Takano Asuka, Sekita Gaku, Watanabe Minako, Mukaida Hiroshi, Komatsu Sayaka, Tabuchi Haruna, Hayashi Hidemori, Tokano Takashi, Sumiyoshi Masataka, Nakazato Yuji, Daida Hiroyuki
Graduate School of Medicine, Juntendo University, Tokyo, Japan; Department of Clinical Engineering, Juntendo University Hospital, 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan.
Department of Cardiology, Juntendo University School of Medicine, Tokyo, Japan.
J Arrhythm. 2017 Feb;33(1):12-16. doi: 10.1016/j.joa.2016.04.008. Epub 2016 Jun 22.
Active fixation leads have provided stable atrial and ventricular pacing; however, long-term follow-up data have not been satisfactory. The purpose of this study was to investigate the long-term reliability of active fixation leads and their electrical characteristic stability.
A total of 1196 pacing leads were implanted in 830 patients consecutively between 2002 and 2013. In this retrospective study, we were able to trace 1092 leads in 750 patients to investigate the prognosis of implanted leads. The measurement values (including pacing thresholds, sensing amplitudes, and lead impedances of both the atrial and ventricular leads) were obtained from medical records at the time of implantation and during follow up at the outpatient device clinic. All pacing leads were FINELINE II Sterox EZ Leads (Boston Scientific, MN, USA), which are sweet-tip type screw-in active fixation leads, except for the shock leads in patients with implantable cardioverter defibrillator.
The mean follow-up period was 51.3±29.2 months (median, 48 months). A total of 1092 leads were implanted in either the atrium (682 leads) or the ventricle (410 leads). Venous access was achieved through cephalic vein cut down (CVC) method (914 leads) or the subclavian vein puncture (SVP) method (178 leads). The overall lead survival rate was 99.6% at both 5 and 10 years. Lead fracture was observed in 4 of 1092 leads (0.37%), all of which were implanted by the SVP method. No lead fracture occurred among patients wherein CVC method was applied (<0.01). Device-related infection was observed in four patients (0.53%).
The overall reliability and stability of sweet-tip type screw-in leads were satisfactory throughout the long-term follow-up period (median, 4 years). Because it was associated with less lead fractures, cut-down access from the cephalic vein may be recommended as the first-line approach when considering the importance of long-term durability of pacing leads.
主动固定导线已实现稳定的心房和心室起搏；然而，长期随访数据并不理想。本研究的目的是探讨主动固定导线的长期可靠性及其电特性稳定性。
2002年至2013年期间，共对830例患者连续植入1196根起搏导线。在这项回顾性研究中，我们追踪了750例患者的1092根导线，以研究植入导线的预后情况。测量值（包括心房和心室导线的起搏阈值、感知幅度和导线阻抗）在植入时以及门诊设备诊所随访期间从病历中获取。除植入式心脏复律除颤器患者的除颤导线外，所有起搏导线均为FINELINE II Sterox EZ导线（美国明尼苏达州波士顿科学公司），属于甜型螺旋拧入式主动固定导线。
平均随访期为51.3±29.2个月（中位数为48个月）。共植入1092根导线，其中682根植入心房，410根植入心室。静脉通路通过头静脉切开术（CVC）（914根导线）或锁骨下静脉穿刺术（SVP）（178根导线）建立。5年和10年时的总体导线生存率均为99.6%。在1092根导线中有4根（0.37%）观察到导线断裂，所有这些导线均通过SVP方法植入。采用CVC方法的患者未发生导线断裂（<0.01）。4例患者（0.53%）观察到与设备相关的感染。
在整个长期随访期（中位数为4年）内，甜型螺旋拧入式导线的总体可靠性和稳定性令人满意。考虑到起搏导线长期耐用性的重要性，由于与较少的导线断裂相关，建议将头静脉切开作为一线入路。
