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

Abstract

AIMS: 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 multicentre European registry. METHODS AND RESULTS: All 18 European centres using the AFFERA system in September 2024 agreed to participate. Clinical, procedural, and follow-up data (minimum 3 months) were systematically collected and analysed. 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), and cardiogenic shock due to prolonged VT mapping (n = 1). Within the first month post-procedure, three patients died [from multi-organ failure (n = 2) and sepsis (n = 1)], two had worsening heart failure, one myocardial infarction, one sepsis, and one 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.