Monday, August 9, 2004

Stent patients reassured


Defect in artery tubes no concern if installation went well

By Tim Bonfield
Enquirer staff writer

Greater Cincinnati hospitals say no local patients have been hurt by a series of recalls issued in recent weeks for the world's most commonly used drug-eluting stent.

Since July 2, Boston Scientific Corp. has voluntarily issued three recalls related to its Taxus stent, with the most recent recall issued Thursday. In total, more than 85,000 of the stents have been recalled.

Stents are tiny mesh tubes used to prop open blocked arteries, be they in the heart, neck or legs. The Taxus stent is one of a new generation of stents coated with medications to prevent arteries from re-clogging.

In about 1 in 12,000 cases, the balloon used to expand the Taxus stent has failed to deflate, forcing some patients to go through emergency open heart surgery to remove the device.

The company reports one death and 22 serious injuries resulting from this problem - none of which is believed to have occurred here.

Thousands of Greater Cincinnati residents have received Taxus stents. Depending on the hospital, they account for 50 percent to more than 75 percent of all stents installed.

But if there were no problems with the initial installation, patients have nothing to fear from the recalls, said Dr. Stephen Lewis, director of the cardiac catheterization lab at Bethesda North Hospital.

"We've had some patients who already have the stents calling in asking if something should be done," Lewis said. "We are reassuring them that this recall is just about a problem with deployment. Once placed, the stents are working well."

At Christ Hospital, all the stents from the lots that had the manufacturing problem were pulled from the shelves and have been replaced with new supplies, said Dr. Dean Kereiakes, a cardiologist with the Ohio Heart Health Center, which performs most of the stent placements at the hospital.

"We have not had a non-deflation event," Kereiakes said.

However, Kereiakes echoed criticisms raised last week by doctors at the Cleveland Clinic and Duke University Medical Center that the recall doesn't address a problem with "stickiness" that some doctors have experienced while placing the Taxus stents.

At times, the problem has forced doctors to tug especially hard to remove the catheter used to place the stent, which they say could be risky to patients.

"The stickiness issue is still happening. I had one last week," Kereiakes said. The patient was not harmed, he said.

Neither Boston Scientific nor doctors concerned about the issue has reported any deaths or serious injuries from the stickiness concern.

Meanwhile, the vast majority of hospitals with cardiac programs continue to buy Taxus stents.

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E-mail tbonfield@enquirer.com




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