EXPERIENCE WITH A LEAD FIXATION SUTURE SLEEVE

Current anchoring systems on pacemaker leads are crude in comparison t o the lead technology. Poor anchoring technique may cause damage to th e lead or early displacement from incorrect suture tension. We describ e experience with a locking anchoring sleeve that applies a constant g ripping force to the lead body. This can be locked and unlocked to all ow optimal positioning after fixation of the sleeve to underlying tiss ues. 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 uncomplica ted; data were collected on handling and ease of use. Assessments were made using a scale of 1-10 (10 = excellent, 5 = equivalent to convent ional 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 score d 8.07 +/- 0.77, and ability to slide the sleeve along the lead body s cored 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 str aight path on either side of the sleeve with no evidence of conductor distortion. Follow-up to 3 years has been without problem. All leads r emain intact and in place, with stable thresholds and no evidence of e rosion. There have been no complaints of patient discomfort. We conclu de that this device is safe and effective and offers a significant adv ance in lead fixation.