None listed
Conditions
Brief summary
Stroke is a potential devastating complication of cardiac surgery occurring in up to 3-4% of patients undergoing combined aortic valve replacement (AVR) and coronary artery bypass grafting (CABG). Peri-operative stroke is often multifactorial and resulting from debris from the heart-lung machine and the sites of heart-lung machine into the blood-stream. Traditionally the first part of the main blood vessel leaving the heart (the aorta) punctured to provide oxygen-rich blood inflow from the heart lung machine for patients undergoing heart surgery. In patients with significant aortic atheroma, the risk of stroke may be minimised by reducing manipulation of diseased aorta. Alternative cannulation sites that do not require a puncture of the aorta include: right axillary cannulation (right arm artery) and common femoral cannulation (upper leg artery). Right axillary cannulation is increasingly being used for major aortic surgery due to a proven reduction in stroke. It has not yet been shown if this benefit will extend to other aspects of cardiac surgery that have a higher risk of stroke. This study comparing cannulation strategy to determine if there is a reduction in stroke. Patients undergoing combined aortic valve replacement + coronary artery bypass surgery, who are deemed intermediate or high risk of stroke are randomly assigned to receive either right axillary cannulation or central aortic cannulation Patients in the intervention arm will have arterial cannulation via the right axillary artery. Right axillary cannulation involves an approximately 5cm incision below the right collar bone to get access to the artery used for inflow to the heart-lung machine. The vessel is assessed for suitability to ensure it is suitable for use and if so they are connected to the heart-lung machine via this artery. Patients in the control arm will be have the arterial inflow from the heart lung machine via the aorta as is conventionally done. The remainder of the procedure is unchanged regardless of cannulation strategy. In order to determine a difference in stroke the participant will have an MRI scan of the brain and an assessment performed in the hospital prior to the operation, this will also be repeated within seven days after the operation. The participant will also be required to follow up with a neurologist 3 months after the operation in addition to the routine post-operative review with the cardiothoracic surgeon.
Interventions
Cerebral injury is a debilitating complication of cardiac surgery occurring in up to 3-4% of patients undergoing combined aortic valve replacement (AVR) and coronary artery bypass grafting (CABG). Peri-operative stroke is often multifactorial and resulting from emboli from the heart-lung machine, cannulation site and cross-clamp site. Traditionally the distal ascending aorta is cannulated to provide arterial inflow from the heart lung machine for patients undergoing cardiac surgery. In patient
Cerebral injury is a debilitating complication of cardiac surgery occurring in up to 3-4% of patients undergoing combined aortic valve replacement (AVR) and coronary artery bypass grafting (CABG). Peri-operative stroke is often multifactorial and resulting from emboli from the heart-lung machine, cannulation site and cross-clamp site. Traditionally the distal ascending aorta is cannulated to provide arterial inflow from the heart lung machine for patients undergoing cardiac surgery. In patients with significant aortic atheroma, the risk of stroke may be minimised by reducing instrumentation of diseased aorta. Alternative cannulation sites that prevent cannulation of the aorta include: right axillary cannulation and common femoral cannulation. Right axillary cannulation is increasingly being used for major aortic surgery due to a improved neurological outcomes. It has not yet been shown if this benefit will extend to other aspects of cardiac surgery with a higher risk of stroke. This study is a randomised control trail comparing cannulation strategy; with right axillary cannulation or central aortic cannulation for intermediate or high risk for cerebral injury after combined AVR + CABG. Patients in the intervention arm will have arterial cannulation via the right axillary artery. Right axillary cannulation involves an approximately 5cm incision inferior to the right clavicle with dissection through pectorals major, pectorals minor is either retracted laterally or divided and the axillary artery is secured. The vessel is assess for suitability and is accessed either through direct cannulation with and appropriately sized arterial return cannula or an 8mm pre-clotted Dacron graft is anastomosed to the vessel in an end-to-side fashion through which perfusion is completed. The remainder of the procedure is unchanged regardless of cannulation strategy. All procedures will be undertaken by a consultant cardiothoracic surgeon. Aortic valve replacement + coronary artery bypass surgery takes approximately 4-6 hours with central cannulation, axillary artery cannulation adds approximately 15-20 minutes to the operative time overall, with no additional cardiopulmonary bypass or cross-clamp time.
Sponsors
Departent of cardiothoracic Surgery, Royal North Shore Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients undergoing AVR+CABG at Royal North Shore Hospital including emergency surgery
Exclusion criteria
Patients with previous history of stroke Patients not agreeable/ineligible for MRI brain (e.g claustrophobia, non-compatible implantable devices) Patients with significant right subclavian stenosis Patients with pre-existing brachial plexus palsy Patients unable to complete 3 month follow-up Patients unable to provide their own consent
Outcome results
None listed