The Convergent Procedure Continues to Meet the Challenges of Treating Persistent Atrial Fibrillation -- Multiple European Centers Report Consistent Long-Term Results

Four Studies Including 161 Patients Show Importance of Procedure Standardization


MORRISVILLE, N.C., Oct. 21, 2014 (GLOBE NEWSWIRE) -- Four European centers performing the Convergent Procedure recently presented data that continues to highlight consistent long-term results in the treatment of persistent atrial fibrillation (AF). AF is the most common arrhythmia, estimated to affect 15 million people in the Western world, with an estimated 88% falling into the difficult-to-treat persistent AF population. All patients in the 4 studies had persistent AF, and one third to nearly one half of patients had failed previous endocardial catheter ablations.

The cumulative data included 161 patients who all had persistent AF, and each study was presented at one of 4 European society meetings: Heart Rhythm Congress UK, European Society of Cardiology, American Association for Thoracic Surgery, and International AF Symposium.

             
Author & Institution

 
Society
Meeting
 
N

 
% Persistent or
Longstanding
Persistent
Mean
AF
Duration
Mean Sinus
Rhythm at
Follow-Up
Monitoring

 
Dr. Nick Child
Guy's & St. Thomas'
London, UK
Heart Rhythm Congress UK
London, UK
19

 
100%

 
7.8 yrs

 
90% at 1 year

 
Holter

 
Dr. Dmitri Pajitnev
Kerckhoff Klinik
Bad Nauheim, Germany
European Society of Cardiology
Barcelona, Spain
28

 
100%

 
4.6 yrs

 
80% at 1 year

 
Reveal
24/7
 
Dr. Michael Zembala
Sileasian Center for Heart Diseases
Zabrze, Poland
American Association for Thoracic Surgery,
Toronto, Canada
54

 
100%

 
4.4 yrs

 
85% at 1 year

 
Holter
7-day
 
Dr. Borut Gersak
University Medical Center Ljubljana
Ljubljana, Slovenia
International AF Symposium
Orlando, Florida
60

 
100%

 
6.2 yrs

 
83% at 1 year

 
Reveal
24/7
 

"Our institution, Guy's and St. Thomas' Hospital in London, is the latest site to report Convergent Procedure outcomes, and the results are consistent with other European reported outcomes this year," said Dr. Nick Child, Cardiology Research Fellow, Guy's and St. Thomas' NHS Foundation Trust. "Our study focused on patients not deemed to be standalone catheter ablation candidates. Our Convergent Procedure results have been impressive in these persistent AF patients. Some of these patients were particularly difficult – with large left atrial volumes and up to 8-year histories of persistent AF – and the Convergent Procedure effectively met these challenges. Frankly, we were not expecting such strong results; yet 90% of patients were in sinus rhythm at one year."

The multidisciplinary Convergent Procedure is typically performed as a single procedure in the electrophysiology lab in the United States. Due to European reimbursement requirements, most of the European data presented has involved staging the procedure with the surgical portion performed in the OR, and six weeks later, the patient returns for the catheter procedure. The epicardial lesions are created first under direct endoscopic visualization by a surgeon, through a 2 cm incision in the abdomen, with no chest incisions or ports. The endocardial lesions created by an electrophysiologist ensure lesion set completeness, and specialized EP mapping and diagnostics provide the "checks and balances" to ensure a comprehensive approach.

"These 4 recent studies are consistent with earlier published physician results in both the U.S. and Europe, and demonstrate the increasing value of a multidisciplinary approach," stated John Funkhouser, President of nContact. "Interestingly, the data from the four European sites and the seven latest publications from American sites is almost equivalent, with 84% of patients in NSR at one year in Europe and 85% in the US. The combined European and U.S. studies represent more than 500 patients. The continued physician success using a standardized epicardial-endocardial ablation in these difficult patients furthers our commitment to leading the development of long-term, Arrhythmia Disease Management Programs."

About nContact, Inc.

nContact's mission is to transform the underserved arrhythmia market through the advancement of less invasive ablation alternatives for cardiac arrhythmias. The Company is conducting the CONVERGE IDE Clinical Trial, the first head-to-head superiority study to evaluate the Convergent Procedure to catheter ablation in persistent atrial fibrillation patients. The Company's lead technology, EPi-Sense® Coagulation System with VisiTrax®, has CE Mark approval in Europe for the coagulation of cardiac tissue in the treatment of atrial fibrillation and atrial flutter. The EPi-Sense Coagulation System with VisiTrax is indicated for endoscopic coagulation of cardiac tissue in the U.S. nContact was founded in 2005 and is headquartered in Morrisville, North Carolina, USA.


            

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