The totally subcutaneous implantable defibrillator

Cardiology Clinics

Volumn 32, Issue 2, 2014, Pages 225-237

  Rhyner, John ^a   Knight, Bradley P ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Cardiac arrest; Clinical trial; S ICD; Subcutaneous implantable cardioverter defibrillator; Therapy

Indexed keywords

CLINICAL EFFECTIVENESS; ELECTRODE; HEART EJECTION FRACTION; HEART INFARCTION; HEART TRANSPLANTATION; HEART VENTRICLE FIBRILLATION; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; MYOCARDITIS; PATIENT SELECTION; PRIORITY JOURNAL; PULSE GENERATOR; QRS COMPLEX; R WAVE; REVIEW; SAFETY; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; SUDDEN CARDIAC DEATH; SUPRAVENTRICULAR TACHYCARDIA; T WAVE; TREATMENT INDICATION; DEATH, SUDDEN, CARDIAC; ELECTROCARDIOGRAPHY; PERIOPERATIVE PERIOD; PROCEDURES; PROSTHESIS; PROSTHESIS IMPLANTATION; SECONDARY PREVENTION; TREATMENT OUTCOME;

DEATH, SUDDEN, CARDIAC; DEFIBRILLATORS, IMPLANTABLE; ELECTROCARDIOGRAPHY; HUMANS; PATIENT SELECTION; PERIOPERATIVE CARE; PROSTHESIS DESIGN; PROSTHESIS IMPLANTATION; SECONDARY PREVENTION; TREATMENT OUTCOME;

EID: 84899674138     PISSN: 07338651     EISSN: 15582264     Source Type: Journal    
DOI: 10.1016/j.ccl.2013.12.001     Document Type: Review

References (65)

1. Smith T.W., Cain M.E. Sudden cardiac death: epidemiologic and financial worldwide perspective. JInterv Card Electrophysiol 2006, 17(3):199-203.
2. Bardy G.H., Lee K.L., Mark D.B., et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. NEngl J Med 2005, 352(3):225-237.
3. Moss A.J., Zareba W., Hall W.J., et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. NEngl J Med 2002, 346(12):877-883.
4. Moss A.J., Hall W.J., Cannom D.S., et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. NEngl J Med 1996, 335(26):1933-1940.
5. Buxton A.E., Lee K.L., Fisher J.D., et al. Arandomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. NEngl J Med 1999, 341(25):1882-1890.
6. Anvari A., Stix G., Grabenwoger M., et al. Comparison of three cardioverter defibrillator implantation techniques: initial results with transvenous pectoral implantation. Pacing Clin Electrophysiol 1996, 19(7):1061-1069.
7. Saksena S. Defibrillation thresholds and perioperative mortality associated with endocardial and epicardial defibrillation lead systems. ThePCD investigators and participating institutions. Pacing Clin Electrophysiol 1993, 16(1 Pt 2):202-207.
8. Curtis J.P., Luebbert J.J., Wang Y., et al. Association ofphysician certification and outcomes among patients receiving an implantable cardioverter-defibrillator. JAMA 2009, 301(16):1661-1670.
9. Kleemann T., Becker T., Doenges K., et al. Annual rate of transvenous defibrillation lead defects inimplantable cardioverter-defibrillators over a period of>10 years. Circulation 2007, 115(19):2474-2480.
10. Alter P., Waldhans S., Plachta E., et al. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005, 28(9):926-932.
11. Grimm W., Menz V., Hoffmann J., et al. Complications of third-generation implantable cardioverter defibrillator therapy. Pacing Clin Electrophysiol 1999, 22(1Pt 2):206-211.
12. van Rooden C.J., Molhoek S.G., Rosendaal F.R., et al. Incidence and risk factors of early venous thrombosis associated with permanent pacemaker leads. JCardiovasc Electrophysiol 2004, 15(11):1258-1262.
13. Epstein A.E., Baker J.H., Beau S.L., et al. Performance of the St. Jude Medical Riata leads. Heart Rhythm 2009, 6(2):204-209.
14. Khairy P., Landzberg M.J., Gatzoulis M.A., et al. Transvenous pacing leads and systemic thromboemboli in patients with intracardiac shunts: a multicenter study. Circulation 2006, 113(20):2391-2397.
15. Gold M.R., Peters R.W., Johnson J.W., et al. Complications associated with pectoral implantation ofcardioverter defibrillators. World-Wide Jewel Investigators. Pacing Clin Electrophysiol 1997, 20(1 Pt 2):208-211.
16. Kron J., Herre J., Renfroe E.G., et al. Lead- and device-related complications in the antiarrhythmics versus implantable defibrillators trial. Am Heart J 2001, 141(1):92-98.
17. Dorwarth U., Frey B., Dugas M., et al. Transvenous defibrillation leads: high incidence of failure during long-term follow-up. JCardiovasc Electrophysiol 2003, 14(1):38-43.
18. Ellenbogen K.A., Wood M.A., Shepard R.K., et al. Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications. JAm Coll Cardiol 2003, 41(1):73-80.
19. Tung R., Zimetbaum P., Josephson M.E. Acriticalappraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. JAm Coll Cardiol 2008, 52(14):1111-1121.
20. Hauser R.G., Kallinen L.M., Almquist A.K., et al. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2007, 4(7):892-896.
21. Danik S.B., Mansour M., Singh J., et al. Increased incidence of subacute lead perforation noted with one implantable cardioverter-defibrillator. Heart Rhythm 2007, 4(4):439-442.
22. Hauser R.G., Almquist A.K. Learning from our mistakes? Testing new ICD technology. NEngl J Med 2008, 359(24):2517-2519.
23. Hauser R.G., Maron B.J. Lessons from the failure and recall of an implantable cardioverter-defibrillator. Circulation 2005, 112(13):2040-2042.
24. Sohail M.R., Uslan D.Z., Khan A.H., et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. JAm Coll Cardiol 2007, 49(18):1851-1859.
25. Maisel W.H., Moynahan M., Zuckerman B.D., et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA 2006, 295(16):1901-1906.
26. Lelakowski J., Majewski J., Malecka B., et al. Retrospective analysis of reasons for failure of DDD pacemaker implantation in patients operated on between 1993 and 2005. Cardiol J 2007, 14(2):155-159.
27. Sherrid M.V., Daubert J.P. Risks and challenges of implantable cardioverter-defibrillators in young adults. Prog Cardiovasc Dis 2008, 51(3):237-263.
28. Eckstein J., Koller M.T., Zabel M., et al. Necessity for surgical revision of defibrillator leads implanted long-term: causes and management. Circulation 2008, 117(21):2727-2733.
29. Schoenfeld M.H. The "natural" history of implantable defibrillators under advisory. Heart Rhythm 2008, 5(12):1682-1684.
30. Maisel W.H. Implantable cardioverter-defibrillator lead complication: when is an outbreak out of bounds?. Heart Rhythm 2008, 5(12):1673-1674.
31. Gould P.A., Gula L.J., Champagne J., et al. Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up. Heart Rhythm 2008, 5(12):1675-1681.
32. Ellenbogen K.A., Wood M.A., Swerdlow C.D. The Sprint Fidelis lead fracture story: what do we really know and where do we go from here?. Heart Rhythm 2008, 5(10):1380-1381.
33. Farwell D., Green M.S., Lemery R., et al. Accelerating risk of Fidelis lead fracture. Heart Rhythm 2008, 5(10):1375-1379.
34. Cannom D.S., Fisher J. The Fidelis recall: how much pressure can the ICD world bear?. Pacing Clin Electrophysiol 2008, 31(10):1233-1235.
35. Maisel W.H. Semper fidelis-consumer protection for patients with implanted medical devices. NEngl J Med 2008, 358(10):985-987.
36. Wilkoff B.L. Lead failures: dealing with even less perfect. Heart Rhythm 2007, 4(7):897-899.
37. Corrado A., Gasparini G., Raviele A. Lead malfunctions in implantable cardioverter defibrillators: where are we and where should we go?. Europace 2009, 11(3):276-277.
38. Duray G.Z., Schmitt J., Cicek-Hartvig S., et al. Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices. Europace 2009, 11(3):297-302.
39. Byrd C.L., Wilkoff B.L., Love C.J., et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. Pacing Clin Electrophysiol 1999, 22(9):1348-1357.
40. Lerman B.B., Deale O.C. Relation between transcardiac and transthoracic current during defibrillation in humans. Circ Res 1990, 67(6):1420-1426.
41. Walcott G.P., Killingsworth C.R., Ideker R.E. Do clinically relevant transthoracic defibrillation energies cause myocardial damage and dysfunction?. Resuscitation 2003, 59(1):59-70.
42. Crozier I. The subcutaneous defibrillator will replace the transvenous defibrillator. JInterv Card Electrophysiol 2011, 32(1):73-77.
43. Daubert J.P., Zareba W., Cannom D.S., et al. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. JAm Coll Cardiol 2008, 51(14):1357-1365.
44. van Rees J.B., Borleffs C.J., de Bie M.K., et al. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. JAm Coll Cardiol 2011, 57(5):556-562.
45. Dorian P., Hohnloser S.H., Thorpe K.E., et al. Mechanisms underlying the lack of effect of implantable cardioverter-defibrillator therapy on mortality in high-risk patients with recent myocardial infarction: insights from the Defibrillation in Acute Myocardial Infarction Trial (DINAMIT). Circulation 2010, 122(25):2645-2652.
46. Poole J.E., Johnson G.W., Hellkamp A.S., et al. Prognostic importance of defibrillator shocks in patients with heart failure. NEngl J Med 2008, 359(10):1009-1017.
47. Schuder J.C., Stoeckle H., Gold J.H., et al. Experimental ventricular defibrillation with an automatic and completely implanted system. Trans Am Soc Artif Intern Organs 1970, 16:207-212.
48. Burke M.C., Coman J.A., Cates A.W., 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(12):1332-1338.
49. Gold M.R., Theuns D.A., Knight B.P., et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. JCardiovasc Electrophysiol 2012, 23(4):359-366.
50. Bardy G.H., Smith W.M., Hood M.A., et al. An entirely subcutaneous implantable cardioverter-defibrillator. NEngl J Med 2010, 363(1):36-44.
51. S-ICD system commercial implants analysis, Q2 2012. Data on file. San Clemente (CA): Cameron Health, Inc.
52. Daliento L., Turrini P., Nava A., et al. Arrhythmogenic right ventricular cardiomyopathy in young versus adult patients: similarities and differences. JAm Coll Cardiol 1995, 25(3):655-664.
53. Probst V., Denjoy I., Meregalli P.G., et al. Clinical aspects and prognosis of Brugada syndrome in children. Circulation 2007, 115(15):2042-2048.
54. Priori S.G., Schwartz P.J., Napolitano C., et al. Risk stratification in the long-QT syndrome. NEngl J Med 2003, 348(19):1866-1874.
55. Colan S.D., Lipshultz S.E., Lowe A.M., et al. Epidemiology and cause-specific outcome of hypertrophic cardiomyopathy in children: findings from the Pediatric Cardiomyopathy Registry. Circulation 2007, 115(6):773-781.
56. Alexander M.E., Cecchin F., Walsh E.P., et al. Implications of implantable cardioverter defibrillator therapy in congenital heart disease and pediatrics. JCardiovasc Electrophysiol 2004, 15(1):72-76.
57. Berul C.I., Van Hare G.F., Kertesz N.J., et al. Resultsofa multicenter retrospective implantable cardioverter-defibrillator registry of pediatric and congenital heart disease patients. JAm Coll Cardiol 2008, 51(17):1685-1691.
58. Berul C.I. Defibrillator indications and implantation in young children. Heart Rhythm 2008, 5(12):1755-1757.
59. Sweeney M.O., Sherfesee L., DeGroot P.J., et al. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm 2010, 7(3):353-360.
60. de Bie M.K., Thijssen J., van Rees J.B., et al. Suitability for subcutaneous defibrillator implantation: results based on data from routine clinical practice. Heart 2013, 99(14):1018-1023.
61. Lupo P.P., Pelissero G., Ali H., et al. Development ofan entirely subcutaneous implantable cardioverter-defibrillator. Prog Cardiovasc Dis 2012, 54(6):493-497.
62. Jarman J.W., Lascelles K., Wong T., et al. Clinical experience of entirely subcutaneous implantable cardioverter-defibrillators in children and adults: cause for caution. Eur Heart J 2012, 33(11):1351-1359.
63. Olde Nordkamp L.R., Dabiri Abkenari L., Boersma L.V., et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. JAm Coll Cardiol 2012, 60(19):1933-1939.
64. Köbe J., Reinke F., Meyer C., et al. Implantation andfollow-up of totallysubcutaneous versus conventional implantable cardioverter-defibrillators: a multicenter case-control study. Heart Rhythm 2013, 10(1):29-36.
65. Weiss R., Knight B.P., Gold M.R., et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation 2013, 128(9):944-953.