Aorta Thoracic; Traumatic Rupture
Conditions
Keywords
Thoracic Aorta, Trauma, Endovascular
Brief summary
Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. Aim of this study is to review the experience of a single center with endovascular approach for the treatment of acute traumatic rupture of descending thoracic aorta
Detailed description
From April 2002 to November 2014, patients referred to our Department with a diagnosis of acute transection of thoracic aorta will be studied by preoperative Computed Tomography (CT) evaluation in order to perform thoracic endovascular aortic repair (TEVAR) with left subclavian artery coverage. Then patients will be followed up with clinical and instrumental (CT, Duplex ultrasound) controls at discharge, 1, 3 and 6 months and yearly thereafter. We will evaluate the presence of major and minor neurological complications, episodes of left arm claudication, cardiovascular, respiratory and bleeding complications. Furthermore we will evaluate the technical success of the technique evaluating the onset of failure, collapse, leak or distal migration of the graft.
Interventions
DEVICEValiant™ endoluminal procedure
Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows: The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions. After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak.
Sponsors
University of Catanzaro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with a diagnosis of acute transection of thoracic aorta; * a time frame range from trauma of 1-10 hours.
Exclusion criteria
* Patients who do not fall into the above categories
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Events | from hospital discharge to 1 month after the procedure | Evaluation of mortality, renal failure, cerebrovascular accident. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Acute Transection of Thoracic Aorta Patients with a diagnosis of acute transection of thoracic aorta. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Patients With Acute Transection of Thoracic Aorta |
|---|---|
| Age, Continuous | 36.9 years |
| Region of Enrollment Italy | 11 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Number of Participants With Major Adverse Events
Evaluation of mortality, renal failure, cerebrovascular accident.
Time frame: from hospital discharge to 1 month after the procedure
Population: No serious adverse events recorded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Acute Transection of Thoracic Aorta | Number of Participants With Major Adverse Events | 0 number of serious adverse events |