植入较短起搏导线可行性的单中心临床研究

Feasibility of implanting shorter-leads pacemaker in Chinese-a single-center clinical trial

目的研究国人植入较短起搏导线的成功率以及与多余导线长度相关的因素。方法复旦大学附属中山医院心内科从2016年5月至2017年2月拟行起搏器植入术患者中筛选符合条件的患者，并按随机数字表法将其随机分为常规导线组（R组）和短导线组（S组），并分别植入常规长度的导线和较短导线，术后进行1、3、6个月随访，比较两组患者手术成功率及并发症发生率、不同路径植入时多余导线长度，并分析短导线组多余导线长度与术前各参数的相关性。结果①两组导线成功植入率均为100％；②无论经左侧或右侧锁骨下静脉植入导线，s组与R组右心房、右心室多余导线长度差异有统计学意义[（13．8±2．8）cm对（20．9±3．9）em，P〈0．001；（12．1±3．0）cm对（17．8±3．8）cm，P〈0．001；（16．0±4．2）cm对（24．8±4．2）cm，P=0．028；（17．1±4．6）cm对（23．0±2．1）em，P=0．028]；③S组与R组导线盘绕时间差异有统计学意义[9（8，11）s对17（15，18）s，P〈0．001].S组和R组多余导线首次盘绕成功率差异有统计学意义（90．8％对68．1％，P〈0．001）；④单因素相关性分析发现S组右心房、室多余导线长度与患者年龄、身高、体重、主动脉根部内径、左心房内径呈显著负相关，与穿刺路径相关。多重线性回归分析发现，s组右心房多余导线长度与年龄、体重呈显著负相关，而右心室多余导线长度与上述这些指标均无显著相关性。结论在心脏大小正常的国人中植入短起搏导线安全可行，并且方便手术操作、节省手术时间。在植入短导线前通过评估年龄、身高、体重、主动脉根部内径、左心房室内径、植入路径可预测房室多余导线的长度。

Objective To investigate the success rate of implanting shorter pacing leads, the post- operative complication rate after implanting shorter leads and relative factors to assess surplus lengths of the right ventricalar or right atrial leads. Methods Eligible patients were recruited from patients receiving pacemaker implant between May 2016 and February 2017 in Zhongshan Hospital and were randomized to conventional- lead group and shorter-lead group. The patients in conventional-lead group were implanted with normal length leads and patients in shorter-lead group were implanted with shorter length leads. The complications were recorded at 1,3, 6 months after implantation. The success rate of implanting pacemaker, the complication rates and the surplus lengths of right ventricalar or right atrial leads in different venous paths were compared between groups. Meanwhile, the correlation between these parameters before implanting and the surplus lengths of the right ventricalar or right atrial leads were analyzed. Results The success rate of implanting pacemaker was separately 100% in both of the two groups. There was no significant difference in the post-operative complication rates between groups. When choosing left subclavian vein approach, the surplus length of the right atrial lead and right ventricular lead in shorter-lead group and conventional-lead group separately had statistically significant differences [ （ 13.8 ±2.8 ） cm vs. （ 20.9 ± 3.9 ） cm, P〈0.001, （ 12.1±3.0 ） cm vs. （ 17.8 ± 3.8 ） cm, P〈0.001 ]. When choosing either fight subclavian vein approach or cephalic vein approach, the surplus length of the right atrial were significantly shorter than conventional-lead group. And the rate of coiling leads into the pocket at once in shorter-lead group was higher than in the conventional-lead group （90.8% vs. 68.1%, P〈0.001 ）. The surplus length of the right atrial lead was negative correlated to the age, height, weight, aortic dimension and was associated with different venous paths. The surplus length of the right ventricle lead was negative correlated to height, weight, aortic dimension, left atrial diameter and left ventricular diameter and was associated with different venous paths in shorter-lead group. In multivariate Cox linear regression analysis, we observed that the surplus length of the fight atrial lead was negative correlated to the age and weight and no factors associated with the surplus length of the right ventricle lead was detected. Conclusion It is reliable and safe to implant shorterleads pacemaker in Chinese through either left or right subclavian vein, which reduce the complexity and saved operation time. The surplus lengths can be predicted before implanting through the height, weigh, left atrial, left ventrieular diameters and different venous path.