Radiofrequency balloon ablation: 1-year outcomes of the AURORA study

Ilaria My; Boris Schmidt; Laura Rottner; Shota Tohoku; Marc D. Lemoine; David Schaack; Fabian Moser; Lukas Urbanek; Julius Obergassel; Djemail Ismaili; Jun Hirokami; Paulus Kirchhof; Karin Plank; Bruno Reißmann; Feifan Ouyang; Andreas Rillig; Julian Chun; Andreas Metzner; Stefano Bordignon

doi:10.1007/s10840-024-01938-0

Why the study?

A novel irrigated radiofrequency balloon for pulmonary vein isolation integrated into a 3D mapping platform was recently launched, warranting evaluation of its clinical outcomes.

Does radiofrequency balloon ablation safely and effectively prevent atrial fibrillation recurrence in patients undergoing first-time ablation for paroxysmal or persistent AF?

Structured PICO

Does radiofrequency balloon ablation safely and effectively prevent atrial fibrillation recurrence in patients undergoing first-time ablation for paroxysmal or persistent AF?

P

Population

99 patients undergoing a first atrial fibrillation (AF) ablation for paroxysmal or persistent AF at two German high-volume EP centers. Median age 67 years, 43.4% female, 43.4% persistent AF. Key inclusion criteria: non-valvular AF, age 18-85 years, left atrial size <55 mm, and LVEF ≥45%.

I

Intervention

Pulmonary vein isolation (PVI) using a novel irrigated radiofrequency balloon (RFB) integrated into a 3D mapping platform, delivering temperature-controlled unipolar energy at 15 W for 60 seconds (anterior/superior/inferior) or 20-30 seconds (posterior).

O

Outcome

Atrial fibrillation-free survival after a median follow-up of 361 dayshard clinical

Radiofrequency balloon ablation for pulmonary vein isolation is acutely successful and safe, yielding 1-year AF-free survival rates of approximately 75-78% in patients with paroxysmal or persistent AF.

Limitations

Routine post-ablation endoscopy was not performed to assess asymptomatic esophageal lesions
Exact number of cases of phrenic nerve capture was not systematically recorded

Implication

Supports RFB PVI in AF ablation workflows; extends single-shot observational data but leaves randomized confirmation open.

Abstract

Background A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched. Methods Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360 days following ablation including 48-h Holter ECGs. Results A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67 years (interquartile range [IQR] 59–74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62–55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18–32) and 67 (IQR 57–85) min, respectively. Median dose area product was 761 (IQR 509–1534) mGycm 2 . AF-free survival after a median FU of 361 (IQR 261–375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF ( p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1 year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036–10.32, p value = 0.0433). Conclusion RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90 days predicts later AF recurrence.