Helen C Hancock
Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial
Hancock, Helen C; Maier, Rebecca H; Kasim, Adetayo; Mason, James; Murphy, Gavin; Goodwin, Andrew; Owens, W Andrew; Akowuah, Enoch
Authors
Rebecca H Maier
Adetayo Kasim
James Mason
Gavin Murphy
Andrew Goodwin
W Andrew Owens
Enoch Akowuah
Abstract
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.
Citation
Hancock, H. C., Maier, R. H., Kasim, A., Mason, J., Murphy, G., Goodwin, A., …Akowuah, E. (2021). Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial. BMJ Open, 11(1), Article e041398. https://doi.org/10.1136/bmjopen-2020-041398
Journal Article Type | Article |
---|---|
Acceptance Date | Dec 7, 2020 |
Online Publication Date | Jan 29, 2021 |
Publication Date | Jan 29, 2021 |
Deposit Date | Sep 21, 2021 |
Publicly Available Date | Sep 21, 2021 |
Journal | BMJ Open |
Electronic ISSN | 2044-6055 |
Publisher | BMJ Publishing Group |
Peer Reviewed | Peer Reviewed |
Volume | 11 |
Issue | 1 |
Article Number | e041398 |
DOI | https://doi.org/10.1136/bmjopen-2020-041398 |
Public URL | https://durham-repository.worktribe.com/output/1233258 |
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http://creativecommons.org/licenses/by-nc/4.0/
Copyright Statement
Advanced Online Version Open Access. This article is distributed under the terms of the Creative Commons Attribution License (CC-BY 4.0), which permits any use, distribution and reproduction in any medium, provided the original author(s) and source are credited.
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