Externalized conductors and electrical dysfunction in transvenous ventricular leads: Results of the Cardiac Lead Assessment Study.
Electrical dysfunction
Externalized conductor
High-voltage lead
Implantable cardioverter-defibrillator
Lead insulation
Journal
Heart rhythm O2
ISSN: 2666-5018
Titre abrégé: Heart Rhythm O2
Pays: United States
ID NLM: 101768511
Informations de publication
Date de publication:
Apr 2022
Apr 2022
Historique:
entrez:
2
5
2022
pubmed:
3
5
2022
medline:
3
5
2022
Statut:
epublish
Résumé
The Cardiac Lead Assessment Study (CLAS) was a large prospective, multicenter, international postmarket surveillance study conducted at 45 sites. The purpose of CLAS was to examine the prevalence and incidence of externalized conductors and electrical dysfunction in subjects with selected St. Jude Medical defibrillator and left ventricular leads. Cinefluoroscopy was used to determine the presence of externalized conductors at enrollment and at 12-, 24-, and 36-month follow-up visits. Lead electrical measurements were collected systematically. The study enrolled 2216 subjects with a total of 2847 study leads. The prevalence of externalized conductors through 36 months for Riata leads was 30.9%, Riata ST leads 12.6%, Durata leads 0.5%, and QuickSite/QuickFlex leads 4.7%. The prevalence of electrical dysfunction through 36 months for Riata was 4.0%, Riata ST 3.3%, Durata 2.4%, and QuickSite/QuickFlex 0.3%. In Riata and Riata ST leads with externalized conductors, there was a low risk of electrical dysfunction. None of the Durata or QuickSite/QuickFlex leads with externalized conductors developed electrical dysfunction. There was no evidence of an electrical short in a high-voltage shocking circuit leading to failed shock. A high prevalence of externalized conductors was found in Riata and Riata ST defibrillator leads, with a higher risk of externalization for 8F Riata leads than for 7F Riata ST leads. The 98% reduction in prevalence of externalized conductors in Durata leads compared to Riata/Riata ST leads confirms that the design improvements culminating in Durata leads significantly improved abrasion resistance and durability.
Sections du résumé
Background
UNASSIGNED
The Cardiac Lead Assessment Study (CLAS) was a large prospective, multicenter, international postmarket surveillance study conducted at 45 sites.
Objective
UNASSIGNED
The purpose of CLAS was to examine the prevalence and incidence of externalized conductors and electrical dysfunction in subjects with selected St. Jude Medical defibrillator and left ventricular leads.
Methods
UNASSIGNED
Cinefluoroscopy was used to determine the presence of externalized conductors at enrollment and at 12-, 24-, and 36-month follow-up visits. Lead electrical measurements were collected systematically.
Results
UNASSIGNED
The study enrolled 2216 subjects with a total of 2847 study leads. The prevalence of externalized conductors through 36 months for Riata leads was 30.9%, Riata ST leads 12.6%, Durata leads 0.5%, and QuickSite/QuickFlex leads 4.7%. The prevalence of electrical dysfunction through 36 months for Riata was 4.0%, Riata ST 3.3%, Durata 2.4%, and QuickSite/QuickFlex 0.3%. In Riata and Riata ST leads with externalized conductors, there was a low risk of electrical dysfunction. None of the Durata or QuickSite/QuickFlex leads with externalized conductors developed electrical dysfunction. There was no evidence of an electrical short in a high-voltage shocking circuit leading to failed shock.
Conclusion
UNASSIGNED
A high prevalence of externalized conductors was found in Riata and Riata ST defibrillator leads, with a higher risk of externalization for 8F Riata leads than for 7F Riata ST leads. The 98% reduction in prevalence of externalized conductors in Durata leads compared to Riata/Riata ST leads confirms that the design improvements culminating in Durata leads significantly improved abrasion resistance and durability.
Identifiants
pubmed: 35496462
doi: 10.1016/j.hroo.2022.01.007
pii: S2666-5018(22)00009-5
pmc: PMC9043361
doi:
Types de publication
Journal Article
Langues
eng
Pagination
160-168Informations de copyright
© 2022 Heart Rhythm Society. Published by Elsevier Inc.
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