Dataset Information

Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral).

ABSTRACT:

Introduction

Numbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches.There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice.

Methods and analysis

UK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up.Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years.The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery.

Ethics and dissemination

A favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication.

Trial registration number

ISRCTN13930454.

SUBMITTER: Maier RH

PROVIDER: S-EPMC8054102 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background:Cardiac redo surgery, especially after a full sternotomy, is considered a high-risk procedure. Minimally invasive mitral valve surgery (MIMVS) is a potential therapeutic approach. However, current developments in interventional cardiology necessitate additional discussion regarding the therapy of choice in high-risk patients. In this context, it is necessary to clarify the perioperative and postoperative risks induced by the factor previous sternotomy in the setting of MIMVS. Thus, we present a comparative study analyzing the outcome of MIMVS after previous sternotomy vs. primary operation. Methods:We identified 19 patients who received isolated or combined mitral valve (MV) surgery via the MIMVS approach after previous full sternotomy (PS group) and compared the results to those of a group of 357 patients who received primary MIMVS (non-PS group). After a propensity score analysis, groups of n?=?15 and n?=?131, respectively, were subjected to a comparative evaluation. A 1-year follow-up analysis of functional cardiac parameters and clinical symptoms was performed, accompanied by a Kaplan-Meier analysis. Results:Except for the rate of realized MV reconstructions (PS group: 53.8% vs. non-PS group: 85.5%; p?=?0.011), no significant differences were to be noted within the intraoperative and early postoperative course. However, patients in the PS group experienced an increased intensive care unit stay length (PS group: 2?days, 95% CI, 1-8 vs. non-PS group: 1 day, 95% CI, 1-2; p?=?0.072). The follow-up examinations revealed excellent functional and clinical outcomes for both groups. The Kaplan-Meier analysis displayed no significant difference regarding the postoperative mortality (p?=?0.929) related to the patients at risk. Conclusion:A previous sternotomy remains a risk factor for MIMVS and demands special attention in the early postoperative period. Nevertheless, the early- and late-term results concerning the functional and clinical outcomes suggest that the MIMVS procedure is satisfactory, even after a full sternotomy.