Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting

Summary

The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.

The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events (MACCE) and procedural success.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Heart Diseases

Interventions

PROCEDURE

MICS CABG

Minimally invasive coronary artery bypass grafting - beating heart multi-vessel procedure in which the anastomoses are performed under direct vision through a lateral left mini-thoracotomy. The left internal thoracic artery is used to graft the left anterior descending artery or circumflex artery territories. Radial artery or saphenous vein are used (Y - grafts) to graft another myocardial territories. Right internal thoracic artery can be used as free Y-graft, as in-situ graft with radial artery (extension technique) or as in-situ graft without composite technique. Right gastroepiploic artery can be used to graft right coronary artery territory. Hybrid approach (MICS CABG + PCI), parallel transfemoral extracorporeal circulation without cardioplegia and CABG from the ascending aorta are acceptable for achievement of the complete revascularization.

PROCEDURE

OPCABG

Off-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Mechanical Devices are used for coronary artery stabilization and heart positioning. Pericardial traction sutures are used to position the heart where appropriate. Blowers and Intracoronary shunts are used routinely. Anticoagulation is obtained using sodium heparin at a dose of 2mg/kg with supplemental doses to maintain adequate heparinisation (Activated clotting time\>250seconds).

PROCEDURE

ONCABG

On-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Normothermic cardiopulmonary bypass and complex blood ante-retrograde cardioplegia are used. All patients are cannulated with an proximal aortic cannula and two-stage right atrial cannula. Extracorporeal circulation is provided by the Terumo System-1 heart-lung machine using cardiopulmonary bypass systems with physiological surfaces and opened venous reservoirs. The left internal thoracic artery is used to graft the left anterior descending artery, and radial artery or saphenous vein segments are used to graft another myocardial territories. Anticoagulation is obtained using sodium heparin at a dose of 3mg/kg (ACT, activated clotting time\>450seconds).

DEVICE

Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®)

Octopus® Nuvo - MICS CABG tissue stabilizer available for minimally invasive procedures. It minimizes the motion of a small area of the heart while the rest of the heart continues to beat normally and allows to perform anastomosis through a small incision. Starfish® Non-Sternotomy (NS) - MICS CABG heart positioner available for minimally invasive procedures. It allows for the positioning of the beating heart through a small incision, bringing coronary targets into the operative thoracotomy window. ThoraTrak® - a reusable, stainless steel MICS thoracic retractor system for minimally invasive heart surgery with multiple interchangeable blades, which allows to harvest left internal thoracic artery and to perform anastomosis through a small left thoracotomy(Medtronic, Inc., Minneapolis, MN).

DEVICE

Starfish®, Octopus®, Clearview® blower, ClearView® Shunt

Starfish® - heart positioner is designed to position and to hold the heart to give the surgeon easy access to the vessel requiring the bypass graft. Octopus® - tissue stabilizer minimizes / limits the motion of a small area of the heart while the rest of the heart continues to beat normally. This allows the surgeon to perform CABG surgery without stopping of the heart and without using the heart-lung machine. ClearView® Blower is designed to improve visualization of the surgical site. An irrigation mist gently clears blood from the site, improving visualization without drying or desiccating delicate tissue. The ClearView® shunt - Intracoronary shunt provides a clear anastomotic site during the procedure while providing blood flow to the distal myocardium (Medtronic, Inc., Minneapolis, MN)

Sponsors & Collaborators

• Vitebsk Regional Clinical Hospital

  lead OTHER_GOV

Principal Investigators

• Aliaksandr A Ziankou, MD, PhD · Vitebsk Regional Clinical Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2016-06-30

Completion

2019-06-30

Countries

• Belarus

Study Locations