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Randomized Controlled Trial
. 2023 Jun 13;329(22):1957-1966.
doi: 10.1001/jama.2023.7800.

Minithoracotomy vs Conventional Sternotomy for Mitral Valve Repair: A Randomized Clinical Trial

Enoch F Akowuah  1 , Rebecca H Maier  2 , Helen C Hancock  3 , Ehsan Kharatikoopaei  4 , Luke Vale  5 , Cristina Fernandez-Garcia  5 , Emmanuel Ogundimu  6 , Janelle Wagnild  4 , Ayesha Mathias  3 , Zoe Walmsley  3 , Nicola Howe  3 , Adetayo Kasim  4   7 , Richard Graham  1 , Gavin J Murphy  8 , Joseph Zacharias  9 ; UK Mini Mitral Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Minithoracotomy vs Conventional Sternotomy for Mitral Valve Repair: A Randomized Clinical Trial

Enoch F Akowuah et al. JAMA. .

Abstract

Importance: The safety and effectiveness of mitral valve repair via thoracoscopically-guided minithoracotomy (minithoracotomy) compared with median sternotomy (sternotomy) in patients with degenerative mitral valve regurgitation is uncertain.

Objective: To compare the safety and effectiveness of minithoracotomy vs sternotomy mitral valve repair in a randomized trial.

Design, setting, and participants: A pragmatic, multicenter, superiority, randomized clinical trial in 10 tertiary care institutions in the UK. Participants were adults with degenerative mitral regurgitation undergoing mitral valve repair surgery.

Interventions: Participants were randomized 1:1 with concealed allocation to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon.

Main outcomes and measures: The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) version 2 physical functioning scale 12 weeks after the index surgery, assessed by an independent researcher masked to the intervention. Secondary outcomes included recurrent mitral regurgitation grade, physical activity, and quality of life. The prespecified safety outcomes included death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year.

Results: Between November 2016 and January 2021, 330 participants were randomized (mean age, 67 years, 100 female [30%]); 166 were allocated to minithoracotomy and 164 allocated to sternotomy, of whom 309 underwent surgery and 294 reported the primary outcome. At 12 weeks, the mean between-group difference in the change in the SF-36 physical function T score was 0.68 (95% CI, -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 with no difference between groups. The composite safety outcome occurred in 5.4% (9 of 166) of patients undergoing minithoracotomy and 6.1% (10 of 163) undergoing sternotomy at 1 year.

Conclusions and relevance: Minithoracotomy is not superior to sternotomy in recovery of physical function at 12 weeks. Minithoracotomy achieves high rates and quality of valve repair and has similar safety outcomes at 1 year to sternotomy. The results provide evidence to inform shared decision-making and treatment guidelines.

Trial registration: isrctn.org Identifier: ISRCTN13930454.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms Maier reported receiving grants from the National Institute of Health and Care Research (NIHR). Dr Kharatikoopaei reported receiving grants from the NIHR. Dr Vale reported receiving grants from the NIHR. Dr Ogundimu reported receiving grants from the NIHR. Dr Kasim reported receiving grants from NIHR HTA. Dr Graham reported receiving grants from the NIHR HTA. Dr Murphy reported receiving grants from NIHR HTA, the British Heart Foundation, and the NIHR and Clinical Trials outside the submitted work. Dr Zacharias reported serving as a proctor for minimally invasive mitral surgery from the Edwards Lifesciences Act; speakers fees from Medtronic, Terumo, and Ethicon; and consulting fees from Cambridge Medical robotics. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Selection, Allocation, and Flow in the UK Mini Mitral Trial
aTwo were private patients and 1 was a prisoner. SF-36 indicates 36-Item Short Form Health Survey version 2 physical functioning.
Figure 2.
Figure 2.. Changes in 36-Item Short Form Health Version 2 Physical Functioning T Score in Patients Undergoing Minithoracotomy vs Conventional Sternotomy
The parallel line plot includes 1 vertical line for each participant. The lines extend from the baseline value to the 12-week value. Ascending lines indicate an improvement. Baseline values are arranged in ascending order for the minithoracotomy group and descending order for the conventional sternotomy group. The ends of the boxes in the boxplots indicate the first and third quartiles; the middle black lines, the median; and the white dashed lines, the mean. Whiskers extend to the upper and lower adjacent values, the location of the furthest point within a distance of 1.5 interquartile ranges from the first and third quartiles. Dots indicate extreme values. For the 36-Item Short Form Health version 2 physical function T score calculation, see the Methods section.
Figure 3.
Figure 3.. Mitral Regurgitation Severity From Transthoracic Echocardiogram Data at Baseline, 12 Weeks, and 1 Year
Mitral regurgitation was graded according to the recommendations of the European Association of Cardiovascular Imaging. The Sankey plots include all participants in each group, displayed with bars proportional to the number in each category of mitral regurgitation severity at each time point. Echocardiography demonstrated reduction in mitral regurgitation to none or mild for 92% of participants at 1 year with no difference between groups. Transthoracic echocardiogram assessments were missed by 10.6% of participants at 12 weeks and 17.9% at 1 year (Supplement 3).
See this image and copyright information in PMC

Comment in

References

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