Review: 141 patients got unnecessary heart stents
Medical reviews at Westmoreland Hospital have determined two cardiologists implanted coronary stents in at least 141 patients who may not have needed them, the Tribune-Review has learned.
Two teams that included nationally recognized interventional cardiologists determined that 141 patients in 2010 may not have had enough blockage in their arteries to need a stent -- a tiny wire mesh device to prop open clogged arteries in the heart, according to a letter from the hospital expected to be delivered to the affected patients today. The hospital is now reviewing the two doctors' 2009 cases and is expected to know the results by May.
None of the 141 identified patients is believed to have been harmed, but the hospital is offering counseling and free medical care to all of them as a precaution. The letters do not provide a reason why the patients received the stents but state their condition "may not have justified the placement of a coronary stent."
Hospital officials said the questionable stents were implanted by Drs. Ehab Morcos and George Bousamra, who voluntarily resigned their privileges at Westmoreland on Jan. 12 after being questioned about the results of an initial sample review of 2010 cases. The two doctors performed more than 750 of the up to 2,000 stent procedures done at Westmoreland Hospital that year.
Attempts to reach Morcos, 48, of Export, and Bousamra, 45, of Marshall, at their homes Wednesday evening were unsuccessful.
"This should have never happened," Robert Rogalski, CEO of Excela Health, the hospital's Greensburg-based parent, told the Trib. "There's no excuse for it."
Rogalski is expected to make a public announcement this afternoon at the hospital in Greensburg. He estimated that the hospital has spent $500,000 on the two medical reviews and will have to spend at least another $1 million to hire two interventional cardiologists. The CEO said hospital officials have not made a total estimate of the cost, concentrating instead on making things right with the hospital patients involved.
The doctors' names will be turned over to the Office of the Inspector General in the Department of Health and Human Services, which investigates improprieties involving Medicaid and Medicare reimbursements, Rogalski said. Westmoreland Hospital will return money paid for the procedures, he said, but he could not give a specific amount. Patients insured by both government and private payers received the stents.
Rogalski was named interim CEO at Westmoreland in late 2009 and took over permanently in February 2010. Early last year, he said, several unidentified physicians alerted hospital officials about a pattern of excessive stent use in the cardiac catheterization laboratory, where the procedures are performed.
Those concerns prompted Rogalski to begin an external review of all seven cardiologists and two interventional radiologists who performed stent procedures at Westmoreland. Mercer Medical Audit of San Francisco, a nationally recognized medical review firm, randomly selected between 12 and 17 procedures for each of the nine doctors, for a total of about 100 cases.
Results of the six-month review by Mercer's team of seven cardiologists, concluded in December, suggested a pattern of excessive stent utilization by Morcos and Bousamra, Westmoreland officials said.
Rogalski ordered a second, more thorough review involving all 753 cases performed by the two cardiologists in 2010. The reviewers from American Medical Foundation in Philadelphia -- eight independent cardiologists -- spent three days at the hospital reviewing case records and angiograms. They identified as not medically necessary 149 stent procedures involving 141 people, some of whom had two stents installed.
"Our conclusions are based on the collective wisdom of 15 independent cardiologists," said Dr. Jerome M. Granato, Excela's chief medical officer.
A medically unnecessary stent can pose risks to patients. There generally is a two-year window of concern with any stent, but risks are higher in the first year, Granato said. There is a 1 percent chance that a blood clot could form on the stent, causing a heart attack, he said. Those chances could be minimized because the patients, who in almost every case had another stent in the heart for a purposeful reason, are taking blood thinners.
"The actual dangers are small," Granato said. "It may not be serious at all. The overwhelming majority will do just fine."
Widely accepted medical standards call for the use of stents when artery blockage is greater than 70 percent. Doctors in some cases use stents for arteries that are narrow as much as 60 percent. The Westmoreland patients who received stents had "angiographically insignificant narrowing of 50 percent or less," Granato said.
Morcos and Bousamra joined Westmoreland Hospital's medical staff about five years ago but were not employees of the facility. Their medical licenses are in good standing, according to the Pennsylvania Department of State, which licenses physicians and other medical workers. Spokeswoman Larissa Bedrick said both doctors renewed their licenses in December and have no disciplinary actions on file.
Rogalski said the other five cardiologists and the two interventional radiologists who implant stents at Westmoreland Hospital have been cleared by the medical reviewers.
In the letter sent FedEx overnight to the affected patients, Granato states that reviewers "did not uncover any concerns about the quality or safety of the coronary stent device itself." Excela assigned a personal patient liaison to all patients and encouraged them to make an appointment with one of the hospital's cardiologists.
To prevent problems, the hospital on Feb. 1 hired an undisclosed but "internationally recognized university" to oversee quality control in the catheterization laboratory. Corazon Consultants, a Pittsburgh-based consulting firm, is reviewing all policies and record-keeping practices. The hospital hired Dr. Howard Grill to serve as director of the catheterization laboratory. The last director resigned in 2009.
The impact of unnecessary stent procedures on patients and government reimbursements have prompted intense federal scrutiny. In December, the Senate Finance Committee issued a report on an investigation into St. Joseph Medical Center in Towson, Md., where they said a cardiologist implanted 585 stents that were medically unnecessary.
The committee's report referred to the case as a "clear example of potential fraud, waste and abuse," and stated that Medicare spent $25.7 billion from 2004 to 2009 on cardiac stent procedures. More than 100 patients have filed malpractice claims against the hospital, according to The Baltimore Sun.
Rogalski stressed that Westmoreland is being proactive about its discovery and intends to be transparent with patients as well as federal and state agencies.
"The fact that we investigated this quickly, in an in-depth and professional manner, in a transparent way, should signal that we're committed to having a transparent organization," he said.