Introduction: This study analyzed lead failure and mortality in patients with respect to the number of recalled leads implanted.
Methods: Subjects included all Winthrop University Hospital patients that underwent defibrillator lead implantation between 1996 and 2011. Patients with no recalled leads, one recalled lead, and two recalled leads were compared using Kruskal-Wallis and Chi-Square tests.
Results: This study included 3802 patients (2326 with no recalled leads, 1447 with one recalled lead, 29 with two recalled leads). The two recalled lead group had one failure (3%) and eight deaths (28%). The one recalled lead group had 75 failures (5%) and 671 deaths (46%). The no recalled leads group had 75 failures (3%) and 871 deaths (37%). Mortality was lower in the two recalled lead group when compared to the one recalled lead group (p=0.0006) as well as the no recalled lead group (p=0.0063).
Conclusions: The highest mortality was observed in those with one recalled ICD lead. The unfortunate circumstance in which patients received two recalled ICD leads, did not translate into any adverse impact on lead failure and survival.