Safety and efficacy of a lattice-tip catheter for ventricular arrhythmia ablation: the AFFERA Ventricular Arrhythmia Ablation Registry (AVAAR)
Frédéric Sacher, Andrea Sarkozy, Helmut Pürerfellner, Alexandra Steyer, Jonathan Lyne, Charlène Coquard, Romain Tixier, Nicolas Combes, Michel Haı̈ssaguerre, Michalis Efremidis, Josselin Duchâteau, Víctor Castro‐Urda, Claire A Martin, Marc D. Lemoine, Alejandro Carta, Frank Bogun, Nick Linton, Nicolas Derval, F.J.V. Schlösser, Thomas Pambrun, Jan Petrů, Mélèze Hocini, Luigi Pannone, Martin Mudroch, Josef Kautzner, Pierre Jaı̈s, Tobias Reichlin, Petr Neužil, Petr Peichl
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.