Evaluation of an electromagnetic 3D navigation system to facilitate endovascular tasks: a feasibility study.
BACKGROUND
We describe a novel approach to arterial cannulation using the StealthStation(®) Guidance System (Medtronic, USA). This uses electromagnetic technology to track the guidewire, displaying a 3D image of the vessel and guidewire.


METHODS
The study was performed on a 'bench top' simulation model called the Cannulation Suite comprising of a silicone aortic arch model and simulated fluoroscopy. The accuracy of the StealthStation(®) was assessed. 16 participants of varying experience in performing endovascular procedures (novices: 6 participants, ≤5 procedures performed; intermediate: 5 participants, 6-50 procedures performed; experts: 5 participants, >50 procedures performed) underwent a standardised training session in cannulating the left subclavian artery on the model with the conventional method (i.e. with fluoroscopy) and with the StealthStation(®). Each participant was then assessed on cannulating the left subclavian artery using the conventional method and with the StealthStation(®). Performance was video-recorded. The subjects then completed a structured questionnaire assessing the StealthStation(®).


RESULTS
The StealthStation(®) was accurate to less than 1 mm [mean (SD) target registration error 0.56 mm (0.91)]. Every participant was able to complete the cannulation task with a significantly lower use of fluoroscopy with the navigation system compared with the conventional method [median 0 s (IQR 0-2) vs median 14 s (IQR 10-19), respectively; p = <0.001]. There was no significant difference between the StealthStation(®) and conventional method for: total procedure time [median 17 s (IQR 9-53) vs median 21 s (IQR 11-32), respectively; p=0.53]; total guidewire hits to the vessel wall [median 0 (IQR 0-1) vs median 0 (IQR 0-1), respectively; p=0.86]; catheter hits to the vessel wall [median 0.5 (IQR 0-2) vs median 0.5 (IQR 0-1), respectively; p=0.13]; and cannulation performance on the global rating scale [median score, 39/40 (IQR 28-39) vs 38/40 (IQR 33-40), respectively; p=0.40]. The intra-class correlation coefficient for agreement between video-assessors for all scores was 0.99. 88% strongly agreed that the StealthStation(®) can potentially decrease exposure of the patient to contrast and radiation.


CONCLUSIONS
Arterial cannulation is feasible with the StealthStation(®).
Sidhu
R
R
The Department of Surgery & Cancer, Imperial College London, United Kingdom. sidhu49@googlemail.com
Weir-McCall
J
J
Cochennec
F
F
Riga
C
C
DiMarco
A
A
Bicknell
C D
CD
D001013:Aorta, Thoracic / Q000000981:diagnostic imaging; D002404:Catheterization / Q000295:instrumentation*; D002983:Clinical Competence; D055590:Electromagnetic Phenomena; D057510:Endovascular Procedures / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005471:Fluoroscopy; D006801:Humans; D021621:Imaging, Three-Dimensional / Q000295:instrumentation*; D008131:London; D008953:Models, Anatomic; D015641:Radiography, Interventional; D012828:Silicones; D013348:Subclavian Artery / Q000000981:diagnostic imaging; D025321:Surgery, Computer-Assisted / Q000295:instrumentation*; D011795:Surveys and Questionnaires; D013647:Task Performance and Analysis; D013997:Time Factors; D014741:Video Recording
D012828:Silicones