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Published on: November 19, 2020
Femoral access site closure without prior femoral angiography : A retrospective analysis
Christoph Brenner1, Julian Margreitter2, Alexandra Gratl3
1Department of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria. mail@med.cbrenner.net.
Insights
Femoral artery closure with the FemoSeal™ vascular closure device (FVCD) is safe without pre-deployment angiography. This approach yields low complication rates, comparable to studies using angiography, but pseudoaneurysm risk warrants consideration.
Area of Science:
- Cardiovascular Interventions
- Vascular Access Management
- Interventional Cardiology
Background:
- Femoral artery access remains a key vascular access route for complex coronary interventions, despite a shift towards transradial approaches.
- The FemoSeal™ vascular closure device (FVCD) aims to decrease compression time and access site complications post-catheter sheath removal.
- Manufacturer guidelines recommend femoral artery angiography before FVCD deployment to ensure safety.
Purpose of the Study:
- To evaluate the safety and efficacy of omitting pre-deployment femoral angiography before FVCD use.
- To determine if this omission increases vascular complication rates in patients undergoing coronary interventions.
Main Methods:
- Retrospective analysis of an all-comers population (n=1923) undergoing percutaneous coronary intervention (PCI).
- Comparison of complication rates in patients who did not undergo pre-deployment femoral angiography with historical data from a randomized trial that included angiography.
- Assessment of risk factors for vascular complications, including pseudoaneurysm formation.
Main Results:
- Low combined vascular complication rates (4.6%) were observed in patients treated without femoral angiography.
- These rates were comparable to a randomized clinical trial cohort that underwent diagnostic coronary angiography with pre-procedure angiography.
- Patients with acute coronary syndrome, on anticoagulation or anti-platelet therapy, had a higher risk of arterial pseudoaneurysms, but no ischemic events occurred post-FVCD deployment.
Conclusions:
- Femoral access site closure with FVCD after coronary angiography is safe without pre-deployment femoral angiography.
- The risk of pseudoaneurysm formation is elevated in specific patient groups, necessitating careful consideration.
- Transradial access is recommended for patients with an increased bleeding risk.
Aims And Background:
Although guideline recommendations have shifted towards a transradial route, femoral puncture is still an established vascular access, especially for complex coronary interventions. The FemoSeal™ vascular closure device (FVCD) helps to reduce femoral compression time and access site complications after removal of the catheter sheath. To ensure safe use, an angiography of the femoral artery prior to FVCD deployment is recommended by the manufacturer. We postulate that omitting this angiography does not relevantly increase the risk for vascular complications.
Methods And Results:
In this retrospective analysis of an all-comers population (n = 1923) including patients receiving a percutaneous coronary intervention (PCI), we could show that combined vascular complication rates without femoral angiography were low (primary endpoint 4.6%) and comparable to a randomized clinical trial that did perform angiography of the vascular access site in a cohort of patients receiving diagnostic coronary angiography only. In addition to this analysis, we could demonstrate that patients with an acute coronary syndrome, receiving periprocedural anticoagulation or anti-platelet therapy had an increased risk for the formation of arterial pseudoaneurysms; however, we did not observe any ischemic vascular event after FVCD deployment.
Conclusion:
Closure of the femoral access site after coronary angiography using the FVCD can be safely performed without femoral angiography; however, due to an increased risk for the formation of pseudoaneurysms we recommend the transradial access in situations with increased bleeding risk.
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