Cardiologists at Beth Israel Medical Center are currently enrolling patients in an investigational study that is looking at the safety and efficacy of an innovative new treatment for moderate to severe heart failure, in which a unique pacemaker-like device helps strengthen the heart's pumping power.
The FIX-HF-5 (Fix Heart Failure 5) study involves a pulse generator, the Optimizer(TM) System, that delivers electrical signals to the heart muscle in the midst of its pumping action, "fooling" it into producing more intracellular calcium and thus increasing the heart's ability to pump and contract. The study is sponsored by Impulse Dynamics (USA) Inc., the manufacturer of the Optimizer System.
More than 5 million Americans are living with heart failure, a debilitating condition in which the heart is too weak to pump blood at its full ability, leading to a continuing decline in a patient's health and an increased frequency of hospitalization and premature death. Chronic heart failure is implicated in more than 300,000 deaths in North America each year and is the leading cause of hospital admissions for patients over 65. A person aged 40 or older has a one-in-five chance of developing chronic heart failure, according to a recent study in Circulation: Journal of the American Heart Association, and the average five-year survival rate for all patients with heart failure is currently only about 50 percent.
Similar to a pacemaker, the Optimizer System consists of a programmable implantable pulse generator, a portable programmer and two right ventricular leads. Whereas pacemakers focus on modulating the heart's rhythm, the Optimizer System is based on a new technology known as Cardiac Contractility Modulation (CCM). Unlike with pacemaker signals, which are delivered during a period of the cardiac cycle when a new beat can be initiated, the CCM signals are "non-excitatory," meaning they are delivered during the absolute refractory period and therefore cannot initiate a new contraction. Instead, the CCM delivers impulses to the heart muscle during a moment in the heartbeat known as the absolute refractory period. The result, believe investigators, is that CCM signals trigger a response in the calcium that is cycling within the heart cells, in a manner that improves the strength of the heart muscle's contraction, and without adding to its overall workload.