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Leiden Case

An independent study1 shows major differences in failure rates between different groups of transvenous implantable cardioverter defibrillator leads. Small diameter leads of a specific manufacturer may have a higher risk of early lead failure. Furthermore, with the current lead survival rate of 73% after ten years, every effort should be addressed to improve lead performance.

Boston Scientific transvenous implantable cardioverter defibrillator leads show a failure rates lower than the average failure rates across all manufacturers.

Analysis Purpose:
• Evaluate long term failure rate of ICD leads in a large single center

Clinical Relevance:
• Leiden University in the Netherlands conducted a long term study to determine the lead survivability in transvenous leads over multiple manufacturers:
- Large number of defibrillation leads (n=2161)
- Implanted over a 16 year period
- 4 manufacturers: Biotronik, Boston Scientific, Medtronic, St. Jude

• The follow-up was from transvenous lead implantation, occurring between 1992 and 2007, to February 1st 2008.
• Any case of lead removal or capping, placing additional pacing/sensing lead, or lead repositioning due to dislodgement was recorded. Cases were classified at “lead failure” or “non-lead failure.”
• Three end-points: (1) all-cause lead removal or capping; (2) lead failure; (3) lead failure or dislodgement within 6 months
• Event rates adjusted for age, sex, and left ventricular ejection fraction (LVEF).

The findings can be summarized as follows:

1. Cumulative (Figure 1) lead failure at one year was 1.9%, at two years 3.5%, at five years 10.4% and at ten years 26.9% meaning that after 10 years, 73.1% of all implanted leads were still functioning.
2. The incidence of lead failure is 1.3 (95% CI 1.0,1.6) per 100 lead-years;
3. Grouping by manufacturer and lead diameter revealed major differences in event rates, according to the author;
4. Specific manufacturer’s small diameter defibrillation leads exhibit a higher failure rate.

Figure 1. Kaplan-Meier curve for all-cause lead removal or capping.
1 Borleffs W, van Erven, J. van Bommel R. et al. Risk of Failure of Transvenous Implantable Cardioverter Defibrillator Leads. Circulation of Arrhythmia and Electrophysiology (2009). DOI: 0.1161/CIRCEP.108.834093