Objective: The aim of this study was to evaluate the safety and rates of adverse vascular events, including occurrence of access-site haematoma, pseudoaneurysm, ipsilateral limb ischaemia, ipsilateral vascular surgical intervention or access-site infection, of a novel post-closure methodology to achieve haemostasis at the femoral arteriotomy, as compared to the gold standard of continuous manual pressure.
Background: The use of percutaneous mechanical circulatory support has grown exponentially. Vascular complications remain a growing concern for large-bore endovascular devices and best practices for device removal do not exist. The latest generation Impella CP now has a stylet for wire re-access. We describe a novel technique of Impella CP removal using a rapid exchange, double-wire approach to deploy two suture-mediated closure devices for immediate haemostasis with the Impella CP.
Methods: Eight consecutive patients requiring Impella CP support between 2017 and 2019 were included in the analysis. Demographic, adverse vascular event and bleeding data among patients who underwent manual compression or post-closure Impella CP removal were collected from individual patient electronic medical records. Descriptive statistics were applied to evaluate numerical and categorical data between the manual compression and post-closure groups; p≤0.05 was believed to be significant.
Results: No patients undergoing post-closure suffered an adverse vascular event: haematoma, pseudoaneurysm, ipsilateral limb ischaemia, ipsilateral vascular surgery or access-site infection. The incidence of access-site haematoma formation post device removal in patients receiving manual compression was significantly higher than among patients undergoing post-closure (7/20; 35% versus 0/8; 0%, p=0.05). There was a trend towards reduced access-site bleeding post-Impella CP removal in post-closure patients. Post-Impella CP removal access-site bleeding occurred in 5/20 (25%) patients in the manual compression group, compared to 0/8 (0%) in the post-closure group (p=0.12).
Conclusion: The post-closure technique, when compared to manual compression for access-site haemostasis after Impella CP removal, significantly reduces the rate of access-site haematoma formation. No patient who underwent the post-closure technique developed other access-site adverse events. Additionally, no patient who underwent post-closure suffered post-Impella CP removal access-site bleeding. The preliminary signal from this observational analysis suggests that the practice of post-closure may help to reduce the incidence of access-site vascular adverse events and reduce the likelihood of access-site bleeding post-Impella CP removal.