Six-Center Study of Chronic Atrial Fibrillation Indicates Importance of Confirming Conduction Block Intra-operatively in Radiofrequency Ablation
18 Jul, 2011, 12:01 BST
MORRISVILLE, North Carolina, July 18, 2011 /PRNewswire/ --
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, Slovenia, 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."
Disclaimer
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) approach.
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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Media Contacts
Edgar Rey Kimberly Muscara
nContact, Inc The Ruth Group
T +1-(404)-285-0466 T +1-(646)-536-7011
erey@ncontactinc.com kmuscara@theruthgroup.com
SOURCE nContact, Inc.