Steinberg Christian, Sarrazin Jean-François, Philippon François, Champagne Jean, Bouchard Marc-André, Molin Franck, Nault Isabelle, Blier Louis, O'Hara Gilles
Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ), Division of electrophysiology, 2725, chemin Sainte-Foy, Quebec, QC, G1V 4G5, Canada,
J Interv Card Electrophysiol. 2014 Dec;41(3):217-22. doi: 10.1007/s10840-014-9951-6. Epub 2014 Nov 16.
Riata(TM) defibrillation leads are susceptible to conductor externalization. The point prevalence of insulation defect in Riata(TM) leads is up to 33 %, but prospective data concerning incidence of new lead abnormalities are lacking. The purpose of our study was to determine the annual incidence of new conductor externalizations and electrical lead failure.
A prospective observational study was conducted at a single tertiary center. One hundred forty-one patients were followed over 12 months. A posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming was performed at baseline and at 12 months to screen for conductor externalization. Electrical abnormalities and clinical outcome were also assessed.
The overall incidence of new insulation defects was 8.5 % at 12 months. High-risk leads for new conductor externalization were lead models 1580, 1582, and 1590 with an annual rate of 11.9, 11.1, and 10 %, respectively. New conductor externalizations were three times more common in 8 Fr leads compared to 7 Fr leads. The overall incidence of new electrical dysfunction was 6.4 % at 12 months. Electrical dysfunction was significantly higher in abnormal leads (25 % [3/12], 4.7 % [6/129]; p = 0.03) and mostly driven by high ventricular pacing thresholds. There was no difference in inappropriate shock or failure of high-voltage therapy.
The annual incidence of new insulation defects in Riata(TM) leads is much higher than previously reported. Lead models 1580, 1582, and 1590 are at highest risk for new conductor externalization. Electrical dysfunction in Riata(TM) leads is also much higher than reported and is associated with conductor externalization.
Riata™除颤导线易发生导线外部化。Riata™导线绝缘缺陷的点患病率高达33%，但缺乏关于新导线异常发生率的前瞻性数据。我们研究的目的是确定新导线外部化和电导线故障的年发生率。
在一家单一的三级中心进行了一项前瞻性观察研究。对141例患者进行了12个月的随访。在基线和12个月时进行后前位（PA）/侧位胸部X线摄影（CXR）并放大以筛查导线外部化。还评估了电异常和临床结果。
12个月时新绝缘缺陷的总体发生率为8.5%。新导线外部化的高风险导线型号为1580、1582和1590，年发生率分别为11.9%、11.1%和10%。与7Fr导线相比，8Fr导线中新导线外部化的发生率高3倍。12个月时新电功能障碍的总体发生率为6.4%。异常导线中的电功能障碍明显更高（25%[3/12]，4.7%[6/129]；p = 0.03），且主要由高心室起搏阈值驱动。不适当电击或高压治疗失败方面无差异。
Riata™导线中新绝缘缺陷每年的发生率远高于先前报道。导线型号1580、1582和1590发生新导线外部化的风险最高。Riata™导线中的电功能障碍也远高于报道水平，且与导线外部化相关。
