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Registry data identified risk factors linked with complications after ICD replacement
Krahn A. Circ Arrhythm Electrophysiol. 2011;doi:10.1161/CIRCEP.110.959791.
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New data from a Canadian registry suggest that angina, antiarrhythmic therapy and low implanter volume are among the risk factors associated with complications after implantable cardioverter defibrillator replacement.
The population-based, prospective registry included all patients treated with an ICD at 18 centers in Ontario, Canada. Investigators looked at 45-day complication and all-cause mortality rates in patients who underwent ICD generator replacement between February 2007 and August 2009.
During this period, 1,081 (20.8%) of 5,176 patients had an ICD replacement, with 47 patients (4.3%) experiencing a complication within 45 days. Among the major complications, the most common were lead revision (n=35), pocket revision or sepsis (n=23), electrical storm (n=14) and pulmonary edema (n=13), whereas the most common minor complications were incisional infection (n=10) and pocket hematoma (n=10).
After multivariate analysis, the risk factors correlating with major complications were Canadian Cardiovascular Society (CCS) angina Class II to IV vs. zero to Class I (adjusted HR=3.70; 95% CI, 0.96-11.70) and any previous surgery (adjusted HR=3.35; 95% CI, 1.16-11.81), whereas the risk factors associated with any complication were implanter volume (adjusted HR=10.40; 95% CI, 1.32-82.14 for <60/year vs. >120/year), antiarrhythmic therapy (adjusted HR=6.29; 95% CI, 2.07-19.09) and CCS angina Class II to IV vs. zero to Class I (adjusted HR=3.00; 95% CI, 1.11-8.15).
“The clinical utility of the findings include the provision of benchmarks for quality improvement and informed consent,” the researchers wrote. “Generator change is a higher risk procedure than new implants, which argues for developing longer-lasting devices, minimizing unnecessary battery drain, replacing normally functioning advisory components, particularly when the incremental benefit of a discretionary procedure such as system upgrade is known. This suggests that clinicians and researchers should consider strategies to minimize the need for device replacement, particularly since most devices are implanted for primary prevention.”
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