The Article of "Experience with the Columbus™ 3D EP Navigation System in the Dominican Republic" Published in Cardiac Rhythm News

Santo Domingo, Dominican Republic – Recently, Cardiac Rhythm News published the article of "Experience with the Columbus™ 3D EP Navigation System in the Dominican Republic," written by electrophysiologists Manuel Ayala Patete, Dulce Garcia, Mikel Liñero, Vanesa Burgos and Carlos Garcia Lithgow from Centro Cardio-Neuro-Oftalmologico y Transplante ("CECANOT") in Santo Domingo, Dominican Republic about their experience using the Columbus™ 3D EP Navigation System ("Columbus™") at their institution. Columbus™ is a product in-house developed by Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP"). According to the article, from August 2014 to August 2016, 222 cases of patients between seven and 90 years-old (55% female) were performed using the Columbus™ System.
In recent years, three dimensional ("3D") mapping for ablation of complex arrhythmias has become routine and necessary in electrophysiology ("EP") laboratories. A standard laboratory for treatment of arrhythmias should include a cardiac 3D mapping system to facilitate complex procedures such as ablation of atrial fibrillation ("AF") and ventricular arrhythmias. However, according to the latest Latin American Report of Arrhythmias (Keegan et al, Europace 2015;17,794–800), only 42% of the arrhythmia laboratories in the Latin American region have a 3D mapping system and only four laboratories have two systems.
Over the past two years, in CECANOT, they have been working at their center in the Dominican Republic with Columbus™. This technology is based on electromagnetic tracking of the irrigated ablation catheter FireMagic™ 3D Irrigated Ablation Catheter ("FireMagic™ 3D") and a single patch placed on the patient's back with an electromagnetic field generator under the operating table. According to the article, Columbus™ has helped to improve the life of local patients suffering from complex arrhythmias—to a large extent—and has allowed physicians to treat complex arrhythmias with satisfactory results. The system is user-friendly and includes a new ECG recording module.
The authors of the article said, in their center, Columbus™ helped to launch their ablation programme thanks to its accessibility and the possibility that a single machine can have a 3D mapping system and an ECG recording module integrated. During this period, they have performed significant cases such as an incessant AVNRT in a 32-week pregnant woman, an ischaemic storm in a 57-year-old male and ablation of an unsustained ventricular tachycardia in a seven-year-old child. "We have also seen the evolution of the Columbus™ System, from having only the ability to make maps point-by-point to the currently developed real-time mapping ("RTM") function. That is a true evolution that allows faster mapping and a more suitable anatomy. "
According to Professor Manuel Ayala Patete, another advantage of Columbus™ is real time display of FireMagic™ 3D catheter curve because multiple magnetic sensors are embedded. The system also allows reviewing of previous catheter curve, catheter position and mapping information of the interesting point when this is selected again. Another benefit they have achieved with Columbus™ is bringing 3D technology to the treatment of arrhythmias such as atrioventricular reciprocal tachycardia ("AVRT"), AVNRT, typical atrial flutter, etc, which were not previously accessible due to high costs. This achievement improves efficiency and reduces fluoroscopy time in these procedures. "In our opinion, the Columbus™ System is ideal when you start a programme of radiofrequency ablation of all arrhythmia substrates or to complement a programme with another 3D mapping system. It is striking that you can make a lot of cases of most arrhythmia substrates at a reasonable cost and in this way 'massify' invasive treatment of arrhythmias. In conclusion, the Columbus™ System has been successfully placed in our laboratory, and has helped us to be comparable to large laboratories in the region in terms of statistics and number of complex cases solved."
According to statistics, from August 2014 to August 2016, 222 cases of patients between seven and 90 years-old (55% female) were performed using Columbus™. The most frequently treated arrhythmia was ventricular arrhythmia without structural heart disease (35%), followed by atrioventricular nodal re-entrant tachycardia (AVNRT) (22%). Fifteen percent of AF patients underwent pulmonary vein isolation. The immediate success rate was 87.5% for ventricular arrhythmia and 98% for AVNRT. Pulmonary vein isolation in AF was achieved during the procedure in 95% of cases. The complication rate in all procedures was 1.1%, most commonly vascular (72% of all complications). Columbus™ has proved to be reliable for treatment of the simplest to the most complex arrhythmias, in various age groups, with comparable results to other 3D mapping systems. The complication rate is also comparable to that described in other records.
Columbus™ is the first domestically developed 3D EP navigation system that features real time electromagnetic device tracking with cardiac motion compensation. It offers vivid 3D simulation of the catheter deflectable segment and accurate geometric reconstruction of intra cardiac chambers. With the help of FireMagic™ Cool 3D Irrigated Ablation Catheter that shows precise location of the catheter curve in the body, Columbus™ provides physicians with a comprehensive solution for the radiofrequency ablation treatment of complex arrhythmias. It also features powerful workstation with integrated ECG recording module, automatic 3D image segmentation of cardiac chambers with one mouse click, and accurate preoperative CT image registration and integration. Meanwhile, the system is all Chinese interface and easy to operate.
Columbus™ was granted CE approval in 2013 and is the only domestically made 3D EP navigation system with the CE certificate. So far it has been exported to Spain, Turkey and Greece and has gained high market recognition. Following the historically renowned navigator Christopher Columbus' footsteps, the system was first exported to Dominican Republic in 2014 and the newly released clinical data showed that it has brought high-end medical service to the arrhythmia patients in the Caribbean nation. MicroPort® EP President Yiyong Sun said: "With scientific design concept and solid clinical evidence, we believe Columbus™ will offer better and easier assistance to domestic and international electrophysiologists as well as provide safe, effective and affordable solutions to global arrhythmia patients."