IMPROVED CONTACT FORCE AND FLEXIBILITY IN A THIRD GENERATION IRRIGATED REMOTE MAGNETIC NAVIGATION ABLATION CATHETER
K.J. Gutleben, G. Nölker, S. Molatta, B. Körber, D. Horstkotte
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany
Introduction: Remote magnetic navigation (RMN) has been adopted by many centers. However, RMN catheters remained unchanged after initial improvements.
Methods: Thirteen prototypes with various magnetic volumes, magnet positions and shafts equipped with an irrigatable gold-tip were compared to two commercially available systems. For contact-force (CF) testing they were inserted in a standard sheath, which was centered within a highly sensitive CF sensing instrument in a magnetic lab and maneuvered in parallel and perpendicular orientation by a motor-drive and a magnetic field of 0.1 Tesla. Three measurements were averaged for each position (figure 1A). Flexibility was tested by advancing all catheters out of the sheath to a defined distance, arranging the magnetic field in a 180° orientation and measuring the distance between sheath and electrode tip (figure 1B).
Results: The data for the prototype most advantageous to two commercial versions are detailed in table 1.
Conclusions: CF and flexibility could be improved compared to commercially available RMN catheters. These findings led to the design of a RMN catheter also integrating most recent irrigation technology. Clinical advantages have to be evaluated.
Figure 2. Figure 1:
Title: CF measuring system placed in RMN environment (A). Set-up for measurement of flexibility (B).
Baseline characteristics of the study groups (n=182).
|
|
Commercial product 1
|
Commercial product 2
|
Prototype
|
|
Distal magnet
(in mm³)
|
19.2
|
15.3
|
29.2
|
|
Total magnetic volume
(in mm³)
|
48.7
|
45.9
|
59.8
|
|
Contact Force average
perpendicular (in g)
|
10.9
(± 0.2)
|
10.9
(± 0.1)
|
14.6
(± 0.4)
|
|
Contact Force average parallel
(in g)
|
4.4
(± 0.1)
|
6.6
(± 0.1)
|
5.6
(± 0.00)
|
|
Tip distance to shaft at 180° opposite field orientation
(in mm)
|
41
|
47
|
40
|
