Full Sternotomy vs Mini-sternotomy for Ascending Aortic Pathology

Tomsk Cardiology Research Institute

Status: Enrolling

Conditions: Ascending Aortic Aneurysm

Treatments: Procedure: Full sternotomy; Procedure: J-shaped mini-sternotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07386028

260

Details and patient eligibility

About

This study investigates outcomes after hemiarch repair in patients with chronic ascending aortic disease. The patients will be divided into two groups according to surgical approach: 100 patients will undergo hemiarch repair via full sternotomy (FS group) and 100 patients will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Early and late outcomes will be recorded.

Full description

1. Relevance of the study Hemiarch repair is an effective treatment for patients with ascending aortic aneurysm (AAR). All aortic procedures are routinely performed from full mean sternotomy but nowadays this standard could be performed via minimally invasive approach as well. There are some data that mini-J sternotomy is associated with less blood loss and blood products transfusion, improved lung function and eliminates wound complications risks. The aim of this study was to assess the morbidity and mortality after hemiarch repair via full or J-shaped mini-sternotomy.
2. Patients and methods Patients who will undergo hemiarch repair procedure via full sternotomy (FS group) will be compared with patients who will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Baseline characteristics including preoperative clinical status, details on surgery, and postoperative outcomes will be compared between these groups. Follow-up data will be recorded.

Imaging All aortic measurements will be assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta will be performed within 2 weeks after surgery. Analysis will be 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. All measurements will be taken 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. All images will be independently assessed by two experienced cardiologists.

Surgical technique The hemiarch repair is performed via a full sternotomy or J-shaped mini-sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion through the innominate artery with side graft. The distal aortic anastomosis is performed using an open anastomosis fashion and involved resection of the inferior portion of the aortic arch from the base of the innominate artery to the projection of the origin of the left subclavian artery. Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) is used for cerebral monitoring during the operation. When the target temperature is achieved, lower body circulatory arrest with antegrade cerebral perfusion is initiated. The distal aortic anastomosis is performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic reconstruction including Bentall procedure, David procedure, proximal aortic anastomosis, etc. are performed during the rewarming period. The patient is weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation are the same for all patients.

Follow-up Follow-up will be performed according to the institutional database supplemented by individual patient records. Data will be obtained via medical records of clinical encounters or phone calls with patients and/or relatives. Postoperative computed tomographic scans will be performed upon discharge, at 12 months from the last procedure and at 60 months thereafter.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent.
• Ascending aorta greater than 5 cm without involving the aortic arch

Exclusion criteria

• Acute aortic dissection or urgent/emergent cases.
• Redo aortic surgery.
• Aortic arch surgery.
• Concomitant CABG or left ventricle restoration

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Full Sternotomy

Active Comparator group

Description:

100 patients who will undergo hemiarch repair via full sternotomy

Treatment:

Procedure: Full sternotomy

Mini J-Sternotomy

Active Comparator group

Description:

100 patients who will undergo hemiarch repair via J-shaped mini-sternotomy

Treatment:

Procedure: J-shaped mini-sternotomy