Femoral; Aneurysm
Conditions
Brief summary
Since the 2000s, endovascular procedures have been expanding rapidly in multiple disciplines: cardiology, radiology, interventional neuroradiology, and of course vascular surgery. Most procedures are performed by puncture of the common femoral artery with introducers ranging in size from 4F to 26F for aortic procedures. The most frequent complications of percutaneous punctures are false femoral aneurysms due to failure to close the arterial gap (up to 8% in some studies). A false aneurysm is a pocket of blood communicating with an artery and secondary to the rupture of the arterial wall. The blood is then contained by the adjacent structures and often a fibrous shell which distinguishes it from an aneurysm which retains the integrity of its wall. The management of false femoral aneurysms is variable. Below 2 cm, monitoring may be performed with or without manual or ultrasound-guided compression. In case of persistence of the false aneurysm and/or complication, open surgery can be performed. Endovascular treatment of false aneurysms was first proposed in 1986. Different endovascular techniques can be proposed to occlude false aneurysms such as the use of coils, biological glue, the use of arterial closure systems... Echoguided injection of thrombin to occlude the false aneurysm in a manner has been published since the late 1990s. The treatment is evaluated as reliable and safe. A recent article in the EJVES (6) investigates the value of low-dose thrombin for this indication, and the results appear to be very encouraging for low-dose thrombin in false femoral aneurysms. Thrombin injection for the treatment of iatrogenic false femoral aneurysms is the technique currently favoured by the vascular surgery team at the Paris Saint Joseph Hospital Group (GHPSJ). Open surgery is a second-line treatment and remains indicated in case of acute symptoms (radiculalgia, motor/sensory deficits; ischemia, skin necrosis), a false aneurysm that is too deep or without a neck, an infectious origin or a patient treated with dabigatran. Patients will be reviewed at 1 and 12 months according to the usual follow-up. In this work, investigators will study the efficacy of false aneurysm closure using human thrombin injection. This work is intended to confirm previous work. A socio-economic study may be conducted in parallel. Follow-up after the use of percutaneous closure systems and in the context of bypass surgery may also be of interest.
Interventions
None listed
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient whose age ≥ 18 years * Patient with iatrogenic false femoral arterial aneurysm, post arterial or venous puncture, following management for a diagnostic or therapeutic examination. * Circulating false aneurysm confirmed by an imaging examination (echo-Doppler, angioscanner; angio-MRI). * Indication for exclusion of false aneurysm * False aneurysm treated at GHPSJ between 01/09/2020 and 31/12/2022 by thrombin injection
Exclusion criteria
* Patient under guardianship or curatorship * Patient under court protection * Patient objecting to the use of his/her data for this research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy at 1 month of thrombin injection | Month 1 | This outcome corresponds to the percentage of false aneurysm thrombosis at 1 month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative effectiveness of thrombin injection | Year 1 | This outcome corresponds to the number of intraoperative false aneurysm thrombosis and the number of false aneurysm thrombosis at 12 months. |
| Re-intervention | Year 1 | This outcome corresponds to the number of no re-intervention at the target lesion at 1 and 12 months. |
Countries
France
Contacts
Primary ContactYann GOUEFFIC, MD, PhD
Backup ContactHelene BEAUSSIER, PharmD, PhD
Outcome results
None listed