Evaluation of the Treatment of Abdominal Aortic Pathology With Hostile Necks, Para-/Juxra-renal and Sovrarenal Pathology at Short, Mid and Long Term
Condition: Proximal Abdominal Aortic Aneurysms
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Observational

Summary: 
      Although open repair (OR) is currently reported as the gold standard of treatment,
      fenestrated endovascular repair (FEVAR) is being increasingly applied for the treatment of
      proximal abdominal aortic aneurysms (p-AAA) such as hostile-necked, juxta-, para- and
      supra-renal aortic aneurysms.1 Nevertheless, advantages of FEVAR in terms of lowering
      postoperative complications, should be balanced with the need of both complex device
      configurations and operators with large endovascular expertise. The aim of this study is to
      report the experience of Data from patients treated will be prospectively collected. All
      post-operative results will be recorded. Major adverse event (MAE) are defined as the
      presence of one of the following: all-cause mortality, bowel ischemia, myocardial infarction,
      paraplegia, respiratory failure, stroke and renal insufficiency.

      Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all
      patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with
      OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed in our Unit for imaging
      assessment.

      Patients will undergo standard control with the execution of a Doppler ultrasound and
      creatinine serum levels at 1, 6, 12, 24, 36, 48 and 60 months. A CTA will also be performed
      at 12 months as per standard clinical practice.

      of p-AAA treatment.
    

Detailed description: 
      Primary end-point is to evaluate the mortality and major adverse events (MAE) at 30 days, 2
      years and 5 years prospectively in the cohort of patients p-AAA treated by means of open
      repair in the next 100 patients that will be treated between 2018 and 2020 in the Vascular
      Surgery Unit of the San Raffaele Hospital.

      Data from patients treated will be prospectively collected. All post-operative results will
      be recorded. Major adverse event (MAE) are defined as the presence of one of the following:
      all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, respiratory failure,
      stroke and renal insufficiency.

      Patients will undergo standard control with the execution of a Doppler ultrasound and
      creatinine serum levels at 1, 6, 12, 24, 36, 48 and 60 months. A CTA will also be performed
      at 12 months as per standard clinical practice The 100 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.

      Expected results are:

        -  death at 30 days: 2%

        -  any MAE at 30 day: 25% Patients characteristics and anatomical data on the visceral
           vessels will be analyzed on Wizard Statistics software to investigate the presence of
           statistically significant Pearson correlations among the identified variables.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with abdominal aneurysm with hostile, para- / juxta-renal and supra-renal collars,
        undergoing open or surgical treatment.