Comparative durability of pacemaker leads in transvenous lead extraction: An evaluation through bench testing

Abstract

Background

Transvenous lead extraction (TLE) is a less invasive alternative to surgical removal, but leads may break during TLE.

Objective

The purpose of this study was to compare the tensile strength and behavior under stress of leads from different manufacturers during TLE using different extraction techniques.

Methods

Different lead types (Tendril STS, INGEVITY, INGEVITY+, Solia S, and CapSure Fix) were subjected to tensile testing using a testing machine. The leads were tested in up to 3 different configurations: terminal removed, terminal retained, and removal using a snare. Lead durability was assessed by increasing force and measuring elongation and the force required for complete disruption.

Results

The tensile strength of leads varied greatly based on the extraction technique and lead type. The INGEVITY leads showed improved durability when secured with a snare, despite weak performance when the terminal was removed or retained. The INGEVITY+ lead exhibited enhanced durability, particularly when removed using a snare. The Tendril STS lead exhibited the least durability when the terminal was removed but had comparable durability to the Solia S and CapSure Fix leads when the terminal was retained. The Solia S and CapSure Fix leads had consistent higher durability, irrespective of whether or not the terminal was removed.

Conclusion

This study found wide variability of lead behavior among manufacturers and with different extraction techniques. Terminal retention and snare usage enhanced lead durability, suggesting that these techniques should be considered depending on lead type and for leads with longer implantation periods or if higher extraction forces are anticipated.