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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Sternotomy | Active Comparator | 100 patients who will undergo hemiarch repair via full sternotomy |
|
| Mini J-Sternotomy | Active Comparator | 100 patients who will undergo hemiarch repair via J-shaped mini-sternotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full sternotomy | Procedure | hemiarch repair via full sternotomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Early mortality | The difference in the incidence of early mortality between groups (p-value). | during follow-up time - 60 months |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitri S. Panfilov, MD, PhD | Contact | +79039130879 | pand2006@yandex.ru | |
| Andrey V. Sofronov | Contact | +79521542201 | andreysofronov@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Boris N. Kozlov, MD, PhD | Cardiology Research Institute, Tomsk National Research Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia | Recruiting | Tomsk | 634012 | Russia |
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| ID | Term |
|---|---|
| D000094625 | Aneurysm, Ascending Aorta |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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| J-shaped mini-sternotomy |
| Procedure |
hemiarch repair via J-shaped mini-sternotomy |
|
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |