Abstract 19880: High Failure Rate of Linox Defibrillator Leads
Introduction: Recent lead failures have resulted in large recalls with a significant global impact, not only financially, but also physically and mentally for those carrying an implantable cardiac defibrillator (ICD). Following the introduction of the ‘Linox S’ and ‘Linox SD’ ICD leads in 2006 by manufacturer ‘Biotronik’, we observed several cases with early failure. The objective of this study was to determine the failure rate of ‘Biotronik Linox’ leads implanted at our centre, and to compare them with the performance of two comparators, the Durata (St. Jude Medical) and the Endotak (Boston Scientific) lead.
Methods: As of 2012, all ‘Linox S or SD’ (n=408), Durata (model 7122, n=340) and Endotak (model 0125, 0138 and 0158, n=343) leads were identified form the Erasmus MC prospective ICD registry. Lead failure was defined by low/high-voltage impedance, failure to capture, sense or defibrillate, or the presence of non-physiological signals not due to external interference.
Results: A total of 1091 high-voltage defibrillation leads were implanted between April 2000 and May 2012 in 1066 patients (78% males, median age 62 years). The median time from implantation to lead failure was 3.6 years (IQR, 1.5 to 4.8 years). ‘Linox’ leads demonstrated a sudden increase in failure at 3-3.5 years after implantation and their estimated failure rates were 5.5% and 10.1%, at 5 and 8 years after implantation, respectively. Durata and Endotak demonstrated gradual malfunction and failure rates were 2.1% and 2.1%, and 0.4% and 0.8%, at 5 and 8 years, respectively. The mechanism of failure was noise in the majority of failed leads (50%) followed by impedance out-of-range (29%).
Conclusions: ‘Linox S/SD’ leads demonstrate a significant high failure rate. Remote monitoring is reasonable as electrical dysfunction (noise or impedance out-of-range) is observed in the majority of cases. National device safety and advisory committees worldwide might be facing a new challenge.
Author Disclosures: S.C. Van Malderen: None. T. Szili-Torok: None. S.C. Yap: None. R. Bhagwandien: None. S. Wijchers: None. D.A. Theuns: None.
- © 2015 by American Heart Association, Inc.