Patients show three-year freedom from atrial fibrillation,
PRAGUE--(BUSINESS WIRE)--Jun. 18, 2013--
A leading German cardiovascular heart center reported promising mid-term
results for the surgical treatment of persistent atrial fibrillation
(Afib) during last week’s International Society for Minimally Invasive
Cardiothoracic Surgery (ISMICS) meeting being held in Prague, Czech
Republic. At three-year follow-up, 80 percent of persistent Afib
patients were free from Afib and off anti-arrhythmic medications using
AtriCure’s Bipolar RF Ablation System. These results compare favorably
with a more commonly performed, catheter-based approach. The team at
Sana Heart Center in Stuttgart, Germany performed the beating heart
thoracoscopic surgical procedures under the guidance of Professor
Nicolas Doll, Chief of Cardiovascular Surgery at Sana.
Afib is an irregular heartbeat that affects up to 2 percent of the
population worldwide. The risk of stroke is five times greater in
patients suffering from this disease. Afib is responsible for 15-20
percent of all strokes and is associated with increased mortality,
morbidity and a reduced quality of life.
Catheter ablation is a common treatment in patients with symptomatic
Afib not responding to medications. However, mid-term results of more
chronic forms of Afib even after repeat catheter ablation have been
marginal. Surgical ablation is a promising, single procedure alternative
being researched in advanced heart centers like Sana Heart Center.
“Catheter ablation is quite effective in less severe forms of Afib, but
chronic Afib demands a more intensive approach in terms of making robust
scars on the heart to thoroughly interrupt the electrical signals that
cause the problem. We have demonstrated that this minimally invasive
approach yields superior results in these challenging forms of Afib,”
said Prof. Nicolas Doll, M.D., Director of the Sana Heart Center.
From 2009 to 2013 Stuttgart group enrolled 121 patients in the study, 25
percent of whom had failed at least two previous catheter ablation
procedures. The objective of the study was to evaluate the efficacy of
an endoscopic approach in performing a left atrial lesion set on the
beating heart. Radiofrequency ablation was performed via a bilateral
endoscopic ablation approach using small ports and a microscopic camera
for visualization. Post procedure heart rhythms were evaluated using
sophisticated monitoring protocols at 6, 12, 24 and 36 months to
determine procedural success.
During the study, there were no deaths, no conversions to sternotomy and
no early or late strokes. The data showed that 80 percent of patients
were free from Afib three years after their procedures, and 80 percent
were free from both Afib and anti-arrhythmic drugs three years after
surgery. Quality of life improvements were shown to increase
significantly from preoperative assessments.
“This new thoracoscopic approach to treat chronic Afib is a big step
toward a less invasive treatment with excellent clinical and cosmetic
results. We believe that working in collaboration with our
electrophysiologists that the results can be improved further. However
randomized trials are necessary to establish this approach as a standard
of care,” said Dr. Doll.
For details on this study, please see ISMICS website http://meetings.ismics.org/abstracts/2013/C9.cgi.
About AtriCure, Inc.
Inc. (NASDAQ: ATRC) is a medical device company providing innovative
atrial fibrillation (Afib) solutions designed to produce superior
outcomes that reduce the economic and social burden of atrial
fibrillation. AtriCure’s Synergy Ablation System is the first and only
device approved for the treatment of persistent and longstanding
persistent forms of Afib in patients undergoing certain open concomitant
procedures. AtriCure’s AtriClip Left Atrial Appendage (LAA) exclusion
device is the most widely implanted device for LAA management worldwide.
The company believes cardiothoracic surgeons are adopting its ablation
and LAA management devices for the treatment of Afib and reduction of
Afib related complications such as stroke. Afib affects more than 5.5
million people worldwide.
The FDA has not cleared or approved certain AtriCure products for the
treatment of Afib or a reduction in the risk of stroke. Synergy Ablation
RF clamps are approved for the treatment of Afib. AtriCure reference
Source: AtriCure, Inc.
AtriCure Media Contact:
Rasor Marketing Communications