CCM Therapy from the Impulse Dynamics Optimizer Smart System

Recently, I had the privilege to implant a new type of medical device in one of my patients with heart failure.

This is a very active 76-year-old female patient who has had a myocardial infarction (heart attack) in 2019, and has had multiple stents, and the patient has continued to have symptoms of congestive heart failure which include shortness of breath on exertion, exercise intolerance, and the ejection fraction was low at 30-35%.  The patient ready has an ICD in place.

On account of the ongoing symptoms of shortness of breath on exertion, and exercise intolerance, in spite of maximum medical management including beta-blockers and Ace inhibitors and diuretics, the decision was made to implant the new cardiac contractility modulation (CCM) device.

The fluoroscopic images clearly demonstrates that this patient ready had a dual chamber ICD.  The ICD is identified by the large electrode inside the right ventricle, and there are now 2 additional pacemaker wires which abut against the interventricular septum in the image.

Click here to sign up for Dr. J's Newsletter!

Video courtesy of Impulse Dynamics

Learn more about the CCM Therapy

What is the Optimizer Smart System and CCM Therapy?

The Optimizer Smart system 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.

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.

Rendering of the Optimizer Smart device and leads in the left ventricle.