Utilization, Outcomes and Costs of Implantable Cardioverter Defibrillators in Italy: A Population-Based Analysis Using Healthcare Administrative Databases

Abstract

Introduction: The high cost of treatment with an implantable cardioverter defibrillator (ICD) requires continuous monitoring of its real effectiveness and appropriateness. The aim of this study was to evaluate epidemiological and economic impacts of ICD therapy in Lombardy, the most populated Italian region. Materials and Methods: We extracted data from DENALI, a data warehouse that organizes healthcare administrative databases concerning about ten million people covered by the Lombardy Health System (LHS). We estimated annual rates of first implant and of first replacement from 2000 to 2008. The cohort of patients who underwent a first ICD implantation between 2005 and 2007 was followed from discharge to December 31, 2008 in order to evaluate mean annual total healthcare cost per-capita, mortality and device replacement. Results: We identified 12,732 first implants and 4,833 replacements performed from 2000 to 2008 and we estimated the annual rates: first ICD implants increased from 55 to 236 (per million person-years), and the first replacement rates increased with a peak in 2005. A first ICD implantation cost €23,934 (standard deviation 4,986) on average and the LHS bore a further mean annual cost of €5,760 (95% confidence interval 5,592-5,931) percapita during follow-up: 17% due to drugs, 12% to outpatient visits and 71% to hospitalizations. Conclusions: The results confirm the increase in ICD utilization in Italy, especially in the Lombardy region, and its high economic burden. Age and comorbidities of ICD recipients should be considered in assessing care since they influence survival outcome. Moreover, this study shows how healthcare administrative databases could be useful to understand the impact of a health intervention in large unselected populations.