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Lookup NU author(s): Professor Enoch AkowuahORCiD, Rebecca Maier, Professor Helen HancockORCiD, Dr Janelle Wagnild, Professor Luke Vale, Dr Cristina Fernandez-GarciaORCiD, Dr Emmanuel Ogundimu, Ayesha Mathias, Zoe WalmsleyORCiD, Nicola HoweORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Background: The safety, effectiveness and cost-effectiveness of mitral valve repair via thoracoscopically guided minithoracotomy compared with conventional median sternotomy (Sternotomy) in patients with degenerative mitral valve regurgitation is uncertain and widely debated. Objectives: To determine if Mini was more effective than Sternotomy in terms of physical functioning and associated return to usual activities and was cost-effective compared with Sternotomy. Design: A pragmatic, multicentre, expertise-based, superiority, randomised trial. Participants: Adults with degenerative mitral valve regurgitation undergoing mitral valve repair surgery. Setting: Ten tertiary care institutions in the United Kingdom. Intervention: Mini or Sternotomy mitral valve repair performed by an expert surgeon. Blinding: Primary outcome measure [Short Form 36-item Health Survey, version 2 (SF-36v2) physical functioning score] was measured by an independent assessor, blinded to allocation. Echocardiographic findings were measured in a core laboratory, blinded to allocation. Outcome Measures: Primary outcomes were physical functioning and associated return to usual activities measured by change from baseline in SF-36v2 physical function domain at 12 weeks following index surgery. The primary economic measure was incremental cost per quality-adjusted life-year over the year following surgery. Secondary outcomes included recurrent mitral regurgitation grade, physical activity and quality of life measured at time points to 1 year. Safety outcomes included death, repeat mitral valve surgery or heart failure hospitalisation up to 1 year. Results: Between November 2016 and January 2021, 330 participants were randomised; 166 to Mini and 164 to Sternotomy. Of these, 309 underwent surgery and 294 reported the primary outcome. Thirty per cent were female. At 12 weeks, mean difference between groups in the change in SF-36v2 physical function T-scores was 0.68 (95% confidence interval -1.89 to 3.26). Valve repair rates (96%) were similar in both groups. Echocardiography demonstrated mitral regurgitation severity as none or mild for 92% of participants at 1 year in both groups. The composite safety outcome occurred in 5.4% (9/166) of Mini and 6.1% (10/163) of Sternotomy participants at 1 year. On average, Mini was more costly £29,424 (95% confidence interval 26,909 to 31,940) versus £27,397 (95% confidence interval 25,172 to 29,620) and more effective 0.81 quality-adjusted life-years (95% confidence interval 0.78 to 0.84) versus 0.78 (95% confidence interval 0.75 to 0.81) than Sternotomy. The adjusted incremental cost-effectiveness ratio was £74,863 per quality-adjusted life-year for the comparison between Mini and Sternotomy. Mini has a probability of < 50% of being cost-effective at the range of willingness-to-pay values considered. Limitations: To minimise bias, SF-36v2 and all echocardiographic measures were independently assessed by personnel blinded to allocation. Expertise-based randomisation was important to address the limitations of previous studies; however, it is possible that it may have introduced potential confounders. Conclusions: Mini is not superior to Sternotomy in recovery of physical function at 12 weeks. Mini achieves high rates and quality of valve repair and has similar safety outcomes at 1 year to Sternotomy. The balance of probabilities favoured Sternotomy as the preferred surgical procedure in the base-case analysis over the range of willingness-to-pay values society might consider worthwhile for a quality-adjusted life-year. Nevertheless, additional factors such as equity or patient preferences for one procedure over another may need to also be taken into account. Results provide high-quality evidence to inform shared decision-making and treatment guidelines. Future work: Work is ongoing to disseminate findings and influence guidelines; patients have consented to longer-term follow-up. From an economics perspective, the currently available evidence shows that further research into patient preferences is important to inform the choice of surgical procedure. Trial registration: This trial is registered as ISRCTN 13930454. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/110) and is published in full in Health Technology Assessment; Vol. 29, No. 55. See the NIHR Funding and Awards website for further award information.Mitral valve regurgitation is a disease where one of the valves in the heart becomes leaky, allowing blood to flow the wrong way. This usually happens with age as the valve becomes floppy, or the muscles around it are weakened. Patients usually become short of breath. When it becomes severe, the best treatment is heart surgery to repair the valve. During surgery, the heart valve can be accessed by cutting through the breastbone (sternotomy) or using keyhole surgery (mini thoracotomy). The UK Mini Mitral Trial compared these two types of surgery. Over 300 UK patients were split into two groups, with each group receiving one type of surgery. Both types of surgery led to patients getting better, with 96% having their valve successfully repaired. After surgery, patients in the keyhole group were discharged from hospital a day earlier than those in the Sternotomy group. To measure recovery, patients completed a questionnaire and wore an activity monitor. Those in the keyhole group did more vigorous exercise early after surgery, such as brisk walking or swimming, and had better sleep than the Sternotomy group. By 12 weeks, both groups had an equally improved activity levels and physical function than before the surgery. Heart scans at 3 months and 1 year showed that almost all patients in both groups had mild or no mitral regurgitation. This tells us that both operations continued to be successful for patients, and their regurgitation has been fixed. Complications were low among both groups. Patients in the keyhole group were less likely to experience a complication early after surgery, and at 1 year after surgery, the results were similar. Mini was on average more costly but had slightly better quality of life over 1 year than sternotomy.
Author(s): Akowuah EF, Maier RH, Hancock HC, Wagnild J, Vale L, Fernandez-Garcia C, Kharati E, Ogundimu E, Mathias A, Walmsley Z, Howe N, Graham R, Ainsworth K, Zacharias J
Publication type: Article
Publication status: Published
Journal: Health Technology Assessment
Year: 2025
Volume: 29
Issue: 55
Pages: 1-121
Print publication date: 01/11/2025
Acceptance date: 31/03/2025
Date deposited: 27/11/2025
ISSN (electronic): 2046-4924
Publisher: NIHR Journals Library
URL: https://doi.org/10.3310/PKOT2391
DOI: 10.3310/PKOT2391
PubMed id: 41217391
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