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Saturday, September 8, 2012

Health Care Reform Articles -September 8, 2012

Unpredictable Danger Looms Close to the Heart




Monsters attacked Avery de Groh when she was 4. That is how she remembers the day in 2007 when the defibrillator in her chest misfired, sending nine electric shocks through her body in less than 30 minutes.
Today, Avery is a chatty 9-year-old who just learned to roller-skate. She is old enough to know that she was not really attacked by monsters. The culprit was a broken wire from the defibrillator that keeps her heart beating normally. Like her mother and two brothers, she has an inherited condition that makes her prone to a fatal heart rhythm. After Avery’s episode, doctors removed the faulty wire, made by Medtronic, and replaced it with a new one made by St. Jude Medical.
Now it is possible that one is damaged, too. The wire, or lead, known as the Riata, was recalled in December after St. Jude warned doctors that internal cables were poking through the outer casing, causing unwanted shocks or failing to work when needed. Nearly 20 percent of the 128,000 people worldwide who have the Riata may be affected, according to the company.
Molly de Groh, Avery’s mother, said she worried that Avery’s new lead would also malfunction. “When I think about how scary it was for her,” she said, “I feel like, give that to me, and let her be fine.”
Heart device specialists have struggled for months to determine how best to treat patients with damaged leads. There is no easy fix: removing the wires can be dangerous, but so can leaving them in. In August, the Food and Drug Administration recommended that all patients with the Riata undergo imaging to see if their lead was failing. But the guidelines did little to settle the matter after some doctors questioned the wisdom of the advice.
Patients are caught in the middle, forced to grapple with life-or-death decisions for which there are no easy answers
http://www.nytimes.com/2012/09/08/business/patients-with-st-jude-medicals-defibrillator-wires-face-a-dilemma.html?_r=1&pagewanted=print


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