Abstract
Purpose
Since the introduction of the Biotronik Linox S/SD leads in 2006, there have been multiple reports of premature lead failure. The purpose of this study was to investigate the longevity of the Linox S/SD leads and to identify the possible predictors of lead failure in a single tertiary implant center.
Methods
We retrospectively reviewed patients who underwent implantation of Linox S/SD leads or Sorin Vigila 1CR/2CR leads (the same Linox S/SD leads marketed by Sorin) at our center. The cumulative lead survival was estimated using the Kaplan-Meier curve, and variables associated with lead failure were assessed by Cox proportional hazard model.
Results
A total of 187 patients (154 (82%) male) underwent Linox S/SD or Vigila 1CR/2CR implantation between 2007 and 2013. During follow-up with a median time of 75 months, nine lead failures were identified (4.8%). The mean and median times from lead implantation to lead failure were 70.7 ± 21 months and 64 (45–111) months, respectively. The cumulative survival probability for the Linox S/SD at 5 years was 97.1% and at 12 years was 90.3%. Non-physiological high-rate sensing was the most common type of lead failure in patients. In two-thirds of these patients, this led to inappropriate shock. We did not find any significant relationships between patients’ clinical and procedural characteristics and lead failure.
Conclusions
At our center, the 5-year lead survival of the Linox S/SD has been better than reports from other centers. The majority of lead failures presented as non-physiological high-rate sensing with subsequent inappropriate therapy.
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References
Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, et al. 2017 AHA/ACC/HRS Guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2018;138:e272–391.
De Maria E, Borghi A, Bonetti L, Fontana PL, Cappelli S. Externalized conductors and insulation failure in Biotronik defibrillator leads: history repeating or a false alarm? World J Clin Cases. 2017;5(2):27–34.
Lam A, Buehler S, Goulouti E, Sweda R, Haeberlin A, Medeiros-Domingo A, et al. Comparison of lead failure manifestation of Biotronik Linox with St. Jude Medical Riata and Medtronic Sprint Fidelis lead. J Interv Card Electrophysiol. 2019;54:161–70.
Biotronik Product Performance Report, 2017. https://www.biotronik.com/en-us/ healthcare-professionals/product-performance-report.
Noti F, Lam A, Klossner N, Seiler J, Servatius H, Medeiros-Domingo A, et al. Failure rate and conductor externalization in the Biotronik Linox/Sorin Vigila implantable cardioverter-defibrillator lead. Heart Rhythm. 2016;13:1075–82.
Padfield GJ, Steinberg C, Karim SS, Tung S, Bennett MT, Le Maitre JP, et al. Early failure of the Biotronik Linox implantable cardioverter-defibrillator lead. J Cardiovasc Electrophysiol. 2015;26:274–81.
Howe AJ, McKeag NA, Wilson CM, Ashfield KP, Roberts MJ. Insulation failure of the Linox defibrillator lead: a case report and retrospective review of a single center experience. J Cardiovasc Electrophysiol. 2015;26:686–9.
van Malderen SCH, Szili-Torok T, Yap SC, Hoeks SE, Zijlstra F, Theuns DAMJ. Comparative study of the failure rates among 3 implantable defibrillator leads. Heart Rhythm. 2016;13:2299–305.
Manfredi JA, Smithgall SM, Kircher CM, Lollis MA. Insulation failure with externalized conductor of a Linox SD lead: a case report. J Cardiovasc Electrophysiol. 2014;25:440–1.
Kawada S, Nishii N, Morimoto Y, Miyoshi A, Tachibana M, Sugiyama H, et al. Comparison of longevity and clinical outcomes of implantable cardioverter-defibrillator leads among manufactures. Heart Rhythm. 2017;14:1496–503.
O’Connor M, Hooks D, Webber M, Shi B, Morrison S, Harding S, et al. Long-term single-center comparison of ICD lead survival: evidence for premature Linox lead failure. J Cardiovasc Electrophysiol. 2018;29(7):1024–31.
Marai I, Milman A, Nof E, Gurevitz O, Barlev D, Lipchenca I, et al. Performance of the Linox implantable cardioverter defibrillator leads: a single-center experience. Pacing Clin Electrophysiol. 2019;42(12):1524–8.
McKeag NA, Noad RL, Ashfield K, Wilson CM, McEneaney DJ, Roberts MJD. Prospective assessment of Linox implantable cardioverter defibrillator leads for structural or electrical abnormalities. Adv Ther. 2018;35(5):666–70.
Good ED, Cakulev I, Orlov MV, Hirsh D, Simeles J, Mohr K, et al. Long-term evaluation of Biotronik Linox and Linox (smart) implantable cardioverter defibrillator leads. J Cardiovasc Electrophysiol. 2016;27(6):735–42.
Díez DP, Rubín JM, Cuervo DC, Iglesias DG, De La Tassa CM. Analysis of early failure of Biotronik Linox Smart implantable cardioverter-defibrillator leads: a comparative study of three defibrillator leads. Pacing Clin Electrophysiol. 2018;41(9):1165–70.
Guédon-Moreau L, Lacroix D, Sadoul N, Clémenty J, Kouakam C, Hermida JS, et al. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013;34(8):605–14.
Varma N, Michalski J, Epstein AE, Schweikert E. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010;3(5):428–36.
Varma N. Remote monitoring for advisories: automatic early detection of silent lead failure. PACE. 2009;32(4):525–7.
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Alasti, M., Machado, C., Mirzaee, S. et al. Long-term longevity and clinical outcomes of Linox S/SD implantable cardioverter-defibrillator leads: a single-center experience. J Interv Card Electrophysiol 61, 115–121 (2021). https://doi.org/10.1007/s10840-020-00787-x
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DOI: https://doi.org/10.1007/s10840-020-00787-x