Journal Article

Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial

Owens, W. Andrew, Akowuah, Enoch, Goodwin, Andrew T., Mellor, Adrian, Hancock, Helen C., Kasim, Adetayo, Murphy, Gavin, Maier, Rebecca, Khan, Khalid, Mason, James

2017

Overview

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 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. 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 surgery. Trial registration International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN29567910 . Registered on 3 February 2014.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Aortic Valve - surgery / Biomarkers - blood / Biomedicine / Blood & organ donations / Blood Loss, Surgical - prevention & control / Blood products / Blood transfusion / Blood transfusions / Clinical outcomes / Clinical Protocols / Coronary vessels / Cost-Benefit Analysis / England / Erythrocyte Transfusion / Health Care Costs / Health Sciences / Heart surgery / Heart Valve Prosthesis Implantation - adverse effects / Heart Valve Prosthesis Implantation - economics / Heart Valve Prosthesis Implantation - methods / Heart valve replacement / Hemoglobins - metabolism / Hospitals / Humans / Hypotheses / Inflammation Mediators - blood / Intervention / Manubrium - surgery / Medicine / Medicine & Public Health / Methods / Patient outcomes / Patients / Postoperative Hemorrhage - etiology / Postoperative Hemorrhage - therapy / Pulmonary arteries / Research Design / Risk Factors / Single-Blind Method / Statistics for Life Sciences / Sternotomy - adverse effects / Sternotomy - economics / Sternotomy - methods / Study Protocol / Sutures / Time Factors / Trauma / Treatment Outcome