For people with moderate to severe chronic heart failure, in which the heart is unable to pump blood adequately, treatment options are limited, especially if a person is not a good candidate for other devices used to treat heart failure. But now, the U.S. Food and Drug Administration has approved a new device for those patients. The device, called the Optimizer Smart System, can be used to treat heart failure in people who don’t have other treatment options.
The system includes an implantable pulse generator that resembles a pacemaker, a battery charger, and software. The pulse generator is implanted under the skin in the upper chest and connected to three leads in the heart. The device can then deliver electrical impulses to the heart during regular heartbeats to improve the organ’s ability to pump blood.
In clinical trials, 191 patients with moderate to severe heart failure received the implant along with standard treatment, and 198 heart failure patients had standard therapy alone. Those treated with the device were able to improve their distance in a six-minute walking test and reduce the impact of heart failure symptoms in their daily lives. Possible complications-as with similar devices-include infection, bleeding, a worsening of heart failure, and problems with the device, such as dislodgement.
You may be a candidate for the device if you have heart failure symptoms despite getting optimal therapy, have a regular heartbeat, are not eligible for cardiac resynchronization therapy (a pacemaker that restores the normal timing of heartbeats), and have a left ventricular ejection fraction (the percentage of blood pumped out with each heartbeat) of 25 to 45 percent. The device is expected to be available in the United States later this year.