Patient Outcomes 6 Months Following Pulmonary Vein Isolation for Atrial Fibrillation With a Novel RF Catheter: Initial Data From NEwTON AF

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Introduction: The combination of local impedance (LI), a direct measure of electrical resistance at the catheter tip, and contact force (CF) may facilitate treatment of atrial fibrillation (AF). This trial is designed to examine the safety and effectiveness of a novel RF catheter that allows measurement of both LI and CF.

Hypothesis: Demonstrate the safety and effectiveness of a novel radiofrequency catheter with LI and CF for treatment of drug refractory, recurrent, symptomatic Paroxysmal AF (PAF).

Methods: NEwTON AF is a multi-center, global, prospective, single arm study. Patients received index treatment for PAF with the study catheter. The present 6-month endpoint analysis was prospectively planned.

Results: The study treated 299 patients at 45 sites in North America, Europe, and Asia. Patients were 39.5% female with a mean age of 62yrs (±12), and had a mean LVEF of 59% and an LA diameter of 3.9cm. Procedure time, LA dwell, and fluoroscopy times were 166, 136, and 15 minutes, respectively. High-power short-duration (HSPD, 45-50W) was exclusively used in 210 cases, which had notably shorter procedure times than the 82 cases that used conventional power, 148 vs 208 min, respectively. Acute procedural success was observed in 98.3% of cases. As of 6 months, freedom from documented recurrence of any atrial arrhythmia was 79.9% (Figure). Recurrence in relation to LI shows that pts with a 20Ω LI drop (in at least 60% of lesions) had better 6m outcomes (84.2% vs 73.3, p=0.04). The freedom from safety event rate at 30d was 96.0%; events included pericarditis (6), access complications (2), pulmonary edema (2), embolism (2), cerebrovascular accident (1), tamponade (1). Pericarditis was higher in pts with a history of COVID at enrollment, 16.3% vs 5.9%, p=0.025.

Conclusions: This data suggests that patient outcomes and safety for this novel catheter are promising. Further data from this study, including 12m outcomes, and detailed analysis of local impedance data are forthcoming.




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American Heart Association Scientific Sessions, November 11-13, 2023, Philadelphia, PA