News and Society

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.

Mark Ulrich has decided not to wait. Several years ago, Mr. Ulrich’s defibrillator misfired in reaction to a medication he was taking. “I was pretty well barbecued,” said Mr. Ulrich, who is 68 and lives in Manhattan. “I would rather not be turned into a shish kebab.”

Dr. Jeffrey N. Rottman, a heart device specialist at Vanderbilt University, said most of his patients with damaged leads had elected to have them removed. “I think people who have a defibrillator already have a ‘just fix it’ type of approach,” he said.

That was Jacob Everidge’s attitude. Mr. Everidge, a 23-year-old from Athens, Ala., who has a condition that thickens the heart muscle, had his Riata removed by Dr. Rottman on Aug. 20. “I would much rather go ahead and get it out,” he said. “It wasn’t even a decision.”

For now, Ms. de Groh said, she will follow her doctor’s advice to wait and see if Avery’s lead begins to fail. But that raises other painful questions. Should the de Grohs cancel a family vacation in the Catskills, where they’ll be a half-hour from the nearest hospital? Can they send Avery to a sleepover? “As a mom of a fourth grader, I’ve got to send her to school,” said Ms. de Groh, a nurse in McHenry, Ill., a small town northwest of Chicago. But “for her not to be in my sight at all times is scary.”

Ms. de Groh and all three of her children were born with Long QT syndrome, which can cause their hearts to beat abnormally. She has a defibrillator made by Boston Scientific. Her 5-year-old son, Oliver, has the Durata, a newer lead made by St. Jude, whose safety has also been questioned recently. Her younger son, 3-month-old Monty, is too young for the operation, but he will eventually need a defibrillator, too. Because of her family history, Ms. de Groh has traveled twice to Washington to lobby lawmakers on device safety, but said she learned of the Riata recall only in August, after reading a newsletter written by a patient advocacy group.

She said she was angry at the F.D.A. and St. Jude for not contacting patients directly. “When something is implanted in a body, especially a child’s body, how can I find out about it through a newsletter?” she asked. Avery’s doctor, Marc Ovadia, said he chose not to tell Ms. De Groh about the recall because Avery’s lead is functioning “perfectly” and replacing it would require cracking open her chest. Telling patients about the recall, he said, could lead to unnecessary worry. “We want to make sure before we yell ‘fire’ in a crowded theater that this is fire,” he said. Still, he said, he regrets that Ms. de Groh found out about the recall the way she did. “These are tough, tough issues,” he said.

Mrs. de Groh’s frustration echoed that of consumer advocates who have criticized manufacturers and the F.D.A. for what they said was inadequate testing of medical devices before approval and a chaotic system for identifying problems once they are on the market.

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