How the Profit Motive Feeds the Risks of Coronary Stents

As retold in a story last month on Bloomberg.com, what happened to Bruce Peterson is characteristic of the troubling overuse in U.S. health care of cardiac stents. These tubular devices are surgically implanted to prop open arteries, and in the last 10 years, about 7 million Americans received one at a cost of more than $110 billion.

There’s no question that stents are appropriate and necessary for some heart attack patients to restore blood flow. But those cases represent only about half of the 700,000 stent procedures each year in the U.S.

Peterson was not among the appropriate patients.

He consulted cardiologist Samuel DeMaio for chest pain, and DeMaio implanted 21 stents in Peterson’s chest over an eight-month period. During one procedure, he tore a blood vessel and placed five of the metal-mesh tubes in a single artery, according to a Texas Medical Board staff complaint. Unnecessary stents weakened Peterson’s heart, exposed him to complications such as clots and ultimately was responsible for his death.

DeMaio, according to the Bloomberg story, paid $10,000 and was subject to two years’ oversight to settle the complaint over Peterson and other patients. He contended that his treatment had not contributed to Peterson’s death.

The Bloomberg investigation found that among the half of heart patients who are in stable condition and don’t need stents but electively get them, sometimes because of fraud. Injury and death are too often the result. The scenario reflects a system that rewards doctors for a higher volume of care instead of a higher quality of care. A cardiologist, says Bloomberg, gets paid less than $250 to discuss the risks of and alternatives to stents, but four times that much to implant one.

“Stenting belongs to one of the bleakest chapters in the history of Western medicine,” Dr. Nortin Hadler, professor of medicine at the University of North Carolina at Chapel Hill and a contributor to The Health Care Blog, told Bloomberg. “[T]he interventional cardiology industry has a cash flow comparable to the GDP of many countries,” he said, and doesn’t want to lose it.

Stenting abuse isn’t exactly routine, but it’s not rare. About 2 in 3 elective stents-more than 200,000 procedures a year-are unnecessary, according to Dr. David Brown of Stony Brook University School of Medicine in New York. Brown bases his numbers on eight clinical trials of 7,000 patients in the last decade, which he analyzed in the JAMA Archives of Internal Medicine. Two cardiology researchers who have studied the use of stents told Bloomberg that the number could be as low as half Brown’s estimate, and one said it is probably larger.

Some patients who got them are living with risks including blood clots, bleeding from anti-clotting medicine and blockages from coronary scar tissue.

Those complications were fatal for Monica Crabtree. She died after one of her arteries was torn in a stent procedure and became infected. Her widower received several hundred thousand dollars from a settlement of his lawsuit against her doctor, after another cardiologist reviewed the case and determined that the stent was unnecessary.

Other stent patients are alive, but live in fear.

Jim Simecek told Bloomberg that he worries every morning that a nick from shaving could bleed out of control. He must take blood-thinning medicine for life to ward off clots in the six stents implanted by a cardiologist who’s under federal investigation for his stent work.

Rhonda McClure got eight stents from a cardiologist who agreed to plead guilty to Medicaid fraud for falsifying records to justify a stent. McClure suffers from chest pain, shortness of breath and has been told that she may need more stents and surgery to keep her coronary arteries from closing.

Last year, reports to the FDA’s MAUDE site (Manufacture and User Facility Device Experience) linked cardiac stents to nearly 800 deaths. That was 71% higher, says Bloomberg, than the number found in the FDA’s public files for 2008. The 4,135 nonfatal stent injuries reported to the FDA last year from events such as perforated arteries and blood clots and other incidents were 33% percent higher than 2008 levels.

The FDA told Bloomberg that adverse-event reports tied to medical devices have increased overall due to agency efforts, and warned that data can be incomplete and unverified.

Still, since 2010, more than 1,500 patients have received letters from hospitals alerting them that their stents may have been unnecessary. The University of Pennsylvania Health System sent 700 such notices in April.

Several hospitals have settled federal allegations of charging for needless stenting and other suspect cardiac procedures. Investigations of stenting practices are underway in at least five states. In March, we blogged “Hospital’s Unnecessary Heart Procedures Were Routine.”

In July, a panel of experts assembled by the American Medical Association and the Joint Commission, which accredits hospitals, said that elective stenting was one of five overused treatments that too often “provide zero or negligible benefit to patients, potentially exposing them to the risk of harm.”

The popularity of cardiac stents boomed in the 2000s when they were found to be a more effective heart attack treatment than angioplasty, in which a small balloon is inflated to widen blood passages and then withdrawn. Stenting facilities, or catheterization labs, became hospital profit centers.

According to Bloomberg, at least five hospitals have reached settlements with the Justice Department over allegations that they paid illegal kickbacks to doctors for patient referrals to their cath labs.

According to Healthcare Blue Book, a website that tracks reimbursements, the average payment is about $25,000 per stent case from private insurers. Medicare pays less. Doctors who implant stents get separate fees averaging about $1,000.

The stent is inserted via a catheter through a small incision in the groin or wrist. The procedure usually takes less than 45 minutes.

If you are a cardiac patient and your doctor wants to implant a stent, get a second opinion, especially if your condition is stable and the surgery is deemed “elective.” Ask about alternative treatments. See “Treatment Choices for Stable Angina” on the website of the Informed Medical Decisions Foundation

You can also research reports filed on MAUDE, the FDA’s Adverse Event Reporting System (FAERS) and MedWatch.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information