Need for real-world data on management of the (potentially) failing lead

This editorial refers to ‘Management of recalled implantable cardioverter-defibrillator leads at generator replacement: a decision analysis model for Fidelis leads’ by H. Burri and C. Combescure, on page 1210. Pacemaker and implantable cardioverter-defibrillator (ICD) therapy have had many successful years with extended indications, lower costs, and prolonged patient survival leading to a continuously growing population of patients with a cardiovascular implantable electronic device (CIED). Despite the fact that the device may present random and systematic failures, the lead connecting the CIED with the heart has turned out to be the ‘weakest link’ in CIED systems.1 The history has shown a series of mistakes in design and engineering giving rise to smaller enclaves of affected patients, e.g. the J-shaped Teletronics Accufix atrial lead.However, it is the combination of the surge in using ICDs for primary prophylaxis in heart failure and the quest for smaller diameter ICD leads that has created a problem of sizable dimensions as a large series of the requested new thinner ICD leads have shown poor long-term performance.2–4 Healthcare authorities and the device industry have learned important lessons regarding both short-term testing and long-term surveillance5 as well as the inferiority of product performance reports based on returned product analysis. Lead-related problems with new products will hopefully decrease in the future. Nevertheless we currently have a large population of patients with either a Medtronic Sprint Fidelis lead with a potential risk of fracture or a St Jude Medical Riata ICD lead prone to insulation defects, in whom we are only beginning to learn the extent and mechanisms of failure.Although the problematic leads have been identified and errors have been corrected in new models (or older models have been …