Schwarzwald Sam N, Kersten Daniel J, Shaikh Zohaib A, Needelman Brandon S, Feldman Alyssa M, Germano Joseph, Islam Shahidul, Cohen Todd J
Department of Medicine, NYU Winthrop Hospital, 212 Jericho Turnpike, Mineola, NY 11501 USA.
J Invasive Cardiol. 2018 Apr;30(4):147-151.
The aim of this study was to determine the differences in lead failure mechanisms across the major United States implantable defibrillator lead manufacturers (Boston Scientific, Medtronic, and St. Jude Medical), between all non-recalled and recalled leads, and between two recalled lead families (Medtronic Sprint Fidelis and the St. Jude Medical Riata and Riata ST).
This was a single-center, non-randomized, retrospective study analyzing 3802 patients with 4078 leads who underwent implantable defibrillator lead implantation between February 1, 1996 and December 31, 2011. Lead failure mechanisms were defined as lead fracture, insulation defect, and other.
A total of 153 leads (3.8%) failed during the trial period. Failed Medtronic and St. Jude Medical leads presented predominantly as lead fractures (75.8% and 52.8%, respectively). Failed Boston Scientific leads displayed greater variability, although many also failed by fracture (44.4%). The majority of failed non-recalled and recalled leads presented as fractures (50.7% and 82.9%, respectively). The recalled Medtronic Sprint Fidelis and St. Jude Medical Riata/Riata ST leads primarily presented as fractures (89.3% and 65.0%, respectively). Patients whose lead failed via an insulation defect or other mechanism appeared to have a faster time to mortality following lead failure than patients whose lead failed via fracture (P<.01 and P=.02, respectively).
Lead fracture is the most common form of lead failure regardless of the failure points previously identified in these leads. Patients who experienced a lead failure as a result of an insulation defect or other mechanism appeared to die faster than patients whose lead failed via fracture.
本研究旨在确定美国主要植入式除颤器导线制造商（波士顿科学公司、美敦力公司和圣犹达医疗公司）之间、所有未召回和召回导线之间以及两个召回导线系列（美敦力Sprint Fidelis和圣犹达医疗公司Riata及Riata ST）之间导线故障机制的差异。
这是一项单中心、非随机、回顾性研究，分析了1996年2月1日至2011年12月31日期间接受植入式除颤器导线植入的3802例患者的4078根导线。导线故障机制定义为导线断裂、绝缘缺陷和其他。
在试验期间，共有153根导线（3.8%）发生故障。美敦力和圣犹达医疗公司发生故障的导线主要表现为导线断裂（分别为75.8%和52.8%）。波士顿科学公司发生故障的导线表现出更大的变异性，尽管许多也是因断裂而故障（44.4%）。大多数未召回和召回的故障导线表现为断裂（分别为50.7%和82.9%）。召回的美敦力Sprint Fidelis和圣犹达医疗公司Riata/Riata ST导线主要表现为断裂（分别为89.3%和65.0%）。导线因绝缘缺陷或其他机制发生故障的患者，其导线故障后的死亡时间似乎比导线因断裂发生故障的患者更快（分别为P<0.01和P = 0.02）。
无论这些导线先前确定的故障点如何，导线断裂都是最常见的导线故障形式。因绝缘缺陷或其他机制导致导线故障的患者似乎比因导线断裂导致故障的患者死亡更快。
