Editorial Are We Improving Care of Medicare Patients Undergoing Primary Prevention Implantable Cardioverter-Defibrillator Implantation? Andrea M. Russo, MD
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ultiple clinical trials have demonstrated the benefit of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death in selected highrisk 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
Article see p 845 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 to 79 years old; 17% are 80 to 89 years old; and 0.9% are ≥90 years.6 Trends have shown that the age of patients undergoing The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From the Cooper Medical School of Rowan University, Camden, NJ. Correspondence to Andrea M. Russo, MD, FACC, FHRS, Director, Electrophysiology and Arrhythmia Services, Cooper University Hospital, 426 Dorrance Bldg, 1 Cooper Plaza, Camden, NJ 08103. E-mail [email protected] (Circulation. 2014;130:808-810.) © 2014 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.114.011855
ICD implantation has increased over time in smaller studies or those performed outside the United States.10–12 In this issue of Circulation, Borne et al13 analyzed data from the US NCDR ICD registry to assess temporal trends in patient characteristics and outcomes of a very large number of elderly patients undergoing primary prevention ICD implantation. This study included 117 100 Medicare fee-for-service beneficiaries ≥65 years of age with left ventricular ejection fraction ≤35% who underwent primary prevention ICD implantation (with or without concomitant cardiac resynchronization therapy [CRT]) between 2006 and 2010 who could be matched to Medicare claims data. They identified that the characteristics of patients undergoing primary prevention ICD implantation changed very little from 2006 to 2010. Although some observed differences were statistically significant because of the very large number of patients, these small differences are not necessarily clinically relevant. There was no evidence for any substantial trend in the use of ICDs in patients with greater burden of coexisting illness, providing reassurance that there has been a consistent approach to patient selection for ICD therapy in United States without any indication for increased permissiveness in use of devices. In fact, the 6-month mortality among patients receiving ICDs for primary prevention declined over the study years. Complications were also reduced over time, even in this elderly population that has previously been demonstrated to have higher complication rates than younger patients.9 There was also a lower rate of rehospitalization, including heart failure rehospitalization, and an increased proportion of patients receiving CRT over time. So what is the procedural outcome of ICD therapy in elderly patients compared with younger patients? Prior investigation demonstrated a higher rate of complications in older patients.9,14,15 An analysis of Medicare beneficiaries revealed that 10.8% experienced complications before hospital discharge.14 Patients ≥75 years of age were more likely to suffer any adverse event or death after ICD implantation compared with patients
M
ultiple clinical trials have demonstrated the benefit of implantable cardioverter-defibrillators (ICDs) for the primary prevention of sudden cardiac death in selected highrisk 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
Article see p 845 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 to 79 years old; 17% are 80 to 89 years old; and 0.9% are ≥90 years.6 Trends have shown that the age of patients undergoing The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From the Cooper Medical School of Rowan University, Camden, NJ. Correspondence to Andrea M. Russo, MD, FACC, FHRS, Director, Electrophysiology and Arrhythmia Services, Cooper University Hospital, 426 Dorrance Bldg, 1 Cooper Plaza, Camden, NJ 08103. E-mail [email protected] (Circulation. 2014;130:808-810.) © 2014 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.114.011855
ICD implantation has increased over time in smaller studies or those performed outside the United States.10–12 In this issue of Circulation, Borne et al13 analyzed data from the US NCDR ICD registry to assess temporal trends in patient characteristics and outcomes of a very large number of elderly patients undergoing primary prevention ICD implantation. This study included 117 100 Medicare fee-for-service beneficiaries ≥65 years of age with left ventricular ejection fraction ≤35% who underwent primary prevention ICD implantation (with or without concomitant cardiac resynchronization therapy [CRT]) between 2006 and 2010 who could be matched to Medicare claims data. They identified that the characteristics of patients undergoing primary prevention ICD implantation changed very little from 2006 to 2010. Although some observed differences were statistically significant because of the very large number of patients, these small differences are not necessarily clinically relevant. There was no evidence for any substantial trend in the use of ICDs in patients with greater burden of coexisting illness, providing reassurance that there has been a consistent approach to patient selection for ICD therapy in United States without any indication for increased permissiveness in use of devices. In fact, the 6-month mortality among patients receiving ICDs for primary prevention declined over the study years. Complications were also reduced over time, even in this elderly population that has previously been demonstrated to have higher complication rates than younger patients.9 There was also a lower rate of rehospitalization, including heart failure rehospitalization, and an increased proportion of patients receiving CRT over time. So what is the procedural outcome of ICD therapy in elderly patients compared with younger patients? Prior investigation demonstrated a higher rate of complications in older patients.9,14,15 An analysis of Medicare beneficiaries revealed that 10.8% experienced complications before hospital discharge.14 Patients ≥75 years of age were more likely to suffer any adverse event or death after ICD implantation compared with patients
