Clinical surveillance of a tined, bipolar, silicone-insulated ventricular pacing lead.

ABSTRACT

AIMS: This study assesses short- and long-term performance of the S80TB ventricular lead manufactured by Sorin Biomedica, Italy. METHODS AND RESULTS: Three hundred and thirty leads were implanted and had complete follow-up with us for a minimum of 60 months or up to failure, removal, and/or patient death (mean 40 months, range 1 day to 81 months). Thirty-two patients (9.6%) had spontaneous lead-related complications 7 (2.1%) occurred during the first week; 25 (7.6%) had chronic complications, of which 20 (6.1%) necessitated re-operations; 3 (0.9%) were lead material failures. Of the 110 re-operations (90 pacemaker replacements and 20 operations due to complications), 7 additional cases (6.4%) were complicated by unique connector damage that occurred during disconnection of the lead from the connector block. The Kaplan-Meier estimated 5-year lead survival free of lead material failure and free of any significant lead complication were 97.9 and 87%, respectively. CONCLUSION: The S80TB lead demonstrates an acceptable rate of acute and chronic spontaneous complications and very few lead material failures over 5 years of follow-up. However, there seems to be a relatively high incidence of connector damage during disconnection from the connector block. Extra caution is required during those procedures in patients with this lead.