The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Experimental investigation of the elasticity of the human diaphragm.

BACKGROUND: Traumatic diaphragmatic ruptures affect mainly the left side. In an experimental study in human corpses we examined the stretch behaviour of the left and right diaphragmatic halves. METHODS: In a total of 8 male and 8 female corpses each diaphragmatic half was divided into 4 different segments. Each segments stretch behaviour was investigated. In steps of 2 N the stretch was increased up to 24 N. RESULTS: In the female the left diaphragm showed a stronger elasticity compared to the right. Additionally the left diaphragm in females showed a higher elasticity in comparison to the left in males. Traumatic diaphragmatic ruptures affect mostly the central tendineous part or the junction between tendineous and muscular part of the diaphragmatic muscle. Accordingly we found a lower elasticity in these parts compared with the other diaphragmatic segments. CONCLUSION: In summary it can be said that albeit some restrictions we were able to determine the elasticity of different diaphragmatic segments quantitatively and reproduceably with our presented method. Thereby a comparison of results of different diaphragmatic segments as well as of both diaphragmatic halves and of both genders was possible.

Magnetic resonance-guided angioplasty with delivery of contrast-media doped solutions to the vessel wall: an experimental study in swine.

OBJECTIVES: To assess the feasibility of magnetic resonance (MR)-guided delivery of a solution containing contrast-medium and immediate online monitoring of its distribution to the vessel wall during MR-guided angioplasty in peripheral arteries. MATERIALS AND METHODS: In 3 pigs, the feasibility of MR-guided atraumatic delivery of a solution containing contrast-medium and tissue dye (0.05 mmol/mL Gd-DTPA, 3% Evans blue dye) into the vessel wall of the iliac arteries was tested using a permeable balloon catheter (8 mm). Catheter placement was monitored using a steady-state free precession real-time imaging sequence.Additionally, in 5 pigs, surgically created bilateral stenoses in the external iliac artery were dilatated with the porous balloon. In these animals, contrast-enhanced MR angiography was performed before and after the interventions to assess the degree of the stenosis. In all animals, the vessel wall was delineated before and after dilatation using a T1-weighted gradient echo (GE) sequence. RESULTS: In the 3 animals without stenosis, contrast medium was successfully applied to the vessel wall. On the GE images, the normalized signal intensity of the vessel wall was 0.95 +/- 0.015 arbitrary units (a. u.) prior and 2.15 +/- 0.105 a. u. after the intervention (P < 0.01). In the animals with stenosis, MR angiography performed before and after the intervention demonstrated successful dilatation of 9 of the 10 stenoses. Before the intervention, 7 stenoses were severe (76%-99%) and 3 moderate (50%-75%), and after the intervention, 4 stenoses were completely removed and 5 mild (<50%). Also in these 5 animals, the solution was visible in the vessel wall of the arteries on the T1-weighted GE MR images (normalized signal intensity prior the intervention 1.33 +/- 0.16 a. u. and 2.97 +/- 0.23 after angioplasty; P < 0.05). Histology demonstrated the distribution of the Evan's blue dye within the vessel wall in all animals. CONCLUSIONS: MR-guided delivery of a contrast-medium containing solution and immediate online assessment of its distribution to the vessel wall during angioplasty in peripheral arteries is feasible.

Prospective evaluation of image quality with use of a patient image gallery for dose reduction in pediatric 16-MDCT.

OBJECTIVE: The purposes of this study were to evaluate prospective adjustment of dose settings in pediatric 16-MDCT by use of computer-simulated images in a patient image gallery and to compare the dose reduction achieved with that of standard pediatric protocols. SUBJECTS AND METHODS: The image gallery consisted of images from weight-dependent sample examinations performed with varied simulated tube current-exposure time settings. The scanning parameters prospectively chosen on the basis of the image quality of the image gallery were used for 30 16-MDCT examinations (chest, n = 15; abdomen, n = 8; pelvis, n = 7) of 22 children (14 boys, eight girls; mean age, 6.8 +/- 5.8 years; mean body weight, 26.7 +/- 19.6 kg). Three blinded radiologists used a 4-point grading scale to rate the overall image quality of the image gallery and the 16-MDCT scans. Objective and subjective image quality was assessed for the simulated and actual CT scans. The concordance correlation coefficient (K) was determined. RESULTS: There was mainly moderate concordance with regard to objective (chest, K = 0.69; abdomen, K = 0.33; pelvis, K = 0.55) and subjective (chest soft-tissue window, kappa coefficient [kappa] = 0.00; chest lung window, kappa = 0.53; abdomen, kappa = 1.00; pelvis, kappa = 0.48) analysis of image gallery compared with actual 16-MDCT examinations. Compared with use of previous weight-adapted pediatric standard protocols, use of an image gallery resulted in further dose reduction for abdominal and pelvic CT but not for thoracic CT. CONCLUSION: A patient image gallery can be used as a basis for pediatric 16-MDCT examinations. The gallery provides a preexamination overview of expected image quality. Radiation exposure can be optimized with regard to patient weight and the image quality needed to answer the clinical question.

Evaluation of automated attenuation-based tube current adaptation for coronary calcium scoring in MDCT in a cohort of 262 patients.

The aim of our study was to evaluate attenuation-based tube current adaptation in coronary calcium scoring using ECG-gated multi-detector-row CT (MDCT). A total of 262 patients underwent non-enhanced cardiac MDCT. Group 1 was scanned using a standard protocol with 120 kV and 150 mAs(eff). Groups 2-4 were scanned using an attenuation-based dose-adaptation template (CARE Dose) with different effective reference mAs settings (150, 180, 210 mAs(eff)). Body-mass index (BMI) and CT-dose index values were calculated for each patient. Image noise and subjective image quality were assessed. Regression analysis was performed, and the variation coefficient of image noise was determined. Compared to the standard scan protocol a dose reduction of 31.1% for group 2 and 20.1% for group 3 was observed. Measurement variation of image noise was smaller for the attenuation-based dose adaptation protocols (group 2-4) (16.2-17.1%) compared to the standard scan protocol (32.3%). Regression analysis of groups 2-4 showed better correlation with improved dose usage based on BMI (all P

Evaluation of aortocoronary bypass stents with cardiac MDCT compared with conventional catheter angiography.

OBJECTIVE: The objective of our study was to determine the accuracy of 16-MDCT for evaluation of stent patency and in-stent stenosis in venous coronary bypass grafts. SUBJECTS AND METHODS: Fourteen patients who had previous stent placements in stenosed venous coronary bypass grafts underwent contrast-enhanced MDCT of the heart (collimation, 16 x 0.75 mm; 120 kV; 550 mAs(eff)) and invasive coronary angiography. A total of 20 stents were evaluated: Vessel and stent diameters proximal to, distal to, and at various sites inside the stent were measured on both techniques, and Bland-Altman plots and correlations were calculated. Image noise and image quality were also assessed applying a Student's t test for data comparison of image noise. RESULTS: All 20 bypass stents were correctly classified as patent. Vessel diameters outside the stent showed an excellent correlation (r = 0.90) and in-stent diameters showed a good correlation (r = 0.72), with lower values for MDCT due to blooming artifacts. All significant in-stent stenoses were correctly classified. CONCLUSION: In patients suspected of bypass in-stent stenosis, 16-MDCT may be considered as a valuable alternative to conventional angiography for evaluating bypass patency and in-stent stenosis.

The accuracy of 1- and 3-mm slices in coronary calcium scoring using multi-slice CT in vitro and in vivo.

The accuracy of coronary calcium scoring using 16-row MSCT comparing 1- and 3-mm slices was assessed. A thorax phantom with calcium cylinder inserts was scanned applying a non-enhanced retrospectively ECG-gated examination protocol: collimation 12 x 0.75 mm; 120 kV; 133 mAs(eff). Thirty-eight patients were examined using the same scan protocol. Image reconstruction was performed with an effective slice thickness of 3 and 1 mm. The volume score, calcium mass and Agatston score were determined. Image noise was measured in both studies. The volume score and calcium mass varied less than the Agatston score. The overall measured calcium mass compared to the actual calcium mass revealed a relative difference of +2.0% for 1-mm slices and -1.2% for 3-mm slices. Due to increased image noise in thinner slices in the patient study (26.1 HU), overall calcium scoring with a scoring threshold of 130 HU was not feasible. Interlesion comparison showed significantly higher scoring results for thinner slices (all P<0.001). A similar accuracy comparing calcium scoring results of 1- and 3-mm slices was shown in the phantom study; therefore, the potentially necessary increase of the patient's dose in order to achieve assessable 1-mm slices with an acceptable image-to-noise-ratio appears not to be justified.

Coronary artery calcium scoring with multislice computed tomography: in vitro assessment of a low tube voltage protocol.

OBJECTIVES: We sought to compare an 80-kVp coronary calcium scoring protocol with the standard protocol of 120 kVp in terms of accuracy and reproducibility and to assess its dose reduction potential. MATERIALS AND METHOD: An anthropomorphic heart phantom with calcium cylinders was scanned with different tube currents at 80 kVp and 120 kVp using a 16-slice multislice CT (MSCT) scanner. An adapted threshold for 80 kVp was calculated. Accuracy and reproducibility for calcium mass, volume, and Agatston score were analyzed using F-tests. The radiation doses needed to produce artifact-free images were determined. RESULTS: Accuracy (measurement errors: mass 120 kVp +4.6%, mass 80 kVp -6.9%, volume 120 kVp +78.8%, volume 80 kVp +58.2%) and reproducibility (F-tests: mass: P = 0.4998, volume: P = 0.9168, Agatston: P = 0.5422) were comparable at both tube voltages. Avoiding the appearance of artificial lesions, a CTDI(w,eff) of 10.7 mGy was needed at 120 kVp versus 4.6 mGy at 80 kVp (dose reduction of 57%). CONCLUSIONS: Using an 80-kVp protocol in coronary calcium scoring, a relevant dose reduction is possible without compromising reproducibility and accuracy.

Value of virtual tracheobronchoscopy and bronchography from 16-slice multidetector-row spiral computed tomography for assessment of suspected tracheobronchial stenosis in children.

PURPOSE: To evaluate the value of dose-reduced 16-slice multidetector-row spiral computed tomography (16-MDCT) using virtual tracheobronchoscopy (VTB) and virtual bronchography (VBG) in children with suspected tracheobronchial stenosis. MATERIALS AND METHODS: 12 children (4 d to 3 years, body weight 1.2 kg to 13.5 kg) with stridor and suspected tracheobronchial stenosis were examined by contrast-enhanced low-dose 16-MDCT. Conventional axial slices, MPRs, VTB, and VBG were calculated. Image findings were correlated with the results of fiberoptic bronchoscopy (12 out of 12) as a gold standard and subsequent surgery (8 out of 12). RESULTS: VTB and VBG demonstrated the fiberoptic bronchoscopically suspected tracheal stenosis in 11 of 12 children due to vascular compression because of the brachiocephalic trunk (6), a double aortic arch (2), a vascular compression of the left main bronchus (2), and a right aberrant subclavian artery (1). Eleven out of 12 stenoses were correctly depicted by conventional axial slices, MPRs, VTB, and VBG. Dose reduction was 79 to 85.8% compared to a standard adult chest CT. CONCLUSION: Dose-reduced 16-MDCT with the use of VTB and VBG is effective for the evaluation of tracheobronchial stenosis in children and correlates well with fiberoptic bronchoscopy.

Effect of varying slice thickness on coronary calcium scoring with multislice computed tomography in vitro and in vivo.

OBJECTIVES: To compare coronary calcium scoring results (calcium volume, calcium mass, Agatston score, and number of lesions) of different slice thicknesses using a 16-slice CT (MSCT) scanner. MATERIALS AND METHODS: A nonmoving anthropomorphic thorax phantom with calcium cylinders of different sizes and densities was scanned 30 times with repositioning applying a standardized retrospectively ECG-gated MSCT (SOMATOM Sensation 16; Siemens, Forchheim, Germany) scan protocol: collimation 12 x 0.75 mm, tube voltage 120 kV, effective tube current time-product 133 mAs(eff). Fifty patients (29 male; age 57.2 +/- 8.4 years) underwent a nonenhanced scan applying the same scan protocol. Two image sets (effective slice thicknesses 3 mm and 1 mm) were reconstructed at 60% of the RR interval. Image noise was measured in both studies. Calcium volume, calcium mass and Agatston score were calculated using a commercially available software tool. RESULTS: Due to increased image noise in thinner slices, calcium scoring in all scans was performed applying a scoring threshold of 350 HU. In the phantom study, 1-mm slices showed significantly higher scoring results in respect to calcium volume (+8.2%), calcium mass (+12.5%), and Agatston score (+5.3%) (all P < 0.0001). In the patient study, 27 patients had coronary calcifications in 3-mm slices, and 31 patients had coronary calcifications in 1-mm slices. Thinner slices showed significantly higher scoring results in respect to volume (+47.1%), mass (+47.2%), and Agatston score (+29.7%) (all P < 0.0001). CONCLUSIONS: When comparing 3-mm and 1-mm slices in coronary calcium scoring in MSCT, thinner slices lead to significantly increased scoring results.

Radiation dose reduction to the male gonads during MDCT: the effectiveness of a lead shield.

OBJECTIVE: Our study was designed to quantify the effect of a standard gonad shield on the testicular radiation exposure due to scatter during routine abdominopelvic MDCT. SUBJECTS AND METHODS: Routine abdominopelvic MDCT was performed in 34 patients with gonadal lead shielding and 32 patients without this shielding; the testes were not exposed to the direct beam during the examination. We estimated the testicular dose administered with thermoluminescent dosimetry, taking into account each patient's body weight and body mass index (BMI). RESULTS: With a 1-mm lead shield, the mean testicular dose was reduced from 2.40 to 0.32 mSv, a reduction of 87%. The difference was found to be statistically significant (p < 0.0001). No correlation between testicular dose and body weight or BMI was found. CONCLUSION: Shielding the male gonads reduces the testicular radiation dose during abdominopelvic MDCT significantly and can be recommended for routine use.

Phase-inversion tissue harmonic imaging compared with conventional B-mode ultrasound in the evaluation of pancreatic lesions.

The aim of this study was to compare the diagnostic sensitivity, specificity, and image quality of conventional B-mode US (BM) and phase-inversion tissue harmonic imaging (PTHI) regarding pancreatic pathology. In a prospective study, 107 patients, aged between 28 and 85 years, underwent US examinations of the pancreas with both BM and PTHI in a randomly chosen order. As diagnostic reference, either contrast-enhanced CT or MRI examinations of the upper abdomen were obtained in all patients. Sensitivity and specificity were evaluated using the Student's t test. Differences in overall image quality, lesion conspicuity, fluid-solid differentiation, and delineation of the pancreatic tail were analyzed using Wilcoxon's signed ranks test and Bowker's symmetry test. Sixteen of 107 examined patients (15%) were non-diagnostic and excluded due to technical limitations such as abdominal gas. A total of 60 pancreatic lesions (cysts, acute pancreatitis, dilatation of the pancreatic duct, calcifications, and solid tumors) were diagnosed by CT or MRI. Phase-inversion tissue harmonic imaging had a higher sensitivity of 70% (14 of 20) than BM (60%; 24 of 40) for the detection of pancreatic lesions; however, the difference was not statistically significant ( p=0.46). In the assessment of lesions <1 cm of size, PTHI had a sensitivity of 70% and BM 46.7%, whereby the difference again was not statistically significant. Phase-inversion tissue harmonic imaging proved to be superior to BM regarding overall image quality ( p<0.0001), lesion conspicuity ( p=0.0045), and fluid-solid differentiation ( p=0.0002), as well as the delineation of the pancreatic tail ( p<0.0001). These differences were statistically significant. The statistically significant improvement of image quality with regards to lesion conspicuity, fluid-solid differentiation, and delineation of the pancreatic tail favors the use of PTHI when evaluating the pancreas with US. Sensitivity for pancreatic lesions is increased with PTHI in comparison with conventional sonography (BM), especially in lesions <1 cm in diameter, although the difference was not statistically significant.

Diagnostic accuracy of phase-inversion tissue harmonic imaging versus fundamental B-mode sonography in the evaluation of focal lesions of the kidney.

OBJECTIVE: We compared phase-inversion tissue harmonic imaging with fundamental B-mode sonography in the evaluation of focal lesions of the kidney. SUBJECTS AND METHODS: For our prospective study, 114 patients underwent sonography of the kidneys in both modes, fundamental B-mode sonography and phase-inversion tissue harmonic imaging, in a randomly chosen scanning order. Imaging parameters were standardized. Sonographic diagnoses were made under real-time conditions by the examining radiologist. All sonographic diagnoses were compared with a diagnostic reference modality: contrast-enhanced CT, contrast-enhanced MR imaging, or histopathology. Three radiologists different from the examiners evaluated overall image quality, lesion conspicuity, and fluid-solid differentiation for both modalities using hard-copy images. RESULTS: In 70 patients, fundamental B-mode sonography as the first technique depicted 73 of 111 lesions 10 mm or larger and enabled 71 lesions to be correctly characterized (sensitivity, 65.8%; accuracy, 64.0%). As the first mode, phase-inversion tissue harmonic imaging depicted 57 of 65 focal lesions and enabled 54 lesions to be accurately classified in 44 patients (sensitivity, 87.7%; accuracy, 83.1%). The differences in sensitivity and accuracy were statistically significant (95% confidence interval). For overall image quality, lesion conspicuity, and fluid-solid differentiation phase-inversion harmonic imaging was superior to fundamental B-mode sonography (p < 0.0001). CONCLUSION: Phase-inversion tissue harmonic imaging is superior to fundamental B-mode sonography in the sonography of focal kidney lesions because phase-inversion tissue harmonic imaging has better overall image quality, lesion conspicuity, and fluid-solid differentiation. In six cases, phase-inversion tissue harmonic imaging added crucial diagnostic information that changed patient management.