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First time description of early lead failure of the Linox Smart lead compared to other contemporary high-voltage leads

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Abstract

Purpose

Early lead failure has recently been reported in ICD patients with Linox SD leads. We aimed to compare the long-term performance of the following lead model Linox Smart SD with other contemporary high-voltage leads.

Methods

All patients receiving high-voltage leads at our center between November 2009 and May 2017 were retrospectively analyzed. Lead failure was defined as the occurrence of one or more of the following: non-physiological high-rate episodes, low- or high-voltage impedance anomalies, undersensing, or non-capture.

Results

In total, 220 patients were included (Linox Smart SD, n = 113; contemporary lead, n = 107). During a median follow-up of 3.8 years (IQR 1.6–5.9 years), a total of 16 (14 in Linox Smart SD and 2 in contemporary group) lead failures occurred, mostly due to non-physiological high-rate sensing or impedance abnormalities. Lead failure incidence rates per 100 person-years were 2.9 (95% CI 1.7–4.9) and 0.6 (95% CI 0.1–2.3) for Linox Smart SD compared to contemporary leads respectively. Kaplan Meier estimates of 5-year lead failure rates were 14.0% (95% CI 8.1–23.6%) and 1.3% (95% CI 0.2–8.9%), respectively (log-rank p = 0.028). Implantation of a Linox Smart SD lead increased the risk of lead failure with a hazard ratio (HR) of 4.53 (95% CI 1.03–19.95, p = 0.046) and 4.44 (95% CI 1.00–19.77, p = 0.05) in uni- and multivariable Cox models.

Conclusions

The new Linox Smart SD lead model was associated with high failure rates and should be monitored closely to detect early signs of lead failure.

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Acknowledgements

Richard Kobza, MD, has received institutional grant support from Abbott, Biotronik, Biosense Webster, Boston, Medtronic and St. Jude Medical. The other authors have no conflicts of interest to declare.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Correspondence to Vanessa Weberndörfer.

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Weberndörfer, V., Nyffenegger, T., Russi, I. et al. First time description of early lead failure of the Linox Smart lead compared to other contemporary high-voltage leads. J Interv Card Electrophysiol 52, 173–177 (2018). https://doi.org/10.1007/s10840-018-0372-9

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  • DOI: https://doi.org/10.1007/s10840-018-0372-9

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