Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis

Zeitler, Emily P.; Pokorney, Sean D.; Zhou, Ke; Lewis, Robert K.; Greenfield, Ruth Ann; Daubert, James P.; Matchar, David B.; Piccini, Jonathan P.

doi:10.1016/j.hrthm.2015.03.005

Cited by 38 publications

(40 citation statements)

References 37 publications

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“…Thus, the majority of patients with cable externalization do not have electrical failure. Zeitler et al 11 performed a meta-analysis examining the risk of cable externalization as they relate to electrical failure and found that they were associated with a 6-fold risk, but that there was ongoing risk of electrical failure without visible cable externalization, similar to our findings. The mechanism of electrical failure in these patients is not elucidated by this study, but the results do correspond to previous work where inside-out abrasion was found in only 27.9% when returned product analysis was performed on leads with documented electrical failure.…”

Section: Discussionsupporting

confidence: 85%

Canadian Registry of Implantable Electronic Device Outcomes

Parkash¹,

Thibault²,

Mangat³

et al. 2016

Circ: Arrhythmia and Electrophysiology

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Background— The Riata lead under advisory has posed a unique clinical scenario where inside-out abrasion results in externalization of conductor cables, with a higher risk of electrical failure. We developed a comprehensive registry to assist with clinical management of this lead. Methods and Results— This Canadian registry reports the findings of 3763 (74.2% of all Riata leads in Canada) Riata leads under advisory, with a mean follow-up time of 8.9±1.5 years. The overall electrical failure rate was 5.2% at 8 years, with no difference between 7-French and 8-French lead models. Cable externalization was found to be more common in the 8-French model (12.3% versus 5.2%, P <0.0001) and was associated with a higher risk of electrical failure. Predictors of electrical lead failure included cable externalization, higher left ventricular ejection fraction, younger age, higher body mass index, and a passive fixation lead. One patient died due to electrical failure, a further 2 patients survived an event where the device failed to deliver high-voltage therapy. Major complications because of lead extraction were higher when compared with lead abandonment, no difference among lead model observed. Two deaths occurred as a consequence of lead extraction, in the context of an underlying infection. Conclusions— The Riata lead under advisory has a steady electrical failure rate over time. There are identifiable predictors of lead failure that can assist with clinical decisions as to whether lead revision should be performed prophylactically.

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Section: Discussionsupporting

confidence: 85%

Canadian Registry of Implantable Electronic Device Outcomes

Parkash¹,

Thibault²,

Mangat³

et al. 2016

Circ: Arrhythmia and Electrophysiology

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“…The risk for the patients is mainly linked to electrical failure[1,6] ranging from 1.3%[2] to 17.3%[10]. In our experience electrical abnormalities were found in 15% of patients, the majority with 8Fr leads.…”

Section: Discussionmentioning

confidence: 83%

“…Some other studies have shown that leads with EC were more prone to electrical dysfunction, in particular lower R waves[4,6,11]. A recent prospective observational study showed[12] that the incidence of new electrical dysfunction was 6.4% at 12 mo and was associated with EC.…”

Section: Discussionmentioning

confidence: 98%

“…The body of lead is insulated with pure silicone rubber that has an increased risk of abrasion[1,6]. The anatomy of these leads accounts for the mechanism of externalization caused by the movement of the redundant cables within their lumen (“inside-out” abrasion).…”

Section: Discussionmentioning

confidence: 99%

“…The rate of electrical failure can be > 6% per year[3] and it is not always associated with EC[2,4,5]. However, a meta-analysis of 23 observational studies showed that the presence of EC increased the risk of electrical failure by more than 6-fold[6]. …”

Section: Introductionmentioning

confidence: 99%

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Riata silicone defibrillation lead with normal electrical measures at routine ambulatory check: The role of high-voltage shock testing

Maria¹,

Borghi²,

Bonetti³

et al. 2016

WJC

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AIMTo describe our experience with shock testing for the evaluation of patients with Riata™ leads.METHODSAmong 51 patients with normal baseline electrical parameters, 20 died during follow-up. Of the remaining 31 patients, 15 underwent the test: In 10 cases a defibrillation testing with ventricular fibrillation (VF) induction and in 5 cases a R-wave-synchronized shock (> 20 J, without inducing VF). The test was performed under sedation with Midazolam.RESULTSTwelve patients (80%) had a normal behavior during shock testing: In 8 cases induced VF was correctly detected and treated; in 4 cases of R-wave-synchronized shock electrical parameters remained stable and normal. Three patients (20%) failed the test. One patient with externalized conductors showed a sudden drop of high-voltage impedance (< 10 Ohm) after a 25 J R-wave-synchronized shock. Two other patients with externalized conductors, undergoing defibrillation testing, showed a short-circuit during shock delivery and the implantable cardioverter defibrillator was unable to interrupt VF.CONCLUSIONIn Riata™ leads the delivery of a low current during routine measurement of high-voltage impedance may not reveal a small short circuit, that can only be evident by attempting to deliver a true shock, either for spontaneous arrhythmias or in the context of a shock testing.

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