The Gender Specific Effect on the Results of Ascending Aortic Replacement

The Gender Specific Effect on the Results of Ascending Aortic Replacement in Small Ascending Aortic Aneurysm

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.

Study Overview

• Status: Completed
• Conditions: Ascending Aortic Aneurysm
• Intervention / Treatment: Procedure: Ascending aortic replacement

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation, 634012
    • Tomsk NRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with ascending aortic aneurysm with Hemiarch replacement

Description

Inclusion Criteria:

• Patients with small ascending aortic aneurysm (5.0-5.5 cm)
• Elective procedure
• Able to provide written informed consent

Exclusion Criteria:

• Surgery for acute aortic dissection or emergent operations
• Refusal of surgical treatment
• Oncological disease (high degrees)
• Multiple organ failure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Ascending aortic replacement; Ascending aortic replacement in ascending aortic aneurysm in men and women

Procedure: Ascending aortic replacement; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative mortality	Operative mortality (%) as assessed by data linkage to medical records Comparison of men vs women in aortic hemiarch surgery with respect to the incidence of death	During the first 30 days after the procedure
All-cause mortality	all-cause mortality as assessed by data linkage to medical records or or phone contact with relatives or physicians	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Myocardial Infarction	Incidence of the myocardial infarction (%) is assessed by complex evaluation based on the ECG and echocardiographic changes as well as increase of the troponin level using serum assay	During the first 30 days after the procedure (assessed by daily serum assay and ECG in the ICU and every 5 days after discharge from ICU. )
Rates of re-exploration for bleeding	Percentage of patients requiring re-exploration for bleeding.	During the first 3 days after the procedure
Respiratory failure	Percentage of patients requiring prolonged lung ventilation (> 72 hours) or tracheostomy	During the first 30 days after the procedure
The duration of a patient's stay in the intensive care unit and on the hospital ward	The duration of a patient's stay in the intensive care unit and on the hospital ward	Up to 90 days after surgery
Incidence of Acute Kidney Injury (AKI)	Percentage of patients requiring renal replacement therapy (i.e. haemodialysis or haemofiltration	During the first 30 days after the procedure
Composite of neurologic injury	Percentage of patients with neurological complications is assessed. Single assessment by CT or MRI. More often if necessary.	During the first 30 days after the procedure

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Study Director: Boris N Kozlov, Dr, TOMSK NRMC CARDIOLOGY RESEARCH INSTITUTE

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: May 23, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm, Thoracic; Aneurysm; Aortic Aneurysm; Aneurysm, Ascending Aorta
• Other Study ID Numbers: Tomsk NRMC CRI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No