Outcome of advisory implantable cardioverter-defibrillator replacement: One-year follow-up

Heart Rhythm

Volumn 5, Issue 12, 2008, Pages 1675-1681

  Gould, Paul A ^a   Gula, Lorne J ^a   Champagne, Jean ^b   Healey, Jeffrey S ^c   Cameron, Doug ^d   Simpson, Christophers ^e   Thibault, Bernard ^f   Pinter, Arnold ^g   Tung, Stanley ^h   Sterns, Laurence ⁱ   Birnie, David ^j   Exner, Derek ^k   Parkash, Ratika ^l   Skanes, Allan C ^a   Yee, Raymond ^a   Klein, George J ^a   Krahn, Andrew D ^a  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b LAVAL UNIVERSITY   (Canada)

^c HAMILTON HEALTH SCIENCES   (Canada)

^d UNIVERSITY HEALTH NETWORK   (Canada)

^e QUEEN S UNIVERSITY   (Canada)

^f MONTREAL HEART INSTITUTE   (Canada)

^g ST MICHAEL'S HOSPITAL   (Canada)

^h ST PAUL S HOSPITAL   (Canada)

ⁱ Vancouver Island Health Authority (VIHA)   (Colombia)

^j UNIVERSITY OF OTTAWA HEART INSTITUTE   (Canada)

^k FOOTHILLS HOSPITAL   (Canada)

^l QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

more..

Author keywords

Advisory; Complications; Implantable cardioverter defibrillator; Infection; Risk factors

Indexed keywords

AGED; ARTICLE; CARDIOGENIC SHOCK; CASE CONTROL STUDY; COHORT ANALYSIS; COMPARATIVE STUDY; CONTROLLED STUDY; DEATH; DECISION MAKING; DEFIBRILLATOR; DEVICE INFECTION; FEMALE; FOLLOW UP; GENDER; GENERATOR; HEART INFARCTION; HEMATOMA; HUMAN; INSTITUTIONAL CARE; MALE; MULTIVARIATE ANALYSIS; OPERATOR; OUTCOME ASSESSMENT; PAIN; POPULATION; PRIORITY JOURNAL; REOPERATION; RISK FACTOR;

AGED; CANADA; DEFIBRILLATORS, IMPLANTABLE; ELECTRIC COUNTERSHOCK; EQUIPMENT FAILURE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INCIDENCE; MALE; POSTOPERATIVE COMPLICATIONS; PROSTHESIS IMPLANTATION; REOPERATION; RETROSPECTIVE STUDIES; RISK FACTORS; SURVIVAL RATE; TACHYCARDIA, VENTRICULAR; TIME FACTORS;

EID: 57249094409     PISSN: 15475271     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.hrthm.2008.09.020     Document Type: Article

References (23)

1. Gould P.A., and Krahn A.D. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 295 (2006) 1907-1911
2. Carlson M.D., Wilkoff B.L., Maisel W.H., et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm 3 (2006) 1250-1273
3. Kapa S., Hyberger L., Rea R.F., et al. Complication risk with pulse generator change: implications when reacting to a device advisory or recall. Pacing Clin Electrophysiol 30 (2007) 730-733
4. Costea A., Rardon D.P., Padanilam B.J., et al. Complications associated with generator replacement in response to device advisories. J Cardiovasc Electrophysiol 19 (2008) 266-269
5. 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 116 (2007) 1349-1355
6. Sohail M.R., Uslan D.Z., Khan A.H., et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 49 (2007) 1851-1859
7. Kallinen L.M., Hauser R.G., Lee K.W., 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 5 (2008) 775-779
8. Hauser R.G., Hayes D.L., Kallinen L.M., et al. Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study. Heart Rhythm 4 (2007) 154-160
9. 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 4 (2007) 892-896
10. Hauser R.G., Hayes D.L., Epstein A.E., et al. Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators. Heart Rhythm 3 (2006) 640-644
11. Hauser R.G., Hayes D.L., Almquist A.K., et al. Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress. Pacing Clin Electrophysiol 24 (2001) 1046-1054
12. Blanchard J.F., Ludwig S., Wajda A., et al. Incidence and prevalence of diabetes in Manitoba, 1986-1991. Diabetes Care 19 (1996) 807-811
13. Pauwels R.A., Buist A.S., Ma P., et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: National Heart, Lung, and Blood Institute and World Health Organization Global Initiative for Chronic Obstructive Lung Disease (GOLD): executive summary. Respir Care 46 (2001) 798-825
14. Tang A.S., Roberts R.S., Kerr C., et al. Relationship between pacemaker dependency and the effect of pacing mode on cardiovascular outcomes. Circulation 103 (2001) 3081-3085
15. Amin M.S., Matchar D.B., Wood M.A., et al. Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model. JAMA 296 (2006) 412-420
16. Gula L.J., Massel D., Krahn A.D., et al. Survival rates as a guide to implanted cardioverter-defibrillator replacement strategies for device recalls-adding statistical insight to clinical intuition. Am Heart J 153 (2007) 253-259
17. Consensus paper on the surveillance of surgical wound infections. The Society for Hospital Epidemiology of America; the Association for Practitioners in Infection Control; the Centers for Disease Control; the Surgical Infection Society. Infect Control Hosp Epidemiol 13 (1992) 599-605
18. Krahn A.D., Champagne J., Healey J.S., et al. Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Device Advisory Committee. Heart Rhythm 5 (2008) 639-642
19. Urgent Medical Device Information: Sprint Fidelis® lead patient management recommendations. http://www.medtronic.com/product-advisories/physician/sprint-fidelis/PROD-ADV-PHYS-OCT.htm
20. Wilkoff B.L., Byrd C.L., Love C.J., et al. Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol 33 (1999) 1671-1676
21. Current product advisories. http://www.bostonscientific-international.com/templatedata/imports/HTML/CRM/pprc_intl/current_advis.shtml
22. St. Jude Medical product performance report. http://www.sjm.com/globals/sitemap.aspx
23. Biotronik product perfromance report. http://www.biotronik.com/portal/4608