OBJECTIVES: The epidemiology of complications associated with implantable cardioverter defibrillators (ICD) has been well-studied. However, economic data are needed to understand the overall impact of lead-related complications and the cost effectiveness of alternative treatment strategies. The objective of this study was to estimate the direct medical cost to Medicare of transvenous (TV) lead complications that required reoperation. METHODS: Using Medicare enrollment and claims data from 1/1/2010 through 12/31/2014, we identified 1,691 patients (cases), age ≥ 65, who underwent reoperation (repositioning, repair, or removal) of TV leads between 1/1/2011 and 12/31/2013. For comparison, we identified a pool of candidate controls who underwent initial ICD implantation between 1/1/2010 and 12/31/2010, but who did not undergo lead reoperation thereafter. From these, two controls were selected for each case (n=3,382) matched on age, sex, and geographic region. All patients were followed from six months before, to up to six months after, their index date, which was defined as the date of reoperation in cases and 1/1/2013 in controls. We calculated the cumulative direct medical cost to Medicare (Medicare allowed charges) of all services related to ICD complications during the observation period, and compared costs between cases and controls. RESULTS: The mean age was 78, 40% were female, 92% were white, and 72% had a Charlson Comorbidity score ≥ 2. Among cases, 63% were hospitalized for lead reoperation and 65% underwent removal. Overall, the average cumulative cost of TV lead complications requiring reoperation was $47,548 and $3,956 among controls (difference $43,592; 95% confidence interval $41,726-$45,459; p <0.001). The average cumulative cost of TV lead complications among those requiring lead reoperation in the presence of infection (21% of cases) was $86,745. CONCLUSIONS: The economic consequences of TV lead complications requiring reoperation are substantial. Effective approaches to reducing lead reoperations are likely to result in significant cost-offsets.