Hauser R G, Kurschinski D T, McVeigh K, Thomas A, Mower M M
Cardiac Pacemakers, Inc., St. Paul, Minnesota.
Pacing Clin Electrophysiol. 1993 Jan;16(1 Pt 2):141-8. doi: 10.1111/j.1540-8159.1993.tb01551.x.
The results of two separate US Food and Drug Administration clinical trials that involved endocardial and epicardial leads were compared with regard to patient demographics, detection and conversion characteristics, and subsequent clinical course including long-term survival experience. The patient groups, although not strictly contemporaneous, were sufficiently similar to allow meaningful comparisons. There were no significant differences in detection of induced arrhythmias and ability to convert them. The surgical mortality, infection rate, and incidence of other morbid complications were lower in patients who had received endocardial leads; however, the differences did not reach statistical significance. Survivals through 1 year of follow-up were uniformly high. These results suggest that the performance of the endocardial lead system is comparable to existing epicardial leads in similar patient populations.
对美国食品药品监督管理局开展的两项分别涉及心内膜导线和心外膜导线的临床试验结果，就患者人口统计学特征、检测与转复特性以及包括长期生存经验在内的后续临床病程进行了比较。尽管这两组患者并非严格同期，但相似度足以进行有意义的比较。在诱发心律失常的检测以及将其转复的能力方面，并无显著差异。接受心内膜导线的患者手术死亡率、感染率及其他严重并发症的发生率较低；然而，这些差异未达到统计学显著性。随访1年的生存率均普遍较高。这些结果表明，在类似患者群体中，心内膜导线系统的性能与现有的心外膜导线相当。
