Clinical Safety of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations.

BACKGROUND: The macrocyclic gadolinium-based contrast agent gadobutrol was introduced to the market in February 1998. Over the last 25 years, gadobutrol has been administered more than 100 million times worldwide providing a wealth of data related to safety. OBJECTIVE: The aim of this study was to perform a thorough review and status update on gadobutrol's safety. MATERIALS AND METHODS: Safety data from the clinical phase II-IV program and postmarketing surveillance were descriptively analyzed from February 1998 until December 31, 2022. Literature on special at-risk populations and specific safety aspects was critically summarized. RESULTS: Forty-five clinical phase II-IV studies recruited 7856 patients receiving gadobutrol. Drug-related adverse events (AEs) were reported in 3.4% and serious AEs in <0.1% of patients. Nausea (0.7%) and dysgeusia (0.4%) were the most reported AEs. All other drug-related AEs occurred ≤0.3%. After more than 100 million gadobutrol administrations, overall adverse drug reactions (ADRs) from postmarketing surveillance (including clinical trials) were rare with an overall reporting rate of 0.0356%, hypersensitivity reactions (0.0147%), nausea (0.0032%), vomiting (0.0025%), and dyspnea (0.0010%). All other ADRs were <0.001%. No trend for higher rates of AEs was found in patients with reduced renal or liver function. Seven clinical studies reported safety findings in 7292 children ≤18 years, thereof 112 newborns/toddlers younger than 2 years. Overall, 61 ADRs (0.84%) were reported, including 3 serious ones. Adverse events in patients ≥65 years of age ("elderly") were significantly less frequent than in younger patients. A total of 4 reports diagnostic of or consistent with nephrogenic systemic fibrosis have been received. No causal relationship has been established between clinical signs and symptoms and the presence of small amounts of gadolinium in the body in patients with normal renal function after use of gadobutrol. CONCLUSIONS: More than 100 million administrations worldwide have shown gadobutrol's well-established benefit-risk profile in any approved indication and populations.

Artificial Intelligence-Based Prediction of Contrast Medium Doses for Computed Tomography Angiography Using Optimized Clinical Parameter Sets.

OBJECTIVES: In this paper, an artificial intelligence-based algorithm for predicting the optimal contrast medium dose for computed tomography (CT) angiography of the aorta is presented and evaluated in a clinical study. The prediction of the contrast dose reduction is modelled as a classification problem using the image contrast as the main feature. METHODS: This classification is performed by random decision forests (RDF) and k-nearest-neighbor methods (KNN). For the selection of optimal parameter subsets all possible combinations of the 22 clinical parameters (age, blood pressure, etc.) are considered using the classification accuracy and precision of the KNN classifier and RDF as quality criteria. Subsequently, the results of the evaluation were optimized by means of feature transformation using regression neural networks (RNN). These were used for a direct classification based on regressed Hounsfield units as well as preprocessing for a subsequent KNN classification. RESULTS: For feature selection, an RDF model achieved the highest accuracy of 84.42% and a KNN model achieved the best precision of 86.21%. The most important parameters include age, height, and hemoglobin. The feature transformation using an RNN considerably exceeded these values with an accuracy of 90.00% and a precision of 97.62% using all 22 parameters as input. However, also the feasibility of the parameter sets in routine clinical practice has to be considered, because some of the 22 parameters are not measured in routine clinical practice and additional measurement time of 15 to 20 minutes per patient is needed. Using the standard feature set available in clinical routine the best accuracy of 86.67% and precision of 93.18% was achieved by the RNN. CONCLUSION: We developed a reliable hybrid system that helps radiologists determine the optimal contrast dose for CT angiography based on patient-specific parameters.

Clinical Efficacy of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations.

BACKGROUND: Gadobutrol has been administered more than 100 million times worldwide, since February 1998, that is, over the last 25 years. Numerous clinical studies in a broad range of indications document the long-term experience with gadobutrol. OBJECTIVE: The aim of this study was to provide a literature-based overview on gadobutrol's efficacy in 9 approved indications and use in children. MATERIALS AND METHODS: Efficacy results in patients of all age groups including sensitivity, specificity, accuracy, and positive/negative predictive values were identified by a systematic literature search on Embase until December 31, 2022. Nine approved indications were considered: central nervous system (CNS), magnetic resonance angiography (MRA), breast, heart, prostate, kidney, liver, musculoskeletal, whole body, and various indications in children. RESULTS: Sixty-five publications (10 phase III, 2 phase IV, 53 investigator-initiated studies) reported diagnostic efficacy results obtained from 7806 patients including 271 children, at 369 centers worldwide. Indication-specific sensitivity ranges were 59%-98% (CNS), 53%-100% (MRA), 80%-100% (breast), 64%-90% (heart), 64%-96% (prostate), 71-85 (kidney), 79%-100% (liver), 53%-98% (musculoskeletal), and 78%-100% (children). Indication-specific specificity ranges were 75%-100% (CNS), 64%-99% (MRA), 58%-98% (breast), and 47%-100% (heart). CONCLUSIONS: The evaluated body of evidence, consisting of 65 studies with 7806 patients, including 271 children and 7535 adults, showed that gadobutrol is an efficacious magnetic resonance imaging contrast agent for all age groups in various approved indications throughout the whole body.

[Statement paper on the implementation of a national organized program in Germany for the early detection of lung cancer in risk populations using low-dose CT screening including management of screening findings]. / Positionspapier zur Implementierung eines nationalen organisierten Programms in Deutschland zur Früherkennung von Lungenkrebs in Risikopopulationen mittels Low-dose-CT-Screening inklusive Management von abklärungsbedürftigen Screeningbefunden.

The process of implementing early detection of lung cancer with low-dose CT (LDCT) in Germany has gained significant momentum in recent years. It is expected that the ordinance of the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV) on the early detection of lung cancer, which has been commented on by the professional societies, will come into effect by the end of 2023. Based on this regulation, the Federal Joint Committee (G-BA) will set up a program for early lung cancer detection with LDCT in the near future. In this position paper, the specialist societies involved in lung cancer screening present key points for a uniform, structured and quality-assured early detection program for lung cancer in Germany to make a constructive contribution to this process. CITATION FORMAT: · Vogel-Claussen J, Blum TG, Andreas S et al. Position paper on the implementation of a nationally organized program in Germany for the early detection of lung cancer in high-risk populations using low-dose CT screening including the management of screening findings requiring further workup. Fortschr Röntgenstr 2024; 196: DOI 10.1055/a-2178-2846.

[Statement paper on the implementation of a national organized program in Germany for the early detection of lung cancer in risk populations using low-dose CT screening including management of screening findings]. / Positionspapier zur Implementierung eines nationalen organisierten Programms in Deutschland zur Früherkennung von Lungenkrebs in Risikopopulationen mittels Low-dose-CT-Screening inklusive Management von abklärungsbedürftigen Screeningbefunden.

The process of implementing early detection of lung cancer with low-dose CT (LDCT) in Germany has gained significant momentum in recent years. It is expected that the ordinance of the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV) on early detection of lung cancer, which has been commented on by the professional societies, will come into effect by the end of 2023. Based on this regulation, the Federal Joint Committee (G-BA) will set up a program for early lung cancer detection with LDCT in the near future. In this position paper, the specialist societies involved in lung cancer screening present concrete cornerstones for a uniform, structured and quality-assured early detection program for lung cancer in Germany to make a constructive contribution to this process.

[Statement Paper on the Implementation of a National Organized Program in Germany for the Early Detection of Lung Cancer in Risk Populations Using Low-dose CT Screening Including Management of Screening Findings]. / Positionspapier zur Implementierung eines nationalen organisierten Programms in Deutschland zur Früherkennung von Lungenkrebs in Risikopopulationen mittels Low-Dose-CT-Screening inklusive Management von abklärungsbedürftigen Screening-Befunden.

The process of implementing early detection of lung cancer with low-dose CT (LDCT) in Germany has gained significant momentum in recent years. It is expected that the ordinance of the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV) on early detection of lung cancer, which has been commented on by the professional societies, will come into effect by the end of 2023. Based on this regulation, the Federal Joint Committee (G-BA) will set up a program for early lung cancer detection with LDCT in the near future. In this position paper, the specialist societies involved in lung cancer screening present concrete cornerstones for a uniform, structured and quality-assured early detection program for lung cancer in Germany to make a constructive contribution to this process.

Random Forest and Gradient Boosted Trees for Patient Individualized Contrast Agent Dose Reduction in CT Angiography.

This work aims to recognize the patient individual possibility of contrast dose reduction in CT angiography. This system should help to identify whether the dose of contrast agent in CT angiography can be reduced to avoid side effects. In a clinical study, 263 CT angiographies were performed and, in addition, 21 clinical parameters were recorded for each patient before contrast agent administration. The resulting images were labeled according to their contrast quality. It is assumed that the contrast dose could be reduced for CT angiography images with excessive contrast. These data was used to develop a model for predicting excessive contrast based on the clinical parameters using logistic regression, random forest, and gradient boosted trees. In addition, the minimization of clinical parameters required was investigated to reduce the overall effort. Therefore, models were tested with all subsets of clinical parameters and each parameter's importance was examined. In predicting excessive contrast in CT angiography images covering the aortic region, a maximum accuracy of 0.84 was achieved by a random forest with 11 clinical parameters; for the leg-pelvis region data, an accuracy of 0.87 was achieved by a random forest with 7 parameters; and for the entire data set, an accuracy of 0.74 was achieved by gradient boosted trees with 9 parameters.

Repeatability and reproducibility of various 4D Flow MRI postprocessing software programs in a multi-software and multi-vendor cross-over comparison study.

BACKGROUND: Different software programs are available for the evaluation of 4D Flow cardiovascular magnetic resonance (CMR). A good agreement of the results between programs is a prerequisite for the acceptance of the method. Therefore, the goal was to compare quantitative results from a cross-over comparison in individuals examined on two scanners of different vendors analyzed with four postprocessing software packages. METHODS: Eight healthy subjects (27 ± 3 years, 3 women) were each examined on two 3T CMR systems (Ingenia, Philips Healthcare; MAGNETOM Skyra, Siemens Healthineers) with a standardized 4D Flow CMR sequence. Six manually placed aortic contours were evaluated with Caas (Pie Medical Imaging, SW-A), cvi42 (Circle Cardiovascular Imaging, SW-B), GTFlow (GyroTools, SW-C), and MevisFlow (Fraunhofer Institute MEVIS, SW-D) to analyze seven clinically used parameters including stroke volume, peak flow, peak velocity, and area as well as typically scientifically used wall shear stress values. Statistical analysis of inter- and intrareader variability, inter-software and inter-scanner comparison included calculation of absolute and relative error (ER), intraclass correlation coefficient (ICC), Bland-Altman analysis, and equivalence testing based on the assumption that inter-software differences needed to be within 80% of the range of intrareader differences. RESULTS: SW-A and SW-C were the only software programs showing agreement for stroke volume (ICC = 0.96; ER = 3 ± 8%), peak flow (ICC: 0.97; ER = -1 ± 7%), and area (ICC = 0.81; ER = 2 ± 22%). Results from SW-A/D and SW-C/D were equivalent only for area and peak flow. Other software pairs did not yield equivalent results for routinely used clinical parameters. Especially peak maximum velocity yielded poor agreement (ICC ≤ 0.4) between all software packages except SW-A/D that showed good agreement (ICC = 0.80). Inter- and intrareader consistency for clinically used parameters was best for SW-A and SW-D (ICC = 0.56-97) and worst for SW-B (ICC = -0.01-0.71). Of note, inter-scanner differences per individual tended to be smaller than inter-software differences. CONCLUSIONS: Of all tested software programs, only SW-A and SW-C can be used equivalently for determination of stroke volume, peak flow, and vessel area. Irrespective of the applied software and scanner, high intra- and interreader variability for all parameters have to be taken into account before introducing 4D Flow CMR in clinical routine. Especially in multicenter clinical trials a single image evaluation software should be applied.

German Radiological Society and the Professional Association of German Radiologists Position Paper on Coronary computed tomography: Clinical Evidence and Quality of Patient Care in Chronic Coronary Syndrome. / Positionspapier von DRG und BDR zur Computertomografie des Herzens: Klinische Evidenz und Versorgungsqualität beim chronischen Koronarsyndrom.

This position paper is a joint statement of the German Radiological Society (DRG) and the Professional Association of German Radiologists (BDR), which reflects the current state of knowledge about coronary computed tomography. It is based on preclinical and clinical studies that have investigated the clinical relevance as well as the technical requirements and fundamentals of cardiac computed tomography. CITATION FORMAT: · Langenbach MC, Sandstede J, Sieren M et al. DRG and BDR Position Paper on Coronary CT: Clinical Evidence and Quality of Patient Care in Chronic Coronary Syndrome. Fortschr Röntgenstr 2023; 195: 115 - 133.

Design and Rationale of the HANSE Study: A Holistic German Lung Cancer Screening Trial Using Low-Dose Computed Tomography.

Despite the high prevalence and mortality of lung cancer and proven effectiveness of low-dose computed tomography (LDCT) to reduce mortality, Germany still lacks a national screening program. The German Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Office for Radiation Protection (BfS) both published positive scientific evaluations recommending a quality-controlled national screening program. IQWiG underlined the importance of a clear risk definition, integrated smoking cessation programs, and quality assurance, highlighting the necessity of procedural optimization.In the HANSE study, former and current smokers aged 55-79 years are assessed for their lung cancer risk by the NELSON and PLCOM2012 risk scores. 5000 high-risk participants, defined as PLCOM2012 6-year risk ≥ 1.58 % or fulfilling NELSON risk inclusion criteria, will be screened by LDCT at baseline and after 12 months. Lung nodules are analyzed by a modified Lung-RADS 1.1 score of the HANSE study, and values of emphysema and coronary calcium are determined and randomly reported to the participants. 7100 low-risk participants serve as a control. All patients are followed-up for up to 10 years. The sensitivity and specificity of the two risk assessments and LDCT screening, effects of the randomized LDCT reporting, efficiency of lung nodule management, and several other factors are assessed to analyze the success and quality of the holistic screening program.The HANSE study is designed as a holistic lung cancer screening study in northern Germany to answer pressing questions for a successful implementation of an effective German lung cancer screening program. · HANSE is designed to address pressing questions for the implementation of lung cancer screening in Germany.. · HANSE compares NELSON and PLCOM2012 risk assessments for optimal definition of the high-risk group. . · HANSE integrates cardiac calcium and pulmonary emphysema scoring in a holistic screening approach.. CITATION FORMAT: · Vogel-Claussen J, Lasch F, Bollmann B et al. Design and Rationale of the HANSE Study: A Holistic German Lung Cancer Screening Trial Using Low-Dose Computed Tomography. Fortschr Röntgenstr 2022; 194: 1333 - 1345.

Work and Training Conditions of German Residents and Young Radiologists in Interventional Radiology - A Nationwide Survey.

With the increasing need for minimally invasive procedures based on lower complication rates, higher patient acceptance, and technical developments, there is a growing focus on the sound interventional training of young radiologists. This survey aimed to analyze the current situation in interventional radiology (IR) training in Germany to detect shortcomings and identify areas for improvement.From November 1-30, 2020, an online questionnaire was distributed to representative radiological associations and societies with the request to forward it to radiology residents and radiologists < 40 years. The 44 questions covered six distinct areas from personal working conditions to the characterization of the IR department, training conditions, role of women in IR, and attendance at congresses/external training.A total of 330 participants completed the questionnaire. 77 % of participants expressed a high interest in IR, and 47 % could even imagine subspecializing in interventional radiology. Most institutions provided the necessary learning conditions and infrastructure. The rate of overall satisfaction with IR training conditions was 45 % (vs. a dissatisfaction rate of 39 %). However, females showed a lower satisfaction rate with their training environment than male participants (28 % vs. 51 %; P = 0.06). Positive correlations with work satisfaction were found for the presence and duration of the IR rotation, the number of partly independently/mentored performed interventions, and structured feedback. Moreover, the need for a structured training curriculum was expressed by 67 % of participants.Radiological residents and young radiologists expressed a high interest in interventional radiology, and they rate the infrastructure of German hospitals regarding IR as sufficient. However, they expressed the need for consistent IR rotations and better-structured resident and postgraduate education (curricula & interviews).Interest in interventional radiology among radiological residents and young radiologists in Germany is high, but satisfaction with interventional radiology training leaves room for improvement. The most frequently mentioned aspects that can improve IR training were · organized rotations of at least 6 months. · structured curriculums with face-to-face feedback. · structured guidance by senior interventionists during procedures. CITATION FORMAT: · Sieren M, Katoh M, Mahnken AH et al. Work and Training Conditions of German Residents and Young Radiologists in Interventional Radiology - A Nationwide Survey. Fortschr Röntgenstr 2022; 194: 1346 - 1357.

First Dedicated Balloon Catheter for Magnetic Particle Imaging.

Vascular interventions are a promising application of Magnetic Particle Imaging enabling a high spatial and temporal resolution without using ionizing radiation. The possibility to visualize the vessels as well as the devices, especially at the same time using multi-contrast approaches, enables a higher accuracy for diagnosis and treatment of vascular diseases. Different techniques to make devices MPI visible have been introduced so far, such as varnish markings or filling of balloons. However, all approaches include challenges for in vivo applications, such as the stability of the varnishing or the visibility of tracer filled balloons in deflated state. In this contribution, we present for the first time a balloon catheter that is molded from a granulate incorporating nanoparticles and can be visualized sufficiently in MPI. Computed tomography is used to show the homogeneous distribution of particles within the material. Safety measurements confirm that the incorporation of nanoparticles has no negative effect on the balloon. A dynamic experiment is performed to show that the inflation as well as deflation of the balloon can be imaged with MPI.

Sensitivity of Contrast-Enhanced Breast MRI vs X-ray Mammography Based on Cancer Histology, Tumor Grading, Receptor Status, and Molecular Subtype: A Supplemental Analysis of 2 Large Phase III Studies.

Background: The impact of certain tumor parameters on the sensitivity of imaging tools is unknown. The purpose was to study the impact of breast cancer histology, tumor grading, single receptor status, and molecular subtype on the sensitivity of contrast-enhanced breast magnetic resonance imaging (CE-BMRI) vs X-ray mammography (XRM) to detect breast cancer. Materials and Methods: We ran a supplemental analysis of 2 global Phase III studies which recruited patients with histologically proven breast cancers. The sensitivity of CE-BMRI vs XRM to detect cancer lesions with different histologies, tumor grading, single receptor status, and molecular subtype was compared. Six blinded readers for each study evaluated the images. Results were summarized as the "Mean Reader." For each reader, sensitivity was defined as the proportion of detected lesions vs the total number of lesions identified by the standard of reference. Two-sided 95% confidence intervals were calculated for within-group proportions, and for the difference between CE-BMRI and XRM, using a normal approximation to the binomial distribution. Results: In 778 patients, 1273 cancer lesions were detected. A total of 435 patients had 1 lesion, 254 had 2 lesions, and 77 had 3 or more lesions. The sensitivity of CE-BMRI was significantly higher compared with XRM irrespective of the histology. The largest difference was seen for invasive lobular carcinoma (22.3%) and ductal carcinoma in situ (19%). Across all 3 tumor grades, the sensitivity advantage of CE-BMRI over XRM ranged from 15.7% to 18.5%. Contrast-enhanced breast magnetic resonance imaging showed higher sensitivity compared with XRM irrespective of single receptor expressions (15.3%-19.4%). The sensitivities for both imaging methods were numerically higher for the more aggressive ER- (estrogen receptor), PR- (progesterone receptor), and HER2+ (human epidermal growth factor receptor 2) tumors. Irrespective of molecular subtype, sensitivity of CE-BMRI was 14.8% to 18.9% higher compared with XRM. Conclusions: Contrast-enhanced breast magnetic resonance imaging showed significantly higher sensitivity compared with XRM independent of tumor histology, tumor grading, single receptor status, and molecular subtype.Trial Registration: ClinicalTrials.gov: NCT01067976 and NCT01104584.

Sarcomas of fat and bone: a case report.

Osteosarcomas are the most common primary malignant bone tumors and are classified by the WHO into several intramedullary and surface subtypes. One of these is the rare parosteal osteosarcoma. Liposarcomas are the second most common soft tissue sarcoma and are classified into several types ranging from intermediate to high grade tumors. In one of our recent patients we found an unusual combination of a parosteal osteosarcoma and a large fatty component, which fluorescence-in-situ-hybridization revealed as liposarcoma. Radiologists, pathologists, and surgeons should consider the possibility of bone and soft tissue malignancies consisting of different components, as this may be of paramount importance for oncologically complete resection.

CoRad-19 - Modular Digital Teaching during the SARS-CoV-2 Pandemic. / CoRad-19 ­ Modulare Digitale Lehre während der SARS-CoV-2-Pandemie.

PURPOSE: During the SARS-CoV-2 pandemic, higher education worldwide had to switch to digital formats. The purpose of this study was to evaluate CoRad-19, a digital teaching tool created by the German Radiological Society for medical students during the COVID-19 pandemic. MATERIALS AND METHODS: A total of 13 German-speaking universities implemented CoRad-19 in their curriculum and partially or completely replaced their classes with the online courses. Previous experience and contact with radiology and the participants' opinions regarding the medium of e-learning were surveyed using a custom questionnaire. The subjective level of knowledge regarding the individual modules was also surveyed before and after participation to measure learning effects. The data of 994 medical students from the participating sites were analyzed and compared intraindividually using the Friedman test. RESULTS: From 4/1/2020-10/1/2020, 451 complete data sets from a total of 994 surveys were included. E-learning was rated "very useful" both before and after course participation (4 [IQR 3-4], p = 0.527, r = 0.16). E-learning as a method was also rated as a "very good" medium both before and after participation (4 [IQR 3-4], p = 0.414, r = 0.17). After participation, participants rated radiology as particularly suitable for digital teaching (before: 3 [IQR 3-4] vs. after 4 [IQR 3-4], p = 0.005, r = 0.6). Significant learning gains were measurable in all course modules (p ≤ 0.009). Post-hoc analysis showed interest in radiology to increase significantly after course participation (p = 0.02). CONCLUSION: In the representative survey, significant learning effects were observed in all course modules. In addition, it should be particularly emphasized that the students' interest in radiology was increased by course participation. Thus, the German Radiological Society provided significant support to German-speaking medical faculties with respect to maintaining excellent education using CoRad-19. KEY POINT: · Co-Rad-19 course participation results in measurable subjective learning effects and increases student interest in radiology.. CITATION FORMAT: · Brendlin AS, Molwitz I, Oechtering TH et al. CoRad-19 - Modular Digital Teaching during the SARS-CoV-2 Pandemic. Fortschr Röntgenstr 2022; 194: 644 - 651.

Current Status of Cardiovascular Imaging in Germany: Structured Data from the National Certification Program, ESCR Registry, and Survey among Radiologists.

PURPOSE: In the light of the increasing importance of cardiovascular cross-sectional imaging in current guidelines, the goal of this study is to provide a comprehensive overview of cardiovascular imaging (CVI) offered by radiological institutions across Germany. MATERIALS AND METHODS: Data were extracted from the national certification program database of the German Roentgen Society (DRG) from 2015-2021. A nationwide online survey among radiology institutes (university hospitals, non-university hospitals, and private practices) was conducted for 2019, and data was extracted from the European Society of Cardiovascular Radiology (ESCR) registry. The data collection's key points included the number of centers and individuals certified for CVI, the number of cardiac CT and MRI examinations performed, the reporting habits, and the participation in the ESCR registry. RESULTS: 71 centers and 1278 persons, both with a substantial increase since 2015, were registered and certified by the DRG to perform CVI. According to the survey, a total of 69,286 CT and 64,281 MRI examinations were performed annually. Data from the survey and the ESCR registry indicated that reporting was mostly done solely by radiologists or, to a lesser degree, in joint consensus meetings with non-radiologists. The overall participation rate in the ESCR registry was 48 % among the survey's participants. CONCLUSION: This comprehensive analysis demonstrates that high-quality CVI by radiologists is available nationwide. The current challenges are to provide the best medical and technical quality of CVI by radiology for patient care and to ensure economic sustainability in the German health care system to accommodate the predicted substantial need for CVI in the future. KEY POINTS: · High-quality advanced CVI service by radiologists is available nationwide.. · Highly qualified specialist knowledge is widely represented from university to private practices.. · Certification programs successfully contribute to the dissemination & deepening of CVI expertise.. · The ESCR registry is an established international tool for the documentation of CVI.. CITATION FORMAT: · Sieren M, Maintz D, Gutberlet M et al. Current Status of Cardiovascular Imaging in Germany: Structured Data from the National Certification Program, ESCR Registry, and Survey among Radiologists. Fortschr Röntgenstr 2022; 194: 181 - 191.

Comprehensive analysis of haemodynamics in patients with physiologically curved prostheses of the ascending aorta.

OBJECTIVES: This is a comprehensive analysis of haemodynamics after valve-sparing aortic root replacement (VSARR) with anatomically curved prosthesis (CP) compared to straight prosthesis (SP) and age-matched volunteers (VOL) using 4D flow MRI (time-resolved three-dimensional magnetic resonance phase-contrast imaging). METHODS: Nine patients with 90° CP, nine patients with SP, and twelve VOL were examined with 4D flow MRI. Analyses included various characteristic anatomical, qualitative and quantitative haemodynamic parameters. RESULTS: Grading of secondary flow patterns was lower in CP patients than in SP patients (P = 0.09) and more comparable to VOL, albeit not reaching statistical significance. However, it was easy to differentiate between VSARR patients and healthy volunteers: Patients more often had angular aortic arches (CP: 89%, SP: 100%; VOL: 17%; P ≤ 0.002), increased average curvature (CP: 0.17/cm [0.15, 0.18]; SP: 0.15/cm [0.14, 0.16]; VOL: 0.14/cm [0.13, 0.16]; P ≤ 0.007; values given as median [interquartile range]), and more secondary flow patterns (CP: 3 [2, 4] SP: 3 [2, 3] VOL: 2 [1, 2]; P < 0.01). Maximum circulation (CP: 142.7 cm2/s [116.1, 187.3]; SP: 101.8 cm2/s [77.7, 132.5]; VOL: 42.8cm2/s [39.3, 65.6]; P ≤ 0.002), maximum helicity density (CP: 9.6 m/s2 [9.3, 23.9]; SP: 9.7 m/s2 [8.6, 12.5]; VOL 4.9 m/s2 [4.2, 7.7]; P ≤ 0.007), and wall shear stress gradient (e.g., proximal ascending aorta CP: 0.97 N/m2 [0.54, 1.07]; SP: 1.08 N/m2 [0.74, 1.24]; VOL: 0.41 N/m2 [0.32, 0.60]; P ≤ 0.01) were increased in patients. One CP patient had a round aortic arch with physiological haemodynamic parameters. CONCLUSIONS: The restoration of physiological aortic configuration and haemodynamics was not fully achieved with the curved prostheses in our study cohort. However, there was a tendency towards improved haemodynamic conditions in the patients with curved prostheses overall but without statistical significance. A single patient with a CP and near-physiological configuration of the thoracic aorta underlines the importance of optimizing postoperative geometric conditions for allowing for physiological haemodynamics and cardiovascular energetics after VSARR.

Retrograde Revascularization of Tibial Arteries in Patients with Critical Limb Ischemia: Plantar-Arch Versus Transpedal Approach.

PURPOSE: To compare retrograde plantar-arch and transpedal-access approach for revascularization of below-the-knee (BTK) arteries in patients with critical limb ischemia (CLI) after a failed antegrade approach. MATERIALS AND METHODS: Retrospectively we identified 811 patients who underwent BTK revascularization between 1/2014 and 1/2020. In 115/811 patients (14.2%), antegrade revascularization of at least 1 tibial artery had failed. In 67/115 (58.3%), patients retrograde access to the target vessel was achieved via the femoral access and the plantar-arch (PLANTAR-group); and in 48/115 patients (41.7%) retrograde revascularization was performed by an additional retrograde puncture (TRANSPEDAL-group). Comorbidities, presence of calcification at pedal-plantar-loop/transpedal-access-site, and tibial-target-lesion was recorded. Endpoints were technical success (PLANTAR-group: crossing the plantar-arch; TRANSPEDAL-group: intravascular placement of the pedal access sheath), procedural success [residual stenosis <30% after plain old balloon angioplasty (POBA)], and procedural complications limb salvage and survival. Correlations between calcification at access site/tibial-target-lesion and technical/procedural-success were tested. RESULTS: Technical success was achieved in 50/67 (75%) patients of the PLANTAR-group and in 39/48 (81%) patients of the TRANSPEDAL-group (p=0.1). Procedural success was obtained in 23/67 (34%) patients of the PLANTAR-group and in 25/48 (52%) patients of the TRANSPEDAL-group (p=0.04). In 14/49 (29%) cases with calcification at the pedal-plantar loop, technical success was not achieved (p=0.04), and in 33/44 (75%) patients with calcification at the tibial-target-lesion, procedural success was not attained (PLANTAR-group) (p=0.026). In the TRANSPEDAL-group, correlations between calcification at access site/tibial-target-lesion and technical/procedural-success were not observed (p=0.2/p=0.4). In the PLANTAR-group, minor complications occurred in 13/67 (19%) and in the TRANSPEDAL-group in 4/48 patients (8%) (p=0.08). Limb salvage at 12 (18) months was 90% (82%) (PLANTAR-group; 95%CI 15.771-18.061) and 84% (76%) (TRANSPEDAL-group; 95%CI 14.475-17.823) (Log-rank p=0.46). Survival at 12 (18) months was 94% (86%) (PLANTAR-group; 95%CI 16.642-18.337) and 85% (77%) (TRANSPEDAL; 95%CI 14.296-17.621) (Log-rank p=0.098). CONCLUSION: Procedural success was significantly higher using the transpedal-access approach. Calcifications at pedal-plantar loop and target-lesion significantly influenced technical/procedural failure using the plantar-arch approach. No significant difference between both retrograde techniques in terms of feasibility, safety, and limb salvage/survival was found.