Update on small-diameter implantable cardioverter-defibrillator leads performance

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Technology

Background:

• Small diameter implantable cardioverter defibrillator (ICD) leads raise concerns regarding their long-term performance.
• Limited data exists on the long-term follow-up performance of specific ICD leads, necessitating further investigation.
• This study focuses on evaluating the lead failure and cardiac perforation rates of Medtronic Sprint Fidelis and St. Jude Medical Riata ICD leads.

Purpose of the Study:

• To provide an updated assessment of lead failure and cardiac perforation rates for Medtronic Sprint Fidelis and St. Jude Medical Riata ICD leads.
• To compare the performance of these specific ICD leads against a benchmark cohort over an extended follow-up period.

Main Methods:

• A retrospective analysis of ICD system implantations registered since 1996 at Leiden University Medical Center.
• Inclusion of data up to February 2011 for 396 Sprint Fidelis leads, 165 8-French (F) Riata leads, and 30 7-F Riata leads.
• Comparison of lead failure and cardiac perforation rates with a benchmark cohort of 1,602 ICD leads.

Main Results:

• Yearly lead failure rates were 3.54% for Sprint Fidelis, 2.28% for 7-F Riata, 0.78% for 8-F Riata, and 1.14% for the benchmark cohort.
• The Sprint Fidelis lead exhibited an adjusted hazard ratio of 3.7 (95% CI 2.4-5.7) and the 7-F Riata lead showed 4.2 (95% CI 1.0-18.0) for lead failure compared to the benchmark.
• One cardiac perforation (3.3%) occurred in the 7-F Riata group; no perforations were observed in the 8-F Riata or Sprint Fidelis groups.

Conclusions:

• Both the Sprint Fidelis and 7-F Riata ICD leads demonstrate a significantly increased risk of lead failure during long-term follow-up.
• The study highlights the importance of continued monitoring for small-diameter ICD leads.
• Cardiac perforation rates were low across the studied lead types.