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Clinical Evidence for the Stereotaxis Niobe® Magnetic Navigation
System: Advantages of Electrophysiology (EP) Ablation
1. Introduction
Approximately 180 leading global hospitals have adopted the Niobe® Magnetic
Navigation System (MNS) for EP ablation. The current Niobe MNS is a 4th Generation
system, an evolution from earlier Stereotaxis clinical systems. To date, over 80,000 EP
procedures have been performed with magnetic navigation. Of the estimated 280 total
peer-reviewed scientific publications highlighting remote magnetic navigation
technology listed in Stereotaxis’ PRO-240, more than 85% of the publications discuss its
use in cardiac EP procedures and are featured in peer-reviewed journals such as the
Journal of Cardiovascular Electrophysiology, PACE, Europace, the Journal of American
College of Cardiology, and the Journal of Interventional Cardiac Electrophysiology.
This body of clinical research, resulting journal publications and physician advocacy has
led to greater market access, regulatory and reimbursement support, and provider
adoption.
This peer-reviewed published research with Stereotaxis’ innovative technologies and
published papers have established overwhelming evidence supporting magnetic
navigation’s clinical benefits, including:
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Improving long-term patient clinical outcomes (complex left atrial [CLA]
arrhythmia, ventricular tachycardia [VT], and congenital heart disease treatment)
Continued improvements in procedural efficiency through reduced treatment
times and improved patient work flow when compared to older Niobe systems
Excellent patient safety due to the flexible catheter shaft
Low X-ray fluoroscopic radiation for physicians, laboratory staff and patients
(especially for the vulnerable pediatric population)
The following is a review of the literature up to December 2016 and includes a series of
recent publications and presented abstracts that support these advantages.
2. Clinical Evidence Summary
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Improved CLA Outcomes and Efficiency
Magnetic navigation has been widely used for CLA arrhythmia ablation with strong
reported clinical outcomes (acute and chronic), significantly less radiation exposure and
improved safety profiles in comparison to previously published manual ablation
procedures. Magnetic stable focal contact of the catheter and the subsequent lesion
formation may be the underlying reason for reported improving trends for those clinical
advantages.
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This hypothesis was tested using a myocardial phantom model. Bhaskaran et al.
demonstrated that the use of magnetic navigation of the catheter provided greater catheter
stability than manual navigation, resulting in deeper lesions.(1) Stable focal contact and
deeper lesion formation may be contributing factors to the observed trends in higher
success rates for ablation procedures using Remote Magnetic Navigation (RMN).
A recent clinical study conducted by the Princess Grace Hospital of Monaco
demonstrated positive findings in the remote magnetic navigation platform's success in
treating CLA cases.(2) This study of 90 consecutive patients compared the acute success
and recurrence rates in two patients groups that were given the choice to be either
administered general anesthesia or local anesthesia. All patients underwent the
Stereotaxis magnetic navigation ablation procedure for symptomatic paroxysmal/
persistent CLA arrhythmias.
Both groups experienced 100% acute success rates. After 12 months of
follow-up, and inclusion of repeat procedures, the general anesthesia group was 86.6%
free from any arrhythmias without using antiarrhythmic drugs, compared to 88.8% for the
local anesthesia group.
Jin et al. analyzed data from over 1000 CLA procedures from Rigshospitalet,
Copenhagen University Hospital.(3) The objectives were to evaluate peri-procedural
complications, assess procedural outcomes and compare procedural outcomes between
patients undergoing first and repeat ablation procedures. Total complication rates for the
1006 procedures were 0.6%. Fluoroscopy time for the 726 patients was 5.4 ± 3.7 min
with total procedure times lasting 134 ± 35 mins. Overall repeat procedures for these 726
patients were 33% with the time since initial ablation being 17.5 ± 9.8 months.
Adapted data from Jin et al. 2016
Most recently, Da Costa et al. compared procedural efficiency times of the Niobe II and
the Niobe ES systems.(4) They analyzed procedural parameters of 92 consecutive
patients in each group. This study demonstrated that the 4th generation system, Niobe ES,
significantly reduced total procedure time by 30% and fluoroscopy time by 30% when
compared to the older Niobe II system, which further supports continued improvements
in efficiency and work flow.
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Adapted data from Da Costa et al. 2016
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Improved VT Ablation Outcomes
Magnetic navigation provides significant advantages in VT ablation due to its catheter
tip’s unique omni-directional flexibility. This flexibility along with magnetic stable focal
contact are key reasons that magnetic navigation has been repeatedly shown to be more
effective than manual pull-wire catheter technologies. This gives remote magnetic
navigation a distinct advantage in VT ablation, since the catheter often needs to create
deep lesions in challenging anatomical areas within diseased ventricular chambers. Many
Stereotaxis magnetic navigation users believe that they can achieve much better results in
VT ablation using magnetic navigation across all clinical endpoints (including acute
success, long-term outcome, procedure time, safety, and X-ray fluoroscopic time) as
described with the following reported studies:
Szili-Torok et al. studied 72 patients who underwent MNS guidance for VT ablation vs.
41 patients with manual (MAN) VT ablation.(5) The authors reported significant
benefits using MNS in VT ablation (acute success, procedure time, X-ray fluoroscopy
time, safety, and 20-month chronic success):
Adapted data from Szili-Torok et al. 2016
Bauernfeind et al. also reported significantly improved acute VT success rate and
fluoroscopy times when using MNS:(6)
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Adapted data from Bauernfeind et al. 2011
Di Biase et al. presented a poster at 2015 American Heart Association Scientific Sessions
also reporting that RMN has significantly better long-term success rates than manual
navigation when ablating ventricular arrhythmias, particularly those caused by large
ventricular scar (scar size greater than 60 cm2):(7)
Adapted data from Di Biase et al. 2015
Hendriks et al. from the Erasmus Medical Center in the Netherlands recently released the
results of a study comparing the success of VT ablation procedures using manual,
magnetic, and contact force (CF) catheters.(8) Only 1.2% of RMN patients experienced
major complications during the ablation procedure, compared with 2.7% of MAN
patients and 10.0% of CF patients. After a median follow-up period of 25 months, the
Kaplan-Meier analysis showed that the RMN group had the lowest rate of VT recurrence
at 42%, compared to 59% for the MAN group and 57% for the CF group.
Adapted and Original data from Hendriks et al. 2015
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Lastly, Skoda et al. evaluated MNS mapping and ablation of post infarction VT in a
multicenter, prospective single-arm study (STOP-VT Trial). They reported no procedural
complications and very favorable acute and 12 month follow-up success rates: (9)
Adapted data from Skoda et al 2016
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Improved EP Ablation for Pediatric Patients
Pediatric patients are highly vulnerable to harmful X-ray radiation exposure, as physician
scientists believe that children exposed to X-ray radiation have a 4 fold increase in
developing cancer at a later stage in these children’s lives.(10) Magnetic navigation has
improved upon manual catheter results by achieving the same treatment outcome while
reducing X-ray radiation exposure.
Kim et al. studied the use of magnetic navigation (MN) in ablation of children (n=73 using
RMN technology, and n=72 using MAN procedure), and reported that magnetic
navigation can deliver the same treatment outcome while reducing the X-ray radiation
time by 50%.(11)
Schwagten et al. studied 58 pediatric patients that were less than 10 yrs in age (n=29 for
ablation with RMN, and n=29 for MAN ablation). The authors concluded their data
strongly suggest that using the MNS for treating young children is advantageous, because
it significantly reduced the procedure and fluoroscopy times without compromising
efficacy(12)
Most recently, PACES/HRS published an Expert Consensus Statement on the Use of
Catheter Ablation in Children and Patients with Congenital Heart Disease giving a Class
IIb recommendation for using RMN as a procedural consideration when navigating
through complex anatomies and retrograde approaches and reducing fluoroscopy times.
They stated that a remote magnetic navigation system might be reasonable for catheter
ablation of tachyarrhythmias in complex CHD with difficult intracardiac anatomy or
vascular access. (13)
• Improved EP Ablation for Patients with Congenital Heart Diseases (CHD)
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CHD patients are among the most challenging group for manual EP treatment, due to
abnormal anatomy in these patients’ heart chambers. Magnetic navigation presents
unique advantages in EP treatment for CHD patients, as it helps surmount three major
challenges: limited access to the target chamber, extensive atrial enlargement, and/or
extensive wall thickness.
Ueda et al. published the largest CHD-related study to date using magnetic navigation in
ablation treatment of SVT in CHD patients (n=116).(14) There were three groups of
patients, with varying degree of pathologies for each group (progressively more
challenging pathologies for RMN). Fluoroscopy times were lower in the 2 RMN groups
(median ranges 4-6 minutes) versus 8 minutes in the manual procedure group. The less
complex cases performed with manual ablation demonstrated an approximate 90% acute
success and in the more complex set of patients treated with RMN, acute success was over
80% in both RMN groups. The authors reported increasing trends in 20-month success
rate (long-term) for RMN (82%) vs. manual ablation (80%). This is an important finding
given the more difficult cases targeted with RMN.
Schwagten et al. studied 12 CHD patients who underwent ablation for supraventricular
tachycardia (& congenital heart disease) with magnetic navigation.(15) The authors
reported favorable results for magnetic navigation procedure time, fluoroscopy time and
complication rates. They concluded that using RMN for congenital heart disease is safe
and effective.
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Improved Patient Safety and Reduced X-Ray Fluoroscopic Radiation
The flexible ablation catheters designed for Stereotaxis’ remote magnetic navigation
systems offers a much safer ablation procedure. The magnetic field that guides these
catheters with a level of precision has led to few complications as well as significantly
reduced X-ray radiation exposure for both physicians and patients as supported by
Bauernfeind et al. (6)
In summary, as the Niobe ES system continues to be enhanced and users become more
proficient, complication rates, average procedure times, and average fluoroscopy times will
continue to improve.(16) These improvements will potentially reduce occupational risks
associated with the manual ablation procedure. RMN exposes physicians and laboratory staff to
less radiation and relieves them of the orthopedic burden of wearing lead aprons. Much more of
the direct clinical proof demonstrating magnetic navigation’s clinical benefits will come from
future perspective, multi-center, randomized controlled clinical studies.
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Bibliography
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Bhaskaran A, Barry MA, Al Raisi SI, Chik W, Nguyen DT, Pouliopoulos J, et al.
Magnetic guidance versus manual control: comparison of radiofrequency lesion
dimensions and evaluation of the effect of heart wall motion in a myocardial phantom. J
Interv Card Electrophysiol. 2015;44(1):1-8.
Bun SS, Latcu DG, Allouche E, Errahmouni A, and Saoudi N. General anesthesia is not
superior to local anesthesia for remote magnetic ablation of atrial fibrillation. Pacing Clin
Electrophysiol. 2015;38(3):391-7.
Jin QI, Pehrson S, Jacobsen PK, and Chen XU. Efficacy and Safety of Atrial Fibrillation
Ablation Using Remote Magnetic Navigation: Experience from 1,006 Procedures. J
Cardiovasc Electrophysiol. 2016;27 Suppl 1:S23-8.
Da Costa A, Guichard JB, Maillard N, Romeyer-Bouchard C, Gerbay A, and Isaaz K.
Substantial superiority of Niobe ES over Niobe II system in remote-controlled magnetic
pulmonary vein isolation. Int J Cardiol. 2016.
Szili-Torok T, Schwagten B, Akca F, Bauernfeind T, Abkenari LD, Haitsma D, et al.
Catheter ablation of ventricular tachycardias using remote magnetic navigation: a
consecutive case-control study. J Cardiovasc Electrophysiol. 2012;23(9):948-54.
Bauernfeind T, Akca F, Schwagten B, de Groot N, Van Belle Y, Valk S, et al. The
magnetic navigation system allows safety and high efficacy for ablation of arrhythmias.
Europace. 2011;13(7):1015-21.
Di Biase L, Burkhardt J, and Natale A. Scar homogenization ablation in patients with
ischemic cardiomyopathy and large scar; comparison between remote magnetic
navigation and manual ablation. Circulation 2015;132:A14384.
Hendriks AA, Akca F, Dabiri Abkenari L, Khan M, Bhagwandien R, Yap SC, et al.
Safety and Clinical Outcome of Catheter Ablation of Ventricular Arrhythmias Using
Contact Force Sensing: Consecutive Case Series. J Cardiovasc Electrophysiol. 2015.
Skoda J, Arya A, Garcia F, Gerstenfeld E, Marchlinski F, Hindricks G, et al. Catheter
Ablation of Ischemic Ventricular Tachycardia With Remote Magnetic Navigation:
STOP-VT Multicenter Trial. J Cardiovasc Electrophysiol. 2016;27 Suppl 1:S29-37.
Beels L, Bacher K, De Wolf D, Werbrouck J, and Thierens H. gamma-H2AX foci as a
biomarker for patient X-ray exposure in pediatric cardiac catheterization: are we
underestimating radiation risks? Circulation. 2009;120(19):1903-9.
Kim JJ, Macicek SL, Decker JA, Kertesz NJ, Friedman RA, and Cannon BC. Magnetic
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children. Circ Arrhythm Electrophysiol. 2012;5(4):804-8.
Schwagten B, Witsenburg M, De Groot NM, Jordaens L, and Szili-Torok T. Effect of
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catheter ablation. Am J Cardiol. 2010;106(1):69-72.
Philip Saul J, Kanter RJ, Writing C, Abrams D, Asirvatham S, Bar-Cohen Y, et al.
PACES/HRS expert consensus statement on the use of catheter ablation in children and
patients with congenital heart disease: Developed in partnership with the Pediatric and
Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS).
Endorsed by the governing bodies of PACES, HRS, the American Academy of Pediatrics
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(AAP), the American Heart Association (AHA), and the Association for European
Pediatric and Congenital Cardiology (AEPC). Heart Rhythm. 2016;13(6):e251-89.
Ueda A, Suman-Horduna I, Mantziari L, Gujic M, Marchese P, Ho SY, et al.
Contemporary outcomes of supraventricular tachycardia ablation in congenital heart
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Schwagten B, Jordaens L, Witsenburg M, Duplessis F, Thornton A, van Belle Y, et al.
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Da Costa A, Guichard JB, Romeyer-Bouchard C, Gerbay A, and Isaaz K. Robotic
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