Key result
In vivo exposure of silicone (MED-4719) cardiac leads significantly decreased load to failure after 94 months (from 21.9 N to 15.3 N, p=0.0063) and elongation to failure after 8 months.
Why the study?
Because the in-vivo environment affects the mechanical behavior of implantable devices, there was a need to evaluate the residual properties of implantable silicone leads over time.
Does prolonged in vivo exposure affect the residual mechanical properties of silicone (MED-4719) pacing leads?
Population
Silicone (MED-4719) leads from 150 collected devices
Comparison
Leads with different in vivo exposure times vs a new unused lead
Authors
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May signal increased long-term lead failure risk; leaves open need for clinical outcome studies.
Does prolonged in vivo exposure affect the residual mechanical properties of silicone (MED-4719) pacing leads?
Absolute Event Rate: 15.27% vs 21.9272%
p-value: p=0.0063
Salih et al. (2022) studied Retrieved cardiac pacing leads (n=25). In vivo environment exposure vs. New, unexposed leads was evaluated on Load to failure (p=0.0063). In vivo exposure of silicone (MED-4719) cardiac leads significantly decreased load to failure after 94 months (from 21.9 N to 15.3 N, p=0.0063) and elongation to failure after 8 months.
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