open access

Vol 24, No 3 (2017)
Original articles — Interventional cardiology
Published online: 2016-11-30
Get Citation

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study

Marcin Grabowski, Jakub K. Rokicki, Sylwia Gajda, Łukasz Januszkiewicz, Andrzej Cacko, Przemysław Stolarz, Grzegorz Opolski
DOI: 10.5603/CJ.a2016.0110
·
Pubmed: 27910085
·
Cardiol J 2017;24(3):259-265.

open access

Vol 24, No 3 (2017)
Original articles — Interventional cardiology
Published online: 2016-11-30

Abstract

Background: Over the last several years significant rises in the use of implanted cardioverter-defibrillators (ICD) have also resulted in a number of associated complications. This number includes lead failure. Sprint Fidelis (SF) ICD lead is regarded as a lead with elevated failure risk. Every center acting in accordance with the guidelines should observe patients more thoroughly especially with recalled leads and run a registry of their follow-up. The aim of this research was to present follow-up of the patients with SF leads (types 6948, 6949) from a single implantation center.

Methods: There were 36 SF leads implanted in 36 patients. Mean follow-up period was 76 months (IQR 40.3–86.8). Patients were subjected to regular check-ups in 3 to 6 month intervals.

Results: Patients were implanted at a median age of 66.5 years and majority of them had ischemic cardiomyopathy (72%). A majority of the studied population were men (72.2%). Predominantly dual-chamber ICD (ICD-DR) were implanted (50% ICD-DR vs. 47.2% ICD-VR). The guidelines for management of patients implanted with SF were fully implemented. During the follow-up 14 (38.9%) patients died. No deaths were noted that could be attributed to lead failure. In 5 cases lead failure was identified and of these 4 leads were replaced. Median time from implantation to the detection of lead dysfunction was 52 months (IQR 49; 83). The symptoms of failure consisted of: inappropriate shocks, alternating ventricular lead signal, or loss of ventricular stimulation.

Conclusions: The follow-up of patients with recalled SF leads in a single center supports that implementation SF management guidelines could be effective in clinical practice.

Abstract

Background: Over the last several years significant rises in the use of implanted cardioverter-defibrillators (ICD) have also resulted in a number of associated complications. This number includes lead failure. Sprint Fidelis (SF) ICD lead is regarded as a lead with elevated failure risk. Every center acting in accordance with the guidelines should observe patients more thoroughly especially with recalled leads and run a registry of their follow-up. The aim of this research was to present follow-up of the patients with SF leads (types 6948, 6949) from a single implantation center.

Methods: There were 36 SF leads implanted in 36 patients. Mean follow-up period was 76 months (IQR 40.3–86.8). Patients were subjected to regular check-ups in 3 to 6 month intervals.

Results: Patients were implanted at a median age of 66.5 years and majority of them had ischemic cardiomyopathy (72%). A majority of the studied population were men (72.2%). Predominantly dual-chamber ICD (ICD-DR) were implanted (50% ICD-DR vs. 47.2% ICD-VR). The guidelines for management of patients implanted with SF were fully implemented. During the follow-up 14 (38.9%) patients died. No deaths were noted that could be attributed to lead failure. In 5 cases lead failure was identified and of these 4 leads were replaced. Median time from implantation to the detection of lead dysfunction was 52 months (IQR 49; 83). The symptoms of failure consisted of: inappropriate shocks, alternating ventricular lead signal, or loss of ventricular stimulation.

Conclusions: The follow-up of patients with recalled SF leads in a single center supports that implementation SF management guidelines could be effective in clinical practice.

Get Citation

Keywords

defibrillators, implantable (E07.305.250.159.175) lead failure, Sprint Fidelis, lead extraction, lead survival

About this article
Title

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study

Journal

Cardiology Journal

Issue

Vol 24, No 3 (2017)

Pages

259-265

Published online

2016-11-30

DOI

10.5603/CJ.a2016.0110

Pubmed

27910085

Bibliographic record

Cardiol J 2017;24(3):259-265.

Keywords

defibrillators
implantable (E07.305.250.159.175) lead failure
Sprint Fidelis
lead extraction
lead survival

Authors

Marcin Grabowski
Jakub K. Rokicki
Sylwia Gajda
Łukasz Januszkiewicz
Andrzej Cacko
Przemysław Stolarz
Grzegorz Opolski

References (30)
  1. Hauser RG, Kallinen LM, Almquist AK, et al. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm. 2007; 4(7): 892–896.
  2. Medtronic. Urgent Medical Device Information: Sprint Fidelis Lead Patient Management. Recommendations.2007. http://www.medtronic.com/product-advisories/physician/sprint-fidelis/PROD-ADV-PHYS-OCT (2007-10-15).
  3. Kutarski A, Chudzik M, Mitkowski P, et al. Postępowanie w przypadku pacjentów z elektrodami z rodziny Sprint-Fidelis — wytyczne Zespołu Ekspertów Konsultanta Krajowego w dziedzinie kardiologii. Kardiol Pol. 2011; 69: 995–996.
  4. Catanchin A, Anderson L, Jones S, et al. When life-saving devices terminate life. J Cardiovasc Electrophysiol. 2008; 19(3): 316–318.
  5. Epstein AE, Carlson MD, Fogoros RN, et al. Classification of death in antiarrhythmia trials. J Am Coll Cardiol. 1996; 27(2): 433–442.
  6. Vollmann D, Woronowicz S, Kmiec L, et al. Passive-fixation lead failure rates and long-term patient mortality in subjects implanted with Sprint Fidelis electrodes. Europace. 2014; 16(2): 258–264.
  7. Birnie DH, Parkash R, Exner DV, et al. Clinical predictors of Fidelis lead failure: report from the Canadian Heart Rhythm Society Device Committee. Circulation. 2012; 125(10): 1217–1225.
  8. Hauser RG, Maisel WH, Friedman PA, et al. Longevity of Sprint Fidelis implantable cardioverter-defibrillator leads and risk factors for failure: implications for patient management. Circulation. 2011; 123(4): 358–363.
  9. Morrison TB, Friedman PA, Kallinen LM, et al. Impact of implanted recalled sprint Fidelis lead on patient mortality. J Am Coll Cardiol. 2011; 58(3): 278–283.
  10. Brown J, Bilchick K, Alonso A, et al. OptiVol Impedance Threshold Crossing Predicts Patients with Higher Mortality or Hospitalization Risk Among Medicare Recipients. J Cardiac Failure. 2015; 21(8): S122.
  11. CareLINK Plus data: Sprint Fidelis model 6949 lead performance. http://wwwmedtroniccom/product-advisories/physician/sprint-fidelis/6949-LEAD-PERFORMANCE (January 2015).
  12. Cheung JW, Tobin-Hess A, Patel A, et al. Trends in Fidelis lead survival: transition from an exponential to linear pattern of lead failure over time. Circ Arrhythm Electrophysiol. 2012; 5(5): 906–912.
  13. Parsonnet V, Roelke M. The cephalic vein cutdown versus subclavian puncture for pacemaker/ICD lead implantation. Pacing Clin Electrophysiol. 1999; 22(5): 695–697.
  14. Frey SM, Sticherling C, Bucher U, et al. Long-term performance of the Medtronic Sprint Fidelis lead: a matter of lead type? Europace. 2012; 14(11): 1620–1623.
  15. Piot O, Deballon R, Nitu D, et al. Factors predicting Sprint Fidelis lead fracture: Results at 5 years from a French multicentre registry. Arch Cardiovasc Dis. 2015; 108(4): 220–226.
  16. Lovelock JD, Patel A, Mengistu A, et al. Generator exchange is associated with an increased rate of Sprint Fidelis lead failure. Heart Rhythm. 2012; 9(10): 1615–1618.
  17. Tzogias L, Bellavia D, Sharma S, et al. Natural history of the Sprint Fidelis lead: survival analysis from a large single-center study. J Interv Card Electrophysiol. 2012; 34(1): 37–44.
  18. Bernstein NE, Karam ET, Aizer A, et al. Right-sided implantation and subpectoral position are predisposing factors for fracture of a 6.6 French ICD lead. Pacing Clin Electrophysiol. 2012; 35(6): 659–664.
  19. Krahn AD, Bashir J, Birnie DH, et al. Impact of generator replacement on the risk of Fidelis lead fracture. Heart Rhythm. 2016; 13(8): 1618–1623.
  20. Burke MC, Gold MR, Knight BP, et al. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015; 65(16): 1605–1615.
  21. Ha ACT, Vezi BZ, Keren A, et al. Predictors of fracture risk of a small caliber implantable cardioverter defibrillator lead. Pacing Clin Electrophysiol. 2010; 33(4): 437–443.
  22. Arias MA, Domínguez-Pérez L, Toquero J, et al. [Sprint fidelis defibrillation lead: a nine-center experience in Spain]. Rev Esp Cardiol. 2011; 64(4): 312–318.
  23. Faulknier BA, Traub DM, Aktas MK, et al. Time-dependent risk of Fidelis lead failure. Am J Cardiol. 2010; 105(1): 95–99.
  24. Farwell D, Green MS, Lemery R, et al. Accelerating risk of Fidelis lead fracture. Heart Rhythm. 2008; 5(10): 1375–1379.
  25. Verlato R, Facchin D, Catanzariti D, et al. Clinical outcomes in patients with implantable cardioverter defibrillators and Sprint Fidelis leads. Heart. 2013; 99(11): 799–804.
  26. Parsonnet V, Roelke M. The cephalic vein cutdown versus subclavian puncture for pacemaker/ICD lead implantation. Pacing Clin Electrophysiol. 1999; 22(5): 695–697.
  27. Erkapic D, Duray GZ, Bauernfeind T, et al. Insulation defects of thin high-voltage ICD leads: an underestimated problem? J Cardiovasc Electrophysiol. 2011; 22(9): 1018–1022.
  28. Salgado R, Martín J, Martínez J, et al. Small-Caliber Lead Failure After Generator Exchange. J Cardiovasc Electrophysiol. 2016; 27(7): 846–850.
  29. Mehta NK, Taylor M, Kalbfleisch S. The Impact of Inappropriate Implantable Cardiac Defibrillator Shocks on Cardiovascular Morbidity and Mortality. Pacing Clin Electrophysiol. 2016; 39(8): 858–862.
  30. Yang XW, Hua W, Ding LG, et al. OptiVol fluid index predicts acute decompensation of heart failure with a high rate of unexplained events. J Geriatr Cardiol. 2013; 10(3): 253–257.

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

By "Via Medica sp. z o.o." sp.k., ul. Świętokrzyska 73, 80–180 Gdańsk, Poland
tel.:+48 58 320 94 94, fax:+48 58 320 94 60, e-mail: viamedica@viamedica.pl