Cardiac Contractility Modulation is a unique and innovative method for treating patients with moderate-to-severe Chronic Heart Failure
(CHF) that are symptomatic despite optimal medical therapy. The signals are unique electrical pulses delivered by the Optimizer® implantable device during a special period of the heart cycle (the absolute refractory period or the period just after the heart’s excitation). Research suggests that the 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.
European Clinical trials have suggested that chronic Cardiac Contractility Modulation treatment is safe and significantly improves exercise tolerance and quality of life in symptomatic heart failure patients with normal QRS duration. Studies examining safety, exercise tolerance and quality of life in symptomatic heart failure patients with normal QRS duration implanted with the Optimizer system are on-going in the United States.
The Optimizer® system is a device-based treatment option for the approximately 70 percent of CHF patients with advanced symptoms that have normal QRS duration and, hence, are not suitable for Cardiac Resynchronization Therapy (CRT).
The Optimizer® 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 technology, and delivers non-excitatory electric pulses.
In the United States, an IDE trial of the Optimizer IVs model of the IPG has been completed (FIX-HF-5C, clinicaltrials.gov NCT01381172) and the results are currently being reviewed by the FDA. Two additional IDE protocols are currently in progress with the new Optimizer SMART model in a 3-Lead configuration (FIX-HF-5CA, clinicaltrials.gov NCT03102437) and the new Optimizer SMART model in a 2-lead configuration (FIX-HF-5C2, clinicaltrials.gov NCT03339310).
The Optimizer® Smart Implantable Pulse Generator (IPG) unit senses the heart’s electrical activity and delivers Cardiac Contractility Modulation 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 Cardiac Contractility Modulation 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 Cardiac Contractility Modulation signals.
“Optimizer®” is a registered United States trademark of Impulse Dynamics N.V.
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 and an optional atrial lead used to sense atrial activity that are threaded through veins into the right ventricle. 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. Cardiac Contractility Modulation 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.
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.
Activities such as walking and climbing steps frequently become easier and sensations of shortness of breath may become less frequent with the Optimizer®. 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. These changes are thought to be the result of processes induced by the Cardiac Contractility Modulation pulses that affect the function and expression of certain proteins in the heart and, through that, modify the function of the heart muscle cells.
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 soon after implant. Patients can usually expect to gradually return to everyday activities shortly after the procedure.
The doctor will prescribe a schedule of post-implant follow-ups which will become a regular part of each patient’s life. Routine follow-up visits and monitoring help ensure that the device is meeting the patient’s health requirements.
Unlike defibrillators and pacemakers, the pulses are delivered at regular intervals throughout the day and generally go unnoticed by implanted patients.
The Optimizer® Smart which delivers Cardiac Contractility Modulation therapy, is indicated for patients with moderate-to-severe Chronic Heart Failure (NYHA III-IV) who are already on optimal medical therapy. Cardiac Contractility Modulation is most suitable for patients with 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 Cardiac Contractility Modulation therapy.
Some patients that are suitable for Optimizer® implant may also require an ICD device or may already have one implanted. An ICD 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.
If you are suffering from moderate to severe heart failure and do not find relief despite medical treatment, ask your doctor about Cardiac Contractility Modulation treatment. You may print this page and bring it to your next appointment:
Cardiac Contractility Modulation (Cardiac Contractility Modulation) is an innovative technology for treating heart failure in patients that have normal QRS duration. The therapy uses non-excitatory electrical pulses that are delivered to the heart during the absolute refractory period using the Optimizer® Smart implantable device.