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Patients’ deaths spur allegations of use of ‘unneeded’ cardiac stents

WASHINGTON – When Bruce Peterson left the Postal Service after 24 years delivering mail, he started a travel agency. It was his dream career, said his wife, Shirlee.

Then he went to see cardiologist Samuel DeMaio for chest pain. DeMaio put 21 coronary stents in Peterson’s chest over eight months, and in one procedure tore a blood vessel and placed five of the metal-mesh tubes in a single artery, the Texas Medical Board staff said in a complaint.

Unneeded stents weakened Peterson’s heart and exposed him to complications including clots, blockages “and ultimately his death,” the complaint said.

DeMaio paid $10,000 and agreed to two years’ oversight to settle the complaint over Peterson and other patients in 2011. He said his treatment didn’t contribute to Peterson’s death.

“We’ve learned a lot since Bruce died,” Shirlee Peterson said. “Too many stents can kill you.”

Peterson’s case is part of the expanding impact of U.S. medicine’s binge on cardiac stents – implants used to prop open the arteries of 7 million Americans in the last decade at a cost of more than $110 billion.

When stents are used to restore blood flow in heart attack patients, few dispute that they are beneficial.

These and other acute cases account for about half of the 700,000 stent procedures in the U.S. annually.

Among the other half – elective-surgery patients in stable condition – overuse, death, injury and fraud have accompanied the devices’ use as a go-to treatment, according to thousands of pages of court documents and regulatory filings, interviews with 37 cardiologists and 33 heart patients or their survivors, and more than a dozen medical studies.

These sources point to stent practices that underscore the waste and patient vulnerability in a U.S. health care system that rewards doctors based on volume of procedures rather than quality of care.

Hospitals receive an average payment of about $25,000 per stent case from private insurers, according to Healthcare Blue Book, a website that tracks reimbursements. The federal Medicare program pays less. Doctors who implant stents earn a separate fee that averages about $1,000 and ranges from $500 to $2,850, according to Medicare and Blue Book data.

“Stenting belongs to one of the bleakest chapters in the history of Western medicine,” said Nortin Hadler, a professor of medicine at the University of North Carolina at Chapel Hill. Cardiologists “are marching on” because “the interventional cardiology industry has a cash flow comparable to the GDP of many countries.”

Stenting abuse is by no means the norm, but neither is it a rarity. Federal cases have extended from regional medical centers in Louisiana, Kentucky and Georgia to a top-ranked metropolitan hospital system in Ohio.

A doctor practicing at a hospital owned by the Cleveland Clinic, rated the premier heart center in the country by U.S. News and World Report, had his assets seized by federal agents in a stent investigation, according to federal court filings in April.

The clinic has not been accused of wrongdoing and says it’s cooperating with the investigation.

Two out of three elective stents, or more than 200,000 procedures a year, are unnecessary, according to David Brown, a cardiologist at Stony Brook University School of Medicine in New York. That works out to about a third of all stents.

Brown said his estimate is based on eight clinical trials of 7,000 patients in the last decade, which he analyzed in the Archives of Internal Medicine last year.

Two cardiology researchers who have studied the use of stents say the number could be as low as about half Brown’s estimate, and one said it is probably larger.

Even the low end of these estimates translates into more than a million Americans in the past decade with implants in their coronary arteries they didn’t need, said William Boden, chief of medicine at a Veterans Affairs hospital in Albany.

Boden was the principal investigator of a 2007 study known as Courage that found stents added no benefit over medicines, exercise and dietary changes in stable patients.

Unnecessary stents cost the U.S. health care system $2.4 billion a year, according to Sanjay Kaul, a cardiologist and researcher at Cedars-Sinai Medical Center in Los Angeles.

Patients who received them are living with risks that include blood clots, bleeding from anti-clotting medicine and blockages from coronary scar tissue, any of which can be fatal, Kaul said.

Monica Crabtree died at 64 after one of her arteries was torn in a stent procedure that led to infection, according to her widower, Gary Crabtree.

“It wasn’t just a simple mistake,” said the retired auto worker in Largo, Fla.

“If the stent was something she really needed, I could have handled it. But it was a total loss of life that didn’t need to happen.”