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Randomized Controlled Trial
. 2021 Jan 29;11(1):e041398.
doi: 10.1136/bmjopen-2020-041398.

Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial

Helen C Hancock  1 , Rebecca H Maier  1 , Adetayo Kasim  2 , James Mason  3 , Gavin Murphy  4 , Andrew Goodwin  5 , W Andrew Owens  5 , Enoch Akowuah  6
Affiliations
Randomized Controlled Trial

Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial

Helen C Hancock et al. BMJ Open. .

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.

Keywords: adult intensive & critical care; adult surgery; cardiac surgery; clinical trials; health economics.

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Conflict of interest statement

Competing interests: GM: Declares research grant funding from Zimmer Biomet for a trial of blood transfusion. He is supported by the British Heart Foundation (CH/12/1/29419) and the NIHR Leicester Biomedical Research Centre. HCH, RHM, AK, JM, AG, WAO and EA: None.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials diagram. Flow of participants through trial.
Figure 2
Figure 2
Valve size distribution: mini-sternotomy group.
Figure 3
Figure 3
Valve size distribution: conventional sternotomy group.
Figure 4
Figure 4
Cost-effectiveness plane, cost/QALY (£): mini-sternotomy versus conventional surgery.
See this image and copyright information in PMC

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