Cardiovascular Monitoring

Background

The major causes of death in the developed world include circulatory diseases, ischaemic heart disease and cerebrovascular disease. (Most are usually described as strokes or heart Attacks). The ageing of western populations (it is estimated that the over 65 age group in the US will increase by 78 per cent by 2015) and the advent of numerous therapeutics to improve the performance of the heart, (reducing heart attacks) in older persons (drugs, transmyocardial revascularisation devices, balloon angioplasty, cardiovascular surgery implantable pacemakers and ventricular support devices) indicate that the cardiovascular treatment market has significant prospects for growth.

As a result of the risks which are perceived to be associated with conventional heart surgery, including, in particular, cognitive impairment, one of the key developments in this area is the more frequent use of less invasive "beating heart" surgery. As a result of increasing cardiovascular intervention, the company believes that there is a considerable accompanying market need for the monitoring of key cardiovascular parameters.

The company also believes that further improvements in minimally invasive surgery will continue to expand the use of cardiovascular monitoring of hospital patients.

Demand for cardiovascular monitoring

During an average life span of 70 years, the human heart will pump more than 400 million litres of blood. Monitoring of the key cardiovascular parameters - blood pressure, cardiac output and oxygen delivery - can provide a practical, early warning of cardiovascular change and potential adverse events in surgery and critical care patients who are monitored both during and after surgery via an arterial line inserted in the radial artery.

At least 10 million surgery and critical care patients per annum world-wide are involved in such monitoring procedures. However, a significant majority of these patients are currently monitored only for blood pressure and not for cardiac output or oxygen delivery. The Group has developed a minimally invasive product, disposables and other monitoring equipment which, the company believes, can:

(a) improve the standards of care and monitoring of high risk patients, both during and after surgery;
(b) reduce the incidence of adverse events in hospitals; and
(c) also reduce costs.

(a) Improving standards of care in high risk surgery
The ageing population of the western world and the improving success rate of surgery place increasing demands on healthcare providers. In the United States, for example, over 30 million operations are performed annually, of which approximately 2.4 million are considered to be high risk. The mortality rate of high risk patients in the month after surgery is reported to be in the region of between 20 and 30 per cent. One of the principal risks for such patients is a reduction in global oxygen delivery during and following surgery. Analysis of 17 studies designed to evaluate the effects of peri-operative optimisation of high risk patients suggests that, for every 100 patients undergoing such surgery, 11 lives would have been saved if optimisation had taken place. The company believes that effective cardiovascular monitoring is an important element of optimisation.

(b) Reducing adverse events
A recent UK study has shown that adverse events are currently estimated to affect approximately 10 per cent of hospital patients. It is estimated that approximately half of these adverse events are preventable and that at least one third of such events lead to disability or death. In the United Kingdom, the consequences of all hospital adverse events are calculated to lead to an extra three million bed days at a minimum cost of £1 billion per year. The company believes that a significant number of those adverse events which relate to cardiovascular care could be prevented by improved cardiovascular monitoring.

(c) Reducing costs
On average, healthcare costs account for between seven and 14 per cent of gross domestic product (GDP) in a number of developed countries. For example in 1999, in the United States, 14 per cent of GDP was spent on healthcare, of which 10 per cent was committed to intensive or critical care patients. High staff-to-patient ratios, the equipment and personnel required to monitor patients and the drugs for treatment result in intensive and critical care patient costs which are significantly higher than those in a general ward. The company believes that these costs can be substantially reduced by improved cardiovascular monitoring which, if it is easy to use at the point of care, should reduce staffing costs and result in earlier discharge of patients from an ICU.

Current technologies and market trends

As a result of the demands on healthcare resources and the costs of providing surgical and intensive care, one of the current trends in the medical industry is towards providing point-of-care healthcare treatment, that is, treatment which is minimally invasive, portable and easy to use. Point-of-care treatment is more efficient for both patients and healthcare providers, potentially reducing delays in treatment, mortality and costs.

The current market leader for the additional measurement of cardiac output (as opposed to merely blood pressure) is the traditional thermodilution pulmonary artery catheter, which measures thermal changes in the pulmonary artery blood temperature and which currently accounts for 85 per cent of measurements of cardiac output.

However, the company believes that a number of limitations apply to the existing market leading thermodilution pulmonary artery catheter, which result in cardiac output and oxygen delivery being measured in only a limited number of acute conditions in which these measurements would be beneficial.