Cardiologists Call for Closer Monitoring of Heart Defibrillator Wires

A group of prominent cardiologists is calling for stricter monitoring of the thin metal wires which connect implanted defibrillators and pacemakers to the heart and have been blamed for deadly malfunctions in some patients.

The wires, also called leads, are made by many medical-device makers, including Medtronic Inc., which was forced in 2007 to recall its Sprint Fidelis defibrillator leads after the devices were shown to malfunction. In some cases, Medtronic patients were forced to undergo painful additional surgeries to remove the faulty leads and replace them with other products.

The Heart Rhythm Society, a group of doctors who treat cardiac arrhythmias, is now recommending closer oversight of the medical devices including the release of more company data about the performance of the products.

“The measurement and reporting of lead performance are important for clinical decision making, for setting realistic expectations for patients and physicians, for transparency, and for monitoring and improving performance,” said Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center and co-chair of the group’s task force on lead performance.

New Guidelines Issued

The group’s guidelines released this week would apply to both pre-market evaluation and post-market monitoring of the devices. The group also encouraged the Food and Drug Administration to give additional guidance to the medical device industry on when and how makers of the devices can use terms other than “recall” in advisories issued about the products.

For example, the group said using the term “recall” when issuing warnings about the implanted defibrillator wires could imply that patients should undergo surgery to have the devices removed and returned to the manufacturer, which has not been the case. Such language in warnings can create unnecessary anxiety and inappropriate medical interventions, the group cautioned.

The cardiologists also set standards for physicians in removing leads from patients, including training requirements and thresholds for the number of such lead-removal surgeries doctors should perform in training and each year to remain qualified for the operations.

Medtronic Recall in 2007

The Medtronic Sprint Fidelis leads were the most high-profile of such products involved in controversy over defective heart defibrillator leads. Before the products were recalled and further sales were stopped in 2007, five patients had died when the metal leads fractured and failed to work properly.

In some cases, the wires did not deliver a life-saving electrical shock when needed to restore normal heart rhythm. Other patients complained that the faulty wires were causing their defibrillators to deliver unnecessary and painful shocks when they were not suffering heart arrhythmia.

Medtronic is the world’s largest maker of implantable defibrillators.

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