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Stents stir growing doubts, legal action

Charles E. Johnson Jr. was a hearty 62 in early 2008. He walked about 20 miles a month, worked out four times a week and played tennis on weekends.

But he noticed a tightness in his chest sometimes. So he went to St. Joseph Medical Center in Towson and saw Dr. Mark G. Midei, who found significant blockage in three major coronary arteries and used mesh stents to prop open two of them.

Johnson says he has been irreversibly disabled ever since. According to a lawsuit filed this year in Baltimore County Circuit Court, the stents caused a blood clot, which led to a heart attack and a series of medical events that left Johnson with permanent heart damage.

And now Johnson is questioning whether he should have gotten a stent in the first place.

"A lot of doctors would argue that he wasn't a candidate," said his attorney, Robert Weltchek.

Johnson's medical history illustrates what patients and researchers have found throughout the country since coronary stents became a multibillion-dollar medical industry: The devices might not be as safe — or as effective — as once thought.

But cardiologists are unclear about much more than simply whether stents have medical value, as evidenced by the case of Midei, who is accused of performing hundreds of unnecessary procedures yet is defended vociferously by patients and colleagues.

Some doctors still argue over seemingly fundamental details, such as how to measure blockage on an X-ray, or when it is appropriate to choose surgery over stenting or medication. And now they have a new uncertainty to resolve: Will placing a stent lead to a patient's survival or the doctor's indictment?

"Every interventional cardiologist is going to be afraid that some angry patient or angry attorney or disgruntled colleague or competitor is going to turn him in for doing unnecessary procedures," said Dr. William O'Neill, executive dean of clinical affairs at the University of Miami's Miller School of Medicine. He was hired by Midei's attorneys to review some of the Towson cardiologist's case files and says he found no unwarranted stents.

"Though we kind of brought it on ourselves," he added. "Two or four years ago, [the field of interventional cardiology] became overly aggressive."

Since the mid-1990s, stents have been hailed as a relatively risk-free alternative to coronary artery bypass graft surgery. But their use soared after the 2003 introduction of a drug-coated version that prevents scarring. The devices have brought in more than $1 billion to Maryland hospitals since mid-2004.

Recent scientific studies have cast doubt that stents are any more effective than surgery, however. And that, combined with the regulatory and legal climate created by Midei and a handful of other physicians across the county accused of similarly overusing stents, is contributing to a steady decline in the use of the devices.

The number of stent procedures in Maryland is expected to drop 25 percent this fiscal year to about 10,650, compared with a peak in 2006 of 14,255, according to data from the state Health Services Cost Review Commission.

"Everyone's taking a bit of a step back, and saying, 'Gee, should we really be doing all this?' and I think that answer is probably now no," said Dr. Thomas Aversano, an associate professor at the Johns Hopkins University's School of Medicine and its Heart and Vascular Institute.

The recent studies "gave some evidence that [stenting] really isn't any better to [some patients than] pills," Aversano said. "There is some downside to it, and there are risks."

O'Neill sees the slowdown as a correction from earlier days, when doctors were stenting patients specifically because they didn't see a "downside."

The tiny, tubular, mesh devices, which act as a sort of scaffolding to widen compromised arteries, are lucrative. They've improved thousands of lives by restoring healthy blood flow. And they're easy to insert, often placed during the same procedure that's used to determine whether a patient has blocked blood vessels in the first place, called a cardiac catheterization.

"For some of these doctors, it was like, 'I'm here, so let me go ahead and put a stent in,' " O'Neill said. "What we've learned in the last two years is that there is a price to pay, and you should be conservative."

Midei is accused of falsifying hundreds of medical records going back two years at St. Joseph to make it appear that patients needed stent procedures when they didn't. Investigators who have since reviewed the records say they show far less blockage than Midei wrote in his notes. He lost his privileges to practice at St. Joseph last year, and he has denied the accusations made against him.

Where St. Joseph's investigators found mistakes, however, O'Neill says he found good medical care. Hired by a defense attorney more than a year ago to review dozens of Midei's cases, he said he found no unnecessary stenting and considers Midei's technique flawless.

But if Midei worked for him, O'Neill said he might have suggested he more carefully document the reasons he chose to stent, including the patients' clinical symptoms, and that he take more time before forging ahead.

A half-dozen lawsuits have been filed against Midei by patients, and state regulators have filed paperwork that could revoke his license to practice medicine.

Among their concerns are that people living with stents run the risk of serious complications. And those who didn't need them in the first place will "unnecessarily suffer a lifetime of increased medical risks and medical consequences," claims one court case filed last month.

All medical procedures carry risks, including the cardiac catheterization used to diagnose artery blockage and place stents. A botched catheterization killed a 72-year-old Woodlawn woman in 2005, according to her family, who filed a lawsuit against her doctors in 2008 alleging that the procedure caused massive bleeding. The suit was settled in March, though the terms are confidential.

Stents add to the risks. They can lead to blood clots, as they did in Johnson, and subsequent heart attacks. And the blood-thinning drugs most stent patients take have side effects, including bleeding, bruising and fatigue.

Stents were approved for use in the United States in 1994, but scar tissue formed around those early versions about 25 percent of the time, slowly reclogging arteries. A new stent, coated in drugs that prevent such tissue buildup, was approved by the U.S. Food and Drug Administration in 2003.

At the time, Midei was quoted in The Baltimore Sun calling the new stents "the hottest thing in cardiology in years."

They were said to cut in half the need for additional treatment — including bypass surgery — making them an instant medical hit and leading some to fret that cardiac surgeons would lose money as the need for bypass operations fell.

"A major financial impact on the cardiac service line is expected," a Maryland Health Care Commission advisory committee concluded.

But recent studies have shown that drug-coated stents aren't without problems.

Results of a study known as the BASKET-LATE trial, led by a Swiss cardiologist, suggested in 2006 that late, sudden scarring can occur, which is potentially more fatal than the gradual scarring associated with the first stents.

A year later, the COURAGE trial, funded by U.S. and Canadian health organizations along with grants from various pharmaceutical companies, showed that drug-coated stents may not even reduce the risk of death, heart attack or "other major cardiovascular events."

The news continued last year, when the New England Journal of Medicine published results of the SYNTAX trial, which was sponsored by stent-maker Boston-Scientific Corp. That study concluded that surgery is the standard of care for severe coronary artery disease, because it leads to fewer adverse events in the first year than stenting.

A different 2009 study — known as the FAME trial and sponsored by St. Jude Medical Inc. — recommended using a "fractional flow reserve" method to gauge artery health and implied that people were getting stents they didn't need because doctors weren't measuring the blockage effectively.

Before the FFR technology came into use, cardiologists relied on clinical symptoms and an X-ray assessment to determine whether a stent should be used. Such visual assessments are "notoriously variable," Aversano said. Because of that, cardiologists tend to talk in ranges of stenosis, or blockage, and use percentage figures as shorthand, he said.

"Anybody who recognizes we have a tremendous amount of [observer variability] knows that the statement that there's a 60 percent stenosis is ridiculous. We understand that it's shorthand, a way of saying this is probably significant," Aversano said.

Midei told St. Joseph hospital investigators that he used the figures 70, 80 and 90 as shorthand "surrogates" to denote mild, moderate and significant percentages of stenosis. (Clinical guidelines generally suggest that an artery be at least 70 percent blocked before a stent is placed.)

But he also "found significantly lower percentages of stenosis than he had initially dictated" when he reviewed his own records, according to the Maryland Board of Physicians, which has scheduled a conference with Midei next month to discuss charges that he violated professional rules of conduct.

St. Joseph has sent letters to 585 Midei patients suggesting that they had different levels of stenosis than Midei noted. But some of the recipients have a hard time believing it.

Joseph Charles Healy, 75, of Fallston got a letter and immediately fired back with a note of his own to the hospital, saying Midei saved his life.

Midei "said I had a blockage in my left main artery and that I had a choice: I could either have a stent put in or have bypass surgery," Healy remembers.

He chose the stent, and he says his quality of life improved immediately. "I felt like I could do things that I used to do without any problems," Healy said.

Others have offered similar stories, saying they can feel the difference their stents make, whether their records show they had significant blockage or not.

Johnson, who referred questions to his attorney, Weltchek, is suing St. Joseph and Midei for alleged negligence after his heart attack. Midei and the hospital deny the allegation.

In his lawsuit, he says that his medical problems began when he received the two stents. How real Johnson understood the risks to be is hard to say, according to Weltchek.

"He signed the [consent] form, like most people do," he said.