Please leave the reliable ICD leads alone

Abstract

Le mieux est l’ennemi du bien —by Voltaire The first transvenous high-voltage implantable cardioverterdefibrillator (ICD) lead failure occurred in 1988 when a patient with an investigative lead received multiple inappropriate shocks due to noise generated by a conductor fracture. This failure was the harbinger of multiple ICD lead debacles that would affect 4500,000 patients with failed or recalled leads during the next 20 years. Indeed, no other implantable medical device has been plagued by so many problems. In retrospect, physicians, the Food and Drug Administration (FDA), and industry could have done many things differently to avert this costly cascade of lead failures and recalls. Physicians could have resisted the enticement of smaller diameter leads, which have not been shown to be more effective in preventing sudden cardiac death than the original 12-F Endotak; the FDA could have insisted on long-term clinical trials before new leads were approved for widespread use; and industry could have exercised better judgment in bringing new designs and materials to market without human safety data. What physicians should do now is use the good leads with a track record of long-term reliability and demand that industry leave them alone. The development of an effective transvenous ICD lead was a critical milestone that allowed the conduct of primary prevention trials such as MADIT II and SCD-HeFT as well as the safe application of defibrillation therapy in millions of patients worldwide. Most patients today have an ICD lead with 1 or 2 shocking coils that reliably defibrillate the heart by using the pulse generator can as a separate electrode. The implant procedure is safe in experienced hands, with hospital mortality o1% and major 30-day complications o5%. However, it is the ICD lead’s long-term durability—or lack thereof—that has driven adverse outcomes. Fragile conductors and flawed insulating materials have caused serious complications, including failure to deliver therapy, inappropriate shocks, and death. Tens of thousands of patients have had surgical revisions to replace failed or suspect leads, and many thousands will likely need revisions in the future. Indeed, ICD lead