1. Mini-sternotomy versus conventional sternotomy for aortic valve replacement: a randomised controlled trial
- Author
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W. Andrew Owens, James Mason, Andrew T. Goodwin, Helen C. Hancock, Adetayo Kasim, Gavin J. Murphy, Enoch Akowuah, and Rebecca Maier
- Subjects
Adult ,medicine.medical_specialty ,medicine.medical_treatment ,lcsh:Medicine ,030204 cardiovascular system & hematology ,State Medicine ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Aortic valve replacement ,Quality of life ,Randomized controlled trial ,law ,Blood Component Transfusion ,medicine ,health economics ,Humans ,Minimally Invasive Surgical Procedures ,Single-Blind Method ,adult surgery ,030212 general & internal medicine ,adult intensive & critical care ,Retrospective Studies ,Heart Valve Prosthesis Implantation ,clinical trials ,Intention-to-treat analysis ,business.industry ,lcsh:R ,General Medicine ,medicine.disease ,QP ,Sternotomy ,Surgery ,Cardiac surgery ,Clinical trial ,Treatment Outcome ,Median sternotomy ,Aortic Valve ,Quality of Life ,business ,RD ,cardiac surgery - Abstract
ObjectiveTo compare clinical and health economic outcomes after manubrium-limited mini-sternotomy (intervention) and conventional median sternotomy (usual care).DesignA single-blind, randomised controlled trial.SettingSingle centre UK National Health Service tertiary hospital.ParticipantsAdult patients undergoing aortic valve replacement (AVR) surgery.InterventionsIntervention 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 measuresThe 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.Results270 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).ConclusionsAVR via mini-sternotomy did not reduce red blood cell transfusion within 7 days following surgery when compared with conventional sternotomy.Trial registration numberISRCTN29567910; Results.
- Published
- 2021
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