1980s-1990sCatheter ablation quickly starts to increase in usage over other arrhythmia treatment options.5,6 New 3D systems give more accurate real-time data than previous approaches. This is particularly valuable for patients who have complex arrhythmias or patients with complicated cardiac anatomy.7

The Rise to RHYTHMIA HDx:The evolution of cardiac mapping and navigation technology

Early technology

The advent of combined mapping and navigation

From standard de�nition to high de�nition

Early 1900s-1950s

1950s-1970

1970s

The first human electrocardiogram (ECG) is recorded on a string galvanometer,1 and biplane imaging of the heart is developed and refined to complement ECG findings to locate arrhythmias.2

The first 2D images of the heart are produced when an ultrasound beam directed toward the heart is swept back and forth through an arc, reflecting signals on a oscillograph.4

First use of catheter-based imaging devices provide physicians an inside look at heart anatomy.3

1997: The CARTO™ electroanatomical mapping system is introduced, offering the first picture of heart anatomy and electrical activity in 3D.8

1999: The LocaLisa™ 3D and EnSite™ mapping systems are introduced, enabling catheter localization in real-time.9,10

2014-2016The innovation of three software updates for the RHYTHMIA Mapping System provide continually enhanced, high-definition map imaging with consistency and speed.

2016FDA approves the INTELLANAV™ XP, INTELLANAV MIFI™ XP and INTELLANAV™ OI magnetic navigation-enabled ablation catheters for use with the RHYTHMIA Mapping System, enhancing the mapping and ablation potential of the system.19

2017and beyondRHYTHMIA HDx is the innovative new platform built for scalability, optimized workflow and maximum efficiency and includes the same high-quality, rapid mapping and navigation as its predecessor.

A variable deployment catheter, now known as INTELLAMAP ORION™ Mapping Catheter, that fits into different sized cardiac structures, making it easy to use in a variety of individual anatomies.

The smallest electrodes available for this purpose along with a technique to print electrodes onto INTELLAMAP ORION to reduce noise.

An algorithm that automates mapping.

The technology shifts from a manual, time intensive mapping process to an automated, novel approach, with the first publication11 describing a comprehensive electroanatomical mapping system where hardware and software were designed together. The RHYTHMIA™ Mapping System was developed from the ground up as a high-definition system incorporating a high-resolution 64-electode catheter, 3D ultra-high-density mapping capabilities and an algorithm that automates the signal capture and mapping processes.11

2012

2004-2012Pioneering engineers design a series of firsts in the field:

2013The RHYTHMIA Mapping System becomes the first high-definition mapping system with regulatory clearance in Europe and the United States. Unlike conventional cardiac mapping systems, the RHYTHMIA Mapping System rapidly and automatically generates 3D maps of any chamber of the heart to help locate and treat the source of rhythm abnormality13,14 – allowing electrophysiologists to see the heart like never before.

More than 70 data publications support and reinforce the clinical utility of the RHYTHMIA Mapping System hardware, catheter and software to comprehensively and accurately map even the most complex arrhythmias.12

Activation map courtesy of Dr. Elad Anter, Beth Israel Deaconess Medical Center.

faster mapping capability

Studies have shown:

annotation accuracy the data points5X15,16 25X17 99.98%18

New advancements in electroanatomical mapping technology have enabled electrophysiologists (EPs)to see rhythm abnormalities like never before.

™

2012-present

References

Indications, Safety and Warnings

1 The ECG Library website. http://www.ecglibrary.com/ecghist.html. Updated May 11, 2009. Accessed February 7, 2017.2 Abrams HL. History of cardiac radiology. AJR. 1996;167:431-438. http://www.ajronline.org/doi/pdfplus/10.2214/ajr.167.2.8686621. 3 Hijazi ZM, Shivkumar K, Sahn DJ. Intracardiac electrocardiography (ICE) during interventional & electrophysiological cardiac catheterization. Circulation. 2009;119(4):587-596. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2761099/.4 Maleki, M, Esmaeilzadeh, M. The Evolutionary Development of Echocardiography. Iranian Journal of Medical Sciences. 2012: 37(4): 22-232. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3565194/#B24. 5 Joseph JP, Rajappan K. Radiofrequency ablation of cardiac arrhythmias: past, present and future. QJM. 2012:105:303-314. https://academic.oup.com/qjmed/article-lookup/doi/10.1093/qjmed/hcr189. 6 University of California San Francisco Cardiology website. History of AF ablation. https://cardiology.ucsf.edu/care/clinical/electro/ablation_hist.html. Accessed February 7, 2017.7 Bhakta D, Miller JM. Principles of electroanatomic mapping. Indian Pacing Electrophysiol J. 2008 Jan-Mar; 8(1): 32–50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2231602/. 8 Gepstein L, Evans SJ. Electroanatomical mapping of the heart: basic concepts and implications for the treatment of cardiac arrhythmias. Pacing Clin Electrophysiol. 1998;21(6):1268-1278. http://onlinelibrary.wiley.com/doi/10.1111/j.1540-8159.1998.tb00187.x/abstract. 9 Wittkampf FHM, Wever EFD, Derksen R, et al. LocaLisa-New Technique for Real-Time 3-Dimensional Localization of Regular Intracardiac Electrodes. Circulation. 1999;99:1312-1317. http://circ.ahajournals.org/content/99/10/1312. 10 Endocardial Solutions, Inc. Endocardial Solutions Announces FDA Approval of EnSite NavX(TM) [press release]. Published April 22, 2003. http://www.prnewswire.com/news-releases/endocardial-solutions-announces-fda-approval-of-ensite-navxtm-70899022.html. Accessed April 10, 2017. 11 Nakagawa, H., et al., Rapid high resolution electroanatomical mapping: evaluation of a new system in a canine atrial linear lesion model. Circ Arrhythm Electrophysiol, 2012. 5(2): p. 417-24.12 Data on file. RHYTHMIA Bibliography. EP-429509-AB. 13 Boston Scientific. Boston Scientific Receives CE Mark Approval For The Rhythmia™ Mapping System: Company Offers Mapping System with IntellaMap Orion™ Mapping Catheter in Effort to Significantly Enhance Physician Treatment Options [press release]. Published May 10, 2013. http://news.bostonscientific.com/2013-05-10-Boston-Scientific-Receives-CE-Mark-Approval-For-The-Rhythmia-Mapping-System. Accessed February 7, 2017.14 Boston Scientific. Boston Scientific Receives FDA 510(k) Clearance for the Rhythmia™ Mapping System [press release]. Published July 24, 2013. http://news.bostonscientific.com/2013-07-24-Boston-Scientific-Receives-FDA-510-k-Clearance-for-the-Rhythmia-Mapping-System. Accessed February 7, 2017.15 Based on approximate mapping speed of 95 pts / minute in the right atrium in 5 swine USING THE ST. JUDE PRECISION ENSITE MAPPING SYSTEM. Ptaszek LM, et al. “Rapid High-Density Automated Electroanatomical Mapping Using Multiple Catheter Types.” Poster Session PO097 APHRS 2015. 16 Based on approximate mapping speed of 491 pts / minute in the right atrium in 5 swine USING THE BOSTON SCIENTIFIC RHYTHMIA MAPPING & NAVIGATION SYSTEM. Ptaszek LM, et al. “Rapid Acquisition of High-Resolution Electroanatomical Maps Using a Novel Multielectrode Mapping System.” JICE. Nov 2012.17 Ptaszek L, Chalhoub F, Perna F, Beinart R, Barrett C, Danik S, Heist EK, Ruskin J, Mansour M, Rapid Acquisition of High-Resolution Electroanatomical Mapping Using a Novel Multi-Electrode Mapping System. J Interv Card Electrophysiol. 2012 Nov 22.18 Mantziari L, Butcher C, Kontogeorgis A, Panikker S, Roy K, Markides V, Wong T. Utility of a Novel Rapid High-Resolution Mapping System in the Catheter Ablation of Arrhythmias: An Initial Human Experience of Mapping the Atria and the Left Ventricle. JACC Clin Electrophysiol. 2015;1 (5): 411–20. http://dx.doi.org/10.1016/j.jacep.2015.06.002.19 Boston Scientific. Boston Scientific Announces U.S. FDA Approval of Navigation-Enabled Ablation Catheters: New catheters and software enhancement expand capabilities of high-definition Rhythmia™ Mapping System [press release]. Published May 3, 2016. http://news.bostonscientific.com/2016-05-03-Boston-Scientific-Announces-U-S-FDA-Approval-of-Navigation-Enabled-Ablation-Catheters. Accessed February 7, 2017.

Activation map courtesy of Dr. Frederic Sacher, CHU Bordeaux.

For RHYTHMIA HDx™, RHYTHMIA™ Mapping System, and INTELLAMAP ORION Mapping Catheter Indications, Safety and Warnings click hereFor INTELLANAV™ OPEN-IRRIGATED Ablation Catheter Indications, Safety and Warnings click hereFor INTELLANAV™ XP Ablation Catheter and INTELLANAV MIFI™ XP Ablation Catheter Indications, Safety and Warnings click here

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Image courtesy of theIranian Journal of Medical Sciences.