Canadian Registry of Implantable Electronic Device Outcomes: Longer Term Follow up of the Riata Lead Under Advisory

TitleCanadian Registry of Implantable Electronic Device Outcomes: Longer Term Follow up of the Riata Lead Under Advisory
Publication TypeJournal Article
Year of Publication2017
AuthorsParkash, R, Thibault, B, Philippon, F, Mangat, I, Coutu, B, Bennett, M, Crystal, E, Healey, J, Verma, A, Sandhu, R, Cameron, D, Ayala-Paredes, F, Sterns, L, Essebag, V, Sturmer, M, Nery, P, Wells, G, Krahn, A
JournalHeart Rhythm
Date Published12/2017
ISSNPrint: 1547-5271; Online: 1556-3871
Abstract

BACKGROUND:

The Riata lead advisory was announced in 2011 and has posed unique management challenges due to cable externalization and insulation abrasion, in some cases leading to sudden loss of defibrillation.

OBJECTIVE:

We sought to provide further data on the rate of electrical failure in population of patients with a Riata lead under advisory.

METHODS:

Using the Canadian Registry of Electronic Device Outcomes, prospective follow up data was collected on 1352 Riata leads under advisory in 17 ICD implantation centers in Canada. Electrical and structural failure were collected, as well as peri-procedural complications related to lead revision (abandonment or extraction).

RESULTS:

Of the 1352 leads included in this 12 month follow up cohort, there were 110 leads revised. The mean follow up time was 10.4±1.5 years. The 12 year rate of electrical failure for the 8 French lead was 9.45%, while the 10 year failure rate for the 7 French lead was 7.25%, and was not found to be accelerating. Of the leads revised due to advisory only (patient preference, advisory related, electrical or structural failure), the majority were abandoned (n=54, 76.0%), while 17 (24.0%) were extracted with power tools. The rate of major complications in each group was 5.6% and 5.9%, respectively.

CONCLUSIONS:

This report provides further data as to the risk of electrical lead failure over a long lead dwell time. The risk of failure exceeds the risk of peri-procedural major complications, indicating that risk-benefit is favourable to revise the lead in appropriate clinical scenarios.

DOI10.1016/j.hrthm.2017.11.033