Probe focuses on heart stents

St. Joseph Medical Center in Towson, whose cardiology business is a focus of a continuing federal health-care fraud investigation, has notified hundreds of its heart patients that they may have received expensive and potentially dangerous coronary implants they didn't need.

An internal review, begun last May at the behest of federal investigators and in response to a patient complaint, has turned up 369 patients with stents that appear to have been implanted in their arteries unnecessarily, CEO Jeffrey K. Norman said in an interview yesterday. Patients began receiving letters alerting them to the finding early last month, and more notifications are expected as the review continues."We take our interaction and the care of our patients with the utmost seriousness, and so we wanted to alert patients and their physicians to what we found," said Norman.

In several cases reviewed by The Baltimore Sun, patients who received coronary stents at St. Joseph - purportedly to open a clogged artery to correct a severe blockage - have since learned they had only minor blockage, if any. One 69-year-old man was told his artery had a 95 percent blockage, yet the new review suggests something closer to 10 percent, which is considered insignificant. A 55-year-old woman who agreed to receive a stent after being told she had a 90 percent blockage has since learned she had virtually no problem and that she never suffered from the heart diagnosis that has consumed her life for the past 18 months.

St. Joseph calls itself the busiest heart catheterization center in Maryland, and it is regarded as one of the primary cardiac care facilities in the region. The center typically performs about 6,500 cardiac procedures a year - an average of 18 a day. Last year St. Joseph highlighted the placement of its 100,000th coronary stent since 1980.

Hospital officials say the only doctor implicated in their review is one of the center's marquee physicians, Dr. Mark G. Midei, who abruptly stopped practicing and lost his privileges at the hospital last summer without notice to his patients or any comment from hospital officials.

Midei declined to discuss the matter in detail but released a statement Thursday saying he expects to be exonerated and to return to medical practice.

"I am confident that I have always acted in the best interest of my patients, and when all the facts are presented, I will continue providing quality medical care to my patients," he said.

Coronary stents are cylindrical devices that can open arteries clogged with plaque or create a bridge across areas of damage. They are typically inserted during a procedure called cardiac catheterization, in which a tool is inserted into the bloodstream at a small incision in the leg and threaded up to the arteries near the heart.

An alternative to open- chest surgery, cardiac catheterization with stent placement is a lucrative business for hospitals in the United States, which often charge $10,000 or more for the procedure. Most clinical guidelines, and reimbursement rules for Medicare and private insurance, set minimum thresholds for the procedure, often requiring at least 70 percent blockage of an artery before a stent should be placed. St. Joseph's guidelines regard blockage of 50 percent or less to be "insignificant."

Letters began arriving at patients' homes last month, alerting them to "differences" or "variances" uncovered in their medical files, and advising them to call their cardiologists. Packages sent to their cardiologists contained copies of the patients' X-ray images, along with the written laboratory report prepared when the stent was placed.

Jay D. Miller, a prominent medical malpractice attorney in Towson, said he has spoken with people who received letters and that many are contemplating legal action.

"A very substantial number of people received coronary artery stents they did not need," Miller said.

"And they not only had a procedure that wasn't needed, they have a stent in their artery for the rest of their life, they're on a serious blood-thinning drug, and there's the psychological effect of being led to believe that you have heart disease."

Vicki Marrs, a 55-year-old patient from Conowingo, is typical. She got a stent in July 2008 after arriving at St. Joseph's with chest discomfort and being told one of her arteries was 90 percent blocked. Now doctors and lawyers who have reviewed her files say Marrs had only a 10 percent blockage at most, and that she never suffered from the kind of heart disease described by Midei 18 months ago.

"I'm angry and I'm upset," said Marrs, after telling of the changes in her emotions and lifestyle following that diagnosis. Patients who receive stents must take blood thinners, and she said she battles fatigue from her daily dose of the drug.

"You go to a doctor thinking he's going to take care of you and make you better, and now I have this thing that I don't need and that can't be removed," she said. "I trusted him."

Norman, while acknowledging the hospital has enountered patients "who've been upset and angry," said the hospital's investigation and patient notification process has been conducted in the interest of getting information to patients quickly so they can consult with their cardiologists. The investigation focused solely on Midei after a random sampling raised questions about him, Norman said, and it will include reviews of patient records over the past two years - the time during which potential complications from the procedure would be expected to surface.

While stent placement is a common and relatively safe procedure, it is not without complications and potential hazards. One study published four years ago in the Netherlands reported a 5.7 percent rate of "major" complications from stent placement, including a 2.3 percent death rate. Physicians with more experience at the procedure had fewer complications, it concluded.

Norman said that no other employees of the hospital have been implicated in the review.

"The physician is the captain," he said. "The physician is in charge."

Asked if the hospital bears any additional liability for the patients who received stents they didn't need, Norman said:

"I suppose we do. I think that we'll see what comes from these attorneys that are looking for cases, and we'll respond to that."

Doctors and hospitals in other parts of the country who placed stents when that blockage threshold wasn't met have faced lawsuits, fines and even prison time.

In 2007, a doctor at Peninsula Regional Medical Center in Salisbury was accused of performing unnecessary stent procedures and is being sued by 24 patients. The doctor, John R. McLean, resigned from practice, citing deteriorating eyesight.

Last year, a Louisiana doctor was sentenced to 10 years in federal prison on health-care fraud charges for placing unnecesary coronary stents and then billing Medicare and private insurance companies. Two hospitals where he worked paid a combined $5.7 million penalty to the federal government, and one paid an additional $7.4 million to settle a class action lawsuit brought by the doctor's patients.

St. Joseph announced in July that it had negotiated a settlement with federal health-care fraud investigators related to the hospital's relationship with MidAtlantic Cardiovascular Associates, the dominant cardiology practice in suburban Baltimore. Details of that settlement were not disclosed and are expected to be announced soon, but court records have speculated that the hospital will pay a fine that exceeds $5 million.

When federal subpoenas arrived at St. Joseph in June 2008 seeking records related to the cardiology business, the hospital's then-CEO, John Tolmie, was suspended along with two other top executives. All of them have since resigned.

Norman said the federal investigation is not directly related to the issues with stent placements. But Midei was a founding member of MidAtlantic, who left in January 2008 to become an employee of St. Joseph. In statements sent to The Baltimore Sun last year, St. Joseph's officials repeatedly said the federal investigation "has nothing to do with the quality of patient care." Yesterday, they noted that statements from the hospital ceased to include that claim around mid-2009.

When St. Joseph opened its new cardiac care center in early 2008, Midei was regarded as one of its big draws. His recruitment by the hospital, away from the MidAtlantic practice just as it was poised to enter a lucrative merger with Medstar Health, created tension among doctors and executives at the hospital that boiled over into the court system. In one court record, then-CEO of MidAtlantic, Hank Yurow, said he threatened in 2008 to "make it my mission to destroy him [Midei] personally and professionally."

In interviews with attorneys and other patients, it is clear that some of Midei's patients - even after getting letters from the hospital - reject the suggestion that he has done anything wrong.

Peggy Lambdin, 66, of Timonium describes waking up in July 2008 feeling as if she were drowning, and being diagnosed at St. Joseph a few days later with a 90 percent blockage. Midei placed a stent, and the symptoms cleared up almost immediately, she said.

She has since received a letter suggesting the blockage was less than 50 percent, but said she considers the details immaterial.

"No one can ever tell me that I didn't need that stent," Lambdin said. "I feel like he saved my life."

She also recounted another trip to the St. Joseph's lab during which Midei performed a heart catheterization but decided that no stent or other treatment was needed.

"I trusted him, and I still trust him," Lambdin said. "If I needed another stent, I would want Dr. Midei to do it."

Norman said he hopes the hospital's efforts to inform patients about the investigation demonstrate they can trust St. Joseph's.

"Like anything in healthcare, heart care is a team effort. And if there's any one individual on the team who isn't performing at the highest level, you take action, as we have in this case," Norman said. "We're confident that we still provide the highest quality care."

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