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ORLANDO – Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.
The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.
The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.
Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.
Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.
The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.
Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, consisting mainly of pneumothorax and bleeding.
Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.
"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.
"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," the surgeon added.
The FAST trial was funded by St. Antonius Hospital and the University of Barcelona Thorax Institute. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov is a consultant to Edwards Lifesciences and AtriCure.
Concurrently with Dr. Boersma’s presentation at the AHA meeting, the FAST results were published in Circulation (doi:10.1161/CIRCULATIONAHA.111.074047).
ORLANDO – Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.
The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.
The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.
Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.
Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.
The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.
Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, consisting mainly of pneumothorax and bleeding.
Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.
"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.
"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," the surgeon added.
The FAST trial was funded by St. Antonius Hospital and the University of Barcelona Thorax Institute. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov is a consultant to Edwards Lifesciences and AtriCure.
Concurrently with Dr. Boersma’s presentation at the AHA meeting, the FAST results were published in Circulation (doi:10.1161/CIRCULATIONAHA.111.074047).
ORLANDO – Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.
The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.
The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.
Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.
Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.
The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.
Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, consisting mainly of pneumothorax and bleeding.
Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.
"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.
"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," the surgeon added.
The FAST trial was funded by St. Antonius Hospital and the University of Barcelona Thorax Institute. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov is a consultant to Edwards Lifesciences and AtriCure.
Concurrently with Dr. Boersma’s presentation at the AHA meeting, the FAST results were published in Circulation (doi:10.1161/CIRCULATIONAHA.111.074047).
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN HEART ASSOCIATION
Major Finding: A total of 66% of patients who were treated with minimally invasive surgical ablation achieved freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs, compared with 37% treated with catheter ablation.
Data Source: A two-center randomized trial in 124 patients with "difficult" paroxysmal or persistent atrial fibrillation.
Disclosures: The trial was funded by St. Antonius Hospital and the University of Barcelona Thorax Institute. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov is a consultant to Edwards Lifesciences and AtriCure.