Long-Term Risk for Device-Related Complications and Reoperations After Implantable Cardioverter-Defibrillator Implantation: An Observational Cohort Study
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Published on: February 28, 2012
Insights
Older adults receiving an implantable cardioverter-defibrillator (ICD) face significant risks of complications and reoperations. Careful consideration of ICD implantation benefits versus risks is crucial for patient care.
Area of Science:
- Cardiology
- Medical Devices
- Health Outcomes Research
Background:
- Long-term nonfatal outcomes following implantable cardioverter-defibrillator (ICD) placement are not well-defined.
- Understanding these outcomes is critical for patient management and device selection.
- The American College of Cardiology Foundation's National Cardiovascular Data Registry provides valuable data for such research.
Purpose of the Study:
- To determine the long-term risk of ICD-related complications requiring reoperation or hospitalization.
- To assess the risk of reoperation for reasons other than complications.
- To identify patient and device characteristics associated with these risks.
Main Methods:
- An observational cohort study utilized data from the National Cardiovascular Data Registry ICD registry linked with Medicare fee-for-service claims.
- The study included 114,484 patients aged 65 years or older who received their first ICD between 2006 and 2010 across 1437 U.S. hospitals.
- Outcomes assessed included ICD-related complications requiring reoperation/hospitalization and reoperations for other causes, with a median follow-up of 2.7 years.
Main Results:
- The study found 6.1 ICD-related complications per 100 patient-years requiring reoperation or hospitalization and 3.9 reoperations per 100 patient-years for other reasons.
- Younger age at implantation, receipt of a cardiac resynchronization therapy with a defibrillator (CRT-D) device, female sex, and black race were associated with increased risks.
- Overall, 10 patients experienced complications or reoperation per 100 patient-years.
Conclusions:
- Patients aged 65 and older have a high rate of device-related complications and reoperations after ICD implantation.
- Factors such as younger age, CRT-D device type, female sex, and black race increase the risk of complications.
- The risks associated with ICD implantation and strategies to mitigate them warrant active consideration prior to the procedure.
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.
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