Managing patients with advisory defibrillator leads: what can we learn from published data?

详细信息    查看全文

• 作者：F. A. Bracke (1)
  B. M. van Gelder (1)
  
  1. Department of Cardiology ; Catharina Hospital ; Michelangelolaan 2 ; 5623 EJ ; Eindhoven ; The Netherlands
  
• 关键词：Defibrillators ; Implantable ; Electrodes ; Implanted ; Complications ; Advisory leads
• 刊名：Netherlands Heart Journal
• 出版年：2015
• 出版时间：April 2015
• 年：2015
• 卷：23
• 期：4
• 页码：199-204
• 全文大小：370 KB
• 参考文献：1. Kay, GN, Brinker, JA, Kawanishi, DT (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: pp. 2344-52 itle="It opens in new window">CrossRef
  2. Maisel, WH, Hauser, RG, Hammill, SC (2009) Recommendations from the Heart Rhythm Society task force on lead performance policies and guidelines: developed in collaboration with the American College of Cardiology and the American Heart Association. Heart Rhythm 6: pp. 869-85 itle="It opens in new window">CrossRef
  3. Abdelhadi, RH, Saba, SF, Ellis, CR (2013) Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm 10: pp. 361-5 itle="It opens in new window">CrossRef
  4. Hayes, D, Freedman, R, Curtis, AB (2013) Prevalence of externalized conductors in Riata and Riata ST silicone leads: Results from the prospective, multicenter Riata Lead Evaluation Study. Heart Rhythm 10: pp. 1778-82 itle="It opens in new window">CrossRef
  5. Parkash, R, Exner, D, Champagne, J (2013) Failure rate of the Riata lead under advisory: a report from the CHRS Device Committee. Heart Rhythm 10: pp. 692-5 itle="It opens in new window">CrossRef
  6. Barrett, CD, Danik, SB (2013) The Riata lead recall. Heart Rhythm 10: pp. 1783-4 itle="It opens in new window">CrossRef
  7. Kleemann, T, Becker, T, Doenges, K (2007) Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation 115: pp. 2474-80 itle="It opens in new window">CrossRef
  8. Demirel, F, Adiyaman, A, Delnoy, PPHM, Smit, JJJ, Ramdat Misier, AR, Elvan, A (2014) Mechanical and electrical dysfunction of Riata implantable cardioverter-defibrillator leads. Europace 16: pp. 1787-94 itle="It opens in new window">CrossRef
  9. Theuns, DAMJ, Elvan, A, Voogt, W, Cock, CC, 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. Circ Arrhythm Electrophysiol 5: pp. 1059-63 itle="It opens in new window">CrossRef
  10. http://www.medtronic.com/product-advisories/physician/sprint-fidelis/6949-LEAD鈥揚ERFORMANCE. Accessed on 20 February 2015.
  11. Birnie, DH, Parkash, R, Exner, DV (2012) Clinical predictors of Fidelis lead failure: report from the Canadian Heart Rhythm Society Device Committee. Circulation 125: pp. 1217-25 itle="It opens in new window">CrossRef
  12. Hauser, RG, Abdelhadi, R, McGriff, D, Retel, LK (2012) Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm 9: pp. 1227-35 itle="It opens in new window">CrossRef
  13. Morrison, TB, Friedman, PA, Kallinen, LM (2011) Impact of implanted recalled sprint Fidelis lead on patient mortality. J Am Coll Cardiol 58: pp. 278-83 itle="It opens in new window">CrossRef
  14. Welsenes, GH, van Rees, JB, Borleffs, CJW (2011) Long-term follow-up of primary and secondary prevention implantable cardioverter defibrillator patients. Europace 13: pp. 389-94 itle="It opens in new window">CrossRef
  15. Moss, AJ, Zareba, W, Hall, WJ (2002) Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 346: pp. 877-83 itle="It opens in new window">CrossRef
  16. Bardy, GH, Lee, KL, Mark, DB (2005) Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 352: pp. 225-37 itle="It opens in new window">CrossRef
  17. Bashir, J, Cowan, S, Raymakers, A (2013) A cost-effectiveness analysis of a proactive management strategy for the Sprint Fidelis recall: a probabilistic decision analysis model. Heart Rhythm 10: pp. 1761-7 itle="It opens in new window">CrossRef
  18. Wilkoff, BL, Williamson, BD, Stern, RS (2008) Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol 52: pp. 541-50 itle="It opens in new window">CrossRef
  19. Moss, AJ, Schuger, C, Beck, CA (2012) Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 367: pp. 2275-83 itle="It opens in new window">CrossRef
  20. Wijers, SC, Kolk, BYM, Tuinenburg, AE, Doevendans, PAF, Vos, MA, Meine, M (2013) Implementation of guidelines for implantable cardioverter-defibrillator therapy in clinical practice: which patients do benefit?. Neth Heart J 21: pp. 274-83 itle="It opens in new window">CrossRef
  21. Krahn, AD, Champagne, J, Healey, JS (2008) Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Device Advisory Committee. Heart Rhythm 5: pp. 639-42 itle="It opens in new window">CrossRef
  22. Sung, RK, Massie, BM, Varosy, PD (2012) Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans Affairs experience. Heart Rhythm 9: pp. 1954-61 itle="It opens in new window">CrossRef
  23. Poole, JE, Johnson, GW, Hellkamp, AS (2008) Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med 359: pp. 1009-17 itle="It opens in new window">CrossRef
  24. Pedersen, SS, Hoogwegt, MT, Jordaens, L, Theuns, DAMJ (2013) Procedure- and device-related complications and psychological morbidity in implantable cardioverter defibrillator patients. Int J Cardiol 168: pp. 606-7 itle="It opens in new window">CrossRef
  25. Keren, A, Sears, SF, Nery, P (2011) Psychological adjustment in ICD patients living with advisory fidelis leads. J Cardiovasc Electrophysiol 22: pp. 57-63 itle="It opens in new window">CrossRef
  26. Magyar-Russell, G, Thombs, BD, Cai, JX (2011) The prevalence of anxiety and depression in adults with implantable cardioverter defibrillators: a systematic review. J Psychosom Res 71: pp. 223-31 itle="It opens in new window">CrossRef
  27. Kallinen, LM, Hauser, RG, Tang, C (2010) Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures. Heart Rhythm 7: pp. 1048-55 itle="It opens in new window">CrossRef
  28. Swerdlow, CD, Gunderson, BD, Ousdigian, KT, Abeyratne, A, Sachanandani, H, Ellenbogen, KA (2010) Downloadable software algorithm reduces inappropriate shocks caused by implantable cardioverter-defibrillator lead fractures: a prospective study. Circulation 122: pp. 1449-55 itle="It opens in new window">CrossRef
  29. Hauser, RG, Hayes, DL (2009) Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm 6: pp. 605-10 itle="It opens in new window">CrossRef
  30. Johansen, JB, J酶rgensen, OD, M酶ller, M, Arnsbo, P, Mortensen, PT, Nielsen, JC (2011) Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J 32: pp. 991-8 itle="It opens in new window">CrossRef
  31. Gould, PA, Krahn, AD (2006) Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 295: pp. 1907-11 itle="It opens in new window">CrossRef
  32. Costea, A, Rardon, DP, Padanilam, BJ, Fogel, RI, Prystowsky, EN (2008) Complications associated with generator replacement in response to device advisories. J Cardiovasc Electrophysiol 19: pp. 266-9 itle="It opens in new window">CrossRef
  33. Poole, JE, Gleva, MJ, Mela, T (2010) Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation 122: pp. 1553-61 itle="It opens in new window">CrossRef
  34. Eckstein, J, Koller, MT, Zabel, M (2008) Necessity for surgical revision of defibrillator leads implanted long-term: causes and management. Circulation 117: pp. 2727-33 itle="It opens in new window">CrossRef
  35. Olde Nordkamp, LRA, Knops, RE, Bardy, GH (2012) Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy.. Am Heart J 163: pp. 753-60 itle="It opens in new window">CrossRef
  36. Wilkoff, BL, Love, CJ, Byrd, CL (2009) Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm 6: pp. 1085-104 itle="It opens in new window">CrossRef
  37. Maytin, M, Wilkoff, BL, Brunner, M (2014) Multicenter experience with extraction of the Riata/Riata ST ICD lead. Heart Rhythm 11: pp. 1613-8 itle="It opens in new window">CrossRef
  38. Bohm, A, Pinter, A, Duray, G (2001) Complications due to abandoned noninfected pacemaker leads. Pacing Clin Electrophysiol 24: pp. 1721-4 itle="It opens in new window">CrossRef
  39. Suga, C, Hayes, D, Hyberger, L, Lloyd, M (2000) Is there an adverse outcome from abandoned pacing leads?. J Interv Card Electrophysiol 4: pp. 493-9 itle="It opens in new window">CrossRef
  40. Glikson, M, Suleiman, M, Luria, DM (2009) Do abandoned leads pose risk to implantable cardioverter-defibrillator patients?. Heart Rhythm 6: pp. 65-8 itle="It opens in new window">CrossRef
  41. Bode, F, Himmel, F, Reppel, M, Mortensen, K, Schunkert, H, Wiegand, UKH (2012) Should all dysfunctional high-voltage leads be extracted? Results of a single-centre long-term registry. Europace 14: pp. 1764-70 itle="It opens in new window">CrossRef
  42. Amelot, M, Foucault, A, Scanu, P (2011) Comparison of outcomes in patients with abandoned versus extracted implantable cardioverter defibrillator leads. Arch Cardiovasc Dis 104: pp. 572-7 itle="It opens in new window">CrossRef
  43. Bracke, F, Meijer, A, Gelder, LM (2003) Symptomatic occlusion of the access vein after pacemaker or ICD lead extraction. Heart 89: pp. 1348-9 itle="It opens in new window">CrossRef
  44. Cock, C, Vinkers, M, Campe, L, Verhorst, P, Visser, C (2000) Long-term outcome of patients with multiple (>鈥塷r鈥?鈥?) noninfected transvenous leads: a clinical and echocardiographic study. Pacing Clin Electrophysiol 23: pp. 423-6 itle="It opens in new window">CrossRef
  45. Ricciardi, D, La Meir, M, Asmundis, C, Brugada, P (2013) A case of in vivo thrombogenicity of an externalized Riata ST lead. Europace 15: pp. 428 itle="It opens in new window">CrossRef
  46. Goyal, SK, Ellis, CR, Rottman, JN, Whalen, SP (2013) Lead thrombi associated with externalized cables on Riata ICD leads: a case series. J Cardiovasc Electrophysiol 24: pp. 1047-50 itle="It opens in new window">CrossRef
  47. Pfeiffer, D, Jung, W, Fehske, W (1994) Complications of pacemaker-defibrillator devices: diagnosis and management. Am Heart J 127: pp. 1073-80 itle="It opens in new window">CrossRef
  48. Venkataraman, G, Hayes, DL, Strickberger, SA (2009) Does the risk-benefit analysis favor the extraction of failed, sterile pacemaker and defibrillator leads?. J Cardiovasc Electrophysiol 20: pp. 1413-5 itle="It opens in new window">CrossRef
  49. Mehrotra, AK, Knight, BP, Smelley, MP (2011) Medtronic Sprint Fidelis lead recall: determining the initial 5-year management cost to Medicare. Heart Rhythm 8: pp. 1192-7 itle="It opens in new window">CrossRef
  50. Maytin, M, Love, CJ, Fischer, A (2010) Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. J Am Coll Cardiol 56: pp. 646-50 itle="It opens in new window">CrossRef
  51. Parkash, R, Crystal, E, Bashir, J (2010) Complications associated with revision of Sprint Fidelis leads: report from the Canadian Heart Rhythm Society Device Advisory Committee. Circulation 121: pp. 2384-7 itle="It opens in new window">CrossRef
  52. Patel, D, Adelstein, E, Nemec, J (2012) Extraction of defibrillator leads recalled for cable externalization and failure. J Interv Card Electrophysiol 34: pp. 105-13 itle="It opens in new window">CrossRef
  53. Brunner, MP, Cronin, EM, Jacob, J (2013) Transvenous extraction of implantable cardioverter-defibrillator leads under advisory鈥揳 comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads. Heart Rhythm 10: pp. 1444-50 itle="It opens in new window">CrossRef
  54. Brunner, MP, Cronin, EM, Duarte, VE (2014) Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions. Heart Rhythm 11: pp. 799-805 itle="It opens in new window">CrossRef
  
• 刊物主题：Medicine/Public Health, general;
• 出版者：Bohn Stafleu van Loghum
• ISSN：1876-6250

文摘

Defibrillator lead advisories stir a lot of emotions, both with patients and physicians, and this may influence lead management. We reviewed the literature for a more evidence-based approach to this issue. From the complications of two of the current advisory leads, the Medtronic Sprint Fidelis and St. Jude Riata leads, and the consequences of possible interventions, we can conclude that a restrained approach to premature replacement is appropriate. It may be opportune to replace the leads during a scheduled generator replacement in case of a higher electrical failure rate, in order to prevent future premature interventions. We found no support to extract non-functional advisory leads. In contrast, extraction is often more demanding than anticipated, and the risk substantially exceeds that of simply abandoning the leads.