The manufacturer of a recalled pacemaker part is preparing some new advice for heart patients debating whether to risk surgically removing the wire or leaving it alone.
Data from a study by Telectronics Pacing Systems will be mailed in a few weeks to the doctors of 25,000 Americans who have the Accufix "J" lead implanted in their chests.Occasionally, this wire can break and cause a dangerous tear in the heart. It was recalled last year, and the Food and Drug Administration advised patients in January to have special X-rays to see if their wires were about to break. Only those at highest risk were advised to have the wires surgically removed.
Some 1,717 Americans have had this extraction surgery since then, the FDA says. Four died from the procedure and 26 suffered injuries but recovered, some after emergency open-heart surgery, agency figures show.
The FDA cannot tell how many of the extractions were medically necessary. But "most of the patients who died while having extractions actually had normal leads," said Dr. Stuart Portnoy, an FDA medical officer.
A fifth patient also died after having the wire removed, but the FDA says his death was from other diseases, not the surgery.
The Accufix wire is a J-shaped hook used to implant an electrical coil that sends shocks to a pacemaker to keep a diseased heart beating regularly. Once the pacemaker is implanted, this hook is no longer important to the device's functioning. But punctures from broken hooks have killed at least two people.