1. THE UK MINI MITRAL TRIAL
SCTS 2017

2. Equipoise ? 2000/Year in the UK
75 year old gentleman known murmur for 5 years
Fit and well till 6 months
Now has dyspnoea and new onset AF
TOE confirmed severe MR due to P2 prolapse
Angio confirmed normal coronary arteries
Referred for isolated mitral repairvalve repair
2000/Year in the UK

3. MINI or CONVENTIONAL ?

4. Equipoise

5. Challenges
Equipoise
Outcome Measure (Surgeons, Cardiologist, Patients )
Multicentre RCT (2000/yr)
Expertise based randomisation
Recruitment

6. Trial Overview and Design
A prospective randomised controlled trial
Multicentre study (UK)
Compares minimally invasive thoracotomy versus conventional sternotomy
In patients undergoing mitral valve repair surgery
400 patients over 4 years
All patients will be followed up for 1 year after initial surgery

7. (Middlesbrough, Blackpool, Kings, Basildon) 6 month pilot
Overview
£1.6 million
5 Years
NIHR (HTA) funded
Largest ever RCT of MICS anywhere in the world
4-8 Units
(Middlesbrough, Blackpool, Kings, Basildon) 6 month pilot

8. Main Objectives
Primary Objective: To determine if physical functioning and associated return to usual activities improves in patients who undergo mini mitral versus conventional sternotomy at 12 weeks.
Primary Economic Objective: To estimate if mini mitral compared to conventional sternotomy is more cost-effective at 52 weeks

9. Secondary Objectives
Assess cardiac function using echo early ( up to 12 weeks) and late (52 weeks) after surgery, using blinded echocardiography.
To quantify the level and variability in physical activity and quality of sleep (using an accelerometer over 52 weeks post MVr)
To quantify a range of adverse event over the 52 weeks from index surgery (stroke, re-operation, infection etc)
To estimate QALYs from responses to the EQ-5D-5L (2-4) and SF-6D (derived from the SF-36v2)
To estimate costs to the NHS over 4.5 years

10. Expert Units
Units must demonstrate organisational and collegiate support for Mini Mitral
Performed MI-MVR surgery for at least 1 year
Have performed at least 50 procedures
Have a dedicated MI-MVR team (surgeon, anaesthetist, perfusion, scrub staff)
A mitral valve MDT

11. Expertise Based randomisation
Mini Mitral will be performed by mini mitral experts
Performed MI-MVr surgery for at least 1 year
Have performed at least 50 procedures
Conventional Mitral will be performed by conventional experts
Performed Conventional-MVr surgery for at least 1 year

12. STUDY DESIGN (Farrokhyar et al. 2010) Assumptions
Operating surgeons have equivalent level of expertise and the effect of surgeons is zero.
If this assumption holds, the required sample size will be 382.
Surgeons to be included as a random effect for proper analysis.
Assumptions

14. International talks

15. Progress 6-Month Pilot (September 2016 to February 2017)
39 patients randomised so far in 4 units
4 more units to open in the next 3 months

16. Summary
Unique challenges in conducting RCTs in cardiac and thoracic surgery
There are pressing questions to answer
Patients are willing to work with us to answer these
Increasingly research funding bodies are keen to fund good projects
What are the levers required to achieve this?

17. THANK YOU

18. Funding Acknowledgement: This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 14/192/110) Department of Health Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health.