Department of Medicine, Division of Cardiology, Albany Medical Center, Albany, New York, USA.
J Cardiovasc Electrophysiol. 2021 Apr;32(4):1111-1121. doi: 10.1111/jce.14941. Epub 2021 Feb 24.
Several recent studies have raised concern about noise detections on Tendril pacemaker leads, which may represent insulation failure or algorithm-driven overreporting of physiologic signals.
We identified all pacemaker leads actively followed at Albany Medical Center, of which 1111 leads (262 Abbott Tendril, 576 Medtronic CapSure, 30 Fineline, 195 Ingevity, 48 Dextrus) in 703 patients were included in this observational study. Electrical abnormalities, comprising low-impedance measurements <200 Ω and repeated noise detections, were catalogued, as was initial management and subsequent need for surgical intervention.
During 54 months median follow-up (interquartile range 24-105), 63 leads (5.7%) demonstrated electrical abnormalities, including low impedances in 21 and noise in 59. Tendril leads manifested abnormalities most frequently (n = 50; 19.1%) compared with CapSure (n = 9; 1.6%), Fineline (n = 0), Ingevity (n = 0), and Dextrus (n = 4; 8.3%) leads. The risk of abnormalities was significantly higher in Tendril leads (HR 9.6, 95% CI 5.2-17.6; p < .001). Low impedances were measured on 19 Tendril leads, a significantly higher risk than on other leads (HR 23.8, 95% CI 5.5-102.1; p < .001). Although observation and reprogramming sensitivity were the initial management strategy for 45 and 7 leads, respectively, 18 ultimately required surgical intervention, including 15 Tendrils. No electrical abnormalities were observed in 12 non-Tendril leads attached to Abbott devices compared with 48 of 252 Tendrils attached to Abbott devices (log-rank p = .035).
Tendril leads demonstrate significantly higher risk of repeated low impedances and noise compared to other manufacturers' models, raising concern that these findings reflect early insulation failure. Increased scrutiny is warranted.
最近的几项研究引起了人们对 Tendril 起搏器导联上噪声检测的关注，这些检测可能代表绝缘故障或算法驱动的生理信号过度报告。
我们确定了奥尔巴尼医疗中心正在积极监测的所有起搏器导联，其中包括 703 名患者的 1111 根导联（262 根雅培 Tendril、576 根美敦力 CapSure、30 根 Fineline、195 根 Ingevity、48 根 Dextrus）被纳入本观察性研究。对包括低阻抗测量值<200Ω和反复出现噪声检测在内的电异常进行了分类，并记录了初始管理和随后是否需要手术干预。
在 54 个月的中位随访期间（四分位距 24-105），63 根导联（5.7%）出现电异常，包括 21 根低阻抗和 59 根噪声。Tendril 导联出现异常的频率最高（n=50；19.1%），其次是 CapSure（n=9；1.6%）、Fineline（n=0）、Ingevity（n=0）和 Dextrus（n=4；8.3%）导联。Tendril 导联发生异常的风险显著高于其他导联（HR 9.6，95%CI 5.2-17.6；p<.001）。19 根 Tendril 导联测量到低阻抗，风险明显高于其他导联（HR 23.8，95%CI 5.5-102.1；p<.001）。尽管分别对 45 根和 7 根导联进行了观察和重新编程作为初始管理策略，但最终有 18 根导联需要手术干预，其中包括 15 根 Tendril 导联。与连接 Abbott 设备的 252 根 Tendril 导联相比，在连接 Abbott 设备的 12 根非 Tendril 导联中未观察到电异常（对数秩检验 p=.035）。
与其他制造商的模型相比，Tendril 导联反复出现低阻抗和噪声的风险明显更高，这引发了人们的担忧，即这些发现反映了早期绝缘故障。需要加强审查。
