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Erschienen in: Journal of Interventional Cardiac Electrophysiology 3/2014

01.12.2014 | MULTIMEDIA REPORT

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

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

Erschienen in: Journal of Interventional Cardiac Electrophysiology | Ausgabe 3/2014

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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.
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Literatur
1.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
2.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
3.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
4.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
5.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
6.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
7.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
8.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
9.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
11.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
12.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
13.
Zurück zum Zitat 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. 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.
14.
Zurück zum Zitat Parkash, R. Canadian Heart Rhythm Society Device Committee: Advisory Response Notification, December 1, 2011. Parkash, R. Canadian Heart Rhythm Society Device Committee: Advisory Response Notification, December 1, 2011.
15.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
16.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
17.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
18.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
Metadaten
Titel
Longitudinal follow-up of Riata leads reveals high annual incidence of new conductor externalization and electrical failure
verfasst von
Christian Steinberg
Jean-François Sarrazin
François Philippon
Jean Champagne
Marc-André Bouchard
Franck Molin
Isabelle Nault
Louis Blier
Gilles O’Hara
Publikationsdatum
01.12.2014
Verlag
Springer US
Erschienen in
Journal of Interventional Cardiac Electrophysiology / Ausgabe 3/2014
Print ISSN: 1383-875X
Elektronische ISSN: 1572-8595
DOI
https://doi.org/10.1007/s10840-014-9951-6

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