Concomitant Surgical Ablation Using a Novel Bipolar Radiofrequency Clamp: Outcomes from the TRAC-AF Registry

Background/Objectives: Surgical ablation for atrial fibrillation (AF) during cardiac surgery decreases perioperative morbidity and mortality and improves long-term patient outcomes. Because of these benefits, it has been designated a Class I surgical society recommendation. As surgical ablation techniques have evolved, so too have ablation tools such as radiofrequency and cryothermal devices. In this study, we evaluated real-world evidence (RWE) of concomitant surgical ablation featuring an epicardial left atrial encircling lesion created by a novel bipolar radiofrequency clamp. Methods: Thirteen centers in the observational Tracking Results of Ablation to Combat AF (TRAC-AF) Registry (NCT05111015) contributed data used in this analysis. Included patients had AF and received the epicardial encircling lesion during cardiac surgery. Additional ablation and follow-up were per institutional standard of care. Freedom from AF/atrial tachycardia (AT)/atrial flutter (AFL) and survival were evaluated using the Kaplan-Meier method. Safety was evaluated within 30 days of the procedure. Results: Among 327 patients, 70% were male with a median age of 69 years. Sixty-nine percent had paroxysmal AF. Median left atrial diameter was 4.1 cm, and CHA₂DS₂-VASc score was 3. Isolated coronary artery bypass graft and aortic valve surgery were performed in 51% and 11% of patients, respectively. One- and two-year survival rates were 95.3% (95% CI, 91.7-97.3%) and 88.1% (95% CI, 81.5-92.5%). Through 12- and 24-months freedom from AF/AT/AFL was 87.4% (95% CI, 81.3-91.6%) and 79.9% (95% CI 72.0-85.8%). Mortality within 30 days of the index procedure was 1.5%. No serious adverse events were related to the epicardial cardiac ablation procedure or device. Conclusions: RWE from the TRAC-AF Registry demonstrates surgical ablation including an epicardial left atrial encircling lesion made by a novel bipolar RF clamp was safe and resulted in favorable long-term rhythm outcomes.