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This bibliography includes a selection of conferences, abstracts, and peer-reviewed, published data about the ECVUETM Cardiac Mapping System and CardioInsightTM Noninvasive 3D Mapping System technology.
Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, et al. Driver domains in persistent atrial fibrillation. Circulation. 2014;130:530-538.
Evaluate use of non-invasive 3D Mapping (ECM) to identify drivers in distinct categories of persistent atrial fibrillation (AF).
Acute results: 82/103 patients experienced AF termination (80%).
Average RF duration to terminate AF:
“The noninvasive system can map AF pre-procedurally and help shorten invasive procedural time by performing an important task of identification of AF drivers."
Jamil-Copley S, Bokan R, Kojodjojo P, Qureshi N, Koa-Wing M, Hayat S, et al. Noninvasive electrocardiographic mapping to guide ablation of outflow tract ventricular arrhythmias. Heart Rhythm. 2014;11:587-594.
Assess the performance of non-invasive mapping (ECM) in the pre-/periprocedural localization of OTVT origin to guide ablation and to compare the accuracy of ECM with that of published pre-procedure ECG algorithms.
|Noninvasive ECM||Pre-procedure ECG Algorithms|
|Chamber of origin||96%||50-88%
Results varied based on which of 3 algorithms used
|Acute ablation success||100%||-----|
“ECM can accurately identify OTVT/PVC origin in the left and the right ventricle pre- and periprocedurally to guide catheter ablation with an accuracy superior to that of published ECG algorithms.”
Erkapic D, Greiss H, Pajitnev D, Zaltsberg S, Deubner N, Berkowitsch A, et al. Clinical impact of a novel three-dimensional electrocardiographic imaging for non-invasive mapping of ventricular arrhythmias-a prospective randomized trial. Europace. 2015;17:591-597.
Evaluate use of non-invasive 3D Mapping (ECM) in routine clinical mapping and ablation of ventricular arrhythmias (VAs)
|ECVUE||12 Lead ECG|
|Chamber||20/21 (95.2%)||16/21 (76.2%)|
|Region of interest*||20/21 (95.2%)||8/21 (38.1%)|
|Radiation exposure*||3.21 mSv||0.39 mSv|
*=P-value ≤ 0.005
“ECVUETM technology offers a clinically useful tool to map VAs with high accuracy and more targeted ablations superior to body surface ECG, but had significantly higher radiation exposure due to computer tomography scan.”
Shah AJ, Hocini M, Xhaet O, Pascale P, Roten L, Wilton SB, et al. Validation of novel 3-dimensional electrocardiographic mapping of atrial tachycardias by invasive mapping and ablation: a multicenter study. J Am Coll Cardiol. 2013;62:889-897.
Prospective evaluation of the role of a 3D non-invasive mapping system (ECM), in facilitating the diagnosis of atrial tachycardias (AT).
ECM and EP Diagnosis achieved in 48/52 pts (92%)
In 4 patients clinical AT converted to another rhythm (AT, AF, or sinus) before invasive mapping could be completed therefore pts excluded from analysis.
ECM correctly diagnosed AT mechanisms in 44/48 (92%)
The 2:1 ventricular conduction and low-amplitude P waves challenged the diagnosis of 4/27 macroreentrant ATs that could be overcome by injecting AV node blockers and signal averaging, respectively.
|Electrophysiological Laboratory Diagnosis||n||Previous AF Ablation||ECM Correct by Diagnosed||Diagnostic Accuracy %|
|Around the scar||1||0||1||100|
Accuracy for a) unablated atria — 100% (25/25); b) previously ablated atria — 83% (19/23).
"This prospective multicenter series shows high success rate of ECM in accurately diagnosing the mechanism of AT and the location of focal arrhythmia."
Hocini M, Shah AJ, Neumann T, Kuniss M, Erkapic D, Chaumeil A, et al. Focal Arrhythmia Ablation Determined by High-Resolution Noninvasive Maps: Multicenter Feasibility Study. J Cardiovasc Electrophysiol. 2015;26:754-760.
Prospective evaluation of the role of a high resolution non-invasive mapping system for patients with PVC’s, AT’s, and WPW.
Successful ablation in 32/33 patients (97%) without complications.
Average cumulative radiation exposure (CT scan and fluoro): 7.57 mSv
|Procedure Data||Mean ± SER||Range Min-Max|
|Procedure time (minutes)||48.0 ± 24.0||(24-72)|
|Mapping time (minutes)||4.5 ± 0.6||(4.1-4.9)|
|Total RF (seconds)||387.5 ± 237.5||(150-625)|
|Fluoro time (minutes)||8.8 ± 1.5||(8-9)|
|RF to arrhythmia elimination (seconds)||8.5 ± 0.5||(8.0-46)|
|Wolff Parkinson White|
|Procedure time (minutes)||85.0 ± 15.1||(40-125)|
|Mapping time (minutes)||7.3 ± 2.2||(2.7-15.4)|
|Total RF (seconds)||717.0 ± 391.8||(96-2123)|
|Fluoro time (minutes)||12.9 ± 3.9||(4.8-26.0)|
|RF to arrhythmia elimination (seconds)||7.0 ± 1.7||(2.0-11)|
|Premature ventricular contraction|
|Procedure time (minutes)||76.7 ± 9.1||(11-222)|
|Mapping time (minutes)||15.0 ± 3.1||(3.0-68)|
|Total RF (seconds)||376.0 ± 70.0||(52-1654)|
|Fluoro time (minutes)||15.6 ± 2.6||(3.1-55.0)|
|RF to arrhythmia elimination (seconds)||26.1 ± 4.0||(2.0-72)|
“ECVUETM is a noninvasive tool allowing pre-procedural localization of the origin of the arrhythmia and direct RF delivery to the focal source without the need for intracardiac mapping.”
Dubois, R., Shah, A.J., Hocini, M., Denis, A., Derval, N., Cochet, H., Sacher, F., Bear, L., Duchateau, J., Jais, P. and Haissaguerre, M., 2015. Non-invasive cardiac mapping in clinical practice: Application to the ablation of cardiac arrhythmias. Journal of Electrocardiology, 48(6), pp.966-974.
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.
Upper & Middle Panels: The endpoint of local ablation is increase in local cycle length and transformation of rapid and complex signals into slower local rhythm.
Lower Panel: It is not desirable to achieve complete electrogram abolition locally which results in tissue scarring post-ablation.
“Various atrial and ventricular arrhythmias including complex fibrillatory processes can be mapped non-invasively to guide catheter ablation. The pre- and peri-procedural utility of the system in panoramic 3D mapping expresses its potential to reduce invasive procedural, fluoroscopic and ablation times.”