Following leads to improve patient outcomes: it's about time.

Abstract

As lifesaving devices, implantable cardioverter-defibrillators (ICDs) and leads used with ICD systems require the highest possible standards of reliability. Despite meticulous design, careful manufacturing, and rigorous testing, ICDs and leads have finite rates of failure. ICD leads are designed to transfer information to, and life-sustaining therapy from, the ICD in the hostile and mechanically stressful intravascular and cardiac environment of the human body. With the high-profile failure of multiple ICD lead models over the last several years, they now are considered a “weak link” in the ICD systems, just as pacemaker leads are in pacing systems. The result has been to undermine trust in ICD therapy. Recommendations for timely detection, characterization, communication, and correction of product lead performance issues were developed to provide a systematic approach to improve lead reliability. Definitions of ICD lead malfunction, performance, and reliability have been standardized to allow comparison of leads. Lead reliability represents the measure of freedom of a specific lead from structural or functional failure as a function of time. This time dependence of assessing lead performance represents 1 of many ongoing challenges. Manufacturer product performance reports and independent registries are significantly limited by underreporting of lead malfunction, insufficient patient follow-up, lack of uniform definitions, lack of returned product for fault analysis, and a passive monitoring system based on voluntary reporting. Multiple recommendations related to lead performance, communication, premarket evaluation, postmarket surveillance, lead advisories, and clinical management have been advanced. The responsibilities of the many stakeholders in addressing acknowledged limitations of ICD lead design, testing, manufacturing, surveillance, reporting, and improvement are clearly specified. Cooperation among manufacturers, regulatory agencies, physicians, and patients is critical to establish and maintain trust in all of these areas.