Cleveland Clinic, OH (D.P., M.B., P.S., K.G.T., M.S., B.L.W.).
Allina Health Minneapolis, MN (P.V., I.S.).
Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e010779. doi: 10.1161/CIRCEP.121.010779. Epub 2022 Oct 28.
Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes.
We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group.
A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; <0.001). There were 5 major complications with 3 vascular lacerations all occurring in zone 2 in the study.
Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths.
URL: https://www.
gov; Unique identifier: NCT03772704.
提取难度与程序并发症并不完全相关，但几项小型回顾性研究表明，计算机断层扫描（CT）上的 Lead 纤维化是提取难度大的重要指标。本研究的目的是应用标准化门控心脏 CT 方案评估纤维化，并前瞻性研究其必要性，以评估是否需要使用动力鞘和风险结局。
我们在高容量的 Lead 提取中心进行了一项前瞻性、盲法、多中心、国际研究，纳入了因至少有一条植入时间>1 年且能够接受心脏 CT 的静脉 Lead 提取而转诊的患者。纤维化程度（通过 Lead 与血管壁的附着量来衡量）由专门的 CT 阅读器在 3 个区域（静脉入口到上腔静脉、上腔静脉和右心房到 Lead 尖端）上按 1 到 4 级评分。该研究的主要结局是每个纤维化组在 2 区需要使用动力鞘的提取数量。
共有 200 名患者参与了该试验，其中 196 名患者完成了全门控 CT 和 Lead 提取分析。在 2 区 CT 显示纤维化程度较高（评分 3+4；67.8%）的患者中，使用动力鞘（激光和机械）的比例显著高于纤维化程度较低（评分 1+2；38.6%；<0.001）。该研究中共有 5 例主要并发症，其中 3 例血管撕裂均发生在 2 区。
门控、对比 CT 可以通过识别纤维化来预测是否需要使用动力鞘，但没有确定不需要使用动力鞘的绝对低风险患者。
