The 8-French Riata lead model had a higher rate of cable externalization compared to the 7-French model (12.3% vs 5.2%, P<0.0001), while the overall electrical failure rate was 5.2% at 8 years.
Observational (n=3,763)
Yes
Does the 8-French Riata lead model increase cable externalization and electrical failure compared to the 7-French model in patients with Riata leads under advisory?
The Riata lead has a steady electrical failure rate of 5.2% at 8 years, with cable externalization being more common in the 8-French model and serving as a predictor of failure.
Absolute Event Rate: 12.3% vs 5.2%
p-value: p=<0.0001
BACKGROUND: The Riata lead under advisory has posed a unique clinical scenario where inside-out abrasion results in externalization of conductor cables, with a higher risk of electrical failure. We developed a comprehensive registry to assist with clinical management of this lead. METHODS AND RESULTS: This Canadian registry reports the findings of 3763 (74.2% of all Riata leads in Canada) Riata leads under advisory, with a mean follow-up time of 8.9±1.5 years. The overall electrical failure rate was 5.2% at 8 years, with no difference between 7-French and 8-French lead models. Cable externalization was found to be more common in the 8-French model (12.3% versus 5.2%, P<0.0001) and was associated with a higher risk of electrical failure. Predictors of electrical lead failure included cable externalization, higher left ventricular ejection fraction, younger age, higher body mass index, and a passive fixation lead. One patient died due to electrical failure, a further 2 patients survived an event where the device failed to deliver high-voltage therapy. Major complications because of lead extraction were higher when compared with lead abandonment, no difference among lead model observed. Two deaths occurred as a consequence of lead extraction, in the context of an underlying infection. CONCLUSIONS: The Riata lead under advisory has a steady electrical failure rate over time. There are identifiable predictors of lead failure that can assist with clinical decisions as to whether lead revision should be performed prophylactically.
Parkash et al. (Sat,) conducted a observational in Riata leads under advisory (n=3,763). 8-French Riata lead model vs. 7-French Riata lead model was evaluated on Cable externalization (p=<0.0001). The 8-French Riata lead model had a higher rate of cable externalization compared to the 7-French model (12.3% vs 5.2%, P<0.0001), while the overall electrical failure rate was 5.2% at 8 years.