Management and long-term outcomes associated with recalled implantable cardioverter-defibrillator leads: A multicenter experience

Mar, Philip L.; John, Anub; Kumar, Sundeep; Barry, Neil; Chen, Guanhua; Longserre, Sarah; Kabra, Rajesh; Atkins, Donita; Koerber, Scott; Hussein, Ahmed; Bhakta, Deepak; Lakkireddy, Dhanunjaya; Gopinathannair, Rakesh

doi:10.1016/j.hrthm.2020.06.004

Cited by 3 publications

(2 citation statements)

References 16 publications

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“…15,19 When restricted to recalled non-infected Fidelis® and Riata® leads, findings have been similar. 20,21 These findings are comparable with the estimate of procedural risk from our analysis of 2% in the setting of lead abandonment. This congruency of lead abandonment procedural risk suggests that the findings from this multicenter Registry analysis are accurate and that complications from lead abandonment and replacement are similar for recalled versus nonrecalled lead abandonment.…”

Section: Discussionsupporting

confidence: 83%

“…15,19 This is compared with a serious complication rate of 1%-1.5% reported in other cohorts for extraction of these leads in particular. [21][22][23][24] It is notable, that the average maximum dwell time for extraction procedures involving a Riata® and Fidelis® lead in this analysis (94 months) was substantially longer than dwell time reported in prior studies (31-66 months) [20][21][22][23] (Figure 1), and lead dwell time has been well demonstrated to have a powerful impact on procedural risk. 25,26 Finally, extraction risks are reported over the entire period of analysis despite heterogeneity in risk over time (Figure 3).…”

Section: Discussionmentioning

confidence: 47%

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Comparative outcomes of Riata and Fidelis lead management strategies: Results from the NCDR‐ICD Registry

Zeitler

Wang

Pokorney

et al. 2021

Pacing Clinical Electrophis

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Background:The Medtronic Sprint Fidelis® and Abbott Riata®/Riata ST® leads are at risk of failure and are subject to FDA recall. Comparative risks of various lead management strategies during elective generator change in a multi-center population are unknown. We aim to describe patients with functional, recalled ICD leads undergoing elective generator replacement and report outcomes according to lead management strategies.Methods: Using data from the NCDR ICD Registry, patients with a functioning Riata® or Fidelis® lead undergoing generator replacement are described according to lead management: reuse, abandon/replace, and extract/replace. Adjusted rates of death and pre-discharge complications are reported.Results: There were 13,144 generator replacement procedures involving a functioning, non-infected Riata® or Fidelis® lead (extraction n = 414, abandonment n = 427).Extraction patients were younger (mean 58 vs. 67 years) with fewer comorbidities than the reuse group. Maximum lead dwell time was similar between groups with average 94, 90, and 99 months in the extraction, abandonment, and reuse groups, respectively. In-hospital complications or mortality were more common in the extraction group (10.14%, 4.35%) compared with abandonment (1.64%, 0.47%) and reuse (0.22%, 0.07%). Compared with reuse, the adjusted odds of death or pre-discharge complication were significantly higher in the extraction group (OR 7.77 95% CI 2.42-24.95, p < .001) but not the abandonment group (OR 1.70 95% CI 0.52-5.61, p = .38). Conclusions:In this real-world population, extraction of functional recalled ICD leads was associated with significant risk of in-hospital mortality and complications. Additional work is needed to clarify whether longer term outcomes balance these periprocedural risks.

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