Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)
Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)
The study aims to analyzing the impact of the staged endovascular treatment (divided into two
 or more distinct procedures) of thoracoabdominal aneurysmatic pathology on short and medium
 term, technical and clinical outcomes and on the possible benefits or complications
 associated with this approach.
Since the development of custom-made fenestrated and branched endografts a novel therapeutic
 option for the management of thoracoabdominal aortic aneurysms was made accessible. In order
 to achieve complete aneurysm exclusion more than one endovascular graft is usually needed
 according to device characteristics and aneurysm extent. Usually a straight tube graft is
 initially placed in the proximal descending aorta, followed by a custom-made device for the
 visceral abdominal aorta, and completed with a bifurcated infrarenal graft landing at the
 level of the common iliac arteries. Many variations are available according to patient
 anatomy, pathology, and previous aortic surgeries.

 The different components required can be deployed in the patient in one setting (i.e.
 single-stage endovascular repair) or across more than one surgeries (i.e. multi-stage
 endovascular repair), depending on procedural needs and surgeon choice. According to limited
 reported series the latter option seems to be associated to better clinical outcomes both in
 terms of spinal cord ischemia and overall survival.

 In addition to the number, type and order of stages required for patient treatment, primary
 and secondary end-points are the evaluation of the short-term (6 months) and mid-term (5
 years) outcomes as illustrated in the Society for Vascular Surgery reporting standards for
 TEVAR.

 The investigators review a prospectively compiled Microsoft Office Excel database with the
 procedural details of the 47 patients treated at our Institution between October 2013 and
 October 2017 by means of total endovascular thoracoabdominal aortic aneurysm repair and of
 those of the next 50 patients which will be treated until December 2020. All patients will be
 recorded together with their characteristics and number and type of stages required for
 treatment completion.

 All enrolled patients will be contact yearly by phone, in addition to standard follow-up
 imaging, to confirm persistence of technical and clinical success and to evaluate the
 eventual onset of any treatment related complication or disease evolution Possible stage
 types will be differentiated as: proximal thoracic component (TEVAR), visceral component
 (Custom-Made), bifurcated component (EVAR), iliac extensions, iliac branch devices.

 All but the visceral component may or may not be present in each patient depending on the
 aneurysm extension and previous aortic surgery.

 All the assessed variables will be prospectively recorded in a Microsoft Office Excel
 database together with patients' data.

 All patients involved in the retrospective part of the study have already signed informed
 consent for data collection and analysis at hospital admission.

 The 50 patients that will be enrolled until December 2020 will also sign an "ad hoc"
 consents, specific for this study.

 Sensitive patient information will not be available during data analysis. The clinical study
 will be carried out according to the ethical principles of the Declaration of Helsinki and
 following the active regulations on observational studies.

 Participation in the study does not involve ethical implications as the patients in the study
 will be subjected to the standard procedures commonly used to treat the pathology from which
 they are affected. The investigators just want to store participant' s data in anonymous
 database.

 Patients characteristics, procedural data, technical and clinical outcomes, and follow-up
 data will be analyzed on Wizard Statistics software to investigate the presence of
 statistically significant correlations among the identified variables.

 The extracted data will be the property of the investigator and San Raffaele Hospital, and
 their relevant clinical and procedural implications will be submitted for publication in
 peer-reviewed scientific journals focused on the field of vascular and endovascular surgery.
 Also in these works the data will be reported anonymously.
Inclusion Criteria:

 patient with ≥ 18 years of age, undergoing total endovascular treatment of thoracoabdominal
 pathology (single-stage or multi-stage endovascular repair) at San Raffaele Hospital in
 between October 2013 and December 2020.

 Exclusion Criteria:

 none