Section of Electrophysiology, Division of Cardiology, Emory University, Atlanta, Georgia.
Section of Electrophysiology, Division of Cardiology, Emory University, Atlanta, Georgia.
Heart Rhythm. 2019 Apr;16(4):572-578. doi: 10.1016/j.hrthm.2018.10.024. Epub 2018 Oct 24.
The performance of Abbott/St. Jude Medical (Sylmar CA) Tendril pacing leads has not been well characterized.
We sought to assess the performance of Tendril leads as compared with that of different pacing leads.
We retrospectively identified patients implanted with the following leads: Tendril leads 1888 TC, 2088 TC, and 1688 TC, Medtronic (Fridely, MN) 4076 CapSureFix Novus, and Boston Scientific (Natick, MA) FINELINE II Sterox Pacing EZ leads (models 4469, 4470, and 4471). The primary end point was the incidence of lead malfunction assessed by Kaplan-Meier analysis.
During the study period, 9782 leads were implanted, including 8512 Tendril leads, 731 Medtronic 4076 CapSureFix Novus leads, and 539 FINELINE II leads. A total of 540 leads (5.5%) malfunctioned during a mean follow-up of 3.6 ± 2.9 years. Lead malfunction manifested predominantly as noise and/or low impedance (95%). Lead malfunction rates were significantly higher at 5 years for Tendril vs non-Tendril leads (7.0% vs 2.1%; P < .001). The highest rate of failure at 5 years was seen in the Tendril 1888 TC leads (9.9%), followed by Tendril 1688 (5.7%) and Tendril 2088 (5.2%) leads. In contrast, malfunction rates were significantly lower for the Medtronic 4076 (2.6%) and FINELINE II (1.7%) leads. During follow-up to 10 years, the incidence of lead malfunction for Optim-insulated Tendril leads (models 1888 TC and 2088 TC) was significantly higher than that for the non-Optim-insulated Tendril 1688 TC lead (24.5% vs 7.1%) (P = .008).
Tendril leads appear to have a higher rate of malfunction than do comparator leads. Optim insulation may partly explain the higher failure rate.
雅培/圣犹达医疗（加利福尼亚州西尔马） Tendril 起搏导线的性能尚未得到充分描述。
我们旨在评估 Tendril 导线与其他起搏导线的性能。
我们回顾性地确定了植入以下导线的患者：Tendril 导线 1888 TC、2088 TC 和 1688 TC、美敦力（弗雷德里克，明尼苏达州）4076 CapSureFix Novus 和波士顿科学（马萨诸塞州纳提克）FINELINE II Sterox Pacing EZ 导线（型号 4469、4470 和 4471）。主要终点是通过 Kaplan-Meier 分析评估导线故障的发生率。
在研究期间，植入了 9782 根导线，其中包括 8512 根 Tendril 导线、731 根美敦力 4076 CapSureFix Novus 导线和 539 根 FINELINE II 导线。在平均 3.6 ± 2.9 年的随访期间，共有 540 根导线（5.5%）发生故障。导线故障主要表现为噪声和/或低阻抗（95%）。与非 Tendril 导线相比，Tendril 导线在 5 年内的故障发生率明显更高（7.0%比 2.1%；P<.001）。在 5 年内，Tendril 1888 TC 导线的失败率最高（9.9%），其次是 Tendril 1688（5.7%）和 Tendril 2088（5.2%）导线。相比之下，美敦力 4076（2.6%）和 FINELINE II（1.7%）导线的故障发生率明显较低。在 10 年的随访中，Optim 绝缘 Tendril 导线（型号 1888 TC 和 2088 TC）的导线故障发生率明显高于非 Optim 绝缘 Tendril 1688 TC 导线（24.5%比 7.1%）（P=.008）。
Tendril 导线似乎比比较导线更容易出现故障。Optim 绝缘可能部分解释了更高的失败率。
