LAUSR

BACKGROUND Pacing leads are the Achilles heel of pacemakers. Most manufacturers report a 3-year survival rate of >99% of their leads. We observed several failures of the Beflex™/Vega™ leads (MicroPort, formerly Sorin/LivaNova). OBJECTIVE To investigate failure rates of Beflex™/Vega™ leads. METHODS We analyzed the performance of Beflex™/Vega™ leads implanted at our tertiary referral center. All-cause lead failures (any issues requiring re-interventions such as lead dislocations, cardiac perforations, electrical abnormalities) were identified during follow-up. The Beflex™/Vega™ lead was compared to a reference lead (Medtronic CapSureFix Novus 5076™) implanted within the same period and by the same operators. RESULTS 585 leads were analyzed (382 Beflex™/Vega™ and 203 CapSureFix Novus 5076™ leads). Cumulative failure rate estimates were 5.2%, 6.3%, and 12.4% after one, two, and three years for the Beflex™/Vega™ lead. This was worse compared to the reference lead (1.5%, 1.5%, 3.7% after one, two, and three years, p=0.001). Early failure manifestations up to 3 months occurred at a similar rate (1.3% vs. 0.5% for dislocations; 1.3% vs. 1.0% for perforations (Beflex™/Vega™ vs. CapSureFix Novus 5076™ lead)). During follow-up, electrical abnormalities such as noise oversensing (p=0.013) and increased pacing thresholds (p=0.003) became more frequent in the Beflex™/Vega™ group. Electrical abnormalities were the most common failure manifestation three years after implantation in this group (9.4% vs. 2.2% for the CapSureFix Novus 5076™). CONCLUSION The failure rate of the Beflex™/Vega™ lead of >10% after three years was higher compared to a competitor lead. This gives rise to concern since >135'000 such leads are active worldwide.