Increasing lead burden correlates with externalized cables during systematic fluoroscopic screening of Riata leads

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• 作者：Liza P. Moorman (1)
  J. Randall Moorman (1)
  John P. DiMarco (1)
  Rohit Malhotra (1)
  Andrew Darby (1)
  Kenneth Bilchick (1)
  John D. Ferguson (1)
  J. Michael Mangrum (1)
  Sandeep Kamath (1)
  Pamela K. Mason (1)
  
• 关键词：Implantable cardioverter–defibrillator ; Fluoroscopy ; Defibrillation ; Recall ; Inappropriate shocks
• 刊名：Journal of Interventional Cardiac Electrophysiology
• 出版年：2013
• 出版时间：June 2013
• 年：2013
• 卷：37
• 期：1
• 页码：63-68
• 全文大小：291KB
• 参考文献：1. St. Jude Medical (2011). FDA classifies voluntary physician advisory letter on Riata and Riata ST silicone defibrillation leads as class I recall (URGENT MEDICAL DEVICE ADVISORY), December 15, 2011. http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1640339. Accessed 1 April 2012.
  2. Hauser, R. G., McGriff, D., & Retel, L. K. (2012). Riata implantable cardioverter–defibrillator lead failure: Analysis of explanted leads with a unique insulation defect. / Heart Rhythm, 9, 742-49. CrossRef
  3. Chester, K.M. (2010). Important information about Riata and Riata ST silicone endocardial leads, December 15, 2010. http://www.sjmprofessional.com/Resources/communications/important-information-about-riata-and-riata-st-silicone-endocardial-leads.aspx. Accessed 1 April 2012.
  4. Kresbsbach, A., Alhumaid, F., Henrikson, C. A., Calkins, H., Berger, R. D., & Cheng, A. (2011). Premature failure of a Riata defibrillator lead without impedance change or inappropriate sensing: A case report and review of the literature. / Journal of Cardiovascular Electrophysiology, 22, 1070-072. CrossRef
  5. Duray, G. Z., Israel, C. W., Schmitt, J., & Hohnloser, S. H. (2008). Implantable cardioverter–defibrillator lead disintegration at the level of the tricuspid valve. / Heart Rhythm, 5, 1224-225. CrossRef
  6. Jalal, Z., Derval, N., Ploux, S., & Bordachar, P. (2010). Unusual failure of a multilumen, small-diameter implantable cardioverter–defibrillator lead. / Heart Rhythm, 7, 1166-167. CrossRef
  7. Schmutz, M., Delacretaz, E., Schwick, N., Roten, L., Fuhrer, J., Boesch, C., Tanner, H. (2012). Prevalence of asymptomatic and electrically undetectable intracardiac inside-out abrasion in silicon-coated Riata and Riata ST implantable cardioverter–defibrillator leads. / International Journal of Cardiology. doi:10.1016/j.ijcard.2011.12.076
  8. Erkapic, D., Duray, G. Z., Bauernfeind, T., De Rosa, S., & Hohnloser, S. H. (2011). Insulation defects of thin high-voltage ICD leads: An underestimated problem. / Journal of Cardiovascular Electrophysiology, 22, 1018-022. CrossRef
  9. Kodoth, V., Cromie, N., Lau, E., McEneaney, D., Wilson, C., Roberts, M.J. (2011). Riata lead failure: A report from Northern Ireland Riata lead screening programme. http://spo.escardio.org/AbstractDetails.aspx?id=98075&eevtid=48. Accessed 7 March 2012.
  10. Carlson, M., Tsung, P. (2011). Medical device advisory: Important product information update, November 28, 2011. http://www.riatacommunication.com/riata-us.aspx. Accessed 1 April 2012.
  11. St. Jude Medical. (2012). Riata? lead programming and monitoring considerations, May 25, 2012. http://www.riatacommunication.com/us/physician-information.aspx. Accessed 6 June 2012.
  12. Parvathaneni, 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), 1218-224.
  13. Shen, S., Bhave, P., Giedrimas, E., Patel, T., Arora, R., Chicos, A.B., Goldberger, J.J., Ilkhanoff, L., Kim, M.H., Lin, A.C., Passman, R., Lee, R., Knight, B.P., Kim, S.S. (2012). Prevalence and predictors of cable extrusion and loss of electrical integrity with the Riata defibrillator lead. / Journal of Cardiovascular Electrophysiology, 23(11), 1207-212.
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  16. Leong, D. P., & Erven, L. V. (2012). Unrecognized failure of a narrow caliber defibrillation lead: The role of defibrillation threshold testing in identifying an unprotected individual. / Pacing and Clinical Electrophysiology, 35, 1-. CrossRef
  17. Birnie, D. H., Parkash, R., & Exner, D. (2012). Clinical predictors of Fidelis lead failure: A report from the Canadian Heart Rhythm Society Device Committee. / Circulation, 125, 1217-225. CrossRef
  18. FDA. (2012). FDA safety communication: Premature insulation failure in recalled Riata implantable cardioverter defibrillator (ICD) leads manufactured by St. Jude Medical, Inc., August 16, 2012. http://www.fda.gov/MedicalDevices/Safety/AltertsandNotices/ucm314930.htm. Accessed 24 October 2012.
  19. Krahn, A. D., & Gould, P. A. (2006). Complications associated with implantable cardioverter–defibrillator replacement in response to device advisories. / Journal of the American Medical Association, 295, 1907-911. CrossRef
  20. Kay, G. N., Brinker, J. A., Kawanishi, D. T., Love, C. J., Lloyd, M. A., Reeves, R. C., Pioger, G., Fee, J., Overland, M. K., Ensign, L. G., & Grunkemeier, G. L. (1999). Risks of spontaneous injury and extraction of an active fixation pacemaker lead: Report of the Accufix Multicenter Clinical Study and Worldwide Registry. / Circulation, 100, 2344-352. CrossRef
  
• 作者单位：Liza P. Moorman (1)
  J. Randall Moorman (1)
  John P. DiMarco (1)
  Rohit Malhotra (1)
  Andrew Darby (1)
  Kenneth Bilchick (1)
  John D. Ferguson (1)
  J. Michael Mangrum (1)
  Sandeep Kamath (1)
  Pamela K. Mason (1)
  
  1. University of Virginia Health System, P.O. Box 800158, Charlottesville, VA, 22908, USA
  
• ISSN：1572-8595

文摘

Purpose Riata and Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) have been recalled due to increased risk of insulation failure leading to externalized cables. As this mechanical failure does not necessarily correlate with electrical failure, it can be difficult to diagnose. Fluoroscopic screening can identify insulation failure. Studies have suggested that insulation failure is predominantly seen in 8-Fr, single-coil models. Our patients have exclusively dual-coil leads and a high proportion of 7-Fr leads. Methods Fluoroscopic screening was performed in 48 patients with recalled Riata leads. Twenty-three patients had 8-Fr Riata leads and 25 patients had 7-Fr Riata ST leads. Images were recorded in at least three projections and studies were reviewed by seven attending electrophysiologists. Results Externalized cables were seen in ten patients (21?%), and another five patients (10?%) had abnormal cable spacing. All device interrogations showed normal parameters. Patients with abnormal leads had more leads in situ (2.5?±-.7 vs. 1.6?±-.8 leads; P--.002) and a higher rate of nonischemic cardiomyopathy (80 vs. 24?%; P--.03). There were no differences between the groups with regards to patient age, body mass index, lead age, lead parameters, or vascular access site. There was no difference with regard to lead size (P--.76). Conclusions The Riata family of leads has a high incidence of mechanical failure, as demonstrated on fluoroscopic screening. In this study, the 7-Fr models were just as likely to mechanically fail as the 8-Fr models. Increasing lead burden and a diagnosis of nonischemic cardiomyopathy correlated with insulation failure.