Lipchenca Igor A, Bar-Lev David S, Luria David M, Gurevitz Osnat T, Granit Chava, Rotstein Zeev, Ovsyshcher Eli I, Eldar Michael, Glikson Michael
Heart Institute Sheba Medical Center, Tel Hashomer, Israel.
Europace. 2006 Feb;8(2):118-21. doi: 10.1093/europace/euj029. Epub 2006 Jan 9.
This study assesses short- and long-term performance of the S80TB ventricular lead manufactured by Sorin Biomedica, Italy.
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.
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.
本研究评估意大利索林生物医学公司生产的S80TB心室导线的短期和长期性能。
共植入330根导线，并接受我们至少60个月的完整随访，或直至出现故障、移除和/或患者死亡（平均40个月，范围：1天至81个月）。32例患者（9.6%）出现与导线相关的自发并发症：7例（2.1%）在第一周内发生；25例（7.6%）出现慢性并发症，其中20例（6.1%）需要再次手术；3例（0.9%）为导线材料故障。在110次再次手术中（90次更换起搏器和20次因并发症进行的手术），另外7例（6.4%）因在导线与连接块断开连接时发生独特的连接器损坏而出现并发症。Kaplan-Meier法估计5年导线无材料故障且无任何严重导线并发症的生存率分别为97.9%和87%。
S80TB导线在5年随访期间显示出可接受的急慢性自发并发症发生率，且导线材料故障极少。然而，在与连接块断开连接时，连接器损坏的发生率似乎相对较高。对于植入该导线的患者，在这些操作过程中需要格外小心。
