Conference To Address Performance, Safety Of Defibrillator Lead Wires

-Medical News Today

11/05/2007- The safety and reliability of the wires (leads) that connect implantable cardioverter defibrillators (ICDs) to patients' hearts will be discussed and examined at the ICD Lead Performance Conference, to be held Thursday, Dec. 13.

Sponsored by the Medical Device Safety Institute (MDSI) at Beth Israel Deaconess Medical Center (BIDMC), the day-long program will address a number of critically important issues that have come to the forefront following the recall of hundreds of thousands of ICD leads earlier this month after certain wires were reported to be prone to fracture.

"ICDs have been successfully implanted in millions of patients," explains conference organizer William Maisel, MD, MPH, Director of both the MDSI and the Pacemaker and Defibrillator Service at BIDMC. "But recently, the reliability of certain lead models has been questioned. This conference will focus on ICD lead safety and performance issues to identify where changes to the current system are needed so that we may improve ICD lead reliability and restore our patients' trust and confidence in these devices."

Maisel will chair the program, which has been endorsed by the Heart Rhythm Society.

"We have commitments from physicians, patient advocates, and representatives of the U.S. Food and Drug Administration (FDA), ICD manufacturers, and the Heart Rhythm Society, to attend this important meeting," says Maisel. Topics to be addressed include the clinical management and communication of ICD lead performance issues as well as pre-market evaluation and post-market monitoring of the devices.

ICDs are the pager-sized devices implanted in the chests of patients with cardiac disease to restore the heart beat to normal rhythm after the heart has gone into cardiac arrest and begun beating chaotically. The devices work by delivering a high-energy "jolt" via a wire, or lead, which is directly connected to the patient's heart. Device manufacturer Medtronic recently recalled 268,000 ICD leads due to a small increase in the risk of wire fracture.

"These devices have saved countless lives," says Maisel. "But as recent events have shown, defective leads can prevent the device from functioning properly, can cause unnecessary painful shocks to the patient, and can even put a patient's life at risk." The ICD Lead Performance Conference will be held at the Westin Copley Place Hotel, 10 Huntington Ave., Boston. It is open to the public; pre-registration is required.

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and consistently ranks among the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox.