Experience with a lead fixation/suture sleeve

Current anchoring systems on pacemaker leads are crude in comparison to the lead technology. Poor anchoring technique may cause damage to the lead or early displacement from incorrect suture tension. We describe experience with a locking anchoring sleeve that applies a constant gripping force to the lead body. This can be locked and unlocked to allow optimal positioning after fixation of the sleeve to underlying tissues. The sleeve was fitted to a 55D polyurethane lead (Medtronic 4024, 7 Fr, bipolar, steroid eluting) implanted in the ventricular position in 22 patients at four European centers. All implants were uncomplicated; data were collected on handling and ease of use. Assessments were made using a scale of 1-10 (10 = excellent, 5 = equivalent to conventional sleeve). Overall ease of use compared to conventional sleeve was 7.79 +/- 0.62 (mean +/- SD). Mean scoring of flexibility of the lead at the transition points was 7.92 +/- 0.72; ability to lock/unlock the sleeve scored 6.28 +/- 1.78. Ease of suturing around the sleeve scored 8.07 +/- 0.77, and ability to slide the sleeve along the lead body scored 6.48 +/- 1.99. Chest X rays at 6 weeks showed no change in lead position with respect to postimplant films, and all leads showed a straight path on either side of the sleeve with no evidence of conductor distortion. Follow-up to 3 years has been without problem. All leads remain intact and in place, with stable thresholds and no evidence of erosion. There have been no complaints of patient discomfort. We conclude that this device is safe and effective and offers a significant advance in lead fixation.