The use of conventional transvenous pacing devices has been associated with a variety of complications, including pocket and lead complications. A significant proportion of patients, approximately 10%, have reported complications such as infection, hematoma, pneumothorax, or lead dislodgement within months of the traditional implantation [4, 5]. Additionally, long-term complications associated with traditional pacing include lead fracture, venous thrombosis, and injury to the tricuspid valve [1, 4].
Recent advancements in battery chemistry and device miniaturization in electrophysiology have significantly mitigated the requirement for a subcutaneous pocket in pacing devices.
The Micra leadless pacemaker (Medtronic) is a newly developed, fully self-contained, encapsulated cardiac pacemaker that includes both battery and electrodes. It is delivered in a non-surgical manner through the use of a 27 French catheter sheath via the femoral vein to the right ventricle.
While the Micra has shown significant reduction in associated complications, a small percentage of vascular complications, reported as high as 1.2% [9], still persist. The diameter of the delivery device has been identified as the primary contributing factor to these complications.
To the best of our knowledge, no studies have been conducted to date to decrease the incidence of known vascular complications associated with Micra implantation. We conducted an observational, single-center study on a cohort of 45 patients who received Micra implantation over a 2-year period. The goal of this observational study was to assess the associated vascular complications through the use of real-time ultrasound-guided venipuncture for venous access and the Z suture technique for hemostasis.
The analysis from our study demonstrated that there were no complications associated with Micra implantation following ultrasound-guided access and Z suture for hemostasis.
It should be noted that this study is limited by its observational design in a single center, and there is no comparison group of patients who underwent Micra implantation without ultrasound-guided venous access and Z suture. Therefore, it is difficult to draw direct conclusions about the relative safety and efficacy of these techniques. Nevertheless, our data clearly showed that no vascular complications were observed in our cohort using these techniques. This suggests that the use of these techniques may lead to a significant reduction in the risk of vascular complications as compared to the 1.2% risk reported in published data [9].
LimitationsThere are several limitations inherent to this observational study. First, this is an observational study on a relatively small patient cohort. Therefore, it cannot test for any controls or draw any conclusions on superiority/ non-inferiority or establish causation with any other modalities. However, it does share a real-world view of the authors’ experience with observed complications associated with Micra implementation in a tertiary cardiac centre within a universal health care setting. Furthermore, there is no data collected on the time on US- access or achievement of hemostasis in each case. Whilst authors appreciate this as a limitation, in this observational study, all the cases were carried out by only two senior electrophysiologists (GG & KA) to reduce the risk of this potential variation. Finally, there is no information on the type of anticoagulation for our cohort of patients, which could potentially influence their post procedure bleeding risk as well as the time to achieve hemostasis. However, as this study was carried in a universal healthcare setting, the patients would have been given the same, medication-specific, instructions for pre-operative management of anticoagulation as per the UK’s National Health Service (NHS) guidelines [10].
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