Optimization of Cardiac Resynchronization Therapy Using Cheetah Medical's NICOM(R) Hemodynamic Monitoring System was Found to Lead to Improvement in Heart Failure Outcomes

TEL AVIV, Israel, May 24, 2011 /PRNewswire/ --

In a two studies published recently in Heart Rhythm Society annual meeting, Investigators from the department of cardiology in Addenbrooke's Hospital in Cambridge, UK found that Cheetah Medical's NICOM system is an effective and practical method for optimizing the function of Cardiac Resynchronization Therapy (CRT) pacemakers. The investigators found that heart failure patients whose pacemaker parameter settings were adjusted to maximize cardiac output measured noninvasively by NICOM had better outcomes than patients who did not receive such an optimization procedure. Another finding of the studies was that patients who demonstrated a significant increase in cardiac output measured by NICOM (so called "acute responders") experienced better 2-year survival with CRT treatment than patients who did not exhibit such a response.

CRT pacemakers are standard treatment for a large portion of heart failure patients and the number of CRT device implantations has grown rapidly over the past decade since they have been shown to improve patient symptoms and prognosis. However, as many as 40% of CRT patients do not improve clinically; they are considered "non-responders". Among the proposed reasons for such a high rate of non-responsiveness is lack of appropriate adjustment of key parameters of the CRT device to effectively treat the pathology of individual patients.

In the two studies, the investigators demonstrate that by measuring patients' cardiac output with NICOM in a simple bed-side procedure it is possible to fine-tune pacemaker settings in order to maximize cardiac function. This led to a significant improvement in patients' clinical response, manifesting by heart failure severity score, improved quality of life, improvement in cardiac architecture and heart strength. Those results were significantly superior in comparison to the group of patients who did not undergo the optimization procedure with NICOM. Another interesting finding was that patients who showed significant response to the NICOM-guided optimization procedure experienced better long term survival. This finding has potentially profound implications on clinical decisions physicians may make immediately after or even during the CRT implantation procedure.

Lead investigator Dr. Fakhar Khan says "The two recent studies suggest an important potential role of non invasive acute hemodynamic monitoring in patients with advanced heart failure. The current work suggests that hemodynamically driven optimization is feasible using NICOM and in this small study, outcomes appear to be better. The results do have to be tested in larger randomized studies but offer the promise of a simple widely accessible method of CRT device optimization. The relationship of acute changes in NICOM to longer term survival suggests that NICOM can help prognosticate in CRT recipients and holds the promise for an early endpoint to guide treatment, not only through device optimization but also potentially the implant procedure itself."

Daniel Burkhoff, M.D., Ph.D., Medical Director of Cheetah Medical, an Adjunct Associate Professor of Medicine at Columbia University Medical School and a leading clinical researcher in the field of heart failure added "These studies confirm what has long been believed: that CRT optimization significantly improves clinical outcomes and symptoms. Prior studies have noted that only a small percentage of patients receiving a CRT device ever undergo optimization. The main obstacle to CRT optimization usually noted is that the techniques previously available for this procedure are difficult; they take a lot of time and require highly trained technicians. NICOM makes this procedure easy and does not require highly trained technicians. Accordingly, these studies have potentially profound implications for the care of CRT patients."

Over the last decades CRT became a valuable tool in the armamentarium of heart failure specialists for their patients. With an increasing number of CRT device implantations, clinicians began looking for ways to improve clinical results and overall quality of life. Custom tailoring the device settings, a procedure referred to as "CRT optimization," has long been suggested as one way to achieve those goals. NICOM enables, for the first time, a simple user friendly, non-invasive, bedside solution for CRT optimization and can provide clinicians insight as to the patients' long term results. These studies demonstrate that there is significant clinical benefit in NICOM-based optimization of CRT devices.

About Cheetah Medical and NICOM(R)

Cheetah Medical's NICOM Non-invasive Cardiac Output and Hemodynamic Monitoring System uses the company's proprietary BIOREACTANCE(R) Technology to deliver continuous, accurate, non-invasive cardiac output and other vital hemodynamic parameters, useful for fluid management and drug titration. NICOM is the only non-invasive hemodynamic monitor whose predicate for FDA clearance was the gold standard Continuous Cardiac Output Swan-Ganz catheter (pulmonary artery catheter). Cheetah Medical headquarters is located in Tel-Aviv, Israel and its United States headquarters is located in Vancouver, Washington. For more information, visit http://www.cheetah-medical.com.

    
    Contact:

    Yoav Avidor, MD
    Chief Executive Officer
    Cheetah Medical
    +972-3-644-0288
    yoav@cheetah-medical.com