Bansal Neha, Samuel Sharmeen, Zelin Kathleen, Karpawich Peter P
Section of Pediatric Cardiology, Department of Pediatrics, The Children's Hospital of Michigan, Wayne State University School of Medicine, Detroit, Michigan.
Pacing Clin Electrophysiol. 2017 Jan;40(1):17-25. doi: 10.1111/pace.12995. Epub 2017 Jan 17.
Patients with congenital heart defects (CHD) often present more challenges to pacing therapy due to anatomy than those without CHD. The lumenless, 4.1Fr diameter M3830 pacing lead (Medtronic, Inc., Minneapolis, MN, USA), approved for use in 2005, has, to date, reported to have excellent short-term (<6 years) lead performance. Unfortunately, very long-term performance is unknown, especially among CHD patients and with implants at alternate pacing (AP) sites. This study reports a 10-year clinical experience with the M3830 lead.
Records of patients who received the M3830 lead were reviewed: patient demographics, implant techniques and locations, sensing and pacing characteristics, impedances (Imp), and any complications at implant and follow-up.
From 2005 to 2015, 141 patients (ages 2-50, mean 20.1 years, 57% males) received 212 leads: atrial 115; ventricle 97. CHD was present in 62% of patients. Leads were inserted at AP sites in 96% of patients. Postimplant follow-up was from 3 months to 10 years (mean 56.3 months). Comparative implant versus follow-up values (mean ± standard deviation) were available on 196 leads (92.5%), showing persistently low (<1 v @ 0.4-0.5 ms) pacing thresholds (P = 0.57). Sensing was also comparable (atrial leads, P = 0.41; ventricular leads, P = 0.9). Impedances differed (P < 0.05) but remained within the normal range. Two A leads became dislodged and one was repositioned while two other leads (1 A, 1 V) were extracted. There are no differences observed in the pacing characteristics between the CHD and non-CHD groups on follow-up.
The 4.1Fr lumenless pacing lead shows ease of implant regardless of CHD or AP site, excellent very long-term (10 years) stability, and performance indices with a very low rate of complications.
与无先天性心脏病（CHD）的患者相比，先天性心脏病患者由于解剖结构的原因，起搏治疗往往面临更多挑战。2005年获批使用的无内腔、直径4.1Fr的M3830起搏导线（美敦力公司，明尼阿波利斯，明尼苏达州，美国），迄今为止，据报道其短期（<6年）导线性能优异。不幸的是，其长期性能尚不清楚，尤其是在CHD患者以及在备用起搏（AP）部位植入的患者中。本研究报告了使用M3830导线的10年临床经验。
回顾了接受M3830导线患者的记录：患者人口统计学资料、植入技术和部位、感知和起搏特性、阻抗（Imp）以及植入和随访时的任何并发症。
2005年至2015年，141例患者（年龄2 - 50岁，平均20.1岁，57%为男性）接受了212根导线：心房导线115根；心室导线97根。62%的患者患有CHD。96%的患者在AP部位植入导线。植入后随访时间为3个月至10年（平均56.3个月）。196根导线（92.5%）有植入与随访的比较值（均值±标准差），显示起搏阈值持续较低（0.4 - 0.5毫秒时<1伏）（P = 0.57）。感知情况也相当（心房导线，P = 0.41；心室导线，P = 0.9）。阻抗有所不同（P < 0.05），但仍在正常范围内。两根心房导线脱位，一根重新定位，另外两根导线（1根心房导线，1根心室导线）被拔除。随访时CHD组和非CHD组的起搏特性未观察到差异。
4.1Fr无内腔起搏导线无论CHD情况或AP部位如何，植入都很容易，具有出色的长期（10年）稳定性，且性能指标良好，并发症发生率极低。
