Are We Improving Care of Medicare Patients Undergoing Primary Prevention Implantable Cardioverter-Defibrillator Implantation?
Multiple clinical trials have demonstrated the benefit of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death in selected high-risk populations.1–5 On the basis of the results from clinical trials and incorporation of evidence into practice guidelines, >12 000 ICD implantation procedures are now performed each month in the United States.6 After publication of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), the Centers for Medicare & Medicaid Services expanded coverage for the implantation of primary prevention ICDs for Medicare beneficiaries. This was accompanied by the decision for Coverage with Evidence Development (CED), mandating that all implantations in Medicare patients be recorded in a prospective registry, now the National Cardiovascular Data Registry (NCDR), as a requirement for reimbursement. There has been increased focus related to the potential use of this therapy outside criteria specified in selected clinical trials, and the possibility of potential overuse of ICDs has also been raised, heightened by recent Department of Justice investigations that included use of ICDs in situations in which gaps in evidence exist.7 Because ICD therapy is costly, the need to measure the long-term outcome of patients receiving ICDs for primary prevention indications in an aging population has been recognized, allowing assessment of outcomes beyond the confines of randomized, clinical trials.8
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Were elderly patients (≥65 years) well represented in clinical trials to support the practice of implantation in the Medicare population? Although no trial specifically focused on ICD use in the elderly, primary prevention ICD trials have included a substantial number of elderly patients (Table). In real-life clinical practice, 61% of ICD recipients in the United States are ≥65 years of age,9 with an average age of 67.3±13.0 years in the NCDR.6 Thirty percent of patients are 70 …