Chronic heart failure (CHF) occurs when your heart is unable to pump sufficient blood to meet the needs of your body due to weakened heart pumping strength. Measured by ejection fraction (EF), a normal EF is greater than 55%. In patients with CHF, this value can fall to 25%, or even lower.

Heart failure is often caused by damage to the heart muscle due to a heart attack, untreated coronary artery disease, or persistent high blood pressure. The symptoms of heart failure include, but are not limited to:

• Dyspnea or shortness of breath during movement or while resting
• Fatigue and general weakness
• Edema or swelling in your legs, ankles, and feet
• Fast or irregular heartbeat
• Swelling of your abdomen
• Nausea and lack of appetite
• Chest pain

You may also notice that tasks such as grocery shopping or climbing stairs are increasingly difficult for you due to fatigue and shortness of breath.

Cardiac Contractility Modulation is a therapy which is intended for the treatment of patients with moderate to severe chronic heart failure (NYHA class III–IV), LVEF 25-45% and QRS <130ms with symptoms despite optimal medical therapy. The short and long-term use of this therapy may enhance the strength of ventricular contraction and therefore the heart’s pumping capacity by modulating (adjusting) the myocardial contractility.

The Optimizer®Smart is a minimally invasive implantable device that delivers precisely timed electrical pulses to the heart cells during a special period of the beating cycle (called the absolute refractory period, or the period just after the heart contracts). In doing so, it strengthens and helps the heart contract more forcibly, thereby delivering more blood and oxygen to the body. Studies have shown CCM therapy to improve 6-minute hall walk distance, quality of life and functional status among patients who are candidates for the device.

The Optimizer® Smart Implantable Pulse Generator (IPG) unit is a rechargeable device that senses the heart’s electrical activity and delivers Cardiac Contractility Modulation signals during the absolute refractory period (just after the heart contracts) via two electrodes placed in the heart’s right ventricle. There is also a lead placed in the right atrium to assist with the therapy timing cycle. The IPG is about the size of a pacemaker IPG.

The Optimizer® Smart System includes an implantable stimulation device (similar in size to a pacemaker) and  an external charging station. The device is implanted in a small pocket under the skin of the upper chest, along with commercially available pacemaker leads that are placed in the heart’s right ventricular septum, while the patient is under light sedation. After implantation, the physician custom-programs and activates the device for the patient. The Optimizer® Smart then begins sending electrical pulses to the heart muscle for a total of 5 to 7 hours a day, in one-hour treatments separated by regular intervals. The patient charges the device one hour per week  using the external charger. The Optimizer® Smart device is expected to last at least 15 years without replacement.

The implant procedure doesn’t require open-heart surgery and most patients can return home soon after the implant is complete. Plus, most patients are able to return to everyday activities shortly after the procedure.