MANual vs. automatIC local activation time annotation for guiding Premature Ventricular Complex ablation procedures (MANIaC-PVC study)

AIMS: To assess potential benefits of a local activation time (LAT) automatic acquisition protocol using wavefront annotation plus an ECG pattern matching algorithm [automatic (AUT)-arm] during premature ventricular complex (PVC) ablation procedures. METHODS AND RESULTS: Prospective, randomized, controlled, and international multicentre study (NCT03340922). One hundred consecutive patients with indication for PVC ablation were enrolled and randomized to AUT (n = 50) or manual (MAN, n = 50) annotation protocols using the CARTO3 navigation system. The primary endpoint was mapping success. Clinical success was defined as a PVC-burden reduction of ≥80% in the 24-h Holter within 6 months after the procedure. Mean age was 56 ± 14 years, 54% men. The mean baseline PVC burden was 25 ± 13%, and mean left ventricular ejection fraction (LVEF) 55 ± 11%. Baseline characteristics were similar between the groups. The most frequent PVC-site of origin were right ventricular outflow tract (41%), LV (25%), and left ventricular outflow tract (17%), without differences between groups. Radiofrequency (RF) time and number of RF applications were similar for both groups. Mapping and procedure times were significantly shorter in the AUT-arm (25.5 ± 14.3 vs. 32.8 ± 12.6 min, P = 0.009; and 54.8 ± 24.8 vs. 67.4 ± 25.2, P = 0.014, respectively), while more mapping points were acquired [136 (94-222) AUT vs. 79 (52-111) MAN; P < 0.001]. Mapping and clinical success were similar in both groups. There were no procedure-related complications. CONCLUSION: The use of a complete automatic protocol for LAT annotation during PVC ablation procedures allows to achieve similar clinical endpoints with higher procedural efficiency when compared with conventional, manual annotation carried out by expert operators.