Mohammed Moghniuddin, Arshi Juwairiya, Ramza Brian M, Wimmer Alan P, Steinhaus Daniel A, Giocondo Michael J, Gupta Sanjaya K, Yousuf Omair K
Department of Medicine, Saint Luke's Hospital, Kansas City, MO, USA; Department of Biomedical and Health Informatics, University of Missouri Kansas City, MO, USA.
Department of Medicine, Saint Luke's Hospital, Kansas City, MO, USA.
Indian Pacing Electrophysiol J. 2020 May-Jun;20(3):105-111. doi: 10.1016/j.ipej.2020.03.001. Epub 2020 Mar 4.
Comparison of outcomes, device deployment time (DT), and total time (TT) using a single tapered Coons dilator versus sequential serial dilation for implantation of the Micra leadless pacemaker.
Micra leadless pacemaker placement requires a 23 French Micra introducer sheath (MIS) for percutaneous delivery. We sought to evaluate outcomes with use of a single tapered Coons dilator (CD) versus sequential serial dilatation (SD) method to facilitate insertion of the Micra introducer sheath.
35 patients were included in the SD arm and 49 in the CD arm. DT and TT were recorded in minutes and cost in dollars. Analysis was performed using independent t-test between two groups and one-way ANOVA to evaluate inter-operator variability in the CD arm.
Both DT and TT were significantly lower for the CD arm (15.1 ± 5.1 vs 23.5 ± 9.3, p < 0.0005 and 29.9 ± 14 vs 39.3 ± 13.5 min, p = 0.000374; respectively). The cost was also significantly lower using a CD versus SD. There was no inter-operator variability in the CD arm between 6 operators (p = 0.177 for DT and p = 0.304 for TT). No complications occurred in the SD arm. There were 3 vascular access site complications in the CD arm, all of which occurred early in the operator's experience.
Coons dilator is an efficient and cost-effective method for vascular dilatation to facilitate Micra leadless pacemaker insertion. Rate of complications is low and expected to improve with greater experience.
比较使用单一锥形库恩扩张器与序贯连续扩张法植入Micra无导线起搏器时的手术结果、器械部署时间（DT）和总时间（TT）。
Micra无导线起搏器植入需要一个23F的Micra导入鞘（MIS）经皮递送。我们试图评估使用单一锥形库恩扩张器（CD）与序贯连续扩张（SD）法来促进Micra导入鞘插入的手术结果。
SD组纳入35例患者，CD组纳入49例患者。DT和TT以分钟记录，费用以美元记录。使用两组间的独立t检验和单因素方差分析进行分析，以评估CD组不同操作者之间的变异性。
CD组的DT和TT均显著更低（分别为15.1±5.1 vs 23.5±9.3，p<0.0005；29.9±14 vs 39.3±13.5分钟，p=0.000374）。使用CD的费用也显著低于SD。6名操作者在CD组中不存在操作者间变异性（DT的p=0.177，TT的p=0.304）。SD组未发生并发症。CD组有3例血管穿刺部位并发症，均发生在操作者经验积累的早期。
库恩扩张器是一种有效且经济的血管扩张方法，有助于Micra无导线起搏器的植入。并发症发生率低，且随着经验增加有望改善。
