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Mini-sternotomy versus conventional sternotomy for aortic valve replacement : a randomised controlled trial
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Hancock, Helen C., Maier, Rebecca H., Kasim, Adetayo, Mason, James, Murphy, Gavin, Goodwin, Andrew, Owens, W. Andrew and Akowuah, Enoch (2021) Mini-sternotomy versus conventional sternotomy for aortic valve replacement : a randomised controlled trial. BMJ Open, 11 (1). e041398. doi:10.1136/bmjopen-2020-041398
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Official URL: http://dx.doi.org/10.1136/bmjopen-2020-041398
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
| Item Type: | Journal Article | ||||||
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| Subjects: | Q Science > QP Physiology R Medicine > RD Surgery |
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| Divisions: | Faculty of Medicine > Warwick Medical School | ||||||
| Library of Congress Subject Headings (LCSH): | Aortic valve, Aortic valve -- Surgery | ||||||
| Journal or Publication Title: | BMJ Open | ||||||
| Publisher: | BMJ | ||||||
| ISSN: | 2044-6055 | ||||||
| Official Date: | 29 January 2021 | ||||||
| Dates: |
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| Date of first compliant deposit: | 8 February 2021 | ||||||
| Volume: | 11 | ||||||
| Number: | 1 | ||||||
| Article Number: | e041398 | ||||||
| DOI: | 10.1136/bmjopen-2020-041398 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access | ||||||
| RIOXX Funder/Project Grant: |
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