Skip to main content

Advertisement

SpringerLink
Log in

Longitudinal follow-up of Riata leads reveals high annual incidence of new conductor externalization and electrical failure

  • MULTIMEDIA REPORT
  • Published:
Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Background and purpose

RiataTM defibrillation leads are susceptible to conductor externalization. The point prevalence of insulation defect in RiataTM leads is up to 33 %, but prospective data concerning incidence of new lead abnormalities are lacking. The purpose of our study was to determine the annual incidence of new conductor externalizations and electrical lead failure.

Methods

A prospective observational study was conducted at a single tertiary center. One hundred forty-one patients were followed over 12 months. A posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming was performed at baseline and at 12 months to screen for conductor externalization. Electrical abnormalities and clinical outcome were also assessed.

Results

The overall incidence of new insulation defects was 8.5 % at 12 months. High-risk leads for new conductor externalization were lead models 1580, 1582, and 1590 with an annual rate of 11.9, 11.1, and 10 %, respectively. New conductor externalizations were three times more common in 8 Fr leads compared to 7 Fr leads. The overall incidence of new electrical dysfunction was 6.4 % at 12 months. Electrical dysfunction was significantly higher in abnormal leads (25 % [3/12], 4.7 % [6/129]; p = 0.03) and mostly driven by high ventricular pacing thresholds. There was no difference in inappropriate shock or failure of high-voltage therapy.

Conclusion

The annual incidence of new insulation defects in RiataTM leads is much higher than previously reported. Lead models 1580, 1582, and 1590 are at highest risk for new conductor externalization. Electrical dysfunction in RiataTM leads is also much higher than reported and is associated with conductor externalization.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Parvathaneni, S. V., Ellis, C. R., & Rottman, J. N. (2012). High prevalence of insulation failure with externalized cables in St. Jude medical Riata family ICD leads; fluoroscopic grading scale and correlation to extracted leads. Heart Rhythm, 9(8), 1218–1224.

    Article  PubMed  Google Scholar 

  2. Shen, S., Bhave, P., Giedrimas, E., Patel, T., Arora, R., Chicos, A. B., et al. (2012). Prevalence and predictors of cable extrusion and loss of electrical integrity with the Riata defibrillator lead. Journal of Cardiovascular Electrophysiology, 23(11), 1207–1212.

    Article  PubMed  Google Scholar 

  3. Steinberg, C., Sarrazin, J. F., Philippon, F., Bouchard, M. A., O’Hara, G., Molin, F., et al. (2013). Detection of high incidence of Riata lead breaches by systematic postero-anterior and lateral chest X-ray in a large cohort. Europace, 15(3), 402–408.

    Article  PubMed  Google Scholar 

  4. Abdelhadi, R. H., Saba, S. F., Ellis, C. R., Mason, P. K., Kramer, D. B., Friedman, P. A., et al. (2013). Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm, 10(3), 361–365.

    Article  PubMed  Google Scholar 

  5. Parkash, R., Exner, D., Champagne, J., Mangat, I., Thibault, B., Healey, J. S., et al. (2013). Failure rate of the Riata lead under advisory: a report from the CHRS Device committee. Heart Rhythm, 10(5), 692–695.

    Article  PubMed  Google Scholar 

  6. Hauser, R. G., Abdelhadi, R., McGriff, D., & Retel, L. K. (2012). Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm, 9(8), 1227–1235.

    Article  PubMed  Google Scholar 

  7. Liu, J., Rattan, R., Adelstein, E., Barrington, W., Bazaz, R., Brode, S., et al. (2012). Fluoroscopic screening of asymptomatic patients implanted with the recalled Riata lead family. Circulation. Arrhythmia and Electrophysiology, 5(4), 809–814.

    Article  PubMed  Google Scholar 

  8. Theuns, D. A., Elvan, A., de Voogt, W., de Cock, C. C., van Erven, L., & Meine, M. (2012). Prevalence and presentation of externalized conductors and electrical abnormalities in Riata defibrillator leads after fluoroscopic screening: Report from the Netherlands heart rhythm association device advisory committee. Circulation. Arrhythmia and Electrophysiology, 5(6), 1059–1063.

    Article  PubMed  Google Scholar 

  9. Demirel, F., Adiyaman, A., Delnoy, P. P., Smit, J. J., Ramdat Misier, A. R., & Elvan, A. (2014). Mechanical and electrical dysfunction of Riata implantable cardioverter-defibrillator leads. Europace.

  10. Valk, S. D., Theuns, D. A., & Jordaens, L. (2013). Long-term performance of the St Jude Riata 1580-1582 ICD lead family. Neth Heart J, 21(3), 127–134.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  11. Hayes, D., Freedman, R., Curtis, A. B., Niebauer, M., Neal, K., Dinerman, J., et al. (2013). Prevalence of externalized conductors in Riata and Riata ST silicone leads: Results from the prospective, multicenter Riata lead evaluation study. Heart Rhythm, 10(12), 1778–1782.

    Article  PubMed  Google Scholar 

  12. Kodoth, V. N., Hodkinson, E. C., Noad, R. L., Ashfield, K. P., Cromie, N. A., McEneaney, D. J., et al. (2012). Fluoroscopic and electrical assessment of a series of defibrillation leads: Prevalence of externalized conductors. Pacing and Clinical Electrophysiology, 35(12), 1498–1504.

    Article  PubMed  Google Scholar 

  13. FDA News Release August 16. (2012). FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical: Riata leads to help guide treatment.

    Google Scholar 

  14. Parkash, R. Canadian Heart Rhythm Society Device Committee: Advisory Response Notification, December 1, 2011.

  15. Rordorf, R., Poggio, L., Savastano, S., Vicentini, A., Petracci, B., Chieffo, E., et al. (2013). Failure of implantable cardioverter-defibrillator leads: a matter of lead size? Heart Rhythm, 10(2), 184–190.

    Article  PubMed  Google Scholar 

  16. Sung, R. K., Massie, B. M., Varosy, P. D., Moore, H., Rumsfeld, J., Lee, B. K., et al. (2012). Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans affairs experience. Heart Rhythm, 9(12), 1954–1961.

    Article  PubMed  Google Scholar 

  17. Lakshmanadoss, U., Lahoda, D., & Deshmukh, P. (2013). Riata lead failure with normal electrical lead parameters and normal fluoroscopic appearance. Journal of Interventional Cardiac Electrophysiology, 36(1), 87–89.

    Article  PubMed  Google Scholar 

  18. Choi, K., Kim, J. H., Kim, H. J., Lee, S. O., Jang, E. Y., & Kim, J. S. (2013). A case of Riata® dual coil defibrillator lead failure in a patient with ventricular fibrillation. Korean Circ J, 43(5), 336–339.

    Article  PubMed Central  PubMed  Google Scholar 

Download references

Conflict of interests

None of the authors have a conflict of interests to declare.

Disclosures

None.

Author information

Authors and Affiliations

  1. Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ), Division of electrophysiology, 2725, chemin Sainte-Foy, Quebec, QC, G1V 4G5, Canada

    Christian Steinberg, Jean-François Sarrazin, François Philippon, Jean Champagne, Marc-André Bouchard, Franck Molin, Isabelle Nault, Louis Blier & Gilles O’Hara

Authors
  1. Christian Steinberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jean-François Sarrazin
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. François Philippon
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jean Champagne
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Marc-André Bouchard
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Franck Molin
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Isabelle Nault
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Louis Blier
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Gilles O’Hara
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Christian Steinberg.

Electronic supplementary material

Below is the link to the electronic supplementary material.

ESM 1

(DOCX 38 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Steinberg, C., Sarrazin, JF., Philippon, F. et al. Longitudinal follow-up of Riata leads reveals high annual incidence of new conductor externalization and electrical failure. J Interv Card Electrophysiol 41, 217–222 (2014). https://doi.org/10.1007/s10840-014-9951-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10840-014-9951-6

Keywords

Search

Navigation