Biomechanical Properties of the Human Ascending Aortic Wall in Aneurysm
Condition: Ascending Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aneurysm, Ascending Aorta
Study type: Interventional

Summary: 
      The aim of the study is to analyze the efficacy of the surgical tretment in patients with
      ascending aortic aneurysm and dilatation. And to assess rate of negative clinical scenarios
      in non-oparated patients with ascending aortic dilatation
    

Detailed description: 
      Description of the procedures:

      All surgical procedures will be performed via median sternotomy. During the aortic arch
      anastomosis, continuous, unilateral SACP using innominate artery will be employed. Unilateral
      SACP may be converted to bilateral ACP at the surgeon's discretion if adequate cerebral flows
      are not achieved or if there are concerns with cerebral oximetry measurements.

      Once on CPB, the patient will be cooled to a nasopharyngeal (NP) temperature of 28-30 °C.
      Rectal temperature with be monitored as an additional temperature sites. Unilateral SACP will
      only be initiated once the target temperature has been reached. SACP via the innominate
      artery will be commenced with target flows of 8-10 ml/kg/min and perfusion pressure of 60-80
      mmHg. Perfusion adequacy will be evaluated using measurement of blood pressure in both radial
      arteries and cerebral oximetry using near-infrared spectroscopy (NIRS).

      After completion of the aortic hemiarch replacement, CPB will be resumed and the patient
      re-warmed to 36 °C prior to coming off CPB, with a = 1 °C temperature difference between
      temperature monitoring sites (NP and rectal).

      Intraoperative information will be collected from the anesthetic record, surgical notes and
      perfusion records. Intraoperative data collection will include total operative time, CPB
      time, cross-clamp time, hypothermic cardiac arrest time, uSACP time, lowest nasopharyngeal
      and rectal temperature, arterial pressure in both radial arteries, perfusion rate and
      perfusion pressure during both of CPB and unilateral SACP, lowest hemoglobin concentration
      (g/L) and hematocrit (%), acid-base indices, intraoperative red blood cell transfusion
      (units), highest dose/agent used for intraoperative inotrope or vasopressor support. Also
      during the surgery will be performed NIRS and BIS-monitoring.

      Postoperative data will include valuation of following indicators: mortality (hospital
      mortality and death from any cause); neurological injury (TIA, stroke, delirium), MRI and
      CT-scan only in event of postoperative stroke; acute kidney injury (creatinine level prior
      and 1, 2, 4 postoperative day (POD), urine output-up to 24-48 h, renal replacement therapy
      (dialysis); time of mechanical ventilation; re-exploration for bleeding, tamponade or other
      reasons; postoperative transfusion (packed red blood cells, platelets, fresh frozen
      platelets, cryoprecipitate); postoperative myocardial infarction (electrocardiogram and
      troponins); inotropic support during 24-48 h (agent and dose (VIS)); length of stay
      (intensive care unit and total hospital days).

      In non-operted grop of patients annually echo cardiography, CT scans will be performed.

      Aortic imaging All measurements will be taken using electrocardiography-gated computed
      tomographic angiography. Analysis was performed using 64-slice scanner Discovery NM-CT 570c
      (GE Healthcare, Milwaukee, WI, USA) with spatial resolution of the angiographic phase ranging
      from 0.6 to 1.25 mm. Adopted computed tomographic protocol included unenhanced, arterial, and
      delayed data acquisition. The arterial phase will be acquired after intravenous injection of
      80-100 mL of nonionic iodinated contrast at 5 mL/s, followed by a 50-mL bolus of saline
      solution. Delayed-phase scans will be obtained 120-180 seconds after contrast injection. All
      measurements will be taken in multiplanar reconstruction, always in the plane perpendicular
      to the manually corrected local aortic centre line. Ascending aortic diameter will be
      measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm)
      will be measured from the outer contours of the aortic wall. Normalized aortic diameter
      (cm/m2) will be calculated by dividing the maximum aortic diameter (cm) by the body surface
      area (m2). The body surface area will be calculated based on the Mosteller formula: body
      surface area (m2) = √([Height (cm) x Weight (kg)]/3600). Analysis and assessment of the
      images will be based on the consensus between two experienced investigators.

      Follow-up information will be collected using direct or phone contact with patients,
      relatives, or physicians.
    

Intervention name(s): Surgery
Intervention type(s): Procedure
Intervention description(s): Replacement of the ascending aorta in case of anerysm and dilatation
Other intervention name(s): Surgical treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic