LID.L Regulatory News (LID)

LiDCO Group Plc

("LiDCO" or the "Company")

OPTIMISE study results and updated systematic review of surgical hemodynamic optimisation

LiDCO Group Plc (AIM: LID), the cardiovascular monitoring company, announces that the results of the OPTIMISE study, a multi-centre trial in the UK which aimed to improve surgical outcomes by optimising cardiovascular management, have been published in the Journal of the American Medical Association, concluding that when included in a meta-analysis* the intervention was associated with a clinically important 24% reduction in complication rates and a shorter length of stay.

About OPTIMISE

OPTIMISE was a multi-centre, randomised controlled trial conducted in 17 acute NHS hospitals to evaluate the clinical effectiveness of a peri-operative hemodynamic therapy algorithm on high-risk patients undergoing major gastrointestinal surgery The Company's LiDCOrapid monitor, was selected as the cardiac output monitoring system used in the trial because it could be used both intraoperatively and postoperatively to guide fluid and drug administration. The primary outcome score, a combined 30-day complications and mortality rate, was improved in the intervention group, compared to controls, but fell slightly short of statistical significance (p=0.07). The authors commented that a number of factors "reduced the power of the trial, perhaps resulting in a failure to achieve statistical significance for the primary outcome." Importantly, further analysis of the data showed that: "inclusion in an updated meta-analysis indicates that the intervention was associated with a clinically important reduction in complication rates."

The Short Summary from the paper is reproduced below:

Findings from small trials suggest post-operative outcomes may be improved by cardiac output-guided, hemodynamic therapy but this remains unconfirmed. In a multi-center randomized trial, we allocated 734 high-risk patients undergoing major gastrointestinal surgery to a hemodynamic therapy algorithm for intra-venous fluid and inotrope (dopexamine) infusion during and six hours following surgery, or usual care. The primary outcome of pre-defined moderate or major post-operative complications was met by 36.6% of intervention patients and 43.4% of usual care patients (RR 0.84 [0.71-1.01]; p=0.07). Whilst not statistically significant, these findings were consistent with those of a recent Cochrane systematic review. When the systematic review was updated to include our results, significantly fewer patients developed complications having received this intervention (RR 0·77 [0·71-0·83]). The combined findings of the randomized trial and systematic review suggest cardiac output-guided hemodynamic therapy may be associated with a clinically important reduction in complications after surgery.

Commenting, Terry O'Brien, Chief Executive Officer of LiDCO, said: "It is exciting to see to see that the OPTIMISE trial data has been shown by this new meta-analysis to be consistent with the findings of the previous Cochrane review, namely that perioperative hemodynamic intervention is associated with a reduced complication rate and length of stay in hospital after surgery. "

* Meta-analysis: A systematic review of clinical trials with a meta-analysis is often considered the most objective of all types of reviews. A meta-analysis provides a quantitative analysis and estimation of the effectiveness of an intervention. In this meta-analysis the intervention was the protocolized and hemodynamically monitored use of a drug and/or fluid to increase blood flow in surgery patients.

About LiDCO Group Plc (www.lidco.com)

LiDCO is a supplier of non-invasive and minimally invasive hemodynamic equipment to hospitals used to monitor the amount of blood flowing around the body and ensure that vital organs are adequately oxygenated. LiDCO's products facilitate the application of hemodynamic optimisation protocols for high risk patients in both critical care units and in the operating theatre. 

Increasingly clinical studies are showing that the optimisation of patients' hemodynamic status in high risk patients produces better outcomes and reduced hospital stay. LiDCO's computer-based technology, developed at St Thomas' Hospital in London, has been shown to significantly reduce morbidity and complications, length of stay and overall costs associated with major surgery.

Key Products:

LiDCOplus: a computer-based platform monitor used in the Intensive Care Unit for real-time continuous display of hemodynamic parameters including cardiac output, oxygen delivery and fluid-volume responsiveness (PPV% and SVV%).

LiDCOrapid: a cardiac output monitor designed specifically for use in the operating theatre for fluid and drug management. The monitor enables anaesthetists to receive accurate and immediate feedback on the patient's fluid and hemodynamic status - a key measure of overall well-being before, during and after surgery. The LiDCOrapid provides:

· early and rapid warning of hemodynamic change to aid choice of therapeutic route: fluid or drug

· quantification of hemodynamic response

· guidance on effective delivery of fluids to ensure the right amount at the right time

LiDCOview: an easy-to-use graphical display of historical LiDCOplus and LiDCOrapid hemodynamic data.

LiDCO Unity Software: software incorporated into LiDCOrapid v2 that allows the LiDCOrapid monitor to co-display Covidien's level of consciousness parameter ('BISTM')* and add the convenience of CNSystem's continuous non-invasive blood pressure monitoring ('CNAP')**. This will address a growing requirement for non-invasive monitoring solutions that are more comprehensive and can effectively replace multiple single parameter monitors. 

*BISTM and Bispectral Index are trademarks of Covidien LP registered in the US and foreign countries.

* CNAPTM is a trademark of CNSystems Medizintechnik AG.

LiDCO monitors use single-patient disposables (sensors or smartcards) which provide an ongoing revenue stream.

LiDCO Distribution Network:

LiDCO sells directly to hospitals in the UK and USA and through a network of specialty critical care and anaesthesia distributors in the rest of the world.

LiDCO's marketing office is in Cambridge, its manufacturing facility and headquarters are in London and its shares are traded on AIM.