The overall ICD complication rate was 9.1% in RCTs compared to a significantly lower 3.08% in the NCDR registry, suggesting potential under-reporting of complications in real-world registries.
Systematic Review (n=362,948)
Yes
Are ICD complication rates reported in randomised controlled trials different from those reported in real-world registries?
ICD complication rates in real-world registries appear significantly lower than in RCTs, likely reflecting under-reporting in registries and highlighting the need for standardized complication classification.
Absolute Event Rate: 9.1% vs 3.08%
Implantable cardioverter defibrillator (ICD) implantation carries a significant risk of complications, however published estimates appear inconsistent. We aimed to present a contemporary systematic review using meta-analysis methods of ICD complications in randomised controlled trials (RCTs) and compare it to recent data from the largest international ICD registry, the US National Cardiovascular Data Registry (NCDR). PubMed was searched for any RCTs involving ICD implantation published 1999-2013; 18 were identified for analysis including 6433 patients, mean follow-up 3 months-5.6 years. Exclusion criteria were studies of children, hypertrophic cardiomyopathy, congenital heart disease, resynchronisation therapy and generator changes. Total pooled complication rate from the RCTs (excluding inappropriate shocks) was 9.1%, including displacement 3.1%, pneumothorax 1.1% and haematoma 1.2%. Infection rate was 1.5%.There were no predictors of complications but longer follow-up showed a trend to higher complication rates (p=0.07). In contrast, data from the NCDR ICD, reporting on 356 515 implants (2006-2010) showed a statistically significant threefold lower total major complication rate of 3.08% with lead displacement 1.02%, haematoma 0.86% and pneumothorax 0.44%. The overall ICD complication rate in our meta-analysis is 9.1% over 16 months. The ICD complication reported in the NCDR ICD registry is significantly lower despite a similar population. This may reflect under-reporting of complications in registries. Reporting of ICD complications in RCTs and registries is very variable and there is a need to standardise classification of complications internationally.
Ezzat et al. (Sun,) conducted a systematic review in ICD implantation (n=362,948). ICD implantation in RCTs vs. ICD implantation in NCDR registry was evaluated on Total major complication rate (excluding inappropriate shocks). The overall ICD complication rate was 9.1% in RCTs compared to a significantly lower 3.08% in the NCDR registry, suggesting potential under-reporting of complications in real-world registries.
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