Slide 1: CardioInsight Noninvasive 3D Mapping System Clinical Evidence Summary
CARDIOINSIGHTTM NONINVASIVE 3D MAPPING SYSTEM CLINICAL EVIDENCE SUMMARY April 2017
Slide 2: Supporting Evidence: Rhythm Publications Synopsis
SUPPORTING EVIDENCE RHYTHM PUBLICATIONS SYNOPSIS AF • Driver Domains in Persistent Atrial Fibrillation • The longer a patient is in AF, the more complex the (Haissaiguerre, et al) AF becomes1 • Complexity and Distribution of Drivers in • “The complexity of AF drivers increases with Relation to Durat
Slide 3: Supporting Evidence: Benefit Publications Synopsis
SUPPORTING EVIDENCE BENEFIT PUBLICATIONS SYNOPSIS NON- • Utility of Noninvasive Arrhythmia Mapping in • All studies demonstrated that pre-procedural Patients with Adult Congenital Heart Disease mapping allowed for customization of ablation INVASIVE (Ernst, et al) strategy by the physician1,5,9,10 •
Slide 4: Studies of AF
STUDIES OF AF Medtronic Further, Together
Slide 5: Driver Domains in Persistent Atrial Fibrillation
DRIVER DOMAINS IN PERSISTENT ATRIAL FIBRILLATION Aims Anatomical Distribution of AF Drivers (above) Evaluate use of non-invasive 3D Mapping (ECM) to identify Distribution of Mean Number of Rotations per Patient (n=103) (below) “drivers” in distinct categories of persistent atrial fibrillation (AF).
Slide 6: Complexity and Distribution of Drivers in Relation to Duration of Persistent AF
COMPLEXITY AND DISTRIBUTION OF DRIVERS IN RELATION TO DURATION OF PERSISTENT ATRIAL FIBRILLATION Distribution of Re-entrant and Focal Drivers Aims “…to investigate the complexity and distribution of AF drivers in” Persistent AF (PeAF) of varying durations Methods Prospective, non-randomized n=10
Slide 7: Multicenter Evaluation of Noninvasive Biatrial Mapping: AFACART Study
MULTICENTER EVALUATION OF NONINVASIVE BIATRIAL MAPPING FOR PERSISTENT ATRIAL FIBRILLATION ABLATION – THE AFACART STUDY Aims Results Cont. To evaluate the utility of ECG mapping as a practical tool Remaining 11 AF recurrences were paroxysmal prior to ablation for persistent AF in centers with no
Slide 8: Non-Invasive Cardiac Mapping in Clinical Practice
NON-INVASIVE CARDIAC MAPPING IN CLINICAL PRACTICE: APPLICATION TO THE ABLATION OF CARDIAC ARRHYTHMIAS Aims Description of clinical experience in using non-invasive mapping technique to identify the sources of electrical disorders and guide catheter ablation of atrial and ventricular arrhythmias. Met
Slide 9: Studies of VT
STUDIES OF VT Medtronic Further, Together
Slide 10: Non-Invasive Electrocardiographic Mapping to Guide Ablation of Outflow Tract Ventricular Arrhythmias
NON-INVASIVE ELECTROCARDIOGRAPHIC MAPPING TO GUIDE ABLATION OF OUTFLOW TRACT VENTRICULAR ARRHYTHMIAS Aims Study Authors’ Conclusion Assess the performance of non-invasive mapping (ECM ) in the pre-/periprocedural localization of OTVT origin to guide “ECM can accurately identify OTVT/PVC ablation and
Slide 11: Clinical Impact of Novel 3D Electrocardiographic Imaging for Ventricular Arrhythmias
CLINICAL IMPACT OF A NOVEL THREE-DIMENSIONAL ELECTROCARDIOGRAPHIC IMAGING FOR NON-INVASIVE MAPPING OF VENTRICULAR ARRHYTHMIAS – A PROSPECTIVE RANDOMIZED TRIAL Aims Evaluate use of non-invasive 3D Mapping (ECM) in routine clinical mapping and ablation of ventricular arrhythmias (VAs) Methods Prospe
Slide 12: Noninvasive Electrocardiomapping Facilitates Previously Failed Ablation
NONINVASIVE ELECTROCARDIOMAPPING FACILITATES PREVIOUSLY FAILED ABLATION OF RIGHT APPENDAGE DIVERTICULUM ASSOCIATED LIFE- THREATENING ACCESSORY PATHWAY Aims Results Case Study overview of successful ablation of accessory Successful ablation with one single RF application pathway with complex anatomy
Slide 13: Studies of SVT
STUDIES OF SVT Medtronic Further, Together
Slide 14: Validation of Novel 3D Electrocardiographic Mapping of Atrial Tachycardias
VALIDATION OF NOVEL 3D ELECTROCARDIOGRAPHIC MAPPING OF ATRIAL TACHYCARDIAS BY INVASIVE MAPPING AND ABLATION: A MULTICENTER STUDY Aims Prospective evaluation of the role of a 3D non-invasive mapping system (ECM), in facilitating the diagnosis of atrial tachycardias (AT). Methods Multicenter, Prospe
Slide 15: Focal Arrhythmia Ablation Determined by High-Resolution Noninvasive Maps
FOCAL ARRHYTHMIA ABLATION DETERMINED BY HIGH-RESOLUTION NONINVASIVE MAPS: MULTICENTER FEASIBILITY STUDY Aims Prospective evaluation of the role of a high resolution non- invasive mapping system for patients with PVC’s, AT’s, and WPW. Methods Multicenter, Prospective, non-randomized 3 centers, n=
Slide 16: Clinical Experience: Kerckhoff Klinik, Bad Nauheim, Germany
CLINICAL EXPERIENCE KERCKHOFF KLINIK, BAD NAUHEIM, GERMANY Aims To provide a real world example of clinical experience to Findings cont. compare identification of chamber and site of origin of Clinical complexity of these cases reviewed did not the arrhythmia in each patient using the mapping system
Slide 17: Thank You
THANK YOU Medtronic
Slide 18: Indication for Use
INDICATION FOR USE The CardioInsight™ Noninvasive 3D Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. Indications, warnings and instructions for use can be found in the product labeling supplied with
Slide 19: Citations
CITATIONS 1. Haissaiguerre, et al. Driver Domains in Persistent Atrial Fibrillation. Circulation. 2014. 130:530-538 2. Knecht, et al. Multicenter evaluation of noninvasive biatrial mapping for persistent atrial fibrillation ablation – the AFACART Study. Europace 2017 online published, doi: 10.1093/e