May 2, 2016
Ver artículo completoLong-Term Risk for Device-Related Complications and Reoperations After Implantable Cardioverter-Defibrillator Implantation
Resultado clave
First-time ICD implantation in older adults was associated with 10 complications or reoperations per 100 patient-years, with higher risks in younger patients, females, and those receiving CRT-D.
Diseño del estudio
Tipo
Cohort (n=114,484)
Multicéntrico
Sí
PICO estructurado
What is the long-term risk of device-related complications and reoperations after first-time ICD implantation in older adults?
P
Población
114,484 Medicare fee-for-service patients aged 65 years or older receiving a first-time ICD, followed for a median of 2.7 years.
E
Exposición
First-time implantable cardioverter-defibrillator (ICD) implantation (single-chamber, dual-chamber, or CRT-D)
O
Resultado
Rate and cumulative incidence of ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complicationssafety
Older patients receiving a first-time ICD face a substantial long-term risk of device-related complications and reoperations, highlighting the need for careful risk-benefit consideration prior to implantation.
Limitaciones
- The analysis was limited to Medicare fee-for-service patients aged 65 years or older.
Resumen
BACKGROUND: Long-term nonfatal outcomes after implantable cardioverter-defibrillator (ICD) placement are poorly defined. OBJECTIVE: To determine the long-term risk for ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications, and to assess associated patient and device characteristics. DESIGN: Observational cohort study of ICD implantations from the National Cardiovascular Data Registry ICD registry linked with Medicare fee-for-service claims data. SETTING: 1437 U.S. hospitals. PATIENTS: 114 484 patients aged 65 years or older (mean, 74.8 years SD, 6.2; 72.4% male) receiving an ICD for the first time from 2006 to 2010 (single-chamber, 19.8%; dual-chamber, 41.3%; cardiac resynchronization therapy with a defibrillator CRT-D, 38.9%). MEASUREMENTS: Rate and cumulative incidence of ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications. RESULTS: During a median follow-up of 2.7 years (interquartile range, 1.8 to 3.9 years), 40 072 patients died, representing 12.6 (95% CI, 12.5 to 12.7) deaths per 100 patient-years of follow-up. When the risk for death was accounted for, there were 6.1 (CI, 6.0 to 6.2) ICD-related complications per 100 patient-years that required reoperation or hospitalization and 3.9 (CI, 3.8 to 4.0) reoperations per 100 patient-years for reasons other than complications. Overall, 10 patients had complications or reoperation per 100 patient-years of follow-up. Younger age at implantation (65 to 69 vs. >85 years) (hazard ratio HR, 1.55 CI, 1.43 to 1.69), receipt of a CRT-D device (HR, 1.38 CI, 1.31 to 1.45) versus a single-chamber device, female sex (HR, 1.16 CI, 1.12 to 1.21), and black race (HR, 1.14 CI, 1.05 to 1.23) were associated with the greatest increased risks for ICD-related complications. LIMITATION: The analysis was limited to Medicare fee-for-service patients aged 65 years or older. CONCLUSION: Patients have a high rate of device-related complications and reoperation for other causes after ICD implantation. Risks of ICD implantation and strategies to reduce them should be actively considered before implantation. PRIMARY FUNDING SOURCE: American College of Cardiology Foundation's National Cardiovascular Data Registry.