University of Leicester
Browse

File(s) under permanent embargo

Reason: No embargo on AAM - Requested from author

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

journal contribution
posted on 2023-07-12, 09:19 authored by EF Akowuah, RH Maier, HC Hancock, E Kharatikoopaei, L Vale, C Fernandez-Garcia, E Ogundimu, J Wagnild, A Mathias, Z Walmsley, N Howe, A Kasim, R Graham, GJ Murphy, J Zacharias

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

Funding

NIHR HTA programme

History

Author affiliation

Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester

Version

  • VoR (Version of Record)

Published in

JAMA

Volume

329

Issue

22

Pagination

1957 - 1966

Publisher

American Medical Association (AMA)

issn

0098-7484

eissn

1538-3598

Copyright date

2023

Spatial coverage

United States

Language

eng

Usage metrics

    University of Leicester Publications

    Categories

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC