Early Failure of the Biotronik Linox Implantable Cardioverter Defibrillator Lead

Abstract

This multicenter registry indicates a high rate of Linox lead failure, particularly in female patients. Ongoing surveillance of the Linox ICD lead performance is recommended.

Failure rate and conductor externalization in the Biotronik Linox/Sorin Vigila implantable cardioverter-defibrillator lead

“…In the Canadian study, female sex was an independent predictor of Linox lead failure, 8 whereas in our study younger age at implant was an independent predictor. It has been postulated that ICD leads are exposed to additional stress in younger and active patients as well as in patients with smaller hearts, such as female patients or patients with hypertrophic cardiomyopathy or channelopathies.…”

“…8 All but one of our cases with nonphysiological high-rate sensing received a high rate of inappropriate shocks. Because most Linox leads in the Canadian study were implanted with a Medtronic ICD, the integrated lead integrity alert may have prevented inappropriate shocks in some patients.…”

Lead Integrity Alert Is Useful for Assessment of Performance of Biotronik Linox Leads

“…Outside‐in insulation abrasion was documented in 6 patients and frank conductor fracture was present in 2 patients. A detailed description of the observed lead abnormalities was reported previously . Three patients had conductor externalization inside the pocket and another 3 patients along the high‐voltage coil or ring electrode.…”

“…Despite the overwhelming benefits of ICDs in prevention for sudden cardiac death, premature device failure due to HV lead problems remains a challenging problem for the ICD recipient …”

“…To date, more than 55,100 Linox SD leads and 31,000 Linox S leads have been implanted worldwide . Biotronik reports a cumulative lead survival of 95.6% at 7 years for the Linox SD lead and of 96.8% at 5 years for the Linox S lead; however, recently published data suggest a significantly higher rate of premature failure in these leads …”