Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study

Abstract

Among a large group of operators, implantation success was high regardless of experience. While procedure duration and fluoroscopy times decreased with implant number, complications were low and not associated with case number. Procedure and safety outcomes were similar between distinct training methodologies.

Determinants of the difficulty of leadless pacemaker implantation

“…Our data showed that the requirement for device redeployment decreased with operator's experience. This was also observed by El‐Chami et al for the Micra and by Tjong et al for the Nanostim 15,16 . Furthermore, we showed that the need for device redeployment was correlated with the presence of prominent septomarginal trabeculation.…”

“…The analysis included 720 successful procedures performed by 94 operators with a median of four implantations (range 1‐55). The procedure time decreased from the first quartile (two first procedures: 42.7 ± 29.9 min) to the fourth quartile (>12 implants: 25.9 ± 13 min) representing a reduction by 2% from the prior procedure with each subsequent implant (95% CI, 0.7‐3.2%; P = .002) 15 . However, due to the design of the study protocol, the number of procedures needed to achieve optimal procedure performance could not be assessed.…”

Successful implantation of a Micra leadless pacemaker via collateral femoral vein and inferior vena cava filter

“…Although the implementation of this device has shown to be effective with high success and low complication rates, the study design only utilized a transfemoral venous approach and excluded patients with inferior vena cava filters 4, 5. As a result, complex vascular cases such as this patient with bilateral subclavian vein, superior vena cava, and bilateral common femoral vein occlusions make delivery of this novel device difficult.…”

“…The Medtronic Micra transcatheter pacemaker system (TPS; Medtronic, Minneapolis, MN) is a leadless singlechamber pacemaker that appears to be a suitable alternative option, especially when traditional approaches have failed. Although the implementation of this device has shown to be effective with high success and low complication rates, the study design only utilized a transfemoral venous approach and excluded patients with inferior vena cava filters [4,5]. As a result, complex vascular cases such as this patient with bilateral subclavian vein, superior vena cava, and bilateral common femoral vein occlusions make delivery of this novel device difficult.…”

Development of simulation combining a physical heart model and three‐dimensional system for electrophysiology training

“…The latter are of crucial importance to perform procedures using an electroanatomic mapping (EAM) system without fluoroscopy . The learning curve to achieve this level of skills may be quite long and operators have suboptimal performances during the initial phase of their learning curve …”