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CE-520-04 FORWARD-SOLUTION COMPUTATIONAL ARRHYTHMIA SOURCE MAPPING: THE VMAP STUDY

      Background

      The accuracy of arrhythmia source localization using a forward solution computational mapping system has not yet been evaluated in blinded, multicenter analysis.

      Objective

      The study tested the hypothesis that a computational mapping system using a comprehensive arrhythmia simulation library would provide accurate localization of the site of origin for atrial and ventricular arrhythmias and pacing using the 12-lead ECG compared with the gold standard of invasive electrophysiology study and ablation.

      Methods

      The VMAP study was a blinded, multicenter evaluation with final data analysis performed by an independent core laboratory. Eligible episodes included atrial and ventricular: tachycardia (VT), fibrillation, pacing, premature complexes (PACs and PVCs; figure panel A); and orthodromic atrioventricular reentrant tachycardia. Forward solution mapping system results (panel B) were compared with the gold standard site of successful ablation or pacing during invasive electrophysiology study and ablation (panel C). Mapping time performance was assessed from timestamped analysis logs. Pre-specified performance goals were used for statistical comparisons.

      Results

      A total of 255 episodes from 225 patients were enrolled from 4 study centers. Regional accuracy for VT and PVCs in patients without significant structural heart disease (n=75, primary endpoint) was 98.7% (95% CI: 96.0-100%, p<0.001 to reject study null hypothesis, panel D). Regional accuracy for all episodes (secondary endpoint 1) was 96.9% (95% CI: 94.7-99.0%, p<0.001). Accuracy for the exact or neighboring segment for all episodes (secondary endpoint 2) was 97.3% (95% CI: 95.2-99.3%, p<0.001). Median center-to-center spatial accuracy was 15 mm (n=255, IQR: 7 - 25 mm, panel E). The mapping process was completed in a median of 0.8 minutes (IQR: 0.4 - 1.4 minutes, panel F).