Comparative ergonomic workflow and user experience analysis of MRI versus fluoroscopy-guided vascular interventions:an iliac angioplasty exemplar case study

Purpose A methodological framework is introduced to assess and compare a conventional fluoroscopy protocol for peripheral angioplasty with a new magnetic resonant imaging (MRI)-guided protocol. Different scenarios were considered during interventions on a perfused arterial phantom with regard to time-based and cognitive task analysis, user experience and ergonomics. Methods Three clinicians with different expertise performed a total of 43 simulated common iliac angioplasties (9 fluoroscopic, 34 MRI-guided) in two blocks of sessions. Six different configurations for MRI guidance were tested in the first block. Four of them were evaluated in the second block and compared to the fluoroscopy protocol. Relevant stages’ durations were collected, and interventions were audio-visually recorded from different perspectives. A cued retrospective protocol analysis (CRPA) was undertaken, including personal interviews. In addition, ergonomic constraints in the MRI suite were evaluated. Results Significant differences were found when comparing the performance between MRI configurations versus fluoroscopy. Two configurations [with times of 8.56 (0.64) and 9.48 (1.13) min] led to reduce procedure time for MRI guidance, comparable to fluoroscopy [8.49 (0.75) min]. The CRPA pointed out the main influential factors for clinical procedure performance. The ergonomic analysis quantified musculoskeletal risks for interventional radiologists when utilising MRI. Several alternatives were suggested to prevent potential low-back injuries. Conclusions This work presents a step towards the implementation of efficient operational protocols for MRI-guided procedures based on an integral and multidisciplinary framework, applicable to the assessment of current vascular protocols. The use of first-user perspective raises the possibility of establishing new forms of clinical training and education

Long-Term Alterations of Cytokines and Growth Factors Expression in Irradiated Tissues and Relation with Histological Severity Scoring

PURPOSE: Beside its efficacy in cancer treatment, radiotherapy induces degeneration of healthy tissues within the irradiated area. The aim of this study was to analyze the variations of proinflammatory (IL-1α, IL-2, IL-6, TNF-α, IFN-γ), profibrotic (TGF-β1), proangiogneic (VEGF) and stem cell mobilizing (GM-CSF) cytokines and growth factors in an animal model of radiation-induced tissue degeneration. MATERIALS AND METHODS: 24 rats were irradiated unilaterally on the hindlimb at a monodose of 30 Gy. Six weeks (n=8), 6 months (n=8) and 1 year (n=8) after irradiation the mediators expression in skin and muscle were analyzed using Western blot and the Bio-Plex® protein array (BPA) technology. Additional histological severity for fibrosis, inflammation, vascularity and cellularity alterations scoring was defined from histology and immnunohistochemistry analyses. RESULTS: A significant increase of histological severity scoring was found in irradiated tissue. Skin tissues were more radio-sensitive than muscle. A high level of TGF-β1 expression was found throughout the study and a significant relation was evidenced between TGF-β1 expression and fibrosis scoring. Irradiated tissue showed a chronic inflammation (IL-2 and TNF-α significantly increased). Moreover a persistent expression of GM-CSF and VEGF was found in all irradiated tissues. The vascular score was related to TGF-β1 expression and the cellular alterations score was significantly related with the level of IL-2, VEGF and GM-CSF. CONCLUSION: The results achieved in the present study underline the complexity and multiplicity of radio-induced alterations of cytokine network. It offers many perspectives of development, for the comprehension of the mechanisms of late injuries or for the histological and molecular evaluation of the mode of action and the efficacy of rehabilitation techniques

Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

Wireless MR tracking of interventional devices using phase-field dithering and projection reconstruction

PURPOSE: Device tracking is crucial for interventional MRI (iMRI) because conventional device materials do not contribute to the MR signal, may cause susceptibility artifacts and are generally invisible if moved out of the scan plane. A robust method for wireless tracking and dynamic guidance of interventional devices equipped with wirelessly connected resonant circuits (wRC) is presented. METHODS: The proposed method uses weak spatially-selective excitation pulses with very low flip angle (0.3°), a Hadamard multiplexed tracking scheme and employs phase-field dithering to obtain the 3D position of a wRC. RF induced heating experiments (ASTM protocol) and balloon angioplasties of the iliac artery were conducted in a perfused vascular phantom and three Thiel soft-embalmed human cadavers. RESULTS: Device tip tracking was interleaved with various user-selectable fast pulse sequences receiving a geometry update from the tracking kernel in less than 30 ms. Integrating phase-field dithering significantly improved our tracking robustness for catheters with small diameters (4–6 French). The volume root mean square distance error was 2.81 mm (standard deviation: 1.31 mm). No significant RF induced heating (<0.6°C) was detected during heating experiments. CONCLUSION: This tip tracking approach provides flexible, fast and robust feedback loop, intuitive iMRI scanner interaction, does not constrain the physician and delivers very low specific absorption rates. Devices with wRC can be exchanged during a procedure without modifications to the iMRI setup or the pulse sequence. A drawback of our current implementation is that position information is available for a single tracking coil only. This was satisfactory for balloon angioplasties of the iliac artery but further studies are required for complex navigation and catheter shapes before animal trials and clinical application

Preclinical feasibility of a technology framework for MRI-guided iliac angioplasty

PURPOSE: Interventional MRI has significant potential for image guidance of iliac angioplasty and related vascular procedures. A technology framework with in-room image display, control, communication and MRI-guided intervention techniques was designed and tested for its potential to provide safe, fast and efficient MRI-guided angioplasty of the iliac arteries. METHODS: A 1.5T MRI scanner was adapted for interactive imaging during endovascular procedures using new or modified interventional devices such as guidewires and catheters. A perfused vascular phantom was used for testing. Pre-, intra- and post-procedural visualization and measurement of vascular morphology and flow was implemented. A detailed analysis of X-Ray fluoroscopic angiography workflow was conducted and applied. Two interventional radiologists and one physician in training performed 39 procedures. All procedures were timed and analyzed. RESULTS: MRI-guided iliac angioplasty procedures were successfully performed with progressive adaptation of techniques and workflow. The workflow, setup and protocol enabled a reduction in table time for a dedicated MRI-guided procedure to 6 min 33 s with a mean procedure time of 9 min 2 s, comparable to the mean procedure time of 8 min 42 s for the standard X-Ray guided procedure. CONCLUSIONS: MRI-guided iliac vascular interventions were found to be feasible and practical using this framework and optimized workflow. In particular the real-time flow analysis was found to be helpful for pre- and post-interventional assessments. Design optimization of the catheters and in vivo experiments are required before clinical evaluation

Wireless mobile technology to improve workflow and feasibility of MR-guided percutaneous interventions

PURPOSE: A wireless interactive display and control device combined with a platform-independent web-based User Interface (UI) was developed to improve the workflow for interventional Magnetic Resonance Imaging (iMRI). METHODS: The iMRI-UI enables image acquisition of up to three independent slices using various pulse sequences with different contrast weighting. Pulse sequence, scan geometry and related parameters can be changed on the fly via the iMRI-UI using a tablet computer for improved lesion detection and interventional device targeting. The iMRI-UI was validated for core biopsies with a liver phantom (n=40) and Thiel soft-embalmed human cadavers (n=24) in a clinical 1.5T MRI scanner. RESULTS: The iMRI-UI components and setup were tested and found conditionally MRI-safe to use according to current ASTM standards. Despite minor temporary touchscreen interference at a close distance to the bore (<20 cm), no other issues regarding quality or imaging artefacts were observed. The 3D root-mean-square distance error was 2.8±1.0 (phantom) / 2.9±0.8 mm (cadaver) and overall procedure times ranged between 12–22 (phantom) / 20–55 minutes (cadaver). CONCLUSIONS: The wireless iMRI-UI control setup enabled fast and accurate interventional biopsy needle placements along complex trajectories and improved the workflow for percutaneous interventions under MRI guidance in a preclinical trial