Long-term complication, reoperation high following ICD implantation
Long-term complication and reoperation rates appear to be substantially high in implantable cardioverter-defibrillator (ICD) recipients, a study has found. Additionally, increasing age strongly predicts reduced long-term complications and decreased absolute and relative survival.
Researchers assessed the rate, cumulative incidence and predictors of long-term reoperation in 3,410 patients (mean 63.3 years; 81.7 percent male) with new primary (n=1,854) or secondary prevention (n=1,556) ICD implant. The median follow-up duration was 34 months. Of the patients, 1,069 had a single-chamber device, 1,905 had a dual chamber and 436 had biventricular.
The overall reoperation rate was 12.0 percent per patient-year, with diminishing rates for single vs dual vs biventricular ICDs (17.8 vs 12.5 vs 9.1 percent per patient-year). The respective Kaplan-Meier complication estimates (excluding generator end of life) at 1, 3 and 5 years were 10.2, 16.2 and 21.6 percent for single chamber ICD; 11.7, 19.1 and 27.4 percent for dual chamber ICD; and 15.9, 22.2 and 24.7 percent for biventricular ICD.
The rate of early lead complications was highest for cardiac resynchronization therapy, although it had a lower long-term need for upgrade. Cox regression models showed that device complexity, age and atrial fibrillation were independent predictors of complications. Overall mortality was 5.4 percent at 1 year, 17.4 percent at 3 years and 32.7 percent at 5 years.
In younger patients, the observed 5-year survival was nearly similar to the expected survival in the general population (relative survival ratio, 0.96; 95 percent CI, 0.90 to 0.98). Observed survival steadily declined with increasing age, relative to expected.
The present data indicate that complication and reoperation rates are high and warrant careful consideration for informed shared decision making, researchers said.
While reducing the risk of arrhythmic death and overall mortality in select populations, ICDs are associated with high short-term complication rates. Researchers highlighted the centrality of age to complications/reoperations and benefit, with age being the most powerful predictor of survival, followed by comorbidities.