Corbisiero Raffaele, Armbruster Rebecca
Department of Cardiology, Electrophysiology Division, Deborah Heart and Lung Center, Browns Mills, New Jersey 08015, USA.
Pacing Clin Electrophysiol. 2008 Jun;31(6):722-6. doi: 10.1111/j.1540-8159.2008.01076.x.
Recently, the performance and safety of smaller diameter implantable cardioverter defibrillator (ICD) leads has been questioned. The purpose of this analysis was to determine the impact of size on lead performance and perforation rates by comparing the performance of 7 French (7F) and 8 French (8F) leads with similar design characteristics implanted by a single operator.
Patients implanted with a Riata 1580 (8F) or 7000 (7F) series leads (St. Jude Medical, Sylmar, CA, USA) over a 2-year period were evaluated to compare performance and perforation rates.
There were 357 Riata 8F leads and 357 Riata 7F leads implanted in 714 patients. Follow-up ranged from 1 to 24 months. The 8F leads were implanted in the right ventricular apex more often than were 7F leads (129 or 37% vs 72 or 20%, P < 0.0001). Oversensing that did not result in therapy occurred in 2 pts (0.56%) with 8F leads and 1 pt. (0.28%) with a 7F lead (P = 0.56). Oversensing with therapy occurred once in both groups (0.28%, P = NS). One perforation occurred in each group (0.28%, P = NS). Both occurred in leads that were implanted in the right ventricular apex (P = 0.02).
The performance of St. Jude Medical 7F and 8F Riata leads was similar. The incidence of lead-related adverse events was within or below the low end of published acceptable ranges for ICD lead perforation and sensing anomalies. Perforations were less likely to occur in leads that were implanted in nonapical positions.
最近，较小直径的植入式心脏复律除颤器（ICD）导线的性能和安全性受到质疑。本分析的目的是通过比较由单一操作者植入的具有相似设计特征的7F和8F导线的性能，来确定尺寸对导线性能和穿孔率的影响。
对在2年期间植入Riata 1580（8F）或7000（7F）系列导线（美国加利福尼亚州西尔玛市圣犹达医疗公司）的患者进行评估，以比较性能和穿孔率。
714例患者中植入了357根Riata 8F导线和357根Riata 7F导线。随访时间为1至24个月。8F导线比7F导线更常植入右心室心尖（129例或37%对72例或20%，P<0.0001）。8F导线组有2例患者（0.56%）出现未导致治疗的过感知，7F导线组有1例患者（0.28%）出现过感知（P = 0.56）。两组均有1例出现导致治疗的过感知（0.28%，P = 无显著性差异）。每组均发生1例穿孔（0.28%，P = 无显著性差异）。两者均发生在植入右心室心尖的导线中（P = 0.02）。
圣犹达医疗公司的7F和8F Riata导线性能相似。导线相关不良事件的发生率在已发表的ICD导线穿孔和感知异常可接受范围的低端或以下。非心尖位置植入的导线发生穿孔的可能性较小。
