Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry

Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry (ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0\ub110.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7\ub173.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. Conclusion: In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months

CT arthrography of the glenohumeral joint: CT fluoroscopy versus conventional CT and fluoroscopy--comparison of image-guidance techniques.

PURPOSE: To compare examination time with radiologist time and to measure radiation dose of computed tomographic (CT) fluoroscopy, conventional CT, and conventional fluoroscopy as guiding modalities for shoulder CT arthrography. MATERIALS AND METHODS: Glenohumeral injection of contrast material for CT arthrography was performed in 64 consecutive patients (mean age, 32 years; age range, 16-74 years) and was guided with CT fluoroscopy (n = 28), conventional CT (n = 14), or conventional fluoroscopy (n = 22). Room times (arthrography, room change, CT, and total examination times) and radiologist times (time the radiologist spent in the fluoroscopy or CT room) were measured. One-way analysis of variance and Bonferroni-Dunn posthoc tests were performed for comparison of mean times. Mean effective radiation dose was calculated for each method with examination data, phantom measurements, and standard software. RESULTS: Mean total examination time was 28.0 minutes for CT fluoroscopy, 28.6 minutes for conventional CT, and 29.4 minutes for conventional fluoroscopy; mean radiologist time was 9.9 minutes, 10.5 minutes, and 9.0 minutes, respectively. These differences were not statistically significant. Mean effective radiation dose was 0.0015 mSv for conventional fluoroscopy (mean, nine sections), 0.22 mSv for CT fluoroscopy (120 kV; 50 mA; mean, 15 sections), and 0.96 mSv for conventional CT (140 kV; 240 mA; mean, six sections). Effective radiation dose can be reduced to 0.18 mSv for conventional CT by changing imaging parameters to 120 kV and 100 mA. Mean effective radiation dose of the diagnostic CT arthrographic examination (140 kV; 240 mA; mean, 25 sections) was 2.4 mSv. CONCLUSION: CT fluoroscopy and conventional CT are valuable alternative modalities for glenohumeral CT arthrography, as examination and radiologist times are not significantly different. CT guidance requires a greater radiation dose than does conventional fluoroscopy, but with adequate parameters CT guidance constitutes approximately 8% of the radiation dose

Spiral 2D T2-Weighted TSE Brain MR Imaging: Initial Clinical Experience

BACKGROUND AND PURPOSE: Spiral MR imaging may enable improved image quality and higher scan speeds than Cartesian trajectories. We sought to compare a novel spiral 2D T2-weighted TSE sequence with a conventional Cartesian and an artifact-robust, non-Cartesian sequence named MultiVane for routine clinical brain MR imaging. MATERIALS AND METHODS: Thirty-one patients were scanned with all 3 sequences (Cartesian, 4 minutes 14 seconds; MultiVane, 2 minutes 49 seconds; spiral, 2 minutes 12 seconds) on a standard clinical 1.5T MR scanner. Three readers described the presence and location of abnormalities and lesions and graded images qualitatively in terms of overall image quality, the presence of motion and pulsation artifacts, gray-white matter differentiation, lesion conspicuity, and subjective preference. Image quality was objectivized by measuring the SNR and the coefficients of variation for CSF, GM, and WM. RESULTS: Spiral achieved a scan time reduction of 51.9% and 21.9% compared with Cartesian and MultiVane, respectively. The number and location of lesions were identical among all sequences. As for the qualitative analysis, interreader agreement was high (Krippendorff α > .75). Spiral and MultiVane both outperformed the Cartesian sequence in terms of overall image quality, the presence of motion artifacts, and subjective preference (P  .15). Spiral and MultiVane outperformed the Cartesian sequence in coefficient of variation WM and SNR (P < .01). CONCLUSIONS: Spiral 2D T2WI TSE is feasible for routine structural brain MR imaging and offers high-quality, artifact-robust brain imaging in short scan times

BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries.

The BIOLUX P-III registry was initiated to further assess the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) in infrainguinal lesions in a real-world environment and in prespecified risk groups. BIOLUX P-III is a prospective, global, all-comers registry with patients treated under real-world conditions. We herein report 24-month results of the prespecified subgroup of 151 patients with 185 below-the-knee (BTK) lesions. The primary safety and efficacy endpoints were freedom from major adverse events (a composite of freedom from device and procedure mortality through 30 days, major target limb amputation and clinically driven target lesion revascularization) at 6 months and freedom from clinically driven target lesion revascularization (FfTLR) at 12 months. At baseline, 76.0% of patients had critical limb ischemia and 48.9% of lesions were TASC C or D lesions. Technical success was achieved in 97.8%, and bailout stenting was required in 1.1%. Freedom from major adverse events was 86.2% [95% CI 79.4; 90.8] at 6 months, and FfTLR was 90.9% [95% CI 85.2; 94.4] at 12 months. At 24 months, FfTLR was 90.9% [95% CI 85.2; 94.4], freedom from major amputation was 90.1% [95% CI 83.9, 94.0], and overall survival was 79.2% [70.7, 85.5]. There was a significant clinical improvement (mean Rutherford class improvement of - 2.9 ± 1.9, p &lt; 0.0001) and an improvement in pain (mean improvement on Wong-Baker Faces Pain Scale of - 2.7 ± 2.9, p &lt; 0.0001). In this real-world DCB registry, 24-month outcomes of Passeo-18 Lux demonstrated safety and efficacy in BTK lesions with high patency rates and sustained clinical improvements at 24 months. NCT02276313

High-Resolution 3D versus Standard-Resolution 2D T2-Weighted Turbo Spin Echo MRI for the Assessment of Lumbar Nerve Root Compromise

Radiculopathy can be caused by nerve root irritation and nerve root compression at the level of the lateral recess or at the level of the intervertebral foramen. T2-weighted (T2w) MRI is considered essential to evaluate the nerve root and its course, starting at the lateral recess through the intervertebral foramen to the extraforaminal space. With the introduction of novel MRI acceleration techniques such as compressed SENSE, standard-resolution 2D T2w turbo spin echo (TSE) sequences with a slice-thickness of 3–4 mm can be replaced with high-resolution isotropic 3D T2w TSE sequences with sub-millimeter resolution without prolonging scan time. With high-resolution 3D MRI, the course of the nerve root can be visualized more precisely due to a detailed depiction of the anatomical situation and less partial volume effects, potentially allowing for a better detection of nerve root compromise. In this intra-individual comparison study, 55 patients with symptomatic unilateral singular nerve root radiculopathy underwent MRI with both 2D standard- and 3D high-resolution T2w TSE MRI sequences. Two readers graded the degree of lumbar lateral recess stenosis and lumbar foraminal stenosis twice on both image sets using previously validated grading systems in an effort to quantify the inter-readout and inter-sequence agreement of scores. Inter-readout agreement was high for both grading systems and for 2D and 3D imaging (Kappa = 0.823–0.945). Inter-sequence agreement was moderate for both lumbar lateral recess stenosis (Kappa = 0.55–0.577) and lumbar foraminal stenosis (Kappa = 0.543–0.572). The percentage of high degree stenosis with nerve root deformity increased from 16.4%/9.8% to 41.8–43.6%/34.1% from 2D to 3D images for lateral recess stenosis/foraminal stenosis, respectively. Therefore, we show that while inter-readout agreement of grading systems is high for both standard- and high-resolution imaging, the latter outperforms standard-resolution imaging for the visualization of lumbar nerve root compromise

Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry.

After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months. 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up. The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313)

Single shot zonal oblique multislice SE-EPI diffusion-weighted imaging with low to ultra-high b-values for the differentiation of benign and malignant vertebral spinal fractures

PURPOSE: To investigate the diagnostic yield of low to ultra-high b-values for the differentiation of benign from malignant vertebral fractures using a state-of-the-art single-shot zonal-oblique-multislice spin-echo echo-planar diffusion-weighted imaging sequence (SShot ZOOM SE-EPI DWI). MATERIALS AND METHODS: 66 patients (34 malignant, 32 benign) were examined on 1.5 T MR scanners. ADC maps were generated from b-values of 0,400; 0,1000 and 0,2000s/mm(2). ROIs were placed into the fracture of interest on ADC maps and trace images and into adjacent normal vertebral bodies on trace images. The ADC of fractures and the Signal-Intensity-Ratio (SIR) of fractures relative to normal vertebral bodies on trace images were considered quantitative metrics. The appearance of the fracture of interest was graded qualitatively as iso-, hypo-, or hyperintense relative to normal vertebrae. RESULTS: ADC achieved an area under the curve (AUC) of 0.785/0.698/0.592 for b = 0,400/0,1000/0,2000s/mm(2) ADC maps respectively. SIR achieved an AUC of 0.841/0.919/0.917 for b = 400/1000/2000s/mm(2) trace images respectively. In qualitative analyses, only b = 2000s/mm(2) trace images were diagnostically valuable (sensitivity:1, specificity:0.794). Machine learning models incorporating all qualitative and quantitative metrics achieved an AUC of 0.95/0.98/0.98 for b-values of 400/1000/2000s/mm(2) respectively. The model incorporating only qualitative metrics from b = 2000s/mm(2) achieved an AUC of 0.97. CONCLUSION: By using quantitative and qualitative metrics from SShot ZOOM SE-EPI DWI, benign and malignant vertebral fractures can be differentiated with high diagnostic accuracy. Importantly qualitative analysis of ultra-high b-value images may suffice for differentiation as well