AI Article Synopsis
- The study evaluated the performance of the S80TB ventricular lead from Sorin Biomedica over a minimum of 60 months, tracking complications and failures.
- Approximately 9.6% of patients experienced lead-related complications, with a significant portion occurring early or requiring surgical re-operations.
- The S80TB lead showed a high 5-year survival rate with minimal material failures, but highlighted concerns about connector damage during disconnections, indicating the need for careful handling.
Article 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.
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| http://dx.doi.org/10.1093/europace/euj029 | DOI Listing |
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