Update on small-diameter implantable cardioverter-defibrillator leads performance

PACE - Pacing and Clinical Electrophysiology

Volumn 35, Issue 6, 2012, Pages 652-658

  Van Rees, Johannes B ^a   Van Welsenes, Guido H ^a   Borleffs, C Jan Willem ^a   Thijssen, Joep ^a   Van Der Velde, Enno T ^a   Van Der Wall, Ernst E ^a   Van Erven, Lieselot ^a   Schalij, Martin J ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Cardiac lead perforation; Implantable cardioverter defibrillator; Lead failure; Riata; Sprint fidelis

Indexed keywords

ADULT; ARTICLE; COHORT ANALYSIS; CONFIDENCE INTERVAL; CONTROLLED STUDY; DEFIBRILLATOR; FEMALE; FOLLOW UP; HAZARD RATIO; HEART VENTRICLE PERFORATION; HUMAN; MAJOR CLINICAL STUDY; MALE; NETHERLANDS; PERFORMANCE; QUALITY CONTROL;

ADULT; AGED; AGED, 80 AND OVER; DEFIBRILLATORS, IMPLANTABLE; ELECTRODES, IMPLANTED; EQUIPMENT FAILURE; FEMALE; HEART INJURIES; HUMANS; MALE; MIDDLE AGED; NETHERLANDS; POSTOPERATIVE COMPLICATIONS; PREVALENCE; RISK FACTORS;

EID: 84861960596     PISSN: 01478389     EISSN: 15408159     Source Type: Journal    
DOI: 10.1111/j.1540-8159.2011.03338.x     Document Type: Article

References (26)

1. Roelke M, O'Nunain SS, Osswald S, Garan H, Harthorne JW, Ruskin JN. Subclavian crush syndrome complicating transvenous cardioverter defibrillator systems. Pacing Clin Electrophysiol 1995; 18:973-979.
2. 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; 4:892-896. (Pubitemid 46959208)
3. Farwell D, Green MS, Lemery R, Gollob MH, Birnie DH. Accelerating risk of Fidelis lead fracture. Heart Rhythm 2008; 5:1375-1379.
4. Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm 2009; 6:605-610.
5. Danik SB, Mansour M, Heist EK, Ellinor P, Milan D, Singh J, Das S, et al. Timing of delayed perforation with the St. Jude Riata lead: A single-center experience and a review of the literature. Heart Rhythm 2008; 5:1667-1672.
6. Ellis CR, Rottman JN. Increased rate of subacute lead complications with small-caliber implantable cardioverter-defibrillator leads. Heart Rhythm 2009; 6:619-624.
7. Borleffs CJ, van Erven L, van Bommel RJ, van der Velde ET, van der Wall EE, Bax JJ, Rosendaal FR, et al. Risk of failure of transvenous implantable cardioverter-defibrillator leads. Circ Arrhythm Electrophysiol 2009; 2:411-416.
8. Groves R. Sprint Fidelis Lead Performance Update (Models 6949, 6948, 6931, 6930). Minneapolis, Medtronic, May 7, 2008. Available at: http://www.medtronic.com/ product-advisories/ physician/sprint-fidelis/index.htm (accessed March 9, 2011).
9. Groves R. Urgent medical device information: Sprint Fidelis lead patient management recommendations. Minneapolis, Medtronic, October 15, 2007. Available at: http://www.medtronic.com/ product-advisories/physician/sprint-fidelis/PROD- ADV-PHYS-OCT (accessed March 9, 2011).
10. Chester KM. Important product information: St. Jude Medical Riata and Riata ST Silicone Enodocarial Leads. Minneapolis, St. Jude Medical, December 15, 2010. Available at: http://www. sjmprofessional.com/Resources/communications/ important-information- about-riata-and-riata-st-silicone-endocardial-leads.aspx (accessed March 9, 2011).
11. van Rees JB, Borleffs CJ, Bax JJ, Nagtegaal EM, van der Velde ET, van Erven L, Schalij MJ. Implementation of lead safety recommendations. Pacing Clin Electrophysiol 2010; 33:431-436.
12. Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, et al. ACC/AHA/ESC 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006; 114:e385-e484.
13. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NAIII, Freedman RA, Gettes LS, Gillinov AM, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): Developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation 2008; 117:e350-e408. (Pubitemid 351771339)
14. Ha AC, Vezi BZ, Keren A, Alanazi H, GollobMH, Green MS, Lemery R, et al. Predictors of fracture risk of a small caliber implantable cardioverter defibrillator lead. Pacing Clin Electrophysiol 2010; 33:437-443.
15. Hauser RG, Maisel WH, Friedman PA, Kallinen LM, Mugglin AS, Kumar K, Hodge DO, et al. Longevity of Sprint Fidelis implantable cardioverter- defibrillator leads and risk factors for failure: Implications for patient management. Circulation 2011; 123:358-363.
16. Kallinen LM, Hauser RG, Tang C, Melby DP, Almquist AK, Katsiyiannis WT, Gornick CC. Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures. Heart Rhythm 2010; 7:1048-1055.
17. Faulknier BA, Traub DM, Aktas MK, Aguila A, Rosero S, Daubert JP, Hall B, et al. Time-dependent risk of Fidelis lead failure. Am J Cardiol 2010; 105:95-99.
18. Fischer A. How much scrutiny and stress can the Fidelis lead withstand? Circulation 2011; 123:353-354.
19. Samsel T. Sprint Fidelis Lead Patient Management Recommendations Update Models 6949, 6948, 6931, 6930. Minneapolis, Medtronic, April 2011. Available at:http://www. medtronic.com/product-advisories/physician/sprint-fidelis/ PHYSLETTER-2011-04 (accessed April 15, 2011).
20. Maytin M, Love CJ, Fischer A, Carrillo RG, Garisto JD, Bongiorni MG, Segreti L, et al. Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. J Am Coll Cardiol 2010; 56:646-650.
21. Parkash R, Crystal E, Bashir J, Simpson C, Birnie D, Sterns L, Exner D, et al. Complications associated with revision of Sprint Fidelis leads: Report from the Canadian Heart Rhythm Society Device Advisory Committee. Circulation 2010; 121:2384-2387.
22. Carlson MD, Freedman RA, Levine PA. Lead perforation: Incidence in registries. Pacing Clin Electrophysiol 2008; 31:13-15.
23. Lloyd MS, Shaik MN, Riley M, Langberg JJ. More late perforations with the Riata defibrillator lead from a high-volume center: An update on the numbers. Pacing Clin Electrophysiol 2008; 31:784-785. (Pubitemid 351749327)
24. Epstein AE, Baker JH, Beau SL, Deering TF, Greenberg SM, Goldman DS. Performance of the St. Jude Medical Riata leads. Heart Rhythm 2009; 6:204-209.
25. Porterfield JG, Porterfield LM, Kuck KH, Corbisiero R, Greenberg SM, Hindricks G, Wazni O, et al. Clinical performance of the St. Jude Medical Riata defibrillation lead in a large patient population. J Cardiovasc Electrophysiol 2010; 21:551-556.
26. Goette A, Cantu F, van Erven L, Geelen P, Halimi F, Merino JL, Morgan JM. Performance and survival of transvenous defibrillation leads: Need for a European data registry. Europace 2009; 11:31-34.