Guidelines for Managing Pacemaker and Implantable Defibrillator Advisories

Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy

Volumn , Issue , 2011, Pages 1028-1039

  Kramer, Daniel B ^a   Maisel, William H ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84857543864     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-1-4377-1616-0.00034-5     Document Type: Chapter

References (102)

1. Maisel WH Cardiovascular device development: lessons learned from pacemaker and implantable cardioverter-defibrillator therapy. Am J Ther 2005, 12:183-185.
2. Mirowski M, Reid PR, Mower MM, et al. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med 1980, 303:322-324.
3. Maisel WH Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. JAMA 2005, 294:955-958.
4. Maisel WH, Hauser R Proceedings of the ICD Lead Performance Conference. Heart Rhythm 2008, 5:1331-1338.
5. Carlson MD, Wilcoff BL, Maisel WH, et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines. Heart Rhythm 2006, 3:1250-1273.
6. Maisel WH, Hauser RG, Hammill SC, et al. Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines. Heart Rhythm 2009, 6:869-885.
7. Maisel WH, Sweeney MO, Stevenson WG, et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001, 286:793-799.
8. Song SL Bilitch Report: performance of implantable cardiac rhythm management devices. Pacing Clin Electrophysiol 1994, 17:692-708.
9. Kawanishi DT, Song S, Furman S, et al. Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: formal monitoring of performance is still needed. Bilitch Registry and STIMAREC. Pacing Clin Electrophysiol 1996, 19:1819-1823.
10. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA 2006, 295:1901-1906.
11. Maisel WH Pacemaker and ICD generator reliability: meta-analysis of device registries. JAMA 2006, 295:1929-1934.
12. Maisel WH, Kramer DB ICD lead performance. Circulation 2008, 117:2721-2723.
13. Biotronik Cardiac Rhythm Management Product Performance Report, January 2010 http://www.biotronik.com/sixcms/media.php/162/BIOTRONIK%20Product%20Performance%20Report%20January%202010.pdf.
14. Boston Scientific CRM Product Performance Report 2010 Q2 Summary Edition. http://www.bostonscientific.com/templatedata/imports/HTML/CRM/Product_Performance:Resource:Center/report_archives/q2_10_ppr.pdf.
15. Medtronic Cardiac Rhythm Disease Management Product Performance Report 2010 ed 1, issue 62. http://www.medtronic.com/crm/performance/downloads/mdt-prod-performance-2010-1-en.pdf.
16. Sorin Group Cardiac Rhythm Management Product Performance Report. November 2009 http://www.sorin-crm.com/uploads/Media/SorinCRM_PPR-worldwide.pdf.
17. St. Jude Medical Cardiac Rhythm Management Product Performance Report. May 2010 http://www.sjmprofessional.com/Resources/reference-guides/~/media/Cardiac%20Pro/Reference%20and%20Resources/Reference%20Guides/Product_Performance:Report_CRM_May2010.ashx.
18. Maisel WH Semper Fidelis: consumer protection for patients with implanted medical devices. N Engl J Med 2008, 358:985-987.
19. Danish Pacemaker and ICD Register 2007 Annual Report. Odense, Denmark http://www.pacemaker.dk.
20. Eckstein J, Koller MT, Zabel M, et al. Necessity for surgical revision of defibrillator leads implanted long-term: causes and management. Circulation 2008, 117:2727-2733.
21. Aass H, Ilvento J Short and medium time experience with a tined, multilumen steroid eluting defibrillation lead. J Interv Card Electrophysiol 2002, 6:81-86.
22. Kron J, Herre J, Renfroe EG, et al. Lead- and device-related complications in the Antiarrhythmics versus Implantable Defibrillators Trial. Am Heart J 2001, 141:92-98.
23. Dorwarth U, Frey B, Gugas M, et al. Transvenous defibrillation leads: high incidence of failure during long-term follow-up. J Cardiovasc Electrophysiol 2003, 14:38-43.
24. Ellenbogen KA, Wood MA, Shepard RK, et al. Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications. J Am Coll Cardiol 2003, 41:73-80.
25. Luria D, Glikson M, Brady PA, et al. Predictors and mode of detection of transvenous lead malfunction in implantable defibrillators. Am J Cardiol 2001, 87:901-904.
26. Kleemann T, Becker T, Doenges K, et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation 2007, 115:2474-2480.
27. Kitamura S, Satomi K, Kurita T, et al. Long-term follow-up of transvenous defibrillation leads: high incidence of fracture in coaxial polyurethane lead. Circ J 2006, 70:273-277.
28. Hauser RG, Cannom D, Hayes DL, et al. Long-term structural failure of coaxial polyurethane implantable cardioverter defibrillator leads. Pacing Clin Electrophysiol 2002, 25:879-882.
29. Borleffs CJW, Van Erven L, Van Bommel RJ, et al. Risk of failure of transvenous implantable cardioverter-defibrillator leads. Circ Arrhythm Electrophysiol 2009, 2:411-416.
30. Corbisiero R, Armbruster R Does size really matter? A comparison of the Riata lead family based on size and its relation to performance. Pacing Clin Electrophysiol 2008, 31:722-726.
31. Koplan BA, Weiner S, Gilligan D, et al. Clinical and electrical performance of expanded polytetrafluoroethylene-covered defibrillator leads in comparison to traditional leads. Pacing Clin Electrophysiol 2008, 31:47-55.
32. Kupper B, Yee R, O'Hara G, et al. Do small (6.6 Fr.) active and passive fixation defibrillation leads perform as well as larger sized leads? A multi-centre analysis. Europace 2007, 9:657-661.
33. Luria D, Bar-Lev D, Gurevitz O, et al. Long-term performance of screw-in atrial pacing leads: a randomized comparison of J-shaped and straight leads. Pacing Clin Electrophysiol 2005, 28:898-902.
34. Maisel WH Transvenous implantable cardioverter leads-the weakest link. Circulation 2007, 115:2461-2463.
35. Maisel WH Medical device regulation: an introduction for the practicing physician. Ann Intern Med 2004, 296-302.
36. US Food and Drug Administration Center for Devices and Radiological Health Annual Reports http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm109733.htm.
37. Kirkpatrick JN, Ghani SN, Burke MC, Knight BP Postmortem interrogation and retrieval of implantable pacemakers and defibrillators: a survey of morticians and patients. J Cardiovasc Electrophysiol 2007, 18:478-482.
38. US Food and Drug Administration MAUDE: Manufacturer and User Facility Device Experience http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
39. Shah JS, Maisel WH Recalls and safety alerts affecting automated external defibrillators. JAMA 2006, 296:655-660.
40. Hauser RG, Kallinen LM, Almquist AK, et al. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2007, 4:892-896.
41. Maisel WH Implantable cardioverter-defibrillator lead complication: when is an outbreak out-of-bounds?. Heart Rhythm 2008, 5:1673-1674.
42. Padeletti L, Pappone C, Curnis A, et al. Product-experience reporting on endocardial defibrillation leads: a 4-year national perspective. Expert Rev Med Devices 2009, 6:383-388.
43. US Food and Drug Administration MedSun: Medical Product Safety http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm.
44. National Cardiovascular Data Registry ICD Registry https://www.ncdr.com/webncdr/ICD/Default_ssl.aspx.
45. Hammill SC, Kremers MS, Kadish AH, et al. Review of the ICD Registry's third year, expansion to include lead data and pediatric ICD procedures, and role for measuring performance. Heart Rhythm 2009, 6:1397-1401.
46. Duru F, Luechinger R, Scharf C, Brunckhorst C Automatic impedance monitoring and patient alert feature in implantable cardioverter defibrillators: being alert for the unexpected!. J Cardiovasc Electrophysiol 2005, 16:444-448.
47. US Food and Drug Administration Background and definitions http://www.fda.gov/Safety/Recalls/ucm165546.htm.
48. Basile EM, Lorell BH The Food and Drug Administration's regulation of risk disclosure for implantable cardioverter-defibrillators: has technology outpaced the agency's regulatory framework?. Food Drug Law J 2006, 61:251-272.
49. Tyers GF FDA recalls: how do pacemaker manufacturers compare?. Ann Thorac Surg 1989, 48:390-396.
50. Mahajan T, Dubin AM, Atkins DL, et al. Impact of manufacturer advisories and FDA recalls of implantable cardioverter-defibrillator generators in pediatric and congenital heart disease patients. J Cardiovasc Electrophysiol 2008, 19:1270-1274.
51. Maisel WH, Stevenson WG, Epstein LM Changing trends in pacemaker and implantable-cardioverter-defibrillator generator advisories. Pacing Clin Electrophysiol 2002, 25:1670-1678.
52. Levine PA, Stanton MS, Sims JJ High quality performance of pacemakers and implantable defibrillators. Pacing Clin Electrophsyiol 2002, 25:1667-1669.
53. Krahn AD, Simpson CS, Parkash R, et al. Formation of a national network for rapid response to device and lead advisories: the Canadian Heart Rhythm Society Device Advisory Committee. Can J Cardiol 2009, 25:403-405.
54. Stutts LA, Conti JB, Aranda JM, et al. Patient evaluation of ICD recall communication strategies: a vignette study. Pacing Clin Electrophysiol 2007, 30:1105-1111.
55. Wilkoff BL, Auricchio A, Brugada J, et al. HRS/EHRA Expert Consensus on the monitoring of cardiovascular implantable electronic devices (CIED): description of the techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm 2008, 5:907-925.
56. Maisel WH Physician management of pacemaker and implantable cardioverter-defibrillator advisories. Pacing Clin Electrophysiol 2004, 27:437-442.
57. Kay GN, Brinker JA, Kawanishi DT, et al. Risks of spontaneous injury and extraction of an active fixation pacemaker lead: report of the Accufix Multicenter Clinical Study and Worldwide Registry. Circulation 1999, 100:2344-2352.
58. Gould PA, Krahn AD Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 2006, 295:1907-1911.
59. Klug D, Balde M, Pavin D, et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation 2007, 116:1349-1355.
60. Priori SG, Auricchio A, Nisam S, Yong P To replace or not to replace: a systematic approach to respond to device advisories. J Cardiovasc Electrophysiol 2009, 20:164-170.
61. Amin MS, Ellenbogen KA Should recent defibrillator and lead advisories affect decisions to refer patients for implantable cardioverter-defibrillator therapy?. Curr Opin Cardiol 2010, 25:23-28.
62. Amin MS, Wood MA, Shepard RK, et al. Clinical judgment versus decision analysis for managing device advisories. Pacing Clin Electrophysiol 2008, 31:1236-1240.
63. Al-Khatib SM, Lucas FL, Jollis JG, et al. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. J Am Coll Cardiol 2005, 46:1536-1540.
64. Curtis JP, Luebbert JJ, Wang Y, et al. Association of physician certification and outcomes among patients receiving an implantable cardioverter-defibrillator. JAMA 2009, 301:1661-1670.
65. Amin MS, Matchar DB, Wood MA, Ellenbogen KA Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model. JAMA 2006, 296:412-420.
66. Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med 1997, 337:1576-1583.
67. Gold MR, Peters RW, Johnson JW, Shorofsky SR Complications associated with pectoral cardioverter-defibrillator implantation: comparison of subcutaneous and submuscular approaches. Worldwide Jewel Investigators. J Am Coll Cardiol 1996, 28:1278-1282.
68. Rosenqvist M, Beyer T, Block M, et al. Adverse events with transvenous implantable cardioverter-defibrillators: a prospective multicenter study. European 7219 Jewel ICD Investigators. Circulation 1998, 98:663-670.
69. Kiviniemi MS, Pirnes MA, Eranen HJ, et al. Complications related to permanent pacemaker therapy. Pacing Clin Electrophysiol 1999, 22:711-720.
70. Gould PA, Gula LJ, Champagne J, et al. Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up. Heart Rhythm 2008, 5:1675-1681.
71. Moore JW, Barrington W, Bazaz R, et al. Complications of replacing implantable devices in response to advisories: a single center experience. Int J Cardiol 2009, 134:42-46.
72. Costea A, Rardon DP, Padanilam BJ, et al. Complications associated with generator replacement in response to device advisories. J Cardiovasc Electrophysiol 2008, 19:266-269.
73. Anderson KP Estimates of implantable cardioverter-defibrillator complications: caveat emptor. Circulation 2009, 119:1069-1071.
74. Tompkins C, Cheng A, Dalal D, et al. Dual antiplatelet therapy and heparin "bridging" significantly increase the risk of bleeding complications after pacemaker or implantable cardioverter-defibrillator device implantation. J Am Coll Cardiol 2010, 55:2376-2382.
75. Thal S, Moukabary T, Boyella R, et al. The relationship between warfarin, aspirin, and clopidogrel continuation in the peri-procedural period and the incidence of hematoma formation after device implantation. Pacing Clin Electrophysiol 2010, 33:385-388.
76. Jamula E, Douketis JD, Schulman S Perioperative anticoagulation in patients having implantation of a cardiac pacemaker or defibrillator: a systematic review and practical management guide. J Thromb Haemost 2008, 6:1615-1621.
77. Kaluza GL, Joseph J, Lee JR, et al. Catastrophic outcomes of noncardiac surgery soon after coronary stenting. J Am Coll Cardiol 2000, 35:1288-1294.
78. Maytin M, Love CJ, Fischer A, et al. Multicenter experience with extraction of the Sprint Fidelis ICD lead. J Am Coll Cardiol 2010, 56.
79. Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm 2009, 6:1085-1104.
80. Byrd CL, Wilkoff BL, Love CJ, et al. Clinical study of the laser sheath for lead extraction: the total experience in the United States. Pacing Clin Electrophysiol 2002, 25:804-808.
81. Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol 2010, 55:579-586.
82. Jones SO, Eckart RE, Albert CM, Epstein LM Large, single-center, single-operator experience with transvenous lead extraction: outcomes and changing indications. Heart Rhythm 2008, 5:520-525.
83. Kennergren C, Bjurman C, Wiklund R, Gabel J A single-centre experience of over one thousand lead extractions. Europace 2009, 11:612-617.
84. Wilkoff BL, Byrd CL, Love CJ, et al. Trends in intravascular lead extraction: analysis of data from 5339 procedures in 10 years. XIth World Symposium on Cardiac Pacing and Electrophysiology, Berlin. Pacing Clin Electrophysiol 1999, 22(6 pt II):A207.
85. Bracke FA, Meijer A, Van Gelder B Learning curve characteristics of pacing lead extraction with a laser sheath. Pacing Clin Electrophysiol 1998, 21:2309-2313.
86. Smith HJ, Fearnot NE, Byrd CL, et al. Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database. Pacing Clin Electrophysiol 1994, 17:2016-2020.
87. Ghosh N, Yee R, Klein GJ, et al. Laser lead extraction: is there a learning curve?. Pacing Clin Electrophysiol 2005, 28:180-184.
88. Hauser RG, Katsiyiannis WT, Gornick CC, et al. Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction. Europace 2010, 12:395-401.
89. Glikson M, Suleiman M, Luria DM, et al. Do abandoned leads pose risk to implantable cardioverter-defibrillator patients?. Heart Rhythm 2009, 6:65-68.
90. Silvetti MS, Drago F Outcome of young patients with abandoned, nonfunctional endocardial leads. Pacing Clin Electrophysiol 2008, 31:473-479.
91. Kallinen LM, Hauser RG, Lee KW, et al. Failure of impedance monitoring to prevent adverse clinical events caused by fracture of a recalled high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2008, 5:775-779.
92. Simons EC, Feigenblum DY, Nemirovsky D, Simons GR Alert tones are frequently inaudible among patients with implantable cardioverter-defibrillators. Pacing Clin Electrophysiol 2009, 32:1272-1275.
93. Kallinen LM, Hauser RG, Tang C, et al. Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures. Heart Rhythm 2010, 7:1048-1055.
94. Swerdlow CD, Gunderson BD, Ousdigian KT, et al. Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads. Circulation 2008, 118:2122-2129.
95. Sears SF, Todaro JF, Lewis TS, et al. Examining the psychosocial impact of implantable cardioverter-defibrillators: a literature review. Clin Cardiol 1999, 22:481-489.
96. Sears SF, Matchett M, Conti JB Effective management of ICD patient psychosocial issues and patient critical events: clinical reviews. J Cardiovasc Electrophysiol 2009, 20:1297-1304.
97. Undavia M, Goldstein NE, Cohen P, et al. Impact of implantable cardioverter-defibrillator recalls on patients' anxiety, depression, and quality of life. Pacing Clin Electrophysiol 2008, 31:1411-1418.
98. Birnie DH, Sears SF, Green MS, et al. No long-term psychological morbidity living with an implantable cardioverter-defibrillator under advisory: the Medtronic Marquis experience. Europace 2009, 11:26-30.
99. Gibson DP, Kuntz KK, Levenson JL, Ellenbogen KA Decision-making, emotional distress, and quality of life in patients affected by the recall of their implantable cardioverter-defibrillator. Europace 2008, 10:540-544.
100. Cuculi F, Herzig W, Kobza R, Erne P Psychological distress in patients with ICD recall. Pacing Clin Electrophysiol 2006, 29:1261-1265.
101. Sears SF, Conti JB Psychological aspects of cardiac devices and recalls in patients with implantable cardioverter defibrillators. Am J Cardiol 2006, 98:565-567.
102. Fisher JD, Koulogiannis KP, Lewallen L, et al. The psychological impact of implantable cardioverter-defibrillator recalls and the durable positive effects of counseling. Pacing Clin Electrophysiol 2009, 32(8):1012-1016.