Best Practice Guideline - DEGUM Recommendations on Breast Ultrasound. / Best Practice Guideline ­ Empfehlungen der DEGUM zur Durchführung und Beurteilung der Mammasonografie ­ TEIL I ­ Untersuchungstechnik, Ultraschall-DEGUM-Kriterien und deren Dokumentation.

For many years, breast ultrasound has been used in addition to mammography as an important method for clarifying breast findings. However, differences in the interpretation of findings continue to be problematic 1 2. These differences decrease the diagnostic accuracy of ultrasound after detection of a finding and complicate interdisciplinary communication and the comparison of scientific studies 3. In 1999, the American College of Radiology (ACR) created a working group (International Expert Working Group) that developed a classification system for ultrasound examinations based on the established BI-RADS classification of mammographic findings under consideration of literature data 4. Due to differences in content, the German Society for Ultrasound in Medicine (DEGUM) published its own BI-RADS-analogue criteria catalog in 2006 3. In addition to the persistence of differences in content, there is also an issue with formal licensing with the current 5th edition of the ACR BI-RADS catalog, even though the content is recognized by the DEGUM as another system for describing and documenting findings. The goal of the Best Practice Guideline of the Breast Ultrasound Working Group of the DEGUM is to provide colleagues specialized in senology with a current catalog of ultrasound criteria and assessment categories as well as best practice recommendations for the various ultrasound modalities.

Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses.

PURPOSE: To determine whether adding shear-wave (SW) elastographic features could improve accuracy of ultrasonographic (US) assessment of breast masses. MATERIALS AND METHODS: From September 2008 to September 2010, 958 women consented to repeat standard breast US supplemented by quantitative SW elastographic examination in this prospective multicenter institutional review board-approved, HIPAA-compliant protocol. B-mode Breast Imaging Reporting and Data System (BI-RADS) features and assessments were recorded. SW elastographic evaluation (mean, maximum, and minimum elasticity of stiffest portion of mass and surrounding tissue; lesion-to-fat elasticity ratio; ratio of SW elastographic-to-B-mode lesion diameter or area; SW elastographic lesion shape and homogeneity) was performed. Qualitative color SW elastographic stiffness was assessed independently. Nine hundred thirty-nine masses were analyzable; 102 BI-RADS category 2 masses were assumed to be benign; reference standard was available for 837 category 3 or higher lesions. Considering BI-RADS category 4a or higher as test positive for malignancy, effect of SW elastographic features on area under the receiver operating characteristic curve (AUC), sensitivity, and specificity after reclassifying category 3 and 4a masses was determined. RESULTS: Median participant age was 50 years; 289 of 939 (30.8%) masses were malignant (median mass size, 12 mm). B-mode BI-RADS AUC was 0.950; eight of 303 (2.6%) BI-RADS category 3 masses, 18 of 193 (9.3%) category 4a lesions, 41 of 97 (42%) category 4b lesions, 42 of 57 (74%) category 4c lesions, and 180 of 187 (96.3%) category 5 lesions were malignant. By using visual color stiffness to selectively upgrade category 3 and lack of stiffness to downgrade category 4a masses, specificity improved from 61.1% (397 of 650) to 78.5% (510 of 650) (P<.001); AUC increased to 0.962 (P=.005). Oval shape on SW elastographic images and quantitative maximum elasticity of 80 kPa (5.2 m/sec) or less improved specificity (69.4% [451 of 650] and 77.4% [503 of 650], P<.001 for both), without significant improvement in sensitivity or AUC. CONCLUSION: Adding SW elastographic features to BI-RADS feature analysis improved specificity of breast US mass assessment without loss of sensitivity.

Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial.

OBJECTIVE: To evaluate the diagnostic efficacy (accuracy, sensitivity, specificity) of 1.0 M gadobutrol versus 0.5 M gadopentetate for the classification of lesions as either benign or malignant in patients with known or suspected liver lesions. METHODS AND MATERIALS: A multicenter, phase-III, randomized, interindividually controlled comparison study with blinded reader evaluation was performed to investigate the diagnostic efficacy of a bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentetate at a dose of 0.1 mmol Gd/kg BW. The imaging protocol included a dynamic 3D-evaluation, static conventional, and fat saturated T1-weighted sequences. MR datasets were evaluated by 3 independent radiologists. The standard of reference was defined by an independent truth panel (radiologist or hepatologist). The safety evaluation included adverse events, vital signs, and physical examination. RESULTS: A total of 497 of 572 patients were eligible for the final efficacy analysis. Noninferiority of gadobutrol-enhanced magnetic resonance imaging (MRI) for the classification of liver lesions was demonstrated on the basis of diagnostic accuracy determined by the on-site investigators (-0.098, 0.021) as well as for the average reader of the blinded evaluation (-0.096, 0.014) (95% confidence interval), compared with the predefined standard of reference. Very similar increases in sensitivity (ranging from approximately 10% to approximately 55%) and specificity (ranging from approximately 1% to approximately 18%) compared with precontrast MRI were also observed for the 2 contrast agent groups, with maximum differences of 4%.Very similar, low rates of adverse events were recorded for each of the 2 groups. No clinically relevant changes in vital signs or the results of the physical examination were observed in any patient. CONCLUSION: This study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol (0.1 mmol/kg body weight) to 0.5 M gadopentetate (0.1 mmol/kg body weight) in the diagnostic assessment of liver lesions with contrast-enhanced MRI. The known excellent safety profile of gadobutrol was confirmed in this clinical trial and is similar to that of gadopentetate.

2005 Dr. Gary J. Becker Young Investigator Award: periprocedural oral administration of the leflunomide analogue FK778 inhibits neointima formation in a double-injury rat model of restenosis.

PURPOSE: To test the efficacy of limited oral administration of the new leflunomide analogue FK778 for suppression of neointima proliferation in a double-injury restenosis model in the rat. MATERIALS AND METHODS: For induction of aortic lesions, silicon cuffs were placed operatively around the infrarenal aortas of Lewis rats. After 21 days, the aortic cuffs were removed and the lesions were dilated with 2-F Fogarty catheters inserted via the left common carotid artery. The novel immunosuppressant FK778 was administered at a dose of 5 mg/kg body weight (group 1) or 15 mg/kg body weight (group 2) in a total of 38 animals. For both doses, three different periinterventional time periods, each with a 5-day course of oral FK778, were defined as follows: (i) days -2 to 2, (ii) days 1-5, and (iii) days 7-11, with six or seven rats in each group. After 3 weeks, intima/media ratios were assessed morphometrically and immunohistochemistry for quantification of intimal alpha-actin expression was performed. RESULTS: In both dose groups, there was a trend toward inhibition of neointima formation when the 5-day course of FK778 was started before or 1 day after the intervention. However, in the lower-dose group, inhibition of neointima was not statistically significant regardless of the time frame of treatment (groups 1a-c). With the higher dose, suppression of intimal hyperplasia was significant when FK778 was administered between days 1 and 5 after angioplasty (group 2b; P<.01). Expression of alpha-actin in the intima of FK778-treated rats was significantly reduced when the drug was started 2 days before angioplasty in group 1a (P<.05) or 1 day after angioplasty in both dosage groups (group 1b, P<.01; group 2b, P<.05). CONCLUSION: In the double-injury rat model presented, balloon-mediated proliferation of smooth muscle cells in the intima with consecutive intimal thickening was influenced by FK778 in a dose-dependent manner. However, long-term studies are needed to exclude a delay of vascular healing in this particular model.

Characterization of a new double-injury restenosis model in the rat aorta.

PURPOSE: To characterize a new rat model of restenosis for evaluation of local or systemic drug strategies. METHODS: Arterial lesions were induced by placement of silicone cuffs around the aorta of Lewis rats. After 21 days, the cuffs were removed, and a subgroup of rat aortas was subjected to secondary balloon injury. Remodeling of wall compartments and cell kinetics were assessed morphometrically at 3, 7, 14, 21, and 28 days after the single and double-injury approaches. Immunohistochemistry was used to assess the distribution of macrophages, smooth muscle cells, and proliferating cells within the layers of the arterial wall in the experimental groups versus sham-operated and untreated controls. RESULTS: After cuff placement, the adventitia initially undergoes significant enlargement, while the media shows a reduction in relative thickness. Accumulation of cells within the adventitia at 3 and 7 days is followed by a marked decline in cell density at 14 days, with simultaneously increasing cell numbers in the intima. At this time, activated macrophages are detected in the adventitia, indicating chronic inflammation. Following cuff placement, mild intimal hyperplasia develops. In the double-injury model, extensive neointimal hyperplasia forms rapidly, with a peak at 14 days. CONCLUSIONS: This new double-injury model is technically easy, and multiple experiments can be accrued in short periods of time. It provides an additional platform to identify new targets and strategies for the prophylaxis of postangioplasty restenosis.

Short-term rapamycin for inhibition of neointima formation after balloon-mediated aortic injury in rats: is there a window of opportunity for systemic prophylaxis of restenosis?

PURPOSE: To evaluate the efficacy of limited short-term systemic administration of rapamycin to prevent neointimal intimal hyperplasia (NIH) in a double-injury rat model of restenosis. METHODS: Aortic lesions were induced by perivascular placement of silicone cuffs around the aorta of 36 Lewis rats. After 3 weeks, the cuffs were removed, and the vessels were subjected to secondary balloon injury. Rapamycin (sirolimus) was intravenously administered for 5 days in dosages of 0.5 or 2 mg/kg/d beginning at various time points relative to the balloon injury: (1) days -2 to +2, (2) days 1 to 5, or (3) days 7 to 11. For each treatment period, 6 rats received the 5-day course of the lower or higher dose of rapamycin. Eight rats served as controls undergoing 2-stage injury without rapamycin treatment. Morphometry and immunohistochemistry were performed at 21 days after angioplasty. RESULTS: NIH and intimal alpha-actin expression were inhibited by both dosages when treatment started 2 days before or 1 day after angioplasty. Results were statistically significant for the lower dose when started 1 day after angioplasty (p < 0.01) and for the higher dose when initiated 2 days before the intervention (p < 0.05). Treatment commencing at 7 days did not reduce NIH in either dosage group. CONCLUSIONS: In a double-injury rat model, NIH can be inhibited by short-term systemic rapamycin, but suppression of early cell migration and proliferation is pivotal. A limited peri-interventional antiproliferative therapy may be of value as an adjunct to control restenosis after balloon angioplasty and/or stenting.

Gadobutrol-enhanced moving-table magnetic resonance angiography in patients with peripheral vascular disease: a prospective, multi-centre blinded comparison with digital subtraction angiography.

The purpose of this study was to compare moving-table three-dimensional contrast-enhanced magnetic resonance angiography (CE MRA), using 1.0-mol gadobutrol, with intra-arterial digital subtraction angiography (i.a. DSA) for evaluation of pelvic and peripheral arteries in patients with peripheral arterial occlusive disease. A total of 203 patients were examined in a prospective, multi-centre study at 1.0/1.5 T. Ten vessel segments of one leg were evaluated on-site and by three independent blinded reviewers off-site. One hundred eighty-two patients were evaluable in blinded reading. For pelvis and thigh, there was statistically significant diagnostic agreement between CE MRA and i.a. DSA on-site (94%) and off-site (86-88%). Overall, for detection of clinically significant stenoses, 93% sensitivity and 90% specificity were achieved in on-site evaluation, with 71-76 and 87-93% off-site; for detection of occlusion, sensitivity and specificity on-site were 91 and 97%, with 75-82 and 94-98% off-site. Evaluation was more sensitive on-site than off-site for detection of stenoses and occlusion, whereas specificity was similar. The CE MRA with 1.0-mol gadobutrol gave results comparable to those of i.a. DSA for the larger arteries of pelvis and thigh. Results for calf arteries were compromised by spatial resolution and technical limitations.

Hemobahn stent-grafts for treatment of femoropopliteal arterial obstructions: midterm results of a prospective trial.

PURPOSE: To report a prospective study to evaluate safety, effectiveness, and midterm patency of self-expanding stent-grafts in patients with femoropopliteal occlusive disease. MATERIALS AND METHODS: Sixty-three Hemobahn stent-grafts were used in 52 patients for treatment of medium- or long-segment (>3 cm) occlusions (82.7%) and stenoses (17.3%) of the femoropopliteal artery. The mean length of vessel segments covered was 10.9 cm +/- 5.13. Follow-up with documentation of clinical symptoms, assessment of Rutherford clinical stage of peripheral vascular disease, and color-coded duplex sonography was performed at discharge, at 1, 3, 6, 12, 18, and 24 months after implantation, and yearly thereafter. Mean follow-up duration was 23.8 months +/- 6.9 (range, 8-36 mo). Follow-up data at 12 and 24 months after treatment were available for 47 of 52 (90.4%) and 31 of 52 patients (59.6%), respectively. RESULTS: Device implantation was technically successful in all 52 patients, yielding an overall technical success rate of 100%. Procedure-related complications were observed in 12 of 52 patients (23.1%) and consisted of distal embolization (n = 4, 7.7%), minor groin hematoma (n = 7, 13.5%), and arteriovenous fistula (n = 1, 1.9%), but prolonged hospitalization and further medical, interventional, or surgical measures were not required. Stent-graft placement induced an initial improvement of the mean resting ankle-brachial index from 0.54 +/- 0.12 to 0.89 +/- 0.14 (P <.01). Primary patency rates at 12 and 24 months were 78.4% +/- 5.8 and 74.1% +/- 6.2, respectively. Primary assisted patency rates were 82.4% +/- 5.3 at 12 months and 80.3% +/- 5.6 at 24 months. Secondary patency rates at 12 and 24 months were 88.3% +/- 4.5 and 83.2% +/- 5.5, respectively. There was no significant difference (log-rank test, P >.3) between primary patency rates in patients grouped according to lengths of implanted grafts (ie, length of the treated lesions). CONCLUSION: Endovascular placement of Hemobahn stent-grafts for percutaneous treatment of medium- to long-segment high-grade stenoses and occlusions of the femoropopliteal artery is a safe procedure with excellent initial success rates and promising midterm results.