Objective structured clinical examination to teach competency in planetary health care and management - a prospective observational study.

BACKGROUND: Health professionals are increasingly called upon and willing to engage in planetary health care and management. However, so far, this topic is rarely covered in medical curricula. As the need for professional communication is particularly high in this subject area, this study aimed to evaluate whether the objective structured clinical examination (OSCE) could be used as an accompanying teaching tool. METHODS: During the winter semester 2022/2023, 20 third- and fifth-year medical students voluntarily participated in a self-directed online course, three workshops, and a formal eight-station OSCE on planetary health care and management. Each examinee was also charged alternatingly as a shadower with the role of providing feedback. Experienced examiners rated students' performance using a scoring system supported by tablet computers. Examiners and shadowers provided timely feedback on candidates` performance in the OSCE. Immediately after the OSCE, students were asked about their experience using a nine-point Likert-scale survey and a videotaped group interview. Quantitative analysis included the presentation of the proportional distribution of student responses to the survey and of box plots showing percentages of maximum scores for the OSCE performance. The student group interview was analyzed qualitatively. RESULTS: Depending on the sub-theme, 60% -100% of students rated the subject of planetary health as likely to be useful in their professional lives. Similar proportions (57%-100%) were in favour of integrating planetary health into required courses. Students perceived learning success from OSCE experience and feedback as higher compared to that from online courses and workshops. Even shadowers learned from observation and feedback discussions. Examiners assessed students' OSCE performance at a median of 80% (interquartile range: 83%-77%) of the maximum score. CONCLUSIONS: OSCE can be used as an accompanying teaching tool for advanced students on the topic of planetary health care and management. It supports learning outcomes, particularly in terms of communication skills to sensitise and empower dialogue partners, and to initiate adaptation steps at the level of individual patients and local communities.

Men with erectile dysfunction (ED) should be screened for cardiovascular risk factors - Cost-benefit considerations in Swiss men.

Background: Current evidence indicates that erectile dysfunction (ED) is an independent risk factor for future cardiovascular events. This study aimed to estimate the cost-effectiveness of screening and subsequent preventive treatment for cardiovascular risk factors among men newly diagnosed with ED from the Swiss healthcare system perspective. Methods: Based on known data on ED and cardiovascular disease (CVD) prevalence and incidence costs and effects of a screening intervention for cardiovascular risk including corresponding cardiovascular prevention in men with ED were calculated for the Swiss population over a period of 10 years. Results: Screening and cardiovascular prevention over a period of 10 years in Swiss men with ED of all seriousness degrees, moderate and severe ED only, or severe ED only can probably avoid 41,564, 35,627, or 21,206 acute CVD events, respectively. Number needed to screen (NNS) to prevent one acute CVD event is 30, 23, and 10, respectively. Costs for the screening intervention are expected to be covered at the seventh, the fifth, and the first year, respectively. Conclusion: Screening and intervention for cardiovascular risk factors in men suffering from ED is a cost-effective tool not only to strengthen prevention and early detection of cardiovascular diseases but also to avoid future cardiovascular events.

Artificial intelligence for assistance of radiology residents in chest CT evaluation for COVID-19 pneumonia: a comparative diagnostic accuracy study.

BACKGROUND: In hospitals, it is crucial to rule out coronavirus disease 2019 (COVID-19) timely and reliably. Artificial intelligence (AI) provides sufficient accuracy to identify chest computed tomography (CT) scans with signs of COVID-19. PURPOSE: To compare the diagnostic accuracy of radiologists with different levels of experience with and without assistance of AI in CT evaluation for COVID-19 pneumonia and to develop an optimized diagnostic pathway. MATERIAL AND METHODS: The retrospective, single-center, comparative case-control study included 160 consecutive participants who had undergone chest CT scan between March 2020 and May 2021 without or with confirmed diagnosis of COVID-19 pneumonia in a ratio of 1:3. Index tests were chest CT evaluation by five radiological senior residents, five junior residents, and an AI software. Based on the diagnostic accuracy in every group and on comparison of groups, a sequential CT assessment pathway was developed. RESULTS: Areas under receiver operating curves were 0.95 (95% confidence interval [CI]=0.88-0.99), 0.96 (95% CI=0.92-1.0), 0.77 (95% CI=0.68-0.86), and 0.95 (95% CI=0.9-1.0) for junior residents, senior residents, AI, and sequential CT assessment, respectively. Proportions of false negatives were 9%, 3%, 17%, and 2%, respectively. With the developed diagnostic pathway, junior residents evaluated all CT scans with the support of AI. Senior residents were only required as second readers in 26% (41/160) of the CT scans. CONCLUSION: AI can support junior residents with chest CT evaluation for COVID-19 and reduce the workload of senior residents. A review of selected CT scans by senior residents is mandatory.

[Angioplasty with Sirolimus-coated Balloon: the New Standard in the Treatment of PAD?] / Angioplastie mit Sirolimus-beschichtetem Ballon: der neue Standard in der Behandlung der PAVK?

Endovascular revascularisation with paclitaxel-coated balloons for the treatment of peripheral artery disease has been shown to be an effective therapeutic option in the femoropopliteal segment. The antiproliferative effect of paclitaxel prevents restenosis. In contrast, in the infra-popliteal segment, the evidence is currently conflicting. However, there is evidence of an increased risk of amputation and mortality from the second year after angioplasty with paclitaxel-coated balloons. This may be due to a dose-dependent cytotoxic effect of paclitaxel. Sirolimus-coated balloons might therefore be an alternative because sirolimus is cytostatic rather than cytotoxic and thus has a wide therapeutic window.Three single-arm pilot studies (50, 25, and 50 patients, respectively) show that angioplasty with sirolimus-coated balloons leads to comparable results to those reported from paclitaxel-coated balloons (late lumen loss at 6 months: 0.29 mm; primary patency at 12 months: femoropopliteal 79%-82%, infra-popliteal 59%; freedom from target lesion revascularization at 12 months: femoropopliteal 83%-94%, infra-popliteal 86%). Randomised controlled trials comparing standard balloon angioplasty and paclitaxel-coated balloons for the treatment of intermittent claudication or chronic limb-threatening ischaemia are active and are expected to provide efficacy and safety results from mid 2024.This review presents the results of pilot studies on angioplasty with sirolimus-coated balloons for the treatment of peripheral artery disease and reviews currently ongoing randomised controlled trials.

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry.

PURPOSE: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. MATERIALS AND METHODS: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. RESULTS: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6-98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0-94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4-98.1) and 93.8% (95% CI, 89.9-97.6) at 12 and 24 months, respectively. CONCLUSIONS: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).

Diabetes mellitus and femoropopliteal in-stent restenosis.

Background: The influence of diabetes mellitus (DM) on recurrent in-stent restenosis (ISR) of femoropopliteal arteries remains understudied. We investigated whether DM has an impact on recurrent restenosis after femoropopliteal stenting in patients included in the dRug-coatEd balloon angioPlasty for femoropopliteAl In-stent Restenosis (REPAIR) cooperation. Patients and methods: The REPAIR cooperation pooled the patient-level data from 3 randomized trials in which patients with ISR of femoropopliteal arteries received either drug-coated balloon (DCB) or plain balloon angioplasty. For this analysis, patients were divided in two groups based on whether they had or had not a DM diagnosis at the time of enrollment. The primary outcome was target lesion revascularization (TLR). The main secondary outcome was recurrent ISR. Other outcomes of interest were death, Rutherford class improvement and ankle-brachial index at follow-up. Results: 256 patients (DM, n=99 vs. non-DM, n=157) with 12-month follow-up were included in the analysis. Compared to non-DM patients, DM patients displayed no difference in terms of TLR [adjusted hazard ratio (95% Confidence intervals): 0.96 (0.55, 1.69), p=0.89] and recurrent ISR [1.04 (0.61, 1.77), p=0.88], whilst mortality was higher [9.38 (1.06, 83.11), p=0.044]. There were no differences between groups with respect to other secondary outcomes. The percutaneous treatment with DCB as compared to plain balloon angioplasty significantly reduced the risk of TLR and recurrent ISR without an excess risk of death irrespective of DM (p for interaction ≥0.70). Conclusions: In patients with femoropopliteal ISR, diabetes has a neutral effect on the risk of recurrence, but increases mortality at 12-month follow-up. DCB as compared to plain balloon angioplasty is associated with superior efficacy without trade-off in safety, regardless of diabetes.

Ruling out COVID-19 by chest CT at emergency admission when prevalence is low: the prospective, observational SCOUT study.

BACKGROUND: It is essential to avoid admission of patients with undetected corona virus disease 2019 (COVID-19) to hospitals' general wards. Even repeated negative reverse transcription polymerase chain reaction (RT-PCR) results do not rule-out COVID-19 with certainty. The study aimed to evaluate a rule-out strategy for COVID-19 using chest computed tomography (CT) in adults being admitted to the emergency department and suspected of COVID-19. METHODS: In this prospective, single centre, diagnostic accuracy cohort study, consecutive adults (≥ 18 years) presenting with symptoms consistent with COVID-19 or previous contact to infected individuals, admitted to the emergency department and supposed to be referred to general ward were included in March and April 2020. All participants underwent low-dose chest CT. RT-PCR- and specific antibody tests were used as reference standard. Main outcome measures were sensitivity and specificity of chest CT. Predictive values were calculated based on the theorem of Bayes using Fagan's nomogram. RESULTS: Of 165 participants (56.4% male, 71 ± 16 years) included in the study, the diagnosis of COVID-19 was confirmed with RT-PCR and AB tests in 13 participants (prevalence 7.9%). Sensitivity and specificity of chest CT were 84.6% (95% confidence interval [CI], 54.6-98.1) and 94.7% (95% CI, 89.9-97.7), respectively. Positive and negative likelihood ratio of chest CT were 16.1 (95% CI, 7.9-32.8) and 0.16 (95% CI, 0.05-0.58) and positive and negative predictive value were 57.9% (95% CI, 40.3-73.7) and 98.6% (95% CI, 95.3-99.6), respectively. CONCLUSION: At a low prevalence of COVID-19, chest CT could be used as a complement to repeated RT-PCR testing for early COVID-19 exclusion in adults with suspected infection before referral to hospital's general wards. Trial registration ClinicalTrials.gov: NCT04357938 April 22, 2020.

Access Site Complications of Peripheral Endovascular Procedures: A Large, Prospective Registry on Predictors and Consequences.

PURPOSE: The purpose of this study was to investigate predictors and consequences of acute vascular access site complications (ASCs) related to peripheral endovascular diagnostic or interventional procedures. Despite improvement of puncture techniques, access site-related morbidity and mortality is still considerable. MATERIALS AND METHODS: A total of 5263 participants who underwent 5385 endovascular procedures at a single center were consecutively included in this prospective, observational study. Primary outcomes were ASCs defined as composite of puncture site hematoma, pseudoaneurysm, arteriovenous fistula, and overt puncture site bleeding on the first day after procedure. RESULTS: ASCs occurred in 16.6% of peripheral endovascular procedures (78.6% hematomas, 18.9% pseudoaneurysms, 1.4% arteriovenous fistulas, 1.1% overt bleedings). Independent predictors were advanced age [odds ratio (OR) per 10 years: 1.12, p=0.004], female sex (OR men, 0.77; p=0.001), lysis (OR 3.56; p<0.001), periprocedural heparin (OR 5000 IU, 1.96; p=0.001; OR >5000 IU, 3.56; p=0.02), time to access (OR per 10 seconds, 1.01; p<0.001), sheath size (OR per French, 1.59; p<0.001), brachial artery access (OR vs retrograde transfemoral, 4.58; p<0.001), and compression only (OR Angio-Seal, 0.57, p=0.02; ProGlide, 0.36, p<0.001; FemoSeal, 0.57, p<0.001). Treatment was required in 20.2% and prolonged hospitalization in 17.7% of ASC. Three participants died from access site-related bleeding. CONCLUSION: ASCs after peripheral endovascular procedures are associated with advanced age, female sex, periprocedural antithrombotic medication, brachial artery access, postinterventional bleeding, and nonuse of vascular closure devices.

Virtual inverted classroom to replace in-person radiology lectures at the time of the COVID-19 pandemic - a prospective evaluation and historic comparison.

BACKGROUND: In the time of the coronavirus disease 2019 (COVID-19) pandemic, in-person lectures had to be shifted to online learning. This study aimed to evaluate students' and lecturers' perception and effectiveness of a virtual inverted classroom (VIC) concept on clinical radiology in comparison to a historic control. METHODS: In the winter semester 2020/21, 136 fourth year medical students who completed the clinical radiology VIC during the pandemic, were included in the single centre, prospective study. Results were compared with a historic control that had finished the physical inverted classroom (PIC) in the immediately preceding year. The VIC consisted of an initial phase of self-determined preparation with learning videos and a second interactive phase of clinical case studies alternating between the virtual lecture hall and virtual buzz groups. At the end of the lecture series, students rated the lecture on a scale of 1 (most positive assessment) to 6 (most negative assessment) through an online survey platform. Additionally, they reported their impressions in free-form text. Lecturers were invited to comment on the VIC in a group interview. Main outcomes were final grades and student perception of the VIC. RESULTS: Students' general impression of VIC was lower than that of PIC (median value of 3 [IQR 4, 2] and 1 [IQR 0, 0], p < 0.001), respectively, p < 0.001). The highest rating was achieved concerning use of the audience response system (median 1 [IQR 1, 0]), and the lowest concerning the buzz groups (median 4 [IQR 5, 3]). Students stated that they would have appreciated more details on reading images, greater focus on plenary case studies, and provision of exam related scripts. Lecturers would have liked better preparation by students, more activity of students, and stronger assistance for group support. Exam grades after VIC were better than after PIC (median 1 [IQR 2, 1] and 2 [IQR 2,1], respectively, p < 0.001). CONCLUSIONS: Students' overall perception of VIC was satisfactory, although worse than PIC. Final grades improved compared to PIC. Provided an adapted buzz group size and support, VIC may serve as complement in medical education once the pandemic is over.

Structured work-based learning in undergraduate clinical radiology immersion experience.

BACKGROUND: Practical courses in undergraduate medical training often lack a didactic concept. Active participation and learning success largely depend on chance. This study was initiated to evaluate a novel concept of structured work-based learning (WBL) in the course of students' half-day radiology immersion experience (IE). METHODS: This prospective, single-centre cohort study included 228 third-year students of the 2019 summer semester who underwent the obligatory radiology IE at a university hospital. The course was based on a novel structured WBL concept that applied established didactic concepts including blended learning, the FAIR principles of feedback, activity, individualization, and relevance, and Peyton's four-step approach. Outcomes of equal weight were student and supervisor satisfaction with the clinical radiology IE assessed by paper-based- and online survey, respectively. Secondary outcome was achievement of intended learning outcomes assessed by means of mini clinical evaluation exercises and personal interviews. RESULTS: Satisfaction with structured WBL was high in 99.0% of students. Students' expectations were exceeded, and they felt taken seriously at the professional level. Dissatisfaction was reasoned with quality of learning videos (0.6%), little support by supervisors (0.5%), or inadequate feedback (0.6%). Supervising resident physicians rated achievement of intended learning outcomes regarding cognitive and psychomotor competences as excellent for all students. Personal interviews revealed achievement of affective competence in some students. Twelve of 16 (75.0%) supervising physicians were satisfied with focussing on intended learning outcomes and student preparation for IE. Two of 15 (13.3%) supervisors were unsatisfied with time spent, and 4 of 16 (25%) with the approach of assessment. CONCLUSIONS: This study demonstrated that both students and supervisors were satisfied with the novel concept of structured WBL within the scope of clinical radiology IE. Achievement of intended learning outcomes was promising.

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial.

BACKGROUND: Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. METHODS AND RESULTS: One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related. CONCLUSIONS: DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01305070.

German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization.

PURPOSE: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants. METHODS: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047). CONCLUSION: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

Added value of chest CT in a machine learning-based prediction model to rule out COVID-19 before inpatient admission: A retrospective university network study.

PURPOSE: During the coronavirus disease 2019 (COVID-19) pandemic, hospitals still face the challenge of timely identification of infected individuals before inpatient admission. An artificial intelligence approach based on an established clinical network may improve prospective pandemic preparedness. METHOD: Supervised machine learning was used to construct diagnostic models to predict COVID-19. A pooled database was retrospectively generated from 4437 participant data that were collected between January 2017 and October 2020 at 12 German centers that belong to the radiological cooperative network of the COVID-19 (RACOON) consortium. A total of 692 (15.6 %) participants were COVID-19 positive according to the reference of the reverse transcription-polymerase chain reaction test. The diagnostic models included chest CT features (model R), clinical examination and laboratory test features (model CL), or all three feature categories (model RCL). Performance outcomes included accuracy, sensitivity, specificity, negative and positive predictive value, and area under the receiver operating curve (AUC). RESULTS: Performance of predictive models improved significantly by adding chest CT features to clinical evaluation and laboratory test features. Without (model CL) and with inclusion of chest CT (model RCL), sensitivity was 0.82 and 0.89 (p < 0.0001), specificity was 0.84 and 0.89 (p < 0.0001), negative predictive value was 0.96 and 0.97 (p < 0.0001), AUC was 0.92 and 0.95 (p < 0.0001), and proportion of false negative classifications was 2.6 % and 1.7 % (p < 0.0001), respectively. CONCLUSIONS: Addition of chest CT features to machine learning-based predictive models improves the effectiveness in ruling out COVID-19 before inpatient admission to regular wards.

Exercise Training for Patients With Peripheral Arterial Occlusive Disease.

BACKGROUND: One-third of all persons with peripheral arterial occlusive disease (PAOD) suffer from intermittent claudication. Exercise training under appropriate supervision is recommended in the pertinent guidelines, but physicians order it too rarely, and so-called vascular exercise groups are not available everywhere. This situation needs improvement in view of the impor - tance of walking ability and cardiorespiratory fitness for patients' quality of life and long-term disease outcome. METHODS: We review the scientific evidence on exercise training and on ways to lower barriers to the ordering of exercise training and to patient participation, on the basis of pertinent articles retrieved by a search of PubMed and in specialized sports science journals. RESULTS: 10 meta-analyses, 12 randomized controlled trials (RCTs), and 7 cohort studies were considered for this review. Largescale cohort studies have shown that exercise is associated with a lower risk of death (relative risk 0.65-0.78 after 12 months of exercise training, compared to an inactive lifestyle). Exercise training also improves the maximal walking distance by a mean of 136 m (training at home) or 180-310 m (supervised training). An additional improvement by a mean of 282 m can be expected from a combination of exercise training and endovascular revascularization. Further behavior-modifying interventions, such as goal-setting, planning, and feedback, increase both the maximum walking distance and the weekly duration of exercise. CONCLUSION: Exercise improves walking ability and lowers mortality. To attract patients with intermittent claudication to exercise training, a broad assortment of analog, digital and telemetric tools and a dense network of vascular exercise groups should be made available, along with regular contact between physicians and patients.

Sirolimus-Coated Balloon Angioplasty of Infra-popliteal Lesions for the Treatment of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized Controlled LIMES Study.

PURPOSE: Evidence on efficacy and long-term safety of paclitaxel-coated devices is still conflicting. Therefore, this study aims to assess whether sirolimus-coated balloon angioplasty is safe and effective for the treatment of infra-popliteal occlusions in patients with chronic limb-threatening ischemia (CLTI). STUDY DESIGN: The randomized controlled, single-blinded, multicentre, investigator-initiated study aims to enrol 230 participants with CLTI and infra-popliteal occlusions at up to 25 centres. Patients will be randomized in a 1:1 ratio to either sirolimus-coated balloon angioplasty or to plain old balloon angioplasty (POBA). Bailout stenting in case of flow-limiting dissection or ≥ 50% residual diameter stenosis is permitted. OUTCOME MEASURES: Primary outcome is the Kaplan-Meier estimate of primary patency at 6 months, defined as the absence of target lesion occlusion with restoration of in-line flow to the ankle. Key secondary outcome is non-inferiority in the proportionate occurrence of major adverse limb events and perioperative all-cause death at 30 days. Overall, participants will be followed for 36 months to assess further secondary efficacy and safety outcomes. ASSUMED GAIN OF KNOWLEDGE: If sirolimus-coated balloon angioplasty turns out to be superior to uncoated-balloon angioplasty regarding patency of infra-popliteal lesions without safety signals, it could become a welcome treatment option for patients with CLTI. Trial Registration ClinicalTrial.gov Identifier: NCT04772300, German Clinical Trials Register: DRKS00024629. Level of Evidence Level 2a, randomized controlled trial.

iRECIST-based versus non-standardized free text reporting of CT scans for monitoring metastatic renal cell carcinoma: a retrospective comparison.

PURPOSE: Therapy decision for patients with metastatic renal cell carcinoma (mRCC) is highly dependent on disease monitoring based on radiological reports. The purpose of the study was to compare non-standardized, common practice free text reporting (FTR) on disease response with reporting based on response evaluation criteria in solid tumors modified for immune-based therapeutics (iRECIST). METHODS: Fifty patients with advanced mRCC were included in the retrospective, single-center study. CT scans had been evaluated and FTR prepared in accordance with center's routine practice. For study purposes, reports were re-evaluated using a dedicated computer program that applied iRECIST. Patients were followed up over a period of 22.8 ± 7.9 months in intervals of 2.7 ± 1.8 months. Weighted kappa statistics was run to assess strength of agreement. Logistic regression was used to identify predictors for different rating. RESULTS: Agreement between FTR and iRECIST-based reporting was moderate (kappa 0.38 [95% CI 0.2-0.6] to 0.70 [95% CI 0.5-0.9]). Tumor response or progression according to FTR were not confirmed with iRECIST in 19 (38%) or 11 (22%) patients, respectively, in at least one follow-up examination. With FTR, new lesions were frequently not recognized if they were already identified in the recent prior follow-up examination (odds ratio for too favorable rating of disease response compared to iRECIST: 5.4 [95% CI 2.9-10.1]. CONCLUSIONS: Moderate agreement between disease response according to FTR or iRECIST in patients with mRCC suggests the need of standardized quantitative radiological assessment in daily clinical practice.

Integration of ultrasonography training into undergraduate medical education: catch up with professional needs.

OBJECTIVE: Ultrasonography (US) has become the first-line imaging modality even for physicians who are not imaging specialists. The progress has not yet been sufficiently considered in medical education. The aim was to develop a curriculum that integrates US as a compulsory part into medical education directly from the start, to build up professional competencies toward residency. METHODS: Development was based on Kern's six-step approach to identify problems, specify needs, define goals, outline strategies, and propose methods. RESULTS: The proposed curriculum follows a spiral course within which students should pass through four levels of training with increasing complexity. Students will be asked to independently prepare for courses by using learning videos. On the first training level, US should be closely linked to anatomy and physiology courses. Competency-centered courses should be held in small groups. On the second level, in the third year of education, students will apply point-of-care ultrasonography concerning multiple medical disciplines. On the third level, they will select a compulsory course in a specialty of their choice, held at five consecutive dates. From then on, US will be conducted in patients. Finally, during the final year, students are expected to use US under pro-active supervision with a large degree of independence and confidence. Throughout the curriculum, the discipline of radiology combines vertically with foundational sciences and horizontally with other medical specialties. CONCLUSION: The conceptual proposal for a longitudinal US curriculum presented here has been developed by radiologists to equip students with competencies needed for contemporary patient care.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

PURPOSE: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). MATERIALS AND METHODS: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. RESULTS: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). CONCLUSIONS: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).