Subcutaneous chronic implantable defibrillation systems in humans

Journal of Interventional Cardiac Electrophysiology

Volumn 34, Issue 3, 2012, Pages 325-332

  Cappato, Riccardo ^a   Smith, Warren M ^b   Hood, Margaret A ^b   Crozier, Ian G ^c   Jordaens, Luc ^f   Spitzer, Stefan G ^e   Ardashev, Andrey V ^d   Boersma, Lucas ^g   Lupo, Pierpaolo ^a   Grace, Andrew A ^h   Bardy, Gust H ⁱ  

^a IRCCS POLICLINICO SAN DONATO   (Italy)

^b AUCKLAND CITY HOSPITAL   (New Zealand)

^c CHRISTCHURCH HOSPITAL   (New Zealand)

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

^e UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^f ERASMUS MEDICAL CENTER   (Netherlands)

^g ST ANTONIUS HOSPITAL   (Netherlands)

^h UNIVERSITY OF CAMBRIDGE   (United Kingdom)

ⁱ Seattle Institute for Cardiac Research   (United States)

Author keywords

Subcutaneous ICD; Sudden death; Ventricular fibrillation

Indexed keywords

DEFIBRILLATION; DEFIBRILLATOR; HEART RIGHT BUNDLE BRANCH BLOCK; HEART VENTRICLE ARRHYTHMIA; HEART VENTRICLE FIBRILLATION; HUMAN; OUTCOME ASSESSMENT; PACEMAKER FAILURE; PRIORITY JOURNAL; QRS COMPLEX; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SINUS TACHYCARDIA; STERNOTOMY; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; SURVIVAL; TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR;

DEFIBRILLATORS, IMPLANTABLE; ELECTRIC COUNTERSHOCK; ELECTROCARDIOGRAPHY; ELECTRODES, IMPLANTED; EQUIPMENT DESIGN; HUMANS; VENTRICULAR FIBRILLATION;

EID: 84864708270     PISSN: 1383875X     EISSN: 15728595     Source Type: Journal    
DOI: 10.1007/s10840-012-9665-6     Document Type: Review

References (39)

1. The AVID Investigators. (1997). A comparison of antiarrhythmicdrug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The New England Journal of Medicine, 337, 1576-1583.
2. Connolly, S. J., Hallstrom, A. P., Cappato, R., Schron, E. B., Kuck, K. H., Zipes, D. P., Greene, H. L., Boczor, S., Domanski, M., Follmann, D., Gent, M., & Roberts, R. S. (2000). on behalf of the investigators of the AVID, CASH and CIDS studies. Meta-Analysis of the implantable cardioverter defibrillator secondary prevention trials. European Heart Journal, 21, 2071-2078. (Pubitemid 32006221)
3. Moss, A. J., Hall, W. J., Cannom, D. S., Daubert, J. P., Higgins, S. L., Klein, H., Levine, J. H., Saksena, S., Waldo, A. L., Wilber, D., Brown, M. W., & Heo, M. (1996). for the Multicenter Automatic Defibrillator Implantation Trial Investigators. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. The New England Journal of Medicine, 335, 1933-1940. (Pubitemid 26428217)
4. Moss, A. J., Zareba,W.,Hall,W. J., Klein, H.,Wilber, D. J., Cannom, D. S.,Daubert, J. P.,Higgins, S. L., Brown, M.W.,&Andrews, M. L. (2002). for the Multicenter Automatic Difibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. The New England Journal of Medicine, 346, 877-883. (Pubitemid 34984635)
5. Bardy, G. H., Lee, K. L., Mark, D. B., Poole, J. E., Packer, D. L., Boineau, R., Domanski,M., Troutman, C., Anderson, J., Johnson, G., McNulty, S. E., Clapp-Channing, N., Davidson-Ray, L. D., Fraulo, E. S., Fishbein, D. P., & Luceri, R. M. (2005). Ip JH for the SCD-HeFT Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. The New England Journal of Medicine, 352, 225-237. (Pubitemid 40110811)
6. Mirowski, M., Reid, P. R., Mower, M. M., Walkins, L. Jr., Platia, E. V., Griffith, L. S., & Juanteguv, J. Ml. (1984). The automatic implantable cardioverter-defibrillator. Pacing and Clinical Electrophysiology, 7, 534-540. (Pubitemid 14078671)
7. Brodman, R., Fisher, J. D., Furman, S., Johnston, D. R., Kim, S. G., Matos, J. A., & Waspe, L. E. (1984). Implantation of automatic cardioverter defibrillators via median sternotomy. Pacing and Clinical Electrophysiology, 7, 1363-1369. (Pubitemid 15221239)
8. Echt, D. S., Armstrong, K., Schmidt, P., Oyer, P. E., Stinson, E. B., & Winckle, R. A. (1985). Clinical experience, complications, and survival in 70 patients with the automatic implantable cardioverter/defibrillator. Circulation, 71, 289-296. (Pubitemid 15157089)
9. Ellenbogen, K. A., Hellkamp, A. S., Wilkoff, B. L., Camunas, J. L., Love, J. C., Hadjis, T. A., Lee, K. L., & Lamas, G. A. (2003). Complications arising after implantation of DDD pacemakers: the MOST experience. The American Journal of Cardiology, 92(6), 740-741. (Pubitemid 37103036)
10. Parsonnet, V., Bernstein, A. D., & Lindsay, B. (1989). Pacemakerimplantation complication rates: an analysis of some contributing factors. Journal of the American College of Cardiology, 13, 917-921. (Pubitemid 19087915)
11. Tobin, K., Stewart, J., Westveer, D., & Frumin, H. (2000). Acute complications of permanent pacemaker implantation: their financial implications and relation to volume and operator experience. The American Journal of Cardiology, 85, 774-776. (Pubitemid 30133406)
12. Trigano, A. J., Taramasco, V., Paganelli, F., Gerard, R., & Levy, S. (1996). Incidence of perforation and other mechanical complications during dual active fixation. PACE, 19, 1828-1831. (Pubitemid 26398460)
13. Kai, H., Honma, T., & Imaizumi, T. (2001). Superior vena cava syndrome caused by multiple pacing leads. Heart, 86, 80. (Pubitemid 32977787)
14. Chua, J. D.,Wilkoff, B. L., Lee, I., Juratli, N., Longworth, D. L., & Gordon, S. M. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Ann Int Med, 133, 604-608.
15. Grimm,W., Flores, B. F.,&Marchlinski, F. E. (1993). Complications of implantable cardioverter defibrillator therapy: follow-up of 241 patients. PACE, 16, 218-222. (Pubitemid 23062033)
16. Pavia, S., & Wilkoff, B. (2001). The management of surgical complications of pacemakers and implantable cardioverter-defibrillators. Current Opinion in Cardiology, 16, 66-71. (Pubitemid 32060033)
17. Dorwarth, U., Frey, B., Dugas, M., Matis, T., Fiek, M., Schmoeckel, M., Remp, T., Durchlaub, I., Gerth, A., Steinbeck, G., & Hoffmann, E. (2003). Transvenous defibrillation leads: high incidence of failure during long-Term follow-up. Journal Cardiovasc Electrophys, 14, 38-43. (Pubitemid 36246720)
18. Ellenbogen, K. A., Wood, M. A., Shepard, R. K., Clemo, H. F., Vaughn, T., Holloman, K., Dow, M., Leffler, J., Abeyratne, A., & Verness, D. (2003). Detection and management of an implantable cardioverter defibrillator lead failure incidence and clinical implications. Journal of the American College of Cardiology, 41, 73-80. (Pubitemid 36044407)
19. Kleemann, T., Becker, T., Doenges, K., Vater, M., Senges, J., Schneider, S., Saggau, W., Weisse, U., & Seidl, K. (2007). Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of>10years. Circulation, 115, 2474-2480. (Pubitemid 46763220)
20. Tung, R., Zimetbaum, P., & Josephson, M. E. (2008). A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. JACC, 52, 1111-1121.
21. Maisel,W. H. (2007). Transvenous implantable cardioverter defibrillator leads: the weakest link. Circulation, 115, 2461-2463. (Pubitemid 46763216)
22. Kitamura, S., Satomi, K., Kurita, T., Shimizu, W., Suyama, K., Aihara, N., Niwaya, K., Kobayashi, J., & Kamakura, S. (2006). Long-Term follow-up of transvenous defibrillation leads: high incidence of fracture in coaxial polyurethane lead. Circulation Journal, 70, 273-277.
23. Lindsay BD. Task force on lead performance. Available at: http://www.hrsonline.org/News/taskforce-leadperformance.cfm?zbran did-3077&zidType-CH&zid-813428&zsubscriberId-751606938. Accessed March 30, 2008
24. Multicenter Registry of Pacemaker, ICD Pulse Generator, and Lead Failures. Available at: http://www.pacerandicdregistry.com/mhif/. Accessed March 30, 2008
25. Jones, G. K., et al. (1995). Mechanical complications after implantation of multiple-lead nonthoracotomy defibrillator systems: implications for management and future system design. American Heart Journal, 130, 327-333.
26. Bardy, G. H., et al. (1993). Implantable transvenous cardioverterdefibrillators. Circulation, 87, 1152-1168.
27. Kron, J. (2001). Lead-And device-related complications in the antiarrhythmics versus implantable defibrillators trial. American Heart Journal, 141, 92-98. (Pubitemid 32061317)
28. Maisel, W. H., & Kramer, D. B. (2008). Implantable cardioverterdefibrillator lead performance. Circulation, 117, 2721-2723.
29. Cappato, R., & Bardy, G. H. (2005). Sub-cutaneous electrical defibrillation in canines. Journal of the American College of Cardiology, 45 Suppl, 106A. Abstract.
30. Bardy, G., Smith,W. M., Hood, M. A., Crozier, I. G., Melton, I. C., Jordaens, L., Theuns, D., Park, R., Wright, D. J., Connelly, D. T., Fynn, S. P., Murgatroyd, F. D., Sperzel, J., Neuzner, J., Spitzer, S., Ardashev, A. V., Oduro, A., Boersma, L., Maass, A. H., Van Gelder, I. C., Wilde, A. A., van Dessel, P. F., Knops, R. E., Barr, C. S., Lupo, P. P., Cappato, R., & Grace, A. A. (2010). An entirely subcutaneous implantable cardioverter defibrillator. New Engl Journal of Medicine, 308, 23-31.
31. Epstein, A. E., DiMarco, J. P., Ellenbogen, K. A., Estes, N. A. M., Freedman, R. A., Gettes, L. S., Gillinov, A. M., Gregoratos, G., Hammill, S. C., Hayes, D. L., Hlatky, M. A., Newby, L. K., Page, R. L., Schoenfeld, M. H., Silka, M. J., Stevenson, L. W., & Sweeney, M. O. (2008). ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: executive summary. Heart Rhythm, 5, 935-955.
32. Gradaus, R., Hammel, D., Kotthoff, S., & Bocker, D. (2001). Nonthoracotomy implantable cardioverter defibrillator placement in children: use of subcutaneous array leads and abdominally placed implantable cardioverter defibrillator in children. Journal of Cardiovascular Electrophysiology, 12, 356-360. (Pubitemid 32225467)
33. Thogersen, A. M., Helvind, M., Jensen, T., Andersen, H., Jacobsen, J. R., & Chen, X. (2001). Implantable cardioverter defibrillator in a 4month old infant with cardiac arrest associated with a vascular heart tumor. PACE, 24, 1699-1700. (Pubitemid 33065534)
34. Alter, P., Waldhaus, S., Plachta, E., Moosdorf, R., & Grimm, W. (2005). Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing and Clinical Electrophysiology, 28, 926-932. (Pubitemid 43960867)
35. Khairy, P., Landzberg, M. J., Gatzoulis, M. A., Mercier, L. A., Fernandes, S. M., Côte, J. M., Lavoie, J. P., Fournier, A., Guerra, P. G., Frogoudaki, A., &Walsh, E. P. (2006). Dore A for the Epicardial Versus ENdocardial pacing and Thromboembolic events (EVENT) Investigators. Transvenous pacing leads and systemic thromboemboli in patients with intracardiac shunts: a multicenter study. Circulation, 113, 2391-2397. (Pubitemid 43948046)
36. Sohail, M. R., Uslan, D. Z., Khan, A. H., Friedman, P. A., Hayes, D. L., Wilson, W. R., Steckelberg, J. M., Stoner, S., & Baddour, L. M. (2007). Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. Journal of the American College of Cardiology, 49, 1851-1859. (Pubitemid 46661104)
37. Danik, S. B., Mansour, M., Singh, J., Reddy, V. Y., Ellinor, P. T., Milan, D., & Heist, K. (2007). 'Avila A, Ruskin JN, Mela T. Increased incidence of subacute lead perforation noted with one implantable cardioverter-defibrillator. Heart Rhythm, 4, 439-442. (Pubitemid 46610410)
38. Reynolds, M. R., Cohen, D. J., Kugelmass, A. D., Brown, P. P., Becker, E. R., Culler, S. D., & Simon, A. W. (2006). The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators. Journal of the American College of Cardiology, 47, 2493-2497. (Pubitemid 43866387)
39. Byrd, C. L., Wilkoff, B. L., Love, C. J., et al. (1999). Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. Pacing and Clinical Electrophysiology, 22, 1348-1357. (Pubitemid 29485035)