An entirely subcutaneous implantable cardioverter-defibrillator

New England Journal of Medicine

Volumn 363, Issue 1, 2010, Pages 36-44

  Bardy, Gust H ^a   Smith, Warren M ^b   Hood, Margaret A ^b   Crozier, Ian G ^c   Melton, Iain C ^c   Jordaens, Luc ^o   Theuns, Dominic ^o   Park, Robert E ^c   Wright, David J ^d   Connelly, Derek T ^e   Fynn, Simon P ^g   Murgatroyd, Francis D ^f   Sperzel, Johannes ^l   Neuzner, Jörg ⁿ   Spitzer, Stefan G ^m   Ardashev, Andrey V ^j   Oduro, Amo ^g   Boersma, Lucas ^p   Maass, Alexander H ^q   Van Gelder, Isabelle C ^q   Wilde, Arthur A ^r   Van Dessel, Pascal F ^r   Knops, Reinoud E ^r   Barr, Craig S ^h   Lupo, Pierpaolo ^k   Cappato, Riccardo ^k   Grace, Andrew A ^g,i   more..

^a Seattle Institute for Cardiac Research   (United States)

^b AUCKLAND CITY HOSPITAL   (New Zealand)

^c CHRISTCHURCH HOSPITAL   (New Zealand)

^d LIVERPOOL HEART AND CHEST HOSPITAL   (United Kingdom)

^e GLASGOW ROYAL INFIRMARY   (United Kingdom)

^f KING'S COLLEGE LONDON   (United Kingdom)

^g PAPWORTH HOSPITAL   (United Kingdom)

^h RUSSELLS HALL HOSPITAL   (United Kingdom)

ⁱ UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^j Ministry of Defense of the Russian Federation   (Russian Federation)

^k IRCCS POLICLINICO SAN DONATO   (Italy)

^l KERCKHOFF HEART CENTER   (Germany)

^m DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

ⁿ KLINIKUM KASSEL   (Germany)

^o ERASMUS MEDICAL CENTER   (Netherlands)

^p ST ANTONIUS HOSPITAL   (Netherlands)

^q UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^r ACADEMIC MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DEFIBRILLATOR; ELECTROCARDIOGRAM; ELECTRODE; FEMALE; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PULSE GENERATOR; THORAX RADIOGRAPHY;

EID: 77954191108     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa0909545     Document Type: Article

References (51)

1. The Antiarrhythmics versus Implant able 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; 337:1576-83.
2. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-83.
3. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:22537. [Erratum, N Engl J Med 2005;352:2146.]
4. Myerburg RJ. Implantable cardioverter-defibrillators after myocardial infarction. N Engl J Med 2008;359:2245-53.
5. Epstein AE. Benefits of the implantable cardioverter-defibrillator. J Am Coll Cardiol 2008;52:1122-7.
6. Grimm W, Menz V, Hoffmann J, et al. Complications of third-generation implantable cardioverter defibrillator therapy. Pacing Clin Electrophysiol 1999;22:206-11.
7. van Rooden CJ, Molhoek SG, Rosen daal FR, Schalij MJ, Meinders AE, Huisman MV. Incidence and risk factors of early venous thrombosis associated with permanent pacemaker leads. J Cardiovasc Electrophysiol 2004;15:1258-62.
8. Alter P, Waldhans S, Plachta E, Moos dorf R, Grimm W. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005;28:926-32.
9. Khairy P, Landzberg MJ, Gatzoulis MA, et al. Transvenous pacing leads and systemic thromboemboli in patients with intracardiac shunts: a multicenter study. Circulation 2006;113:2391-7.
10. Epstein AE, Baker JH II, Beau SL, Deering TF, Greenberg SM, Goldman DS. Performance of the St. Jude Medical Riata leads. Heart Rhythm 2009;6:204-9.
11. Jones DG, Stiles MK, Stewart JT, Arm strong GP. Ultrasound-guided venous access for permanent pacemaker leads. Pacing Clin Electrophysiol 2006;29:852-7.
12. Lelakowski J, Majewski J, Malecka B, Bednarek J, Stypula P, Szeglowski M. Retrospective analysis of reasons for failure of DDD pacemaker implantation in patients operated on between 1993 and 2005. Cardiol J 2007;14:155-9.
13. Sherrid MV, Daubert JP. Risks and challenges of implantable cardioverter-defibrillators in young adults. Prog Cardiovasc Dis 2008;51:237-63.
14. Sohail MR, Uslan DZ, Khan AH, et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 2007;49:1851-9.
15. Danik SB, Mansour M, Singh J, et al. Increased incidence of subacute lead perforation noted with one implantable cardioverter-defibrillator. Heart Rhythm 2007;4: 439-42. (Pubitemid 46610410)
16. Hauser RG, Almquist AK. Learning from our mistakes? Testing new ICD technology. N Engl J Med 2008;359:2517-9.
17. Hauser RG, Maron BJ. Lessons from the failure and recall of an implantable cardioverter-defibrillator. Circulation 2005; 112:2040-2.
18. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA 2006; 295:1901-6.
19. Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2007;4:892-6.
20. Dorwarth U, Frey B, Dugas M, et al. Transvenous defibrillation leads: high incidence of failure during long-term follow-up. J Cardiovasc Electrophysiol 2003;14: 38-43.
21. 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.
22. 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;115:2474-80.
23. Tung R, Zimetbaum P, Josephson ME. A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. J Am Coll Cardiol 2008;52:1111-21.
24. Byrd CL, Wilkoff BL, Love CJ, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996: U.S. Extraction Database, MED Institute. Pacing Clin Electrophysiol 1999; 22:1348-57.
25. Duray GZ, Schmitt J, Cicek-Hartvig S, Hohnloser SH, Israel CW. Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices. Europace 2009;11:297-302.
26. Eckstein J, Koller MT, Zabel M, et al. Necessity from surgical revision of defibrillator leads implanted long-term: causes and management. Circulation 2008;117: 2727-33.
27. Corrado A, Gasparini G, Raviele A. Lead malfunctions in implantable cardioverter defibrillators: where are we and where should we go? Europace 2009;11: 276-7.
28. Wilkoff BL. Lead failures: dealing with even less perfect. Heart Rhythm 2007;4: 897-9.
29. Maisel WH. Semper fidelis - consumer protection for patients with implanted medical devices. N Engl J Med 2008;358:985-7.
30. Cannom DS, Fisher J. The Fidelis recall: how much pressure can the ICD world bear? Pacing Clin Electrophysiol 2008;31: 1233-5.
31. Farwell D, Green MS, Lemery R, Gollob MH, Birnie DH. Accelerating risk of Fidelis lead fracture. Heart Rhythm 2008;5:1375-9.
32. Food and Drug Administration. Statement on Medtronic's voluntary market suspension of their Sprint Fidelis defibrillator leads. October 15, 2007. (Accessed April 27, 2010, at http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/2007/ucm109007.htm.)
33. Ellenbogen KA, Wood MA, Swerdlow CD. The Sprint Fidelis lead fracture story: what do we really know and where do we go from here? Heart Rhythm 2008;5:1380-1.
34. Gould PA, Gula LJ, Champagne J, et al. Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up. Heart Rhythm 2008;5:1675-81.
35. Maisel WH. Implantable cardioverter defibrillator lead complication: when is an outbreak out of bounds? Heart Rhythm 2008;5:1673-4.
36. Schoenfeld MH. The "natural" history of implantable defibrillators under advisory. Heart Rhythm 2008;5:1682-4.
37. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: executive summary. Heart Rhythm 2008;5:93455. [Erratum, Heart Rhythm 2009;6(1):e1.]
38. Armitage P, Berry G, Matthews JNS. Statistical methods in medical research. 4th ed. Malden, MA: Blackwell Science, 2002.
39. Winer BJ. Statistical principles in experimental design. 2nd ed. New York: McGrawHill, 1971.
40. Al-Khatib SM, Greiner MA, Peterson ED, Hernandez AF, Schulman KA, Curtis LH. Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 200-2005. Circ Arrhythmia Electrophysiol 2008;1:240-9.
41. Sacher F, Probst V, Iesaka Y, et al. Outcome after implantation of a cardioverter-defibrillator in patients with Brugada syndrome: a multicenter study. Circulation 2006;114:2317-24.
42. Friedman RA, Garson A Jr. Implantable defibrillators in children: from whence to shock. J Cardiovasc Electrophysiol 2001; 12:361-2.
43. Alexander ME, Cecchin F, Walsh EP, Triedman JK, Bevilacqua LM, Berul CI. Implications of implantable cardioverter defibrillator therapy in congenital heart disease and pediatrics. J Cardiovasc Electrophysiol 2004;15:72-6. (Pubitemid 38147223)
44. Rhee EK. Finite element modeling of novel ICD configurations in pediatric and congenital heart disease: validation of the MacGyver principle? Heart Rhythm 2008;5: 573-4.
45. Nanthakumar K. Trying to make "sense" of extra thoracic implantable defibrillator. Heart Rhythm 2007;5:35-6.
46. Jolley M, Stinstra J, Pieper S, et al. A computer modeling tool for comparing novel ICD electrode orientations in children and adults. Heart Rhythm 2008;5:565-72.
47. Gradaus R, Hammel D, Kotthoff S, Böcker D. Nonthoracotomy implantable cardioverter defibrillator placement in children: use of subcutaneous array leads and abdominally placed implantable cardioverter defibrillators in children. J Cardiovasc Electrophysiol 2001;12:356-60. (Pubitemid 32225467)
48. Lieberman R, Havel WJ, Rashba E, DeGroot PJ, Stromberg K, Shorofsky SR. Acute defibrillation performance of a novel, non-transvenous shock pathway in adult ICD indicated patients. Heart Rhythm 2008;5:28-34.
49. Burke MC, Coman JA, Cates AW, et al. Defibrillation energy requirements using a left anterior chest cutaneous to subcutaneous shocking vector: implications for a total subcutaneous implantable defibrillator. Heart Rhythm 2005;2:1332-8.
50. Cappato R, Bardy G. Sub-cutaneous electrical defibrillation in canines. J Am Coll Cardiol 2005;45:Suppl 1:106A. abstract.
51. Bardy GH, Cappato R, Smith WM, et al. The totally subcutaneous ICD system. Pacing Clin Electrophysiol 2002;25:Suppl:II-578. abstract.