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

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