open access

Vol 22, No 1 (2015)
Original articles
Published online: 2015-02-24
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Fluoroscopic investigation of Riata® transvenous defibrillator leads

Gurjit Singh, Marc K. Lahiri, Arfaat Khan, Kan D. Fang, Claudio D. Schuger
DOI: 10.5603/CJ.a2014.0039
·
Pubmed: 24846515
·
Cardiol J 2015;22(1):57-67.

open access

Vol 22, No 1 (2015)
Original articles
Published online: 2015-02-24

Abstract

Background: Implantable cardioverter-defibrillator leads from Riata® family (St. Jude Medical Inc., Sylmar, CA, USA) have been recently recalled by Food and Drug Administration for concerns of a unique type of “inside-out” insulation failure leading to conductor externalization. The objective of this study was to evaluate the prevalence and predictors of conductor externalization in patients implanted with Riata 8 French (Fr) and 7 Fr leads.

Methods: Patients implanted with Riata® and Riata ST® who were actively followed up in our institution were scheduled for high resolution 3 view fluoroscopy and device interrogation including high voltage (HV) lead impedance testing. Fluoroscopic images were graded as presence of externalization or no externalization.

Results: Of the 90 patients who underwent screening fluoroscopy, majority had dual coil leads (62.5%) and median duration from the implant time to screening was 79.5 months. Twenty four (26.7%) patients exhibited evidence of lead externalization with 10 (41.6%) of these showing electrical abnormalities at the time of screening. No externalization was seen in the 7 Fr leads. Pacing thresholds were significantly elevated in the externalized cohort compared to non-externalized group (1.42 ± 1.23 vs. 0.93 ± 0.53; p = 0.01). Time since lead implant and lead diameter emerged as significant predictors of lead externalization on univariate analysis with only lead diameter being significant on multivariate analysis (odds ratio 30.68; 4.95–∞, p = 0.001).

Conclusions: Prevalence of insulation failure exhibiting as conductor externalization is high (26.7%) among the large diameter 8 Fr Riata® leads with a significant proportion of patients manifesting electrical failure. High resolution 3 view fluoroscopy is a reasonable approach to screen for this unique type of insulation failure.

Abstract

Background: Implantable cardioverter-defibrillator leads from Riata® family (St. Jude Medical Inc., Sylmar, CA, USA) have been recently recalled by Food and Drug Administration for concerns of a unique type of “inside-out” insulation failure leading to conductor externalization. The objective of this study was to evaluate the prevalence and predictors of conductor externalization in patients implanted with Riata 8 French (Fr) and 7 Fr leads.

Methods: Patients implanted with Riata® and Riata ST® who were actively followed up in our institution were scheduled for high resolution 3 view fluoroscopy and device interrogation including high voltage (HV) lead impedance testing. Fluoroscopic images were graded as presence of externalization or no externalization.

Results: Of the 90 patients who underwent screening fluoroscopy, majority had dual coil leads (62.5%) and median duration from the implant time to screening was 79.5 months. Twenty four (26.7%) patients exhibited evidence of lead externalization with 10 (41.6%) of these showing electrical abnormalities at the time of screening. No externalization was seen in the 7 Fr leads. Pacing thresholds were significantly elevated in the externalized cohort compared to non-externalized group (1.42 ± 1.23 vs. 0.93 ± 0.53; p = 0.01). Time since lead implant and lead diameter emerged as significant predictors of lead externalization on univariate analysis with only lead diameter being significant on multivariate analysis (odds ratio 30.68; 4.95–∞, p = 0.001).

Conclusions: Prevalence of insulation failure exhibiting as conductor externalization is high (26.7%) among the large diameter 8 Fr Riata® leads with a significant proportion of patients manifesting electrical failure. High resolution 3 view fluoroscopy is a reasonable approach to screen for this unique type of insulation failure.

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Keywords

implantable cardioverter-defibrillators, Riata leads, fluoroscopy screening, externalization, electrical failure, lead recall

About this article
Title

Fluoroscopic investigation of Riata® transvenous defibrillator leads

Journal

Cardiology Journal

Issue

Vol 22, No 1 (2015)

Pages

57-67

Published online

2015-02-24

DOI

10.5603/CJ.a2014.0039

Pubmed

24846515

Bibliographic record

Cardiol J 2015;22(1):57-67.

Keywords

implantable cardioverter-defibrillators
Riata leads
fluoroscopy screening
externalization
electrical failure
lead recall

Authors

Gurjit Singh
Marc K. Lahiri
Arfaat Khan
Kan D. Fang
Claudio D. Schuger

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