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What did we learn from Riata™?

Was haben wir von Riata™ gelernt?

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Herzschrittmachertherapie + Elektrophysiologie Aims and scope Submit manuscript

Abstract

The Riata™ 8 French (Fr) and Riata ST™ 7 Fr families of silicone leads have experienced a specific form of insulation abrasion characterized by externalization of conductor cables outside the lead body. Design differences between the 8 Fr and 7 Fr leads make conductor externalization less likely in the smaller diameter lead. The Riata Lead Evaluation Study (RLES) reported on the prevalence of externalized conductors (EC) in patients implanted with Riata™ and Riata ST™ silicone leads and provided details on the incidence of electrical abnormalities in Riata™ and Riata ST™ leads with and without EC. The prevalence of EC was significantly lower for the Riata ST™ leads (7 Fr) as compared with Riata™ leads (8 Fr) (24/259 (9.3 %) vs. 125/517 (24.2 %), P < 0.001), and the majority of leads with EC were not associated with electrical malfunction. The aim of this manuscript is to describe the design of the Riata™ and Riata ST™ families of leads, provide details regarding the mechanisms and rates of lead failure, and discuss recommendations for patient management.

Zusammenfassung

Bei den silikonbeschichteten Elektrodenfamilien Riata™ 8 French (Fr) und Riata ST™ 7 Fr ist es zu einer speziellen Form des Abriebs der Sondenisolation gekommen, die durch eine Freilegung der Leitungskabel außerhalb des Elektrodenkörpers charakterisiert ist. Aufgrund des unterschiedlichen Designs der 8 Fr- und 7 Fr-Elektroden sind freiliegende Sondenleiter bei Elektroden mit geringerem Durchmesser weniger wahrscheinlich. Die Riata Lead Evaluation Study (RLES) berichtete über die Prävalenz von freiliegenden Sondenleitern („externalized conductors“, EC) bei Patienten, denen Riata™- und Riata-ST™-Silikonelektroden implantiert worden waren und bietet Details zur Inzidenz elektrischer Abnormalitäten bei Riata™- und Riata-ST™-Elektroden mit und ohne EC. Die Prävalenz von EC war signifikant geringer bei RiataTM-ST-Elektroden 7 Fr verglichen mit Riata™-Elektroden 8 Fr [24/259 (9,3 %) vs. 125/517 (24,2 %); p < 0,001] und die Mehrzahl der Elektroden mit EC war nicht mit elektrischen Funktionsstörungen assoziiert. Ziel dieses Beitrags ist es, das Design der Riata™- und Riata-ST™-Elektroden zu beschreiben, Einzelheiten zu den Mechanismen und Raten von Elektrodenversagen aufzuführen sowie die Empfehlungen für das Patientenmanagement zu diskutieren.

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References

  1. Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, Saggau W, Weisse U, Seidl K (2007) Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of > 10 years. Circulation 115:2474–2480

    Article  PubMed  Google Scholar 

  2. Fischer A, Klehn R (2013) Contribution of ethylenetetrafluoroethylene (ETFE) insulation to the electrical performance of Riata silicone leads having externalized conductors. J Interv Card Electrophysiol 37(2):141–145. doi:10.1007/s10840-013-9790-x

    Article  PubMed  Google Scholar 

  3. Hackler J, Sun Z, Lindsay B, Wilkoff B, Neibauer M, Tchou P, Chung M (2010) Effectiveness of implantable cardioverter-defibrillator lead coil treatments in facilitating ease of extraction. Heart Rhythm 7(7):890–897

    Article  PubMed Central  PubMed  Google Scholar 

  4. Cairns JA, Epstein AE, Rickard J, Connolly SJ, Buller C, Wilkoff BL, Pogue J, Themeles E, Healey JS (2014) Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads. Heart Rhythm 11(12):2156–2162

    Article  PubMed  Google Scholar 

  5. Duray GZ, Israel CW, Schmitt J, Hohnloser SH (2008) Implantable cardioverter-defibrillator lead disintegration at the level of the tricuspid valve. Heart Rhythm 5(8):1224–1225

    Article  PubMed  Google Scholar 

  6. Kodoth VN, Hodkinson EC, Noad RL, Ashfield KP, Cromie NA, McEneaney DJ, Wilson CM, Roberts MJ (2012) Fluoroscopic and electrical assessment of a series of defibrillation leads: prevalence of externalized conductors. Pacing Clin Electrophysiol 35(12):1498–1504

    Article  PubMed  Google Scholar 

  7. Parkash R, Exner D, Champagne J, Mangat I, Thibault B, Healey JS, Tung S, Crystal E, Simpson C, Nery PB, Sterns L, Connors S, Cameron D, Verma A, Beardsall M, Wolfe K, Essebag V, Ayala-Paredes F, Sanatani S, Coutu B, Fraser J, Toal S, Philippon F, Tang AS, Yee R, Krahn A (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 

  8. Sung RK, Massie BM, Varosy PD et al (2012) Long-term electrical survival analysis of Riata and Riata ST silicone leads: national veterans affairs experience. Heart Rhythm 9:1954–1961

    Article  PubMed  Google Scholar 

  9. Hayes D, Freedman R, Curtis AB, Niebauer M, Neal Kay G, Dinerman J, Beau S (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 

  10. Schmutz M, Delacrétaz E, Schwick N, Roten L, Fuhrer J, Boesch C, Tanner H (2013) Prevalence of asymptomatic and electrically undetectable intracardiac inside-out abrasion in silicon-coated Riata and Riata ST ICD leads. Int J Cardiol 167(1):254–257

    Article  PubMed  Google Scholar 

  11. Erkapic D, Duray GZ, Bauernfeind T, De Rosa S, Hohnloser SH (2011) Insulation defects of thin high-voltage ICD leads: an underestimated problem? J Cardiovasc Electrophysiol 22(9):1018–1022

    Article  PubMed  Google Scholar 

  12. Parvathaneni SV, Ellis CR, Rottman JN (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 

  13. St. Jude Medical Product Performance Report (2nd edn; Dec 2014)http://professional.sjm.com/resources/product-performance/product-performance-reports/current

  14. Abi-Saleh B, Refaat M, Khoury M, Wilkoff B, Tomsich R, Tomsich R (2014) Conductor externalization of the Biotronik Kentrox internal cardioverter defibrillator lead: the tip of another iceberg? Heart Rhythm 11(9):1648–1650

    Article  PubMed  Google Scholar 

  15. Bogossian H, Mijic D, Frommeyer G, Winter J (2015) Insulation failure and externalized conductor of a single-coil Kentrox lead: an ongoing story? J Cardiovasc Electrophysiol 26(2):226–227

    Article  PubMed  Google Scholar 

  16. Howe A, McKeag N, Wilson C, Ashfield K, Roberts M (2015) Insulation failure of the Linox defibrillator lead: a case report and retrospective review of a single center experience. J Cardiovasc Electrophysiol (epub ahead of print)

  17. Canadian Heart Rhythm Society. Advisory Response Notification—Update. St. Jude Medical Riata and Riata ST High Voltage Leads. 2012. http://www.chrsonline.ca/index.php/recalls-advisories. Accessed 15 Jan 2015

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Authors and Affiliations

  1. St. Jude Medical, 15900 Valley View Court, 91342, Sylmar, CA, USA

    Avi Fischer MD, FACC, FHRS & C. Jenney PhD

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  1. Avi Fischer MD, FACC, FHRS
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  2. C. Jenney PhD
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Correspondence to Avi Fischer MD, FACC, FHRS.

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A. Fischer and C. Jenney are both paid employees of St. Jude Medical.

This manuscript does not contain studies on humans or animals.

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Fischer, A., Jenney, C. What did we learn from Riata™?. Herzschr Elektrophys 26, 105–110 (2015). https://doi.org/10.1007/s00399-015-0367-5

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  • DOI: https://doi.org/10.1007/s00399-015-0367-5

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