For those with moderate-to-severe chronic heart failure, in which the heart is unable to adequately pump blood, treatment options are limited, especially if a person is not a good candidate for a certain type of implantable pacemaker. But now, the FDA has approved a new device for these patients.
Called Optimizer Smart system, it was given the FDA’s breakthrough device designation because it’s used to treat a life-threatening condition in people without alternative treatment options. The Optimizer Smart system is comprised of an implantable pulse generator, a battery charger, a programmer, and software. The pulse generator is implanted under the skin in the upper chest and connected to three leads in the heart. It’s then tested and programmed by a physician to deliver electrical impulses to the heart during regular heartbeats to improve the organ’s ability to pump blood.
The leading causes of heart failure, which affects about 5.7 million Americans, are high blood pressure, diabetes, and other heart-damaging conditions. Treatment may involve medications like angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta blockers to lower blood pressure and ease strain on the heart. Diuretics (water pills) are also used to lessen symptoms, including the buildup of fluid in the feet, ankles, and lungs.
In clinical trials involving 389 patients with moderate-to-severe heart failure, the 191 patients who received the Optimizer Smart system implant, in addition to standard treatment, showed symptom improvement in compared to those who 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 include infection, bleeding, a worsening of heart failure, and problems with the device, such as dislodgement.