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. 2020 May-Jun;20(3):105-111.
doi: 10.1016/j.ipej.2020.03.001. Epub 2020 Mar 4.

Outcomes using a single tapered dilator for Micra leadless pacemaker implant

Moghniuddin Mohammed  1 , Juwairiya Arshi  2 , Brian M Ramza  3 , Alan P Wimmer  3 , Daniel A Steinhaus  3 , Michael J Giocondo  3 , Sanjaya K Gupta  3 , Omair K Yousuf  4
Affiliations

Outcomes using a single tapered dilator for Micra leadless pacemaker implant

Moghniuddin Mohammed et al. Indian Pacing Electrophysiol J. 2020 May-Jun.

Abstract

Objectives: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Coons tapered dilator; Leadless pacemaker; Micra transcatheter pacing system; Outcomes; Serial dilators; Vascular dilatation.

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Conflict of interest statement

Declaration of competing interest None.

Figures

Fig. 1
Fig. 1
Single tapered Coons dilator – Fig. 1 shows Coons dilator consisting of long distal taper of 6-French to 20-French and a rigid dilator shaft.
Fig. 2
Fig. 2
Patient flow diagram – Fig. 2 shows study population, inclusion and exclusion criteria.
Fig. 3
Fig. 3
Deployment and Total procedural time between the two vascular access strategies – Fig. 3 shows mean deployment and total time for single tapered (CD) and serial dilatation (SD) group.
Fig. 4
Fig. 4
Differences in Deployment and Total Time amongst various operators in the Coons Dilator arm – Fig. 4 shows mean deployment and total time for six operators in the single tapered dilator group.
Fig. 5
Fig. 5
Multiple regression model for Total Time. Use of Coons dilator significantly shortened the total procedural time after accounting for patient and operator characteristics.
See this image and copyright information in PMC

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