The American College of Cardiology is changing its guidelines for when implanting coronary stents is appropriate -- by banishing the term “inappropriate.”
Next year, the main U.S. heart-doctor group will remove the word it has used since 2009 to describe cases where people don’t need the metal-mesh tubes in their blood vessels. The label has become a liability in treatment disputes with insurers and regulators, said Robert Hendel, who led the effort that updated the wording.
“The term ‘inappropriate’ caused such a visceral response,” said Hendel, a cardiologist at the University of Miami. “A lot of regulators and payers were saying, ‘If it’s inappropriate, why should we pay for it, and why should it be done at all?’”
The cardiology group replaced the “Inappropriate” label with “Rarely Appropriate.” Another category -- cases in which there’s medical doubt -- will switch from “Uncertain” to “May be Appropriate.”
The changes reflect the controversy that has enveloped coronary stents, which are threaded through the circulatory system on catheters to prop open blocked arteries. With 700,000 procedures in the U.S. annually -- at an estimated cost of $14 billion -- appropriate use of the devices has become one of the hottest issues in cardiology. Eight studies have found stents are no better than drug-based therapy in preventing heart attacks and death in patients with stable heart disease.
As many as 12 percent of such elective stent cases were “inappropriate” under the ACC’s guidelines, according to a 2011 study in the Journal of the American Medical Association, while 38 percent were “uncertain,” leaving about half that were “appropriate.”
Unnecessary stents cost the U.S. health care system $2.4 billion a year, said Sanjay Kaul, a cardiologist and researcher at Cedars-Sinai Medical Center in Los Angeles.
Founded in 1949, the ACC is the nation’s main professional group of cardiologists, representing about 37,000 members. Its panels issue guidelines on the best treatment options for cardiovascular diseases. Though doctors aren’t bound by the recommendations, insurers, state medical boards and civil courts pay close attention to them when controversies arise.
Regulators are taking an increasingly hard line on stents. Medical licensing boards in Texas, Maryland, Missouri and Kentucky have disciplined doctors who they accused of implanting the devices needlessly. Three interventional cardiologists -- doctors who insert stents -- have been convicted of federal fraud charges related to unnecessary stents and sentenced to prison since 2008.
Insurers, too, are questioning whether doctors adequately inform patients about the risks of stenting or the benefits of alternatives. Drug-based management of partially blocked arteries costs $9,451 less per patient over a lifetime than stenting, according to a 2008 study in the journal Circulation.
Insurer HealthNow New York Inc. brings extra review to cases in which patients seek elective stents under a pilot project in Buffalo that’s aimed at steering them toward medicinal treatments instead, said Alan Saltzman, the company’s medical director. Stents may provide less benefit to such patients, he said.
“There’s more and more evidence that suggests medical therapy offers a long-term advantage,” Saltzman said.
WellPoint Inc., the nation’s second-largest health insurer, is considering coverage changes to better inform patients about elective stents’ risks and benefits, said Alan Rosenberg, the company’s vice president of medical and clinical pharmacy policy.
“Real, informed decision-making with the patient maybe isn’t done by the cardiologist, but should be done by some disinterested physician,” he said.
About 7 million Americans received coronary stents over the past decade. Roughly half of them had a heart attack or other acute syndrome. Stents are beneficial in such cases, most cardiologists agree.
Among the other half -- elective-surgery patients in stable condition -- at least a million didn’t need the implants, according to estimates by William Boden, the chief of medicine at a Veterans Administration hospital in Albany, New York, and three other researchers.
“You can call anything ‘appropriate,’” said Boden, the principal investigator of the “Courage” study, the first large trial to cast doubt on stents’ benefit for stable patients, in 2007. “They’re gilding the lily to justify what’s being done too frequently and shouldn’t be done at all.”
Patients who get unnecessary stents live with foreign objects in their arteries that pose potentially fatal risks of blood clots, bleeding and new blockages from scar tissue, Boden said.
To discourage overuse, the ACC, along with the American Heart Association and six other medical societies, initiated its appropriate-use criteria for stents in 2009. The guidelines rated the evidence for stenting and bypass surgery for some 180 different patient scenarios.
They were intended as recommendations to inform doctors’ decisions, not decrees, Hendel said. Over the years, insurers and regulators “misused” the guidelines to challenge physician discretion, he said. The new phrasing allows for “extenuating circumstances” when doctors may employ unorthodox treatments, he said.
“What we’re trying to do is avoid the sensationalism” of branding treatments inappropriate, Hendel said.
The first stenting guidelines appeared two years after the Courage study spawned arguments about whether stents are ever appropriate for stable patients. The ACC wanted to get ahead of the debate before insurers or the government imposed their own standards, according to Manesh Patel, an interventional cardiologist at Duke University Medical Center who chairs the writing group for the guidelines, officially called the “Appropriate Use Criteria for Coronary Revascularization.”
“We could participate in change, or have change thrust upon us,” said Patel in an interview. The guidelines represented “a first step down the road of self-regulation,” he said.
The criteria, updated in 2012, assume that stable patients considering a stent have a narrowing in their left-main artery of 50 percent or more, or a blockage in at least one other heart vessel of 70 percent or more, as measured on a scan called an angiogram. The guidelines also recommend that all patients try at least two heart drugs to improve symptoms such as chest pain. A 17-member panel considered case descriptions combining such variables as symptom severity, medications, stress-test findings and the number of diseased vessels.
The resulting guidelines give doctors wide latitude to stent and are “not evidence-based,” said Rita Redberg, a cardiologist at the University of California at San Francisco, and editor of the medical journal JAMA Internal Medicine. For example, some patients who have no symptoms and are on little or no heart drugs are rated “Appropriate” or “Uncertain” for stenting, even though “there is no known benefit and definite harms” to stenting asymptomatic patients, Redberg said.
Such patients, whose heart conditions may have been flagged in a routine electrocardiogram or treadmill test, “shouldn’t be getting angiograms in the first place,” she said. “At most they should get medical therapy” and lessen their risk through steps such as diet and exercise, she said.
The only symptom Craig Hohertz recalls before his first stent in 2007 was a loss of stamina during his regular runs around Town Lake in Austin, Texas. Eventually, he lost track of how many he got, he said.
Cardiologist Samuel DeMaio gave Hohertz the first one at age 45. Hohertz had no history of heart disease, a normal stress test and he wasn’t taking heart medicine, according to a complaint by the Texas Medical Board staff. The complaint refers to “Patient I” and doesn’t name Hohertz. He filed a separate lawsuit that identifies him as Patient I in the board’s case.
DeMaio gave him “multiple long stents in only moderately diseased vessels,” and several appeared to be unwarranted, according to the board’s complaint. After the first few stents, Hohertz was symptom-free, the complaint says.
DeMaio paid $10,000 and agreed to two years’ oversight to settle the complaint over his care of Hohertz and others in 2011. The doctor declined to comment on Hohertz. In general, he said that all the stents he implanted were needed and that practices have changed since the last decade. He noted that in its final order, the Texas board didn’t say he did “excessive” stenting.
After his 10th stent, Hohertz had his wisdom teeth out and went off the blood-thinning medicine he’d been prescribed to keep his stents from clotting. Blockages formed in his arteries, requiring two bypass surgeries, according to the Texas complaint. Today, five years after his 21st and final stent, Hohertz said he finally feels strong again and he wonders why DeMaio didn’t try medications from the start.
“If he had, I wouldn’t have needed stents at all,” he said.
The appropriate-use criteria for stenting are particularly lax for patients with so-called high-risk unstable angina, according to Kaul, Redberg and three other researchers. All such cases -- which involve irregular chest pain that’s not linked to exertion -- are considered appropriate for stenting under the 2012 guidelines. They accounted for 29 percent of all stentings, according to the 2011 Journal of the American Medical Association study.
The definition of “high risk” in the appropriate-use criteria is overly broad, said Redberg, who published a 2011 commentary on the subject in the Archives of Internal Medicine, now called JAMA Internal Medicine. Under it, patients who have irregular chest pain are appropriate for stenting if any one of the following applies: they have a high or low heart rate, they have a new or worsening heart murmur or they’re older than 75, she said.
“It’s like asking a barber if you need a haircut,” Redberg said. “To an interventional cardiologist, stents are good for almost everyone.”
John Spertus, a University of Missouri-Kansas City cardiologist who helped write the guidelines, called them “a good start” toward more responsible stenting, but said they aren’t perfect. “We should have been more precise,” he said. “We left it a little wishy-washy.”
Interventional cardiologists are lobbying for the next appropriate-use update to sanction stenting for chest-pain relief and when patients demand it, according to comments submitted to the guidelines panel. The 2012 criteria “generally disregard the essential role of patient preference” and their quality of life as reasons to stent, according to a letter submitted by doctors affiliated with the ACC and the Society for Cardiovascular Angiography and Interventions, which has approximately 4,200 physician members.
The interventionists also want to increase their influence on the panel that votes on the appropriateness of stenting in each patient scenario. Four of them sat on the 2012 committee, with four heart surgeons, eight general cardiologists and one insurance-company medical director. Drop the surgeons and add more stent doctors, the interventionists argued.
“Since our community understands the real life application of the procedure and its benefits and drawbacks better than anyone, we should have a far greater representation,” said the letter, written by lead author Lloyd Klein, an interventional cardiologist in Elmhurst, Illinois. The guidelines panel responded that it expects to change the voting composition to five interventionists, five surgeons, five general cardiologists and two others.
For now, some doctors are eager for the “Inappropriate” label to disappear next year -- hoping it helps remove some of the stigma attached to elective stenting by a small number of bad actors, Klein said in an interview.
“Nobody likes being accused of doing something inappropriate,” he said.