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Clinical Trials/NCT07071857
NCT07071857CompletedNot Applicable

Coronary Artery Bypass Grafting With Concomitant Ascending Aortic Replacement: a Case-control Study

Tomsk Cardiology Research Institute0 sites70 target enrollmentStarted: January 20, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Primary Endpoint
major adverse cerebral and cardiac events (MACCE).

Study Overview

Brief Summary

This retrospective study investigates early outcomes after CABG as well as graft patency rate in patients with concomitant AAR. 35 patients undergoing CABG with concomitant AAR (CABG+AAR group) were case-control matched to 35 patients who received isolated CABG (CABG group) in regard to transit-time flow measurement (TTFM) findings, early and late outcomes.

Detailed Description

  1. Relevance of the study. Coronary artery bypass grafting is an effective treatment for patients with coronary artery disease (CAD). Nowadays, this operation is the most common surgical procedure performed on the heart, with >600,000 operations per year worldwide. Approximately 15-20% of patients with CAD require concomitant cardiac surgery with relatively high incidence of postoperative morbidity and mortality. It is considered that concomitant CAD in patients undergoing thoracic aortic surgery is an independent risk factor for perioperative mortality. Taking into account the recently published data, CABG added to other cardiac surgeries is associated with increased short- and long-term mortality. There are no available data on the relationship between the outcomes of the concomitant CABG and the patency of coronary grafts. The aim of this study was to assess the early outcomes after CABG as well as graft patency rate in patients with concomitant AAR.
  2. Patients and methods. 35 patients who underwent CABG concomitant with ascending aortic replacement (CABG+AAR group) were compared with 35 patients who underwent isolated CABG (CABG group). Baseline characteristics which included preoperative characteristics, details on surgery (duration of cardiopulmonary bypass, cardioplegic arrest, antegrade cerebral perfusion), and early and late postoperative outcomes were compared between these groups.

Imaging All aortic measurements and postoperative graft patency were assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta and/or grafts was performed within 2 weeks after surgery. Analysis was 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 were taken always in the plane perpendicular to the manually corrected local aortic centre line. Ascending aortic diameter was measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm) was measured from the outer contours of the aortic wall.

The postoperative graft status was classified according to Fitzgibbon classification where Grade A is a patent graft, grade B is a stenosed graft (<50% of the grafted coronary artery) or a string sign and grade O is an occluded graft. All images were independently assessed by two experienced cardiologists.

Surgical technique CABG surgery was performed in the standard manner with a cardiopulmonary bypass and carioplegic arrest. Left internal mammary arterial (LIMA) grafts were used as in situ grafts to the LAD in all of the cases. All saphenous vein grafts (SVGs) were used in an aortocoronary bypass fashion. Proximal anastomoses were sewn to the aorta/graft with side-biting clamp on the beating heart.

The surgery was performed through a median sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion via the innominate artery with side graft. The distal aortic anastomosis was 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 (hemiarch repair). Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) was used for cerebral monitoring during the operation. When the target temperature was achieved, lower body circulatory arrest with antegrade cerebral perfusion was initiated. The distal aortic anastomosis was performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic anastomosis as well as coronary artery bypass grafting was performed during the rewarming period. The patient was weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation was the same for all patients.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 18-80 years.
  • •Signed informed consent.
  • •Severe left main stem artery stenosis, or left main equivalent disease (70% or greater stenosis in diameter of the left anterior descending artery, proximal left circumflex artery and right coronary artery).
  • •Ascending aorta greater than 5 cm.

Exclusion Criteria

  • •Dissections or urgent/emergent cases.
  • •Redo aortic surgery.
  • •Total aortic arch surgery.

Arms & Interventions

CABG (Coronary artery bypass grafting)

Experimental

35 patients who underwent isolated coronary artery bypass grafting.

Intervention: ECG CT angiography (Diagnostic Test)

CABG (Coronary artery bypass grafting)

Experimental

35 patients who underwent isolated coronary artery bypass grafting.

Intervention: TTFM (Diagnostic Test)

CABG (Coronary artery bypass grafting)

Experimental

35 patients who underwent isolated coronary artery bypass grafting.

Intervention: computed tomography of the aorta and/or grafts (Diagnostic Test)

CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement)

Experimental

35 patients who underwent CABG concomitant with ascending aortic replacement.

Intervention: ECG CT angiography (Diagnostic Test)

CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement)

Experimental

35 patients who underwent CABG concomitant with ascending aortic replacement.

Intervention: TTFM (Diagnostic Test)

CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement)

Experimental

35 patients who underwent CABG concomitant with ascending aortic replacement.

Intervention: computed tomography of the aorta and/or grafts (Diagnostic Test)

Outcomes

Primary Outcomes

major adverse cerebral and cardiac events (MACCE).

Time Frame: 12 months

The difference in the incidence of MACCE between groups (p-value)

Secondary Outcomes

  • Respiratory failure (%)(Perioperative)
  • Acute kidney injury requiring renal replacement therapy (%)(Perioperative)
  • Re-exploration rate (%)(Perioperative)

Investigators

Sponsor
Tomsk Cardiology Research Institute
Sponsor Class
Other
Responsible Party
Sponsor

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