What is the Optimizer Smart System and CCM Therapy?
The Optimizer Smart system from Impulse Dynamics is an implantable device like a pacemaker that delivers Cardiac Contractility Modulation (CCM) therapy. This is a new therapeutic approach to manage symptoms or slow the progression of heart failure that improves quality of life for patients who are no longer adequately responding to medications intended.
This is an implantable device like a pacemaker, and it consists of the battery and two leads, which applies relatively high voltage, over 20 milliseconds, to the septal wall of the right ventricle during the absolute myocardial refractory period.
How does CCM Therapy Work?
This electrical signal during the absolute myocardial refractory time, does not elicit a new contraction. However, it positively influences the biology of the failing myocardium. It increases the contractility of the left ventricle without increasing the myocardial oxygen demand in animal studies. Reverse remodeling of the left ventricle with improvement of the left ventricular ejection fraction over time has been noted in human studies as well.
Acutely, there appears to be alterations in the myocardial calcium handling and thereby contractility of the myocyte. In the long-term, a multitude of biochemical and molecular changes as well genomic expression in the myelocyte is noted.
The FIX-HF-4 study conducted in Europe, demonstrated that 3 months of CCM therapy improved exercise tolerance, and quality of life. The FIX-HF-5 was the 1st study to show that patients with the ejection fraction between 35% and 45%, benefited the most whereas those with an ejection fraction of less than 25% did not get as much benefit. There was also combined study demonstrating a 50% reduction in the composite endpoint of cardiovascular death and heart failure hospitalization.
If the QRS complex is wide, left bundle branch block configuration, then of course cardiac resynchronization therapy is first offered. If the patient turns out to be a nonresponder, then, Cardiac Contractility Modulation (CCM) can still be offered. The procedure can be done in patients who already have an ICD, or resynchronization therapy with a biventricular pacemaker.
How is the Device Implanted?
The procedure is performed under local anesthesia, and takes approximately a total of 2 hours to perform. The patient is at discharge the same day, and the following day, I see them in the office for a chest x-ray, interrogation of the device, and a wound check.