Outcomes using a single tapered dilator for Micra leadless pacemaker implant.
Moghniuddin Mohammed1, Juwairiya Arshi2, Brian M Ramza3
1Department of Medicine, Saint Luke's Hospital, Kansas City, MO, USA; Department of Biomedical and Health Informatics, University of Missouri Kansas City, MO, USA.
Indian Pacing and Electrophysiology Journal
|March 8, 2020
Summary
The Coons dilator (CD) significantly reduces time and cost for Micra leadless pacemaker implantation compared to sequential dilation (SD). This efficient method offers a low complication rate, improving with operator experience.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Techniques
Background:
- Micra leadless pacemaker implantation requires a 23 French Micra introducer sheath (MIS).
- Evaluating alternative methods for MIS insertion is crucial for procedural efficiency.
Purpose of the Study:
- To compare outcomes, device deployment time (DT), and total time (TT) for Micra implantation.
- To assess the efficacy of a single tapered Coons dilator (CD) versus sequential serial dilation (SD) for MIS insertion.
Main Methods:
- A comparative study involving 35 patients in the SD arm and 49 in the CD arm.
- Recording of device deployment time (DT) and total time (TT) in minutes.
- Analysis using independent t-test and one-way ANOVA for inter-operator variability.
Main Results:
- Significantly lower DT (15.1 ± 5.1 min vs 23.5 ± 9.3 min) and TT (29.9 ± 14 min vs 39.3 ± 13.5 min) in the CD arm (p < 0.0005).
- Significantly lower costs associated with the CD method.
- No inter-operator variability in DT and TT within the CD arm (p > 0.17).
- Three vascular access site complications in the CD arm, occurring early in experience; none in the SD arm.
Conclusions:
- The Coons dilator is an efficient and cost-effective tool for vascular dilatation during Micra leadless pacemaker insertion.
- The complication rate using the Coons dilator is low and anticipated to decrease with increased operator experience.
