Failure Rate and Conductor Externalization of the Biotronik Linox / Sorin Vigila Implantable Cardioverter Defibrillator Lead

Noti, Fabian; Lam, Anna; Klossner, Nicole; Seiler, Jens; Servatius, Helge Simon; Medeiros Domingo, Argelia; Tran, van Nam; Haeberlin, Andreas; Fuhrer, Jürg; Tanner, Hildegard; Roten, Laurent (2016). Failure Rate and Conductor Externalization of the Biotronik Linox / Sorin Vigila Implantable Cardioverter Defibrillator Lead. Heart rhythm, 13(5), pp. 1075-1082. Elsevier 10.1016/j.hrthm.2015.12.038

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BACKGROUND

We observed a case of conductor externalization in a Biotronik Linox lead.

OBJECTIVE

To investigate lead performance of the Linox and identical Sorin Vigila lead and prevalence of conductor externalization.

METHODS

We compared lead performance of all Linox and Vigila leads implanted at our center (BL group; n=93) with all Boston Scientific Endotak Reliance leads (ER group; n=190) and Medtronic Sprint Quattro leads (SQ group; n=202) implanted during the same period. We screened all BL group patients for conductor externalization.

RESULTS

We identified 8 cases of lead failures in the BL group (index case of conductor externalization; 6 cases of non-physiological high rate sensing; one case of high voltage conductor fracture). Prospective, fluoroscopic screening of 98% of all active BL group cases revealed one additional case of conductor externalization. Median follow-up was 41, 27 and 29 months for the BL group, ER group and SQ group, respectively, lead survival 94.9%, 99.2% and 100% at 3 years, and 88%, 97.5% and 100% at 5 years (p=0.038 for BL group vs. ER group, and p=0.007 for BL group vs. SQ group by the log-rank test). Younger age at implant was an independent predictor for lead failure in the BL group (adjusted HR 0.85 [95% confidence interval 0.77-0.94]; p=0.001).

CONCLUSION

At our center, survival of the Linox lead is 88% at five years and significantly worse than its comparators. Conductor externalization is present in a minority of failed Linox leads. Younger age at implant is an independent predictor of Linox lead failure.

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