Full Sternotomy vs Mini-sternotomy for Ascending Aortic Pathology

Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology

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.

Study Overview

• Status: Recruiting
• Conditions: Ascending Aortic Aneurysm
• Intervention / Treatment: Procedure: Full sternotomy; Procedure: J-shaped mini-sternotomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitri S. Panfilov, MD, PhD; Phone Number: +79039130879; Email: pand2006@yandex.ru
• Study Contact Backup: Name: Andrey V. Sofronov; Phone Number: +79521542201; Email: andreysofronov@mail.ru

Study Locations

• Russia
  • Tomsk, Russia, 634012
    • Recruiting
    • Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia
    • Contact: Dmitri S. Panfilov, MD, PhD; Phone Number: +79039130879; Email: pand2006@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Full Sternotomy; 100 patients who will undergo hemiarch repair via full sternotomy	Procedure: Full sternotomy; hemiarch repair via full sternotomy
Active Comparator: Mini J-Sternotomy; 100 patients who will undergo hemiarch repair via J-shaped mini-sternotomy	Procedure: J-shaped mini-sternotomy; hemiarch repair via J-shaped mini-sternotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early mortality	The difference in the incidence of early mortality between groups (p-value).	during follow-up time - 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium (percent)	The difference in the incidence of delirium during follow-up (p-value).	Perioperative/Periprocedural
Transient ischemic attack (percent)	The difference in the incidence of transient ischemic attack during follow-up (p-value).	Perioperative/Periprocedural
Stroke (percent)	The difference in the incidence of stroke during follow-up (p-value).	during follow-up time - 60 months
Respiratory failure (percent)	The difference in the incidence of respiratory failure during follow-up (p-value).	Perioperative/Periprocedural
New arrythmia (percent)	The difference in the incidence of new arrythmia during follow-up (p-value).	during follow-up time - 60 months
Pericardial effusion (percent)	The difference in the incidence of new arrythmia during follow-up (p-value).	Perioperative/Periprocedural
Heart failure (percent)	The difference in the incidence of heart failure during follow-up (p-value).	during follow-up time - 60 months
Myocardial infarction (percent)	The difference in the incidence of myocardial infarction during follow-up (p-value).	during follow-up time - 60 months
Systemic embolism (percent)	The difference in the incidence of systemic embolism during follow-up (p-value).	during follow-up time - 60 months
Acute kidney injury requiring renal replacement therapy (percent)	The difference in the incidence of renal replacement therapy during follow-up (p-value).	during follow-up time - 60 months
Re-exploration rate (percent)	The difference in the incidence of re-operation for bleeding during follow-up (p-value).	during follow-up time - 60 months

Collaborators and Investigators

• Sponsor: Tomsk Cardiology Research Institute
• Investigators: Principal Investigator: Boris N. Kozlov, MD, PhD, Cardiology Research Institute, Tomsk National Research Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: sternotomy; ascending aortic aneurysm; aortic replacement; mini-sternotomy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aneurysm, Ascending Aorta
• Other Study ID Numbers: 260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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