Arnsbo P, Møller M
Department of Cardiology, Odense University Hospital, Denmark.
Pacing Clin Electrophysiol. 2000 Sep;23(9):1401-6. doi: 10.1111/j.1540-8159.2000.tb00970.x.
The Danish Pacemaker Register was established in January 1982, and the 12 implanting centers in Denmark report to the Register on a continuous basis by use of the European Pacemaker Patient Identification Card. As of August 1999, the Register contained data on 33,164 bradycardia, endocardial, and epicardial (n = 159) lead implants performed in Denmark on 27,738 generators in 24,180 patients for a total of 17,988 (54.2%) ventricular unipolar, 5,610 (16.9%) ventricular bipolar, 2,056 (6.2%) atrial unipolar, and 7,242 (21.8%) atrial bipolar leads. Lead failure was defined as need for replacement or surgical abandonment of the lead due to pacing or sensing problems with the exception of lead displacement. The 10-year survival rate for unipolar leads was 97.2 +/- 0.4% (+/- 2 SE) as compared to 79.6 +/- 3.2% for bipolar leads (P < 0.001). The Medtronic 4012, the Telectronics 284, and the Siemens (Pacesetter) 1010T, 105T, and 1050T bipolar lead models were poor performing leads that needed careful monitoring and appropriate replacement. Excluding those five poor performing bipolar leads, the models yielded a 10-year survival rate of 94.3 +/- 2.4% for bipolar leads. The 5-year survival for all bipolar leads implanted after January 18, 1993 (this was the date that the last of the five poor performing bipolar lead models were implanted in Denmark) was 98.7 +/- 0.4% compared with 98.9 +/- 0.3% for all unipolar leads implanted after January 18, 1993 and 86.8 +/- 1.6% for all bipolar leads implanted on or before January 18, 1993. These results indicate a significant improvement in bipolar lead reliability.
丹麦起搏器注册中心于1982年1月成立，丹麦的12个植入中心通过使用欧洲起搏器患者识别卡持续向该注册中心报告数据。截至1999年8月，该注册中心包含了在丹麦对24,180名患者的27,738台发生器进行的33,164次心动过缓、心内膜和心外膜（n = 159）导联植入的数据，其中共有17,988根（54.2%）心室单极导联、5,610根（16.9%）心室双极导联、2,056根（6.2%）心房单极导联和7,242根（21.8%）心房双极导联。导联故障定义为由于起搏或感知问题（导联移位除外）而需要更换导联或手术废弃导联。单极导联的10年生存率为97.2±0.4%（±2个标准误），而双极导联为79.6±3.2%（P < 0.001）。美敦力4012、泰利特ronics 284以及西门子（佩斯赛特）1010T、105T和1050T双极导联型号表现不佳，需要密切监测并适时更换。排除这五种表现不佳的双极导联型号后，双极导联的10年生存率为94.3±2.4%。1993年1月18日之后（这是丹麦植入最后一种表现不佳的双极导联型号的日期）植入的所有双极导联的5年生存率为98.7±0.4%，相比之下，1993年1月18日之后植入的所有单极导联的5年生存率为98.9±0.3%，1993年1月18日或之前植入的所有双极导联的5年生存率为86.8±1.6%。这些结果表明双极导联的可靠性有了显著提高。
