By Peter Waldman, David Armstrong & Sydney P. Freedberg - Sep 25, 2013 9:01 PM PT
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 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. Cardiologists get paid less than $250 to talk to patients about stents’ risks and alternative measures, and an average of four times that fee for putting in a stent.
“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” and doesn’t want to lose it, he said.
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 Administration hospital in Albany, New York. 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 including 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 age 64 after one of her arteries was torn in a stent procedure that led to infection, according to her widower, Gary Crabtree. He received at least $240,000 from a 2011 settlement of his lawsuit against her doctor, after a second cardiologist reviewed the case and told him the stent wasn’t needed. Crabtree choked up speaking about his late wife and showed pictures of their 47 years together.
“It wasn’t just a simple mistake,” said the retired auto worker in Largo, Florida. “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.”
Jim Simecek, of Medina, Ohio, said he worries every morning that a nick from shaving could bleed out of control. Simecek, who works at a Ford dealership, said he has to take blood-thinning medicine for life to ward off clots in the six stents he received from a Cleveland-area cardiologist who’s under federal investigation for his stent work.
“It’s as if your heart was open and somebody was sticking a knife in,” said Rhonda McClure, 54, referring to eight stents she received from a Kentucky cardiologist who agreed in June to plead guilty to a federal Medicaid-fraud charge for falsifying records used to justify a stent he placed.
Cardiac stents were linked to at least 773 deaths in incident reports to the U.S. Food and Drug Administration last year, according to a review by Bloomberg News. That was 71 percent higher than the number found in the FDA’s public files for 2008. The 4,135 non-fatal stent injuries reported to the FDA last year -- including perforated arteries, blood clots and other incidents -- were 33 percent higher than 2008 levels.
The FDA declined to comment on whether the reports were a cause for concern. It said adverse-event reports tied to medical devices have increased overall due to agency efforts. It also said the data can contain incomplete and unverified accounts from reporting parties.
More than 1,500 patients have gotten letters from hospitals since 2010 alerting them that their stents may have been unnecessary. In Philadelphia, the University of Pennsylvania Health System sent 700 such notices in April.
At least 11 hospitals have settled federal allegations of charging for needless stenting and other misdeeds in the catheterization labs where the procedures are performed. Federal probes of stenting practices continue in at least five states. In Louisiana and Maryland, cardiologists went to federal prison last year for implanting the devices and charging for them without medical justification. A third doctor has agreed to do time in a plea bargain.
“There is a huge financial incentive to increase the number of these procedures,” said Jamie Bennett, a former assistant U.S. Attorney in Baltimore who handled stent investigations. “The cases we have seen to date are just the tip of the iceberg.”
Since Boden’s Courage study, stenting procedures have declined by about 20 percent. Still, this July, a panel of experts convened by the American Medical Association and the Joint Commission, a hospital accreditor, named elective stenting as one of five overused treatments that too often “provide zero or negligible benefit to patients, potentially exposing them to the risk of harm.”
Doctors are using fewer stents and choosing more-appropriate patients than they were a few years ago, according to John Harold, president of the American College of Cardiology, the specialty’s main professional group. Harold said that “real-world clinical practice” and research indicates Brown probably overestimated how many people with coronary artery disease could be handled initially only with drug-based treatment.
He said there are examples of inappropriate use and the ACC is taking steps to “address and correct the imbalance” with treatment guidelines and by urging more hospital oversight. Cardiologists who’ve been accused of fraud or are serving prison time are “outliers” who don’t represent the “overwhelming majority.”
Lawyers for John McLean, a Salisbury, Maryland, cardiologist convicted of billing for unwarranted stenting, argued in a federal appeal last year that inappropriate usage is widespread and their client was prosecuted for behavior that’s the industry norm.
They cited a 2011 study in the Journal of the American Medical Association that found only half of elective stent procedures nationally were appropriate under usage guidelines written by societies of heart specialists. The study found 12 percent were inappropriate, and 38 percent fell into the uncertain category of the guidelines.
“The study demonstrated clearly that a large number of stable patients receive coronary artery stents that are later found to be inappropriate or questionable,” the appeal argued. “The same was true of the patients in Dr. McLean’s practice.” McLean’s appeal was denied in April. He is serving an eight-year sentence.
Elective-stent patients typically see rapid quality-of-life improvements, including in their ability to work and be active, according to Ted Bass, president of the Society for Cardiovascular Angiography and Interventions, whose members specialize in cardiac implants. The Courage trial found stents, compared to medication and lifestyle changes, were better at relieving chest pain for as long as two years after placement -- a benefit that ended by 36 months.
First used in Europe in 1986, cardiac stents took off in the 2000s as cardiologists found them to be more effective in heart attacks than angioplasty. In that earlier technology, a small balloon is inflated to widen blood passages and then withdrawn. Stenting facilities, known as “cath labs,” spread at hospitals and became profit centers.
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.
The procedure typically involves inserting the stent with a catheter through a small incision in the groin area or wrist and snaking it through to heart vessels. It usually takes less than 45 minutes.
Stony Brook’s Brown, and Boden, who led the Courage study, argue that many elective patients should be getting medical therapy before they risk stents. Only 44 percent try medication and lifestyle changes before stenting, a 2011 study in the Journal of the American Medical Association found.
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. St. Joseph Medical Center in Towson, Maryland, paid the government $22 million without admitting liability.
Prosecutors alleged the hospital paid kickbacks to a practice co-founded by Baltimore cardiologist Mark Midei for stent referrals. His doctor’s license was revoked in 2011 when the Maryland Board of Physicians found he falsified records to justify unwarranted stents.
St. Joseph told 585 of its patients they may have received unnecessary stents. In May, 252 patients reached a settlement with the hospital under confidential terms, according to Jay D. Miller, an attorney for the plaintiffs.
The hospital settled the government’s case “to avoid the expense and uncertainty of litigation,” it said in a statement. Spokeswoman Julia Sutherland said the hospital declined to comment on any patient lawsuits.
In an interview, Midei denied he stented without medical need. He took issue with experts who deemed many of his stents needless, and said disagreement among cardiologists on cases is common. Midei was not a party to the federal settlement. The government has said its investigation of the case continues.
In June, Sandesh Patil, a cardiologist practicing at another St. Joseph hospital -- this one in London, Kentucky -- agreed to plead guilty to charging Medicaid for a stent that wasn’t medically warranted under the program’s rules. (Although both hospitals were once owned by the same parent, the one in Maryland has been sold.)
Catheterization procedures multiplied at St. Joseph in London after Patil began practicing there in 2000, when the hospital had a different name. In that year, the type of procedure used for stents was done 210 times. They climbed to 929 by 2009, state data show.
Stenting income from Medicare alone was more than a sixth of the hospital’s 2009 operating income, based on data from American Hospital Directory, a research firm. When Patil left London in 2010, catheterization procedures fell 34 percent from their 2009 high. Using the midpoint of the directory’s price range for such procedures, the decline would have cost the hospital about $15 million. David McArthur, the hospital’s spokesman, declined to comment on its revenues.
Rhonda McClure, one of Patil’s patients, had her arteries catheterized 18 times by him and his partners over four years, according to her deposition and other filings in a lawsuit she and 361 other patients have brought against Patil, St. Joseph and other doctors who practiced there. She said she received eight cardiac stents. The defendants deny the negligence and fraud allegations against them.
McClure’s deposition says a cardiologist who reviewed her case after the stents told her that scarring caused by “too many procedures” was her main problem.
McClure said she suffers from chest pain and shortness of breath, and has been told by her new doctor that she may need more stents and surgery to keep her coronary arteries from closing. She said she gets so tired she needs to sit and rest after walking down the stairs.
St. Joseph-London repaid Medicare $256,800 for unnecessary procedures and is cooperating with federal prosecutors, McArthur said. He said Patil was never employed by St. Joseph and lost his privileges to practice there in December 2010. Patil’s attorney said his client had no comment.
Under his plea bargain, Patil agreed to serve 30 to 37 months in federal prison. He forfeited his Kentucky medical license for five years. In 2012, he told a family court judge his monthly income was $53,300.
“Thirty-seven months is nothing for all the injuries he done for money,” McClure said.
After the Courage trial shed doubt on stents’ effectiveness for stable patients, stent-implanting cardiologists felt unfairly attacked and organized a campaign to “better balance the messaging,” said Bonnie Weiner, who was president of the Society for Cardiovascular Angiography and Interventions at the time.
The society hired a public relations firm and paid it more than $300,000 a year to help publicize the benefits of stents, according to the group’s filings with the Internal Revenue Service. The firm helped launch a consumer website for SCAI, SecondsCount.org, which has published several articles, including one under the headline, “For many patients, open arteries are better than closed arteries.”
SCAI collected $2.7 million in donations for “public education” between 2008 and 2011 from stent makers Abbott Laboratories (ABT) Inc., Boston Scientific Corp. (BSX), Cordis Corp. and Medtronic Inc. (MDT), its Web site says. Manufacturers’ sales of cardiac stents were about $5.5 billion globally last year, down 5 percent from 2011, according to the Health Research International consulting firm.
Medtronic spokesman Joseph McGrath said grants to SCAI for patient education are “unrestricted,” and SCAI is solely responsible for how the funds are used. Spokesmen for Abbott, Boston Scientific and Cordis declined to comment.
Interventional cardiologists, the specialty SCAI represents, earn a median income of $562,855 a year, as compared to $207,117 for family doctors, according to Medical Group Management Association, which surveys physician practices. The interventionalists ranked 13th among 118 specialties tracked by MGMA.
Mehmood Patel, a Lafayette, Louisiana, cardiologist who went to prison last year on 51 counts of charging for needless stents, made over $16 million in one three-year span, evidence in the case showed. Prosecutors said he was driven by the desire to be the busiest cardiologist in town.
He unsuccessfully argued that he used his best medical judgment in every case and lost an appeal. Patel is serving a 10-year sentence in a federal penitentiary.
Jashu Patel, an interventionalist in Jackson, Michigan, billed $2.7 million for procedures in 2007, according to a U.S. Justice Department case against him settled in July. (He is no relation to Mehmood Patel).
The suit alleged Patel implanted needless stents in at least two patients, including one that led to a blood clot that killed an unnamed woman who had reported no symptoms of reduced cardiac blood supply. A stress test showed normal blood flow, and notes in her file said she didn’t want interventions, said Julie Kovach, a cardiologist who worked with Patel and brought the case to the government’s attention.
“It was appalling,” Kovach said in an interview. “Patel coerced her into getting a stent she didn’t need, which killed her.”
Kovach said that when she told the chief operating officer of the hospital where Patel worked about the death, the executive, Karen Chaprnka, diverted the conversation. Reached recently by e-mail through a hospital spokesman, Chaprnka said she “disagreed with the allegations made by Dr. Kovach.”
“He’s their cash cow,” said Kovach, now co-director of a clinic that treats congenital heart disease at the Detroit Medical Center. “They’re not about to turn him in.”
Patel and the hospital, Allegiance Health, agreed to pay the U.S. a total of $4 million to settle the federal charges. Kovach was awarded $760,000 as a whistle-blower under the U.S. False Claims Act. Allegiance disagreed with the allegations and settled the claims to avoid “lengthy litigation,” it said in a statement.
Patel continues to practice at the hospital and must improve record-keeping to substantiate cardiology procedures, Allegiance said. In the settlement, Patel agreed to hire a consultant to oversee treatment of his patients and an auditing firm to monitor billings. He didn’t return phone messages.
In Ohio, Simecek, the worker at the Ford dealership, grew suspicious after his sixth stent from cardiologist Harry Persaud at the Cleveland Clinic’s Fairview Hospital in 2011. Simecek said he went for a second opinion and was told he didn’t need any of the stents. Now he said he has to take blood thinners the rest of his life.
“With the littlest cut, the blood starts running,” said Simecek. “What if I am in an auto accident?”
Persaud is under criminal investigation for health care fraud, mail fraud and money laundering, according to federal court filings. Last October, Federal Bureau of Investigation agents raided his office and removed financial records and patient files for procedures at three Cleveland-area hospitals. The government has seized $343,634 from his and his wife’s bank accounts, alleging the funds represent the proceeds of fraud related to a “significant number” of unnecessary stent procedures.
The Cleveland Clinic found “problems related to the use of stents in some patients” at Fairview and reported them to the government, according to spokeswoman Eileen Sheil. She would not say how many patients were affected. Persaud resigned from the hospital staff last year.
At least 64 of Persaud’s patients at St. John Medical Center in suburban Westlake received letters from the hospital saying they may have received an unnecessary stent between 2010 and 2012, according to spokesman Patrick Garmone, who said Persaud no longer practices there.
Persaud denied wrongdoing in court filings and said his stent procedures were proper. Neil Freund, his attorney in lawsuits filed by patients alleging unwarranted stents, said “it is our intent to defend these cases.” He had no comment on the federal investigation.
In Texas, the state medical board’s final order in DeMaio’s case found that the cardiologist placed “multiple, elongated, overlapping” stents in patients in areas of “insignificant or only moderate disease.” Peterson, the retired mailman, was identified only as Patient C in the staff complaint. No patient was mentioned in the final order.
Peterson was thriving in his new career in the travel business, his wife Shirlee said. He had a heart attack in 1997, which didn’t crimp his love of travel and dance, she said. “He was an awesome man who never met a stranger,” she said.
After his death, Shirlee Peterson said a friend told her she had a cardiologist who refused to do multiple stents.
“I do believe that Bruce was a guinea pig,” she said. “That was the way it was done.”
DeMaio said Peterson was extremely sick when he came to him. He said it was significant that the board’s final order didn’t use the word ”excessive” in describing his stent work. That included 31 stents stretching for 14 inches inside the arteries of Patient B in the staff complaint.
“Any patient of mine who received a full metal jacket” -- interventional cardiology’s term for such extensive work -- “would have been turned down by at least one, if not multiple surgeons,” DeMaio said. He said he doesn’t use stents as much these days because standards have changed and he doesn’t see as many seriously ill patients.
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