Clinical Trials In Brief
This article was originally published in The Gray Sheet
Executive Summary
ICD lead failures: About 40% of implantable defibrillator leads fail within eight years after implant, according to a study published April 30 on the Web site of Circulation, the journal of the American Heart Association. In the study at the Herzzentrum Ludwigshafen in Ludwigshafen, Germany, 990 patients implanted with a variety of ICD and lead models were followed for a median of 934 days. A total of 148 leads failed during the follow up. The failure rate increased with time after implantation, reaching 20% annually by the tenth year. Estimated survival rates at eight and five years were 60% and 85%, respectively. Previous studies have suggested that leads with a coaxial single lumen polyurethane insulated design such as Medtronic's Transvene 6936 and 6966 models are prone to failure and inappropriate shocks. Newer leads (after 1997) feature a multi-lumen design and silicone insulation intended to prevent degradation and injury from mechanical stress. However, Kleeman's study showed that the silicone insulation was also prone to failure and the overall survival rates for the older and newer designs were roughly the same at seven years following implantation...