Increased Controversy Leads to Stent Language Changes

Heart_Stent_Language_ChangeCoronary stent guidelines are changing—by just one word—following issues over insurance and regulator disputes

The American College of Cardiology is removing the word “inappropriate” from its guidelines for coronary stent implantation, according to The change will become effective next year and removes the word that has been in effect since 2009. The term has been used to describe those cases in which patients do not require the proceure.

According to Robert Hendel, who led the effort, the wording has been a problem in disputes. “The term ‘inappropriate’ caused such a visceral response,” Hendel, a cardiologist at the University of Miami, told “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 has changed the term “Inappropriate” with “Rarely Appropriate.” Also, a category in which medical doubt exists will change the word “Uncertain” to “May be Appropriate,” reported. The verbiage changes are being made in the midst of heightened controversy over coronary stent procedures, which are costing the health care system $2.4 billion annually, Sanjay Kaul, a cardiologist and researcher at Cedars-Sinai Medical Center in Los Angeles, told

As we’ve written, the issue of cardiac stenting has highlighted potential overuse of the devices that may lead to cardiac complications. Cardiac stenting involves propping open a narrowed coronary artery with a small, metal mesh tube. During emergency surgery, for instance, when a patient is suffering a heart attack, a stent can save a life. Studies have long revealed, however, that stents are being implanted in patients who do not realize any significant benefit from stent implantation. About 700,000 stent procedures are conducted nationwide annually.

Regulators have taken notice. For example, medical licensing boards in a number of states have disciplined surgeons accused of over-implanting the devices, according to Three interventional cardiologists—doctors who insert the devices—have been convicted of federal fraud charges over unnecessary stent implantation and have been serving prison time since 2008. Insurers also question if doctors are appropriately advising their patients about the risks tied to stent procedures, as well as the benefits realized with alternative options, such as drug management.

David Brown, a cardiologist at Stony Brook University School of Medicine in New York recently pointed out that, while some seven million heart patients have been implanted with catheters in the past 10 years, about one-third of those procedures were unnecessary. And, according to a prior report, 11 hospitals have agreed to settlements with the Justice Department to resolve civil allegations of unnecessary stenting and related issues.

Many federal cases have been filed by whistleblowers and, in information made recently public, documents reveal that hospitals benefited financially from stenting procedures. In fact, the documents reveal that, in some cases, hospital administrators sometimes ignored or urged allegedly inappropriate use of stents. The Department of Justice has been conducting investigations into interventional cardiology and stenting since 2006.

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