Publication details for Dr Adetayo KasimAkowuah, E., Goodwin, A.T., Owens, W.A., Hancock, H.C., Maier, R., Kasim, A.K., Mellor, A., Khan, K., Murphy, G. & Mason, J.M. (2017). Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomized controlled trial. Trials 18: 46.
- Publication type: Journal Article
- ISSN/ISBN: 1745-6215
- DOI: 10.1186/s13063-016-1768-4
- Further publication details on publisher web site
- Durham Research Online (DRO) - may include full text
Author(s) from Durham
Background: Aortic valve replacement is one of the most common cardiac surgical procedures performed
worldwide. Conventional aortic valve replacement surgery is performed via a median sternotomy; the sternum is
divided completely from the sternal notch to the xiphisternum. Minimally invasive aortic valve replacement, using a
new technique called manubrium-limited ministernotomy, divides only the manubrium from the sternal notch to 1
cm below the manubrio-sternal junction.
More than one third of patients undergoing conventional sternotomy develop clinically significant bleeding requiring
post-operative red blood cell transfusion. Case series data suggest a potentially clinically significant difference in red
blood cell transfusion requirements between the two techniques. Given the implications for National Health Service
resources and patient outcomes, a definitive trial is needed.
Methods/design: This is a single-centre, single-blind, randomised controlled trial comparing aortic valve replacement
surgery using manubrium-limited ministernotomy (intervention) and conventional median sternotomy (usual care). Two
hundred and seventy patients will be randomised in a 1:1 ratio between the intervention and control arms, stratified by
baseline logistic EuroSCORE and haemoglobin value. Patients will be followed for 12 weeks from discharge following their
index operation. The primary outcome is the proportion of patients who receive a red blood cell transfusion postoperatively
within 7 days of surgery. Secondary outcomes include red blood cell and blood product transfusions, blood loss,
re-operation rates, sternal wound pain, quality of life, markers of inflammatory response, hospital discharge, health care
utilisation, cost and cost effectiveness and adverse events.
Discussion: This is the first trial to examine aortic valve replacement via manubrium-limited ministernotomy versus
conventional sternotomy when comparing red blood cell transfusion rates following surgery. Surgical trials present
significant challenges; strengths of this trial include a rigorous research design, standardised surgery performed by
experienced consultant cardiothoracic surgeons, an agreed anaesthetic regimen, patient blinding and consultant-led patient
recruitment. The MAVRIC trial will demonstrate that complex surgical trials can be delivered to exemplary standards and
provide the community with the knowledge required to inform future care for patients requiring aortic valve replacement
Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN29567910. Registered on 3