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

By Cheetah Medical Ltd, PRNE
Monday, May 23, 2011

TEL AVIV, Israel, May 24, 2011 -

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,
. For more information, visit www.cheetah-medical.com.


    Yoav Avidor, MD
    Chief Executive Officer
    Cheetah Medical


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