Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads

John A. Cairns, Andrew E. Epstein, John Rickard, Stuart J. Connolly, Christopher Buller, Bruce L. Wilkoff, Janice Pogue, Ellison Themeles, Jeff S. Healey

Research output: Contribution to journalArticle

Abstract

Background St Jude Medical Optim-insulated implantable cardioverter-defibrillator leads were designed to impart lubricity, strength, and abrasion resistance while maintaining flexibility and biostability. No long-term prospective follow-up data have been published.

Methods St Jude Medical established 3 prospective registries and enrolled 11,016 leads implanted in 10,835 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reports (verified by expert staff using detailed algorithms), and documentation of lead revisions or inactivation, study withdrawal, and death. The Population Health Research Institute (McMaster University) was engaged to review database functions, adjudicate all potential mechanical lead failures, and conduct independent analyses of the data.

Results During a median follow-up of 3.2 years, there were 51 mechanical failures (0.46%), with 99.0% survival free of this outcome by 5 years of follow-up. Freedom from conductor fracture was identified in 99.4% and from all-cause abrasion in 99.8% of the leads, and there were no reports of externalized conductors. There were no significant differences in survival among Durata DF4, Durata DF1, and Riata ST Optim leads.

Conclusion Over a mean follow-up of 3.2 years, Optim-insulated leads have low rates of all-cause mechanical failure and no observed externalized conductors. Independent analyses of these registries are designed to provide reliable long-term follow-up information and are ongoing.

Original languageEnglish (US)
Pages (from-to)2156-2162
Number of pages7
JournalHeart Rhythm
Volume11
Issue number12
DOIs
StatePublished - Dec 1 2014

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Implantable Defibrillators
Documentation
Registries
Survival
Databases
Health
Population
Lead

Keywords

  • ICD leads
  • Mechanical lead failure
  • Optim insulation
  • Prospective cohort study
  • Prospective registries

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)
  • Medicine(all)

Cite this

Cairns, J. A., Epstein, A. E., Rickard, J., Connolly, S. J., Buller, C., Wilkoff, B. L., ... Healey, J. S. (2014). Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads. Heart Rhythm, 11(12), 2156-2162. https://doi.org/10.1016/j.hrthm.2014.08.023

Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads. / Cairns, John A.; Epstein, Andrew E.; Rickard, John; Connolly, Stuart J.; Buller, Christopher; Wilkoff, Bruce L.; Pogue, Janice; Themeles, Ellison; Healey, Jeff S.

In: Heart Rhythm, Vol. 11, No. 12, 01.12.2014, p. 2156-2162.

Research output: Contribution to journalArticle

Cairns, JA, Epstein, AE, Rickard, J, Connolly, SJ, Buller, C, Wilkoff, BL, Pogue, J, Themeles, E & Healey, JS 2014, 'Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads', Heart Rhythm, vol. 11, no. 12, pp. 2156-2162. https://doi.org/10.1016/j.hrthm.2014.08.023
Cairns, John A. ; Epstein, Andrew E. ; Rickard, John ; Connolly, Stuart J. ; Buller, Christopher ; Wilkoff, Bruce L. ; Pogue, Janice ; Themeles, Ellison ; Healey, Jeff S. / Prospective long-term evaluation of Optim-insulated (Riata ST Optim and Durata) implantable cardioverter-defibrillator leads. In: Heart Rhythm. 2014 ; Vol. 11, No. 12. pp. 2156-2162.
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abstract = "Background St Jude Medical Optim-insulated implantable cardioverter-defibrillator leads were designed to impart lubricity, strength, and abrasion resistance while maintaining flexibility and biostability. No long-term prospective follow-up data have been published.Methods St Jude Medical established 3 prospective registries and enrolled 11,016 leads implanted in 10,835 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reports (verified by expert staff using detailed algorithms), and documentation of lead revisions or inactivation, study withdrawal, and death. The Population Health Research Institute (McMaster University) was engaged to review database functions, adjudicate all potential mechanical lead failures, and conduct independent analyses of the data.Results During a median follow-up of 3.2 years, there were 51 mechanical failures (0.46{\%}), with 99.0{\%} survival free of this outcome by 5 years of follow-up. Freedom from conductor fracture was identified in 99.4{\%} and from all-cause abrasion in 99.8{\%} of the leads, and there were no reports of externalized conductors. There were no significant differences in survival among Durata DF4, Durata DF1, and Riata ST Optim leads.Conclusion Over a mean follow-up of 3.2 years, Optim-insulated leads have low rates of all-cause mechanical failure and no observed externalized conductors. Independent analyses of these registries are designed to provide reliable long-term follow-up information and are ongoing.",
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AU - Connolly, Stuart J.

AU - Buller, Christopher

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N2 - Background St Jude Medical Optim-insulated implantable cardioverter-defibrillator leads were designed to impart lubricity, strength, and abrasion resistance while maintaining flexibility and biostability. No long-term prospective follow-up data have been published.Methods St Jude Medical established 3 prospective registries and enrolled 11,016 leads implanted in 10,835 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reports (verified by expert staff using detailed algorithms), and documentation of lead revisions or inactivation, study withdrawal, and death. The Population Health Research Institute (McMaster University) was engaged to review database functions, adjudicate all potential mechanical lead failures, and conduct independent analyses of the data.Results During a median follow-up of 3.2 years, there were 51 mechanical failures (0.46%), with 99.0% survival free of this outcome by 5 years of follow-up. Freedom from conductor fracture was identified in 99.4% and from all-cause abrasion in 99.8% of the leads, and there were no reports of externalized conductors. There were no significant differences in survival among Durata DF4, Durata DF1, and Riata ST Optim leads.Conclusion Over a mean follow-up of 3.2 years, Optim-insulated leads have low rates of all-cause mechanical failure and no observed externalized conductors. Independent analyses of these registries are designed to provide reliable long-term follow-up information and are ongoing.

AB - Background St Jude Medical Optim-insulated implantable cardioverter-defibrillator leads were designed to impart lubricity, strength, and abrasion resistance while maintaining flexibility and biostability. No long-term prospective follow-up data have been published.Methods St Jude Medical established 3 prospective registries and enrolled 11,016 leads implanted in 10,835 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reports (verified by expert staff using detailed algorithms), and documentation of lead revisions or inactivation, study withdrawal, and death. The Population Health Research Institute (McMaster University) was engaged to review database functions, adjudicate all potential mechanical lead failures, and conduct independent analyses of the data.Results During a median follow-up of 3.2 years, there were 51 mechanical failures (0.46%), with 99.0% survival free of this outcome by 5 years of follow-up. Freedom from conductor fracture was identified in 99.4% and from all-cause abrasion in 99.8% of the leads, and there were no reports of externalized conductors. There were no significant differences in survival among Durata DF4, Durata DF1, and Riata ST Optim leads.Conclusion Over a mean follow-up of 3.2 years, Optim-insulated leads have low rates of all-cause mechanical failure and no observed externalized conductors. Independent analyses of these registries are designed to provide reliable long-term follow-up information and are ongoing.

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