Advice

The technology

The technology

The OPTIMIZER smart system (Impulse Dynamics) is a programmable cardiac stimulation device for patients with chronic heart failure who have symptoms after having optimal drug treatment, when cardiac resynchronisation therapy is not suitable. The system has 3 components: a programmable implantable pulse generator with a rechargeable battery and implantable leads, a charger and an OMNI programmer.

The implantable pulse generator is implanted in the chest and connected to 2 standard pacemaker leads that go through veins into the right ventricle. The leads sense ventricular activity and give out cardiac contractility modulation (CCM) signals. An optional additional lead can sense atrial activity. Unlike a pacemaker or a defibrillator, the OPTIMIZER system is designed to control the strength of contraction of the heart muscle rather than the rhythm. Pulses are given at regular intervals in the day. This increases the contraction strength and the pumping capacity of the heart, which can improve a person's exercise ability and physical and emotional quality of life.

The portable OMNI programmer allows doctors to change the OPTIMIZER signal parameters according to individual patient needs. The implantable pulse generator needs weekly recharging at home for about 40 to 60 minutes. The rechargeable battery should work for 15 years.

Innovations

The OPTIMIZER is currently the only device available that uses CCM therapy, which does not influence the heart rhythm. Instead, it delivers CCM electrical pulses that stimulate the heart, increasing the contraction strength and the pumping capacity of the heart. After these signals, the heart muscle contractility increases with no increased oxygen consumption. The OPTIMIZER can be a treatment option for patients who still have symptoms of heart failure after drug therapy when other cardiac implantable electronic devices are not suitable.

Current care pathway, population, setting and intended user

Treatments for chronic heart failure include cardiac rehabilitation, drugs to improve heart function, cardiac resynchronisation therapy and cardiac transplantation. NICE has published a guideline on chronic heart failure in adults. NICE's technology appraisal guidance on implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure states that cardiac resynchronisation therapy is not recommended for people with a normal QRS interval (less than 120 ms) in New York Heart Association (NYHA) class II to IV with a left ventricular ejection fraction (LVEF) of 35% or lower. According to the company these are the people who would be eligible for, and benefit from, the OPTIMIZER smart system. Currently the only option for these people is to continue with conventional drug treatment.

Over 920,000 people are estimated to have heart failure in the UK (Conrad et al. 2018). The company estimates that there would be about 10,920 people eligible for the OPTIMIZER smart system (on NYHA class II to IV and normal QRS). It would expect around 2,100 people per year to get the device implanted. If the focus is on people with LVEF of 35% and above (for which the company feels there are data showing the strongest clinical effect), there would be 655 devices implanted per year.

Patients who can have the OPTIMIZER system might also need an implantable cardioverter defibrillator (ICD) or might already have 1 implanted. However, there are not expected to be many of these people in the UK. The company has confirmed that this has no effect on CCM treatment and does not prevent implantation of the OPTIMIZER. The system is designed to work alongside any ICD device, and does not interrupt the ICD.

NICE's interventional procedures guidance on cardiac contractility modulation device implantation for heart failure states that although the evidence on CCM device implantation for heart failure raises no major safety concerns, the evidence on efficacy is inadequate in quantity and quality. Therefore, it recommends that CCM device implantation should only be done in the context of research.

The following guidance are relevant to this care pathway:

Costs

An economic evaluation study by Maniadakis et al. (2015) outlined the costs associated with the OPTIMIZER smart system and standard care. It is expected that the device would be used in addition to standard care.

Technology costs

Table 1 Unit costs for the OPTIMIZER smart system

Description

Cost

The OPTIMIZER smart system

£17,000

Leads (n=2)

£395

Other hospital costs (staff)

£245

Other hospital costs (capital)

£120

Other hospital costs (consumables and tests)

£95

Other hospital costs (hospital care)

£510

Total implantation cost

£18,365

Costs of standard care

Drug therapy for heart failure is estimated to cost £1,362 over the patient's lifetime.

Economic studies

Maniadakis et al. (2015) modelled the management of chronic heart failure. This model outlined the cost effectiveness of the OPTIMIZER smart system and drug therapy compared with drug therapy alone for treating heart failure in people with normal QRS when drug therapy has not controlled symptoms adequately. The time horizon was over a patient's lifetime, with 4‑week cycles. The results showed OPTIMIZER with drug therapy had a total mean lifetime cost of £37,467 and drug therapy alone had a total mean lifetime cost of £16,885. In the model, people who had the device and drug therapy gained 5.26 quality-adjusted life years (QALYs) compared with 4.0 in the drug therapy alone arm. There was an incremental increase of 0.96 life years gained in favour of OPTIMZER. The incremental cost per QALY gained was £16,405. The authors did a sensitivity analysis, which showed that at a £30,000 per QALY threshold, the likelihood of the device and drug treatment being cost-effective was 99.8% and was 97% at £25,000 per QALY.

Resource consequences

The OPTIMIZER smart system is currently used in a small number of NHS trusts in England. The device could be implemented using existing infrastructure, using existing cardiac catheter laboratories to implant it. Clinical teams who implant cardiac devices would need minimal additional training to be able to implant the OPTIMIZER, which is very similar to that of other cardiac devices such as a pacemaker. The company offers free training and field clinical specialists to help with advice during device implantation.