Safety and efficacy of a lattice-tip catheter for ventricular arrhythmia ablation: the Affera Ventricular Arrhythmia Ablation (AVAAR) Registry.

Abstract

Background: The feasibility and safety of the lattice-tip catheter for ventricular arrhythmia (VA) ablation in humans remain largely unknown. This study aimed to assess feasibility, safety profile as well as patient outcomes after VA ablation with a lattice-tip catheter in a multicenter European registry.

Methods: All 18 European centers using the AFFERA system on September 2024 agreed to participate. Clinical, procedural, and follow-up data (minimum 3 months) were systematically collected and analyzed.

Results: A total of 126 patients (18% female; mean age 59 ±16 years) underwent VA ablation using the lattice-tip catheter during the inclusion period. Ablation indications included ventricular tachycardia (VT) in 99, premature ventricular complexes (PVCs) in 23, and ventricular fibrillation (VF) in 4 patients.Major and minor acute complications were observed in 7 (6%) and 18 (14%) procedures, respectively. They included thrombo-embolic event (n=2), major bleeding (n=2), ventricular fibrillation induction (n=1), tamponade due to epicardial access (n=1), cardiogenic shock due to prolonged VT mapping (n=1). Within the first month post-procedure, 3 patients died (from multi-organ failure (n=2) and sepsis (n=1)), 2 had worsening heart failure, 1 myocardial infarction, 1 sepsis and 1 major gastro-intestinal bleeding. After a mean follow-up of 5.6 ±3.7 months, absence of recurrence was 78% for PVC, 70% for VT, and 100% for VF.

Conclusion: In this complex population with refractory VA, ablation using the lattice-tip catheter appears feasible and relatively safe. In the absence of large, randomized trials, exhaustive registry is of key importance to ensure safety and efficacy of new catheter technologies.