Key result
The Sprint Fidelis and 7-F Riata ICD leads were associated with significantly higher risks of lead failure compared to a benchmark cohort (HR 3.7, P<0.001 and HR 4.2, P<0.05, respectively).
Why the study?
Do small-diameter ICD leads increase the risk of lead failure and cardiac perforation compared to standard ICD leads in patients undergoing ICD implantation?
Cohort (n=2,193)
No
Do small-diameter ICD leads increase the risk of lead failure and cardiac perforation compared to standard ICD leads in patients undergoing ICD implantation?
Hazard Ratio: 3.7 (95% CI 2.4–5.7)
Absolute Event Rate: 3.54% vs 1.14%
p-value: p=<0.001
Small-diameter ICD leads, specifically the Sprint Fidelis and 7-F Riata, are associated with a significantly higher risk of long-term lead failure compared to standard ICD leads.
Supports selective avoidance and enhanced surveillance of these leads; leaves open perforation risks and requires randomized confirmation.
BACKGROUND: The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long-term follow-up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA). METHODS: Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow-up 3.4 ± 1.5 years), 165 8-French (F) Riata leads (follow-up 4.6 ± 2.6 years), and 30 7-F Riata leads (follow-up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow-up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation. RESULTS: During follow-up, the yearly lead failure rate of the Sprint Fidelis lead, 7-F Riata lead, 8-F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4-5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0-18.0, P < 0.05) for the 7-F Riata lead. One cardiac perforation was observed (3.3%) in the 7-F Riata group versus none in the 8-F Riata and Sprint Fidelis lead population. CONCLUSION: The current update demonstrates that the risk of lead failure during long-term follow-up is significantly increased for both the Sprint Fidelis and the 7-F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.
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Rees et al. (2012) conducted a cohort in ICD system implantations (n=2,193). Sprint Fidelis and 7-F/8-F Riata ICD leads vs. Benchmark cohort of 1,602 ICD leads was evaluated on Lead failure (HR 3.7, 95% CI 2.4-5.7, p=<0.001). The Sprint Fidelis and 7-F Riata ICD leads were associated with significantly higher risks of lead failure compared to a benchmark cohort (HR 3.7, P<0.001 and HR 4.2, P<0.05, respectively).
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