The OPTIMIZER II Implantable Pulse Generator: EP Lab Digest Talks with Hani N. Sabbah, PhD, FACC, FCCP, FAHA

How does the OPTIMIZER work? How does it differ from a pacemaker? What features make the OPTIMIZER unique? Before I tell you about the OPTIMIZER, I would like to make one comment. This is an investigational device that is yet to be proved from a safety and efficacy standpoint in patients with heart failure. The OPTIMIZER works by delivering a non-excitatory electrical signal to the heart from leads placed in the right ventricle on the surface of the septum. The electrical signal is delivered during a specific time of the heartbeat of cardiac cycle, namely the absolute refractory period. Thus, unlike a pacemaker signal, the OPTIMIZER signal does not cause the muscle to contract, which is what a pacemaker does. The OPTIMIZER signal, however, when delivered at the appropriate time, improves the pumping function of the heart, which helps the patient with heart failure. This technology is unique in that there is nothing like it that I know of. It s truly breakthrough technology for the treatment of heart failure. What patients can use it? When this technology is approved, it will be indicated for most patients with heart failure who are symptomatic; by that, I mean patients who have tried all medications but continue to get worse. Typically, such patients are in what is called New York Heart Association (NYHA) Class III or early IV. Unlike biventricular pacing, this technology is not limited to patients with dyssynchrony, which represents about 25% of patients with heart failure. Instead, the OPTIMIZER can be used in a majority of heart failure patients except perhaps, at least for now, those with certain abnormal heart rhythms such as atrial fibrillation. What improvements in health can patients expect? We expect that patients with heart failure who benefit from this therapy will have a marked improvement in their quality of life, as measured by their ability to perform more work and to exercise for longer periods of time. While improved survival is not what this technology is aiming for at this time, I am confident that given enough time of patient follow-up, we will likely also see an improvement in long-term survival, in addition to an improvement in quality of life. Briefly explain what is being presented at this year s HRS abstracts. What information from Impulse Dynamics is coming out at this meeting? There are two abstracts from my research group at Henry Ford Health System that will be presented at the meeting. The first, and perhaps the most important, is a pre-clinical study in animals which shows that delivery of the OPTIMIZER signal over a period of three months in animals with heart failure improves the pumping function of the heart but at no or even lower cost for energy. Most drugs that improve the function of the heart in heart failure cause an increase in myocardial oxygen consumption energy that the failing heart ill affords. The OPTIMIZER improves function of the heart at a lower energy cost. Think of it as providing more miles per gallon. This in and of itself is a breakthrough. Very few devices and drugs can make that claim. The second abstract is more complex and deals with the molecular and cellular mechanisms that, we believe, play an important role in the mechanism of action of the OPTIMIZER. Specifically, we will show data that suggest that the OPTIMIZER, in many respects, optimizes calcium cycling within the heart muscle cell and, in doing so, improves the pumping function of the left ventricle and the heart as a whole. Describe the new Phase 2 Study (FIX-HF 5) evaluating the use of the OPTIMIZER III? This is a prospective, randomized trial of the OPTIMIZER versus optimal medical therapy. The trial will enroll 420 patients with heart failure NYHA Class III and IV. The primary endpoint is anaerobic threshold; in layman terms, it is the ability of the patient to exercise longer, which in essence boils down to improvement in the quality of life of the patient with heart failure. When will you know the final outcome of the study? We anticipate that the trial will be completed during the first quarter of 2007. We will know the outcome then. When will there be FDA approval? When will it be in use in hospitals? The FDA will look at the results of the trial for approval usually six months or so after the trial is over, so I expect that that timeframe will be around the third quarter of 2007. If approved, the device will be available to hospitals sometime in early 2008. Is there anything else you'd like to add? I have been in research looking at drugs and devices for treating heart failure for the past 20 years. I can tell you with all candidness that this technology is truly breakthrough and one of very few that I am optimistic about for success in treating heart failure. By the way, heart failure affects nearly six million people in the US alone, with 450,000 new cases each year. About 250,000 American die each year from heart failure. By all measures, heart failure in the US is an epidemic.. For more information, please visit the Impulse Dynamics website: www.impulse-dynamics.com