To change or not to change... what should we do with recalled leads

Since the advent of implantable rhythm devices, the leads have been the predominant “weak link” in the system. Over the last 40 plus years, there has been an occasional issue with regard to insulation (silicone, polyurethane of various types, or some combination of the 2) but, for the most part, at least pacing leads have been reliable, with leads lasting more than 20 years; however, this is not the case with high-voltage leads, which have had a more rocky road to reliability and longevity. Perhaps the Accufix atrial fixed curve lead from Telectronics (Overland Park, KS) would portend problems we would see later with tachycardia leads. This lead was the first attempt at placing a wire outside the central core of a transvenous lead. The so-called retention wire was placed within the insulation but outside the coaxial conductor coil to maintain the “J” configuration for the ease of implant and to reduce dislodgements. However, as we all know, over time repeated flexing and relaxing of this lead led to the fracture of the retention wire and migration out of the protective insulation, causing collateral damage and, in some cases, death. With the development of transvenous implantable cardioveter-defibrillator (ICD) leads, more complex configurations would come into play. The initial versions of these leads were 11.8 F, and then they decreased to 10 F and subsequently to 9 F. There was a “push” to decrease the French size of bradycardia leads, which may have been brought on by the finding that smaller caliper leads were easier to manipulate, particularly by using a single access technique, as well as the unproven thought that smaller leads would lead to less occlusion. Smaller pacing leads probably fueled the pursuit by at least 2 vendors to produce a 7-F ICD lead, with Medtronic being the first to come to the market. The Sprint Fidelis lead (6.6 F) was approved by the Food and Drug Administration in 2004. Issues with this lead, including at least 2 deaths, surfaced in 2007 and the lead was recalled. The Accufix issue again gave us a premonition since it was reported that more patients had problems, including deaths, secondary to removal of the