Adventist Hospital in Rockville cuffed him flat to a medical table by his calves and thighs. Green rubber hoses poked from the blue cuffs wrapping the legs of the 73-year-old Maryland accountant. Several wires linked his chest to a large gray box near the head of the table.
A switch was flicked, and the machine began a pulsing sound, an unfamiliar whoosh-CLICK! whoosh-CLICK! At each pulse, three sets of cuffs strapped to Redfern's legs rapidly inflated and deflated, one after another, so powerfully that his body jerked upward until he seemed to float above the table. On the box was a bright red knob that Redfern could pull at any time to stop the procedure -- "just in case."
"It's not something you'd want to do for a long time," Redfern admitted as he started the 34th of his recommended 35 hours on Enhanced External Counterpulsation, or EECP.
But the bizarre-looking procedure, which is administered over a period of seven weeks, also has a unique selling point to patients with coronary artery disease: it's nonsurgical. That means less risk, lower cost, less pain, less time in the hospital. And it seems to work.
Yet EECP has never made it into the major leagues of heart disease treatments. That's so even though it's been around for decades and has passed muster with the Food and Drug Administration (FDA) and Medicare as a treatment for angina -- chest pain or discomfort that occurs when the heart muscle does not get enough blood.
A lack of patients isn't the problem. Coronary artery disease (CAD, or clogging of the arteries leading to the heart) is a leading cause of premature death and permanent disability among adults in the United States. According to the American Heart Association (AHA), 7 million Americans suffer from one of the disease's primary symptoms, a painful squeezing or pressing sensation in the chest called angina pectoris. The AHA says 400,000 new cases of angina are diagnosed each year.
But doctors are divided on the merits of EECP.
Even though the treatments are offered at prestigious medical centers including the Mayo Clinic, the Cleveland Clinic and the University of Virginia, most cardiologists -- if they have even heard of EECP -- disparage it.
Stuart Seides, associate director of cardiology at the Washington Hospital Center, is emphatic: "Many of us remain skeptical about the true value" of EECP, he said. "It makes absolutely no physiologic sense."
The minority camp, led by Dennis Friedman, chairman of cardiology and research at Shady Grove Adventist Hospital, is equally outspoken.
"This uncomplicated procedure, with few risks factors, has huge benefits for patients with angina [who] don't have any other options," said Friedman. It shouldn't be so hard, he suggests, for patients who've exhausted other alternatives to learn there's one more option to try.
Made in China
EECP first became popular in China, where coronary heart disease affects a relatively small percentage of the population. There, doctors spent two decades developing and testing a noninvasive technology using counterpulsation to treat coronary heart disease.
Counterpulsation means pumping blood during the heart's rest phase. During treatment, the cuffs compress the blood vessels in the lower limbs -- first calves, then thighs, then buttocks -- pushing blood toward the heart; each wave of increased blood flow is timed to arrive at the heart at the moment the organ relaxes. When the heart pumps again, pressure is released. Some studies suggest the process may produce lasting effects by stimulating the formation of collateral blood vessels in the heart.
Compressing these vessels also mimics the effect of regular physical exercise, releasing hormones and other substances that may promote greater blood flow.
The Chinese "had all this data worked out [on EECP] 20 years ago," said Friedman, "but it wasn't very sexy for the United States."
American doctors, instead, showed more interest in invasive procedures. Though a few Americans researchers experimented with producing counterpulsation, their studies -- which reported symptom relief but didn't look at mortality -- drew little attention.
The Chinese, however, reading the same journals, got to work. Their clinical experience led to the installation of more than 1,500 external counterpulsation units in China during the past 15 years. Germany, Switzerland, the United Kingdom, Ireland and Japan also set up study sites.
Meanwhile, some scientists at the National Institutes of Health, the Cleveland Clinic and Stony Brook Medical Center in New York continued work on the technique. Vasomedical Inc. of Westbury, N.Y., also funded research into its own products; its efforts resulted in 1998 FDA approval for its EECP device and therapy for treatment of angina.
In 1999, Medicare recognized and began reimbursement for EECP as an alternative therapy for advanced angina that is not treatable by bypass surgery or angioplasty. More than 300 health insurers now cover the procedure for this purpose.
And, in June 2002, the FDA also approved EECP as a treatment for congestive heart failure (CHF) -- a condition in which the heart weakens, often as a result of heart attacks, coronary artery disease and uncontrolled blood pressure -- and loses the ability to pump blood to the body. (CHF affects nearly 5 million Americans.)
Show Me the Data
But despite scores of studies -- appearing in such respected journals as the American Journal of Cardiology, Circulation, Heart and the Mayo Clinic Proceedings -- that enthusiasts say show the treatment's benefit -- EECP has had a hard time winning acceptance.
Seides says he and many of his colleagues regard EECP with skepticism because the studies have not been scientifically rigorous; only two randomized controlled trials on EECP have been published to date.
The one most often cited by EECP proponents is a study of 139 angina patients at seven U. S. medical centers, published in 1999 in the Journal of the American College of Cardiology. Some patients received EECP, the rest a sham procedure; patients didn't know until the end of the study which treatment they'd received. Columbia University researchers found patients in the treatment group had a clinically significant decrease in angina episodes and in use of nitroglycerine to relieve chest pain.
But while patients were unaware which treatment was being used, medical staff applying the treatment weren't -- so they may have inadvertently suggested the form of treatment being administered. The study also relied on patient recall -- always fraught with potential bias -- about angina episodes and the use of nitroglycerine. And the study examined short-term effects only.
Another set of studies, published in the American Journal of Cardiology (AJC), followed more than 5,000 patients from more than 100 centers around the world. Researchers found that 73 percent of patients treated with EECP reported a significant reduction in the severity of their angina; half reported an improvement in their quality of life after EECP. These results, the investigators found, still held in a follow-up study on the same group two years later.
The AJC study authors acknowledged, however, that their study lacked a control group and didn't compare EECP's reported benefits with those from other treatments, including medical therapy, lifestyle modification and an invasive procedure called coronary revascularization. The researchers couldn't rule out the possibility that at least some of EECP's reported benefit was the result of the placebo effect, in which patients do well because they believe they will. As the authors wrote, they were working with "a population of highly symptomatic patients enthusiastic for an emerging novel therapy."
Despite their shortcomings, the studies have swayed some cardiologists, Friedman among them.
"I am an interventional cardiologist," he said. "I like to do all these [invasive] techniques, but I also believe in the basics. . . . I don't think intervention and medicine are mutually exclusive. I think they should both be used concomitantly."
He prescribes EECP for patients like Redfern, who "no longer have an option for bypass" or artery stenting either because of frail health, complicating conditions or because they've run out of blood vessels that can be harvested for bypass. (EECP is not appropriate, though, for patients with irregular heartbeats, bleeding disorders, clots or inflammation of blood vessels in the legs, or for pregnant women.)
Gail Driskill, an EECP therapist at the cardiac rehab clinic at Shady Grove Adventist Hospital, said that since 1998 she's seen EECP used with more than 190 patients, each of whom she knows personally.
"Their quality of life is much better, they can do a lot more than they were able to do before," she said. "Some of our patients, when they come here they can't even go one flight of stairs. And we actually have them at the cardiac rehab exercising at the end of treatment."
Redfern, who's a veteran of one heart attack, at least six angioplasties, a bypass surgery, a couple of stents and a pacemaker, said he's convinced EECP has helped him. Since beginning treatment this winter, he's taken fewer nitroglycerine pills, and his exercise tolerance has improved dramatically. Just the other day, he said, he took the stairs to his second-floor office. "I went up 30 steps, no problem, which is amazing, because before I got on this table I could barely go up 10 steps."
But such stories don't impress Seides any more than the studies do. Angina, he said, "is a symptom that can regress and progress spontaneously," and "most of the studies rely on patients' self reporting of symptoms."
Perhaps relevant to the controversy over EECP as well: It's time-consuming (the typical course of treatment requires five hours a week for seven weeks) and, at about $7,000 a treatment course, less profitable for the cardiologist than invasive procedures. Says Friedman: "Maybe it's not as rewarding professionally, or financially, and therefore this does not become a high priority."
(Seides slams that ball back: "I would posit that the driver here is not the unwillingness of the interventional cardiologists to refer," he said, "but rather the opportunity for the noninvasive cardiologists to retain patients and capture income by setting up one of these [EECP] centers.")
Because it makes minimal use of cardiologists' specialized medical training, EECP also presents an image problem: Operating a heaving, chugging set of hoses, say some, just doesn't match the traditional picture of what a cardiologist does.
EECP "smacks of physical therapy," said former University of Pittsburgh professor of medicine Richard Fogoros, an author in the fields of cardiology and cardiac electrophysiology. "It's just not cardiology. It doesn't fit into how [cardiologists] view themselves as practitioners," said Fogoros.
Seides as much as acknowledges that tension when he calls EECP "the revenge of the noninvasive cardiologists." Of colleagues who refer patients to EECP, he said, "You wonder how hard they are trying to treat the angina." The treatment, he said, gives the noninvasive cardiologist "an opportunity to do something . . . rather than refer to a top-end center. . . . The major risk of any treatment like that is that you will delay seeking treatment that is more effective."
More effective, in this case, also means more invasive and more expensive. According to an April 2004 study in the Canadian Medical Association Journal, "charges for full EECP treatment are approximately $7,000, one-third of the charges associated with balloon angioplasty (PTCA) and one-fifth of the cost of bypass surgery (CABG)."
Seides said he's not surprised Medicare likes EECP: "Regulators and payers are conservative, and the notion that here's something that you can treat angina with, that while it ain't cheap, it's cheaper than a bypass," may appeal to them, regardless of the science behind it. In which case, he said, patients lose.
Fogoros worries that patients lose in other situations--if, say, doctors shy away from a treatment like EECP for reasons that have nothing to do with its effectiveness.
"This is a general problem patients face," he laments. "They may not be hearing about all the useful treatments out there." Patients have to educate themselves and "find out what all the alternatives are," he said.
In the meantime, EECP research is picking up. Scientists are continuing to study EECP's effectiveness as a treatment for congestive heart failure. Findings from EECP's second randomized controlled trial, presented at the recent annual meeting of the American College of Cardiology, showed, says the manufacturer of EECP equipment, greater effectiveness for EECP therapy than drugs in improving exercise duration (a marker for how well the heart is working).
Experts meanwhile agree that more studies are needed. "If the proponents of EECP prove the methods by which this works, I think it is going to go a long way to prove that this is science as opposed to witchcraft," said Fogoros.
Seides agrees. "I am open-minded," he said. "Show me the data. If it's the best thing to do for enough patients, we could certainly offer that." ·
Ranit Mishori, a family practice resident at Georgetown University/Providence Hospital, recently wrote for the Health section about the development of needle-free drug delivery.