The OPTIMIZER smart system for managing heart failure

The technology described in this briefing is the OPTIMIZER smart system. It is a programmable cardiac stimulation device for people with chronic heart failure. The system is for people who still have symptoms after having optimal drug treatment, when cardiac resynchronisation therapy is not suitable. It can be used when patients have a normal QRS interval (less than 120 ms) in New York Heart Association class II to IV, with a left ventricular ejection fraction of 25% to 45%.

The innovative aspect is that it is the only device that uses cardiac contractility modulation therapy.

The intended place in therapy would be in addition to drug therapy in people with chronic heart failure.

The main points from the evidence summarised in this briefing are from 6 studies (1 randomised controlled trial, 1 case-control study, 3 observational studies and 1 retrospective analysis) including 633 adults. The studies show that the OPTIMIZER smart system could be more effective than drug therapy alone in patients with heart failure.

Key uncertainties around the evidence or technology are that there is only 1 comparative study, which was unblinded. Also, none of the studies were done in the NHS.

The cost of the OPTIMIZER smart system is £17,000 per unit (excluding VAT). The resource impact would be greater than standard care.

NICE's interventional procedures guidance on cardiac contractility modulation device implantation for heart failure recommends that this technique appears safe, but it should be used in the context of research.