Health Problem: Heart failure (HF) is a chronic condition that develops over time due to circumstances that overwork and damage the heart. The primary causes include coronary heart disease, high blood pressure, and diabetes. HF is characterized by the inability of the heart to pump blood efficiently. HF is estimated to affect approximately 5.7 million people in the United States. Currently, there is no cure for HF. It can affect both children and adults, although it most commonly occurs in adults 65 years of age or older.

Technology Description: The Optimizer Smart System delivers cardiac contractility modulation (CCM) signals to the right ventricular septum during the absolute refractory period. CCM signals, which are biphasic, relatively high-voltage signals, increase the contractile strength of cardiac muscle and have multiple effects at the cellular and molecular level, leading over time to cardiac reverse modeling. The Optimizer pulse generator is implanted in a pocket in the right pectoral region and has 2 leads placed in the right ventricle and 1 placed in the right atrium. The device is preprogramed to deliver CCM signals for 5 periods of 1 hour each, spaced equally throughout the day; however, it can be programed to a different signaling cycle. The battery is recharged transcutaneously approximately weekly.

Controversy: CCM is a minimally invasive treatment option for patients with HF that has not responded sufficiently to optimal medical therapy. The impact of CCM on the mortality rate and on patient quality of life is unknown, as is whether any benefit of CCM outweighs the risks associated with use of an implantable device.

Key Questions:

  • Is CCM with the Optimizer Smart System effective at managing heart failure (HF)?

  • How does CCM with the Optimizer Smart System compare with other therapies for HF (e.g., optimal medical therapy [OMT], cardiac resynchronization therapy [CRT])?

  • Is CCM with the Optimizer Smart System safe?

  • Have definitive patient selection criteria been identified for CCM with the Optimizer Smart System?

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