Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Heart Rhythm. 2012 Sep;9(9):1446-51. doi: 10.1016/j.hrthm.2012.04.033. Epub 2012 Apr 24.
The reported failure rate of the Medtronic Sprint Fidelis defibrillator lead continues to increase over time. Clinicians and patients count on the electrical analysis of leads through device interrogation to determine whether a lead is functioning "normally." Most importantly, this analysis is often the basis for decision making around the ongoing use of this lead at the time of generator change. Can clinicians count on this analysis and feel confident that this "advisory" lead is "normal?"
To describe the incidence of unexpected lead abnormalities among Sprint Fidelis leads removed without prior evidence of electrical abnormalities.
We performed a retrospective cohort study of Medtronic Sprint Fidelis (6930, 6931, 6948, 6949) leads extracted at a single high-volume center. Medtronic analyzed all returned leads for abnormalities. The presence and type of lead abnormalities in addition to patient characteristics, indications for extraction, implant duration, and use of extraction sheath assistance are reported.
Between September 2005 and January 2011, 209 Sprint Fidelis leads were extracted from 208 patients. The average duration of implant was 38.9 months (range 0.2-67.2). Of the analyzed leads, the majority of the extracted leads (63.1%) were active, normal functioning leads (83.8% prophylactically, 9.1% infection, and 7.1% other indication) while 36.9% had clinical evidence of a fracture. Extraction was achieved with simple traction in 39.5% of the leads; extraction sheath assistance was employed in 94 cases (59.9%), and surgical extraction at the time of transplant occurred in 1 case. Analysis of the 99 functionally "normal" leads removed determined that 20 leads had evidence of fractures (20.2%) not related to extraction. Of the fractured leads, 4 leads (20%) had more than 1 fracture and 1 lead had 3 separate fracture sites. There were 17 pacing conductor (10 proximal and 7 distal conductor) and 6 high-voltage conductor (1 superior vena cava and 5 right ventricle defibrillator conductor) fractures observed. Five additional leads (5.2%) had evidence of explant damage.
Functionally "normal" Fidelis leads demonstrate an alarmingly high rate of "subclinical" fractures. Recommendations regarding prophylactic Sprint Fidelis lead extraction, especially at the time of generator change, may warrant reconsideration. To aid in the design of better leads, all leads should be returned for analysis, regardless of the indication for extraction.
美敦力 Sprint Fidelis 除颤器导联的报告故障率持续增加。临床医生和患者依靠设备询问来对导联进行电分析，以确定导联是否“正常”工作。最重要的是，这种分析通常是在更换发生器时决定是否继续使用该导联的基础。临床医生能否依靠这种分析并确信这个“警告”导联是“正常”的？
描述在没有先前电异常证据的情况下， Sprint Fidelis 导联意外出现异常的发生率。
我们对单个高容量中心提取的美敦力 Sprint Fidelis（6930、6931、6948、6949）导联进行了回顾性队列研究。美敦力分析了所有返回的导联是否存在异常。除了患者特征、提取指征、植入持续时间以及使用提取护套辅助外，还报告了导联异常的存在和类型。
2005 年 9 月至 2011 年 1 月，从 208 名患者中提取了 209 根 Sprint Fidelis 导联。植入的平均持续时间为 38.9 个月（范围为 0.2-67.2）。在所分析的导联中，大多数提取的导联（63.1%）是功能正常的导联（83.8%预防性，9.1%感染，7.1%其他指征），而 36.9%有临床骨折证据。在 39.5%的导联中，采用简单牵引进行了提取；在 94 例中使用了提取护套辅助（59.9%），在 1 例中进行了移植时的外科提取。对 99 个功能“正常”的移除导联进行分析，确定其中 20 个导联存在与提取无关的骨折证据（20.2%）。在骨折的导联中，4 个导联（20%）有超过 1 个骨折，1 个导联有 3 个单独的骨折部位。观察到 17 个起搏导体（10 个近端和 7 个远端导体）和 6 个高压导体（1 个上腔静脉和 5 个右心室除颤器导体）骨折。另外 5 个导联（5.2%）有植入物损坏的证据。
功能“正常”的 Fidelis 导联显示出令人震惊的高“亚临床”骨折发生率。建议预防性提取 Sprint Fidelis 导联，特别是在更换发生器时，可能需要重新考虑。为了帮助设计更好的导联，无论提取的指征如何，都应将所有导联返回进行分析。
