A randomized trial of patients undergoing thoracoscopic surgery for advanced atrial fibrillation found that additional ganglionic plexus ablation was associated with significantly more periprocedural major bleeding, sinus node dysfunction and pacemaker implantation.
Patients in the ganglionic plexus ablation group also did not have improvements in rhythm outcomes.
Lead researcher Joris R. de Groot, MD, PhD, of the Academic Medical Center in Amsterdam, Netherlands, presented the results on May 5 during a late-breaking clinical trial session at the Heart Rhythm Society’s scientific sessions in San Francisco.
The study enrolled 240 patients with advanced atrial fibrillation who were subjected to pulmonary vein isolation if they had paroxysmal atrial fibrillation or pulmonary vein isolation plus a roof and trigone line if they had persistent atrial fibrillation. They were then randomized in a 1:1 ratio to receive ganglionic plexus ablation or no ablation.
The mean age of patients was 60 years old, while 73 percent were men. The mean duration of atrial fibrillation was 5.7 years, while 68 percent had an enlarged left atrium, 59 percent had persistent atrial fibrillation and 23 percent had previously failed catheter ablation.
In addition, the mean left atrial volume was 40 ml/m 2 in the ablation group and 41 ml/m 2 in the control group. The mean procedure time was 185 minutes and 168 minutes, respectively.
Patients were followed every three months for a year and given ECG’s and 24-hour Holters. After three months, all patients stopped taking antiarrhythmic drugs.
Major bleeding occurred in nine patients in the ablation group and no patients in the control group. Of the bleedings, eight were managed thoracoscopically. The other patient underwent a sternotomy.
After one year, four patients in the ablation group and no patients in the control group died. None of the deaths were related to the procedure, according to the researchers.
For patients with paroxysmal atrial fibrillation, the rates of freedom of atrial fibrillation occurrence at one year were 80.0 percent in the ablation group and 74.5 percent in the control group. For patients with persistent atrial fibrillation, the rates of freedom of atrial fibrillation occurrence at one year were 65.7 percent and 62.9 percent, respectively.
The researchers defined recurrence as any atrial arrhythmia lasting more than 30 seconds.
Further, clinically relevant sinus node dysfunction occurred in 12 patients in the ablation group and four patients in the control group. Three patients in the ablation group were implanted with pacemakers during admission to the hospital and three received pacemakers during the follow-up period. No patients in the control group needed a pacemaker.
Major procedure-related adverse events occurred in 18 percent of patients in ablation group and 8 percent of patients in the control group.
“We conclude that [ganglionic plexus ablation] should not be performed in this patient population,” de Groot said at a news conference. “These patients should be treated for their arrhythmia with pulmonary vein isolation and additional linear lines or any other lesions. But [ganglionic plexus ablation] should not be part of this.”