Providência Rui, Kramer Daniel B, Pimenta Dominic, Babu Girish G, Hatfield Laura A, Ioannou Adam, Novak Jan, Hauser Robert G, Lambiase Pier D
The Heart Hospital, University College of London Hospitals NHS Trust, London, United Kingdom (R.P., G.G.B., P.D.L.) Barts Heart Centre, Barts Health NHS Trust, London, United Kingdom (R.P., P.D.L.).
Cardiac Electrophysiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D.B.K.).
J Am Heart Assoc. 2015 Oct 30;4(11):e002418. doi: 10.1161/JAHA.115.002418.
Despite the widespread use of implantable cardioverter-defibrillators (ICDs) in clinical practice, concerns exist regarding ICD lead durability. The performance of specific lead designs and factors determining this in large populations need clarification.
The Medline, Embase, and Cochrane Collaboration databases were searched for studies including ≥2 of the most commonly implanted leads. The Mantel-Haenszel random-effects model was used. Seventeen studies were selected, including a total of 49 871 patients-5538 implanted with Durata (St. Jude Medical Inc), 10 605 with Endotak Reliance (Boston Scientific), 16 119 with Sprint Quattro (Medtronic Corp), 11 709 with Sprint Fidelis (Medtronic Corp), and 5900 with Riata (St. Jude Medical Inc)-with follow-up of 136 509 lead-years. Although the Durata lead presented a numerically higher rate, no statistically significant differences in the mean incidence of lead failure (0.29%-0.45% per year) were observed in comparison of the 3 nonrecalled leads. A higher event rate was documented with the Riata (1.0% per-year increase) and Sprint Fidelis (>2.0% per-year increase) leads compared with nonrecalled leads. An indication of increased incidence of Durata lead failure versus Sprint Quattro and Endotak Reliance leads was observed in 1 of 3 included studies, allowing for comparison of purely electrical lead failure, but this requires further evaluation.
Endotak Reliance (8F), Sprint Quattro (8F), and Durata (7F) leads displayed low annual incidence of failure; however, long-term follow-up data are still scarce. More data are needed to clarify the performance and safety of the Durata lead.
尽管植入式心脏复律除颤器（ICD）在临床实践中已广泛应用，但人们对ICD导线的耐用性仍存在担忧。在大量人群中，特定导线设计的性能以及决定该性能的因素尚需阐明。
检索了Medline、Embase和Cochrane协作网数据库，纳入的研究需包含至少2种最常用的导线。采用Mantel-Haenszel随机效应模型。共选取了17项研究，涉及49871例患者，其中5538例植入了Durata导线（圣犹达医疗公司），10605例植入了Endotak Reliance导线（波士顿科学公司），16119例植入了Sprint Quattro导线（美敦力公司），11709例植入了Sprint Fidelis导线（美敦力公司），5900例植入了Riata导线（圣犹达医疗公司），随访时间总计136509导线-年。尽管Durata导线在数值上显示出较高的故障率，但与3种未召回的导线相比，导线故障的年平均发生率（每年0.29%-0.45%）并无统计学显著差异。与未召回的导线相比，Riata导线（每年增加1.0%）和Sprint Fidelis导线（每年增加>2.0%）的事件发生率更高。在3项纳入研究中的1项研究中，观察到Durata导线相对于Sprint Quattro和Endotak Reliance导线的故障率有增加的迹象，从而能够比较单纯的电导线故障，但这需要进一步评估。
Endotak Reliance（8F）、Sprint Quattro（8F）和Durata（7F）导线的年故障率较低；然而，长期随访数据仍然匮乏。需要更多数据来阐明Durata导线的性能和安全性。
