Advertisement

Comparison of the performance of implantable cardioverter-defibrillator leads among manufacturers

  • Yusuke KondoEmail author
  • Masahiro Nakano
  • Takatsugu Kajiyama
  • Miyo Nakano
  • Tomohiko Hayashi
  • Ryo Ito
  • Haruhiro Takahira
  • Yoshio Kobayashi
Article
  • 16 Downloads

Abstract

Background

Leads are often considered the weakest link in implantable cardioverter-defibrillator (ICD) systems, and lead dysfunction is a major concern for ICD recipients. The aim of this study was to compare the lead performance from three different manufacturers.

Methods

We retrospectively reviewed consecutive patients who underwent ICD system implantation at Chiba University Hospital, Japan, between March 2008 and September 2017. The following leads were implanted in our center: Durata (St. Jude Medical, St. Paul, MN, USA, now Abbott) (n = 105), Linox and LinoxSmart (Biotronik, Berlin, Germany) (n = 66), and Sprint Quattro (Medtronic, Minneapolis, MN, USA) (n = 126).

Results

A total of 297 ICD leads were analyzed. Failure rates for Durata, Linox/LinoxSmart, and Sprint Quattro were 0.20%/patient year, 0.95%/patient year, and 1.84%/patient year, respectively, during a mean follow-up of 4.8, 6.4, and 3.0 years, respectively. The cumulative ICD lead survival probability was 98.9%, 100%, and 87.5%, after 5 years, respectively. The survival probability over the entire follow-up time as measured by the log-rank test was lower for Sprint Quattro leads than for either Durata (p = 0.011) or Linox/LinoxSmart (p = 0.028). The difference between Durata and Linox/LinoxSmart was not significant (p = 0.393).

Conclusions

In this single-center retrospective study, the performance of Sprint Quattro was lower than the performance of Linox/LinoxSmart and Durata leads. Large-scale, multi-center studies or manufacturer-independent registries may be necessary to confirm or reject self-reported survival probabilities from manufacturers’ product performance reports.

Keywords

Implantable cardioverter-defibrillator Lead Durata Linox Quattro 

Notes

Compliance with ethical standards

The investigation was approved by the local ethics committee.

Conflict of interest

Dr. Kondo received research grants from Abbott Japan, Biotronik Japan, and Boston Scientific. Dr. Kobayashi received research grants from Abbott Japan, Biotronik Japan, Boston Scientific, and Medtronic Japan. The other authors declare no conflicts of interest.

References

  1. 1.
    Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877–83.CrossRefGoogle Scholar
  2. 2.
    Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–37.CrossRefGoogle Scholar
  3. 3.
    Maisel WH. Transvenous implantable cardioverter-defibrillator leads. Circulation. 2007;115:2461–3.CrossRefGoogle Scholar
  4. 4.
    Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation. 2007;115:2474–80.CrossRefGoogle Scholar
  5. 5.
    Swerdlow CD, Kalahasty G, Ellenbogen KA. Implantable cardiac defibrillator lead failure and management. J Am Coll Cardiol. 2016;67:1358–68.CrossRefGoogle Scholar
  6. 6.
    Sears SF, Conti JB. Understanding implantable cardioverter defibrillator shocks and storms. Clin Cardiol. 2003;26:107–11.CrossRefGoogle Scholar
  7. 7.
    Miyazawa K, Kondo Y, Ueda M, Kajiyama T, Nakano M, Inagaki M, et al. Prospective survey of implantable defibrillator shock anxiety in Japanese patients. Pacing Clin Electrophysiol. 2018;41:1171–7.CrossRefGoogle Scholar
  8. 8.
    Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm. 2007;4:892–6.CrossRefGoogle Scholar
  9. 9.
    Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm. 2009;6:605–10.CrossRefGoogle Scholar
  10. 10.
    Hauser RG, Maisel WH, Friedman PA, Kallinen LM, Mugglin AS, Kumar K, et al. Longevity of Sprint Fidelis implantable cardioverter-defibrillator leads and risk factors for failure: implications for patient management. Circulation. 2011;123:358–63.CrossRefGoogle Scholar
  11. 11.
    Duray GZ, Israel CW, Schmitt J, Hohnloser SH. Implantable cardioverter-defibrillator lead disintegration at the level of the tricuspid valve. Heart Rhythm. 2008;5:1224–5.CrossRefGoogle Scholar
  12. 12.
    Abdelhadi RH, Saba SF, Ellis CR, Mason PK, Kramer DB, Friedman PA, et al. Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm. 2013;10:361–5.CrossRefGoogle Scholar
  13. 13.
    Kodoth VN, Hodkinson EC, Noad RL, Ashfield KP, Cromie NA, McEneaney D, et al. Fluoroscopic and electrical assessment of a series of defibrillation leads: prevalence of externalized conductors. Pacing Clin Electrophysiol. 2012;35:1498–504.CrossRefGoogle Scholar
  14. 14.
    Goldstein MA, Badri M, Kocovic D, Kowey PR. Electrical failure of an ICD lead due to a presumed insulation defect only diagnosed by a maximum output shock. Pacing Clin Electrophysiol. 2013;36:1068–71.CrossRefGoogle Scholar
  15. 15.
    Manfredi JA, Smithgall SM, Kircher CM, Lollis MA. Insulation failure with externalized conductor of a Linox SD lead. J Cardiovasc Electrophysiol. 2014;25:440–1.CrossRefGoogle Scholar
  16. 16.
    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.CrossRefGoogle Scholar
  17. 17.
    Mann IE, Segal OR. A case of Durata ICD lead coil externalization: inside-out lead abrasion? Heart Rhythm Case Rep. 2016;2:283–5.Google Scholar
  18. 18.
    Lau EW, Roberts MJD. Inside-out abrasion and contained conductor cable externalization in a defibrillation lead with asymmetric conductor cable lumen distribution. Heart Rhythm Case Rep. 2018;4:121–6.Google Scholar
  19. 19.
    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.CrossRefGoogle Scholar
  20. 20.
    van Malderen SC, Szili-Torok T, Yap SC, Hoeks SE, Zijlstra F, Theuns DA. Comparative study of the failure rates among 3 implantable defibrillator leads. Heart Rhythm. 2016;13:2299–305.CrossRefGoogle Scholar
  21. 21.
    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 manufacturers. Heart Rhythm. 2017;14:1496–503.CrossRefGoogle Scholar
  22. 22.
    O’Connor M, Hooks D, Webber M, et al. Long-term single-center comparison of ICD lead survival. J Cardiovasc Electrophysiol. 2018;29:1024–31.CrossRefGoogle Scholar
  23. 23.
    Weberndörfer V, Nyffenegger T, Russi I, Brinkert M, Berte B, Toggweiler S, et al. First time description of early lead failure of the Linox Smart lead compared to other contemporary high-voltage leads. J Interv Card Electrophysiol. 2018;52:173–7.CrossRefGoogle Scholar
  24. 24.
    Díez DP, Rubín JM, Cuervo DC, Iglesias DG, De La Tassa CM. Analysis of early failure of Biotronik Linox Smart implantable cardioverter-defibrillator leads. Pacing Clin Electrophysiol. 2018;41:1165–70.CrossRefGoogle Scholar
  25. 25.
    Abbott. Product performance report 2018 First Edition. https://www.sjm.com/en/professionals/resources-and-reimbursement/technical-resources/product-performance-report. Accessed August 4th, 2019
  26. 26.
    BIOTRONIK. Product performance report July 2018. https://www.biotronik.com/en-us/healthcare-professionals/product-performance-report. Accessed August 4th, 2019
  27. 27.
    Medtronic. Product performance report 2018 1st Edition. http://wwwp.medtronic.com/productperformance/past-reports.html. Accessed August 4th, 2019
  28. 28.
    Providência R, Kramer DB, Pimenta D, et al. Transvenous implantable cardioverter-defibrillator (ICD) lead performance. J Am Heart Assoc. 2015;4:e002418.CrossRefGoogle Scholar
  29. 29.
    Shah AD, Hirsh D, Langberg JJ. User-reported abrasion-related lead failure is more common with durata compared to other implantable cardiac defibrillator leads. Heart Rhythm. 2015;12:2376–80.CrossRefGoogle Scholar
  30. 30.
    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;27:735–42.CrossRefGoogle Scholar
  31. 31.
    Lau EW. Differential lead component pulling as a possible mechanism of inside-out abrasion and conductor cable externalization. Pacing Clin Electrophysiol. 2013;36:1072–89.CrossRefGoogle Scholar
  32. 32.
    McKeag NA, Noad RL, Ashfield K, et al. Prospective assessment of Linox implantable cardioverter defibrillator leads for structural or electrical abnormalities. Adv Ther. 2018:1–5.Google Scholar
  33. 33.
    Ząbek A, Boczar K, Dębski M, et al. Analysis of electrical lead failures in patients referred for transvenous lead extraction procedures. Pacing Clin Electrophysiol. 2018:1–7.Google Scholar
  34. 34.
    Dvorak P, Novak M, Kamaryt P, Slana B, Lipoldova J. Histological findings around electrodes in pacemaker and implantable cardioverter-defibrillator patients. Europace. 2011;14:117–23.CrossRefGoogle Scholar
  35. 35.
    Sarrazin J-F, Philippon F, Sellier R, et al. Clinical performance of different DF-4 implantable cardioverter defibrillator leads. Pacing Clin Electrophysiol. 2018;41:953–8.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Yusuke Kondo
    • 1
    Email author
  • Masahiro Nakano
    • 1
  • Takatsugu Kajiyama
    • 2
  • Miyo Nakano
    • 2
  • Tomohiko Hayashi
    • 2
  • Ryo Ito
    • 2
  • Haruhiro Takahira
    • 2
  • Yoshio Kobayashi
    • 2
  1. 1.Department of Advanced Cardiorhythm TherapeuticsChiba University Graduate School of MedicineChibaJapan
  2. 2.Department of Cardiovascular MedicineChiba University Graduate School of MedicineChibaJapan

Personalised recommendations