Department of Cardiology, Barwon Health, Geelong, Vic, Australia.
Department of Cardiology, Barwon Health, Geelong, Vic, Australia.
Heart Lung Circ. 2021 Jul;30(7):986-995. doi: 10.1016/j.hlc.2020.11.002. Epub 2020 Dec 4.
Recent reports describe a high rate of premature lead failure in the St Jude/Abbott Tendril 2088 (St. Jude Medical Inc., St. Paul, MN, USA) pacing lead principally manifested by electrical noise. This finding awaits confirmation.
We performed a retrospective analysis of 2088 Tendril leads among 362 patients implanted from 2010 to 2018. Eligible leads were those with device interrogations beyond one month from lead implantation. Review of serial device interrogations was conducted for each lead, particularly focussing on electrical noise as a marker of premature lead dysfunction.
Four hundred and eight (408) leads among 337 patients were included in this study, with an average patient age of 81±11 years at the time of lead implantation. Mean follow-up was 2.5±1.8 years. There were eight leads with electrical noise indicating premature lead failure. This reflects an overall 1.7% rate of lead dysfunction; the failure rate was 6.2% at 4 years. The majority of cases were detected during routine checks without adverse clinical consequences. Four (4) cases required device reprogramming to avoid interference or inhibition due to noise.
The rate of Tendril 2088 premature lead failure appears to be similar to recent local and international studies. This study reports a significantly higher rate of lead dysfunction at 4 years (6.2%) than the published Abbott product performance reports.
最近的报告描述了一种高的早期失败率的圣犹达/雅培 Tendril 2088（圣犹达医疗公司，明尼苏达州圣保罗，美国）起搏导线，主要表现为电噪声。这一发现有待证实。
我们对 2010 年至 2018 年间植入的 362 例患者的 2088 根 Tendril 导线进行了回顾性分析。符合条件的导线是那些在植入导线后一个月以上进行设备检测的导线。对每根导线的连续设备检测进行了审查，特别是将电噪声作为早期导线功能障碍的标志。
本研究共纳入 337 例患者的 408 根导线，平均植入时患者年龄为 81±11 岁。平均随访时间为 2.5±1.8 年。有 8 根导线出现电噪声，提示早期导线故障。这反映了导线功能障碍的总发生率为 1.7%；4 年时的失败率为 6.2%。大多数病例是在常规检查中发现的，没有不良临床后果。4 例因噪声需要设备重新编程以避免干扰或抑制。
Tendril 2088 早期导线故障的发生率似乎与最近的本地和国际研究相似。本研究报告的 4 年时（6.2%）导线功能障碍的发生率明显高于已发表的雅培产品性能报告。
