Management of recalled implantable cardioverter-defibrillator leads at generator replacement: a decision analysis model for Fidelis leads

AIMS: Fidelis defibrillator leads have been recalled in 2007 because of a high fracture rate, exposing patients to inappropriate shocks, and to re-interventions. There are currently no guidelines on the management of patients with functional Fidelis leads. The dilemma is of particular relevance when the patient undergoes a generator replacement, as this offers an opportunity to perform concomitant lead revision. Our aim was to evaluate long-term outcome with different strategies of Fidelis lead management at generator replacement. METHODS AND RESULTS: A decision analysis model comparing generator replacement only with different additional lead revision strategies was constructed with yearly cycles for up to 10 years. Published data were used to calculate outcomes of mortality, inappropriate shocks due to lead fracture, and major complications related to lead revision. A quality-of-life analysis was also performed. There were no differences in total mortality between the different strategies. In case of a generator replacement only, the probability of Fidelis lead fracture requiring re-intervention cumulated to 36 and 49% at 5 and 10 years, respectively. Likewise, the risk of inappropriate shock due to lead fracture was 11 and 15%, respectively. A sensitivity analysis showed that all-cause mortality rates did not affect the results. Lead revision was also preferable in the quality-of-life analysis. CONCLUSION: In patients with a functional Fidelis lead at generator replacement, lead revision (with or without lead extraction) should be seriously considered to avoid re-intervention for subsequent lead fracture and to reduce inappropriate shocks.