Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial
Objective To compare clinical and health economic outcomes after manubrium-limited mini-sternotomy (intervention) and conventional median sternotomy (usual care).Design A single-blind, randomised controlled trial.Setting Single centre UK National Health Service tertiary hospital.Participants Adult p...
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doaj-25d0e7515398434d86f1145ff297debb2021-02-20T12:32:07ZengBMJ Publishing GroupBMJ Open2044-60552021-01-0111110.1136/bmjopen-2020-041398Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trialEnoch Akowuah0James Mason1Adetayo Kasim2Helen C Hancock3Rebecca H Maier4Gavin Murphy5Andrew Goodwin6W Andrew Owens7Department of Cardiothoracic Surgery, James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UKWarwick Medical School, University of Warwick, Coventry, UKWolfson Research Institute for Health and Wellbeing, Durham University, Stockton-on-Tees, Durham, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UKDepartment of Cardiovascular Sciences and NIHR Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Leicester, UKDepartment of Cardiothoracic Surgery, James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UKDepartment of Cardiothoracic Surgery, James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UKObjective To compare clinical and health economic outcomes after manubrium-limited mini-sternotomy (intervention) and conventional median sternotomy (usual care).Design A single-blind, randomised controlled trial.Setting Single centre UK National Health Service tertiary hospital.Participants Adult patients undergoing aortic valve replacement (AVR) surgery.Interventions Intervention was manubrium-limited mini-sternotomy performed using a 5–7 cm midline incision. Usual care was median sternotomy performed using a midline incision from the sternal notch to the xiphisternum.Primary and secondary outcome measures The primary outcome was the proportion of patients who received a red cell transfusion postoperatively and within 7 days of index surgery. Secondary outcomes included proportion of patients receiving a non-red cell blood component transfusion and number of units transfused within 7 days and during index hospital stay, quality of life and cost-effectiveness analyses.Results 270 patients were randomised, received surgery and contributed to the intention to treat analysis. No difference between mini and conventional sternotomy in red-cell transfusion within 7 days was found; 23/135 patients in each arm received a transfusion, OR 1.0 (95% CI 0.5 to 2.0) and risk difference 0.0 (95% CI −0.1 to 0.1). Mini-sternotomy reduced chest drain losses (mean 181.6 mL (SD 138.7) vs conventional, mean 306·9 mL (SD 348.6)); this did not reduce red-cell transfusions. Mean valve size and postoperative valve function were comparable between mini-sternotomy and conventional groups; 23 mm vs 24 mm and 6/134 moderate or severe aortic regurgitation vs 3/130, respectively. Mini-sternotomy resulted in longer bypass (82.7 min (SD 23.5) vs 59.6 min (SD 15.1)) and cross-clamp times (64.1 min (SD 17.1) vs 46·3 min (SD 10.7)). Conventional sternotomy was more cost-effective with only a 5.8% probability of mini-sternotomy being cost-effective at a willingness to pay of £20 000/QALY (Quality Adjusted Life Years).Conclusions AVR via mini-sternotomy did not reduce red blood cell transfusion within 7 days following surgery when compared with conventional sternotomy.Trial registration number ISRCTN29567910; Results.https://bmjopen.bmj.com/content/11/1/e041398.full |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Enoch Akowuah James Mason Adetayo Kasim Helen C Hancock Rebecca H Maier Gavin Murphy Andrew Goodwin W Andrew Owens |
spellingShingle |
Enoch Akowuah James Mason Adetayo Kasim Helen C Hancock Rebecca H Maier Gavin Murphy Andrew Goodwin W Andrew Owens Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial BMJ Open |
author_facet |
Enoch Akowuah James Mason Adetayo Kasim Helen C Hancock Rebecca H Maier Gavin Murphy Andrew Goodwin W Andrew Owens |
author_sort |
Enoch Akowuah |
title |
Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial |
title_short |
Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial |
title_full |
Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial |
title_fullStr |
Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial |
title_full_unstemmed |
Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial |
title_sort |
mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial |
publisher |
BMJ Publishing Group |
series |
BMJ Open |
issn |
2044-6055 |
publishDate |
2021-01-01 |
description |
Objective To compare clinical and health economic outcomes after manubrium-limited mini-sternotomy (intervention) and conventional median sternotomy (usual care).Design A single-blind, randomised controlled trial.Setting Single centre UK National Health Service tertiary hospital.Participants Adult patients undergoing aortic valve replacement (AVR) surgery.Interventions Intervention was manubrium-limited mini-sternotomy performed using a 5–7 cm midline incision. Usual care was median sternotomy performed using a midline incision from the sternal notch to the xiphisternum.Primary and secondary outcome measures The primary outcome was the proportion of patients who received a red cell transfusion postoperatively and within 7 days of index surgery. Secondary outcomes included proportion of patients receiving a non-red cell blood component transfusion and number of units transfused within 7 days and during index hospital stay, quality of life and cost-effectiveness analyses.Results 270 patients were randomised, received surgery and contributed to the intention to treat analysis. No difference between mini and conventional sternotomy in red-cell transfusion within 7 days was found; 23/135 patients in each arm received a transfusion, OR 1.0 (95% CI 0.5 to 2.0) and risk difference 0.0 (95% CI −0.1 to 0.1). Mini-sternotomy reduced chest drain losses (mean 181.6 mL (SD 138.7) vs conventional, mean 306·9 mL (SD 348.6)); this did not reduce red-cell transfusions. Mean valve size and postoperative valve function were comparable between mini-sternotomy and conventional groups; 23 mm vs 24 mm and 6/134 moderate or severe aortic regurgitation vs 3/130, respectively. Mini-sternotomy resulted in longer bypass (82.7 min (SD 23.5) vs 59.6 min (SD 15.1)) and cross-clamp times (64.1 min (SD 17.1) vs 46·3 min (SD 10.7)). Conventional sternotomy was more cost-effective with only a 5.8% probability of mini-sternotomy being cost-effective at a willingness to pay of £20 000/QALY (Quality Adjusted Life Years).Conclusions AVR via mini-sternotomy did not reduce red blood cell transfusion within 7 days following surgery when compared with conventional sternotomy.Trial registration number ISRCTN29567910; Results. |
url |
https://bmjopen.bmj.com/content/11/1/e041398.full |
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