Fröhlig G, Schwaab B, Schwerdt H, Lawall P, Trendelenburg M, Schieffer H
Medizinische Universitätsklinik III, Homburg, Germany.
Pacing Clin Electrophysiol. 1994 Jun;17(6):1134-42. doi: 10.1111/j.1540-8159.1994.tb01471.x.
A new lead design was tested that combined a small microporous steroid-eluting electrode with an insulated, exposed helix for active fixation. This lead (model 5078, Medtronic, Inc., group I, n = 10) was compared to a conventional model (model Y 60 BP, Biotronik) with a larger surface of polished platinum-iridium, equipped with a fixed, noninsulated screw but without steroid elution (group II, n = 10). The two lead models were studied in the atrial position of dual chamber pacing systems, which all had a tined ventricular lead (model 5024, Medtronic, Inc.), with essentially the same steroid-eluting tip as the new active fixation lead design. Sensing and pacing data were recorded acutely and during 1 year of follow-up, via the telemetry of a Relay pulse generator (Intermedics, Inc.). Intraoperatively, unfiltered atrial electrogram amplitudes did not differ between groups (group I: 7.12 +/- 2.56 mV vs group II: 6.42 +/- 1.87 mV; P > 0.05), nor did sensing thresholds 1 year after implantation (group I: 5.33 +/- 1.70 mV vs group II: 4.26 +/- 1.40 mV; P > 0.05). Atrial pacing thresholds as measured during surgery at a pulse width of 0.5 msec were lower in group I (0.49 +/- 0.15 V) than in group II (0.68 +/- 0.19 V; P < 0.05). From day 5 through day 360 of follow-up, the difference in atrial pacing thresholds was highly significant (P < 0.01), with a smaller peaking of early thresholds and a much lower scattering of data for the steroid screw-in leads than for controls.(ABSTRACT TRUNCATED AT 250 WORDS)
测试了一种新的导线设计,它将一个小型微孔类固醇洗脱电极与一个用于主动固定的绝缘外露螺旋体相结合。将这种导线(型号5078,美敦力公司,第一组,n = 10)与一种传统型号(型号Y 60 BP,百多力公司)进行比较,后者有更大的抛光铂铱表面,配备固定的非绝缘螺旋但无类固醇洗脱(第二组,n = 10)。这两种导线型号在双腔起搏系统的心房位置进行研究,所有系统都有一个翼状心室导线(型号5024,美敦力公司),其类固醇洗脱尖端与新的主动固定导线设计基本相同。通过Relay脉冲发生器(Intermedics公司)的遥测功能,在急性情况下以及随访1年期间记录感知和起搏数据。术中,两组间未滤波的心房电图振幅无差异(第一组:7.12±2.56 mV vs第二组:6.42±1.87 mV;P>0.05),植入后1年的感知阈值也无差异(第一组:5.33±1.70 mV vs第二组:4.26±1.40 mV;P>0.05)。手术中在脉宽0.5毫秒时测量的心房起搏阈值,第一组(0.49±0.15 V)低于第二组(0.68±0.19 V;P<0.05)。在随访的第5天至第360天,心房起搏阈值的差异非常显著(P<0.01),与对照组相比,类固醇旋入式导线的早期阈值峰值较小且数据离散度低得多。(摘要截短于250字)