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

Area of Science:

• Cardiology
• Cardiac Surgery
• Electrophysiology

Background:

• Surgical ablation for atrial fibrillation (AF) during cardiac surgery is a Class I recommendation due to improved patient outcomes.
• Evolving ablation tools include radiofrequency and cryothermal devices.
• This study evaluates real-world evidence (RWE) of a novel bipolar radiofrequency clamp for epicardial left atrial encircling lesions.

Purpose of the Study:

• To evaluate the safety and efficacy of concomitant surgical ablation using a novel bipolar radiofrequency clamp for an epicardial left atrial encircling lesion.
• To assess long-term rhythm outcomes and survival in patients undergoing this procedure.

Main Methods:

• Data from 327 patients with AF undergoing cardiac surgery were analyzed from the TRAC-AF Registry.
• Patients received an epicardial left atrial encircling lesion created by a novel bipolar radiofrequency clamp.
• Freedom from AF/AT/AFL and survival were evaluated using Kaplan-Meier analysis; safety was assessed within 30 days.

Main Results:

• One- and two-year survival rates were 95.3% and 88.1%, respectively.
• Freedom from AF/AT/AFL at 12 and 24 months was 87.4% and 79.9%, respectively.
• Thirty-day mortality was 1.5%, with no serious adverse events related to the ablation procedure or device.

Conclusions:

• RWE from the TRAC-AF Registry indicates that surgical ablation with an epicardial left atrial encircling lesion using a novel bipolar RF clamp is safe.
• The procedure resulted in favorable long-term rhythm outcomes and survival.