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Prospective Assessment of Linox Implantable Cardioverter Defibrillator Leads for Structural or Electrical Abnormalities

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Abstract

Introduction

Insulation failure leading to conductor externalization (CE) of a Linox (Biotronik, Berlin, Germany) implantable cardioverter defibrillator (ICD) lead has recently been reported. The aim of this study was to assess prospectively all Linox family ICD leads implanted at our center for evidence of CE or an electrical abnormality.

Methods

All patients with a Linox family ICD lead implanted at our center, between November 2007 and March 2015, were identified and all living patients were invited to attend for fluoroscopic screening and electrical assessment of the lead.

Results

A total of 183 patients had a Linox family ICD lead implanted at our center. Of these, 5 patients (2.7%) had the lead extracted because of electrical failure and 2 of these leads had evidence of CE. Out of 158 living patients with a Linox family ICD lead, 111 patients attended for screening (mean age 63.1 years, 22.5% female). In this group of patients, no cases of CE or electrical abnormalities of the lead were identified.

Conclusion

In this study evaluating 183 patients with a Linox family ICD lead implanted at a single center, 5 leads (2.7%) were explanted because of electrical failure and 2 of these leads had evidence of CE. Prospective fluoroscopic assessment of 111 Linox family ICD leads, with a mean dwell time of 31.5 months, revealed no further cases of CE.

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Acknowledgements

Funding

No funding or sponsorship was received for this study. The article processing charges were funded by the Cardiology Department, Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, UK.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Compliance with Ethics Guidelines

All procedures performed were in accordance with the ethical standards of the institutional research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Thanking Patients

We thank the participants of the study.

Disclosures

Nicholas A. McKeag: funding from Boston Scientific Corp., Novartis UK, and St. Jude Medical Inc. Rebecca L. Noad: funding from AstraZeneca, Biotronik, and St. Jude Jude Medical Inc. Kyle Ashfield has nothing to disclose. Carol M. Wilson: honorarium from Boehringer Ingelheim, Boston Scientific Corp., Medtronic, Pfizer Inc., Servier, and St. Jude Medical. David J. McEneaney: honorarium from Biotronik, Medtronic, and St. Jude Medical. Michael J. D. Roberts: honorarium from Boston Scientific Corp., Medtronic, Personalis, Sanofi Aventis, and St. Jude Medical.

Data Availability

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

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Correspondence to Nicholas A. McKeag.

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McKeag, N.A., Noad, R.L., Ashfield, K. et al. Prospective Assessment of Linox Implantable Cardioverter Defibrillator Leads for Structural or Electrical Abnormalities. Adv Ther 35, 666–670 (2018). https://doi.org/10.1007/s12325-018-0691-3

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  • DOI: https://doi.org/10.1007/s12325-018-0691-3

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