Témoignages & Publis

Pr. Franco Orsi – IEO, Institut Européen d’Oncologie, Milan, Italie

“Notre challenge au quotidien est de « naviguer dans le corps », afin de réaliser des biopsies percutanées, des ablations complexes et des interventions osseuses. CT-Navigation™ nous apporte une plus grande sécurité, et de l’efficacité, dans des temps réduits, en permettant le ciblage de lésions multiples, dans des espaces réduits et des anatomies complexes. Que ce soit un utilisateur chevronné, ou lors de formations cliniques initiales, la rapidité et la facilité d’utilisation en font notre navigateur de choix, en particulier pour les trajectoires hors-plan.”

Dr. Christian Sengel – CHU Grenoble, France

“Personnellement j’utilise depuis plus de 5 ans l’aide à la navigation Imactis CT-Navigation™. Je suis radiologue interventionnel avec pour spécialité les gestes de prise en charge des cancers abdomino-pelviens. L’intérêt principal réside dans les gestes percutanés de thermoablations (radiofréquence, microondes et cryoablation) pour des nodules à la fois profonds et mobiles, par exemple du segment VII hépatique. Cet appareil apporte une aide considérable permettant d’être plus précis d’emblée du premier coup ou presque. C’est-à-dire de pouvoir réduire le nombre d’acquisitions scanner, de ne pas utiliser de fluoroscanner, d’avoir moins de complications sur le trajet et d’être plus précis sur le traitement (donc d’avoir moins de récidives). Car même si cette technologie théoriquement ne tient pas compte de la respiration l’opérateur peut voir l’image d’intérêt et le volume acquis se déplacer et ainsi extrapoler plus facilement la direction exacte vers la cible.”

Pr. Ivan Bricault – CHU Grenoble, France

“CT-Navigation™ apporte une aide précieuse en faisant gagner en précision et en permettant de réduire le nombre de contrôles scanner. Il est ainsi devenu difficile d’envisager la réalisation de certains gestes complexes (en double obliquité par exemple) sans bénéficier de la sécurité et du confort procurés par CT-Navigation™. Sa simplicité d’utilisation a également permis d’initier à la radiologie interventionnelle sous scanner des radiologues peu expérimentés qui auraient été réticents à pratiquer des gestes sans l’assistance de la navigation.”

Clinical study CT-NAV II

Clinical study CT-NAV II is a multicentric, comparative, prospective and randomized clinical study. It took place in 9 French publics hospitals, more than 450 patients were enrolled.
The aim of this trial is to evaluate the clinical benefit of the navigation system by comparing the results obtained in the navigation-assisted group with those obtained in the conventional group during CT-guided procedures.
Three criterias are used:

• Safety: The number of AEs that are considered to be major.
• Efficacy: The number of targets reached
• Performance: The number of control scans acquired during the needle insertion.

Publication of study protocol
Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. RC. Rouchy, A. Moreau-Gaudry, E. Chipon, S. Aubry, L. Pazart, B. Lapuyade, M. Durand, M. Hajjam, S. Pottier, B. Renard, R. Logier, X. Orry, A. Cherifi, E. Quehen, G. Kervio, O. Favelle, F. Patat, E. De Kerviler, C. Hughes, M. Medici, J. Ghelfi, A. Mounier and I. Bricault.

Trials, July, 6, 2017.

CT guidance assisted by electromagnetic navigation system for percutaneous fixation by internal cemented screws (FICS)

Objective
To evaluate electromagnetic navigation system (ENS) for percutaneous fixation by internal cemented screw (FICS) under CT guidance.

Outcomes
Mean duration of FICS procedures was 111 ± 51 min. Mean post-procedure hospitalization length was 2.1 days. Technical success was achieved in 48 cases (96%) with a total of 76 screws inserted. Mean distance p, mean distance d, and mean angle θ were respectively 8.0 ± 4.5 mm, 7.5 ± 4.4 mm, and 5.4 ± 2°. Angle θ accuracy was higher for screws with a craniocaudal angulation of less than 20° (4.4° vs 6.4°, p = 0.02). The mean number of CT acquisitions during procedures was 6.4 ± 3.0. The mean dose length product was 1524 ± 953 mGy cm and the mean dose area product was 12 ± 8 Gy cm2. Five complications occurred in 4 patients.

Key Points

• ENS-assisted CT enables screw insertion in the pelvic ring and femoral neck, with a wide range of trajectories, even when a significant craniocaudal angulation is required.
• ENS-assisted CT can be used as an alternative to CBCT guidance for percutaneous fixation by internal cemented screw.
• ENS-assisted CT provides high technical success rate with excellent placement accuracy.

Publication 
CT guidance assisted by electromagnetic navigation system for percutaneous fixation by internal cemented screws (FICS). B. Moulin, L. Tselikas, T. De Baere, F. Varin, A. Abed, L. Debays, C. Bardoulat, A. Hakime, C. Teriitehau, F. Deschamps

European Radiology, September 2, 2019

Use of an Electromagnetic Navigation System on a Phantom as a Training Simulator for CT-Guided Procedures

Description of the problem
CT-guided procedures are an essential part of the clinical work at many hospitals across the United States and throughout the world. CT guidance is used for biopsies, abscess drainages, and ablations. Currently, radiology residents and fellows acquire their CT procedural skills on real patients. Both diagnostic and interventional radiologists perform some of these procedures, and therefore the experience and skill set in performing these procedures can vary widely.

Although CT-guided procedures have been used to successfully diagnose and treat a wide range of pathologies, it is at the expense of increased radiation exposure to both operators and patients. Limiting radiation exposure in interventional radiology has been an important discussion point, and societies such as the Cardiovascular and Interventional Radiological Society of Europe and the Society of Interventional Radiology have provided strong recommendations in an effort to reduce excessive radiation exposure.

Over the past several years, multiple new navigational tools have entered the market, helping guide fully trained interventional radiologists during CT-guided procedures. Using fiducials and optical or electromagnetic tracking, these tools create a “global positioning system” of the internal organs and can allow the needle to be tracked in real time. These navigational tools also allow a simulated CT experience, enabling a phantom to be imaged on a CT scanner and a biopsy procedure simulated at a location and time separate from the planning CT scan, without the need for additional radiation to the patient and operator.

Although navigational systems may offer an alternative for training and performing CT-guided procedures in the future for both interventional and noninterventional radiologists, little is known about the difficulty and the amount of procedural experience needed to successfully use these navigational systems.

The purpose of this study was to compare the diagnostic and interventional radiologist trainee’s CT-guided procedural skills using an electromagnetic navigational guidance system (EMN, Imactis, La Tronche, France) that mimics a CT-guided biopsy and determine whether prior experience predicts technical success using these systems.

Methods
This prospective study was reviewed and exempted by the institutional review board. A total of 19 fellows (12 interventional fellows and 7 diagnostic fellows) participated in the study. The study was performed 3 months into the fellows’ training (September 2014).

The study consisted of a skills test that simulated a CT-guided procedure. The simulation consisted of two parts: One part allowed targeting of three progressively difficult lesions on a phantom using standard manual/conventional skills. A second part tested targeting of the same lesions using an EMN.

Publication of study protocol
Use of an Electromagnetic Navigation System on a Phantom as a Training Simulator for CT-Guided Procedures, Yadiel Sánchez, BA, Dmitry S. Trifanov, MD, Taj M. Kattapuram, MD, Haiyang Tao, MD, PhD, Anand M. Prabhakar, MD, MBA, Ronald S. Arellano, MD, Raul N. Uppot, MD

Published on JACR (Journal of the American College of Radiology), June 2017, Volume 14, Issue 6, Pages 795–799

Evaluation of a Computed Assisted Medical Intervention (CAMI) in scientific autopsy

This study is the first step of an ambitious project to use pre-operative post-mortem computed tomography (CT) imaging and a Computer Assisted Medical intervention (CAMI) device for guidance of targeted biopsy in an effort to demonstrate the continuing scientific value of the autopsy in clinical practice and therefore increase the number of autopsies carried out.

The main objectives are :

• Build the first step of the vision associating Computed Assisted Medical Interventions and forensic science.
• Show the possibility to perform mini-invasive autopsy in the autopsy room without a CT-scan in it with a radiology interventional tool.
• Show the limitations and the advantages of the device in this use.
• Show the difficulties linked to the state of the corpse.
• Draw conclusions on the possibilities to improve this protocol, including a per-operative tool, and continue research in this way.

Publication of study protocol
Evaluation of a Computed Assisted Medical Intervention (CAMI) systems in scientific autopsy, Grenier F., Voros S., Scolan V., Paysant F., Boutonnat J., Bricault I., Moreau-Gaudry A.

Journal of Forensic Radiology and Imaging, Volume 11, December 2017, Pages 6-11

Traitement d’une tumeur rénale et préservation néphronique impérative : étude comparative des données périopératoires et des résultats à moyen terme de la néphrectomie partielle et de la radiofréquence

Objectif
Comparer la morbidité, les suites carcinologiques et la fonction rénale à moyen terme de la néphrectomie partielle (NP) et de la radiofréquence percutanée (RFA) dans les indications de traitement d’une tumeur rénale avec préservation néphronique impérative.

Résultats
Trente-six NP et 14 RFA ont été réalisées. Dans le groupe RFA, les patients étaient plus âgés (79,2 vs 62,5 ans), avaient un score ASA supérieur (3 vs 2), un score RENAL inférieur (6 vs 7,5) et moins de tumeurs sur rein unique ou bilatérales (p = 0,009). Les patients traités par NP ont eu plus de complications totales (29,4 % vs 6,3 %), de transfusion (20,6 % vs 0) et une durée d’hospitalisation plus longue (9 vs 3 jours). Sur un suivi médian de 22 mois (4,3–53,7), la perte de fonction rénale n’a pas été différente (p = 0,34). En analyse multivariée, le traitement a été un facteur prédictif indépendant des complications en défaveur de la NP (OR = 14,09, p = 0,02) mais pas de perte de fonction rénale. Aucun patient n’a récidivé.

Conclusion
Chez les patients avec une indication de traitement d’une tumeur rénale et préservation néphronique impérative, la RFA a semblé moins morbide à court terme avec des résultats fonctionnels identiques. Le suivi carcinologique insuffisant n’a pas permis de statuer sur les résultats à long terme.

Publication
Traitement d’une tumeur rénale et préservation néphronique impérative : étude comparative des données périopératoires et des résultats à moyen terme de la néphrectomie partielle et de la radiofréquence, V.Arnoux, J.-L. Descotes, C. Sengel, N. Terrier, J.-J.Rambeaud, J.-A. Long.

Published on Elsevier, « Progrès en Urologie », Volume 23, Issue 2, February 2013, Pages 99-104

Percutaneous osteosynthesis and cementoplasty for stabilization of malignant pathologic fractures of the proximal femur.

Purpose

To retrospectively evaluate the outcome of patients who underwent radiological percutaneous osteosynthesis and cementoplasty (RPOC) for stabilization of malignant pathological fracture of the proximal femur.

Materials and methods

The clinical files of 12 patients who underwent RPOC for stabilization of malignant pathological fracture of the proximal femur were reviewed. There were 9 men and 3 women with a mean age of 56 years ± 13 (SD) (range: 35–82 years). All patients had metastases of proximal femur and a high fracture risk (Mirels score ≥ 8) and were not eligible for surgical stabilization. The primary endpoint was the occurrence of a fracture after RPOC. Secondary endpoints were the procedure time, early complications of RPOC, pain reduction as assessed using a visual analog scale (VAS) and duration of hospital stay.

Results

No patients treated with RPOC had a fracture during a mean follow-up time of 382 days ± 274 (SD) (range: 11–815 days). RPOC was performed under general (n = 10) or locoregional (n = 2) anesthesia. The average duration of the procedure was 95 min ± 17 (SD) (range: 73–121 min). The technical success rate was 100%. All patients were able to walk on the day following RPOC. The average duration of hospital stay was 4 days ± 3 (SD) (range: 2–10 days). No major complication occurred. One patient complained of hypoesthesia in the lateral thigh. For symptomatic patients (n = 7), VAS score decreased from 6.8 ± 1.2 (SD) (range: 5–9) before treatment, to 2.3 ± 1.1 (SD) (range: 1–4) one month later.

IMACTIS Ct-Navigation™ was used for needle positionning.

Conclusion

Preventive RPOC for pathological fracture of the proximal femur is a reliable alternative for cancer patients who are not candidates for surgical stabilization. Studies involving more patients are needed to confirm our preliminary experience.

Publication

Percutaneous osteosynthesis and cementoplasty for stabilization of malignant pathologic fractures of the proximal femur, E. Mavrovi, J.-B. Pialat, H. Beji, A.-C.Kalenderian, G. Vaz, B. Richioud

Published on Elsevier, Diagnostic and Interventional Imaging, Volume 98, Issue 6, June 2017, Pages 483-489

Clinical study CT-NAV I – Increased accuracy and fewer controls

IMACTIS CT-Navigation™ was successfully validated during a comparative, prospective, randomized clinical study on 120 patients at the Grenoble University Hospital on various procedures (drainage, biopsy, tumor ablation, infiltration, sympathicolysis).

The clinical study shows, that when compared to conventional procedures, the use of IMACTIS leads to:

• Increased accuracy (gain in distance and angle accuracy higher than 50%)
• Fewer controls are necessary to reach the target.

Publication

Computer assisted electromagnetic navigation improves accuracy in computed tomography guided interventions: A prospective randomized clinical trial. P. Durand, A. Moreau-Gaudry, A. Silvent, J. Frandon, E. Chipon, M. Medici, I. Bricault.

PLoS One, March, 15, 2017.