Shults, C. et al. (2025). J. Clin. Med. doi:10.3390/jcm14238360

Introduction

The Tracking Results of Ablation to Combat AF (TRAC-AF®) Registry (clinicaltrials.gov identifier: NCT05111015) is a multicenter observational study collecting real-world safety and effectiveness data on surgical or hybrid cardiac ablation and left atrial appendage (LAA) management. A multicenter analysis using data from TRACAF was led by Dr. Christian Shults (MedStar Washington Hospital Center, Washington, DC) to evaluate real world outcomes of concomitant epicardial surgical ablation with a novel bipolar radiofrequency (RF) clamp.

Methods

Patients in the TRAC-AF Registry who underwent open cardiac surgery and concomitant surgical ablation using the RF Isolator® Synergy™ EnCompass® Clamp (AtriCure, Inc., Mason, Ohio) were included.¹ Data were collected between 2022 and 2025. Patients were followed for a median of 12.8 months.

All patients had atrial fibrillation (AF) at baseline and received a left atrial posterior wall ‘Box’ lesion set at a minimum but additional left and right lesions could be performed at the operator’s discretion. Additional ablation and follow-up were per institutional standard of care.

Results

Thirteen centers contributed data from 327 patients [70% male, 69% paroxysmal AF, median left atrial diameter of 4.1 cm and CHA2DS2-VASc score of 3]. The most common concomitant surgery was isolated coronary artery bypass graft in 51% of patients. Most (56%) received a Box lesion and no additional lesions, while 18.7% received a Box lesion + left-sided lesions, 7.6% had Box + right-sided lesions, 17.7% underwent Box lesion + both left- and right-sided lesions and 0.3% had a Box lesion + full left-sided maze.

Of 320 patients who underwent LAA exclusion, 98.1% (314/320) received an AtriClip® device (AtriCure, Inc., Mason, Ohio), while 0.9% (3/320), 0.3% (1/320), 0.3% (1/320) and 0.3% (1/320), had their LAA managed with surgical stapling, amputation, ligation or Penditure™ (Medtronic Inc., Minneapolis, Minnesota), respectively.

Survival was 95.3% (95% CI, 91.7–97.3%) and 88.1% (95% CI, 81.5-92.5%) at one and two years, respectively.

Evaluable rhythm data after the 90-day blanking period were available from 198 patients. Follow-up monitoring was electrocardiogram (ECG)-only in 61.8%, ECG + non-ECG in 14.7%, and non-ECG only in 14.1%.

Freedom from AF, atrial flutter (AFL), atrial tachycardia (AT) was 87.4% (95% CI, 81.3-91.6%) and 79.9% (95% CI 72.0-85.8%), through one and two years, respectively (Table 1). Freedom from AF alone was 92.5% (95% CI, 87.1-95.7%) and 89.8% (95% CI, 83.5-93.8%), at one and two years, respectively.

When evaluating lesion effectiveness by AF type, 89.4% (95% CI, 82.4-93.7%) and 80.5% (95% CI, 58.5-91.6%) with paroxysmal and non-paroxysmal AF were free from AF/AFL/AT through one year, respectively (Table 2). Freedom from AF alone in paroxysmal and non-paroxysmal AF patients was 96.6% (95% CI, 91.2-98.7%) and 80.5% (95% CI, 58.5-91.6%), respectively through one year. In patients treated with a box lesion set, effectiveness was 88.2% (95% CI 80.1-93.1%) through one year.

Among 126 patients with available antiarrhythmic drug (AAD) data, 85.7% off AADs were without AF/AFL/AT through one year.

Mortality within 30 days of the index procedure was 1.5% (5/327). One ischemic stroke (0.3%, 1/327) was resolved without sequalae. Rate of permanent pacemaker implantation was 6.1% (20/327) within 30 days. No serious adverse events related to the epicardial ablation procedure or device were reported.

Table 1. Freedom from Atrial Arrhythmias Through One and Two Years (N=198)

AF=atrial fibrillation; AFL=atrial flutter; AT=atrial tachycardia; Confidence intervals (CI) are 95%

Table 2. Freedom from Atrial Arrhythmias by AF Type Through One Year

AF=atrial fibrillation; AFL=atrial flutter; AT=atrial tachycardia; Confidence Intervals (CI) are 95%

Limitation

Rhythm monitoring via in-office ECG was available for 61% of patients, many of whom had multiple office visits that included rhythm and symptom checks to confirm arrhythmia status.

Key Takeaway

Data captured from the real-world TRAC-AF Registry demonstrates that surgical ablation using the novel RF EnCompass clamp supports the safety, effectiveness, and durability of this ablation approach during concomitant cardiac surgery.