CCM and the Optimizer System

CCM Technology

Cardiac Contractility Modulation (CCM) is a unique and innovative method for treating patients with moderate-to-severe Chronic Heart Failure (CHF) that are symptomatic despite optimal medical therapy. CCM signals are unique electrical pulses delivered by the Optimizer Smart implantable device during a special period of the heart cycle (the absolute refractory period or the period just after the heart’s excitation). Research has shown that CCM signals significantly improve the heart’s contractility by modifying the function and expression of certain proteins in the heart muscle and, through that, the function of the heart. In fact, CCM is the only treatment that actually trains the heart.

European Clinical trials have shown that chronic CCM treatment is safe and significantly improves exercise tolerance and quality of life in symptomatic heart failure patients with normal QRS duration.

Optimizer Smart

The Optimizer Smart is a minimally invasive implantable device designed to treat Chronic Heart Failure (CHF) in patients that are symptomatic despite appropriate medical treatment. The device is based on novel Cardiac Contractility Modulation (CCM) technology, and delivers non-excitatory electric pulses.

The Optimizer Smart Implantable Pulse Generator (IPG) unit senses the heart’s electrical activity and delivers CCM signals via two electrodes placed in the heart’s right ventricle during the absolute refractory period (just after the heart contracts). The IPG is about the size of a pacemaker IPG.
Earlier versions of the Optimizer System, including the Optimizer III and Optimizer IVs have been implanted in more than 3,000 patients over the past ten years.

Optimizer Smart Charger System. Patients can recharge the IPG unit on a weekly basis using a home-based charger system, without supervision. Charging the device assures it has enough energy to provide CCM for years, minimizing the need for Optimizer battery replacement. The charger includes a display that provides instructions and feedback to the patient about the charging process.

OMNI II Programmer System and Omni SMART Application Software. The portable programmer allows medical personnel to customize the Optimizer signal parameters according to individual patient needs. Dynamic evaluations can be made using the patient’s ECG and marker channels in order to optimize the delivery of CCM signals.

“Optimizer” is a registered United States trademark of Impulse Dynamics N.V.

The Procedure

The Optimizer implant is a small device similar to a pacemaker. It is typically implanted in the right pectoral region and is connected to two standard pacemaker leads that are threaded through veins into the right ventricle. One optional additional lead may be used to sense atrial activity. The other two are used to sense ventricular activity and deliver CCM signals. The electrodes in the right ventricle are placed on the ventricular septum (the wall separating the heart’s right and left sides) at least 2 cm apart. In contrast to a pacemaker or a defibrillator, the system is designed to modulate the strength of contraction of the heart muscle rather than the rhythm. CCM therapy is delivered at regular intervals throughout the day.

Recharging of the device is easily performed using a home-based charger system. The charger should be used on a weekly basis and charging sessions typically last about 40 – 60 minutes.

FAQ

How is The Optimizer System different from other devices used to treat heart failure?

There are currently no other devices that provide a similar therapy to that of the Optimizer®. Pacemakers, defibrillators and CRT devices all work to resolve cardiac rhythm management problems or cardiac dyssynchrony. While CRT devices improve cardiac performance, they are beneficial in only a small subgroup of patients (around 30-40% of the CHF population) that have dyssynchrony. The Optimizer® system is designed to modulate the strength of contraction of the heart muscle rather than its rhythm and is the only treatment that actually trains the heart.

How will the Optimizer Smart affect my day-to-day life?

Most patients that receive an Optimizer implant start feeling a change in their level of performance just a few weeks after the implantation procedure. Activities such as walking and climbing steps frequently become easier and sensations of shortness of breath may become less frequent. Patients may also find a reduction in the need to sit down and rest after performing simple activities, they may feel less tired and fatigued and may find a decline in the number of hospitalizations. These changes are the result of processes induced by the CCM pulses that affect the function and expression of certain proteins in the heart and, through that, modify the function of the heart muscle cells.

What should I expect during the Optimizer implant procedure?

Typically, the procedure for heart implant devices is performed under local anesthesia. It does not require open-heart surgery and most patients are discharged to their home after a couple of days, or sooner. Patients can expect to gradually return to everyday activities shortly after the procedure.

What kind of follow-up care can I expect after my device is implanted?

The doctor will prescribe a schedule of post-implant follow-ups which will become a regular part of each patient’s life. The charger has a small memory card that stores data about the implant’s activity. The physician or clinician will use a special programmer to interrogate this memory card in order to evaluate the amount of therapy delivered and optimize the delivery of CCM signals. Routine follow-up visits and monitoring help ensure that the device is meeting the patient’s health requirements.

When are CCM electric pulses delivered? Will I be able to feel them?

Unlike defibrillators and pacemakers, the Optimizer CCM pulses are delivered at regular intervals throughout the day and generally go unnoticed by implanted patients.

Is there insurance reimbursement for this treatment?

Yes, CCM therapy is reimbursed in Germany (DRG F01A/ OPS-Code 5-379.80), Austria, Italy and Russia; and we are submitting for reimbursement in other counties as well.

Is it for me?

Patient population

The Optimizer Smart which delivers CCM therapy, is indicated for patients with moderate-to-severe Chronic Heart Failure (NYHA III) and whose symptoms are not improved by medicines. CCM therapy is most suitable for patients with EF>20% and normal QRS duration independent of underlying heart rhythm that cannot benefit from other device-based treatments such as CRT with pacemaker functionality.

Consult with your doctor as to whether you are a candidate for CCM therapy.

Compatibility with ICD

Some patients that are suitable for Optimizer implant may also require an ICD device or may already have one implanted. This has no effect on CCM treatment and does not prevent implantation of the Optimizer Smart which will usually be performed in a separate procedure. The Optimizer implant is designed to work in parallel with any ICD device, and generally does not cause any interruption of ICD function.

Ask Your Doctor

If you are suffering from moderate to severe heart failure and do not find relief despite medical treatment, ask your doctor about CCM treatment. You may print this page and bring it to your next appointment:

CCM (Cardiac Contractility Modulation) is an innovative technology for treating heart failure in patients that have normal QRS duration. CCM uses non-excitatory electrical pulses that are delivered to the heart during the absolute refractory period using the Optimizer Smart implantable device. These pulses train the heart and increase the heart’s Ejection Fraction.

European Clinical trials have shown that chronic CCM treatment is safe and significantly improves exercise tolerance and quality of life in symptomatic heart failure patients with normal QRS duration.

Optimizer pulse generator is CE approved. A study has recently begun in the US to confirm findings in an earlier study as a step towards FDA approval.

Interview with Prof. Dr. Carsten Tschoepe