Article in The Journal of Innovations in Cardiac Rhythm Management Reports Single Center Experience With 87.5% of Patients in Sinus Rhythm at 12 Months' Follow-Up
MORRISVILLE, N.C., Sept. 12, 2013 (GLOBE NEWSWIRE) -- The Journal of Innovations in Cardiac Rhythm Management has published a comprehensive physician study on the Convergent Procedure, a multidisciplinary, closed-chest epicardial-endocardial approach to treat patients with persistent and longstanding persistent atrial fibrillation (AF). AF is the most common cardiac arrhythmia, estimated to affect 5.9 million people in the U.S., with a majority of patients falling into the difficult-to-treat persistent AF population. This article reports on patients that had been in AF on average for more than 5 years and many had failed traditional treatment alternatives. The physicians at Our Lady of the Lake Hospital evaluated 104 patients: 30% (31 of 104) had persistent AF and 43% (45 of 104) had longstanding persistent AF. At 12 months' follow-up, 87.5% (63 of 72) of patients were in sinus rhythm and 72% (52 of 72) were in sinus rhythm and off antiarrhythmic drug therapy.
"We have performed almost 250 Convergent cases in the three years since our hospital adopted the procedure in mid-2010," said Kenneth C. Civello Jr., MD, MPH, of Our Lady of the Lake Hospital in Baton Rouge, LA. "The Convergent Procedure represents a new standard of care for persistent and longstanding persistent patients. The key clinical advantages of the multidisciplinary Convergent Procedure are closed-chest access and silencing of the atrium's posterior combined with pulmonary vein isolation and EP mapping and diagnostics to ensure a complete and comprehensive approach that can predict positive patient outcomes. These results speak for themselves and offer a viable treatment alternative to open new, large unmet AF markets. We are excited to be part of the upcoming CONVERGE IDE Clinical Trial, a superiority trial that will compare the Convergent Procedure to endocardial-only ablation in the treatment of persistent AF patients. We anticipate that the trial will confirm our experience, and help establish the clinical value of the Convergent Procedure."
The multidisciplinary Convergent Procedure is performed as a single procedure in the electrophysiology lab. 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 help confirm lesion set completeness through specialized EP diagnostics, which also predict outcomes.
"This publication confirms our own experience with the Convergent Procedure," stated James McKinnie, MD, Director Arrhythmia Center East Jefferson General Hospital and West Jefferson Medical Center, Metairie, LA. "Our hospital has done more than 100 Convergent cases since the fall of 2011, all on persistent AF patients, and our results mirror the Our Lady of the Lake experience. Our use of the Convergent Procedure in the persistent AF population has resulted in very high single-procedure efficacy, far exceeding our own results with endocardial catheter ablation. By standardizing the procedure, multiple sites are getting consistent results, which has historically been a problem for catheter-only approaches. The value of the Convergent Procedure is not only good efficacy but the safety experience has been equivalent to endocardial catheter approaches. Another key economic advantage under managed care is the small number of repeat procedures as a result of first procedure failures (<3%). The combination of addressing larger patient populations, strong efficacy and safety, consistent results, and fewer rehospitalizations makes a persuasive case for the Convergent Procedure."
This publication can be found in the current issue of The Journal of Innovations in Cardiac Rhythm Management at: www.innovationsincrm.com
About nContact, Inc.
nContact's mission is to transform the underserved arrhythmia market through the advancement of less invasive, more efficacious ablation alternatives for cardiac arrhythmias. The Company's lead technologies, EPi-Sense™ and Numeris® Coagulation Systems with VisiTrax®, have CE Mark approval in Europe for the coagulation of cardiac tissue in the treatment of atrial fibrillation and atrial flutter. The EPi-Sense and Numeris Coagulation Systems with VisiTrax are indicated for endoscopic coagulation of cardiac tissue in the U.S. nContact was founded in 2005 and is headquartered in Morrisville, North Carolina, USA.
T (919) 655-1351