Six-Center Study of Chronic Atrial Fibrillation Indicates Importance of Confirming Conduction Block Intra-operatively in Radiofrequency Ablation

By Ncontact Inc., PRNE
Sunday, July 17, 2011

MORRISVILLE, North Carolina, July 18, 2011 -

nContact, Inc. (nContact), the leading minimally invasive
epicardial ablation device manufacturer, reports with interest an
article published in the European Journal of Cardio-thoracic
Surgery that demonstrates the importance of a comprehensive
epicardial lesion pattern combined with diagnostics to confirm
conduction block in radiofrequency ablation for the successful
treatment of persistent and long standing persistent atrial
fibrillation (AF).

AF is the most common cardiac arrhythmia (abnormal heartbeat),
affecting an estimated 5 million Americans and millions more
worldwide.  The study focused on persistent and longstanding
persistent AF patients who have historically been the most
challenging populations to treat because the condition is typically
associated with structural heart disease, resulting in enlarged
atria.  The article discusses potential required elements to
bring viable treatment options to this patient population.

Treating chronic AF using existing surgical and catheter
approaches often does not assure complete isolation or interruption
of reentrant conduction pathways, and as well, can produce limited
long term outcomes.  As described in the article, the use of
nContact’s guided coagulation system which produces long, linear
lesions epicardially on a beating heart that may be connected into
a complete, comprehensive, bi-atrial pattern based on the cut and
sew Maze pattern, and can yield meaningful long term results.

The article discusses the importance of improving procedural
effectiveness in treating AF by utilizing a comprehensive,
bi-atrial lesion pattern and confirming conduction block.  The
ability to perform epicardial ablation on a beating heart enables
the evaluation of conduction block during lesion creation.

Prof. Dr. Borut Gersak, MD, PhD, Chief of Department of
Cardiovascular Surgery at University Medical Center Ljubljana,
, stated, “The confirmation of exit block at 15mA improves
procedural effectiveness in treating AF.  Performing
epicardial ablation on a beating heart avoids cardiopulmonary
bypass and aortic cross clamping associated with traditional
procedures such as the cut and sew Maze, and allows for
confirmation of conduction block.”  Since the heart remains
electrically functional during the procedure, metrics may be
evaluated intra-operatively to allow creation of additional lesions
when block testing identifies a gap.

The article concludes that patients in whom exit block was
confirmed at 15mA were statistically more likely to have successful
clinical outcomes.  Results indicate that at 12 months, 87% of
patients with exit block confirmed were in sinus rhythm compared
with 57% patients in which exit block was not tested.  In
addition, the creation of a comprehensive bi-atrial lesion pattern
resulted in an increase in left ventricular ejection fraction and a
reduction in left atrial size.

Prof. Gersak went on to say, “The conclusion of the surgical
work was a complete, comprehensive lesion pattern with confirmation
from intra-operative diagnostics to predict success.  In order
to drive cardiology referrals and appeal to patients, access needs
to avoid chest incisions characteristic of traditional surgical
approaches.  The future of AF treatment must combine
epicardial ablation elements with electrophysiologist diagnostic
and ablation technologies.  Only converging the best practices
from surgeons and EPs will provide a simpler, faster, safer, and
more effective procedure.  This surgical experience and
enabling technology have provided the basis for development of the
Convergent Procedure; closed chest epicardial ablation combined
with endocardial catheter ablation in a single procedure.  The
procedure does not require chest incisions or ports, lung deflation
or heart dissections, and incorporates EP mapping and diagnostic
endpoints to determine procedure completion.”


It is important to note that AF is a complex, multi-variable
condition.  Individual patient results may well vary from the
literature, including those reported here.  A detailed
discussion between the patient and physician is essential to
optimize both expectations and clinical results.

About nContact, Inc.

nContact is a medical device company dedicated to transforming
the underserved arrhythmia market through the advancement of less
invasive, more efficacious ablation alternatives for cardiac
arrhythmias such as atrial fibrillation (AF).  nContact is
expanding treatment options by integrating epicardial ablation into
the existing electrophysiologist technology platform.  Among
its advances is a unique, interdisciplinary investigational
procedure that combines epicardial and endocardial ablation
techniques, while offering direct access to the heart via a
completely closed-chest, SUB-thoracic TotaL Endoscopic (SUBTLE)

nContact’s lead technology, the Numeris® Coagulation System with
VisiTrax®, is indicated for endoscopic coagulation of cardiac
tissue in the United States.  nContact has initiated IDE
clinical studies for the treatment of AF in both open and closed
chest procedures.  The Numeris® Coagulation System with
VisiTrax® has CE Mark approval in Europe for the coagulation of
cardiac tissue for the treatment of AF and atrial flutter.
 nContact was founded in 2005 and is headquartered in
Morrisville, N.C.



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    Edgar Rey                             Kimberly Muscara
    nContact, Inc                         The Ruth Group
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