THE UK MINI MITRAL TRIAL SCTS 2017

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

MINI or CONVENTIONAL ?

Equipoise

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

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

(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

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

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

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

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

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

International talks

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

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?

THANK YOU

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.