title: Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial.
abstract: 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.
  
  
  
  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 post-operatively 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.
  
  
  
  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 surgery.
  
  
  
  International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN29567910 . Registered on 3 February 2014.
authors.affiliation: Cardiothoracic Division, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.
authors.forename: Enoch
authors.initials: E
authors.lastname: Akowuah
authors.affiliation: Cardiothoracic Division, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Goodwin
authors.affiliation: Cardiothoracic Division, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.
authors.forename: W Andrew
authors.initials: WA
authors.lastname: Owens
authors.affiliation: Durham Clinical Trials Unit, School of Medicine, Pharmacy and Health, Durham University, Queen's Campus, University Boulevard, Thornaby, Stockton-on-Tees, TS17 6BH, UK. helen.hancock@durham.ac.uk.
authors.forename: Helen C
authors.initials: HC
authors.lastname: Hancock
authors.affiliation: Durham Clinical Trials Unit, School of Medicine, Pharmacy and Health, Durham University, Queen's Campus, University Boulevard, Thornaby, Stockton-on-Tees, TS17 6BH, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Maier
authors.affiliation: Durham Clinical Trials Unit, School of Medicine, Pharmacy and Health, Durham University, Queen's Campus, University Boulevard, Thornaby, Stockton-on-Tees, TS17 6BH, UK.
authors.forename: Adetayo
authors.initials: A
authors.lastname: Kasim
authors.affiliation: Cardiothoracic Division, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Mellor
authors.affiliation: Cardiothoracic Division, The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Marton Road, Middlesbrough, TS4 3BW, UK.
authors.forename: Khalid
authors.initials: K
authors.lastname: Khan
authors.affiliation: Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, LE3 9QP, UK.
authors.forename: Gavin
authors.initials: G
authors.lastname: Murphy
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
authors.forename: James
authors.initials: J
authors.lastname: Mason
mesh_terms: D001021:Aortic Valve / Q000601:surgery*; D015415:Biomarkers / Q000097:blood; D016063:Blood Loss, Surgical / Q000517:prevention & control; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004739:England; D017707:Erythrocyte Transfusion; D017048:Health Care Costs; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008371:Manubrium / Q000601:surgery*; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000628:therapy; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method; D056346:Sternotomy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006454:Hemoglobins; D018836:Inflammation Mediators
keywords: Aortic valve replacement (AVR); Inflammatory response; Manubrium-limited ministernotomy; Minimally invasive aortic valve replacement; Red blood cell transfusion; Sternotomy