Key result
The retained connector method provided higher rail strength compared to the modified cut lead method (mean 11.42 lbf vs 8.51 lbf) during bench testing of lumenless lead extraction.
Why the study?
Increased use of lumenless leads for conduction system pacing requires an understanding of applicable tensile forces and lead preparation techniques influencing consistent extraction.
Does the retained connector method improve rail strength compared to the modified cut lead method during extraction of lumenless pacing leads in bench testing?
Does the retained connector method improve rail strength compared to the modified cut lead method during extraction of lumenless pacing leads in bench testing?
Absolute Event Rate: 11.42% vs 8.51%
In bench testing of lumenless pacing leads, retaining the IS1 connector during extraction preparation preserves rail strength better than severing the lead body.
Retained connector may enhance rail strength in bench models; leaves open translation to patient outcomes in lumenless lead extraction.
BackgroundWith the advent of conduction system pacing, use of the Medtronic SelectSecure Model 3830 lead has increased substantially. However, with this increased use, the potential need for lead extraction also will increase. Lumenless lead construction requires an understanding of both applicable tensile forces as well as lead preparation techniques that can influence consistent extraction.ObjectiveThe purpose of this study was to use bench testing methodologies to characterize the physical properties of lumenless leads and to describe related lead preparation methods that support known extraction techniques.MethodsMultiple 3830 lead preparation techniques, commonly used in extraction practices, were compared on the bench to assess rail strength (RS) in simple traction and use conditions with simulated scar. Retention of the IS1 connector vs severing the lead body preparation techniques were compared. Distal snare and rotational extraction tools were evaluated.ResultsThe retained connector method provided higher RS compared to the modified cut lead method: mean 11.42 lbf (9.85–12.73 lbf) vs 8.51 lbf (1.66–14.32 lbf), respectively. Snare use distally did not significantly affect RS: mean 11.05 lbf (8.58–13.95 lbf). Lead damage occurred with the TightRail extraction tool at angles ≥90°, which could occur with right-sided implants.ConclusionsWhen extracting SelectSecure leads, the retained connector method to maintain cable engagement benefits preservation of the extraction RS. Limiting traction force to <10 lbf (4.5 kgf) and avoiding poor lead preparation methods are critical to consistent extraction. Femoral snaring does not change RS when needed and offers a method to regain lead rail in cases of distal cable fracture. With the advent of conduction system pacing, use of the Medtronic SelectSecure Model 3830 lead has increased substantially. However, with this increased use, the potential need for lead extraction also will increase. Lumenless lead construction requires an understanding of both applicable tensile forces as well as lead preparation techniques that can influence consistent extraction. The purpose of this study was to use bench testing methodologies to characterize the physical properties of lumenless leads and to describe related lead preparation methods that support known extraction techniques. Multiple 3830 lead preparation techniques, commonly used in extraction practices, were compared on the bench to assess rail strength (RS) in simple traction and use conditions with simulated scar. Retention of the IS1 connector vs severing the lead body preparation techniques were compared. Distal snare and rotational extraction tools were evaluated. The retained connector method provided higher RS compared to the modified cut lead method: mean 11.42 lbf (9.85–12.73 lbf) vs 8.51 lbf (1.66–14.32 lbf), respectively. Snare use distally did not significantly affect RS: mean 11.05 lbf (8.58–13.95 lbf). Lead damage occurred with the TightRail extraction tool at angles ≥90°, which could occur with right-sided implants. When extracting SelectSecure leads, the retained connector method to maintain cable engagement benefits preservation of the extraction RS. Limiting traction force to <10 lbf (4.5 kgf) and avoiding poor lead preparation methods are critical to consistent extraction. Femoral snaring does not change RS when needed and offers a method to regain lead rail in cases of distal cable fracture.
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Vatterott et al. (2023) studied Lead extraction. Retained IS1 connector method vs. Modified cut lead method was evaluated on Rail strength (RS). The retained connector method provided higher rail strength compared to the modified cut lead method (mean 11.42 lbf vs 8.51 lbf) during bench testing of lumenless lead extraction.
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