Catheter Ablation -> Atrial Fibrillation & Atrial Flutter: -> Clinical Trials / Outcomes D-PO03 - Poster Session III (ID 48) Poster

D-PO03-134 - Differences In The US And European Lesion Index-guided Ablation Workflows For Pulmonary Vein Isolation In Paroxysmal Atrial Fibrillation Patients - First Results From The LSI™ Workflow Study (ID 1116)


Background: Lesion Index (LSI™) combines contact force, radiofrequency (RF) duration, and RF current in a single value displayed in the EnSite Velocity™ or EnSite Precision™ Cardiac Mapping Systems and can be used (outside the US) as the AutoMark lesion color or size metric.
Objective: The LSI Workflow Study (NCT-03906461) was designed to systematically gather data from highly experienced operators on the use of LSI with the TactiCath™ Sensor Enabled™ ablation catheter in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-world environment.
Methods: By Oct 2019, 65 patients of a planned 150 were enrolled at 7 centers in the US and Europe. Eligible subjects were adults with PAF undergoing a first pulmonary vein isolation (PVI) using RF ablation.
Results: Successful isolation of PVs was achieved in all 65 patients; all were in sinus rhythm at the end of procedure. The mean minimum LSI target was 4.2 in Europe and 5.2 in the US (P < 0.001). Similarly, mean actual LSI was 4.6 and 5.5 in Europe and the US, respectively (P < 0.001). Total number of lesions per subject was 101.8 in Europe and 84.6 in the US. After a 20 min waiting period, 12 (18.5%) of subjects had a least 1 gap that required touch-up ablation, 10/12 gaps (83.3%) were around the left PVs. LSI values achieved, and location of gaps are in FIGURE. There were no procedure- or device-related Serious Adverse Events at 7 days post-procedure.
Conclusion: The European workflow utilized more lesions with a lower target LSI versus the US workflow. Both strategies were highly effective for acute PVI, confirming that LSI-guided PVI is safe and effective in treating PAF. It will be interesting to determine if the choice in strategy affects long-term outcome.