Suture sleeve improvements to hold force and lead crush resistance improves overall system performance

Abstract Introduction Suture sleeves secure implanted transvenous leads at the venous entry sites. Low holding force between the sleeve and lead body can cause lead dislodgments, leading to overtightening of the sleeve at implant to minimize the risk. Overtightening the sleeve at implant, when combined with low crush resistance, can damage both the sleeve and lead body. Purpose The purpose of this study was to evaluate how bench testing performed during the development of an updated suture sleeve design could improve clinical performance. Methods Engineering assessed the hold force between the sleeve and the lead, and protection of the lead body against overtightening, comparing an updated suture sleeve design vs. the predicate suture sleeve on the same lead. A surgeon knot using a non-resorbable braided size 0 suture was used, with forces of 0.9-3.6 kg and soaked in water prior to testing. Holding force test quantitatively determined the force required to slip the tied sleeve from the lead body. Lead body crush testing quantitatively determined the compressive force applied to the lead body during tie-down. A complaint comparison was performed on approximately 86,000 leads utilizing both suture sleeve designs, implanted between January and September of 2022. Results The hold force showed improvement on 2-groove tie down forces. At 1.8 kg of tie-down force, the hold force of the updated sleeve is 2x greater than the predicate sleeve (Figure 1A). For crush resistance, the updated sleeve had a 1.6x improvement at 3.6 kg tie-down vs. the predicate sleeve (Figure 1B). X-ray scans confirm the crush resistance provided by the updated sleeve vs. the predicate sleeve (Figure 1C). Product performance analysis after three years demonstrates a 47% reduction in system noise (p=0.000), a 54% reduction in general sleeve complaints (p=0.115), and a 34% reduction in pacing (capture) anomalies (p=0.013). Conclusion Bench testing performed on updated suture sleeves showed higher holding force with less tie-down effort while providing greater crush resistance at higher tie-down forces, relative to the predicate design. A side-by-side review of real-world data between both designs shows a reduction of associated complaints in the updated design, relative to the predicate devices.