The Gender Specific Effect on the Results of Ascending Aortic Replacement
Condition: Ascending Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aneurysm, Ascending Aorta
Study type: Observational

Summary: 
      The aim of our study is to analyze the early and late results in men and women who underwent
      ascending aortic replacement in antegrade cerebral perfusion (ACP) with mild-to-moderate
      hypothermic circulatory arrest. Female gender is associated with poorer outcomes after
      surgical aorta replacement. Data on gender specific differences after ascending aortic
      replacement are conflicting.
    

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 either 26-32
      °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(bispectral index).

      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), 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); length of stay
      (intensive care unit and total hospital days).

      Follow-up information will be collected using direct or phone contact with patients,
      relatives, or physicians.
    

Intervention name(s): Ascending aortic replacement
Intervention type(s): Procedure
Intervention description(s): Surgical access will be performed through a median sternotomy. Ascending aortic repair is performed under conditions of cardiopulmonary bypass (CPB) and MHCA with unilateral ACP via innominate artery with a flow rate of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Once CPB is instituted, the aortic cross-clamp is applied, and the heart is arrested with antegrade cardioplegia. Hemiarch replacement involves resection lesser curve of the aortic arch from the base of the innominate artery (Zone 0) to a point immediately distal to the nadir of the lesser curvature (Zone 3 or Zone 2 if the left subclavian artery was too far).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with ascending aortic aneurysm with Hemiarch replacement