Background: The use of an algorithmic method (wavefront, WF) may accurately identify the earliest activation site (EAS) during premature ventricular complex (PVC) ablation procedures.
Objective: To assess the potential benefits of a local activation time (LAT) automatic acquisition protocol using WF + automatic ECG pattern matching recognition (AUT-arm) instead of manual LAT annotation + ECG visual inspection (MAN-arm) during premature ventricular complexes (PVCs) ablation procedures.
Methods: Prospective, randomized, controlled and international multicenter study (NCT03340922). 73 consecutive patients with indication for PVC ablation were enrolled and randomized to AUT (n=36) or MAN (n=37) annotation protocols using the CARTO3 navigation system. The primary endpoint was mapping success, defined as complete PVC abolition after a max. of 2 radiofrequency (RF) applications or up to 90 s at the identified EAS, considered the site of origin (SOO). Complete PVC abolition was considered as the procedure success, whereas clinical success was defined as the PVC-burden reduction of ≥80% in the 24-h Holter at least 1 month after the procedure. Concordance analysis of the maps obtained with both methods was performed.
Results: Mean age was 55±15, 59% men. The mean baseline PVC burden was 26±13%, and mean LVEF 55±12%. The most frequent PVC-SOO were RVOT (43%), LV (23%), and LVOT (16%). Basal characteristics, mapping time, number of RF applications, RF time, and procedure time were similar for both groups. The AUT-arm had a higher number of mapping points acquired (203vs.87; p=0.001). The 10-ms isochronal area was bigger in the MAN-arm (1.95±2.7vs.1.0±1.0; p=0.05). The median distance between AUT-EAS and MAN-EAS was 4 (0-6.8) mm. Mapping success was similar for AUT (64%) and MAN (60%) (p=0.7). Procedure success was significantly better for the AUT-arm (100% AUTvs.87% MAN; p=0.03), without differences in clinical success (87% AUTvs.82% MAN; p=0.6). There were no procedure-related complications.
Conclusion: The proposed automatic protocol for LAT annotation for PVC ablation is feasible and safe, allowing to achieve equivalent procedural and clinical endpoints as compared to manual procedures carried out by expert operators.