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比较不同制造商生产的植入式心脏复律除颤器导线的寿命和临床结果。

Comparison of longevity and clinical outcomes of implantable cardioverter-defibrillator leads among manufacturers.

机构信息

Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.

Department of Cardiovascular Therapeutics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.

出版信息

Heart Rhythm. 2017 Oct;14(10):1496-1503. doi: 10.1016/j.hrthm.2017.05.020. Epub 2017 May 11.

DOI:10.1016/j.hrthm.2017.05.020
PMID:28502870
Abstract

BACKGROUND

An early failure of the Biotronik Linox S/SD implantable cardioverter-defibrillator (ICD) lead has been reported. We have also experienced several cases with early failure of Linox leads.

OBJECTIVE

Our aim was to assess the longevity of Linox S/SD (Biotronik, Berlin, Germany) compared with Sprint Fidelis (Medtronic, Minneapolis, MN), Sprint Quattro (Medtronic), and Endotak Reliance (Boston Scientific, Natick, Massachusetts) leads.

METHODS

We retrospectively reviewed patients who had undergone implantation of Linox S/SD (n = 90), Sprint Fidelis (n = 37), Sprint Quattro (n = 27), or Endotak Reliance (n = 50) leads between June 2000 and December 2013 at our hospital. Variables associated with lead failure were assessed by the Kaplan-Meier method and Cox survival modeling.

RESULTS

Failure rates of Linox, Sprint Fidelis, and Endotak leads were 3.2%/year (7-year survival rate, 81.0%), 3.4%/year (7-year survival rate, 77.2%), and 0.61%/year (7-year survival rate, 95.8%), respectively. No lead failure was found with Sprint Quattro leads. The survival probability of Linox leads was significantly lower than that of Endotak leads (P = .049) and comparable to that of Sprint Fidelis leads (P = .69). In univariate analysis, age was the only predictor of Linox lead failure. Patients <58 years old were at significantly increased risk of lead failure compared with patients ≥58 years old (hazard ratio, 9.0; 95% confidence interval, 1.13-71.3; P = .037).

CONCLUSION

In our single-center experience, the survival rate of Linox leads was unacceptably low. The only predictor of Linox lead failure was age at implantation. This is the first description of a lower survival rate for Linox leads in an Asian population.

摘要

背景

先前有报道称百多力(Biotronik)的 Linox S/SD 植入式心律转复除颤器(ICD)导线出现早期故障。我们也遇到了几例 Linox 导线早期故障。

目的

旨在评估 Linox S/SD(百多力,柏林,德国)与 Sprint Fidelis(美敦力,明尼苏达州明尼阿波利斯市)、Sprint Quattro(美敦力)和 Endotak Reliance(波士顿科学,马萨诸塞州纳提克)导线的使用寿命。

方法

我们回顾性分析了 2000 年 6 月至 2013 年 12 月在我院植入 Linox S/SD(n=90)、Sprint Fidelis(n=37)、Sprint Quattro(n=27)和 Endotak Reliance(n=50)导线的患者。采用 Kaplan-Meier 法和 Cox 生存模型评估与导线故障相关的变量。

结果

Linox、Sprint Fidelis 和 Endotak 导线的故障发生率分别为 3.2%/年(7 年生存率为 81.0%)、3.4%/年(7 年生存率为 77.2%)和 0.61%/年(7 年生存率为 95.8%)。Sprint Quattro 导线未发现故障。Linox 导线的生存概率明显低于 Endotak 导线(P=.049),与 Sprint Fidelis 导线相当(P=.69)。在单变量分析中,年龄是 Linox 导线故障的唯一预测因素。与≥58 岁的患者相比,<58 岁的患者导线故障风险显著增加(危险比,9.0;95%置信区间,1.13-71.3;P=.037)。

结论

在我们的单中心经验中,Linox 导线的生存率低得令人无法接受。Linox 导线故障的唯一预测因素是植入时的年龄。这是亚洲人群中 Linox 导线生存率较低的首次描述。

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