Interim results from a study conducted in patients with atrial fibrillation demonstrated that a port access, paracardioscopic Ex-Maze procedure produced favorable outcomes and allowed patients to discontinue antiarrhythmic drugs, according to a poster session presented by Andy C. Kiser, MD, at the 2008 American College of Cardiology (ACC) Scientific Sessions in Chicago last week.
Epicardial lesions to complete the bi-atrial pattern were created in all patients by coagulating cardiac tissue using the nContact Surgical VisiTrax device, according to the Morrisville, N.C.-based nContact Surgical.
The 37 patients reported in the study had an average age of 61 years, a mean duration of atrial fibrillation of 7.4 years, and a mean left atrial size of 5.7 cm.
The researchers found that 78 percent of the patients had long-standing persistent atrial fibrillation, and analysis of three-month interim outcomes demonstrated normal sinus rhythm in 17/20 (85 percent) patients. For the patients who reached six months, the researchers reported that 100 percent of patients experienced normal sinus rhythm without antiarrhythmic drugs.
“This is a truly minimally invasive approach that treats both the left and right atrium without the use of cardiopulmonary bypass,” said Kiser, chief of thoracic surgery, FirstHealth Moore Regional Hospital and medical director of FirstHealth Arrhythmia Center Pinehurst in North Carolina. “These interim closed-chest results are very promising, particularly, when intra-operative metrics, including spontaneous conversion to normal sinus rhythm and confirmed exit block, are met.”
Additional follow-up data from this group of patients is expected at future medical conferences, according to nContact.
In December 2006, nContact received FDA clearance for its coagulation system (VisiTrax) for the coagulation of cardiac tissue using radiofrequency energy.